Document: leaflet MAH GENERIC_PL 16201-0007 change

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• leaflet MAH GENERIC_PL 16201-0007
• leaflet MAH GENERIC_PL 17780-0174
• leaflet MAH GENERIC_PL 29831-0069

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PACKAGE LEAFLET: INFORMATION FOR THE USER DIHYDROCODEINE 30mg TABLETS (Dihydrocodeine tartrate BP)

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.    WHA DIHYDROCODEINE TABLETS ARE AND WHAT THEY ARE USED FOR

Dihydrocodeine Tablets are used as a strong pain killer (known as an opioid) for the relief of moderate to severe pain.

2.    BEFORE YOU TAKE DIHYDROCODEINE TABLETS Do not take Dihydrocodeine Tablets if:

•    You know that you are allergic to dihydrocodeine tartrate, or any of the other ingredients (refer to section 6 below)

•    You suffer from breathing problems, for example chronic bronchitis or if you are having an asthma attack (both are conditions of shortness of breath, wheezing and chest tightness)

•You suffer from paralytic ileus (paralysis of the gut which stops the movement of food through the intestine)

•    You have a head injury or suffer from increased pressure on the brain.

•    Patients with galactose/lactose intolerance or glucose-galactose malabsorption should not take this medicine.

Dihydrocodeine Tablets are not recommended for children under 12 years.

Take special care and tell your doctor or pharmacist before taking Dihydrocodeine Tablets if:

•    Do not take for longer than directed by your prescriber

•    Taking dihydrocodeine (DHC) 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.

•    You have liver, kidney or thyroid problems, as the dose might need to be lowered.

•    You suffer from asthma.

•    You have a head injury or suffer from increased pressure on the brain.

•    You are elderly.

•    You suffer from paralytic ileus (paralysis of the gut which stops the movement of food through the intestine)

•    You have an enlarged prostrate

•    You suffer from pancreatitis, biliary tract disorder, or obstructive bowel disorder which could give you severe stomach or back pain

•    You suffer from constipation

•    You have a severe heart problem after long-term lung disease (severe corpulmonale);

•    You are or have ever been addicted to drugs.

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:

•    Medicines which affect the nervous system such as sleeping tablets and sedatives (e.g. diazepam andtemazepam).

•    Medicines used to treat some mental problems, like hallucinations (eg. phenothiazines)

•    Monoamine Oxidase Inhibitors (MAOIs, e.g. moclobemide, phenelzine or isocarboxazid can interact with dihydrocodeine if MAOIs have been taken within the last 3 weeks).

•    Medicines to treat heart disease (e.g. mexiletine). Dihydrocodeine Tablets must not be taken with any other medicines containing dihydrocodeine tartrate. Always check the labels for ingredients.

Taking Dihydrocodeine Tablets with food and drink

The tablets should be taken after food if possible. Avoid alcohol whilst taking Dihydrocodeine Tablets as alcohol may increase the sedative effects of Dihydrocodeine Tablets and make you very sleepy.

Pregnancy and breast feeding

Do not take these tablets if you are pregnant or likely to become pregnant. If you are breastfeeding do not take these tablets until you have spoken to your doctor.

Ask your doctor or pharmacist before taking any medicine.

Driving and using machines

Dihydrocodeine Tablets can cause drowsiness. If affected, do not drive or use machines.

You should ask your doctor for advice on 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:

o The medicine has been prescribed to treat a medical or dental problem and o You have taken it according to the instructions given by the prescriber or in the information provided with the medicine and o 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.

Important information about some of the ingredients of Dihydrocodeine Tablets

This medicine contains lactose which is a type of sugar. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. This medicinal product contains less than 1 mmol sodium (23 mg) per 30 mg dose, i.e. essentially ‘sodium- free’.

3. HOW TO TAKE DIHYDROCODEINE TABLETS

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

Adults and children over 12 years

The usual dosage is one tablet every four to six hours after food. The maximum daily dose is 6 tablets in 24 hours. A lower dosage may be needed if you are elderly or have other medical problems. Check with your doctor about this.

Do not take for more than 3 days. If you need to use this medicine for more than three days you must speak to your doctor or pharmacist

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

Do not take for longer than directed by your doctor.

Taking dihydrocodeine regularly over a long period of time can lead to addiction, which might make you feel restless and irritable when you stop taking the tablets. Your doctor will stop your tablets gradually to avoid you having these withdrawal symptoms.

Dihydrocodeine Tablets are not recommended for children under 12 years.

