Oxycodone Depot Teva B.V. 5 mg

Prolonged-release oxycodone hydrochloride tablets for severe pain — 12-hour depot opioid analgesic

Prescription Only Controlled Substance ATC: N02AA05 Opioid Analgesic
Active Ingredient
Oxycodone hydrochloride
Formulation
Prolonged-release (depot) tablet
Strength
5 mg
Marketing Authorization Holder
Teva B.V. (Netherlands)
Dosing Interval
Every 12 hours
Drug Class
Natural opium alkaloid opioid analgesic
Medically reviewed by iMedic Medical Team
Evidence Level 1A

Oxycodone Depot Teva B.V. 5 mg is a generic prolonged-release (depot) oxycodone tablet manufactured under the marketing authorization of Teva B.V., the Dutch subsidiary of the international generics company Teva Pharmaceuticals. Each tablet contains 5 mg of oxycodone hydrochloride released gradually over approximately 12 hours, providing continuous analgesia for severe pain that can only be adequately managed with opioid analgesics. The product is therapeutically equivalent to the originator brand (OxyContin) and is used where steady, around-the-clock pain relief is required under specialist supervision.

Quick Facts

Active Ingredient
Oxycodone HCl
Drug Class
Opioid Analgesic
ATC Code
N02AA05
Typical Use
Severe Pain
Formulation
Depot Tablet 5 mg
Prescription Status
Rx Only

Key Takeaways

  • Oxycodone Depot Teva B.V. 5 mg is a 12-hour prolonged-release opioid tablet for severe pain not adequately relieved by non-opioid analgesics.
  • Tablets must be swallowed whole — crushing, splitting, or chewing them releases a 12-hour dose immediately and can cause fatal overdose.
  • The 5 mg strength is typically used as an opioid-naive starting dose or for gentle upward titration in elderly, frail, or renally impaired patients.
  • Life-threatening respiratory depression can occur when oxycodone is combined with benzodiazepines, gabapentinoids, alcohol, or other CNS depressants.
  • Continuous opioid therapy causes physical dependence; always taper under medical supervision rather than stopping abruptly to avoid withdrawal.

What Is Oxycodone Depot Teva B.V. and What Is It Used For?

Quick Answer: Oxycodone Depot Teva B.V. is a generic prolonged-release oral tablet containing 5 mg of oxycodone hydrochloride. It is indicated for the treatment of severe pain in adults and adolescents aged 12 years and older that can be adequately managed only with opioid analgesics. The depot formulation provides steady pain control for approximately 12 hours, allowing convenient twice-daily dosing.

Oxycodone Depot Teva B.V. belongs to the pharmacological class of natural opium alkaloid opioid analgesics (Anatomical Therapeutic Chemical code N02AA05). The active substance, oxycodone hydrochloride, is a semi-synthetic opioid derived from thebaine. It acts as a full agonist at mu-opioid receptors, with additional affinity for kappa- and delta-opioid receptors in the central nervous system. By activating these receptors in the brain and spinal cord, oxycodone inhibits ascending pain pathways, modulates the emotional response to pain, and produces a generalised depression of central nervous system activity. The result is effective relief of severe pain that does not respond to paracetamol, non-steroidal anti-inflammatory drugs (NSAIDs), or weaker opioids.

The depot (also called prolonged-release, modified-release, or extended-release) formulation is a defining feature of this product. Each 5 mg tablet uses a pharmaceutical matrix system that releases oxycodone in a controlled, biphasic manner: an early rapid-release phase produces onset of analgesia within about one hour, and a sustained second phase maintains therapeutic plasma concentrations for approximately 12 hours. This release profile avoids the peaks and troughs seen with immediate-release oxycodone and is particularly well suited to around-the-clock pain that persists day and night, such as advanced cancer pain or post-surgical pain requiring longer therapy. Immediate-release oxycodone or another short-acting opioid is added separately if breakthrough pain occurs between scheduled doses.

The principal clinical indications for Oxycodone Depot Teva B.V. are severe chronic cancer-related pain, severe post-operative pain when other analgesics are insufficient or a prolonged course is anticipated, and selected severe chronic non-cancer pain conditions where non-opioid and weaker opioid therapies have been tried and found inadequate. International pain guidelines — including those of the World Health Organization and the European Association for Palliative Care — emphasise that strong opioids such as oxycodone should be used as part of a structured, multimodal pain management strategy, with clearly defined goals, time-limited trials, and regular reassessment of benefit and harm. Oxycodone is not a first-line therapy for chronic non-cancer pain.

Oxycodone Depot Teva B.V. is marketed in Europe by Teva B.V., the Dutch affiliate of the international generics manufacturer Teva Pharmaceutical Industries. It is a therapeutic equivalent to the originator product (sold internationally as OxyContin) and to other national generic oxycodone depot tablets such as Oxycodone Depot Orion, OxyContin, and Targiniq. Because oxycodone is classified as a controlled substance in most countries — a Schedule II drug in the United States, a Schedule 2 Controlled Drug in the United Kingdom, and a narcotic drug across the European Union — prescriptions are subject to strict regulatory requirements regarding prescription forms, maximum dispensing quantities, and record-keeping.

