Patient leaflet - Cetirizine Hydrochloride 10 mg tablets (One A Day)

1. What Cetirizine hydrochloride Tablets is and what it is used for

Cetirizine hydrochloride, 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 hydrochloride Tablets 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 hydrochloride Tablets 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.

2. What you need to know before you take Cetirizine hydrochloride Tablets

Do not take Cetirizine hydrochloride Tablets:

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

Warning and precautions

Talk to your doctor or pharmacist before taking Cetirizine hydrochloride 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 Cetirizine hydrochloride tablets with alcohol.

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.

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 Cetirizine hydrochloride tablets

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

Cetirizine hydrochloride tablets with food and drink

Food does not affect absorption of Cetirizine hydrochloride tablets.

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.

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 during breast-feeding unless you have contacted a doctor.

Driving and using machines

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.

Cetirizine hydrochloride Tablets contains 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.

This medicine contains less than 1 mmol sodium (23 mg) per Film-coated tablet, that is to say essentially ‘sodium-free’.

3. How to take Cetirizine hydrochloride Tablets

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

Children aged 6 to 12:

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

Adults and adolescents aged 12 years and over:

The recommended dose is 10 mg 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 hydrochloride 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 Cetirizine hydrochloride Tablets than you should

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.

If you forget to take Cetirizine hydrochloride Tablets

Do not take a double dose to make up for a forgotten tablet. 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 hydrochloride Tablets

Rarely, pruritus (intense itching) and/or urticaria (hives) may return if you stop taking Cetirizine hydrochloride 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), 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 (bed wetting, pain and/or difficulty passing water)

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

Arthralgia (joint pain), myalgia (muscular pain)
Acute generalized exanthematous pustulosis (rash with blisters containing pus)
Increased appetite
Suicidal ideation (recurring thoughts of or preoccupation with suicide), nightmare
Amnesia (memory loss), memory impairment
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 or 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.

5. How to store Cetirizine hydrochloride Tablets

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the blister and the carton. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Cetirizine hydrochloride Tablets contains

The active substance is Cetirizine hydrochloride. One film-coated tablet contains 10 mg of Cetirizine hydrochloride.
The other ingredients are lactose monohydrate, microcrystalline cellulose, maize starch, colloidal anhydrous silica, magnesium stearate, talc, hypromellose, titanium dioxide (E171), macrogol 4000 and sodium citrate.

What Cetirizine hydrochloride Tablets looks like and contents of the pack

White circular film-coated tablets, marked ‘A’ on one side with a break line on the other side

Pack available in blister pack containing 7 tablets.

Marketing Authorisation Holder

Chanelle Medical Unlimited Company, Loughrea, Co. Galway, Ireland.

Manufacturer