Hydroxyzine EQL Pharma
Sedating antihistamine for anxiety and allergic skin conditions
Hydroxyzine EQL Pharma contains the active substance hydroxyzine hydrochloride, a first-generation sedating antihistamine. It is prescribed for the short-term treatment of anxiety in adults when other medications are not suitable, and for treating urticaria (hives) and pruritus (itching) caused by allergic reactions in adults, adolescents, and children aged 5 years and older. Hydroxyzine works by blocking histamine H1 receptors and by suppressing certain areas of the central nervous system, providing both antihistamine and anxiolytic effects without creating dependence.
Quick Facts
Key Takeaways
- Hydroxyzine treats anxiety and allergic skin conditions (urticaria, pruritus) and does not cause dependence, unlike benzodiazepines.
- Use at the lowest effective dose for the shortest possible duration — the maximum daily dose for adults is 100 mg, and only 50 mg for elderly patients.
- Hydroxyzine carries a risk of QT prolongation and serious cardiac arrhythmias — it is contraindicated in patients with known heart rhythm disorders or electrolyte imbalances.
- Do not take hydroxyzine during pregnancy or breastfeeding, and do not combine it with alcohol or other CNS depressants.
- Drowsiness is the most common side effect — avoid driving or operating machinery until you know how the medication affects you.
What Is Hydroxyzine EQL Pharma and What Is It Used For?
Hydroxyzine EQL Pharma belongs to a class of medicines known as sedating (first-generation) antihistamines. The active ingredient, hydroxyzine hydrochloride, has a dual mechanism of action: it competitively antagonises histamine at H1 receptors throughout the body, and it suppresses activity in certain subcortical regions of the central nervous system. This combination gives hydroxyzine both antiallergic properties and anxiolytic (anxiety-reducing) effects.
Unlike benzodiazepines, which are commonly prescribed for anxiety but carry a significant risk of dependence, hydroxyzine does not engage the brain's reward pathways. This means it does not produce the tolerance, withdrawal, or addictive behaviour seen with benzodiazepine-class medications. For this reason, hydroxyzine may be considered when clinicians want to offer short-term anxiety relief without the risk of substance dependence.
Approved Indications
Hydroxyzine EQL Pharma is approved for the following indications:
- Anxiety in adults: Short-term management of anxiety when no alternative medication is appropriate. According to European Medicines Agency (EMA) recommendations, hydroxyzine should be used at the lowest effective dose for the shortest possible duration for this indication.
- Urticaria (hives): Treatment of acute and chronic urticaria in adults, adolescents, and children aged 5 years and older. Hydroxyzine suppresses the histamine-mediated wheals, flares, and itching characteristic of urticaria.
- Pruritus (itching): Symptomatic relief of pruritus associated with allergic conditions in adults, adolescents, and children aged 5 years and older.
Hydroxyzine is rapidly absorbed after oral administration, reaching peak plasma concentrations within approximately 2 hours. It is extensively metabolised in the liver, primarily by the cytochrome P450 enzymes CYP3A4 and CYP3A5, producing the active metabolite cetirizine — a well-known second-generation antihistamine used widely for allergic conditions. The elimination half-life of hydroxyzine is approximately 14 hours in healthy adults, though it may be prolonged in elderly patients and those with hepatic impairment.
Hydroxyzine hydrochloride, the active substance in Hydroxyzine EQL Pharma, may also be approved for other conditions not listed in this information. Always follow the instructions of your prescribing healthcare provider and consult them if you have additional questions about the use of this medication.
What Should You Know Before Taking Hydroxyzine EQL Pharma?
Before starting treatment with Hydroxyzine EQL Pharma, it is essential to discuss your complete medical history with your healthcare provider. Hydroxyzine has several important contraindications and precautions that must be considered to ensure safe and effective use. The information below summarises the key safety considerations based on the approved product information and international pharmacovigilance guidance.
Contraindications
You must not take Hydroxyzine EQL Pharma in the following circumstances:
- Hypersensitivity: If you are allergic to hydroxyzine hydrochloride or any of the other ingredients in the tablet. You should also avoid hydroxyzine if you have a known allergy to cetirizine (an antihistamine and active metabolite of hydroxyzine), aminophylline, ethylenediamine, or other piperazine derivatives.
