Patient Information Leaflet

Galpharm Hayfever & Allergy Relief 1mg/ml Syrup Cetirizine hydrochloride

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

•    This medicine is available without a prescription, however you still need to use Galpharm Hayfever & Allergy Relief 1mg/ml Syrup carefully to get the best results from it.

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

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

•    You must contact your doctor if your symptoms worsen or do not improve.

In this leaflet:

1.    What this medicine is and what it is used for

2.    Before you take this medicine

3.    How to take this medicine

4.    Possible side effects

5.    Storing your medicine

6.    Contents of the pack and other information

1.    What this medicine is and what it is used for

Each 1ml of oral solution contains 1mg of cetirizine hydrochloride. Cetirizine belongs to a group of drugs called antihistamines, which help to relieve the symptoms of some allergies.

The medicine 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).

The medicine can be used to 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 this medicine

Do not take this solution if you:

•    Are allergic (hypersensitive) to cetirizine hydrochloride or any of the other ingredients in your medicine, listed in section 6.

•    Have serious kidney problems (creatinine clearance less than 10 ml/min).

Talk to your doctor or pharmacist before taking this medicine if you have:

•    Mild or moderate kidney problems.

•    Epilepsy or are at risk of convulsions.

•    Predisposition factor of urinary retention (e.g. spinal cord lesion or prostatic hyperplasia) as cetirizine increases the risk of urinary retention.

Taking this medicine with food and drink:

•    As with other antihistamines, it is advisable to avoid drinking large amounts of alcohol whilst using this syrup.

Pregnancy and Breast feeding:

•    Do not take if you are pregnant or breast-feeding.

Driving and using machines:

•    Tests have shown that this medicine does not cause drowsiness in the vast majority of people using it. Therefore it will not normally affect your ability to drive or operate machinery. However there may be very rare exceptions and if you experience dizziness, nausea or drowsiness, do not drive or operate machinery.

Allergy Testing

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

Taking other medicines

•    This medicine is not expected to interact with other medicines you may be taking. However if you are unsure talk to your pharmacist or doctor.

Other precautions you must take:

•    If you take your medicine for a long time there is an increased risk of tooth decay due to mouth dryness. It is important to brush your teeth regularly.

Important information about some of the ingredients of this medicine:

•    This product contains liquid sorbitol (E420).

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 parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) may cause allergic reactions (possibly delayed).

3. How to take this medicine

For oral use.

Use the spoon provided to make sure you have the correct dose.

Adults and children over 12 years of age: Two 5mL spoonfuls once daily.

Children aged 6-12 years: Two 5mL spoonfuls once daily or one 5mL spoonful twice daily. Children aged 2-6 years (for hayfever only): One 5 mL spoonful daily or half a spoonful (2.5mL) twice daily.

Children under 2 years of age: Not recommended.

If drowsiness occurs, take the medicine in the evening.

If you have kidney problems, you may need the dose adjusting.

If you take more solution than you should:

•    If you (or someone else) swallow a lot of the syrup all together, or if you think a child has accidently swallowed any of the syrup, contact your nearest hospital casualty department or your doctor immediately.

If you forget to take a dose:

If you forget to take a dose, take one as soon as you remember, unless it is nearly time to take the next one. Never take two doses together. Take the remaining doses at the correct time.

4. Possible side effects

Like all medicines, Galpharm Hayfever & Allergy Relief 1mg/ml Syrup can have side effects.

If you experience any of the following, stop taking this medicine and seek immediate medical help:

•    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

•    Red skin patches with inflammation and blistering, and fever and malaise

•    Bruising or bleeding more easily than normal

•    Convulsions (fits)

•    In some very rare cases people have thought about committing suicide and if you feel this way then stop taking this medicine and see your doctor

If you experience any of the following, stop taking this medicine and talk to your doctor:

•    Confusion

•    Hallucinations

•    Abnormal liver function tests

•    Rapid heartbeat

•    Loss of consciousness, fainting

Other effects which may occur include:

Common:

•    Headache or dizziness

•    Drowsiness or tiredness

•    Restlessness

•    Dry mouth, sore throat

•    Upset stomach, diarrhoea, nausea

•    Runny nose

Uncommon:

•    Agitation

•    Weakness

•    Malaise

•    Pins & needles

•    Itching

•    Rash

•    Abdominal pain

Rarely:

•    Aggression, depression

•    Weight gain

•    Swelling

•    Insomnia

•    Hives

Very Rarely:

•    Taste disorder

•    Blurred vision, eye movement disorder

•    Difficult, painful or involuntary urination

•    Tremors, tics

•    Muscle spasm

•    Involuntary movements and/or jerking of the limbs

Not known side effects:

•    Increased appetite

•    Vertigo (sensation of spinning or whirling motion)

•    Urinary retention (Difficulty passing water)

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

Do not transfer to another container. Do not use after the expiry date shown on the carton. Keep out of the sight and reach of children. Do not throw away any medicines via waste water or household waste. Ask your pharmacist how to throw away any medicines you no longer use. These measures will help protect the environment.

6.    Contents of the pack and other information

What Galpharm Hayfever & Allergy Relief 1mg/ml Syrup contains:

The active ingredient is: Cetirizine hydrochloride

The other ingredients are: Glycerol, propylene glycol, liquid sorbitol (E420), methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), sodium acetate, acetic acid, saccharin sodium, banana flavour and purified water.

What Galpharm Hayfever & Allergy Relief 1mg/ml Syrup looks like and contents of the pack:

Galpharm Hayfever & Allergy Relief 1mg/ml Syrup is a clear, colourless solution available in bottles containing 70, 75, 100, 150 or 200ml of solution. Not all pack sizes may be marketed. Bottles of 75, 100, 150 and 200ml are only available from your pharmacist.

Marketing Authorisation Holder:

Galpharm Healthcare Ltd., Wrafton, Braunton, Devon, EX33 2DL, United Kingdom This leaflet was last revised in 01/2016

Manufacturer: Galpharm International Ltd., Elmhirst Park, Middle Field Road, Barnsley, South Yorkshire, S75 4LS, United Kingdom.

This leaflet was last revised in 04/2016