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Document: leaflet MAH BRAND 2_PL 02855-0069 change

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HEADACHE

TABLETS Paracetamol, Caffeine

Please read right through this leaflet before you start using this medicine.

This medicine is available without prescription, but you still need to use Solpadeine Headache Tablets carefully to get the best results from them.

Keep this leaflet, you may need to read it again.

If you have any questions, or if there is anything you do not understand, ask your pharmacist.

In this leaflet:

1.    What Solpadeine Headache Tablets do

2.    Check before you take Solpadeine Headache Tablets

3.    How to take Solpadeine Headache Tablets

4.    Possible side effects

5.    How to store Solpadeine Headache Tablets

6.    Further information

1. What Solpadeine Headache Tablets do

Solpadeine Headache Tablets can provide effective relief from headache including migraine. They can also relieve backache, rheumatic and muscle pain, toothache, sore throat, period pain and relieve the fever, aches and pains of colds and flu.

The tablets contain two active ingredients. Paracetamol is a painkiller and also reduces your temperature when you have a fever. Caffeine acts to further help the effectiveness of paracetamol.


2. Check before you take Solpadeine Headache Tablets



Do not take Solpadeine Headache Tablets:


*    if you have ever had an allergic reaction to paracetamol, caffeine or to any of the other ingredients (listed in Section 6)

•    if you are taking other medicines containing paracetamol.


Ask your doctor before you take this medicine:


* if you have liver or kidney disease, including alcoholic liver disease.


If you are taking other medicines


Talk to your doctor or pharmacist before taking these tablets if you are taking any prescribed medicines; particularly metoclopramide or domperidone (for nausea [feeling sick] or vomiting [being sick]) or colestyramine (to lower blood cholesterol). If you take blood thinning drugs (anticoagulants e.g. warfarin) and you need to take a pain reliever on a daily basis, talk to your doctor because of the risk of bleeding. But you can still take occasional doses of Solpadeine Headache Tablets at the same time as anticoagulants.


Pregnancy and breast feeding


Due to the caffeine content of this product it should not be used if you are pregnant or breast feeding.

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• Nausea, sudden weight loss, loss of appetite and yellowing of the eyes and skin.




How to take Solpadeine Headache Tablets

Adults and children aged 12 years and over:

Swallow 2 tablets every 4 hours as needed.

I • Do not take more frequently than every 4 hours.

I • Do not take more than 8 tablets in 24 hours.

•    Do not take more than the recommended dose.

•    Do not give to children under 12 years.

Avoid too much caffeine in drinks like coffee and tea. High caffeine intake can cause difficulty sleeping, shaking and an uncomfortable feeling in the chest.

If you take too many tablets

Immediate medical advice should be sought in the event of

an overdose, even if you feel well, because of the risk of elayed, serious liver damage.

If your symptoms continue or your headache becomes

persistent, see your doctor.

4. Possible side effects

Like all medicines, Solpadeine Headache Tablets can have side ffects, but not everybody gets them. A small number of

people have had side effects.

Stop taking the medicine and tell your doctor immediately if

you experience:

Allergic reactions which may be severe such as skin rash

and itching sometimes with swelling of the mouth or face

or shortness of breath

Skin rash or peeling, or mouth ulcers

Breathing problems. These are more likely if you have

experienced them before when taking other painkillers

such as ibuprofen and aspirin

Unexplained bruising or bleeding


If you do get any side effects, even those not mentioned ir this leaflet, tell your doctor or pharmacist.

5.    How to store Solpadeine Headache Tablets

Keep out of the reach and sight of children.

Do not use this medicine after the 'EXP' date shown on the pack.

Store below 25°C.

6.    Further information

Active ingredients: Each tablet contains Paracetamol 500 mg and Caffeine 65 mg.

Other ingredients: Starch pregelatinised, maize starch, polyvinyl pyrrolidone, potassium sorbate (E 202), purified talc, stearic acid, croscarmellose sodium, hypromellose, triacetin, propylene glycol, shellac, brilliant blue FCF (E 133), sodium lactate and dimethylpolysiloxane (SILFAR SE4).

Packs of Solpadeine Headache Tablets contain 8 or 16 tablets.,

The marketing authorisation holder is

Omega Pharma Ltd., 32 Vauxhall Bridge Road, London,

SW1V 2SA, United Kingdom and all enquiries should be sent to this address.

The manufacturer is GlaxoSmithKline Dungarvan Ltd., Co. Waterford, Ireland.

This leaflet was last revised in June 2016.


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