Anadin Extra 8 Caplets contain three active ingredients: aspirin 300mg, paracetamol 200mg and caffeine 45mg per caplet. This combination is used for the relief of mild to moderate pain, including headaches, migraines, muscular aches, toothache and period pain.

Aspirin is a non-steroidal anti-inflammatory drug (NSAID) that helps relieve pain, inflammation and fever. Paracetamol helps relieve pain and reduce high temperature, while caffeine enhances the pain-relieving effect of the combination.

Anadin Extra Pain Relief Caplets are also used for neuralgia, sore throats, rheumatic pain, sprains, strains, sciatica, lower back pain, fibrositis, joint swelling, stiffness and the symptoms of influenza and feverish colds.

Suitable for adults and adolescents aged 16 years and over, Anadin Extra is taken orally with water. The recommended dose is 2 caplets when required, leaving at least 4 hours between doses. For migraine relief, use is not recommended in anyone under 18 years.

Each pack contains 8 caplets for short-term pain relief.

Do not exceed 8 caplets in 24 hours. Use the lowest effective dose for the shortest time necessary to relieve symptoms.

Patient Information Leaflet

Main ingredients: Aspirin 300mg, Paracetamol 200mg, Caffeine 45mg per caplet. Excipients: Maize starch, microcrystalline cellulose (E460), hydrogenated vegetable oil, hypromellose (E464), macrogol, pregelatinised starch, povidone.

Anadin Extra Caplets are used for the short-term relief of mild to moderate pain, including headache, migraine, neuralgia, toothache, sore throat, period pain, rheumatic pain, sprains, strains, sciatica, lumbago, fibrositis, muscular pain, joint swelling and stiffness, influenza, feverishness and feverish colds.

Adults, the elderly and adolescents aged 16 years and over:

• Take 2 caplets with water, up to 4 times daily as required.
• Leave at least 4 hours between doses.
• Do not exceed 8 caplets in any 24-hour period.
• The maximum daily dose is 2400mg aspirin, 1600mg paracetamol and 360mg caffeine.
• Use the lowest effective dose for the shortest time necessary to relieve symptoms.

Migraine relief: This medicine is not recommended for migraine treatment in children or adolescents under 18 years of age.

Children under 16 years: Do not give this medicine to children under 16 years unless specifically advised by a doctor.

How to take:

1. Take 2 caplets by mouth with water.
2. Leave at least 4 hours before taking another dose.
3. Take only when required for pain or fever relief.
4. Do not exceed 4 doses in 24 hours.

Missed dose: This medicine is taken as required rather than on a fixed schedule. If a dose is missed, take the next dose only when needed, ensuring the recommended interval is maintained. Do not take extra caplets to make up for a missed dose.

Important advice:

• This medicine is intended for short-term use only.
• Do not take with any other medicines containing paracetamol.
• Do not combine with other non-steroidal anti-inflammatory drugs (NSAIDs).
• Avoid excessive consumption of caffeine from coffee, tea, energy drinks or other caffeinated products.
• Avoid drinking alcohol while taking this medicine.
• Consult your doctor if symptoms persist, worsen or do not improve.
• Elderly patients should use this medicine with caution because they may be more susceptible to adverse effects.

Overdose: If you take more than the recommended amount, contact a doctor immediately, even if you feel well.

Taking too much paracetamol may cause delayed, serious liver damage. Aspirin overdose may also cause serious complications.

Take any remaining tablets and the medicine packaging with you when seeking medical help.

Storage:

• Store below 25°C.
• Keep out of the sight and reach of children.
• Do not use after the expiry date printed on the packaging.

Always follow the instructions provided in the Patient Information Leaflet.

Do not take Anadin Extra Caplets if you:

• Are allergic to aspirin, paracetamol, caffeine or any of the other ingredients.
• Have previously experienced asthma, wheezing, facial swelling, hives or breathing difficulties after taking aspirin or other NSAIDs.
• Have or have previously had a stomach ulcer, gastrointestinal bleeding or perforation.
• Have haemophilia or another blood clotting disorder.
• Have gout.
• Have severe kidney or liver failure.
• Are breastfeeding.
• Are in the last 3 months of pregnancy.
• Are under 16 years of age, unless specifically advised by a doctor.

Consult your doctor or pharmacist before taking this medicine if you:

• Have asthma or another allergic condition.
• Have liver or kidney problems.
• Have a history of gout.
• Are dehydrated.
• Have glucose-6-phosphate dehydrogenase (G6PD) deficiency.
• Have high blood pressure or diabetes.
• Have alcoholic liver disease or regularly consume alcohol.
• Are malnourished or have a serious infection such as sepsis.
• Are elderly.
• Are pregnant or planning to become pregnant.
• Are taking other medicines.