- Porphyria: If you have a hereditary metabolic disorder known as porphyria, characterised by the accumulation of toxic porphyrin compounds in the body.
- Pregnancy and breastfeeding: Hydroxyzine crosses the placental barrier and is excreted in breast milk. It is contraindicated during pregnancy and lactation.
- QT prolongation: If your electrocardiogram (ECG) shows prolonged QT interval, or if you have a family history of sudden cardiac death.
- Cardiovascular disease: If you have or have had significant cardiovascular disease, or if you have a very slow heart rate (bradycardia).
- Electrolyte imbalances: If you have low levels of potassium (hypokalaemia) or magnesium (hypomagnesaemia) in your blood.
- Concomitant QT-prolonging drugs: If you are currently taking other medications known to prolong the QT interval (see the drug interactions section below).
Warnings and Precautions
Hydroxyzine EQL Pharma can increase the risk of heart rhythm disorders (arrhythmias), including potentially life-threatening conditions such as QT prolongation and Torsade de Pointes. Seek immediate medical attention if you experience palpitations, difficulty breathing, or loss of consciousness while taking this medication. Treatment with hydroxyzine should be discontinued immediately if cardiac symptoms occur.
Talk to your doctor or pharmacist before taking Hydroxyzine EQL Pharma if any of the following apply to you:
- Kidney or liver disease: You may need a reduced dose. In patients with hepatic impairment, the daily dose should be reduced by one-third. In patients with moderate or severe renal impairment, dosage adjustment is also necessary.
- Seizure risk: If you have an increased risk of seizures (convulsions), hydroxyzine may lower the seizure threshold.
- Risk factors for stroke: Inform your doctor if you have any conditions that increase your risk of cerebrovascular events.
- Heart disease or irregular heartbeat: Hydroxyzine should be used with caution if you have any cardiac conditions.
- Glaucoma: Hydroxyzine's anticholinergic properties may increase intraocular pressure.
- Urinary obstruction: The anticholinergic effects of hydroxyzine may worsen urinary retention.
- Reduced bowel motility: Hydroxyzine may further slow gastrointestinal transit.
- Myasthenia gravis: The muscle-relaxant properties of hydroxyzine may exacerbate severe muscle weakness.
- Dementia: Use with particular caution in patients with cognitive impairment, as anticholinergic drugs may worsen confusion.
Dry mouth is a common side effect of hydroxyzine. Good oral hygiene is important during treatment, as persistent dry mouth can increase the risk of dental caries and oral infections. If you are scheduled for allergy testing, hydroxyzine should be discontinued at least 5 days before the tests, as it can interfere with skin prick test results.
Elderly Patients
Elderly patients are more susceptible to the side effects of hydroxyzine, particularly sedation, cognitive impairment, and cardiac effects. Treatment should begin at half the recommended dose, and the maximum daily dose for elderly patients is 50 mg. The duration of treatment should be as short as possible. Healthcare providers should regularly reassess the need for continued therapy in older patients.
Use in Children
Hydroxyzine EQL Pharma is not recommended for children under 5 years of age. Younger children are more susceptible to central nervous system side effects, including seizures (convulsions). For children aged 5 to 11 years, the dose is weight-based: 1 to 2 mg per kg of body weight per day, divided into 2 to 3 doses. Children weighing up to 40 kg should not exceed 2 mg/kg per day.
Pregnancy and Breastfeeding
Hydroxyzine EQL Pharma must not be taken during pregnancy. The active substance crosses the placenta, and there is a risk of harm to the developing fetus. Animal studies and limited human data suggest potential adverse effects on fetal development. If you are pregnant, think you may be pregnant, or are planning to have a baby, do not take this medicine and consult your healthcare provider about safe alternatives.
Hydroxyzine is also contraindicated during breastfeeding. Hydroxyzine and its active metabolite cetirizine are excreted in human breast milk, and the sedating effects could affect the nursing infant. If treatment with hydroxyzine is medically necessary, breastfeeding must be discontinued for the duration of therapy.
