ZAPAIN 30MG/500MG CAPSULES

Codeine Phosphate/Paracetamol

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

The product is known by the name above but will be referred to as Zapain Capsules throughout the rest of this leaflet.

In this leaflet:

What Zapain Capsules are and what they are used for
Before you take Zapain Capsules
How to take Zapain Capsules
Possible side effects
How to store Zapain Capsules
Further information

1. WHAT ZAPAIN CAPSULES ARE AND WHAT THEY ARE USED FOR

Zapain Capsules contain paracetamol and codeine. Paracetamol is an analgesic (relieves pain) and an antipyretic (lowers raised temperatures).

Codeine is a strong painkiller.

Zapain Capsules are used for the relief of severe pain.

2. BEFORE YOU TAKE ZAPAIN CAPSULES

Do not take with any other paracetamol-containing products. Do not take for longer than directed by your prescriber. Taking codeine regularly for a long time can lead to addiction, which might cause you to feel restless and irritable when you stop the capsules. Taking a painkiller for headaches too often or for too long can make them worse.

Do not take Zapain Capsules if:

you know that you are allergic to paracetamol or codeine, or any of the other ingredients (refer to section 6 below)

you suffer from severe kidney or liver disease

you suffer from asthma or any other breathing problems, for example chronic bronchitis or emphysema

you have just had a head injury or suffer from increased pressure on the brain

you drink a lot of alcohol, or have done in the past

you have recently had an operation to your gall bladder

you have diarrhoea

you are taking monoamine oxidase inhibitors (MAOIs) or have been taking them within the last two weeks. MAOIs such as phenelzine, moclobemide or isocarboxazid are medicines used to treat depression.

Zapain Capsules should not be taken by children under 12 years of age.

Take special care and tell your doctor or pharmacist before taking Zapain Capsules if:

you are elderly or weak

you have any stomach pains or other sudden problems in your abdomen (belly)

you have an underactive thyroid gland

you are prone to suffer from asthma

you have liver, kidney or thyroid problems, because the dose might need to be lower.

you have problems with your adrenal glands (Addison’s disease)

you suffer from an enlarged prostate gland (if male) or narrowing of your urethra (tube through which urine is passed)

you feel you have taken Zapain Capsules for a long time. You may develop a dependence on Zapain Capsules which may be harmful.

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. Some medicines interact with each other and this can alter their effect. It is particularly important to tell your doctor or pharmacist if you are taking the following medicines:

MAOIs used to treat depression, taken within the last 14 days (refer to “do not take if” in section 2 above)

Sedatives and sleeping tablets, eg temazepam and diazepam

Medicines for irregular heart beats (mexilettine, quinine or quinidine)

Drugs used to dry fluids in the mouth and lungs known as anticholinergics

Medicines to treat diarrhoea or sickness (metaclopramide, domperidone)

Medicines used to treat problems of the stomach, gall bladder, heart burn or sickness, (e.g. cimetidine, colestyramine)

Sodium oxybate used to treat sleepiness and sudden loss of muscle tone

Other strong painkillers called opioids

Medicines which prevent blood clotting (anticoagulants such as warfarin).

Zapain Capsules can interfere with some laboratory tests used for determining some diseases. Zapain Capsules must not be taken with any other medicines containing paracetamol or codeine. Some products which can be bought without a prescription may contain paracetamol or codeine, so always check the labels for ingredients.

Taking Zapain Capsules with food and drink:

Do not drink alcohol whilst taking Zapain Capsules. Swallow the capsules with a glass of water. Do not bite or chew the capsules.

Pregnancy and breast-feeding:

Zapain Capsules should not be used during pregnancy as they can affect the baby and can cause breathing problems when the baby is born. Usually it is safe to take Zapain Capsules while breast feeding as the levels of the active ingredients of this medicine in breast milk are too low to cause your baby any problems. However, some women who are at increased risk of developing side effects at any dose may have higher levels in their breast milk. If any of the following side effects develop in you or your baby, stop taking this medicine and seek immediate medical advice; feeling sick, vomiting, constipation, decreased or lack of appetite, feeling tired or sleeping for longer than normal, and shallow or slow breathing. Ask your doctor or pharmacist before taking any medicine.

Driving and using machines:

Zapain Capsules may cause dizziness or drowsiness and you should not drive or operate machinery if you are affected this way. Codeine may disturb your vision.

3. HOW TO TAKE ZAPAIN CAPSULES

Always take Zapain Capsules exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Dose:

The usual dosage is one or two capsules every four hours as needed. You should not take more than 8 Capsules in 24 hours. If you feel the effect of Zapain Capsules is too strong or too weak or your symptoms persist, speak to your doctor or pharmacist.

A lower dosage may be needed if you are elderly or have other medical problems. Check with your doctor about this.

Zapain Capsules are not recommended for children under 12 years.

Do not take with any other paracetamol-containing products.

If you take more Zapain Capsules than you should:

Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of the risk of delayed, serious liver damage.

Bring the remaining capsules and this leaflet with you so that the medical staff know what you have taken.

If you forget to take Zapain Capsules:

Do not take more than one dose at a time. If you forget to take a dose then take your next dose at the usual time. Never take two doses at the same time.

If you stop taking Zapain Capsules:

Zapain Capsules can become habit forming. This is called dependence, if you stop taking your medicine suddenly it can cause symptoms such as restlessness and irritability. Your doctor will stop your capsules gradually to avoid you having these withdrawal symptoms. If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Zapain Capsules can cause side effects, although not everybody gets them. All medicines can cause allergic reactions although serious allergic reactions are very rare. Any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching (especially affecting your whole body) should be reported to a doctor immediately.

Other possible side effects are:

feeling sick (nausea) and being sick (vomiting)

light headedness, dizziness, sleepiness,

stomach pains, constipation.

Lying down may help these effects if they happen.

Other side effects include:

a feeling of extra well being, or of disorientation

small eye pupils, problems with vision, headaches

slowing of the pulse

difficulty in passing urine

liver damage, especially in heavy drinkers

changes in blood cells, such as low number of cells which fight infection and of cells which are involved in blood clotting.

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

5. HOW TO STORE ZAPAIN CAPSULES

Keep this medicine out of the sight and reach of children.

Do not use Zapain Capsules after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.

Keep this medicine in a dry place.

Do not store above 25oC.

Protect from light.

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

6. FURTHER INFORMATION

What Zapain Capsules contain:

The active substances are paracetamol, 500mg and codeine phosphate, 30mg.

The other ingredients are maize starch, sodium lauryl sulphate, talc, magnesium stearate, croscarmellose sodium, gelatin, titanium dioxide E171, erythrosine E127, red iron oxide E172.

What Zapain Capsules look like and contents of the pack:

Zapain Capsules are available in aluminium blister packs or plastic containers with child resistant lids of 56, 100 or 112 capsules.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:

Mercury Pharmaceuticals Ltd., No. 1 Croydon, 12-16 Addiscombe Road, Croydon CR0 0XT, UK

Manufactured By:

Bristol Laboratories Ltd., Laporte Way, Luton, Bedfordshire, LU4 8WL, UK

This leaflet was last revised in March 2012 10013/LF/2

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