The 5 mg strength specifically is designed to support safe initiation of opioid therapy in patients who have not previously taken strong opioids (opioid-naive patients) and to allow fine adjustment of the dose in elderly, frail, or otherwise vulnerable individuals. In clinical practice, 5 mg every 12 hours is the lowest commonly prescribed depot dose; higher strengths (10 mg, 15 mg, 20 mg, 40 mg, 80 mg) are used to titrate the dose upward once tolerance and analgesic needs have been established. The 5 mg tablet is also frequently used for opioid rotation — switching from another opioid to oxycodone — where careful dose conversion and downward adjustment is needed to avoid overdose.

What Should You Know Before Taking Oxycodone Depot Teva B.V.?

Quick Answer: Before starting Oxycodone Depot Teva B.V., your doctor must review your full medical history. The medicine is contraindicated in severe respiratory depression, severe chronic obstructive pulmonary disease, paralytic ileus, acute abdomen, and known hypersensitivity to oxycodone. Numerous conditions require extra caution, and patients should disclose all current medications, alcohol use, and any personal or family history of substance use disorders.

Oxycodone Depot Teva B.V. is a powerful medication with a narrow safety margin in the wrong clinical setting. Before starting treatment, the prescriber will carry out a structured assessment that typically includes a pain assessment, medical and psychiatric history, current and recent medications, alcohol and recreational drug use, kidney and liver function, respiratory status, and (where appropriate) a screening tool for opioid-related risk. This assessment is repeated at regular intervals during therapy. The goal is to establish clear, time-limited treatment goals, use the lowest effective dose, and plan a safe exit strategy from the outset.

Contraindications

Oxycodone Depot Teva B.V. must not be used in any of the following situations:

  • Known hypersensitivity to oxycodone hydrochloride, morphine or related opioids, or to any of the excipients listed in the product information.
  • Severe respiratory depression with hypoxia (low blood oxygen) and/or hypercapnia (elevated carbon dioxide).
  • Severe chronic obstructive pulmonary disease (COPD) with significant airway narrowing, particularly in unmonitored settings.
  • Cor pulmonale (right-sided heart failure secondary to chronic lung disease).
  • Severe bronchial asthma in unmonitored settings or in the absence of resuscitation equipment.
  • Paralytic ileus (where the intestines stop contracting).
  • Acute abdomen or delayed gastric emptying.
  • Moderate to severe hepatic impairment may constitute a contraindication depending on national labelling; in all cases, use is at the discretion of the prescriber.

Warnings and Precautions

Extra caution — and often dose reduction, additional monitoring, or alternative therapy — is required in the presence of any of the following:

  • Older age (typically 65 years and above), frailty, or debilitation, as these increase sensitivity to opioid-induced respiratory and CNS depression.
  • Reduced lung function, including mild to moderate COPD, pulmonary fibrosis, or any condition producing reduced respiratory reserve.
  • Sleep apnoea (obstructive or central) or any sleep-disordered breathing, as opioids can worsen apnoeic episodes.
  • Reduced liver or kidney function, which alter the metabolism and excretion of oxycodone.
  • Endocrine disorders, including hypothyroidism, adrenal insufficiency (e.g., Addison’s disease), and diabetes.
  • A personal or family history of alcohol or drug misuse, or of mental illness (including depression, anxiety, bipolar disorder, and psychosis).
  • Prostatic hypertrophy (enlarged prostate) or other causes of urinary retention.
  • Pancreatitis, gallbladder disease, or biliary tract disease.
  • Inflammatory bowel disease, chronic constipation, or any obstructive gastrointestinal condition.
  • Raised intracranial pressure, head injury, or reduced level of consciousness.
  • Epilepsy or a history of seizures.
  • Low blood pressure, hypovolaemia, or haemodynamic instability.
  • Recent abdominal or intestinal surgery.
  • Concurrent use of monoamine oxidase (MAO) inhibitors or their use within the previous 14 days.
Respiratory Depression

The most serious adverse reaction of opioid therapy is respiratory depression — abnormally slow, shallow, or irregular breathing. Risk is highest at the start of treatment, after dose increases, in elderly or debilitated patients, and in patients with pre-existing lung disease. Oxycodone can also cause and unmask sleep-related breathing disorders, including central sleep apnoea and sleep-related hypoxaemia. Signs to report urgently include pauses in breathing during sleep, waking from sleep feeling short of breath, excessive daytime drowsiness, slurred speech, or difficulty being roused. Caregivers should be educated to recognise these signs.

Sleep-Disordered Breathing

Opioids, including oxycodone, may cause sleep-related breathing disorders such as central sleep apnoea (CSA) and sleep-related hypoxaemia. The risk is dose-dependent and is increased by concomitant CNS depressants. Consider dose reduction or switching therapy if CSA is suspected or diagnosed during treatment.

Pregnancy, Breastfeeding, and Fertility

Tell your doctor if you are pregnant, think you may be pregnant, are planning pregnancy, or are breastfeeding. The decision to use Oxycodone Depot Teva B.V. during pregnancy or lactation must be made by a specialist after careful consideration of the balance of benefits and harms for you and your baby.

