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dolvan tablets    _n___#

norma

Diphenhydramine HCl 7.5 mg,

Ephedrine HCl 7.5 mg,

Paracetamol 300 mg,

Caffeine 30 mg.

Please read this leaflet carefully before using this medicine. if you have any questions or are not sure about anything, ask your doctor or pharmacist.

© You suffer from other liver problems (including drug and alcohol related).

This leaflet contains the following information.

1.    What are Dolvan Tablets and what do they do?

2.    What should I know before using Dolvan Tablets?

3.    How do I use Dolvan Tablets?

4.    Do Dolvan Tablets have any side effects?

5.    How do I store Dolvan Tablets?

6.    Further information.

© You have prostate enlargement.

© You have heart and/or circulatory problems. © You have bladder problems.

Are there any foods or medicines that interact with Dolvan Tablets?

© Dolvan Tablets contain paracetamol. Do not take anything else containing paracetamol while taking this medicine.

© Do not take alcohol during your treatment. Consult your doctor or pharmacist before taking Dolvan Tablets if you are taking any of the following:

© Domperidone or metoclopramide; for feeling sick or being sick (may increase the pain relief effect of paracetamol).

1.    What are Dolvan Tablets and what do they do?

Dolvan Tablets are taken for the symptomatic relief of the symptoms of colds and flu. They contain the following active ingredients:

Diphenhydramine; an antihistamine which works by reducing the body's response to histamine, an agent that causes sneezing, itching and increased mucus production during allergic reactions and viral infections such as the common cold. It will also make you drowsy.

Ephedrine; a decongestant.

Paracetamol; a painkiller that relieves mild to moderate pain and reduces fever. It relieves headache and the symptoms of cold and flu. Caffeine; a mild stimulant to reduce the drowsiness.

2.    What should I know before using Dolvan Tablets? When shouldn't I use Dolvan Tablets?

© Do not take Dolvan Tablets if you are allergic to any of the ingredients listed in section 6 of this leaflet.

£ Do not take Dolvan Tablets if you suffer from severe liver or kidney problems.

© Do not take Dolvan Tablets if you suffer from porphyria.

© Do not take Dolvan Tablets if you have received treatment with Monoamine Oxidase Inhibitors (MAOIs) which are a type of antidepressant medicine within the previous two weeks.

What else should I be aware of before using Dolvan Tablets?

You should inform your doctor or pharmacist before taking this medicine if any of the following apply:

© You have kidney problems.

© Colestyramine; used for lowering blood lipid levels (may reduce the absorption of paracetamol).

© Warfarin or other coumarins (for thinning the blood); if you take warfarin you can take occasional doses of this medicine, but talk to your doctor first before you take it on a more frequent basis.

© Monoamine Oxidase Inhibitors (MAOIs); a class of antidepressants - when taken with Dolvan Tablets can lead to dangerously high blood pressure.

© Beta blockers; used to treat high blood pressure -when taken with Dolvan Tablets can lead to dangerously high blood pressure.

© Bethanidine and debrisoquine ; which have their actions blocked by Dolvan Tablets.

© Bethahistine ; which has its actions blocked by Dolvan Tablets.

© Sleeping preparations; which have their actions increased by Dolvan Tablets.

© Anti-anxiety medicines; which have their actions increased by Dolvan Tablets.

Can I use Dolvan Tablets if I am pregnant or breast-feeding?

Do not take Dolvan Tablets if you are pregnant or breast-feeding.

Is it safe to drive or operate machinery after using Dolvan Tablets?

Dolvan Tablets may cause drowsiness.

Do not drive or operate machinery.

Important information about an ingredient of Dolvan Tablets.

Dolvan Tablets contain sucrose. If you have been told by a doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

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3.    How do I use Dolvan Tablets?

Adults and children over 12 years:

1 or 2 tablets three times a day.

The elderly:

1 tablets three times a day.

Not recommended for children under 12 years of age. Do not take more medicine than the above tells you to. If you do not get better, talk to your doctor. What should I do if I accidentally swallow too many Dolvan Tablets?

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. Go to your nearest hospital casualty department. Take the medicine and this leaflet with you provided it doesn't cause a delay.

4.    Do Dolvan Tablets have any side effects?

All medicines can cause side effects.

The following serious side effects have been reported to the ingredients of Dolvan Tablets:

© Difficulty in breathing.

© Swelling of the face, neck, tongue or throat (severe allergic reactions).

£ Unusual bruising, or infections such as sore throats (this may be a sign of very rare changes in the blood).

If you experience any severe side effect then discontinue use and seek the advice of your doctor. The following minor side effects have also been reported to the ingredients of Dolvan Tablets:

£ Drowsiness.

© Other allergic reactions (e.g. skin rash).

Talk to your pharmacist if these become troublesome.

If a minor side effect becomes severe, or you have a side effect which isn't listed, then discontinue use and seek the advice of your doctor.

You can help make sure medicines remain as safe as possible by reporting any unwanted side-effects via the internet at www.mhra.gov.uk/yellowcard alternatively you can call Freephone 0808 100 3352 (available between 10am-2pm Monday - Friday) or fill in a paper form available from your local pharmacy.

5.    How do I store Dolvan Tablets?

Do not use after the expiry date marked on the pack. Check the foil is not broken before use. If it is, do not take that tablet. Keep all medicines out of the sight and reach of children, preferably in a locked cupboard. Store below 25°C in the original packaging.

6.    Further information.

What is in Dolvan Tablets?

Each tablet contains the following active ingredients:

diphenhydramine hydrochloride 7.5 mg, ephedrine hydrochloride 7.5 mg, paracetamol 300 mg, caffeine 30 mg.

In addition to the above ingredients, the tablets also contain dextrin, corn starch, polyvinylpyrrolidone, stearic acid, magnesium stearate, sucrose, kaolin, talc, calcium carbonate, sodium benzoate, opaseal, gelatine, acacia, beeswax and colourings: titanium dioxide (E171) & Erythrosine (E127).

How are Dolvan Tablets supplied?

Dolvan Tablets are supplied in packs of 20 Tablets.

Who is responsible for Dolvan Tablets?

The tablets are manufactured by:

Wasdell Packaging Ltd., Euroway Industrial Estate, Blagrove, Swindon, Wiltshire SN5 8YW

on behalf of the marketing authorisation holder:

Norma Chemicals Ltd.,

51-53 Stert Street, Abingdon, Oxfordshire, OX14 3JF

PL 00386/5006R

This Leaflet was revised August 2013