Paroxetine Oresund Pharma 20 mg
Selective Serotonin Reuptake Inhibitor (SSRI) for depression, anxiety disorders, OCD, PTSD and panic disorder
Quick Facts About Paroxetine Oresund Pharma
Key Takeaways About Paroxetine Oresund Pharma
- Generic bioequivalent: Paroxetine Oresund Pharma 20 mg contains the same active substance as Paxil, Seroxat and Aropax and has the same therapeutic effect
- Broad indication range: Approved for depression, OCD, panic disorder, social anxiety, PTSD, and generalised anxiety disorder in adults
- Takes time to work: Full therapeutic effects typically develop after 4–6 weeks of consistent daily use; some improvement may be noticed after 2 weeks
- Never stop abruptly: Paroxetine has a relatively high rate of withdrawal symptoms – always taper gradually under medical supervision
- Not for under 18s: Paroxetine Oresund Pharma should not be used in children and adolescents under 18 years due to an increased risk of suicidal behaviour and hostility
What Is Paroxetine Oresund Pharma and What Is It Used For?
Paroxetine Oresund Pharma is a 20 mg film-coated tablet containing paroxetine hydrochloride, a selective serotonin reuptake inhibitor (SSRI) used to treat depression and a range of anxiety disorders in adults. It works by increasing the availability of the neurotransmitter serotonin in the brain, helping to restore chemical balance and improve mood, reduce anxiety, and enhance emotional well-being. As a generic paroxetine product, it is bioequivalent to originator brands such as Paxil and Seroxat and shares their full range of approved indications.
Paroxetine Oresund Pharma belongs to a group of medicines known as selective serotonin reuptake inhibitors (SSRIs). These medicines act by selectively blocking the reabsorption (reuptake) of the neurotransmitter serotonin in the brain. By preventing serotonin from being reabsorbed back into the presynaptic nerve cells, paroxetine increases the amount of serotonin available in the synaptic cleft – the microscopic gap where chemical signals are transmitted between neurons. This enhanced serotonergic activity is believed to help regulate mood, reduce anxiety, and alleviate the symptoms of various psychiatric disorders.
Among all currently available SSRIs, paroxetine is notable for having the highest binding affinity for the serotonin transporter (SERT), making it the most potent inhibitor of serotonin reuptake in its class. Unlike most other SSRIs, paroxetine also exhibits mild anticholinergic activity, which may contribute to some of its characteristic side effects such as dry mouth, constipation, and sedation. The precise mechanism by which SSRIs achieve their long-term antidepressant and anxiolytic effects is not fully understood, but the downstream adaptation of serotonergic neurotransmission and receptor sensitivity is believed to be central to their action.
Paroxetine was first approved by the U.S. Food and Drug Administration in 1992 and has since become one of the most widely prescribed antidepressants globally. Paroxetine Oresund Pharma is one of many generic formulations of paroxetine marketed across Europe, providing the same active substance in a bioequivalent film-coated tablet. Because it is a generic product, Paroxetine Oresund Pharma typically has a more affordable price than the originator brands while offering the same therapeutic profile.
Approved Indications
Paroxetine Oresund Pharma 20 mg is approved for the treatment of the following conditions in adults, in line with the European Medicines Agency (EMA) Summary of Product Characteristics for paroxetine-containing medicines:
- Major depressive disorder (MDD): A clinical condition characterised by persistent low mood, loss of interest, sleep disturbances, fatigue, difficulty concentrating, and feelings of worthlessness or hopelessness lasting two or more weeks
- Obsessive-compulsive disorder (OCD): A condition characterised by recurrent, unwanted thoughts (obsessions) and repetitive behaviours or mental acts (compulsions) that the individual feels driven to perform in response to the obsessions
- Panic disorder: Recurrent unexpected panic attacks accompanied by physical symptoms such as palpitations, sweating, trembling, and shortness of breath – including panic disorder with or without agoraphobia
- Social anxiety disorder (social phobia): Intense anxiety and avoidance of social or performance situations due to fear of embarrassment, negative evaluation, or scrutiny by others
- Post-traumatic stress disorder (PTSD): A condition that develops following exposure to a traumatic event, characterised by intrusive memories, flashbacks, nightmares, hypervigilance, avoidance behaviour, and emotional numbing
- Generalised anxiety disorder (GAD): Persistent, excessive worry about everyday situations lasting six months or more, accompanied by physical symptoms such as muscle tension, restlessness, fatigue, and difficulty concentrating
Depression affects an estimated 280 million people worldwide according to the World Health Organization. Anxiety disorders are among the most common mental-health conditions globally, with a prevalence of roughly 4% of the world population. Paroxetine Oresund Pharma is one of several pharmacological options recommended in international guidelines such as NICE, APA and WFSBP for the treatment of these conditions, typically used alongside psychological therapy where appropriate.