Pregnancy. Use of oxycodone during pregnancy should be avoided whenever possible. Clinical data in pregnant women are limited, and animal studies have shown reproductive toxicity at high doses. Oxycodone crosses the placenta into the fetal circulation. Prolonged use during pregnancy can cause neonatal opioid withdrawal syndrome (NOWS) in the newborn, which may present with irritability, high-pitched crying, tremors, poor feeding, vomiting, diarrhoea, increased tone, sneezing, yawning, and failure to gain weight; NOWS can be life-threatening if not recognised and treated. Use during the final 3–4 weeks of pregnancy or during labour carries an additional risk of respiratory depression in the newborn. If treatment is clinically necessary, the lowest effective dose for the shortest duration is recommended, and the neonate should be monitored for withdrawal and respiratory symptoms for at least several days after birth.

Breastfeeding. Oxycodone Depot Teva B.V. should not be used during breastfeeding. Oxycodone is excreted into breast milk with a milk-to-plasma ratio of approximately 3:1, and there are reports of respiratory depression and sedation in breastfed infants, particularly when the mother is an ultra-rapid CYP2D6 metaboliser. If oxycodone treatment is unavoidable, breastfeeding should be discontinued for the duration of therapy.

Fertility. Long-term opioid use can suppress the hypothalamic-pituitary-gonadal axis, reducing the production of sex hormones, and may therefore reduce fertility in both men and women. These effects are usually reversible on discontinuation.

Driving and Operating Machinery

Oxycodone Depot Teva B.V. can impair the mental and physical abilities needed to drive a motor vehicle or operate machinery. Impairment is most pronounced at the start of treatment, after each dose increase, and when the medication is combined with alcohol or other CNS depressants. Patients should not drive or operate machinery while these conditions apply. In patients on stable, long-term opioid therapy, driving may be acceptable provided there is no clinical evidence of impairment; the prescriber will make this assessment on an individual basis. Many countries have specific legal thresholds for opioid-related driving offences.

Children

The safety and efficacy of oxycodone prolonged-release tablets have not been adequately established in children under 12 years of age, and use in this age group is not recommended. Use in adolescents (12 years and above) should follow specialist paediatric pain guidance and start at low, individualised doses with close monitoring.

Alcohol

Alcohol should be avoided during treatment with Oxycodone Depot Teva B.V. Alcohol and oxycodone each suppress the central nervous system and respiratory drive; the combination is additive and potentially synergistic, increasing the risk of profound sedation, respiratory depression, loss of consciousness, and death. Alcohol can also accelerate the release of oxycodone from prolonged-release matrices (“dose dumping”), raising plasma concentrations beyond the intended therapeutic range.

Excipient Warnings

Oxycodone Depot Teva B.V. 5 mg tablets may contain lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption should not take this medicine. The tablets contain less than 1 mmol (23 mg) of sodium per tablet and are essentially “sodium-free”.

How Does Oxycodone Depot Teva B.V. Interact with Other Drugs?

Quick Answer: Oxycodone interacts with many medications. The most dangerous interactions are with benzodiazepines, gabapentinoids, alcohol, and other CNS depressants, which can cause fatal respiratory depression. MAO inhibitors, CYP3A4 inhibitors and inducers, CYP2D6 inhibitors, and serotonergic drugs also have significant interactions. Always tell the prescriber about every medicine you take, including prescription drugs, over-the-counter medicines, herbal remedies, and recreational substances.

Oxycodone is metabolised in the liver primarily by the cytochrome P450 enzymes CYP3A4 (producing inactive noroxycodone) and CYP2D6 (producing the active metabolite oxymorphone, and via further steps, noroxymorphone). Drugs that inhibit or induce these enzymes can substantially alter plasma levels of oxycodone and its metabolites, changing both analgesic efficacy and the risk of toxicity. In parallel, combining oxycodone with any drug that depresses the central nervous system or respiration produces additive — and in some cases synergistic — effects on breathing, consciousness, and blood pressure.

Major Interactions

Major Drug Interactions with Oxycodone Depot Teva B.V.
Drug / Drug Class Effect Clinical Significance
Benzodiazepines (diazepam, lorazepam, alprazolam, clonazepam) Additive CNS and respiratory depression Potentially fatal. Avoid if possible; if unavoidable, use minimal doses and duration of both agents with close monitoring.
Gabapentinoids (gabapentin, pregabalin) Increased CNS depression and respiratory depression Use lowest effective doses; monitor for excessive sedation. Risk is highest in opioid-naive and elderly patients.
MAO inhibitors (tranylcypromine, phenelzine, moclobemide, linezolid, methylene blue) CNS excitation or depression; hypertensive or hypotensive crisis; serotonin syndrome Contraindicated during and within 14 days of MAO inhibitor therapy.
Alcohol Enhanced CNS depression; accelerated oxycodone release from the prolonged-release matrix (“dose dumping”) Strictly avoid. Combination can be rapidly fatal.
CYP3A4 inhibitors (ketoconazole, itraconazole, voriconazole, clarithromycin, erythromycin, ritonavir, indinavir, nelfinavir, cobicistat, grapefruit juice) Increased oxycodone plasma concentrations (typically 1.5–3×) Greater and prolonged opioid effects, including respiratory depression. Dose reduction and enhanced monitoring required.
CYP3A4 inducers (rifampicin, rifabutin, carbamazepine, phenytoin, phenobarbital, efavirenz, nevirapine, St John’s Wort) Decreased oxycodone plasma concentrations Reduced analgesic efficacy; pain may break through. Dose increase or alternative analgesic may be needed.
CYP2D6 inhibitors (paroxetine, fluoxetine, bupropion, terbinafine, quinidine) Decreased formation of oxymorphone; complex effect on analgesia Clinical significance usually modest but variable; monitor response.
Serotonergic drugs (SSRIs, SNRIs, tricyclic antidepressants, triptans, tramadol, tapentadol, linezolid, methylene blue) Risk of serotonin syndrome Watch for agitation, fever, tremor, clonus, hyperreflexia, diarrhoea, mental status changes. Stop oxycodone and/or serotonergic drug if syndrome develops.
Other opioid analgesics (morphine, fentanyl, buprenorphine, tramadol) Additive CNS and respiratory depression; mixed agonist-antagonists may reduce analgesia or precipitate withdrawal Avoid unintentional co-prescription. Planned opioid rotation needs careful dose conversion and monitoring.

