Cetirizine Hydrochloride 10 mg film-coated tablets
Generic Name: Cetirizine Hydrochloride
Information For The User
Read all of this leaflet carefully before you start taking this medicine.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
1. What Cetirizine is and what it is used for
Cetirizine belongs to a group of anti-allergy medicines. It helps you control your allergic reaction and its symptoms.
In adults and children aged 6 year and above, Cetirizine is indicated
- for the relief of nasal and ocular symptoms of seasonal and perennial allergic rhinitis.
- for the relief of chronic nettle rash (chronic idiopathic urticaria).
2. Before you use Cetirizine
Do not take Cetirizine
• if you are allergic (hypersensitive) to Cetirizine hydrochloride, to any of the other ingredients of Cetirizine tablets, to hydroxyzine or to piperazine derivatives (closely related active substances of other medicines);
• if you have a severe kidney disease (severe renal failure with creatinine clearance below 10 ml/min).
Take special care with Cetirizine
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 are an epileptic patient or a patient at risk of convulsions, you should ask your doctor for advice.
If you take Cetirizine over a long period of time it may lead to an increased risk of tooth decay due to mouth dryness. Oral hygiene is therefore very important.
If you plan having an allergy skin test made. The use of Cetirizine should be interrupted at least 3 days prior to skin tests.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Due to the profile of Cetirizine, no interactions with other drugs are expected.
Taking Cetirizine with food and drink
Food does not affect noticeably the absorption of Cetirizine.
No interactions susceptible to have a noticeable impact have been observed between alcohol (at the blood level of 0.5 per mille corresponding to one glass of wine) and Cetirizine used at the normal doses. However, as it is the case with all antihistamines, it is recommended to avoid concurrent consumption of alcohol.
Pregnancy and breast-feeding
There is limited experience of the use of Cetirizine in pregnant women. Cetirizine should therefore be used with caution during pregnancy. Tell your doctor if you are pregnant or think that you are pregnant.
Cetirizine passes into breast milk. Cetirizine should therefore be used with caution during breast-feeding. Tell your doctor if you are breast-feeding.
Driving and using machines
Clinical studies have produced no evidence of impaired attention, alertness and driving capabilities after taking Cetirizine at the recommended dose.
If you are intending to drive, engage in potentially hazardous activities or operate machinery, you should not exceed the recommended dose. You should closely observe your response to the drug. If you are a sensitive patient, you may find that the simultaneous use of alcohol or other nervous depressant agents may additionally affect your attention and ability to react.
Important information about some of the ingredients of Cetirizine tablets
This medicinal product contains lactose. If you have been told by your doctor that you have an intolerance to some sugars contact your doctor before taking this medicinal product.
3. How to use Cetirizine
Always take Cetirizine tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
How and when should you take Cetirizine
These guidelines apply unless your doctor has given you different instructions on how to use Cetirizine.
Please follow these instructions, otherwise Cetirizine may not be fully effective.
Tablets need to be swallowed with a glass of liquid.
Adults and adolescents over 12 years of age
10mg once daily as 1 tablet.
Children between 6 and 12 years of age
5mg twice daily as a half tablet twice daily.
Patients with moderate renal Impairment
Patients with moderate renal impairment are recommended to take 5mg once daily.
If you feel that the effect of Cetirizine 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 and is determined by your doctor.
If you take more Cetirizine than you should
If you think you have taken an overdose of Cetirizine, 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, dilating of pupil, itching, restlessness, sedation, somnolence, stupor, abnormal rapid heart rate, tremors and urinary retention have been reported.
If you forget to take Cetirizine
Do not take a double dose to make up for a forgotten dose. Continue with the normal prescribed dose.
If you stop taking Cetirizine
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Cetirizine: Possible side effects
Like all medicines, Cetirizine can cause side effects, although not everybody gets them.
Following side effects have been reported in post marketing experience.
