What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

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Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL02855/0069.

Hedex Extra

PATIENT INFORMATION LEAFLET

HEDEX EXTRA

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 Hedex Extra 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 Hedex Extra does
2. Check before you take Hedex Extra
3. How to take Hedex Extra
4. Possible side effects
5. How to store Hedex Extra
6. Further information

1. What Hedex Extra does

Hedex Extra can provide extra 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 Hedex Extra

Do not take Hedex Extra:

  • 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 Hedex Extra 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.

3. How to take Hedex Extra

Adults and children aged 16 years and over:

Swallow 2 tablets every 4-6 hours as needed.

Do not take more frequently than every 4 hours.

Do not take more than 8 tablets in 24 hours

Children aged 12 - 15 years:

Swallow 1 tablet every 4-6 hours as needed.

Do not take more frequently than every 4 hours.

Do not take more than 4 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 delayed, serious liver damage.

If your symptoms continue or your headache becomes persistent, see your doctor.

4. Possible side effects

Like all medicines, Hedex Extra can have side effects, 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
  • Nausea, sudden weight loss, loss of appetite and yellowing of the eyes and skin.

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

5. How to store Hedex Extra

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 and triacetin.

Packs of Hedex Extra contain 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 September 2017.

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