Other Notable Interactions

Other Notable Drug Interactions
Drug / Drug Class Effect Recommendation
Centrally acting muscle relaxants (baclofen, tizanidine, carisoprodol) Enhanced sedation and respiratory depression Monitor closely; reduce doses where possible.
Sedating antihistamines (diphenhydramine, promethazine, hydroxyzine) Increased drowsiness and CNS depression Prefer non-sedating alternatives when possible.
Antipsychotics and neuroleptics Enhanced sedation, orthostatic hypotension, QT prolongation Monitor blood pressure, ECG in at-risk patients.
Diuretics, antihypertensives, vasodilators Enhanced hypotensive effect Monitor blood pressure, especially after dose changes.
Anticholinergic drugs Additive anticholinergic adverse effects (constipation, urinary retention, confusion) Review medication list; minimise anticholinergic burden.
Cimetidine May inhibit oxycodone metabolism Monitor for increased opioid effects.
Coumarin anticoagulants (warfarin, phenprocoumon) Reports of changed INR in both directions Monitor INR closely when starting, changing, or stopping oxycodone.
Grapefruit and grapefruit juice CYP3A4 inhibition, increased oxycodone exposure Avoid during treatment.

What Is the Correct Dosage of Oxycodone Depot Teva B.V.?

Quick Answer: Dosing is strictly individualised. For opioid-naive adults, a typical starting dose is 5 mg every 12 hours — one Oxycodone Depot Teva B.V. 5 mg tablet in the morning and another 12 hours later. The dose is titrated upward in steps of 25–50% according to pain response and tolerability. Tablets must always be swallowed whole with water. The 5 mg strength is also used for slow titration and opioid rotation in elderly, frail, or renally impaired patients.

Oxycodone Depot Teva B.V. must be used exactly as the prescriber directs. Before treatment starts — and at every subsequent review — the clinician will discuss the treatment goal, the expected duration of therapy, indicators that the medicine is working, warning signs that should prompt urgent contact, and a clear exit strategy (tapering plan) once the pain improves. The correct dose depends on the severity of the pain, any prior opioid exposure, body weight, age, comorbidities, and kidney and liver function.

Adults and Adolescents (12 Years and Older)

Prolonged-Release (Depot) Tablets — Oral

  • Opioid-naive adults: Start with 10 mg every 12 hours for most adults, or 5 mg every 12 hours for elderly, frail, or low-body-weight patients and for gentle titration (one 5 mg tablet of Oxycodone Depot Teva B.V. at 12-hour intervals).
  • Titration: Increase by about 25–50% per step, typically every 1–2 days, until adequate pain control is achieved without unacceptable adverse effects.
  • Switching from other opioids: Use an equianalgesic conversion ratio (for oral morphine to oral oxycodone, approximately 2:1), then reduce the calculated dose by 25–50% at initiation to allow for incomplete cross-tolerance and individual variability.
  • Non-cancer severe pain: A daily dose of 20–40 mg is usually sufficient; higher doses should be reserved for patients with a documented need and regular review.
  • Cancer pain: Daily doses of 80–120 mg are often needed; some patients require 200–400 mg or more under specialist supervision.
  • Breakthrough pain: A separate immediate-release oxycodone preparation is usually prescribed for breakthrough episodes, at a dose of approximately one-sixth of the total 24-hour depot dose.
Oxycodone Depot Teva B.V. — Dosage Guidelines by Patient Group
Patient Group Starting Dose Typical Range Notes
Opioid-naive adults (robust) 10 mg every 12 hours 10–40 mg/day Titrate by 25–50% steps; reassess pain and function at each step.
Opioid-naive adults (cautious start) 5 mg every 12 hours 10–30 mg/day Preferred when nausea or drowsiness is a concern, or in patients new to any strong analgesic.
Elderly (≥65 years) or frail 5 mg every 12 hours Individualised, usually ≤40 mg/day Increased sensitivity; slower titration and closer monitoring for sedation and falls.
Renal impairment (eGFR <60 mL/min) Reduce starting dose by 30–50% Individualised Accumulation of metabolites possible; monitor closely for toxicity.
Mild hepatic impairment Reduce starting dose by 30–50% Individualised Reduced clearance; avoid in moderate-to-severe impairment where possible.
Opioid-tolerant adults (cancer pain) Based on prior opioid dose (rotation) 80–400 mg/day Equianalgesic conversion minus 25–50%; specialist supervision.
Adolescents (12–17 years) 5–10 mg every 12 hours Individualised Paediatric pain specialist involvement preferred; careful monitoring required.
Children <12 years Not recommended N/A Safety and efficacy not established in this age group.

