Wockhardt Allergy and Hayfever Relief 10mg Film-coated Tablets

Always take this medicine exactly as described in this leaflet or as your doctor has told you.

• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• If you get any of the side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
• You must talk to your doctor if you do not feel better or if you feel worse after 3 days.

1. What Allergy & Hayfever Relief Tablets are and what they are used for
2. What you need to know before you take Allergy & Hayfever Relief Tablets
3. How to take Allergy & Hayfever Relief Tablets
4. Possible side effects
5. How to store Allergy & Hayfever Relief Tablets
6. Contents of pack and other information

• 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).

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.

Do not give this medicine to children below the age of 6 years because the tablet formulation does not allow the necessary dose adjustments.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Food does not affect absorption of cetirizine.

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.

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

If you have been told by your doctor that you have an intolerance to some sugars, please contact your doctor before taking these tablets.

• The recommended dose is 5mg twice daily as a half tablet twice daily.

• 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 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.

The duration of treatment depends on the type, duration and course of your complaints. Please ask your doctor or pharmacist for advice.

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.

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.

Rarely, pruritus (intense itching) and/or urticaria may return if you stop taking Cetirizine Tablets.

• 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).

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.

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).

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.

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Product name Reference number

Wockhardt Allergy & Hayfever Relief 10mg Tablets PL 29831/0681

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