Pregnancy: Anadin Extra is not recommended during pregnancy.

Do not take this medicine during the last 3 months of pregnancy, as aspirin may affect the unborn baby's circulation and kidney function, increase the risk of bleeding and cause complications during delivery.

During the first 6 months of pregnancy, aspirin should be avoided unless a doctor considers that the potential benefits outweigh the risks.

Breastfeeding: Do not take Anadin Extra while breastfeeding.

Aspirin and caffeine can pass into breast milk. Aspirin may affect blood clotting in the infant, while caffeine may cause irritability or disturbed sleep.

Fertility: Aspirin may temporarily affect female fertility by influencing ovulation. This effect is reversible after stopping treatment.

Interactions with other medicines: Do not take Anadin Extra with other NSAIDs or medicines containing paracetamol.

Consult your doctor or pharmacist before use if you are taking:

• Anticoagulants such as warfarin or heparin.
• Antiplatelet medicines or medicines used to dissolve blood clots.
• Corticosteroids.
• Medicines for high blood pressure or heart conditions.
• Diuretics.
• Antidepressants, including SSRIs.
• Methotrexate.
• Phenytoin or valproate.
• Medicines for diabetes, including sulphonylureas.
• Medicines for gout.
• Flucloxacillin.
• Lithium or other medicines that may interact with caffeine.

This is not a complete list of possible interactions.

Alcohol and caffeine:

• Avoid alcohol while taking this medicine, as it may increase the risk of gastrointestinal bleeding and liver damage.
• Avoid excessive caffeine consumption from coffee, tea, energy drinks and other sources.
• Too much caffeine may increase the likelihood of restlessness, anxiety, difficulty sleeping and palpitations.

Stomach and intestinal bleeding: Aspirin can cause stomach ulcers, gastrointestinal bleeding or perforation, which may be serious.

Stop taking the medicine and seek immediate medical attention if you experience:

• Vomiting blood.
• Black or bloody stools.
• Severe abdominal pain.
• Unusual or prolonged bleeding.

Serious allergic reactions: Stop taking this medicine and seek immediate medical attention if you experience:

• Difficulty breathing or wheezing.
• Swelling of the face, lips, tongue or throat.
• Severe skin rash, blistering or peeling skin.
• Chest pain associated with an allergic reaction.

Chest pain occurring alongside symptoms of an allergic reaction may indicate Kounis syndrome, a potentially serious allergic reaction affecting the heart.

Serious skin reactions: Severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported with paracetamol.

Stop taking the medicine and seek immediate medical attention if you develop blistering, widespread skin redness or peeling skin.

Metabolic acidosis: A serious blood and fluid abnormality called high anion gap metabolic acidosis has been reported in patients with certain risk factors using paracetamol for prolonged periods or together with flucloxacillin.

Symptoms may include deep, rapid breathing, drowsiness, nausea and vomiting.

Seek immediate medical attention if these symptoms develop.

Children and Reye's syndrome: Aspirin is associated with a risk of Reye's syndrome, a rare but potentially fatal condition affecting the brain and liver.

Do not give this medicine to children under 16 years unless advised by a doctor, particularly during or after viral infections.

Driving and operating machinery: The SmPC does not identify a specific effect on driving or operating machinery. However, dizziness may occur as a side effect. Do not drive or operate machinery if affected.

Overdose: Taking more than the recommended dose can cause serious liver damage, aspirin toxicity and other potentially life-threatening complications.

Seek immediate medical attention following an overdose, even if there are no symptoms.

Storage and safety:

• Store below 25°C.
• Keep out of the sight and reach of children.
• Do not use after the expiry date shown on the packaging.
• Do not exceed the recommended dose.

Use the lowest effective dose for the shortest time necessary to relieve symptoms.

Like all medicines, Anadin Extra Caplets can cause side effects, although not everybody will experience them.

Additional safety information:

Side effects may be more serious in elderly patients.

Using the lowest effective dose for the shortest necessary duration may reduce the likelihood of adverse reactions.

Excessive caffeine consumption while taking this medicine may increase nervousness, insomnia, restlessness and palpitations.

Reporting side effects:

If you experience any side effects, including those not listed in the Patient Information Leaflet, speak to your doctor, pharmacist or nurse.

Suspected side effects can also be reported through the MHRA Yellow Card Scheme.

Stop taking this medicine and seek immediate medical attention if you experience severe allergic reactions, serious skin reactions, gastrointestinal bleeding or chest pain associated with an allergic reaction.