How to Take Oxycodone Depot Teva B.V. Tablets

Take one tablet with about half a glass of water at two fixed times each day, 12 hours apart (for example, at 08:00 in the morning and 20:00 in the evening). The tablets can be taken with or without food, but should be taken at roughly the same time in relation to meals each day. If nausea is troublesome, taking the tablet with a light snack may help.

Duration of Therapy

Opioids should be prescribed for the shortest duration that meets the treatment goal. For acute pain (e.g., post-surgical pain), a short, time-limited course is appropriate, with daily reassessment and step-down to non-opioid analgesics as pain improves. For chronic cancer pain, long-term use is justified and the focus shifts to quality-of-life outcomes. For chronic non-cancer pain, recurrent review is essential, and a trial of 4–12 weeks should lead to either clear, documented benefit (reduced pain and improved function) or planned discontinuation.

Missed Dose

If you miss a dose, take it as soon as you remember — provided the next scheduled dose is at least 8 hours away. If less than 8 hours remain until the next dose, skip the missed dose and continue with your regular schedule. Never take two doses close together or double up to “catch up”: this increases the risk of overdose and life-threatening respiratory depression. If you frequently forget doses, tell your doctor or pharmacist, who can help you find a dosing reminder strategy.

Overdose

If you or someone else may have taken too much Oxycodone Depot Teva B.V., seek emergency medical help immediately. Opioid overdose is a medical emergency and is the leading cause of drug-related death in many countries.

Typical signs of oxycodone overdose include:

  • Constricted, pinpoint pupils (miosis)
  • Very slow, shallow, irregular, or absent breathing (respiratory depression)
  • Extreme drowsiness, stupor, or coma
  • Loose, floppy muscles (skeletal muscle flaccidity)
  • Cold, clammy, pale skin; blue or grey lips or fingertips (cyanosis)
  • Low blood pressure (hypotension) and slow heart rate (bradycardia)
  • Pulmonary oedema (fluid in the lungs)
  • In severe cases, circulatory collapse, cardiac arrest, and death

Treatment consists of immediate call for emergency services; maintenance of a patent airway and assisted ventilation; and administration of the opioid antagonist naloxone by qualified responders (nasal spray or injection). Because the duration of action of naloxone is shorter than that of prolonged-release oxycodone, repeated doses or a naloxone infusion are often required, and all patients who have received naloxone should be observed in a monitored setting for at least several hours. Take-home naloxone kits are increasingly available for people prescribed strong opioids and their households; ask your pharmacist or prescriber whether a kit is available where you live.

What Are the Side Effects of Oxycodone Depot Teva B.V.?

Quick Answer: The most common side effects of Oxycodone Depot Teva B.V. are constipation, nausea, vomiting, drowsiness, dizziness, headache, and itching. The most serious adverse effect is respiratory depression, which can be fatal. Stop taking the medicine and seek emergency help if you experience very slow or shallow breathing, a severe allergic reaction, chest pain, or loss of consciousness.

Like all medications, Oxycodone Depot Teva B.V. can cause side effects, although not everyone will experience them. Many of the common adverse effects are predictable consequences of opioid pharmacology and can be anticipated, prevented, or treated. The list below groups adverse reactions by reported frequency based on clinical trial and post-marketing data for oxycodone prolonged-release tablets. Frequencies are defined using the Council for International Organizations of Medical Sciences (CIOMS) categories used in European product information.

Very Common

Affects more than 1 in 10 people

  • Drowsiness or sedation (most pronounced at start of therapy and after dose increases; usually improves within days)
  • Dizziness
  • Headache
  • Constipation (persistent; rarely resolves on its own and usually needs a laxative regimen)
  • Nausea
  • Vomiting
  • Itching (pruritus)

Common

Affects up to 1 in 10 people

  • Reduced appetite (anorexia)
  • Anxiety, confusion, depression, nervousness, insomnia, abnormal dreams
  • Tremor, lethargy, somnolence
  • Shortness of breath (dyspnoea), bronchospasm, reduced cough reflex
  • Abdominal pain, diarrhoea, dry mouth, indigestion (dyspepsia)
  • Skin rash, excessive sweating (hyperhidrosis)
  • Increased urinary frequency
  • Asthenia (weakness) and fatigue
  • Accidental falls, particularly in elderly patients

Uncommon

Affects up to 1 in 100 people

  • Hypersensitivity reactions, including rash and urticaria
  • Syndrome of inappropriate antidiuretic hormone secretion (SIADH) with hyponatraemia
  • Agitation, mood swings, euphoria, hallucinations, disorientation
  • Reduced sex drive, erectile dysfunction; drug dependence and tolerance
  • Seizures (especially in patients with epilepsy), muscle rigidity, involuntary movements (myoclonus)
  • Hypoesthesia (reduced sensation), speech disorder, syncope, paraesthesia
  • Memory impairment, migraine, dysgeusia (altered taste)
  • Visual disturbances, dry eyes, changed lacrimation
  • Tachycardia, palpitations, peripheral oedema
  • Vasodilation and flushing
  • Voice changes, cough, pharyngitis, rhinitis
  • Mouth ulcers, gingivitis, dysphagia, flatulence, eructation, ileus
  • Elevated liver enzymes
  • Dry skin
  • Urinary retention, renal colic
  • Chills, pain (including chest pain), malaise, thirst
  • Physical dependence with withdrawal symptoms on discontinuation

