PAVACOL-D®

pholcodine

Patient Information Leaflet

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

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

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

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

•    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.

•    You must talk to a doctor if you do not feel better or if you feel worse after 5 days.

What is in this leaflet:

1.    What Pavacol-D is and what it is used for

2.    What you need to know before you take Pavacol-D

3.    How you take Pavacol-D

4.    Possible side effects

5.    How to store Pavacol-D

6.    Contents of the pack and other information

1. What Pavacol-D is and what it is used for

Pavacol-D is a dark brown liquid that contains the active ingredient pholcodine. Pholcodine belongs to a group of medicines called anti-tussives (help to prevent coughing).

Pavacol-D is a cough suppressant used to relieve dry and irritating coughs that do not produce phlegm or mucus on the chest.

Ask a doctor before use if you suffer from a chronic or persistent cough, if you have asthma, are suffering from an acute asthma attack or where the cough is accompanied by excessive secretions.

Taking other medicines/alcohol

Do not take Pavacol-D if you are taking any other cough or cold medicines. You should not consume alcohol while you are taking Pavacol-D.

Tell your doctor or pharmacist about any other medicines, including medicines you are taking at the same time, particularly the following:

Antidepressants, antihistamines, sleeping tablets or sedatives, strong painkillers, medicines to treat epilepsy, as Pavacol-D may make you feel more sleepy.

Also tell your doctor or pharmacist if you are taking any of the following medicines:

Diuretics (water tablets) or antihypertensives (blood pressure tablets) as Pavacol-D can increase the effects of these medicines.

Tell your doctor or pharmacist if you are due to have or have recently had a general anaesthetic.

Tell your doctor or nurse if you are going to have any hospital tests as Pavacol-D can interfere with the results.

Pregnancy and breast-feeding

Do not take Pavacol-D during pregnancy or breast-feeding unless your doctor tells you to. If you are pregnant, or breast-feeding, think you may be pregnant or planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

For children aged 6 to 12 years: simple treatments should be tried first before you give this medicine. Further information on 'Treating coughs and colds in children' can be found at the end of this leaflet.

2. What you need to know before you take Pavacol-D

Do not give to children under 6 years of age.

Do not take Pavacol-D if you:

•    are allergic to pholcodine or any other ingredients in

Pavacol-D (these are listed in Section 6 of this leaflet).

•    have liver disease

•    have a very serious breathing problem (ventilatory or respiratory failure)

•    have chronic bronchitis (inflammation of the airways)

•    have bronchiectasis (abnormal widening of one or more airways)

•    have or may have any problems with your airways such as chronic obstructive pulmonary disease (COPD), or other breathing problems

•    are taking or have taken MAOIs in the last 2 weeks (MAOIs [monoamine oxidase inhibitors] are a type of antidepressant such as phenelzine, isocarboxazid, tranylcypromine or moclebemide).

Take special care with Pavacol-D and tell your doctor if you have any of the following conditions:

•    kidney disease

•    a history of drug abuse

•    if you suffer from a chronic or persistent cough

Driving and using machines

Pavacol-D may cause sleepiness. Make sure you are not affected before you drive or operate machinery.

The medicine can affect your ability to drive as it may make you sleepy or dizzy.

•    Do not drive while taking this medicine until you know how it affects you.

•    It is an offence to drive if this medicine affects your ability to drive.

•    However, you would not be committing an offence if:

-    The medicine has been prescribed to treat a medical or dental problem and

-    You have taken it according to the instructions given by the prescriber or in the information provided with the medicine and

-    It was not affecting your ability to drive safely

Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.

Important information about some of the ingredients of Pavacol-D

•    If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Pavacol-D.

•    May have a mild laxative effect. Calorific value 2.6 kcal/g sorbitol.

•    Pavacol-D also contains small amounts of ethanol (alcohol), less than 100 mg per 5 ml.

•    The propyl and methyl hydroxybenzoates in Pavacol-D may cause allergic reactions (possibly delayed).

3.    How you take Pavacol-D

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Do not use for more than 5 days without the advice of a doctor. Seek medical advice if you or your child's condition does not improve or gets worse during the treatment.

