Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Wockhardt Allergy and Hayfever Relief 10mg Film-coated Tablets
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Cetirizine dihydrochloride may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for Cetirizine dihydrochloride, the active ingredient of the tablets is an antihistamine. It blocks the effects of a substance called histamine which occurs naturally in the body. Histamine is involved in allergic reactions. In adults and children aged 6 years and above, cetirizine is used to treat people who have hay fever (seasonal allergic rhinitis), year round allergies such as dust or pet allergies (perennial allergic rhinitis) and urticaria (swelling, redness and itchiness of the skin). Antihistamines like cetirizine relieve the unpleasant symptoms and discomfort associated with these conditions, such as sneezing, irritated, runny and blocked up nose, itchy, red and watering eyes and skin rashes.
What you need to know before you take it
e Allergy & Hayfever Relief Tablets
DUMMY
Do not take Allergy & Hayfever Relief Tablets if:
- you have an end stage kidney disease (severe renal failure requiring dialysis)
- you are allergic to cetirizine dihydrochloride, any of the other ingredients of this medicine (listed in section 6), to hydroxyzine or piperazine derivatives (closely related active ingredients of other medicines).
Warnings and precautions Talk to your doctor or pharmacist before taking Allergy & Hayfever Relief Tablets:
- If you are a patient with renal insufficiency, please ask your doctor for advice; if necessary, you will take a lower dose. The new dose will be determined by your doctor
- If you have problems passing urine (like spinal cord problems or prostate or bladder problems), please ask your doctor for advice
- If you are an epileptic patient or a patient at risk of convulsions, you should ask your doctor for advice
- No clinically significant interactions have been observed between alcohol (at the blood level of 0.5 per mille (g/l) corresponding to one glass of wine) and cetirizine used at the recommended doses. However, there are no data available on the safety when higher doses of cetirizine and alcohol are taken together. Therefore, as it is the case with all antihistamines, it is recommended to avoid taking Allergy & Hayfever Relief Tablets with alcohol
- If you are scheduled for allergy testing, ask your doctor if you should stop taking Allergy & Hayfever Relief Tablets for several days before testing. This medicine may affect your allergy test results. Children Do not give this medicine to children below the age of 6 years because the tablet formulation does not allow the necessary dose adjustments. Other medicines and Allergy & Hayfever Relief Tablets Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Allergy & Hayfever Relief Tablets with food, drink and alcohol Food does not affect absorption of cetirizine. Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Allergy & Hayfever Relief Tablets should be avoided in pregnant women. Accidental use of the drug by a pregnant woman should not produce any harmful effects on the foetus. Nevertheless, the medicine should only be administered if necessary and after medical advice. Cetirizine passes into breast milk. A risk of side effects in breastfed infants cannot be excluded. Therefore, you should not take Allergy & Hayfever Relief Tablets during breast-feeding unless you have contacted a doctor. Driving and using machines This medicine does not normally make you feel sleepy. Clinical studies have produced no evidence of impaired attention, alertness and driving capabilities after taking Allergy & Hayfever Relief Tablets at the recommended dose. However, everyone reacts differently. You should closely observe your response to the drug after you have taken Allergy & Hayfever Relief Tablets if you are intending to drive, engage in potentially hazardous activities or operate machinery. If you do feel sleepy do not drive or use tools or machines. You should not exceed the recommended dose. Do not drink alcohol Allergy & Hayfever Relief Tablets contain lactose If you have been told by your doctor that you have an intolerance to some sugars, please contact your doctor before taking these tablets.
How to take it
Allergy & Hayfever Relief Tablets Always take this medicine exactly as described in this leaflet or as the doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The tablets need to be swallowed with a glass of liquid. The tablet can be divided into equal doses. Do not take more than one tablet each day. Use in children aged 6-12 years:
- The recommended dose is 5mg twice daily as a half tablet twice daily. Adults and adolescents aged 12 years and over:
- The recommended dose is 10mg once daily as one tablet daily. If the tablets make you feel drowsy or dizzy, taking half a tablet twice a day may be better than taking one tablet once a day. Other form(s) of this medicine may be more suitable for children; ask your doctor or pharmacist. Patients with renal impairment Patients with moderate renal impairment are recommended to take 5mg once daily. If you suffer from severe kidney disease, please contact your doctor or pharmacist who may adjust the dose accordingly. If your child suffers from kidney disease, please contact your doctor or pharmacist who may adjust the dose according to your child's needs. If you feel that the effect of Cetirizine Tablets is too weak or too strong, please consult your doctor.