Rare and Very Rare

Affects up to 1 in 1,000 people (or fewer)

  • Herpes simplex reactivation
  • Lymphadenopathy
  • Increased appetite and weight changes
  • Orthostatic hypotension
  • Melaena (black, tarry stools), tooth discoloration, gum bleeding
  • Urticaria, photosensitivity
  • Haematuria (blood in the urine)
  • Exfoliative dermatitis (peeling skin rash)
  • Aggression
  • Opioid-induced hyperalgesia (paradoxical increase in pain sensitivity that does not improve with dose escalation)
  • Dental caries
  • Sphincter of Oddi dysfunction (severe upper abdominal pain)
  • Amenorrhoea, reduced libido, erectile dysfunction from hypogonadism
  • Anaphylactic and anaphylactoid reactions
  • Biliary colic

Endocrine and Hormonal Effects

Prolonged opioid therapy, particularly at moderate or high doses, can suppress the hypothalamic-pituitary-adrenal and -gonadal axes. Patients may develop reduced cortisol (opioid-induced adrenal insufficiency) and reduced sex hormones, with symptoms such as fatigue, loss of libido, erectile dysfunction, menstrual irregularities, infertility, and loss of bone density. If any of these occur, inform your doctor; endocrine testing and specialist input may be indicated.

Opioid-Induced Bowel Dysfunction

Constipation occurs in the majority of patients taking strong opioids and rarely resolves spontaneously with continued use. Preventive measures should be started from the first day of oxycodone therapy: adequate fluid intake, fibre where tolerated, physical activity where possible, and a regular stimulant laxative (e.g., senna) with or without an osmotic laxative (e.g., macrogol). For severe refractory cases, peripherally acting mu-opioid receptor antagonists (PAMORAs) such as naloxegol, methylnaltrexone, or naldemedine may be considered.

Managing Common Side Effects

Nausea and vomiting usually improve within a few days and may be treated with antiemetics (e.g., metoclopramide, ondansetron, or haloperidol) in the early phase. Drowsiness often settles within the first week and after each dose adjustment. Itching may respond to non-sedating antihistamines or, if persistent, may prompt an opioid switch. Dry mouth can be managed with sugar-free sweets or saliva substitutes; good dental hygiene and routine dental review are advisable during long-term therapy.

Reporting Suspected Side Effects

If you experience any adverse effects, talk to your doctor, pharmacist, or nurse. Reporting side effects helps to provide more information on the safety of this medicine. In most countries, patients and healthcare professionals can also report adverse reactions directly to national pharmacovigilance systems — such as the MHRA Yellow Card Scheme in the United Kingdom, the FDA MedWatch programme in the United States, or the European Medicines Agency’s EudraVigilance system in the European Union.

What Happens When You Stop Taking Oxycodone Depot Teva B.V.?

Quick Answer: Do not stop Oxycodone Depot Teva B.V. abruptly. When taken regularly for more than a few days, the body develops physical dependence on oxycodone, and sudden discontinuation can cause uncomfortable and sometimes severe withdrawal symptoms. Your doctor will design an individualised tapering (dose reduction) schedule, typically reducing the dose by 10–25% every few days to weeks depending on duration of use and individual response.

Physical dependence on opioids is a normal, expected physiological adaptation to sustained receptor stimulation, and is distinct from addiction (opioid use disorder). Dependence develops within days to weeks of regular use and means that suddenly stopping the medicine — or rapidly reducing the dose, or giving an opioid antagonist such as naloxone — triggers a recognisable withdrawal syndrome. Most people on long-term opioid therapy have some degree of physical dependence, even when they are using the medicine exactly as prescribed.

Typical signs and symptoms of oxycodone withdrawal include:

  • Frequent yawning, tearing (lacrimation), and runny nose (rhinorrhoea)
  • Dilated pupils (mydriasis)
  • Sweating, goosebumps (piloerection), and hot-and-cold flushes
  • Tremor and restlessness
  • Anxiety, agitation, irritability, and dysphoria
  • Insomnia and vivid dreams
  • Muscle aches, joint pain, and abdominal cramps
  • Nausea, vomiting, and diarrhoea
  • Raised heart rate and blood pressure
  • Craving for the medication

When treatment is no longer needed — because the underlying pain has resolved, treatment is no longer effective, or adverse effects outweigh benefits — the daily dose is reduced gradually. A common approach is to reduce by approximately 10% of the current dose every 1–2 weeks for long-term users, with slower steps once low doses are reached. For shorter courses, faster tapers are appropriate. The exact schedule depends on your total daily dose, the duration of therapy, your individual response, and any coexisting conditions such as mental illness or substance use disorder.

It is extremely important not to self-adjust or stop Oxycodone Depot Teva B.V. on your own, and not to share your tablets with anyone else. If withdrawal symptoms become difficult to manage during a taper, tell your doctor; the taper can be slowed or paused, and symptomatic treatments (for example, loperamide for diarrhoea, an alpha-2 agonist such as clonidine for autonomic symptoms, or short-term anti-emetics) can be added. For patients who find tapering very difficult despite support, specialist opioid dependence services can offer additional options, including transition to buprenorphine or methadone.