If you take more Dihydrocodeine Tablets than you should

You should not take more than 6 tablets in 24 hours. If you think you have taken too many tablets contact your doctor or hospital immediately. People who have taken an overdose may feel very sleepy, sick or dizzy. They may also have breathing difficulties leading to unconsciousness or even death and may need emergency treatment in hospital. When seeking medical attention make sure that you take this leaflet and any remaining tablets with you so that the medical staff know what you have taken.

If you forget to take Dihydrocodeine Tablets

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 have any further question on the use of this product, ask your doctor or pharmacist.

If you continue taking Dihydrocodeine Tablets for too long

This medicine contains dihydrocodeine and can cause addiction if you take it continuously for more than three days. When you stop taking it you may get withdrawal symptoms. You should talk to your doctor or pharmacist if you think you are suffering from withdrawal symptoms.

4. POSSIBLE SIDE EFFECTS

Some people may have side-effects when taking this medicine. If you have any unwanted side effects you should seek advice from your doctor, pharmacist or other healthcare professional. Also you can help to make sure that medicines remain as safe as possible by reporting any unwanted side effects via the internet at www.yellowcard.gov.uk; alternatively you can call Free phone 0808 100 3352 (available between 10am-2pm Monday - Friday) or fill in a paper form available from your local pharmacy.

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

All medicines can cause allergic reactions, although serious allergic reactions are uncommon.

Tell your doctor immediately if you get swelling of the face or throat. The more serious side effect is a condition where you breathe more slowly or weakly than expected (respiratory depression). As with all strong painkillers, there is a risk you may become addicted or reliant on these tablets. Taking a painkiller for headaches too often or for too long can make your headaches worse.

Common side effects (Probably affecting more than 1 in 100 people taking these tablets)

•    Constipation (your doctor can prescribe a laxative to overcome this problem).

•    Feeling or being sick (this should normally wear off after a few days, however your doctor can prescribe an anti-sickness medicine if it continues to be a problem).

•    Drowsiness (this is most likely when you start taking your tablets or when your dose is increased, but it should wear off after a few days).

•    Dry mouth, abdominal pain or discomfort.

Uncommon side effects (Probably affecting fewer than 1 in 100 people taking these tablets)

•. Diarrhoea, a condition where the bowel does not work properly (paralytic ileus).

•    Mood changes.

•Confusion

•    Stomach pain •Weakness

•    Lack of ability to urinate

•    Headache, confusion, a feeling of unusual weakness.

•    Hallucinations.

•    Blurred vision.

•    A feeling of dizziness or 'spinning', seizures, fits or convulsions.

•    Tingling or numbness.

•    Low blood pressure.

•    Decreased sexual drive.

•    Difficulty in passing urine.

•    Flushing of the skin.

•    Rash or itchy skin.

•    Shortness of breath.

•    Sweating.

•    A need to take increasingly higher doses to obtain the same level of pain relief (tolerance).

•    A worsening in liver function tests (seen in a blood test).

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.

How do I know if I am addicted?

If you take the medicine according to the instructions on the pack it is unlikely that you will become addicted to the medicine. However, if the following apply to you it is important that you talk to your doctor:

•    You need to take the medicine for longer periods of time

•    You need to take more than the recommended dose

•    When you stop taking the medicine you feel very unwell but you feel better if you start taking the medicine again.

Also you can help to make sure that medicines remain safe as possible by reporting unwanted side effects via the internet at www.mhra.gov.uk/yellowcard. Alternatively you call freephone 0808 100 3352 (available from 10 a.m. to 2 p.m. Mondays to Fridays) or fill paper form available from your local pharmacy.

5.    HOW TO STORE DIHYDROCODEINE TABLETS

Keep out of the reach and sight of children.

•    Do not use Dihydrocodeine Tablets after the expiry date which is stated on the carton. expiry date refers to the last day of that month.

•    Keep this medicine in a dry place

•    Do not store above 25°C

•    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 INFORMATUION What Dihydrocodeine Tablets contain

•    The active substance is Dihydrocodeine tartrate BP 30mg.

•    The other ingredients are starch, povidone, lactose, sodium starch glycollate, magnesium stearate andcolloidal anhydrous silica.

What Dihydrocodeine Tablets look like and contents of the pack

Dihydrocodeine Tablets are white, flat, circular tablets with bevel edge and a breakline on one side. Dihydrocodeine Tablets are available in containers of 25, 50, 100, 250, 500 or 1000 tablets and blisters pack of 28 and 30 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Mercury Pharma (Generics) Ltd.,

Capital House, 85 King William Street,

London EC4N 7BL, UK

Manufactured By

Bristol Laboratories Ltd., Unit 3 Canalside, Northbridge Road, Berkhamsted, Hertfordshire, HP4 1EG, UK.

This leaflet was last revised in October 2014