Cetirizine Hydrochloride 10mg Tablets

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist 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 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 Cetirizine Hydrochloride Tablets are and what they are used for
2. What you need to know before you take Cetirizine Hydrochloride Tablets
3. How to take Cetirizine Hydrochloride Tablets
4. Possible side effects
5. How to store Cetirizine Hydrochloride Tablets
6. Contents of the pack and other information

• if you are allergic to cetirizine hydrochloride, or any of the ingredients of this medicine (listed in section 6), to hydroxyzine or to any piperazine derivatives (closely related active substances of other medicines)
• if you have an end-stage kidney disease (severe renal failure requiring dialysis).

• 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.
• If you are scheduled for allergy testing, ask your doctor if you should stop taking Cetirizine Hydrochloride Tablets for several days before testing. This medicine may affect your allergy test results.

The use of this medicine is not recommended in children aged less than 6 years since this formulation does not allow for appropriate dose adaptation.

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

Food does not affect absorption of Cetirizine Hydrochloride Tablets.

No clinically significant interactions have been observed between alcohol (at the blood level of 0.5 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 Cetirizine Hydrochloride Tablets with alcohol.

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.

Cetirizine Hydrochloride 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 Cetirizine Hydrochloride Tablets if you are breast-feeding unless you have contacted a doctor.

Clinical studies have produced no evidence of impaired attention, alertness and driving capabilities after taking Cetirizine Hydrochloride Tablets at the recommended dose. You should closely observe your response to the drug after you have taken Cetirizine Hydrochloride Tablets if you are intending to drive, engage in potentially hazardous activities or operate machinery. You should not exceed the recommended dose.

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

The duration of the 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 Cetirizine Hydrochloride 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 Hydrochloride 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 they might start later.

Common side effects (may affect up to 1 in 10 patients)

• Somnolence (sleepiness)
• Dizziness, headache
• Diarrhoea, nausea, dry mouth
• Fatigue
• Pharyngitis, cold-like symptoms of the nose (children only).

Uncommon side effects (may affect up to 1 in 100 patients)

• Feeling agitated
• Paresthesia (abnormal feelings of the skin)
• Abdominal pain
• Pruritus (itchy skin), rash
• Asthenia (extreme fatigue), malaise (feeling generally unwell).

Rare side effects (may affect up to 1 in 1000 patients)

• Depression, hallucination (hearing or seeing things), aggression, confusion, sleeplessness
• Convulsions
• Tachycardia (heart beating too fast)
• Liver function abnormal
• Urticaria (hives)
• Oedema (generalised swelling due to water retention)
• Weight increased.

Very rare side effects (may affect up to 1 in 10,000 patients)

• Low levels of blood platelets causing unusual bleeding or bruising
• Tics (habit spasm)
• Syncope (fainting), dyskinesia (involuntary movements), dystonia (abnormal prolonged muscular contractions), tremor, dysgeusia (altered taste)
• Blurred vision, accommodation disorder (difficulty focusing), oculogyric crisis (eyes having uncontrolled circular movements)
• Angioedema (serious allergic reaction which causes swelling of the face or throat), fixed drug eruption (drug allergy)
• Abnormal elimination of urine (bedwetting, pain and/or difficulty passing water).

Not known frequency of side effects (frequency cannot be estimated from the available data)

• Increased appetite
• Memory loss and forgetfulness
• 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)
• Arthralgia (joint pain), myalgia (muscle pain)
• Acute generalised exanthematous pustulosis (rash with blisters containing pus)
• Suicidal ideation (recurring thoughts of or preoccupation with suicide), nightmares.

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: 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.

Each tablet contains 10mg of cetirizine hydrochloride (the active ingredient). They also contain: lactose, microcrystalline cellulose, maize starch, colloidal anhydrous silica, magnesium stearate, talc, hypromellose, titanium dioxide (E171), macrogol 4000 and sodium citrate.

The tablets are white circular bi-convex, film-coated tablets marked C on one side and a breakline on the other.

Available in cartons containing 7, 14, 21, 28, 30 and 60 tablets.

Not all pack sizes may be marketed.