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Co-Dydramol Tablets Bp

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Document: leaflet MAH BRAND_PL 00530-0228 change

Package Leaflet: Information for the user Co-dydramol Tablets

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

•    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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

•    If you get any side effects, talk to your doctor, pharmacist or nurse .This includes any possible side effects not listed in this leaflet. See section 4.

IN THIS LEAFLET:

1.    What Co-dydramol is and what it is used for

2.    What you need to know before you take Co-dydramol

3.    How to take Co-dydramol

4.    Possible side effects

5.    How to store Co-dydramol

6.    Contents of the pack and other information

1.    What Co-dydramol is and what it is used for

Your tablets are called Co-dydramol Tablets. They are a mixture of two drugs - paracetamol and dihydrocodeine tartrate. They are part of a group of drugs known as analgesics (pain killers).

Co-dydramol tablets are used to treat pain.

2.    What you need to know before you take Co-dydramol Do not take your tablets if you:

•    have ever had a bad reaction to any of the ingredients listed in the “what is in your tablets” section or to other pain killers;

•    have ever had any problems with your kidneys or liver, or have breathing problems that are caused by bronchitis or asthma;

Warnings and precautions

Talk to your doctor or pharmacist before taking Co-dydramol

•    If you have an underactive thyroid gland, dose should be reduced.

•    if you suffer from allergies, for example to food, cosmetics, dust or drugs

•    if you are taking a painkiller for headaches too often or for too long because it can make them worse.

Do not take for longer than directed by your prescriber.

Taking dihydrocodeine regularly for a long time can lead to addiction, which might cause you to feel restless and irritable when you stop the tablets.

Other medicines and Co-dydramol

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

If you see another doctor or visit a hospital, remember to tell them what medicines you are already taking, including ones that you have bought for yourself without a prescription While taking co-dydramol you should not take any other medicines which contain paracetamol (e.g. painkillers, cough and cold remedies).

Tell your doctor if you are taking any of the following medicines:

•    cholestyramine (to lower blood fat) metoclopramide or domperidone (to stop you feeling or being sick)

•    mexiletine (for irregular heart rhythm)

•    hypnotics, antiphyscotics, tranquillizers or medicines for anxiety

•    monoamine oxidase inhibitors (for depression)

•    warfarin and other coumarins ((to stop your blood clotting)

Co-dydramol with food, drink and, alcohol

Do not drink alcohol while you are taking these tablets.

Pregnancy, breast-feeding and fertility

If you are pregnant, planning to become pregnant or are breast-feeding, ask your doctor for advice before taking this medicine.

Co-dydramol can be used during pregnancy. You should use the lowest possible dose that reduces your pain and/or your fever and use it for the shortest time possible. Contact your doctor or midwife if the pain and/or fever are not reduced or if you need to take the medicine more often.

Driving and using machines

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.

3. How to take Co-dydramol For oral use.

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The label will tell you how many to take and how often to take them. The number of tablets you take is called the “dose”.

Swallow the tablets with water. Do not take more often than every four hours.

The usual dose is:

Adults and children over 12 years

The most common dose for adults and children over 12 is one tablet every four hours as you need them. This may be increased to 2 tablets four times a day if necessary.

Children under 12 years

Children under 12 years old should not take Co-dydramol tablets.

Older people

If you are elderly, your doctor will probably tell you to take a lower dose that the one normally recommended for adults.

If you take more Co-dydramol

For adults and children over 12 years

Talk to a doctor at once if you take too much of this medicine even if you feel well. This is because too much paracetamol can cause delayed, serious liver damage.

For children under 12 years

Talk to a doctor at once if your child takes too much of this medicine even if they seem well. This is because too much paracetamol can cause delayed, serious liver damage.

Remember to take this leaflet, and any tablets that you still have to show the doctor.

Do not take for longer than directed by your prescriber It is important not to take too many tablets.

Do not exceed the recommended dose.

If you forget to take Co-dydramol

If you forget to take a dose at the right time, take it as soon as you remember. Do not take a double dose to make up for a forgotten dose. If it is almost time to take the next dose, wait until then and then carry on as before.

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

4. Possible side effects

Like all medicines, Co-dydramol can cause side effects, although not everybody gets them.

•    Taking dihydrocodeine regularly for a long time can lead to addiction, which might cause you to feel restless and irritable when you stop the tablets.

Tell your doctor if you suffer from any of the following for more than a few days.

•    Constipation, feeling and being sick, headache, dizziness, giddiness and skin rashes.

Rarely, Co-dydramol Tablets can lead to the following:

•    blood disorders which can cause fever or chills.

•    Unexplained bleeding or bruising.

•    Very rare cases of serious skin reactions have 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/vellowcard

By reporting side effects you can help provide more information on the safety of this medicine.

5.    How to store Co-dydramol

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

Store in a cool dry place. Store your tablets in the original container. Do not use this medicine after the expiry date which is stated on the outer label. The expiry date refers to the last day of that month.. You should take any tablets that are out of date or which you no longer need back to your pharmacist. Never give them to anyone else.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6.    Contents of the pack and other information

What Co-dydramol tablet contains Each tablet contains:

The active substances are

•    Paracetamol BP 500 milligrams (mg) and Dihydrocodeine Tartrate BP 10mg (active ingredients);

The other ingredients are

•    Maize starch, povidone, pregelatinised starch, sodium starch glycolate, nipasept sodium and magnesium stearate (inactive ingredients).

What Co-dydramol Tablets look like and contents of the pack:

Co-dydramol tablets are white with CO-DYD on one side and a twin triangle logo on reverse. They come in pack of 30 and 100.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation holder

T/A IVAX Pharmaceuticals UK Norton Healthcare Ltd,

Ridings Point,

Whistler Drive,

Castleford,

West Yorkshire,

WF10 5HX.

Manufacturer

Norton (Waterford) Ltd, Waterford Ireland.

This information only applies to Norton Healthcare’s Co-dydramol Tablets.

This leaflet was last revised in June 2015

PL 00530/0228