Cetirizine Hydrochloride 10mg Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
Cetirizine Dihydrochloride 10mg film-coated Tablets
Cetirizine dihydrochloride
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have 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 a doctor if you do not feel better or if you feel worse after 3 days.
What is in this leaflet:
1. What Cetirizine Dihydrochloride 10mg film-coated Tablets are and what they are used for
2. What you need to know before you take Cetirizine Dihydrochloride 10mg film-coated Tablets
3. How to take Cetirizine Dihydrochloride 10mg film-coated Tablets
4. Possible side effects
5. How to store Cetirizine Dihydrochloride 10mg film-coated Tablets
6. Contents of the pack and other information
1. What Cetirizine Dihydrochloride 10mg film-coated Tablets are and what they are used for
Cetirizine Dihydrochloride is an antihistamine for the treatment of allergic diseases. This medicine acts by blocking the effect of histamine, which is involved in the development of the allergic reaction
Cetirizine Dihydrochloride is used for the treatment of symptoms in the following allergic diseases: Adults and children over 6 year:
Seasonal and non-seasonal allergic rhinitis (sneezing, itchy, runny and blocked up nose), allergic inflammation of the eyes (itchy, red and watering eyes) and urticaria (swelling, redness and itchiness of the skin).
2. What you need to know before you take you take Cetirizine Dihydrochloride film-coated 10mg Tablets
Do not take this medicine and tell your doctor
• if you are allergic to cetirizine dihydrochloride, to any of the other ingredients (listed in section 6), to hydroxyzine or to piperazine derivatives (closely related active ingredients of other medicines).
• if you have a severe kidney disease (severe renal failure with creatinine clearance below 10 ml/min).
Warnings and precautions
Talk to your doctor or pharmacist before taking Cetirizine Dihydrochloride 10 mg 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 Dihydrochloride 10 mg tablets with alcohol.
If you are scheduled for allergy testing, ask your doctor if you should stop taking for several days before testing. This medicine may affect your allergy test results.
Children
This medicine is not intended for use in children under 6 years of age. This product is also available as a solution that would be more suitable for this age group.
Other medicines and Cetirizine Dihydrochloride 10 mg tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Due to the profile of cetirizine, no interactions with other drugs are expected.
Cetirizine Dihydrochloride 10 mg tablets with food and drink
Food does not affect absorption of Cetirizine Dihydrochloride 10 mg 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 Dihydrochloride 10mg film-coated 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. Therefore, you should not take Cetirizine Dihydrochloride 10mg film-coated 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 Dihydrochloride 10mg film-coated Tablets at the recommended dose.
You should closely observe your response to the drug after you have taken Cetirizine Dihydrochloride 10mg film-coated Tablets if you are intending to drive, engage in potentially hazardous activities or operate machinery. You should not exceed the recommended dose.
Cetirizine Dihydrochloride film-coated 10mg Tablets contains lactose
Cetirizine Dihydrochloride 10mg film-coated Tablets 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 take Cetirizine Dihydrochloride 10mg Tablets
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is
Adults and adolescents above 12 years old :
1 tablet (10 mg) daily.
Children between 6 and 12 years old:
/ tablet (5 mg) twice daily (morning and evening).
Patients with renal impairment:
Patients with moderate renal impairment are recommended to take / tablet (5 mg) 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 Dihydrochloride 10mg film-coated Tablets is too weak or too strong, please consult your doctor.
Do not exceed the stated dose.
The tablet should preferably be swallowed with liquid (e.g. a glass of water). If the tablets make you drowsy you may take them in the evening. The tablets can be taken with or without food.
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 Dihydrochloride 10mg film-coated Tablets than you should
If you think you have taken an overdose of Cetirizine Dihydrochloride 10mg film-coated 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, 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 Dihydrochloride 10mg film-coated Tablets
If you forget to take Cetirizine Dihydrochloride 10mg film-coated Tablets
Do not take a double dose to make up for a forgotten tablet/dose.
The treatment should be continued as normal.
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.
If any of the following happen, stop taking this medicine and tell your doctor immediately or go to the casualty department at your nearest hospital:
• Cases of allergic reactions such as swelling of the lips, tongue or face (Quincke’s oedema) or difficulty breathing and allergic reactions (flat, burning, itchy marks on the skin with swelling).
These are very serious side effects If you have them, you may have had a serious allergic reaction. You may need urgent medical attention or hospitalisation. All of these very serious side effects are very rare (fewer than 1 in 10,000 patients treated).
Other possible side effects:
Common (may affect up to 1 in 10 people):
• Somnolence (sleepiness),
• Dizziness, headache,
• Pharyngitis, rhinitis (in children)
• Diarrhoea,nausea, dry mouth,
• Fatigue
Uncommon (may affect up to 1 in 100 people):
• Agitation,
• Paresthesia (abnormal feelings of the skin)
• Abdominal pain
• Pruritus (itchy skin), rash
• Asthenia (extreme fatigue), malaise,
Rare(may affect up to 1 in 1,000 people):
• 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 (may affect up to 1 in 10,000 people):
• Thrombocytopenia (low levels of blood platelets)
• Tics (habit spasm)
• Syncope, 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
• Abnormal elimination of urine (bed wetting, pain and/or difficulty passing water)
Not known (cannot be estimated from the available data):
• Increased appetite
• Amnesia, memory impairment
• Vertigo (sensation of rotation or movement)
• Urinary retention (inability to completely empty the urinary bladder)
In very rare cases people have thought about committing suicide and if you feel this way then stop taking the tablets and see your doctor.
Reporting of side effects
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
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Cetirizine Dihydrochloride 10mg 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 and on the blister after ‘Exp:’. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
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. Contents of the pack and other information
What Cetirizine Dihydrochloride 10mg film-coated Tablets contain
The active substance is cetirizine dihydrochloride. One film-coated tablet contains 10 mg.
The other ingredients are:
Tablet core:
Lactose monohydrate Microcristalline cellulose Colloida anhydrous silica Magnesium stearate
Tablet coat:
Titanium dioxide (E171)
Hypromellose Macrogol 400
What Cetirizine Dihydrochloride 10mg film-coated Tablets look like and contents of the pack
White to off-white film-coated tablets, with a break-line on one side.
Blisterpacks containing 2, 7, 10, 14, 20, 20x1, 30, 50, 90, 100, 100x1 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
ratiopharm GmbH, Graf-Arco-Strasse 3, D-89070 Ulm, Germany.
Manufacturer:
Merckle GmbH, Ludwig-Merckle-Strasse 3, D-89143 Blaubeuren, Germany.
For a large print, audio, Braille or CD-rom version of this patient information leaflet, phone 02392 313592.
This leaflet was last revised in May 2015.