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Dihydrocodeine Tablets 30mg

Document: leaflet MAH BRAND_PL 28444-0162 change

PATIENT INFORMATION LEAFLET

Dihvdrocodeine Tablets 30mg (Dihydrocodeine BP)

Please read this leaflet carefully before you start to take this medicine. However, this leaflet does not tell you everything about your medicine. So, if you have any questions or are not sure about anything, ask your doctor or pharmacist.

Description of the Tablets

Dihydrocodeine tablets 30mg are white, flat, circular tablets with a bevel edge and a break-line on one side, each containing Dihydrocodeine BP 30mg.

Each tablet contains Lactose, Colloidal Anhydrous Silica, Maize Starch, Magnesium Stearate, Sodium Starch Glycollate, and Polyvinylpyrrolidone.

What sort of medicine is Dihydrocodeine?

Dihydrocodeine is an analgesic (“pain-killer”), which reduces the feeling of moderate to severe pain experienced by the body, without producing drowsiness.

Dihydrocodeine is available in packs of 25, 50, 100, 250, 500, 1000 but your doctor may prescribe a different number of tablets for you.

Dihydrocodeine Tablets 30mg are available only on prescription from your doctor.

Product License Holder

Activase Pharmaceuticals Limited 11 Boumpoulinas, 3rd Floor P.C. 1060 Nicosia,

Cyprus

Manufacturer

Athlone Laboratories, Ballymurray, Co-Roscommon, Republic of Ireland.

How does your medicine work?

You have been prescribed Dihydrocodeine tablets for the relief of moderate to severe pain. Dihydrocodeine is a narcotic analgesic which relieves the sensation of pain by acting on the brain and stopping the brain messages being received.

Dihydrocodeine is recommended to relieve moderate to severe painful conditions, where it is important to keep the feeling of drowsiness to a minimum.

Conditions where Dihydrocodeine is usually recommended include bone pain such as osteoarthritis, chronic rheumatoid arthritis, arthritis of the spine. It is also used to treat other conditions such as, sciatica (nerve pain), peripheral vascular disease (pain caused in the blood vessels), pain after shingles infection, breast pain, tumour pain and pain after surgery.

Before taking these tablets

-    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 taking the tablets.

-    Taking a painkiller for headaches too often or for too long can make them worse.

If you answer YES to any of the following questions, or are not sure, talk to your doctor or pharmacist before taking Dihydrocodeine tablets.

•    Are you always short of breath?

•    Have you ever had a reaction to Dihydrocodeine or any of the ingredients listed above?

Advice on taking your medicine

Talk to your doctor before taking Dihydrocodeine tablets if you have any of the following conditions:

•    If you are an asthmatic, or have difficulty breathing due to some other illness.

•    If you might be pregnant, or breast feeding.

•    If you have problems with your liver, kidneys or thyroid; if you suffer from low blood pressure

•    Are you taking, or have you been prescribed medicines known as Monoamine Oxidase

Inhibitors (MAOI’s)?

MAOI’s are anti-depressants and include phenelzine (also called Nardate), tranylcypromine (Parnate, Parstelin), isocarboxazid (Marplan) or moclobemide (Manerix). If you have been or are taking these tablets, talk to your doctor before taking Dihydrocodeine.

If you are unsure about taking Dihydrocodeine tablets talk to your doctor before taking them.

Follow this advice when taking Dihydrocodeine tablets,

•    If you suffer from asthma, dihydrocodeine tablets may make this worse, do not take them during

an asthma attack.

•    Elderly people should take a smaller dose of the medicine.

•    Avoid wine, beer and other alcoholic beverages when taking Dihydrocodeine.

Taking other medicines with Dihydrocodeine.

Taking Dihydrocodeine with other medicines may affect how well they work.

•    Do not take anti-depressants called Monoamine Oxidase Inhibitors (MAOI’s) at the same time

as dihydrocodeine as this can cause a serious rise or drop in your blood pressure. There should be at least a 14 day break after stopping the MAOI’s before taking the dihydrocodeine. Examples of this group of anti-depressants include phenelzine (also called Nardil), tranylcypromine (Parnate, Parstelin), isocarboxazid (Marplan) or moclobemide (Manerix).

•    Y ou should avoid alcohol while on this medicine, as it will worsen the sedative (drowsy) and

blood-pressure lowering (hypotension) effects.

•    If you take other medicines such as antihistamines, calmatives (anxiolytics) or sleeping tablets

(hypnotics) which make you feel drowsy, you will become more drowsy when taking Dihydrocodeine tablets as well.

•    If you are taking Mexitil (mexiletine) tablets for your heart, it’s effect will be reduced; talk to

your doctor about this before taking dihydrocodeine.

If you are taking any of these medicines at the same time as Dihydrocodeine, talk to your doctor and make sure that it has been taken into account.

How to take your Tablets

Your doctor has carefully chosen the correct dosage for you and for that reason, you should always take the prescribed dose. You must take your tablets as directed by the doctor. The pharmacist’s container will tell you when to take your tablets.

The usual doses are given below.

Dihydrocodeine tablets should be taken after food with a glass of water.

Adults: One tablet to be taken every 4 to 6 hours when necessary.

Elderly: Dosage should be reduced in the elderly.

Children under 12 years of age: Not recommended.

A lower dose should be used for elderly patients, and if you have liver, kidney or thyroid problems.

A maximum dose of 6 tablets should be taken in any 24 hour period.

If someone else has swallowed any of your tablets tell your doctor and take them to the nearest hospital casualty department immediately.

If you forget to take a dose, take a dose as soon as you remember, but do not take more than 6 tablets in any 24 hour period.

Are there any side effects to this Medicine?

As well as benefits, a medicine may have some effects that you don’t want.

Occasionally, patients may experience nausea and vomiting, headache, dizziness, difficult in passing water, and constipation. The constipation can be treated with a mild laxative.

If you take more than the recommended daily dose of Dihydrocodeine, or for a longer time than your doctor recommends, you may become dependent on your tablets.

If you take too much Dihydrocodeine or you feel unwell or suffer from any of the side-effects mentioned above, after taking Dihydrocodeine, tell your doctor immediately or contact your nearest hospital casualty department.

If you have any other problems that could be caused by taking this medicine, tell your doctor or pharmacist.

Storing your Tablets

Do not use the medicine after the expiry date which is on the container your medicine came in. If the “expiry date” has passed, take the medicine back to the pharmacist.

Keep your tablets in a safe place where children cannot reach them. Your tablets could harm children.

You should store your tablets in a cool, dry place protected from light at a temperature below 25°C (room temperature).

If your doctor decides to stop treatment, return any left over tablets to your pharmacist. Only keep them if your doctor tells you to.

Please keep this leaflet safe while you are taking this medicine as you may need to read it again.

Date of preparation March 2016

Product Licence Number

PL 28444/0162