Driving and Operating Machinery
Hydroxyzine EQL Pharma can significantly impair your reaction time and ability to concentrate. Drowsiness is the most frequently reported side effect, affecting more than 1 in 10 patients. You should not drive or operate heavy machinery until you know how this medication affects you. The sedating effects may be more pronounced at the start of treatment and can be intensified by alcohol or other central nervous system depressants.
Hydroxyzine EQL Pharma contains anhydrous lactose as an excipient. If you have been told by your doctor that you have an intolerance to certain sugars, contact your doctor before taking this medicine.
How Does Hydroxyzine EQL Pharma Interact with Other Drugs?
Drug interactions are a critical safety consideration with hydroxyzine. The medication affects the central nervous system and can influence cardiac electrical activity, meaning it interacts with a wide range of other pharmaceuticals. Always inform your healthcare provider about all medications you are taking, including over-the-counter drugs, herbal supplements, and vitamins.
Major Interactions — Do Not Combine
Hydroxyzine EQL Pharma must not be taken together with any of the following medications, as the combination can cause dangerous heart rhythm disorders:
| Drug Category | Examples | Risk |
|---|---|---|
| Antibiotics | Erythromycin, moxifloxacin, levofloxacin | QT prolongation, cardiac arrhythmia |
| Antifungals | Pentamidine | QT prolongation, cardiac arrhythmia |
| Cardiac / Antihypertensive | Amiodarone, quinidine, disopyramide, sotalol | QT prolongation, Torsade de Pointes |
| Antipsychotics | Haloperidol | QT prolongation, cardiac arrhythmia |
| Antidepressants | Citalopram, escitalopram | QT prolongation, cardiac arrhythmia |
| Gastrointestinal | Prucalopride | QT prolongation |
| Antimalarials | Mefloquine, hydroxychloroquine | QT prolongation, cardiac arrhythmia |
| Oncology | Toremifene, vandetanib | QT prolongation |
| Opioid / Pain | Methadone | QT prolongation, enhanced CNS depression |
Clinically Significant Interactions
Hydroxyzine EQL Pharma can alter the effects of other medications in important ways. The following interactions require careful monitoring or dose adjustment:
Hydroxyzine may reduce the effectiveness of:
- Betahistine: Used to treat Ménière's disease (balance and hearing problems). Hydroxyzine may counteract the histaminergic effects of betahistine.
- Phenytoin: Used for seizure control. Hydroxyzine may reduce phenytoin's anticonvulsant efficacy.
- Epinephrine (adrenaline): Used for severe allergic reactions. Hydroxyzine may attenuate the vasopressor effects of epinephrine. This is clinically significant in emergency situations.
Hydroxyzine may enhance the effects of:
- Anxiolytic and sedative drugs: Including benzodiazepines, barbiturates, and sleep medications. Combining these with hydroxyzine increases the risk of excessive sedation and respiratory depression.
- Anticholinergic drugs: Such as those used for irritable bowel syndrome. Combining with hydroxyzine may intensify anticholinergic side effects (dry mouth, urinary retention, constipation, blurred vision).
Other notable interactions:
- Cimetidine: May increase hydroxyzine blood levels by inhibiting its hepatic metabolism.
- MAO inhibitors (MAOIs): Used for depression. Concurrent use requires careful monitoring due to potential for enhanced anticholinergic and CNS depressant effects.
- Tricyclic antidepressants, SSRIs, lithium, cisapride: May cause additive QT prolongation when combined with hydroxyzine.
- Thiazide diuretics: May increase the risk of irregular heartbeat by causing electrolyte imbalances (hypokalaemia).
Alcohol
You must not drink alcohol while taking Hydroxyzine EQL Pharma. Alcohol significantly enhances the sedating effects of hydroxyzine, leading to increased drowsiness, impaired cognitive function, slowed reaction times, and potentially dangerous levels of central nervous system depression. This combination can be particularly hazardous when driving or operating machinery.
What Is the Correct Dosage of Hydroxyzine EQL Pharma?
Always take Hydroxyzine EQL Pharma exactly as your doctor or pharmacist has told you. The dose should be individualised based on your condition, age, body weight, and response to treatment. The overarching principle is to use the lowest effective dose for the shortest possible duration. Do not change your dose without first consulting your healthcare provider.
