Patient leaflet - Cetirizine 10 mg film-coated tablets
1. What Cetirizine is and what it is used for
Cetirizine dihydrochloride is the active ingredient of Cetirizine. Cetirizine is an antiallergic medication.
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. What you need to know before you take Cetirizine
Do not take Cetirizine
- if you have a severe kidney disease requiring dialysis;
- if you are allergic to cetirizine dihydrochloride or any of the other ingredients of this medicine (listed in section 6), to hydroxyzine or to piperazine derivatives (closely related active substances of other medicines).
Warnings and precautions
Talk to your doctor or pharmacist before taking Cetirizine
- If you have kidney problems. You may need to 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), ask your doctor for advice.
-If you have epilepsy or you are at risk of convulsions (fits).
Skin test
If you need a skin (allergy) test, tell the doctor you are taking these tablets as this medicine can affect skin test results. You will need to stop treatment three days before the test.
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
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Cetirizine with alcohol
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 with alcohol.
Pregnancy and breast-feeding
Cetirizine should be avoided in pregnant women. Accidental use of this medicine by a pregnant woman should not produce any harmful effects on the foetus. Nevertheless, the medicine should only be taken if necessary and after medical advice.
You should not take Cetirizine during breast-feeding because cetirizine passes into breast milk.
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.
Driving and using machines
There is no evidence of impaired attention, alertness and driving capabilities after taking Cetirizine at the recommended dose.
You should closely observe your response to the medicine after you have taken Cetirizine if you are intending to drive, engage in potentially hazardous activities or operate machinery. You should not exceed the recommended dose.
Cetirizine 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
Always take this medicine exactly as your doctor or pharmacist has told you. 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.
The tablet can be divided into equal doses.
Adults and adolescents above 12 years old:
The recommended dose is 10 mg once daily as one tablet.
Children between 6 and 12 years old:
The recommended dose is 5 mg twice daily as a half tablet twice daily.
Patients with kidney impairment
For patients with kidney impairment, the dose will be determined by your doctor based on your kidney function.
Duration of treatment:
The duration of treatment depends on the type, duration and course of your complaints and is determined by your doctor or pharmacist.
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.
If you stop taking Cetirizine
Rarely, pruritus (intense itching) and/or urticaria (hives) may return if you stop taking Cetirizine.
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.
Some side effects could be serious:
Very rare (may affect up to 1 in 10,000 people)
- Sudden signs of allergy such as rash, itching or hives on the skin, swelling of the face, lips, tongue or other parts of the body, shortness of breath, wheezing or trouble breathing
Not known (frequency cannot be estimated from the available data)
- Thoughts of committing suicide
- Unable to pass urine.
If any of the above occurs, tell your doctor straight away.
Other possible side effects
Common (may affect up to 1 in 10 people)
- Tiredness
- Dry mouth
- Feeling sick
- Dizziness
- Headache
- Sleepiness
- Sore throat and discomfort when swallowing
Uncommon (may affect up to 1 in 100 people)
- Weakness
- Generally feeling unwell
- Tingling or numbness of the hands or feet
- Agitation
- Itching
- Rash
- Diarrhoea
- Stomach pain
Rare (may affect up to 1 in 1,000 people)
- Fast heart beat
- Abnormal liver function tests
- Increase in weight
- Convulsions (fits)
- Aggression
- Confusion
- Depression
- Seeing, feeling or hearing things that are not there
- Inability to sleep
- Hypersensitivity (usually occurs with skin reaction like rash, itchy red skin)
- Swelling, fluid retention (oedema)
Very rare (may affect up to 1 in 10,000 people)
- Bleeding or bruising more easily than normal
- Blurred vision, eyes having uncontrolled circular movements
- Fainting
- Shaking
- Taste disturbance or loss of taste
- Uncontrolled body movements
- Difficult, painful or involuntary urination
Not known (frequency cannot be estimated from the available data)
- Loss of memory
- Increased appetite
- Vertigo (spinning sensation) Nightmare
- Pruritus (intense itching) and/or urticaria upon discontinuation
- Arthralgia (joint pain), myalgia (muscular pain)
- Acute generalized exanthematous pustulosis (rash with blisters containing pus)
- Hepatitis (inflammation of the liver)
Side effects in children and adolescents
In children and adolescents, the following side effects occur more commonly and can affect up to 1 in 10 people:
- Runny or blocked nose
- Diarrhoea
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via Yellow Card Scheme Website: 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
Keep out of the sight and reach of children.
Do not use Cetirizine after the expiry date which is stated on the label and carton. The expiry date refers to the last day of that month.
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.
This medicine does not require any special storage conditions.
6. Contents of the pack and other information
What Cetirizine contains
- The active substance of Cetirizine is cetirizine dihydrochloride. Each film-coated tablet contains
10 mg cetirizine dihydrochloride.
- The other ingredients are lactose monohydrate (see section 2 “Cetirizine contain lactose”), pregelatinised maize starch, povidone, magnesium stearate, hypromellose (E464), macrogol, titanium dioxide (E171) and talc.
What Cetirizine looks like and contents of the pack
The tablets are white and capsule-shaped with ‘CZ 10’on one side and ‘G’ on the other. All tablets have a breakline.
Packed in bottles of 30, 100 and 250 tablets and blister packs of 2, 7, 10, 14, 15, 20, 30, 50, 60, 90 and 100 tablets.
Not all pack sizes may be marketed
Marketing Authorisation Holder
Mylan
Station Close Potters Bar Hertfordshire EN6 1TL
United Kingdom
Manufacturer
Gerard Laboratories,
35-36 Baldoyle Industrial Estate
Grange Road
Dublin 13
Ireland
Mylan B.V.
Krijgsman 20,
Amstelveen, 1186DM,
Netherlands
Mylan Hungary Ltd.
Mylan utca 1.,
Komarom, 2900,
Hungary