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Zirtek Allergy Relief For Children 1mg/Ml Oral Solution

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CIA70970D

CIA70970D

Zirtek8


Allergy Relief for Children 1 mg/ml Oral Solution

Cetirizine dihydrochloride

PATIENT INFORMATION LEAFLET

Read all of this leaflet carefully because it contains important information for you.

•    This medicine is available without prescription. However, you still need to take it carefully to get the best results.

•    Keep this leaflet. You may need to read it again

•    Ask your pharmacist if you need more information or advice.

•    You must contact a doctor if your symptoms worsen or do not improve after a few days.

•    In this leaflet Zirtek Allergy Relief for Children 1 mg/ml Oral Solution will be called Zirtek Allergy Relief for Children

In this leaflet:

1.    What Zirtek Allergy Relief for Children is for

2.    Before you take Zirtek Allergy Relief for Children

3.    How to take Zirtek Allergy Relief for Children

4.    Possible side effects

5.    How to store Zirtek Allergy Relief for Children

6.    Further information.

1 .What Zirtek Allergy Relief for Children is for

Cetirizine dihydrochloride, the active ingredient of the solution is an antihistamine. It blocks the effects of a substance called histamine which occurs naturally in the body. Histamine is involved in allergic reactions.

Zirtek Allergy Relief for Children is used to treat adults and children aged 2 and over who have hay fever (seasonal allergic rhinitis), year round allergies such as dust or pet allergies (perennial allergic rhinitis) and urticaria (swelling, redness and itchiness of the skin).

Antihistamines like Zirtek Allergy Relief for Children relieve the unpleasant symptoms and discomfort associated with these conditions, such as sneezing, irritated, runny and blocked up nose, itchy, red and watering eyes and skin rashes.

2. Before you take Zirtek Allergy Relief for Children

Do not take Zirtek Allergy Relief for Children if:

•    You are allergic to cetirizine dihydrochloride

•    You are allergic to any of the other ingredients of Zirtek Allergy Solution (see section 6)

•    You are breast-feeding

•    You have severe kidney failure (creatinine clearance less than 10 ml/min).

•    You have problems of urinary retention.

•    You have fructose intolerance.

If any of the above applies to you talk to your pharmacist.

Check with your pharmacist before taking Zirtek Allergy Relief for Children if:

•    You have problems with your kidneys

•    You have predisposition factors of urinary retention (eg: spinalcord lesion, prostatic hyperplasia) as cetirizine increases the risk of urinary retention.

•    You suffer from epilepsy or are at risk of convulsions.

•    You want to use for children less than 2 years of age Taking Zirtek Allergy Relief for Children with food and drink Avoid alcoholic drink while you are taking this medicine.

Pregnancy

If you are pregnant or trying to become pregnant ask your pharmacist for advice before taking Zirtek Allergy Solution.

Allergy Testing

If you are due to have an allergy test, ask your doctor if you should stop taking Zirtek Allergy Relief for Children for several days before testing. This medicine may affect your allergy test results.

Driving and using machines

Some people have reported that they feel drowsy or dizzy while they are taking Zirtek Allergy Solution. If you are affected do not drive or use machines.

Warnings about some of the ingredients

•    If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine because it contains sorbitol

•    The suspension contains the preservatives methyl and propyl parahydroxybenzoate.

These can sometimes cause allergic reactions (possibly delayed).

3. How to take Zirtek Allergy Relief for Children

Remember the solution can be swallowed as such. Do not take more than 10 ml each day. If you do not feel better within a few days, consult your doctor.

Children aged 2 to 6 years:

Take one 2.5ml half spoonful in the morning and one in the evening.

Children aged 6 to 12 years:

Take one 5 ml spoonful in the morning and one in the evening.

Adults and adolescents over 12 years of age:

Take two 5 ml spoons (10ml) once a day.

Zirtek Allergy Relief for Children is not suitable for children under 2.

If you take more Zirtek Allergy Relief for Children than you should

If you accidentally take too much go and see your doctor straightaway.

If you forget to take a dose

If you forget to take a dose, you should take one as soon as you remember, but wait at least 24 hours before taking the next dose.

If you have any other guestions about taking this medicine, ask your pharmacist.

4. Possible side effects

Like all medicines Zirtek Allergy Relief for Children can cause side effects, although not everybody gets them.

The following side effect is very rare, but you must stop taking the medicine and speak to your doctor straight away if you notice these symptoms:

• A severe allergic reaction including rash, itchiness and fever, swollen throat, face, eyelids or lips. This reaction may start soon after you first take the medicine, or it might start later.

The following side effects have also been reported.

Common side effects (affects less than 1 in 10 people)

•    Tiredness, feeling sleepy    • Pain in the abdomen

• Headache    • Dizziness

• Dry mouth    • Sore throat

•    Nausea    • Cold-like symptoms of the nose (children only).

•    Diarrhoea (children only)

Uncommon side effects (affects less than 1 in 100 people)

•    Itching and rash    • Tingling in the hands and feet

•    Diarrhoea    • Feeling agitated.

•    Feeling weak or generally unwell

Rare side effects (affects less than 1 in 1000 people)

•    Fast heart beat

•    Oedema (generalised swelling due to water retention)

•    Abnormal liver function test results (your doctor will know what to do)

•    Convulsions

•    Increased weight

•    Aggression, confusion, depression, hallucination (hearing or seeing things), sleeplessness

•    Urticaria (hives).

Very rare side effects (affects less than 1 in 10,000 people)

•    Blurred vision, difficulty focussing

•    Rotation of the eyes

•    Bad taste in the mouth

•    Fainting

•    Bed wetting, pain and/or difficulty passing water

•    Unusual bleeding or bruising

•    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

•    A recurring rash.

Not known side effects

•    Increased appetite

•    Vertigo

•    Urinary retention

Some cases of memory loss and/or impairment have also been reported.

In very rare cases people have thought about committing suicide and if you feel this way then stop taking the oral solution and see your doctor.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your pharmacist. Also you can help to make sure that medicines remain as safe as possible by reporting any unwanted side effects via the internet at www.mhra.gov.uk/ yellowcard. Alternatively you can call Freephone 0808 100 3352 (available from 10 a.m. to 2 p.m. Mondays to Fridays) or fill in a paper form available from your local pharmacy

5.    How to store Zirtek Allergy Relief for Children

Keep out of the reach and sight of children.

Do not take the medicine after the expiry date on the carton. The expiry date refers to the last day of that month. Medicines should not be disposed of via wastewater or household waste. Return any medicine you no longer need to your pharmacist.

6.    Further information

What Zirtek Allergy Relief for Children contains

The solution contains 1 mg/ml of the active substance, cetirizine dihydrochloride.

The other ingredients are sorbitol solution (each 10 ml dose contains 3.15 g of glucose), glycerol, propylene glycol, saccharin sodium, methyl and propyl parahydroxybenzoate (E218 and E216), banana flavouring, sodium acetate, acetic acid and purified water.

What Zirtek Allergy Relief for Children looks like

It is a clear, colourless solution with a banana flavour. It is supplied in amber glass bottles containing 70 ml.

Marketing Authorisation Holder and Manufacturer

UCB Pharma Ltd, 208 Bath Road, Slough, Berkshire, SL1 3WE, United Kingdom This leaflet was last updated December 2013

If this leaflet is difficult to see or read or you would like it in a different format, please contact UCB Pharma Ltd, UK

CIA70970D