The film-coated tablets should be swallowed with a sufficient amount of water. They can be taken with or without food. The tablet has a score line on both sides, allowing it to be divided into equal halves for dose adjustment.
Adults and Adolescents (12 Years and Older)
Urticaria and Pruritus
- Starting dose: 25 mg (1 tablet) at bedtime
- Usual maintenance dose: May be increased as needed
- Maximum dose: 100 mg per day (4 tablets)
Anxiety (Adults Only)
- Usual dose: 50 mg per day (2 tablets), divided into separate doses
- Maximum dose: 100 mg per day
- Anxiety treatment with hydroxyzine should always be a supportive measure. Treatment should be initiated, monitored, and concluded by the same physician.
Children (5–11 Years)
Urticaria and Pruritus Only
- Dose: 1 to 2 mg per kg body weight per day, divided into 2–3 doses
- Maximum dose: 2 mg/kg/day for children weighing up to 40 kg
- Hydroxyzine is not recommended for children under 5 years of age
Elderly Patients
Reduced Dosing Required
- Starting dose: Half the recommended adult dose
- Maximum dose: 50 mg per day
- The lowest possible effective dose should be selected. Duration of treatment should be as short as possible.
Special Populations
| Patient Group | Adjustment | Maximum Daily Dose |
|---|---|---|
| Hepatic impairment | Reduce daily dose by one-third | Individualised |
| Moderate to severe renal impairment | Reduce dose | Individualised |
| Elderly patients | Start at half the recommended dose | 50 mg/day |
| Children (up to 40 kg) | Weight-based dosing: 1–2 mg/kg/day | 2 mg/kg/day |
| Adults/children over 40 kg | Standard dosing | 100 mg/day |
Missed Dose
If you forget to take a dose of Hydroxyzine EQL Pharma, do not take a double dose to make up for the missed one. Simply take your next dose at the usual time and continue with your regular dosing schedule. Taking a double dose can increase the risk of side effects, particularly excessive drowsiness and cardiac effects.
Overdose
If you have taken more Hydroxyzine EQL Pharma than prescribed, or if a child has accidentally ingested the medication, contact emergency services or your local poison control centre immediately. Symptoms of overdose may include deep sedation, nausea, vomiting, involuntary movements, hallucinations, confusion, and seizures. In severe cases, ECG monitoring should be performed due to the risk of QT prolongation and Torsade de Pointes.
Stopping Treatment
If you decide to stop taking Hydroxyzine EQL Pharma, your symptoms may return or worsen. Always discuss with your doctor before discontinuing treatment. While hydroxyzine does not cause physical dependence, abruptly stopping treatment for chronic urticaria or anxiety may lead to a rebound of the underlying condition.
What Are the Side Effects of Hydroxyzine EQL Pharma?
Like all medicines, Hydroxyzine EQL Pharma can cause side effects, although not everybody gets them. Side effects are listed below by frequency, from most common to rarest. Most side effects are mild and tend to resolve as your body adjusts to the medication, but some can be serious and require immediate medical attention.
Stop taking hydroxyzine and contact emergency medical services immediately if you experience heart rhythm problems such as palpitations, difficulty breathing, or loss of consciousness. These may be signs of a serious cardiac arrhythmia.
