Teva Cetirizine Hydrochloride 10mg Film-Coated Tablets
Package leaflet: Information for the user
TEVA CETIRIZINE HYDROCHLORIDE 10 mg FILM-COATED TABLETS
Read all of this leaflet carefully before you start using 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 has told you.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• You must talk to a doctor if you do not feel better or if you feel worse after 3 days.
• 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.
This medicine is available without prescription. However, you still need to take Cetirizine carefully to get the best results from it.
What is in this leaflet:
1. What Cetirizine is and what it is used for
2. What you need to know before you take Cetirizine
3. How to take Cetirizine
4. Possible side effects
5. How to store Cetirizine
6. Contents of the pack and other information
1. What Cetirizine is and what it is used for
• Cetirizine is an antihistamine. Antihistamines help to relieve the symptoms of some allergies.
In adults and children aged 6 year and above, Cetirizine is used:
• to relieve hayfever and year-round allergies (runny, itchy and blocked up nose, itchy, red and watery eyes)
• to relieve raised and itchy skin (urticaria, also known as hives or nettle rash).
2. What you need to know before you take Cetirizine Do not take Cetirizine
• if you are allergic (hypersensitive) to the active substance of Cetirizine, to hydroxyzine or to piperazine derivatives (closely related active substances of other medicines) or any of the other ingredients of this medicine (listed in section 6);
• if you have a severe kidney disease (severe renal failure with creatinine clearance below 10 ml/min -this is usually identified through blood and urine tests);
Warnings and precautions
Talk to your doctor or pharmacist before taking Cetirizine.
If you are a patient with kidney problems, 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 fits (convulsions). If you have predisposition factors of urinary retention (eg: spinal cord lesion, prostatic hyperplasia) as cetirizine increases the risk of urinary retention.
No clear interactions between alcohol (at the amount corresponding to one glass of wine) and normal doses of cetirizine have been observed. However, as it is the case with all antihistamines, it is recommended to avoid consumption of alcohol whilst taking this medicine.
Other medicines and Cetirizine
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines,
Due to the profile of cetirizine, no interactions with other drugs are expected.
Allergy testing
If you are due to have an allergy test, ask your doctor if you should stop taking Cetirizine for several days before testing. This medicine may affect your allergy test results.
Cetirizine with food and drink
Food does not affect noticeabily the absorbtion of cetirizine.
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 or pharmacist for advice before taking this medicine
As with other drugs, use of Cetirizine 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 use of the medicine should be discontinued.
You should not take Cetirizine during breast feeding, because cetirizine passes into breast milk.
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, take part 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 medicines used to treat anxiety, insomnia, stress or panic attacks (nervous depressant agents) may additionally affect your attention and ability to react.
Cetirizine contains lactose
Cetirizine tablets contain lactose; if you have been told by your doctor that you have an intolerance to some sugars, please contact your doctor before taking this medicinal product.
3. How to take Cetirizine
The tablets should be swallowed whole, preferably with a drink of water, and not chewed or crushed.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dosage instructions are given below:
Adults and adolescents over 12 years of age
One tablet (10 mg) daily.
Children aged 6 - 12 years
Half a tablet (5 mg) twice daily (morning and evening).
Patients with kidney problems
Patients with moderate kidney problems are recommended to take 5 mg 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 (or someone else) swallow a lot of the tablets all together, or if you think a child has swallowed any of the tablets, contact your nearest hospital casualty department or your doctor immediately. Please take this leaflet, any remaining tablets and the container with you to the hospital or doctor so that they know which tablets were consumed.
After an overdose, the side effects described below may occur with increased intensity. Adverse effects such as confusion, loose stools, dizziness, tiredness, headache, ailing, dilating (widening) of pupil, itching, restlessness, sedation, sleepiness, stupor, abnormal rapid heart rate, tremors (shaking) and urinary retention have been reported.
If you forget to take Cetirizine
If you forget to take a tablet, take one as soon as you remember, unless it is nearly time to take the next one. Do not take a double dose to make up for a forgotten dose. Take the remaining doses at the correct time.
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 the following happens, stop taking the tablets and tell your doctor immediately or go to the casualty department at your nearest hospital:
• a severe allergic reaction (swelling of the face, lips, mouth or throat leading to severe difficulty in breathing or swallowing; skin rash or hives).
This is a very serious but rare side effect. You may need urgent medical attention or hospitalisation.
Following side effects have been reported.
Common side effects (may affect up to 1 in 10 people)
- Tiredness, feeling sleepy
- Headache
- Dizziness
- Dry mouth
- Sore throat (children only)
- Nausea
- Cold-like symptoms of the nose
- Diarrhoea
- Fatigue
Uncommon side effects (may affect up to 1 in 100 people)
- Itching and rash
- Tingling in the hands and feet
- Feeling agitated.
- Feeling weak or generally unwell
- Pain in the abdomen
Rare side effects (may affect up to 1 in 1,000 people)
- Fast heart beat
- Oedema (generalised swelling due to water retention)
- Hepatic function abnormal
- Convulsions
- Increased weight
- Aggression, confusion, depression, hallucination (hearing or seeing things), sleeplessness
- Urticaria (hives)
- Allergic reactions
Very rare side effects (may affect up to 1 in 10,000 people)
- Thrombocytopenia
- Blurred vision, difficulty focussing
- Rotation of the eyes
- Bad taste in the mouth
- Tremor, tics
- Involuntary movements and/or jerking of the limbs
- Muscle spasms in the neck and shoulders
- Swelling of the skin particularly around the face
- Fainting
- A recurring rash
- Bed wetting, pain and/or difficulty passing water
Not known side effects (frequency cannot be estimated)
- Increased appetite
- Memory loss and/or impairment
- Spinning feeling (vertigo)
- Urinary retention
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
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 outer packaging after EXP. 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 to protect the environment.
6. Contents of the pack and other information What Cetirizine contains:
• The active substance is cetirizine dihydrochloride 10 mg (also known as cetirizine hydrochloride).
• The other ingredients are microcrystalline cellulose, lactose monohydrate, colloidal anhydrous silica, magnesium stearate (E572), hypromellose (E464), macrogol, titanium dioxide (E171) and polydextrose.
What Cetirizine look like and contents of the pack:
• Cetirizine tablets are white to off white capsule-shaped tablets, debossed with C10 on one side and a deep breakline on the other.
• Each tablet contains 10 mg of cetirizine dihydrochloride.
• The product is available in pack sizes of 7, 15, 20, 28, 30, 50 or 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer:
United Kingdom
TEVA Pharma B.V.
Swensweg 5,
2031 GA Haarlem,
The Netherlands
Manufacturer:
Pharmachemie B.V.
Swensweg 5, PO Box 552, 2003 RN Haarlem,
The Netherlands
Or*
Teva UK Limited
Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG United Kingdom
Or*
Farmagon AS
Grini Naeringspark 12, Osteras 1361,
Norway
PL 14776/0069