Your doctor has assessed that Paroxetine Oresund Pharma is appropriate for your specific clinical situation. Paroxetine may occasionally be used for other conditions not listed here. Always follow your doctor’s instructions and contact them if you have questions about why you have been prescribed this medicine.
What Should You Know Before Taking Paroxetine Oresund Pharma?
Before taking Paroxetine Oresund Pharma, inform your doctor about all medical conditions, other medicines you are taking, and whether you are pregnant, planning pregnancy, or breastfeeding. It must never be combined with MAO inhibitors, thioridazine, or pimozide. Special caution is needed for patients with epilepsy, heart conditions (including QT prolongation), liver or kidney disease, diabetes, bleeding disorders, and glaucoma. Paroxetine is not recommended for patients under 18 years of age.
Contraindications
You must not take Paroxetine Oresund Pharma in the following situations:
- If you are taking MAO inhibitors (monoamine oxidase inhibitors) such as moclobemide, selegiline, rasagiline, or the intravenous dye methylene blue, or have taken them within the last two weeks. When switching from an MAOI to paroxetine, at least 14 days must elapse; when switching from paroxetine to an MAOI, at least one week must elapse
- If you are taking thioridazine or pimozide – antipsychotic medicines known to prolong the QT interval on the ECG and increase the risk of serious cardiac arrhythmias
- If you are allergic (hypersensitive) to paroxetine or any of the other ingredients listed in section 6 of the package leaflet
Combining Paroxetine Oresund Pharma with MAO inhibitors can trigger serotonin syndrome, a potentially life-threatening condition. Symptoms include extreme agitation, confusion, rapid heartbeat, elevated blood pressure, high body temperature, sweating, trembling, hallucinations, muscle rigidity, and loss of consciousness. Seek emergency medical attention immediately if these symptoms develop.
Warnings and Precautions
Talk to your doctor before taking Paroxetine Oresund Pharma if you have or have previously had any of the following conditions:
- Heart rhythm abnormalities: Including a condition seen on ECG called prolonged QT interval, a family history of QT prolongation, heart failure, slow heart rate (bradycardia), or low potassium or magnesium levels
- Epilepsy or seizures: Contact your doctor immediately if you experience a seizure while taking this medicine
- Bipolar disorder or manic episodes: Paroxetine may trigger mania in susceptible individuals; if you experience overactive behaviour or racing thoughts, contact your doctor at once
- Liver, kidney, or heart problems: Your doctor may need to adjust your dose or monitor you more closely
- Diabetes: Blood sugar control may be affected; antidiabetic medicines may need adjustment
- Bleeding disorders: Paroxetine may increase the risk of bleeding, particularly when taken together with anticoagulants (warfarin, apixaban, rivaroxaban), antiplatelet drugs, NSAIDs (aspirin, ibuprofen, diclofenac), or atypical antipsychotics (clozapine, olanzapine)
- Glaucoma (raised intraocular pressure): Paroxetine may precipitate acute angle-closure glaucoma in susceptible individuals
- Low-salt diet: Inform your doctor if you are on a salt-restricted diet, as hyponatraemia is a recognised adverse effect of SSRIs
- Electroconvulsive therapy (ECT): Inform your doctor if you are receiving ECT, as SSRIs may prolong seizure duration
- Tamoxifen for breast cancer: Paroxetine may significantly reduce the effectiveness of tamoxifen; your doctor may recommend a different antidepressant
Suicidal Thoughts and Worsening of Depression or Anxiety
If you are depressed or suffer from anxiety, you may sometimes have thoughts of self-harm or suicide. These thoughts may increase when first starting antidepressant treatment, as it takes time for these medicines to take effect – usually about two weeks and sometimes longer. You may be more likely to have such thoughts if:
- You have previously had thoughts of self-harm or suicide
- You are a young adult under 25 years of age. Pooled clinical-trial data have shown that young adults with psychiatric conditions treated with antidepressants have an increased short-term risk of suicidal thoughts and self-harm behaviour compared with placebo
If you have thoughts of self-harm or suicide at any time, contact your doctor immediately or go to the nearest emergency department. It may be helpful to tell a relative or close friend that you are depressed or anxious and ask them to read this information. Ask them to tell you if they think your condition is getting worse or if they are worried about changes in your behaviour.
