Document: leaflet MAH GENERIC_PL 36390-0023 change

• leaflet MAH GENERIC_PL 04917-0068
• leaflet MAH GENERIC_PL 36390-0023

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PATIENT INFORMATION LEAFLET CETIRIZINE HYDROCHLORIDE 5mg/5ml ORAL SOLUTION

(cetirizine hydrochloride)

The name of this medicine is Cetirizine Hydrochloride 5mg/5ml Oral Solution, which will be referred to as Cetirizine Solution throughout this leaflet.

Read all of this leaflet carefully before you start taking this medicine.

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

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

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

•    If any of the side effects gets serious, or if you notice any side effects not listed in the leaflet, please tell your doctor or pharmacist.

1. WHAT CETIRIZINE SOLUTION IS AND WHAT IT IS USED FOR

The active ingredient in your medicine is cetirizine hydrochloride, which belongs to a group of medicines called antihistamines. These are used to relieve the symptoms of seasonal allergic rhinitis (e.g. hay fever), perennial allergic rhinitis (e.g. year round allergies often due to house dust mites or animal allergies) and urticaria (itchy, red, swollen skin). These symptoms include itchy skin rashes; sneezing; itchy, runny or blocked nose; red, itchy and watering eyes.

Cetirizine Solution can be used to treat hay fever, year round allergies and urticaria in adults and children over 6 years.

Cetirizine Solution can be used to treat hay fever in children between the ages of 2 and 5.

2. BEFORE YOU TAKE CETIRIZINE SOLUTION

Do not take Cetirizine Solution if you:

•    are allergic (hypersensitive) to cetirizine hydrochloride, or any of the other ingredients

in Cetirizine Solution (these are listed in section 6, Further Information)

•    are breast-feeding

Take special care with Cetirizine Solution

Before you take Cetirizine Solution you should tell your doctor if you:

•    are pregnant, think you might be pregnant or are planning to become pregnant

•    have ever suffered from liver or kidney problems

•    have to have an allergy test (you should stop taking Cetirizine Solution three days

before you have the test).    _{Pa e 1}

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken of the following medicines, as they may decrease or increase the effect of Cetirizine Solution and vice versa.

• medication for anxiety or stress (CNS depressants)

It may still be alright for you to take Cetirizine Solution and your doctor will be able to decide what is suitable for you. Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Taking your medicine with food and drink

Cetirizine Solution can be taken with or without food. Avoid alcohol consumption whilst taking Cetirizine Solution.

Pregnancy and breast-feeding

Tell your doctor if you are pregnant, think you might be pregnant or are planning to become pregnant. Do not take Cetirizine Solution whilst breast-feeding.

Ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

It is unlikely that Cetirizine Solution will affect your ability to drive or use machines. However, if you feel dizzy or drowsy whilst taking Cetirizine Solution do not drive or operate machines.

Important information about some of the ingredients of Cetirizine Solution.

This product contains sorbitol. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

This medicinal product contains 3.5mg of sodium per 10ml dose. To be taken into consideration by patients on a controlled sodium diet.

This medicinal product contains methyl parahydroxybenzoate and propyl parahydroxybenzoate which may cause allergic reactions (possibly delayed), and exceptionally, breathing difficulty caused by narrowing of the airways (bronchospasm).

Always take Cetirizine Solution exactly as your doctor has told you to do so. You should check with your doctor or pharmacist if you are not sure. The label on the carton will tell you how much medicine you should take and when.

Dosage

The usual dosage is:

Adults, elderly and children over 12 years Take two 5ml spoonfuls (10ml) once daily.:

Children aged between 6 - 12 years: Take either one 5ml spoonful twice daily or two 5ml spoonfuls once daily.

Children aged between 2 and 5 years: Take either half of a 5ml spoonful twice daily or one 5ml spoonful once daily.

Not recommended for children under 2 years of age.

The dosage should be reduced to half of the daily dose for patients with kidney disease or if you experience any mild side effects (listed in section 4.'Possible Side Effects')

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Method of administration

For oral use.

If you take more Cetirizine Solution than you should

If you have accidentally taken more than the recommended/prescribed dose, contact your nearest hospital casualty department or tell your doctor or pharmacist immediately Remember to take any packaging with you.

The most common sign of overdose in adults is drowsiness and agitation in children.

If you forget to take Cetirizine Solution

If you have forgotten to take your medicine, take it as soon as you remember and then wait 24 hours before taking your next dose.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Cetirizine Solution can cause side effects, although not everybody gets them. If you get any of the following symptoms after taking this medicine you should contact your doctor or pharmacist immediately:

•    any sudden wheeziness, difficulty in breathing

•    dizziness

•    swelling of the eyelids, face, lips or throat

The following side effects have also been reported:

Common side effects (seen in less than 1 in 10 patients but in more than 1 in 100 patients):

•    drowsiness

•    dry mouth

Uncommon side effects (seen in less than 1 in 100 patients but in more than 1 per 1000 patients):

•    agitation

•    headache, dizziness

•    burning, prickling sensation (feeling of pins and needles)

•    nausea (feeling sick)

•    diarrhoea, stomach ache, indigestion

•    rash, itching, hives

•    feelings of weakness

Rare side effects (seen in less than 1 in 1000 patients)

•    feelings of aggression, confusion and depression

•    hallucinations

•    difficulty in sleeping

•    convulsions (fits), unusual movement of limbs

•    rapid heart beat

•    oedema (swelling of the feet or ankles)

•    unusual weight gain

•    changes in liver function tests, indicating the possibility of damage to the liver.

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Very rare side effects (seen in less than 1 in 10,000 patients)

•    distorted sense of taste

•    fainting, blurred vision

•    difficult and/or painful urination

•    loss of urinary control

•    an increased tendency to bruise or bleed easily

Long term treatment with Cetirizine Solution can lead to a dry mouth, it is therefore important that adequate oral hygiene is maintained.

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 SOLUTION

Keep out of sight and reach of children.

Do not take this medicine after the expiry date stated. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions. Use within 6 months of opening.

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. FURTHER INFORMATION

What Cetirizine Solution contains:

The active ingredient is cetirizine hydrochloride. Each 1ml of solution contains 1mg of cetirizine hydrochloride.

The other ingredients are:

methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), sorbitol solution (70%), glycerol, sodium citrate, citric acid, propylene glycol, monoammonium glycyrrhizinate, purified water, pineapple Singapore flavour, sweet orange no.1.

What Cetirizine Solution looks like and the contents of the pack:

Cetirizine Solution is a clear, colourless, flavoured solution.

Your medicine is available in a 200ml amber glass and polyethylene Terepthalate (PET) bottle. Marketing Authorisation Holder :

Cipla (EU) Limited, Hillbrow House, Hillbrow Road, Esher, Surrey, KT10 9NW, United Kingdom. Manufacturer :

Cipla (EU) Limited, 20 Balderton Street, London W1K 6TL, United Kingdom.

Cipla Europe NV, Uitbreidingstraat 80, 2600 Antwerp, Belgium

This leaflet was last revised in 09/2015.

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Date : 22-09-15