Patient leaflet - Cetirizine Dihydrochloride 10 mg film-coated tablets
1. WHAT CETIRIZINE TABLET IS AND WHAT IT IS USED FOR
Cetirizine dihydrochloride is the active ingredient of Cetirizine tablet, which belongs to a group of medicines called antihistamines. Cetirizine is an antiallergic medication. In adults and paediatric patients 6 years and above, Cetirizine is indicated
- for the relief of hay fever (allergic rhinitis) and year round allergies such as dust or pet allergies (perennial allergic rhinitis)
- for the relief of chronic nettle rash (chronic idiopathic urticaria).
You must talk to a doctor if you do not feel better or if you feel worse after 3 days.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CETIRIZINE TABLETS
Do NOT take Cetirizine Tablets
if you have a severe kidney disease (severe renal failure with creatinine clearance
below 10 ml/min);
if you are allergic to cetirizine dihydrochloride, 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, nurse or pharmacist before taking Cetirizine 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 Tablets with alcohol. If you are scheduled for allergy testing, ask your doctor if you should stop taking Cetirizine Tablets for several days before testing. This medicine may affect your allergy test results. This medicine does not normally make you feel sleepy. However, everyone reacts differently. If you do feel sleepy do not drive or use tools or machines. 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 Tablets
Tell your doctor, nurse or pharmacist if you are taking, have recently taken or might take any other medicines.
Cetirizine Tablets with food and drink
Food does not affect absorption of Cetirizine 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 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 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 Tablets at the recommended dose. You should closely observe your response to the drug after you have taken Cetirizine Tablets if you are intending to drive, engage in potentially hazardous activities or operate machinery. You should not exceed the recommended dose.
3. How to take Cetirizine Tablets
Always take this medicine exactly as described in this leaflet or as your doctor, nurse or pharmacist has told you. Check with your doctor, nurse or pharmacist if you are not sure. The tablets need to be swallowed with a glass of liquid.
The tablet can be divided into 2 equal doses.
Children aged 6 to 12:
The recommended dose is 5 mg 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, nurse or pharmacist.
Patients with renal impairment
Patients with moderate renal impairment are recommended to take 5 mg once daily.If you suffer from severe kidney disease, please contact your doctor, nurse or pharmacist who may adjust the dose accordingly.
If your child suffers from kidney disease, please contact your doctor, nurse 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, nurse or pharmacist for advice.
If you take more Cetirizine Tablets than you should
If you think you have taken an overdose of Cetirizine 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, ailing (feeling unwell), dilating of pupil, itching, restlessness, sedation, somnolence (sleepi-ness), stupor, abnormal rapid heart rate, tremors and urinary retention (difficulty in completely emptying the bladder) have been reported.
If you forget to take Cetirizine 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 Tablets
Rarely, pruritus (intense itching) and/or urticaria (hives) may return if you stop taking Cetirizine Tablets.
If you have any further questions on the use of this medicine, ask your doctor, nurse 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, rhinitis (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)
- Abdominalpain
- 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)
- 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)
- Increased appetite
- Suicidal ideation (recurring thoughts of or preoccupation with suicide),nightmare • Amnesia, 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)
- Arthralgia (joint pain)
Reporting of side effects
If you get any side effects, talk to your doctor, nurse or pharmacist. 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/yellow card 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 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 carton. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions. Do not throw away any medicines via waste water 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 Tablets contain
The active substance is cetirizine dihydrochloride. One film-coated tablet contains 10 mg cetirizine dihydrochloride.
The other ingredients are Croscarmellose sodium, Celloulose Microcrystalline, Silica Colloidal anhydrous, Magnesium stearate, Opadry white (03A28437) (Which contains Hypromellose and Titanium dioxide)
What Cetirizine Tablets look like and contents of the pack
Cetirizine Tablets are White to off-white, oval rectangular film-coated tablets with “10” on one side and score line on other side.
They are supplied in blister packs of 10X10s.
Marketing Authorisation Holder:
Farmak Pharmaceuticals UK Ltd, First Floor, 47 Queen Street, Hull, HU1 1UU, United Kingdom
Manufacturer
Ascenders consulting Services Limited, 110 Butterfield, Great Marlings, Luton, LU2 8DL, United Kingdom.
Marketing Authorisation Number:
PL 59209/0045
This leaflet was last revised: July 2026
140 mm Front side
140 mm Back Side
Size : 140 x 500 mm
Folding Size : 140 x 30 mm