Restlessness (Akathisia)
Some patients who take Paroxetine Oresund Pharma develop a condition called akathisia, characterised by feelings of inner restlessness and an inability to sit or stand still. This typically occurs during the first few weeks of treatment. Paradoxically, increasing the dose may worsen akathisia, so it is important to speak with your doctor if you experience restlessness rather than assuming the medicine is not working.
Serotonin Syndrome and Neuroleptic Malignant Syndrome
In rare cases, patients taking paroxetine may develop serotonin syndrome or symptoms resembling neuroleptic malignant syndrome, particularly when it is combined with other serotonergic medicines. Warning signs include extreme agitation or irritability, confusion, restlessness, feeling hot, profuse sweating, trembling, shivering, hallucinations, muscle stiffness, sudden muscle twitching (myoclonus), and rapid heartbeat. In severe cases the condition can progress to loss of consciousness. Seek immediate medical attention if any of these symptoms develop.
Sexual Dysfunction
SSRIs including Paroxetine Oresund Pharma can cause sexual dysfunction, including decreased libido, delayed or absent orgasm (anorgasmia), erectile difficulties, and ejaculatory disorders. In some cases, these symptoms have persisted after treatment was discontinued – a condition now recognised as post-SSRI sexual dysfunction (PSSD). If you experience troublesome sexual side effects, discuss them openly with your doctor, who may consider a dose reduction or a switch to a different antidepressant.
Children and Adolescents Under 18 Years
Paroxetine Oresund Pharma should not be used in children and adolescents under 18 years of age. Clinical studies in this age group have shown an increased risk of adverse effects including suicidal behaviour, self-harm, hostility (aggression, defiance, anger), loss of appetite, tremor, abnormal sweating, hyperactivity, agitation, emotional lability (including crying and mood swings), and unusual bruising or bleeding such as nosebleeds. Long-term effects on growth, physical maturation, and cognitive and behavioural development have not been fully established in paediatric patients.
When treatment was stopped in studies involving patients under 18, withdrawal symptoms were common and included abdominal pain, nervousness, and emotional changes such as crying, mood swings, self-harm thoughts, and suicide attempts.
Pregnancy and Breastfeeding
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor before taking Paroxetine Oresund Pharma. The decision to use or continue paroxetine in pregnancy must be individualised and balance the risks of untreated maternal depression or anxiety against the recognised foetal risks below.
Pregnancy: There are reports of an increased risk of birth defects, especially congenital heart defects, in babies whose mothers took paroxetine during the first trimester of pregnancy. In the general population, approximately 1 in 100 babies is born with a heart defect. This risk rises to approximately 2 in 100 babies when the mother has taken paroxetine during the first trimester. Together with your doctor you should consider whether it is better to switch to an alternative treatment or to gradually taper off paroxetine during pregnancy.
If Paroxetine Oresund Pharma is used during late pregnancy, particularly in the third trimester, it may increase the risk of:
- Persistent pulmonary hypertension of the newborn (PPHN): A condition in which blood pressure in the vessels between the baby’s heart and lungs remains abnormally high after birth, causing respiratory distress
- Neonatal withdrawal symptoms: Including breathing difficulties, cyanosis (bluish skin), irritability, excessive crying, feeding problems, trembling, muscle stiffness or floppiness, seizures, and exaggerated reflexes. These symptoms usually appear within the first 24 hours after birth and resolve within days
- Increased risk of heavy vaginal bleeding shortly after delivery (postpartum haemorrhage), particularly in women with a history of bleeding disorders
Breastfeeding: Paroxetine passes into breast milk in very small amounts. The benefits of breastfeeding generally outweigh the minimal infant exposure, but consult your doctor before breastfeeding while taking Paroxetine Oresund Pharma. Breast-fed infants should be monitored for irritability, poor feeding, or excessive sleepiness.
Fertility: Animal studies have shown that paroxetine may reduce sperm quality. Although this could theoretically affect male fertility, no such effect has been conclusively demonstrated in humans.
Driving and Operating Machinery
Possible side effects of Paroxetine Oresund Pharma include dizziness, confusion, drowsiness, and blurred vision. If you experience these side effects, do not drive or operate machinery. You are personally responsible for assessing whether you are fit to drive or perform tasks that require sustained alertness.
How Does Paroxetine Oresund Pharma Interact with Other Drugs?