Very Common
May affect more than 1 in 10 people
- Drowsiness (somnolence)
Common
May affect up to 1 in 10 people
- Headache
- Fatigue
- Dry mouth
- Sedation
Uncommon
May affect up to 1 in 100 people
- Agitation, confusion
- Dizziness, insomnia, tremor
- Nausea
- Malaise (general feeling of being unwell), fever
Rare
May affect up to 1 in 1,000 people
- Hypersensitivity (allergic reactions)
- Disorientation, hallucinations
- Seizures (convulsions), dyskinesia (movement disorders)
- Difficulty focusing the eyes, blurred vision
- QT prolongation, Torsade de Pointes, cardiac arrest, ventricular arrhythmias (fibrillation and tachycardia)
- Low blood pressure (hypotension)
- Constipation, vomiting
- Elevated liver enzyme values
- Pruritus, urticaria, bruising or blisters, dermatitis
- Urinary retention
Very Rare
May affect up to 1 in 10,000 people
- Anaphylaxis (potentially fatal allergic reaction)
- Bronchospasm (airway constriction)
- Angioedema (swelling of face, lips, and/or throat)
- Increased sweating, fixed drug eruption
- Acute generalised exanthematous pustulosis (widespread rash with blisters)
- Erythema multiforme (ring-shaped, red rashes, often with blisters)
- Stevens-Johnson syndrome (severe skin and mucous membrane reaction with high fever)
Frequency Not Known
Cannot be estimated from available data
- Thrombocytopenia (reduced blood platelet count)
- Aggression, depression, tics (involuntary muscle twitches)
- Dystonia (abnormal muscle contractions), paraesthesia (tingling or numbness)
- Oculogyric crisis (uncontrolled circular eye movements)
- Diarrhoea
- Abnormal urination (enuresis or difficulty urinating)
- Asthenia (extreme tiredness), oedema (tissue swelling)
- Weight gain
Children and Elderly Patients
Children and elderly patients are more susceptible to the side effects of hydroxyzine. In children, central nervous system effects such as seizures may occur more readily. In elderly patients, sedation, cognitive impairment, falls, and cardiac effects are of particular concern. Dosage adjustments are essential for both populations (see the dosage section above).
It is important to report suspected side effects after the medicine has been authorised. This allows ongoing monitoring of the medicine's benefit-risk balance. Healthcare professionals and patients are encouraged to report any suspected adverse reactions to their national pharmacovigilance authority.
How Should You Store Hydroxyzine EQL Pharma?
Proper storage of medication is essential to maintain its effectiveness and safety. Hydroxyzine EQL Pharma should be stored according to the following guidelines:
- Keep out of sight and reach of children. Store in a secure location that is inaccessible to young children and pets.
- Do not use after the expiry date printed on the carton and blister pack after "EXP." The expiry date refers to the last day of the stated month.
- No special storage conditions are required for this medication. Store at room temperature away from excessive heat and moisture.
- Dispose of properly: Do not throw medicines in the toilet or with household rubbish. Ask your pharmacist how to dispose of medicines you no longer use. These measures help protect the environment.
If you notice any visible changes in the appearance of the tablets (discolouration, crumbling, or damage to the blister packaging), do not use them and consult your pharmacist.
What Does Hydroxyzine EQL Pharma Contain?
Understanding what a medicine contains is important, particularly if you have known allergies or intolerances to specific ingredients. Below is the complete composition of Hydroxyzine EQL Pharma 25 mg film-coated tablets.
Active Ingredient
Each film-coated tablet contains 25 mg of hydroxyzine hydrochloride. Hydroxyzine hydrochloride is the salt form of hydroxyzine, a piperazine-class compound with antihistamine, anxiolytic, and sedative properties.
Inactive Ingredients (Excipients)
- Anhydrous lactose — a sugar used as a tablet filler. Patients with lactose intolerance should consult their doctor.
- Microcrystalline cellulose — a plant-derived bulking agent
- Colloidal anhydrous silicon dioxide — a flow agent to ensure uniform tablet composition
- Magnesium stearate — a lubricant used in tablet manufacturing
- Hypromellose — a polymer used in the film coating
- Titanium dioxide (E171) — a white colourant used in the film coating
- Macrogol — a plasticiser used in the film coating
Appearance and Packaging
Hydroxyzine EQL Pharma 25 mg is a white to off-white, oblong, biconvex film-coated tablet with a score line on both sides, allowing it to be split into two equal halves. It is available in blister packs containing 25 or 100 film-coated tablets.
Frequently Asked Questions About Hydroxyzine EQL Pharma
Hydroxyzine is prescribed for two main conditions: (1) short-term management of anxiety in adults when other medications are not suitable, and (2) treatment of urticaria (hives) and pruritus (itching) caused by allergic reactions in adults, adolescents, and children aged 5 years and older. It works as a sedating antihistamine, blocking histamine receptors and calming certain brain activity without causing addiction or dependence.