Duration of treatment The duration of treatment depends on the type, duration and course of your complaints. Please ask your doctor or pharmacist for advice. If you take more Allergy & Hayfever Relief Tablets than you should If you think you have taken an overdose of Allergy & Hayfever Relief Tablets please inform your doctor. Your doctor will then decide what measures, if any, should be taken. After an overdose, the side effects described below may occur with increased intensity. Adverse effects such as confusion, diarrhoea, dizziness, tiredness, headache, malaise (feeling unwell), dilating of pupil, itching, restlessness, sedation, somnolence (sleepiness), stupor, abnormal rapid heart rate, tremors and urinary retention (difficulty in completely emptying the bladder) have been reported. If you forget to take Allergy & Hayfever Relief Tablets Do not take a double dose to make up for a forgotten dose. If you forget to take a tablet, you should take one as soon as you remember, but wait at least 24 hours before taking your next tablet. If you stop taking Cetirizine Tablets Rarely, pruritus (intense itching) and/or urticaria may return if you stop taking Cetirizine Tablets. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 4. Possible side effects Like all medicines this medicine can cause side effects, although not everybody gets them. The following side effects are rare or very rare, but you must stop taking the tablets and speak to your doctor straight away if you notice them:
- Allergic reactions, including severe reactions and angioedema (serious allergic reaction which causes swelling of the face or throat). These reactions may start soon after you first take the medicine, or it might start later. Common side effects (may affect up to 1 in 10 patients)
- Somnolence (sleepiness)
- Dizziness, headache
- Pharyngitis (sore throat), rhinitis (runny, stuffy nose) (in children)
- Diarrhoea, nausea, dry mouth
- Fatigue. Uncommon side effects (may affect up to 1 in 100 patients)
- Agitation
- Paraesthesia (abnormal feelings of the skin)
- Abdominal pain
- Pruritus (itchy skin), rash
- Asthenia (extreme fatigue), malaise (feeling unwell). Rare side effects (may affect up to 1 in 1,000 patients)
- Allergic reactions, some severe (very rare)
- Depression, hallucination, aggression, confusion, insomnia
- Convulsions
- Tachycardia (heart beating too fast)
- Liver function abnormal
- Urticaria (hives)
- Oedema (swelling)
- Weight increased. Very rare side effects (may affect up to 1 in 10,000 patients)
- Thrombocytopenia (low levels of blood platelets)
- Tics (habit spasm)
- Syncope (fainting), dyskinesia (involuntary movements), dystonia (abnormal prolonged muscular contractions), tremor, dysgeusia (altered taste)
- Blurred vision, accommodation disorder (difficulty focusing), oculogyration (eyes having uncontrolled circular movements)
- Abnormal elimination of urine (bed wetting, pain and/or difficulty passing water)
- Angioedema (serious allergic reaction which causes swelling of the face or throat), fixed drug eruption (drug allergy). Not known frequency of side effects (frequency cannot be estimated from the available data)
- Arthralgia (joint pain), myalgia (muscular pain)
- Acute generalized exanthematous pustolosis (rash with blisters containing pus)
- Increased appetite
- Suicidal ideation (recurring thoughts of or preoccupation with suicide), nightmare
- Amnesia (memory loss), memory impairment
- Rash with blisters containing pus
- Vertigo (sensation of rotation or movement)
- Urinary retention (inability to completely empty the urinary bladder)
- Pruritus (intense itching) and/or urticaria upon discontinuation
- Hepatitis (inflammation of the liver). Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any
Possible side effects
not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: http://www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
How to store it
Allergy & Hayfever Relief Tablets Keep medicine out of the sight and reach of children. This medicinal product does not require any special storage conditions. Do not use after the expiry date which is stated on the blister strip and carton. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.