Paroxetine Oresund Pharma has significant interactions with many medicines. It must never be combined with MAO inhibitors, thioridazine, or pimozide due to the risk of life-threatening reactions. Paroxetine is a potent inhibitor of the CYP2D6 liver enzyme, meaning it can raise the blood levels of numerous other medicines. It also reduces the effectiveness of tamoxifen in breast cancer and should not be used together. Always inform your doctor and pharmacist of all medicines, herbal remedies, and supplements you are taking.
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription and herbal remedies. Some medicines can affect how Paroxetine Oresund Pharma works, and paroxetine can affect how other medicines work. Paroxetine is a potent inhibitor of cytochrome P450 2D6 (CYP2D6), an enzyme that metabolises many medicines. This means paroxetine can raise the blood levels and effects of numerous drugs that depend on this enzyme for their breakdown.
Major Interactions (Do Not Combine)
| Medication | Type | Risk |
|---|---|---|
| MAO inhibitors (moclobemide, selegiline, rasagiline, methylene blue) | Antidepressants / Antiparkinsonian / Diagnostic agents | Serotonin syndrome – potentially life-threatening. Mandatory 2-week washout period required in both directions. |
| Thioridazine | Antipsychotic | Increased thioridazine plasma levels via CYP2D6 inhibition, causing QT prolongation and risk of serious cardiac arrhythmias and sudden death. |
| Pimozide | Antipsychotic | Increased pimozide plasma levels, risk of serious cardiac arrhythmias (QT prolongation, torsades de pointes). |
Moderate Interactions (Use with Caution)
| Medication | Type | Effect |
|---|---|---|
| Tamoxifen | Breast cancer treatment | Paroxetine inhibits CYP2D6, reducing conversion of tamoxifen to its active metabolite endoxifen. May significantly reduce tamoxifen efficacy and increase breast-cancer recurrence risk. Use an alternative antidepressant. |
| Warfarin and other oral anticoagulants | Blood thinners | Increased bleeding risk via combined effects on platelet serotonin and INR. Enhanced INR monitoring required. |
| Lithium, Risperidone, Clozapine | Mood stabiliser / Antipsychotics | Increased risk of serotonin syndrome and elevated antipsychotic plasma levels. Monitor lithium levels and symptoms. |
| Tramadol, Buprenorphine, Pethidine, Fentanyl | Opioid analgesics | Risk of serotonin syndrome and seizures. Tramadol analgesic efficacy may be reduced via CYP2D6 inhibition of its active metabolite. |
| Sumatriptan and other triptans | Migraine medication | Increased risk of serotonin syndrome, particularly at treatment initiation or dose change. |
| St. John’s Wort (Hypericum perforatum) | Herbal supplement | Additive serotonergic activity and increased risk of serotonin syndrome and other side effects. |
| NSAIDs (aspirin, ibuprofen, diclofenac, celecoxib, meloxicam) | Pain / Anti-inflammatory | Significantly increased risk of gastrointestinal and other bleeding events. Consider gastroprotection with a proton pump inhibitor. |
| Tricyclic antidepressants (clomipramine, nortriptyline, desipramine, amitriptyline) | Antidepressants | Paroxetine increases tricyclic levels via CYP2D6 inhibition, raising risk of cardiac and anticholinergic side effects and serotonin syndrome. |
| Metoprolol | Beta-blocker | Paroxetine increases metoprolol levels via CYP2D6 inhibition, potentially causing excessive blood-pressure lowering and bradycardia. |
| Atomoxetine | ADHD medication | Increased atomoxetine plasma levels via CYP2D6 inhibition; dose reduction may be required. |
| Phenytoin, Carbamazepine, Phenobarbital | Antiepileptics | Enzyme induction may reduce paroxetine plasma levels. Phenytoin levels may increase. Monitor for altered efficacy of both medicines. |
| Fosamprenavir / Ritonavir | HIV medication | Altered paroxetine exposure; clinical monitoring and dose adjustment may be needed. |
| Propafenone, Flecainide | Antiarrhythmics | Increased plasma levels via CYP2D6 inhibition, raising risk of cardiac side effects. |
| Procyclidine | Antiparkinsonian | Paroxetine increases procyclidine levels, causing anticholinergic side effects. |
| Linezolid | Antibiotic (weak MAO inhibitor) | Risk of serotonin syndrome due to non-selective MAO inhibition. |
Food and Alcohol Interactions
Paroxetine Oresund Pharma should be taken in the morning with food to reduce the risk of nausea. The following should be noted regarding food and drink:
- Alcohol: Should be strictly avoided during treatment with Paroxetine Oresund Pharma. Alcohol depresses the central nervous system and can worsen side effects such as drowsiness, dizziness, and impaired coordination. It may also worsen symptoms of depression and anxiety, counteracting the therapeutic effects of the medicine
- Tryptophan supplements: Dietary supplements that raise serotonin levels should not be taken together with paroxetine due to the additive risk of serotonin syndrome
- Grapefruit juice: Has minor effects on paroxetine metabolism and is not strictly contraindicated, but occasional caution is advised
What Is the Correct Dosage of Paroxetine Oresund Pharma?