The recommended dose is

Adults and the elderly

One or two 5 ml spoonfuls as required. The dose may be increased to three 5 ml spoonfuls if necessary. No more than 60 ml (12 x 5 ml spoonfuls) should be taken in 24 hours.

Children

From 6 to 12 years: one 5 ml spoon four to five times daily.

No more than 25 ml (5 x 5 ml spoonfuls) should be taken in 24 hours.

Do not give to children under 6 years of age.

Do not exceed the stated dose.

If you take more Pavacol-D than you should

Contact your doctor or go to your nearest hospital immediately. Symptoms of overdose include feeling sick, fever, sleepiness, restlessness, excitement, co-ordination problems, shallow or difficulty in breathing and fits.

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

4.    Possible side effects

Like all medicines, Pavacol-D can cause side-effects, although these do not affect everyone.

If you or your child experience any of the following serious side effects, stop taking Pavacol-D immediately and seek urgent medical advice:

•    sudden wheeziness

•    difficulty in breathing

•    severe allergic reactions including swelling of the eyelids, face or lips, rash or itching, especially affecting your whole body

The following side effects have also been reported:

•    feeling sick (nausea)

•    congestion (sputum retention)

•    constipation

•    mild laxative effect

•    drowsiness

•    dizziness

•    excitation

•    confusion

•    vomiting

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 Pavacol-D

Medicines should not be disposed of via waste-water or with household waste. Ask your pharmacist what you should do with medications you no longer need. These measures will help protect the environment.

6. Contents of the pack and other information

What Pavacol-D contains

The active substance is pholcodine 5 mg in 5 ml.

The other ingredients are:

Tolu balsam, ethanol 96%, star anise oil, clove oil, peppermint oil, capsicum tincture, strong ginger tincture, sorbitol solution (E420), saccharin sodium, hydroxyethylcellulose, treacle flavour, caramel, levomenthol, methyl hydroxybenzoate (E2I8), propyl hydroxybenzoate (E2I6) and purified water.

What Pavacol-D looks like and contents of the pack

Pavacol-D is available as 50 ml, 100 ml, 150 ml, 250 ml, 300 ml, and 1000 ml round amber glass bottles with a child resistant cap.

Not all pack sizes may be marketed.

Treating coughs and colds in children

It's normal for children to get 8 or more colds in a year. Gradually they build up immunity and get fewer colds. Most colds will get better within a few days and you may not need to do more than keep your child comfortable until they get over it. Because colds are caused by viruses, not bacteria, antibiotics don't help. Here are some simple steps to help your child who has a cough or cold:

1. If they are hot/feverish:

Increase the amount of fluid your child normally drinks. Lower their temperature with a paracetamol or ibuprofen medicine which has doses for children. (Paracetamol is not for children under 2 months. Ibuprofen is not for children under 3 months).

2. For coughs:

Although it is distressing to hear your child cough, in fact coughing serves a purpose. It helps clear phlegm on the chest or mucus from the nose. Give your child plenty of warm clear fluids to drink.

3. To help with breathing:

Plain saline nose drops, available from your pharmacy, can help babies with blocked noses who are having trouble feeding.

Marketing Authorisation Holder and Manufacturer

The product licence holder is:

Alliance Pharmaceuticals Limited, Avonbridge House, Bath Road, Chippenham, Wiltshire, SNI5 2BB, United Kingdom.

Pavacol-D is manufactured by:

Pharmaserve (North West) Limited, 9 Arkwright Road, Astmoor Industrial Estate, Runcorn, Cheshire, WA7 INU.

This leaflet was last revised in January 2015

Pavacol-D is a registered trademark of Alliance Pharmaceuticals Limited. Alliance and associated devices are registered trademarks of Alliance Pharmaceuticals Limited.

© Alliance Pharmaceuticals Limited 2015.

□ ALLIANCE

Pavacol-D should be kept out of the sight and reach of children.

Do not store above 25°C and protect from light.

Do not use Pavacol-D after the expiry date as indicated on the box after “EXP”. The expiry date refers to the last day of the month.