Patient Information Leaflet

DIHYDROCODEINE 30mg 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

•    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.

1. WHAT DIHYDROCODEINE IS USED FOR

Dihydrocodeine tablets are used to relieve moderate to severe pain.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DIHYDROCODEINE

Do NOT take Dihydrocodeine if:

•    you are allergic (hypersensitive) to dihydrocodeine or any of the other ingredients of this medicine (listed in section 6)

•    you have a medical condition where you find it difficult to breathe

•    you are having an asthma attack.

•    you have a head injury or increased pressure in your head e.g. due to brain disease

•    you have a condition where the small bowel (part of your gut) does not work properly (paralytic ileus)

•    you are addicted to alcohol.

Warnings and precautions

•    Do not take for longer than directed by your doctor or pharmacist.

•    Avoid drinking alcohol while you are taking these tablets.

•    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.

Talk to your doctor or pharmacist before taking this medicine if you: have kidney or liver problems have an under-active thyroid have asthma or allergic disorders are debilitated (in a weakened state) have low blood pressure or you are suffering from shock

have an obstruction or inflammation of the gut or narrowing of the urethra (tube which passes urine from the bladder) have prostate or adrenal gland problems suffer from fits (convulsions) have a history of drug abuse

have been told that you have an intolerance to some sugars. These tablets contain lactose monohydrate.

Other medicines and Dihydrocodeine

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

*    hypnotics or sedatives (e.g. temazepam or diazepam)

' tricyclic antidepressants e.g. imipramine, or antipsychotics (used to treat mental illness) e.g clozapine

*    antihistamines that make you feel drowsy or dizzy e.g. chlorphenamine, promethazine

■    mexiletine (used to treat certain heart conditions)

*    monoamine oxidase inhibitors (MAOIs), or if you have stopped taking them within the last 14 days

*    domperidone, metoclopramide or cyclizine (used to treat nausea and sickness)

■    anaesthetics or alcohol

' cimetidine (used to treat ulcers)

*    any other tablets or medicines including those not prescribed by your doctor.

Pregnancy and breast feeding

Do not take these tablets until you have spoken to your doctor.

Driving and using machines

These tablets may reduce your mental or physical ability (see section 4 for a full list of side effects). If affected do not 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.

Continued overleaf

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 preserver 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 DIHYDROCODEINE

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

The tablets should be swallowed with a drink of water and are best taken with or after food.

These tablets are not recommended for children under 4 years of age.

Adults (including the elderly) and children over 12 years of age:

•    The usual dose is 1 tablet every 4-6 hours, or as directed by your doctor.

•    The dose may be reduced if you are elderly or have an under-active thyroid or severe kidney or liver problems.

Children 4-12 years of age:

•    The dose will depend on the child’s bodyweight (0.5-1 mg/kg bodyweight every 4-6 hours)

If symptoms persist consult your doctor.

DO NOT EXCEED THE RECOMMENDED DOSE.

If you forget to take a tablet take one as soon as you remember, unless it is nearly time for your next dose.

Never take two doses together.

IF YOU OR ANYONE ELSE TAKES TOO MUCH DIHYDROCODEINE:

Contact your doctor immediately or go to your local hospital casualty department. Please take this leaflet, any remaining tablets and the container with you.

4.    POSSIBLE SIDE EFFECTS

Like all medicines, Dihydrocodeine can cause side effects, although not everybody gets them.

Rare side effects

Signs of an allergic reaction such as skin rash, swelling of the lips, tongue or throat, or difficulty breathing. If affected stop taking the tablets and contact your doctor immediately or go to the nearest casualty department.

Other side effects

•    rash, itching, sweating, facial flushing, tingling or numbness of the skin

•    dizziness, headache, vertigo, breathing difficulties, muscle rigidity (at high doses)

•    visual disturbance, pinpoint pupils

■    drowsiness, mood changes, confusion, hallucination, euphoria

•    sexual dysfunction, gall bladder problems

•    dry mouth, nausea, vomiting, stomach pain, constipation

■    low blood pressure, slow or fast heart beat, feeling your heart beat . difficulty passing urine, fluid retention (which may cause swelling).

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. 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/yellowcand.

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

5.    HOW TO STORE DIHYDROCODEINE

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

Do not store above 25 °C. Keep in the original container or package. Keep the container tightly closed.

Do not use after the expiry date printed on the pack. The expiry date refers to the last day of that month.

6.    CONTENTS OF THE PACK AND OTHER INFORMATION What Dihydrocodeine Tablets contain:

The active ingredient in each tablet is dihydrocodeine tartrate 30mg.

The other ingredients are maize starch, lactose monohydrate, polyvinylpyrrolidone, sodium starch glycollate, colloidal silicon dioxide and magnesium stearate.

What Dihydrocodeine Tablets look like and contents of the pack:

The tablets are white, flat and round. Engraved with “DHC” and “30” on either side of a break line on one side and the M & A logo on the other. They are available in packs of 7,10,14,21,28,30,56,60,84,90,100,110,112,120,150,160,168 tablets. Dispensing packs are also available.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:

M & A Pharmachem Ltd, Bolton BL5 2AL, UK.

Date of last revision: November 2015

PP2445