The recommended starting dose of Paroxetine Oresund Pharma for most conditions is 20 mg once daily, taken in the morning with food. For panic disorder, treatment may start at 10 mg daily (half a 20 mg tablet) to minimise initial worsening of anxiety. Doses may be increased gradually in 10 mg increments based on clinical response, up to a maximum of 50–60 mg daily depending on the condition. The 20 mg tablet is scored and can be split in half for 10 mg doses. Always take Paroxetine Oresund Pharma exactly as prescribed by your doctor.
Adults
| Condition | Starting Dose | Recommended Dose | Maximum Dose |
|---|---|---|---|
| Depression (MDD) | 20 mg/day | 20 mg/day | 50 mg/day |
| Obsessive-Compulsive Disorder | 20 mg/day | 40 mg/day | 60 mg/day |
| Panic Disorder | 10 mg/day | 40 mg/day | 60 mg/day |
| Social Anxiety Disorder | 20 mg/day | 20 mg/day | 50 mg/day |
| Post-Traumatic Stress Disorder | 20 mg/day | 20 mg/day | 50 mg/day |
| Generalised Anxiety Disorder | 20 mg/day | 20 mg/day | 50 mg/day |
Your doctor will advise you on the appropriate starting dose and any subsequent adjustments. Most patients begin to feel better after a few weeks of continuous treatment. If you have not noticed any improvement after this time, consult your doctor. Your doctor may decide to gradually increase the dose by 10 mg per week, up to the maximum daily dose for your condition.
How to Take Paroxetine Oresund Pharma
Take Paroxetine Oresund Pharma exactly as your doctor has instructed. The tablets should be taken once daily in the morning with food to reduce the risk of nausea. Swallow the tablets whole with a glass of water; do not chew them. The 20 mg tablet is scored and can be divided into two equal 10 mg halves for starting doses or gradual tapering.
Your doctor will discuss with you how long you need to continue taking Paroxetine Oresund Pharma. Treatment typically lasts for at least 6–12 months after symptom remission for a first depressive episode, and often longer for anxiety disorders or recurrent depression. It is important to continue taking the medicine even after you feel better in order to prevent relapse.
Children and Adolescents
Paroxetine Oresund Pharma is not recommended for use in children and adolescents under 18 years of age. Clinical trials have not demonstrated efficacy in this age group, and there is an increased risk of suicidal behaviour, hostility, and aggression. If your doctor has prescribed paroxetine for a young person and you wish to discuss this, consult the prescriber.
Elderly Patients
The maximum daily dose of Paroxetine Oresund Pharma for patients over 65 years of age is 40 mg. Starting doses are often lower, typically 10–20 mg per day. Elderly patients are more susceptible to certain side effects, particularly hyponatraemia (low blood sodium levels), falls, and bone fractures, and should be monitored accordingly.
Patients with Liver or Kidney Disease
If you have severe liver or kidney disease, your doctor may prescribe a lower dose than normally recommended. In severe renal impairment (creatinine clearance below 30 mL/min) or severe hepatic impairment, plasma concentrations of paroxetine may be increased, and the lowest effective dose should be used.
Missed Dose
Take your medicine at the same time each day. If you forget to take a dose and remember before bedtime, take it straight away and continue as normal the next day. If you do not remember until night-time or the following day, skip the missed dose. You may experience some minor withdrawal symptoms, but these should resolve after taking your next dose at the usual time. Do not take a double dose to make up for a missed dose.
Overdose
Never take more tablets than prescribed. If you or someone else takes too much Paroxetine Oresund Pharma, contact your doctor, go to the nearest emergency department, or call your local poison-control centre immediately. Always bring the medicine packaging with you. Symptoms of overdose may include exaggerated versions of the normal side effects (nausea, tremor, sweating, drowsiness, dizziness) as well as fever, uncontrollable muscle contractions (myoclonus), rapid heart rate, and in severe cases, seizures, coma, and loss of consciousness. Paroxetine has a relatively wide therapeutic margin; isolated paroxetine overdose is rarely fatal, but risk is significantly increased when combined with alcohol or other medicines.
