PATIENT INFORMATION LEAFLET

STRONG PHOLCODINE LINCTUS BP Pholcodine BP 10 mg/5 ml

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

This medicine is available from your pharmacy without prescription, however, you still need to take Strong Pholcodine Linctus 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 a doctor if your symptoms worsen or do not improve after a few days.

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

In this leaflet:

1.    What Strong Pholcodine Linctus is and what it is used for

2.    Before you take Strong Pholcodine Linctus

3.    How to take Strong Pholcodine Linctus

4.    Possible side effects

5.    How to store Strong Pholcodine Linctus

6.    Further information

1.    WHAT STRONG PHOLCODINE LINCTUS IS AND WHAT IT IS USED FOR

Strong Pholcodine Linctus 10 mg/5 ml is a medicine which helps you to stop coughing, especially if you have a dry non-productive cough. It is related to morphine and codeine, and it acts to stop your automatic cough response.

2.    BEFORE YOU TAKE STRONG PHOLCODINE LINCTUS

Because colds are caused by viruses, not bacteria, antibiotics don’t help. Here are simple steps to help you when you have a cough or cold.

1.    If you are hot/feverish: Increase the amount of fluid you normally drink. Lower your temperature with a paracetamol or ibuprofen medicine.

2.    For coughs: Coughing serves a purpose, it helps clear phlegm and mucous. Drink plenty of warm clear fluids.

3.    To help with breathing: Plain saline nose drops/sprays can help with blocked noses.

Do not take Strong Pholcodine Linctus if you have:

•    an allergy (hypersensitivity) to pholcodine or any of the other ingredients of Strong Pholcodine Linctus (see Section 6 and end of Section 2).

•    liver disease.

•    breathing problems, asthma, bronchitis or bronchiectasis (a lung disorder).

This medicine is not recommended for use in children.

Take special care with Strong Pholcodine Linctus and talk to your doctor or pharmacist if you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, but especially the following:

•    anti-depressants known as monoamine-oxidase inhibitors (MAOIs or tricyclics) or medicines for mood disorders (e.g. phenothiazines). Pholcodine should NOT be taken at the same time as or within 14 days of stopping MAOIs.

You must not consume alcohol while taking this medicine as this may increase drowsiness.

Pregnancy and breast-feeding

Strong Pholcodine Linctus should not be taken unless considered essential by your doctor.

Driving and using machines

Strong Pholcodine Linctus may cause drowsiness. Do not drive or operate machinery until you know how the medicine will affect you.

Important information about some of the ingredients of Strong Pholcodine Linctus

Strong Pholcodine Linctus contains:

•    Liquid maltitol: if you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

•    Ethanol: This product contains small amounts of ethanol (alcohol), less than 100 mg per 5 ml dose.

3. HOW TO TAKE STRONG PHOLCODINE LINCTUS

Always take the product exactly as advised. You should check with your doctor or pharmacist if you are not sure. Only to be taken by mouth.

The usual dose is:

Do not exceed the stated dose.

If you take more Strong Pholcodine Linctus than you should

If you or someone else takes too much Strong Pholcodine Linctus, you should contact your doctor or pharmacist who will recommend what action you should take.

If you forget to take Strong Pholcodine Linctus

If you miss a dose, take it as soon as you remember and take any remaining doses for that day at evenly spaced times. Do not take a double dose to make up for the forgotten 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, Strong Pholcodine Linctus can cause side effects, although not everybody gets them.

STOP using Strong Pholcodine Linctus and seek advice from your doctor if you experience a rare allergic reaction, including skin rashes, swollen face, lips, tongue, difficulty breathing, increased sensitivity to light, inflammation of the blood vessels, fever or shock.

You may also notice the following more common side effects:

•    nausea, constipation

•    drowsiness

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 STRONG PHOLCODINE LINCTUS

Keep out of the sight and reach of children.

Do not store above 20°C. Store in the original container to protect from light.

Do not use Strong Pholcodine Linctus after the expiry date which is stated on the label.

The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist howto dispose of medicines no longer required. These measures will help to protect the environment.

6.    FURTHER INFORMATION

What Strong Pholcodine Linctus contains:

•    The active substance is Pholcodine BP 10 mg/5 ml.

•    The other ingredients are citric acid monohydrate, sodium carboxymethylcellulose, glycerol, sodium benzoate (E211), saccharin sodium, hydrogenated glucose syrup (E965), ethanol, raspberry/cola flavour and purified water. See end of Section 2.

What Strong Pholcodine Linctus looks like and contents of the pack

Strong Pholcodine Linctus is a clear colourless solution, available in 2000 ml, 1000 ml or 500 ml plastic (HDPE) bottles. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Pinewood Laboratories Ltd., Ballymacarbry, Clonmel, Co. Tipperary, Ireland.

PL 04917/0005 Text Revised: May 2015