Contents of the pack and other information
What Allergy & Hayfever Relief Tablets contain The active substance is cetirizine; each tablet contains 10mg of cetirizine dihydrochloride. The other ingredients are microcrystalline cellulose, lactose monohydrate, crospovidone, anhydrous colloidal silica, magnesium stearate, hypromellose (E464), titanium dioxide (E171) and polyethylene glycol (macrogol 400). What Allergy & Hayfever Relief Tablets look like and contents of the pack Allergy & Hayfever Relief Tablets are white, or almost white, oval-shaped tablets with a score line on one side. Allergy & Hayfever Relief Tablets are available from in packs of 7, 10, 14, 20 or 30 Tablets. Not all pack sizes may be marketed. Other formats: To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge: 0800 198 5000 (UK Only). Please be ready to give the following information: Product name
Reference number
Wockhardt Allergy & Hayfever Relief 10mg Tablets
PL 29831/0681
This is a service provided by the Royal National Institute of Blind People. Marketing Authorisation Holder: Wockhardt UK Limited, Ash Road North, Wrexham, LL13 9UF, United Kingdom Manufacturer: CP Pharmaceuticals Limited, Ash Road North, Wrexham, LL13 9UF, United Kingdom This leaflet was last revised in 10/2021. 107821/7 XXXXXX
Frequently asked questions about Wockhardt Allergy and Hayfever Relief 10mg Film-coated Tablets
How do I take Wockhardt Allergy and Hayfever Relief 10mg Film-coated Tablets?
Wockhardt Allergy and Hayfever Relief 10mg Film-coated Tablets comes as tablet containing 10mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Wockhardt Allergy and Hayfever Relief 10mg Film-coated Tablets?
The active substance in Wockhardt Allergy and Hayfever Relief 10mg Film-coated Tablets is cetirizine dihydrochloride.
Are there equivalent medicines to Wockhardt Allergy and Hayfever Relief 10mg Film-coated Tablets?
Medicines with the same active substance, strength and form include: Benadryl Allergy One A Day 10mg Tablets, Piriteze Hayfever & Allergy 10mg Film Coated Tablets, Vividrin Allergy Relief 10 mg film-coated tablets. In total there are 7 equivalent products. They are interchangeable only if your prescriber or pharmacist says so.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Wockhardt Allergy and Hayfever Relief 10mg Film-coated Tablets, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Wockhardt Allergy and Hayfever Relief 10mg Film-coated Tablets without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: cetirizine dihydrochloride
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
In adults and paediatric patients 6 year and above:
- Cetirizine is indicated for the relief of nasal and ocular symptoms of seasonal and perennial allergic rhinitis.
- Cetirizine is indicated for the relief of symptoms of chronic idiopathic urticaria.
4.2. Posology and method of administration
Posology
Adolescents above 12 years of age: 10 mg once daily (1 tablet).
Special population
Elderly
Data do not suggest that the dose needs to be reduced in elderly subjects provided that the renal function is normal.
Renal impairment
There are no data to document the efficacy/safety ratio in patients with renal impairment. Since cetirizine is mainly excreted via renal route (see section 5.2), in cases where no alternative treatment can be used, the dosing intervals must be individualized according to renal function. Refer to the following table and adjust the dose as indicated.
Dosing adjustments for adult patients with impaired renal function
Group
GFR (mL/min)
Dosage and frequency
Normal renal function
≥ 90
10 mg once daily
Mildly decreased renal function
60 - < 90
10 mg once daily
Moderately decreased renal function
30 - < 60
5 mg once daily
Severely decreased renal function
15 - < 30 not requiring dialysis treatment
5 mg once every 2 days
End-stage renal disease
<15 requiring dialysis treatment
Contra-indicated
Hepatic impairment
No dose adjustment is needed in patients with solely hepatic impairment.
In patients with hepatic impairment and renal impairment, adjustment of the dose is recommended (see renal impairment above).
Paediatric population
The tablet formulation should not be used in children under 6 years of age as it does not allow the necessary dose adjustments.
Children aged from 6 to 12 years: 5 mg twice daily (a half tablet twice daily).
In paediatric patients suffering from renal impairment, the dose will have to be adjusted on an individual basis taking into account the renal clearance, age and body weight of the patient.