Paroxetine Oresund Pharma will not relieve your symptoms immediately. All antidepressants require time to work. Some patients notice improvement after two weeks, while others may require six to eight weeks. Some people taking antidepressants experience transient worsening of symptoms (including anxiety) before they begin to feel better. If you have not started to improve after several weeks, contact your doctor. A scheduled follow-up visit a few weeks after starting treatment is recommended.
What Are the Side Effects of Paroxetine Oresund Pharma?
Like all medicines, Paroxetine Oresund Pharma can cause side effects, although not everyone experiences them. The most common side effects are nausea and changes in sexual function. Most side effects are mild to moderate, occur during the first weeks of treatment, and tend to improve with continued use. Serious side effects requiring immediate medical attention include allergic reactions, serotonin syndrome, seizures, unusual bleeding, and acute glaucoma.
Severe allergic reaction (swelling of face, lips, tongue, or throat; difficulty breathing; skin rash with blisters); symptoms of serotonin syndrome (confusion, agitation, rapid heartbeat, high temperature, muscle stiffness, twitching); seizures; unusual bruising or bleeding; bloody vomit or blood in stool; sudden eye pain with blurred vision (acute glaucoma); or thoughts of self-harm or suicide.
Very Common
Affects more than 1 in 10 people
- Nausea (taking with food in the morning reduces this risk)
- Changes in sexual drive or function, including anorgasmia
- Erectile dysfunction and ejaculatory disorders in men
Common
Affects 1 in 10 to 1 in 100 people
- Elevated cholesterol levels
- Decreased appetite
- Insomnia or drowsiness
- Abnormal dreams (including nightmares)
- Dizziness, tremor, headache
- Difficulty concentrating
- Agitation, feeling abnormally weak (asthenia)
- Blurred vision, yawning, dry mouth
- Diarrhoea or constipation, vomiting
- Sweating, weight gain
Uncommon
Affects 1 in 100 to 1 in 1,000 people
- Brief rise or fall in blood pressure (may cause dizziness on standing)
- Faster than normal heart rate (tachycardia)
- Movement impairment, stiffness, abnormal mouth or tongue movements
- Dilated pupils, skin rash, itching
- Confusion, hallucinations
- Decreased white blood cell count
- Urinary retention or urinary incontinence
- Loss of blood-sugar control in diabetic patients
Rare and Very Rare
Affects fewer than 1 in 1,000 people
- Abnormal breast-milk production in men and women (galactorrhoea)
- Slow heart rate (bradycardia), liver enzyme changes
- Panic attacks, mania (overactive behaviour or thoughts)
- Depersonalisation, restless legs syndrome
- Joint and muscle pain, menstrual disturbances
- Increased prolactin levels
- Severe skin reactions (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis)
- Liver problems causing jaundice (yellowing of skin/eyes)
- SIADH (syndrome of inappropriate antidiuretic-hormone secretion) leading to hyponatraemia
- Fluid retention (peripheral oedema)
- Photosensitivity reactions
- Painful, prolonged erection (priapism)
- Decreased platelet count (thrombocytopenia)
- Acute angle-closure glaucoma (sudden eye pain and blurred vision)
Frequency Not Known
The following side effects have been reported, but their exact frequency cannot be determined from available data:
- Suicidal thoughts or behaviour
- Aggression
- Heavy vaginal bleeding shortly after delivery (postpartum haemorrhage)
- Inflammation of the colon (microscopic colitis, causing diarrhoea)
- Teeth grinding (bruxism)
- Tinnitus (ringing, buzzing, or whistling sounds in the ears)
Withdrawal Symptoms
Paroxetine is known to have a relatively high incidence of withdrawal symptoms compared with other SSRIs, partly due to its shorter half-life and potent serotonin reuptake inhibition. According to clinical studies, approximately 3 in 10 patients experience one or more withdrawal symptoms when stopping paroxetine treatment abruptly.