How Should You Store Oxycodone Depot Teva B.V.?

Quick Answer: Store Oxycodone Depot Teva B.V. in a locked cabinet or other secure location, out of sight and reach of children, pets, and other household members. Keep at room temperature, below 25 °C, in the original blister packaging to protect from moisture. Do not use beyond the expiry date. Never share the medicine. Return unused or expired tablets to a pharmacy or authorized take-back programme.

Oxycodone Depot Teva B.V. is a controlled substance and should be stored with the same care as other valuables. Accidental ingestion — especially by a child, pet, or person who has not been prescribed the medicine — can cause a fatal overdose. In many countries, inadvertent paediatric opioid poisoning is a leading cause of emergency department attendance after a household member has been prescribed opioid pain medication.

  • Temperature: Store below 25 °C. Do not refrigerate. Keep away from direct sunlight and sources of heat.
  • Packaging: Keep the tablets in the original blister pack until they are taken. The blister provides protection from moisture and light and displays the batch number and expiry date.
  • Security: Keep the medicine in a locked cabinet or lockable container, out of sight and reach of children and anyone for whom the medicine was not prescribed.
  • Expiry date: Do not use Oxycodone Depot Teva B.V. after the expiry date printed on the blister and carton (the date refers to the last day of the stated month).
  • Travel: Always travel with the medicine in its original labelled container. Many countries require a doctor’s letter or official document to carry controlled substances across international borders; check entry requirements before travelling.
  • Disposal: Do not dispose of oxycodone in household waste, in the sink, or in the toilet. Return unused, expired, or no-longer-needed tablets to a pharmacy or an authorised medicine take-back programme. Many countries operate dedicated opioid take-back schemes precisely because household disposal of controlled drugs contributes both to environmental contamination and to diversion for misuse.
Accidental Exposure Can Be Fatal

Accidental ingestion of even a single Oxycodone Depot Teva B.V. 5 mg tablet — a dose designed for 12 hours of controlled release — can cause a fatal overdose in a child, a pet, or an opioid-naive adult. If accidental exposure is suspected, call emergency services and the local poisons centre immediately. Where available, administer take-home naloxone while awaiting emergency responders. Do not wait for symptoms to develop before seeking help.

What Does Oxycodone Depot Teva B.V. Contain?

Quick Answer: Each Oxycodone Depot Teva B.V. 5 mg prolonged-release tablet contains 5 mg of oxycodone hydrochloride as the active substance. The inactive ingredients form the controlled-release matrix and film coating and typically include polymers, lactose, povidone, stearic acid, magnesium stearate, colloidal silica, and film-coating excipients such as polyvinyl alcohol, titanium dioxide, macrogol, talc, and colourants.

Active substance. Each tablet contains 5 mg of oxycodone hydrochloride, corresponding to 4.48 mg of oxycodone base. Oxycodone hydrochloride is a white, odourless crystalline powder that is freely soluble in water.

Inactive Ingredients (Excipients)

Tablet core. The prolonged-release matrix typically includes release-controlling polymers (for example, ammonio methacrylate copolymer and hypromellose or similar cellulose derivatives), lactose monohydrate, povidone, stearic acid, magnesium stearate, and colloidal anhydrous silica. The exact composition is specified in the current package leaflet supplied with the product.

Lactose Content

Oxycodone Depot Teva B.V. tablets typically contain lactose monohydrate. Patients who have been told by their doctor that they have an intolerance to some sugars (for example, galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption) should consult their doctor before taking this medicine.

Tablet coating. The film coat usually consists of polyvinyl alcohol or hypromellose, titanium dioxide (E171), macrogol (polyethylene glycol), talc, and colourants. In many oxycodone depot product lines, each strength is manufactured in a distinct colour to support safe dispensing and administration. For Oxycodone Depot Teva B.V. 5 mg tablets, refer to the current product packaging and leaflet for the exact tablet appearance and marking.

Marketing Authorization and Manufacture

The marketing authorization holder for Oxycodone Depot Teva B.V. is Teva B.V., the Dutch subsidiary of Teva Pharmaceutical Industries, one of the world’s largest generic medicines companies. Manufacturing is carried out at authorised sites within the European Economic Area and must comply with EU Good Manufacturing Practice (GMP). National medicines agencies (such as the Dutch CBG-MEB, the Swedish Läkemedelsverket, and counterparts in other countries) oversee the quality, safety, and continued post-marketing surveillance of each licensed strength.

Appearance and Pack Sizes

Oxycodone Depot Teva B.V. 5 mg tablets are supplied as round, film-coated prolonged-release tablets marked to identify the strength. Tablets are packaged in aluminium or polyvinyl chloride (PVC) blisters with typical pack sizes of 10, 20, 28, 30, 50, 56, 60, 98, or 100 tablets. Not all pack sizes may be marketed in every country.

Frequently Asked Questions About Oxycodone Depot Teva B.V.

Oxycodone Depot Teva B.V. 5 mg prolonged-release tablets are indicated for severe pain that can only be adequately managed with strong opioid analgesics. The matrix-based depot formulation releases oxycodone hydrochloride gradually over about 12 hours, providing continuous background analgesia for chronic cancer pain, severe post-operative pain requiring prolonged therapy, and certain chronic non-cancer pain conditions when non-opioid treatments have been insufficient. It is not a first-line treatment for chronic non-cancer pain and should always be combined with a broader pain-management plan.