Method of administration
The tablets need to be swallowed with a glass of liquid.
4.3. Contraindications
Hypersensitivity to the active substance, to any of the excipients listed in section 6.1, to hydroxyzine or to any piperazine derivatives.
Patients with end-stage renal disease with GFR (Glomerular Filtration Rate) below 15ml/min.
4.4. Special warnings and precautions for use
At therapeutic doses, no clinically significant interactions have been demonstrated with alcohol (for a blood alcohol level of 0.5 g/L). Nevertheless, precaution is recommended if alcohol is taken concomitantly.
Caution should be taken in patients with predisposition factors of urinary retention (e.g spinal cord lesion, prostatic hyperplasia) as cetirizine may increase the risk of urinary retention.
Caution is recommended in epileptic patients and patients at risk of convulsions.
Response to allergy skin tests are inhibited by antihistamines and a wash-out period (of 3 days) is required before performing them.
Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose- galactose malabsorption should not take this medicine.
Pruritus and/or urticaria may occur when cetirizine is stopped, even if those symptoms were not present before treatment initiation. In some cases, the symptoms may be intense and may require treatment to be restarted. The symptoms should resolve when the treatment is restarted.
Paediatric population
The use of the film-coated tablet formulation is not recommended in children aged less than 6 years since this formulation does not allow for appropriate dose adaptation.
It is recommended to use a paediatric formulation of cetirizine.
4.5. Interaction with other medicinal products and other forms of interaction
Due to the pharmacokinetic, pharmacodynamic and tolerance profile of cetirizine, no interactions are expected with this antihistamine. Actually, neither pharmacodynamic nor significant pharmacokinetic interaction was reported in drug-drug interactions studies performed, notably with pseudoephedrine or theophylline (400 mg/day).
The extent of absorption of cetirizine is not reduced with food, although the rate of absorption is decreased.
The concurrent use of alcohol or other CNS depressants may cause additional reductions in alertness and impairment of performance, although cetirizine does not potentiate the effect of alcohol (0.5 g/L blood levels).
4.6. Fertility, pregnancy and lactation
Pregnancy
For cetirizine prospectively collected data on pregnancy outcomes do not suggest potential for maternal or foetal/embryonic toxicity above background rates.
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or post natal development. Caution should nevertheless be exercised when prescribing to pregnant women.
Breast-feeding
Cetirizine passes into breast milk. A risk of side effects in breastfed infants cannot be excluded. Cetirizine is excreted in human milk at concentrations representing 25% to 90% those measured in plasma, depending on sampling time after administration. Therefore, caution should be exercised when prescribing cetirizine to lactating women.
Fertility
Limited data is available on human fertility but no safety concern has been identified.
Animal data show no safety concern for human reproduction.
4.7. Effects on ability to drive and use machines
Objective measurements of driving ability, sleep latency and assembly line performance have not demonstrated any clinically relevant effects at the recommended dose of 10 mg. However, patients who experience somnolence should refrain from driving, engaging in potentially hazardous activities or operating machinery. They should not exceed the recommended dose and should take their response to the medicinal product into account.
4.8. Undesirable effects
Clinical studies
• Overview
Clinical studies have shown that cetirizine at the recommended dosage has minor undesirable effects on the CNS, including somnolence, fatigue, dizziness and headache. In some cases, paradoxical CNS stimulation has been reported.
Although cetirizine is a selective antagonist of peripheral H1-receptors and is relatively free of anticholinergic activity, isolated cases of micturition difficulty, eye accommodation disorders and dry mouth have been reported.
Instances of abnormal hepatic function with elevated hepatic enzymes accompanied by elevated bilirubin have been reported. Mostly this resolves upon discontinuation of the treatment with cetirizine dihydrochloride.
• Listing of ADRs
Double blind controlled clinical trials comparing cetirizine to placebo or other antihistamines at the recommended dosage (10 mg daily for cetirizine), of which quantified safety data are available, included more than 3200 subjects exposed to cetirizine.
