Hedex tablets – patient leaflet, side effects, dosage

1. What Hedex is and what it is used for

Hedex can provide effective relief of headache, including migraine and tension headaches, backache, rheumatic and muscle pain, toothache, period pain and nerve pain.

It also relieves the fever, aches and pains of colds and flu. The active ingredient is paracetamol which is a painkiller and also reduces your temperature when you have a fever.

2. What you need to know before you take Hedex

Do not take Hedex:

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

Warnings and precautions:

Talk to your doctor or pharmacist before taking this medicine

• if you suffer from any liver or kidney problems, including alcoholic liver disease;

• if you have chronic alcoholism;
• if you are taking other medicines that can affect the liver;
• if you have glutathione deficiency;
• if you are dehydrated;
• if you have had poor diet such that the diet causes health problems;
• if you are elderly or weigh less than 50kg or have low Body Mass Index;
• if you have asthma and are sensitive to aspirin (acetylsalicylic acid);
• if you have Gilbert’s syndrome (familial non-haemolytic jaundice);
• if you have Glucose-6-phosphatehydrogenase enzyme deficiency;
• if you have haemolytic anaemia (abnormal breakdown of red blood cells)

They may reduce the dose or increase the time interval between doses of your medicine.

Immediately contact your doctor in case of overdose, even if you feel well because of the risk of irreversible liver damage. Liver damage can happen if paracetamol is taken for a long time or in higher doses than recommended

Prolonged use of any type of painkiller for headaches can make them worse. If this situation is experienced or suspected (e.g. if you have frequent or daily headaches despite or because of the regular use of headache medications), contact your doctor and stop taking this medicine.

During treatment with Hedex, tell your doctor straight away if you have severe illnesses, including severe renal impairment or sepsis (when bacteria and their toxins circulate in the blood leading to organ damage), or you suffer from malnutrition, chronic alcoholism or if you are also taking flucloxacillin (an antibiotic). A serious condition called metabolic acidosis (a blood and fluid abnormality) has been reported in patients in these situations when paracetamol is used at regular doses for a prolonged period or when paracetamol is taken together with flucloxacillin. Symptoms of metabolic acidosis may include: serious breathing difficulties with deep rapid breathing, drowsiness, feeling sick (nausea) and being sick (vomiting).

Avoid taking other medicines containing paracetamol concurrently.

Children

Do not give this medicine to children below the age of 6 years.

Other medicines and Hedex

Talk to your doctor or pharmacist if you are taking, have recently taken or might take any medicines, especially;

• metoclopramide or domperidone (for nausea [feeling sick] or vomiting [being sick])
• medicines to lower blood cholesterol (e.g. cholestyramine)
• medicines to prevent blood clots (anticoagulants e.g. warfarin)
• probenecid (used to treat gout)
• if you are taking medicine to treat bacterial infections (e.g. chloramphenicol) especially in malnourished patients
• other medicines that can affect the liver
• flucloxacillin (antibiotic), due to a serious risk of blood and fluid abnormality (called metabolic acidosis) that must have urgent treatment (see section 2).

Pregnancy and breast feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. If necessary, Hedex can be used during pregnancy. You should use the lowest possible dose that reduces your pain and/or your fever and use it for the shortest time possible. Contact your doctor or midwife if the pain and/or fever are not reduced. Ask your doctor or pharmacist for advice before taking this medicine whilst breast feeding, it may be present in breast milk.

Driving and using machines

Hedex has no or negligible influence on the ability to drive and use machines

3. How to take Hedex

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you to. Check with your doctor or pharmacist if you are not sure.

If you take more Hedex than you should

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. Symptoms of paracetamol overdose generally appear in the first 24 hours and may include: unusual paleness, feeling sick, vomiting, loss of appetite and abdominal pain, or patients may be asymptomatic.

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

4. Possible side effects

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

Stop taking the medicine and tell your doctor immediately if you experience:

• Sudden, severe allergic reaction with breathing difficulty, swelling, lightheadedness, fast heartbeat, sweating and loss of consciousness (anaphylaxis)
• Swelling of skin or mucous membrane, face, tongue, and throat causing breathing difficulties (angioedema)

• Very rare cases of serious skin reactions have been reported

  • Life-threatening reaction with flu-like effects and blistering in the skin, mouth eyes and genitals (toxic epidermal necrolysis)
  • Life-threatening reaction with flu-like symptoms and painful rash affecting the skin, mouth, eyes and genitals (Stevens-Johnson syndrome)
  • Sudden blisters in large skin areas (acute generalized exanthematous pustulosis)
• Shortness of breath. These are more likely if you have experienced them before when taking other painkillers such as ibuprofen and aspirin
• Unexplained bruising or bleeding as this can be a symptom of thrombocytopenia (reduction in blood platelets, which increases the risk of bleeding or bruising)
• Severe decrease in white blood cells which may lead to severe infections (agranulocytosis)
• A serious condition that can make blood more acidic (called metabolic acidosis), in patients with severe illness using paracetamol (see section 2).

Other side effects

Very rare side effects (may affect up to 1 in 10.000 people)

• Skin rash
• Itching
• Sweating
• Rash of raised red or purple spots, the spots look like small bruises or blood spots
• Hives
• Liver problems
• Cloudy urine

Not known (frequency cannot be estimated from the available data)

• Allergic reactions

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 Hedex

Keep out of the sight and reach of children.

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

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

Active ingredient: Each tablet contains Paracetamol 500 mg.

Other ingredients: Maize starch, potassium sorbate (E 202), purified talc, stearic acid, polyvidone, soluble starch, hydroxypropylmethylcellulose and triacetin.

Packs of Hedex contain 16 or 32 tablets.

The marketing authorisation holder is Omega Pharma Ltd, Wrafton, Braunton, Devon, EX33 2DL, United Kingdom and all enquiries should be sent to this address.

The manufacturer is GlaxoSmithKline Dungarvan Ltd., Co. Waterford, Ireland or GlaxoSmithKline GmbH & Co. KG, Benzstraße 25, 71083 Herrenberg, Germany.

This leaflet was last revised in March 2026.