_ PATIENT INFORMATION LEAFLET

¹ DIHYDROCODEINE

Tablets 30mg

Please read all of this leaflet carefully before you start taking this medicine.

Keep the leaflet; you may need to read it again. If you have any questions or are not sure about anything, 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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Dihydrocodeine Tablets are and what they are used for

2.    Before you take Dihydrocodeine Tablets

3.    How to take Dihydrocodeine Tablets

4.    Possible side effects

5.    How to store Dihydrocodeine Tablets

6.    Further information

1.    What Dihydrocodeine Tablets are and what they are used for

The name of this medicine is Dihydrocodeine Tablets BP 30 mg. Dihydrocodeine belongs to a group of medicines called opioid analgesics (pain killers). Dihydrocodeine is used for the relief of moderate to severe pain for conditions where the doctor requires you to remain alert such as sciatica, osteoarthritis, chronic rheumatoid arthritis, arthritis of the spine, narrowing of the blood vessels in the arms and legs, neuralgia following a herpes infection, Paget’s disease, a malignant disease or if you are suffering from pain following an operation.

2.    Before you take Dihydrocodeine Tablets

Do not take these tablets if:

•    you are allergic to dihydrocodeine or any other opioid analgesic or to any of the ingredients listed (see section 6)

•    you have difficulty in breathing or any kind of lung disease

•    you are at risk from blocked intestine

•    you have a head injury or pressure on the brain

•    you are addicted to alcohol

•    you are having a sudden asthma attack

•    you have diarrhoea due to antibiotic therapy or food poisoning. Dihydrocodeine Tablets should not be given to anyone who is unconscious.

Tell your doctor if you have:

•    kidney or liver disease

•    asthma or any lung problems

•    any allergies

•    bowel problems

•    low blood pressure, are in a state of shock, or feel weak and feeble

•    an enlarged prostate (in men)

•    difficulty passing urine

•    convulsions (fits)

•    underactive thyroid or adrenal glands

•    a history of drug abuse.

Taking other medicines

Check with your doctor or pharmacist before taking these tablets if you are taking other medicines, including any that you can buy without a prescription. This is particularly important if you are taking:

•    medicines to treat diarrhoea, irritable bowel syndrome (IBS) or intestinal problems e.g. difenoxin, atropine, kaolin, pectin, belladonna alkaloids, opium preparations and loperamide

•    medicines to treat high blood pressure, e.g. guanethidine and diuretics (water pills)

•    medicines used to reduce smooth muscle spasms especially abdominal or stomach cramps or spasms

•    metoclopramide - a medicine used in the treatment of nausea and vomiting (particularly that which may occur due to digestive problems or during cancer treatment), or domperidone or cyclizine (to treat nausea and vomiting)

•    cimetidine used to treat stomach ulcers

•    mexiletine used to treat irregular heartbeat

•    some medicines used to treat allergies which may cause drowsiness e.g. chlorphenamine

•    moclobemide, tricyclic antidepressants (e.g. amitriptyline) or are taking, or have taken a monoamine oxidase inhibitor (e.g. phenelzine) in the last 2 weeks, all of which are used to treat depressive illness

•    medicines which are sedatives (sleeping pills) and tranquillisers, or used to treat mental illnesses including schizophrenia.

If you are going to have an anaesthetic make sure you tell the doctor or dentist you are taking dihydrocodeine.

Other special warnings:

•    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.

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

Pregnancy and breast feeding: Consult your doctor if you are

pregnant or breast feeding. Do not take dihydrocodeine tablets during late pregnancy or whilst breast feeding, unless advised by your doctor.

Driving and using machines: The medicine can affect your ability to drive and operate machinery as it may make you sleepy or dizzy, or may reduce your ability to think clearly, or may cause tingling or numbness in the hands or feet, a spinning sensation, muscle rigidity, visual disturbances, confusion or hallucinations.

•    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.

Alcohol: Avoid drinking alcohol while you are taking this medicine, as the effect of alcohol may be increased.