From this pooling, the following adverse reactions were reported for cetirizine 10 mg in the placebo-controlled trials at rates of 1.0 % or greater:
Adverse reactions
(WHO-ART)
Cetirizine 10 mg
(n= 3260)
Placebo
(n = 3061)
General disorders and administration site conditions
Fatigue
1.63 %
0.95 %
Nervous system disorders
Dizziness
Headache
1.10%
7.42%
0.98%
8.07%
Gastro-intestinal disorders
Abdominal pain
Dry mouth
Nausea
0.98 %
2.09 %
1.07 %
1.08 %
0.82 %
1.14 %
Psychiatric disorders
Somnolence
9.63 %
5.00 %
Respiratory, thoracic and mediastinal disorders
Pharyngitis
1.29 %
1.34 %
Although statistically more common than under placebo, somnolence was mild to moderate in the majority of cases. Objective tests as demonstrated by other studies have demonstrated that usual daily activities are unaffected at the recommended daily dose in healthy young volunteers.
Paediatric population
Adverse drug reactions at rates of 1 % or greater in children aged from 6 months to 12 years, included in placebo-controlled clinical trials are:
Adverse reactions
(WHO-ART)
Cetirizine 10 mg
(n= 1656)
Placebo
(n = 1294)
Gastro-intestinal disorders
Diarrhoea
1.0 %
0.6 %
Psychiatric disorders
Somnolence
1.8 %
1.4 %
Respiratory, thoracic and mediastinal disorders
Rhinitis
1.4 %
1.1 %
General disorders and administration site conditions
Fatigue
1.0 %
0.3 %
Post-marketing experience
In addition to the adverse effects reported during clinical studies and listed above, isolated cases of the following undesirable effects have been reported in post-marketing experience.
Undesirable effects are described according to MedDRA System Organ Class and by estimated frequency based on post-marketing experience.
Frequencies are defined as follows: Very common (≥1/10); common (≥1/100 to <1/10); uncommon ( ≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).
Blood and lymphatic disorders:
Very rare: thrombocytopenia
Immune system disorders:
Rare: hypersensitivity
Very rare: anaphylactic shock
Metabolism and nutrition disorders:
Not known: increased appetite
Psychiatric disorders:
Uncommon: agitation
Rare: aggression, confusion, depression, hallucination, insomnia
Very rare: tics
Not known: suicidal ideation, nightmare
Nervous system disorders:
Uncommon: paraesthesia
Rare: convulsions
Very rare: dysgeusia, syncope, tremor, dystonia, dyskinesia
Not known: amnesia, memory impairment
Eye disorders:
Very rare: accommodation disorder, blurred vision, oculogyric crisis
Ear and labyrinth disorders:
Not known: vertigo
Cardiac disorders:
Rare: tachycardia
Gastro-intestinal disorders:
Uncommon: diarrhoea
Hepatobiliary disorders:
Rare: hepatic function abnormal (increased transaminases, alkaline phosphatase, γ-GT and bilirubin)
Not known: hepatitis
Skin and subcutaneous tissue disorders:
Uncommon: pruritus, rash
Rare: urticaria
Very rare: angioneurotic oedema, fixed drug eruption
Not known: acute generalized exanthematous pustulosis
Musculoskeletal and connective tissue disorders:
Not known: arthralgia, myalgia
Renal and urinary disorders:
Very rare: dysuria, enuresis
Not known: urinary retention
General disorders and administration site conditions:
Uncommon: asthenia, malaise
Rare: oedema
Investigations:
Rare: weight increased
Description of selected adverse reactions
After discontinuation of cetirizine, pruritus (intense itching) and/or urticaria have been reported.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
Symptoms
Symptoms observed after an overdose of cetirizine are mainly associated with CNS effects or with effects that could suggest an anticholinergic effect.
Adverse events reported after an intake of at least 5 times the recommended daily dose are: confusion, diarrhoea, dizziness, fatigue, headache, malaise, mydriasis, pruritus, restlessness, sedation, somnolence, stupor, tachycardia, tremor, and urinary retention.
Management
There is no known specific antidote to cetirizine.
Should overdose occur, symptomatic or supportive treatment is recommended. Gastric lavage may be considered shortly after ingestion of the drug.
Cetirizine is not effectively removed by haemodialysis.
💬 Ask about this leaflet
Ask anything about Wockhardt Allergy and Hayfever Relief 10mg Film-coated Tablets. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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