Common withdrawal symptoms (up to 1 in 10 people):
- Dizziness (feeling unsteady, balance difficulties)
- Sensory disturbances including tingling, burning, and less commonly electric-shock sensations (“brain zaps”) and tinnitus
- Sleep disturbances (vivid dreams, nightmares, insomnia)
- Anxiety, headache
Less common withdrawal symptoms (up to 1 in 100 people):
- Nausea, sweating (including night sweats)
- Restlessness or agitation, tremor
- Confusion or disorientation, diarrhoea
- Emotional instability or irritability
- Visual disturbances, palpitations
An increased risk of bone fractures has been observed in epidemiological studies of patients taking SSRIs, including paroxetine. If you have risk factors for osteoporosis – such as postmenopausal status, previous fractures, or corticosteroid use – discuss preventive strategies with your doctor.
How Should You Store Paroxetine Oresund Pharma?
Store Paroxetine Oresund Pharma at room temperature (below 25 °C) in the original packaging, out of the reach and sight of children. Do not use the medicine after the expiry date printed on the packaging. If you split a 20 mg tablet, store the remaining half safely in the original blister. Do not dispose of medicines via wastewater or household waste – return unused medicines to your pharmacy.
Keep Paroxetine Oresund Pharma out of the reach and sight of children. Do not use the medicine after the expiry date stated on the blister, container, or carton after “EXP.” The expiry date refers to the last day of that month. Store in the original packaging in order to protect from moisture. No special temperature storage conditions are normally required for paroxetine film-coated tablets, but extreme heat and humidity should be avoided.
If you are splitting the 20 mg tablet for a 10 mg dose, store the remaining half in the original blister pocket and use it within a few days.
Do not throw away medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer required. These measures help protect the environment and prevent inadvertent access by children.
What Does Paroxetine Oresund Pharma Contain?
Each Paroxetine Oresund Pharma tablet contains 20 mg of paroxetine (as paroxetine hydrochloride) as the active substance. The tablets also contain standard inactive ingredients (excipients) including mannitol, microcrystalline cellulose, sodium starch glycolate, and magnesium stearate, with a film coating based on hypromellose, titanium dioxide, and polyethylene glycol. Patients with known allergies should check the full excipient list on the package leaflet.
Active Ingredient
The active substance is paroxetine hydrochloride. Each film-coated tablet of Paroxetine Oresund Pharma contains paroxetine hydrochloride equivalent to 20 mg of paroxetine base.
Inactive Ingredients (Excipients)
Tablet core: Mannitol, microcrystalline cellulose, sodium starch glycolate (Type A), and magnesium stearate.
Film coating: Hypromellose (E464), titanium dioxide (E171), macrogol/polyethylene glycol (E1521), and talc (E553b). The exact film-coating composition may vary between batches and is detailed on the package leaflet supplied with the medicine.
Tablet Appearance
20 mg tablet: White, round, film-coated, biconvex tablets with a score line on one side. The score line allows the tablet to be divided into two equal 10 mg doses to facilitate dose titration, tapering, or individualised dosing.
Pack Sizes
Paroxetine Oresund Pharma 20 mg film-coated tablets are supplied in blister packs of typically 14, 28, 30, 98, or 100 tablets. Not all pack sizes may be marketed in every country. Check with your pharmacist regarding availability and the most cost-effective pack size for your prescribed course of treatment.
How Should You Stop Taking Paroxetine Oresund Pharma?
Never stop taking Paroxetine Oresund Pharma without consulting your doctor. When it is time to stop, your doctor will help you gradually reduce your dose over several weeks or months to minimise withdrawal symptoms. A typical approach is reducing the dose by 10 mg per week, using the scored tablet to step down from 20 mg to 10 mg and then to alternate-day dosing. Even with gradual tapering, some withdrawal symptoms may occur but usually resolve within two weeks.
Do not stop taking Paroxetine Oresund Pharma until your doctor tells you to. When treatment is to be discontinued, your doctor will help you slowly reduce your dose over a period of weeks or months. A common strategy is to gradually reduce the dose by 10 mg per week, often followed by alternate-day dosing and finally cessation. Most patients find that withdrawal symptoms are mild and resolve on their own within two weeks. For some patients, symptoms may be more severe or last longer.
If you experience withdrawal symptoms when you stop taking Paroxetine Oresund Pharma, your doctor may recommend that you taper more slowly. Contact your doctor if you experience severe withdrawal symptoms. In some cases, your doctor may suggest restarting the medicine at a previous dose and then tapering more gradually – sometimes switching to a longer-acting SSRI such as fluoxetine to facilitate discontinuation.
Even if you experience withdrawal symptoms, it will be possible for you to stop taking Paroxetine Oresund Pharma. The key is to do so gradually, under medical supervision, and at a pace that is comfortable for you. Psychological support and patient education about the transient nature of withdrawal symptoms often help improve tolerability.
