PACKAGE LEAFLET: INFORMATION FOR THE USER Cetirizine 1 mg/ml Oral Solution (cetirizine dihydrochloride)

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

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

•    If you have any further questions, ask your doctor or pharmacist.

•    This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

•    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.

WHAT IS IN THIS LEAFLET:

1. WHAT CETIRIZINE IS AND WHAT IT IS USED 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.

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•    dizziness

•    headache

•    dilated pupils

•    restlessness

•    feeling of being vague (not with it)

•    tremor (shaking)

fatigue feeling unwell itchy skin

sleepiness (sometimes for longer periods) fast heartbeat

not making as much urine as normal.

If you forget to take Cetirizine

If you forget to take your usual dose take the dose as soon as you remember. Do not take a double dose to make up for the missed dose. Take your next dose at the normal time.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicinecan cause side effects, although not everybody gets them.

Some very rare side effects could be serious:

If any of the following happens, stop taking this medicine and tell your doctor immediately or go to the accident and emergency department at your nearest hospital:

• Allergic reactions, including severe allergic reaction (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.

Other side effects:

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Cetirizine 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 Cetirizine 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. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CETIRIZINE

DO NOT take Cetirizine if:

•    You are allergic to cetirizine dihydrochloride

•    You are allergic to any of the other ingredients of this medicine ( listed in section 6)

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

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

You should not take Cetirizine 1mg/ml Oral Solution:

•    if you have rare hereditary problems of fructose intolerance.

Warnings and precautions

Talk to your doctor or pharmacist before taking 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 a patient with predisposition factors of urinary retention ( e.g. spinal cord disease or injury, enlarged prostate

gland) as cetirizine may increase the risk of urinary retention.

•    If you are an epileptic patient or a patient at risk of convulsions, you should ask your doctor for advice.

If you are taking this medicine over a long period of time it may lead to an increased risk of caries (tooth decay) due to mouth dryness. Oral hygiene is therefore very important.

The recommended dose should not be exceeded and if symptoms persist then the doctor or pharmacist should be consulted. Other medicines and Cetirizine

Tell your doctor if you are taking, have recently taken or might take any of the following medications:

•    antidepressants (e.g. fluoxetine, citalopram, venlafaxine)    •    ritonavir (to treat HIV);

•    betahistine (used to treat Meniere's Disease)    •    any other medicines that you have bought without a

.    prescription.

Allergy Testing

If you are due to have an allergy test, ask your doctor if you should stop taking Cetirizine for 3 days before testing. This medicine may affect your allergy test results.

Cetirizine with food and alcohol

No clinically significant interactions have been observed between alcohol (at the blood level of 0.5 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

Pregnancy

Ask your doctor or pharmacist for advice before taking any 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 medicine should only be administered if necessary and after medical advice.

Breast-feeding

Cetirizine is present in breast milk.

I f you are pregnant or breast-feeding, think you may be pegnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine Driving and using machines

Although rare, there have been reports of drowsiness. If you feel drowsy do not drive or operate machinery. You should not take more than the recommended dose as this may affect your ability to perform these tasks.

Cetirizine contains sorbitol, methyl parahyroxybenzoate and propyl parahydroxybenzoate

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. Methyl parahyroxybenzoate and propyl parahyrdoxybenzoate may cause an allergic reaction (possibly delayed).

3. HOW TO TAKE CETIRIZINE

Always take this medicineexactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

The normal doses for Cetirizine are given below. Sometimes doctors prescribe different doses to those mentioned below, if

this applies to you discuss it with your doctor if you have not already done so.

The recommended dose is:

Adults and adolescents over 12 years of age: 10 mg once daily as 10 ml oral solution (2 full spoons).

Children between 6 and 12 years: 5 mg twice daily as 5 ml (one full spoonful).

Children between 2 and 6 years for seasonal rhinitis (hayfever): 2.5 mg twice daily as 2.5 ml oral solution (a half spoonful). When dispensing the product, a measuring spoon (which is available from the pharmacist) should be used and not a standard teaspoon. Children under 2 years: Not recommended.

Older people: As for adults.

Patients with moderate to severe kidney impairment: Patients with moderate kidney impairment are recommended to take 5 mg or 5 ml 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. Please ask your pharmacist for advice.

If you take more Cetirizine than you should

However if you or someone else has taken too much medicine or an overdose contact your doctor or your hospital accident and emergency department immediately.

After an overdose, the side effects described below may occur with increased intensity:

• confusion    • diarrhoea

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Common side effects (may affect up to 1 in 10 people):

•    Tiredness,    feeling    sleepy    •

•    Headache    •

•    Nausea    •

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

Dry mouth

Diarrhoea (children only)

Dizziness

Sore throat

Uncommon side effects (may affect up to 1 in 100 people):

•    Itching and rash    •    Diarrhoea

•    Feeling weak or    generally unwell    •    Tingling in the hands and    feet

•    Feeling agitated    •    Pain in the abdomen.

Rare side effects (may affect up to 1 in 1,000 people):

•    Fast heart beat

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

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

•    Oedema (generalised swelling due to water retention)

•    Convulsions

•    Increased weight

•    Urticaria (hives).

Very rare side effects (may affect up to 1 in 10,000 people):

•    Blurred vision, difficulty focussing    •    Bed wetting, pain and/or difficulty passing water

•    Rotation of the eyes    •    Tremor, tics

•    Fainting    •    Involuntary movements and/or    jerking of the    limbs

•    Unusual bleeding or bruising    •    Muscle spasms in the neck and    shoulders

•    A recurring rash.    •    Swelling of the skin particularly    around the    face

•    Bad taste in the mouth

Not Known (frequency cannot be estimated from the available data):

•    Increased appetite    •    Loss of balance

•    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.

Reporting of suspected adverse reactions

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 the Yellow Card Scheme: 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 sightand reach of children.

Do not use Cetirizine after the expiry date shown on the label. The expiry date refers to the last day of that month.

If you notice any defects in the solution such as floating particles, take the medicine to your pharmacist for advice before taking it.

Do not store above 25°C. Store in the original package. Use within 3 months.

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..

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Cetirizine contains:

Each 1ml of solution contains 1 mg of the active ingredient cetirizine dihydrochloride.

The solution also contains: liquid sorbitol (non-crystallising), glycerol, propylene glycol, methyl parahydroxybenzoate, propyl parahydroxybenzoate, sodium acetate, glacial acetic acid, saccharin sodium, mixed fruit flavour ID 21533 (which contains vanillin, orange oil, ethyl vanillin, amyl acetate, amyl butyrate, amyl propionate, ethyl butyrate, ethyl proprionate, citral, allyl heptylate, linalool, terpeneol, lemon oil, geraniol, butyric acid and propylene glycol), raspberry flavour 249 (which contains raspberry aldehyde, amyl acetate, amyl butyrate, ethyl acetate, ethyl buyrate, hexanyl butyrate, alpha ionone, geraniol, clove oil, cinnamon oil, orris oil, geranium oil and propylene glycol) and purified water. Cetirizine Oral Solution is sugar free.

What Cetirizine looks like and contents of the pack:

Cetirizine 1mg/ml Oral Solution is a clear solution available in bottles of 200ml.

Marketing Authorisation Holder and Manufacturer:

The product licence holder and manufacturer of this medicine is Sandoz Ltd, Frimley Business Park, Frimley, Camberley, Surrey,

GU16 7SR.

This leaflet was last revised in 05/2014.

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