Common side effects (more than 1 in 100 patients, but less than 1 In 10 patients):
|- Dizziness||- Headache|
|- Sleepiness||- Fatigue|
|- Dry mouth||- Nausea|
|- Diarrhoea||- Pharyngitis|
|- Rhinitis (swelling and irritation inside the nose)|
Uncommon side effects (more than 1 in 1,000 patients, but less than 1 in 100 patients):
|- Agitation||- Paraesthesia (feeling of pins and needles)|
|- Abdominal pain|
|- Rash||- Pruritus (itching)|
|- Malaise (vague illness)||- Asthenia (feeling of weakness)|
Rare side effects (more than 1 In 10,000 patients, but less than 1 in 1,000 patients):
|- Allergic reactions||- Aggression|
|- Confusion||- Depression|
|- Insomnia (difficulty in sleeping)||- Hallucination|
|- Fits||- Movement disorders|
|- Changes in liver function||- Rapid heart beat|
|- Swelling||- Hives|
|- Weight increased|
Very rare side effects (less than 1 In 10,000 patients):
|- Thromrjocytopenia (bleeding or bruising easily)||- Life-threatening allergic reaction, including angioedema (which causes swelling of the face or throat)|
|- Tremor||- Dysgeusia (altered taste in the mouth)|
|- Difficulty focussing||- Blurred vision|
|- Oculogyration (eyes having uncontrolled circular movements)||- Fixed drug eruption|
|- Abnormal elimination of urine|
Not known: (cannot be estimated from the available data):
- memory loss, memory impairment If you develop one of the side effects described above, please inform your doctor. At the first signs of a hypersensitivity reaction, stop taking Cetirizine. Your doctor will then assess the severity and decide on any further measures that may be necessary.
You should stop taking Cetirizine and see your doctor immediately if you experience symptoms of angioedema, such as swollen face, tongue or pharynx, difficulty swallowing, hives and difficulty breathing.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. How to store Cetirizine tablets
Keep out of the reach and sight of children.
Do not use Cetirizine tablets after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
Store below 25°C.
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 to protect the environment.
6. Cetirizine tablets: Further information
What Cetirizine tablets contains
- The active substance is Cetirizine hydrochloride. Each film-coated tablet contain 10 mg Cetirizine hydrochloride.
- The other ingredients are lactose monohydrate, crospovidone, pregelatinised starch (maize), magnesium stearate, hypromellose, titanium dioxide and macrogol (400).
What Cetirizine tablets look like and contents of the pack
White to off-white, film-coated, off-rectangular tablets, debossed with “X” on one side with ’20′ on the other side. Score line between ’2′ and ’0′. The tablet can be divided into equal halves.
PVC-PVDC Aluminium blisters:
1, 2, 7,10,14,15, 20, 21, 30, 50, 60, 90, 98 and 100 film-coated tablets
250 film-coated tablets Not all pack sizes may be marketed.
Marketing Authorisation Holder
Aurobindo Pharma (Malta) Limited
46/2, South street, Valletta, VLT11, Malta
Ares, Odyssey Business Park, West End Road,
South Ruislip HA4 6QD, United Kingdom
This medicinal product is authorised in the Member States of the EEA under the following names:
|Austria:||Cetirizin Aurobindo 10 mg Filmtabletten|
|Belgium:||Cetirizine Aurobindo 10 mg filmomhulde tabletten|
|Bulgaria:||Cetirizine Aurobindo 10 mg филмирани таблетки|
|Czech Republic:||Cetirizine Aurobindo 10 mg potahované tablety|
|Finland:||Cetirizin Aurobindo 10 mg kalvopäällysteinen tabletti|
|Germany:||Cetirizin Aurobindo 10 mg Filmtabletten|
|Greece:||Cetirizine Aurobindo 10 mg ετπκαλυμμένα με λετττό υμένιο δισκΐα|
|Hungary||Cetirizine Aurobindo 10 mg filmtabletta|
|Ireland:||Cetirizine Aurobindo 10 mg film-coated tablets|
|Italy:||Cetirizina Aurobindo 10 mg, compresse rivestite con film|
|Lithuania:||Cetirizin Aurobindo 10 mg plévele dengtos tabletas|
|Netherlands:||Cetirizine diHCl Aurobindo 10 mg, filmomhulde tabletten|
|Norway:||Cetirizin Aurobindo 10 mg filmdrasjerte tabletter|
|Romania:||Cetirizin Aurobindo 10 mg comprimate fílmate|
|Slovak Republic:||Cetirizine Aurobindo 10 mg filmom obalené tablety|
|Slovenia:||Cetirizine Aurobindo 10 mg filmsko oblozene tablete|
|Spain:||Cetirizina Aurobindo 10 mg comprimidos recubiertos con película|
|Sweden:||Cetirizine Aurobindo 10 mg filmdragerade tabletter|
|United Kingdom:||Cetirizine hydrochloride 10 mg film-coated tablets|