No, hydroxyzine is not addictive. Unlike benzodiazepines and other commonly used anxiolytic medications, hydroxyzine does not create physical or psychological dependence. It suppresses certain functions in the central nervous system without engaging the reward pathways that lead to addiction. However, it should still be used at the lowest effective dose for the shortest possible duration, as recommended by the European Medicines Agency (EMA) and other regulatory bodies.
Yes, hydroxyzine can increase the risk of heart rhythm problems, specifically a condition called QT prolongation, which can lead to potentially life-threatening arrhythmias such as Torsade de Pointes. This risk is heightened in patients who already have cardiovascular disease, electrolyte imbalances, or who are taking other medications that also prolong the QT interval. If you experience palpitations, difficulty breathing, or fainting while taking hydroxyzine, stop the medication and seek immediate medical attention.
Hydroxyzine is rapidly absorbed after oral administration, with peak blood levels reached within approximately 2 hours. For anxiety relief, effects are typically noticed within 30 to 60 minutes of taking the tablet. For allergic symptoms such as urticaria and itching, the antihistamine effects usually begin within 1 to 2 hours. The sedative effects may persist for several hours. The full duration of action for antihistamine effects is approximately 4 to 6 hours per dose.
No, hydroxyzine must not be taken during pregnancy or breastfeeding. The active substance crosses the placenta and there is a risk of harm to the developing fetus. Hydroxyzine and its active metabolite cetirizine are also excreted in breast milk, potentially affecting the nursing infant. If treatment is medically necessary, breastfeeding must be discontinued. Always consult your healthcare provider about safe alternatives if you are pregnant, planning to become pregnant, or breastfeeding.
The most common side effect of hydroxyzine is drowsiness (somnolence), affecting more than 1 in 10 people. Other common side effects (affecting up to 1 in 10) include headache, fatigue, dry mouth, and sedation. Uncommon side effects include agitation, confusion, dizziness, insomnia, tremor, nausea, and general malaise. Most of these side effects are mild and tend to diminish as your body adjusts to the medication. If any side effects become severe or persistent, consult your healthcare provider.
References
This article is based on the following peer-reviewed sources and authoritative medical guidelines:
- European Medicines Agency (EMA). Assessment report: Hydroxyzine-containing medicinal products (EMEA/H/A-31/1396). EMA/753304/2015. Available at: www.ema.europa.eu
- World Health Organization (WHO). WHO Model List of Essential Medicines — 23rd List, 2023. Geneva: World Health Organization; 2023.
- Simons FER, Simons KJ. Histamine and H1-antihistamines: celebrating a century of progress. Journal of Allergy and Clinical Immunology. 2011;128(6):1161-1174. doi: 10.1016/j.jaci.2011.09.005
- Zuberbier T, et al. The international EAACI/GA²LEN/EuroGuiDerm/APAAACI guideline for the definition, classification, diagnosis, and management of urticaria. Allergy. 2022;77(3):734-766. doi: 10.1111/all.15090
- National Institute for Health and Care Excellence (NICE). Generalised anxiety disorder and panic disorder in adults: management. Clinical guideline CG113. Updated 2020.
- Guaiana G, Barbui C, Chiodo D, et al. Hydroxyzine for generalised anxiety disorder. Cochrane Database of Systematic Reviews. 2010;(12):CD006815. doi: 10.1002/14651858.CD006815.pub2
- British National Formulary (BNF). Hydroxyzine hydrochloride monograph. Available at: bnf.nice.org.uk
- Llorca PM, et al. Efficacy and safety of hydroxyzine in the treatment of generalized anxiety disorder: a 3-month double-blind study. Journal of Clinical Psychiatry. 2002;63(11):1020-1027.
Medical Editorial Team
This article was written and reviewed by the iMedic Medical Editorial Team, comprising board-certified physicians with expertise in clinical pharmacology, dermatology, and psychiatry.
Written by licensed physicians with specialist training in clinical pharmacology and evidence-based medicine. All medical claims are supported by peer-reviewed research and international guidelines.
Independently reviewed by the iMedic Medical Review Board according to EMA, FDA, WHO, and NICE guidelines. Evidence level: 1A (systematic reviews and meta-analyses of RCTs).
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