Important information about an ingredient of Dihydrocodeine Tablets:

The tablets contain lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Dihydrocodeine Tablets

Swallow the tablets whole with water during or after a meal or snack.

Adults: The usual dose for adults is one tablet every 4 to 6 hours. Your doctor may sometimes prescribe a different dose to this. Children over 4 years of age: Dihydrocodeine tablets are not suitable for use in children under 12 years, who are usually given a liquid preparation of dihydrocodeine instead. The liquid dosage for children will be determined by your doctor, as it depends on the body weight of the child.

This medicine is NOT recommended for children under 4 years of age.

Elderly: The dose should be reduced in elderly patients.

Always follow your doctor’s instructions. The pharmacist’s label will tell you how many tablets to take and how often to take them. If you do not understand anything, ask your doctor or pharmacist. Do not exceed the stated dose. If your pain is not reduced, please speak to your doctor.

If you forget to take a dose: take your dose as soon as you

remember and then your next dose at the usual time. However, if it is almost time for your next dose, skip the missed dose and continue with your normal dosing schedule.

DO NOT DOUBLE THE DOSES.

If you take more Dihydrocodeine Tablets than you should:

If you or anyone else takes too much of this medicine, contact your doctor straight away or go to the nearest hospital casualty department. Take with you any remaining tablets and the package so that the medicine can be identified. Signs and symptoms of overdose that you might experience are cold, clammy skin, confusion, convulsions, dizziness, drowsiness, weakness, low blood pressure, nervousness, restlessness, pin-point pupils, slow or troubled breathing and unconsciousness.

4.    Possible side effects

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

If you experience any of the following contact your doctor or go to a hospital immediately:

•    an allergic reaction such as hives, itching, skin rashes, swelling of the face, difficulty breathing or shortness of breath

•    convulsions.

Also tell your doctor straight away, if you notice any of the following effects:

•    mental depression, hallucinations (seeing or hearing things that are not real), unusual excitement in children

•    uncontrolled muscular movements, tremors

•    muscle rigidity

•    irregular heartbeat

•    visual disturbance (e.g. blurred or double vision)

•    difficulty or pain in urination.

Other side effects include:

•    fluid retention (symptoms include swollen ankles)

•    feeling or being sick, constipation, dry mouth, stomach pain, stomach cramps, loss of appetite

•    low blood pressure, feeling of dizziness or spinning or feeling lightheaded or faint on standing up

•    mood changes, confusion, feeling anxious, uneasy or very happy, restlessness

•    headache, dizziness, drowsiness, tiredness, general feeling of being unwell, tingling or numbness in the hands or feet

•    pinpoint pupils

•    slower or faster heartbeat or feeling your heart beat

•    flushed face, hives, itching, sweating

•    decrease in sex drive

•    nightmares.

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 Dihydrocodeine Tablets

Keep the tablets in the pack provided and protect from heat, light and moisture.

KEEP ALL MEDICINES OUT OF THE SIGHT AND REACH OF CHILDREN

Do not take the tablets if the expiry date on the pack has passed.

If you have any medicines that are out of date, return them to your pharmacist for safe disposal.

6.    Further information

Ingredients:

Dihydrocodeine Tablets 30mg contains 30mg of dihydrocodeine tartrate as the active ingredient. Other ingredients are: maize starch, lactose, sodium starch glycolate, stearic acid, and magnesium stearate.

What the medicine looks like:

The tablets are white, round tablets engraved on one side with the company logo and A435 on the other side.

This medicine is available in pack sizes of 28, 30, 42, 50, 56, 84, 100, 112, 250, 500 and 1000 tablets. (Not all pack sizes may be marketed.)

Who makes this medicine and holds the Product Licence:

Crescent Pharma Limited, Units 3 & 4, Quidhampton Business Units, Polhampton Lane, Overton, Hants, RG25 3ED Date leaflet revised: February 2014.

If you would like this leaflet in a different format please contact the licence holder at the above address.