Paroxetine has a relatively short elimination half-life (approximately 21 hours) compared with some other SSRIs such as fluoxetine (which has a half-life of 4–6 days due to its active metabolite norfluoxetine). This means paroxetine levels in the blood drop more quickly after stopping, which is why discontinuation symptoms tend to be more pronounced with paroxetine than with longer-acting SSRIs. Gradual dose reduction allows the brain to slowly adapt to decreasing serotonin levels and receptor occupancy.
Frequently Asked Questions About Paroxetine Oresund Pharma
Paroxetine Oresund Pharma typically begins to show some effects within 1–2 weeks, but it usually takes 4–6 weeks of consistent daily use to experience the full therapeutic benefit. For some conditions such as OCD, it may take 8–12 weeks. It is important to continue taking the medicine as prescribed even if you do not notice immediate improvement. Some patients feel worse before they feel better, especially in the first two weeks. Your doctor will schedule a follow-up visit a few weeks after starting treatment to monitor your progress and adjust the dose if needed.
No, alcohol should be avoided while taking Paroxetine Oresund Pharma. Both substances depress the central nervous system, and combining them can intensify side effects such as drowsiness, dizziness, and impaired coordination. Alcohol can also worsen the underlying symptoms of depression and anxiety, counteracting the therapeutic effects of paroxetine. If you have questions about occasional alcohol consumption during treatment, speak with your doctor or pharmacist.
Yes. Paroxetine Oresund Pharma is a generic bioequivalent of the originator paroxetine brands Paxil (United States), Seroxat (United Kingdom and Europe), and Aropax (Australia). It contains the same active substance (paroxetine hydrochloride) at the same 20 mg strength and has the same therapeutic indications, contraindications, dosing recommendations, and side-effect profile. The differences between generic paroxetine products and the originator brands are limited to excipients, tablet appearance, and price. Generic paroxetine is typically more affordable while offering the same clinical efficacy.
Paroxetine Oresund Pharma is not recommended for patients under 18 years because clinical studies in children and adolescents showed an increased risk of suicidal behaviour, self-harm, hostility (aggression, defiance, anger), and other adverse effects. The studies did not demonstrate sufficient efficacy in this age group to justify these risks. The long-term effects on growth, brain development, and behaviour have not been fully established in paediatric populations. Other SSRIs such as fluoxetine have stronger evidence for use in children and adolescents with depression.
Paroxetine use during pregnancy carries specific and well-documented risks. First-trimester exposure is associated with an increased risk of congenital heart defects (approximately 2 in 100 vs. 1 in 100 in the general population). Third-trimester use may increase the risk of persistent pulmonary hypertension of the newborn (PPHN) and neonatal withdrawal symptoms. Women who are pregnant, planning to become pregnant, or breastfeeding should discuss the risks and benefits with their healthcare provider before starting or continuing Paroxetine Oresund Pharma. In many cases, the doctor may recommend switching to a different antidepressant with a more established safety profile in pregnancy, such as sertraline.
Paroxetine has a shorter half-life (approximately 21 hours) compared with SSRIs such as fluoxetine (4–6 days with its active metabolite). This means paroxetine is eliminated from the body more quickly, leading to a more abrupt drop in serotonin availability when the medicine is stopped or missed. Additionally, paroxetine’s potent serotonin-transporter binding and mild anticholinergic action mean the brain becomes more dependent on the drug to maintain neurotransmitter balance. Studies show that approximately 30% of patients experience withdrawal symptoms when stopping paroxetine, compared with lower rates for longer-acting SSRIs. This is why gradual dose reduction over several weeks is essential when discontinuing Paroxetine Oresund Pharma.
Yes. The 20 mg Paroxetine Oresund Pharma tablet has a functional score line on one side that allows it to be divided into two equal 10 mg halves. This is useful for starting at a lower dose (particularly in panic disorder or in elderly patients), for gradual dose titration, and for tapering when stopping the medicine. Place the tablet on a clean, flat surface with the score line facing upwards and press firmly down on both sides to split. Store any remaining half in the original blister and use within a few days.
References and Sources
This article is based on the following peer-reviewed sources and international guidelines. All medical claims are supported by evidence level 1A (systematic reviews and randomised controlled trials) or by authoritative regulatory documents.
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All content is reviewed by board-certified physicians following international guidelines (WHO, EMA, FDA, BNF, NICE) and the GRADE evidence framework.
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