“Depot” is the European term for a prolonged-release or extended-release formulation. Oxycodone Depot Teva B.V. uses a pharmaceutical matrix that releases oxycodone slowly over roughly 12 hours, creating a drug depot within the gastrointestinal tract. This sustained release avoids the peaks and troughs of immediate-release oxycodone, supports around-the-clock pain relief, and allows convenient twice-daily dosing. It is the same concept as the well-known originator product OxyContin.

Yes. Like all oxycodone products, Oxycodone Depot Teva B.V. carries a significant risk of addiction (opioid use disorder), physical dependence, and tolerance. Some degree of physical dependence is expected in almost everyone who takes strong opioids regularly for more than a few days; addiction is less common but clinically important. Risk factors include a personal or family history of substance use disorders, untreated mental health conditions, and longer duration or higher doses of opioid therapy. Treatment should use the lowest effective dose for the shortest clinically necessary duration, with regular review.

No. Oxycodone Depot Teva B.V. tablets must always be swallowed whole with water. Crushing, chewing, splitting, or dissolving a prolonged-release tablet destroys the matrix release mechanism and liberates the entire 12-hour dose of oxycodone at once. In opioid-naive people this can produce rapidly dangerous and potentially fatal respiratory depression. Injecting dissolved tablet material is also extremely dangerous and can cause tissue damage, pulmonary granulomas, infection, and death. If swallowing tablets is difficult, ask your doctor about alternative oxycodone formulations such as an oral solution.

No. Alcohol must be avoided during treatment. Both alcohol and oxycodone depress the central nervous system and the respiratory drive, and the combination is additive and potentially synergistic. This markedly increases the risk of severe respiratory depression, profound sedation, loss of consciousness, and death. Alcohol can also accelerate the release of oxycodone from the prolonged-release matrix, causing a sudden rise in plasma concentrations. The prohibition applies to beer, wine, spirits, and any alcohol-containing medicines.

If you miss a dose of Oxycodone Depot Teva B.V., take it as soon as you remember — provided the next scheduled dose is at least 8 hours away. If less than 8 hours remain until the next dose, skip the missed dose entirely and continue with your regular 12-hourly schedule. Never take two doses close together, and never double up to compensate for a missed dose, as this significantly increases the risk of respiratory depression and overdose. If you regularly forget doses, speak to your doctor or pharmacist about a dosing reminder strategy.

Unused or expired tablets should never be thrown in household waste or flushed down the toilet. Because of the risks of diversion, misuse, and environmental contamination, all unused opioid medications should be returned to a pharmacy or an authorised medicine take-back programme for safe disposal. Many pharmacies and hospitals operate such programmes. Keeping leftover oxycodone in the home increases the risk of accidental exposure (particularly to children) and of intentional misuse by others.

References

  1. World Health Organization (WHO). WHO Guidelines for the Pharmacological and Radiotherapeutic Management of Cancer Pain in Adults and Adolescents. Geneva: WHO; 2018. Available at: who.int
  2. European Medicines Agency (EMA). Oxycodone Hydrochloride Prolonged-Release Tablets – Summary of Product Characteristics. European public assessment reports. Available at: ema.europa.eu
  3. U.S. Food and Drug Administration (FDA). OxyContin (oxycodone hydrochloride) Extended-Release Tablets – Prescribing Information. FDA Approved Drug Products. Available at: fda.gov
  4. British National Formulary (BNF). Oxycodone hydrochloride. NICE Evidence Services. Available at: bnf.nice.org.uk
  5. Dowell D, Ragan KR, Jones CM, Baldwin GT, Chou R. CDC Clinical Practice Guideline for Prescribing Opioids for Pain – United States, 2022. MMWR Recomm Rep. 2022;71(No. RR-3):1–95. DOI: 10.15585/mmwr.rr7103a1
  6. Caraceni A, Hanks G, Kaasa S, et al. Use of opioid analgesics in the treatment of cancer pain: evidence-based recommendations from the European Association for Palliative Care. Lancet Oncol. 2012;13(2):e58–e68. DOI: 10.1016/S1470-2045(12)70040-2
  7. Chou R, Hartung D, Turner J, et al. Opioid Treatments for Chronic Pain. Comparative Effectiveness Review No. 229. AHRQ Publication No. 20-EHC011. Rockville, MD: AHRQ; 2020.
  8. National Institute for Health and Care Excellence (NICE). Chronic pain (primary and secondary) in over 16s: assessment of all chronic pain and management of chronic primary pain. NICE guideline NG193. London: NICE; 2021.
  9. Busse JW, Craigie S, Juurlink DN, et al. Guideline for opioid therapy and chronic noncancer pain. CMAJ. 2017;189(18):E659–E666. DOI: 10.1503/cmaj.170363
  10. Pöyhiä R, Kalso E. Clinical pharmacokinetics and pharmacodynamics of oxycodone. Clin Pharmacokinet. 2012;51(2):69–86.
  11. Teva B.V. (Haarlem, the Netherlands). Company and product information. Teva Pharmaceuticals. Available at: tevapharm.com

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