Anadin Extra soluble tablets – patient leaflet, side effects, dosage

1. What your medicine is and what it is used for

Each tablet contains: 300 mg of Aspirin, 200 mg of Paracetamol and 45 mg of Caffeine.

Aspirin and paracetamol work by relieving pain and reducing high temperature and fever. Aspirin belongs to a group of medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) and has anti-inflammatory properties. In addition, your medicine contains caffeine, which increases the pain-relieving effect of the product.

Your medicine is for effective relief from: mild to moderate pain including headache, migraine, neuralgia, toothache, sore throat, period pains, symptomatic relief of sprains, strains, rheumatic pain, sciatica, lower back pain (lumbago), fibrositis, muscular aches and pains, joint swelling and stiffness, influenza, feverishness and feverish colds.

2. Before you take your medicine

Please read the following information. There is a possible association between aspirin and Reye’s syndrome when given to children. Reye’s syndrome is a very rare disease, which affects the brain and liver and can be fatal. For this reason aspirin should not be given to children aged under 16 years, unless on the advice of a doctor.

Do not take if you:

• are allergic to aspirin, paracetamol, caffeine, or any of the other ingredients listed in this leaflet • have or have ever had a stomach ulcer, perforation or bleeding
• suffer from haemophilia (your blood does not clot well) or from gout

• are breast feeding

• suffer from asthma caused by aspirin or other NSAIDs
• are in your 3rd trimester of pregnancy.

Take special care and talk to a pharmacist or your doctor before taking this medicine if you:

• suffer from asthma,allergic disease, havea history of gout, kidney orliverdisease(including alcoholic liver disease),dehydration or phenylketonuria (otherwise known as PKU, a condition where there is an excess of phenylalanine in your blood) or G-6-PD deficiency (an hereditary condition leading to low red blood cell counts).

• are pregnant.
• excessive intake of caffeine (e.g., coffee, tea and some canned drinks) should be avoided. • consumption of alcohol should be avoided.
• have severe illnesses, including severe renal impairment or sepsis (when bacteria and their toxins circulate in the blood leading to organ damage), suffer from malnutrition, chronic alcoholism or if you are taking flucloxacillin (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 is taken together with flucloxacillin. Symptoms may include: serious breathing difficulties with deep rapid breathing, drowsiness, feeling sick (nausea) and being sick (vomiting). During treatment withAnadin Extra Soluble, tell your doctor straight away if you get a combination of these symptoms.

When taking acetylsalicylic acid, serious allergic reactions which may include chest pain and even heart attack (Kounis syndrome) have been reported (see section 4). Seek medical care immediately when you notice chest pain with allergic reactions (such as skin rashes, shortness of breath).

Taking other medicines

Anadin Extra Soluble should not be used together with other non-steroidal anti-inflammatory drugs (NSAIDs). Please inform your doctor or pharmacist if you are taking:

• flucloxacillin (antibiotic), due to a serious risk of blood and fluid abnormality (called metabolic acidosis) that must have urgent treatment (see section 2).

This medicine should also be used with caution when taking the following:

• Other NSAIDS and corticosteroids:Do not use in combination with other NSAIDs as these may increase the risk of adverse effects. • medicines to treat blood clots (thrombolytics and anticoagulants) as there is an increased risk of bleeding. • medicines used to treat gout (probenecid, sulfinpyrazone) as there may be an increase of aspirin in the patients plasma levels. • medicines used to treat high blood pressure due to risk of kidney failure.
• anti-sickness medicines (metoclopramide) as it may increase the rate of absorption of aspirin. • medicines used to treate seizures (phenytoin) as aspirin increases the serum level of phenytoin. • medicines used to treat epilepsy and bipolar disorder (valproate) as aspirin inhibits the metabolism of valproate. • methotrexate (to treat some kinds of cancer,arthritis or psoriasis).Use of methotrexate with aspirin,renal function should be measured.
• medicines used to treat diabetes (sulphonylureas) as aspirin can increase the hypoglycaemic effect. • medicines used to treat indigestion (antacids) as use with this medicine may increase the excretion of aspirin. • antidepressants (SSRIs) as there is a risk of bleeding in the abdomen.

10 mm

186,26 mm

117,0 mm

Front side

XXXXX

XXXXX

Reel unwind:

cm

0 1 2 3 4 5 Scale 1:1

Cross Cutting

17 - Aug - 2026V4

AIP_CHAMPS_2023_HALEON

28.3401

224691

Interleaved 2 of 5

Barcode Number:

Magnification:

BWR: 0 Micrometre

62000000224691 • medicines to treat high cholesterol (cholestyramine). Paracetamol absorption is reduced. • medicines used to treat nausea and vomiting (metoclopramide and domperidone) as paracetamol absorption is increased. • medicines used to treat blood clots (warfarin) as there is an increased risk of bleeding.

• carbonic anhydrase inhibitors, such as acetazolamide (to treat glaucoma, seizure, or to increase urine production). Consumption of alcohol and excessive caffeine intake should be avoided.

Important information about some of the ingredients of your medicine

• This medicine contains 3.60 mg aspartame in each soluble tablet.Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly.
• If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine as it contains lactose.

3. How to take your medicine

For oral administration and short term use only

Dosage: Adults, the elderly and young persons aged 16 and over:

The minimum effective dose should be used for the shortest time necessary to relieve symptoms. Take 2 tablets dissolved in a glass of water up to 4 times a day, as required. Take only as much as you need to relieve your symptoms and leave at least 4 hours between each dose.

Do not take more than 8 tablets in any 24 hour period.

Do not give to children aged under 16 years, unless on the advice of a doctor.

For migraine indication: not recommended for children and adolescents (under 18 years of age). Do not take with any other paracetamol containing products.

Do not exceed the stated dose.

If you take more tablets than you should:

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. Bring any remaining tablets with you to show the doctor.

4. Possible Side Effects:

Like all medicines, your medicine can cause side effects, although not everybody gets them. You can reduce the chances of experiencing side effects by using the minimum dose required. Side effects may be more serious in elderly patients. If you experience any of the following serious effects STOP taking this medicine immediately and contact your doctor or pharmacist: The following side effects are all very rare:

• Breathing problems:Wheezing and breathing difficulties may be triggered in patients suffering from or with a previous history of asthma.
• Unexpected bleeding from the nose, gums, blood in the urine and bruising.
• Severe allergic reactions: Symptoms could include difficulty breathing, skin rash or swollen facial features. • Serious skin reactions. Symptoms include skin reddening, blisters or rash.
• Chest pain with allergic reactions (such as skin rashes, shortness of breath); this can be a sign of a potentially serious allergic reaction (Kounis syndrome) (frequency not known).
• Liver dysfunction.

Other possible side effects

If any of the following side effects get serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist:

The following side effects have "Not Known" frequency (cannot be estimated from the available data). • Prolonged bleeding time. • Kidney dysfunction.

• Temporary hearing loss. • Dizziness and headaches.
• Fluid retention (swelling of the limbs). • Fluttering heartbeat.

• Abdominal bleeding, abdominal discomfort,

  gastrointestinal ulceration, indigestion,

  nausea and vomiting.

  • Insomnia, restlessness, anxiety, irritability and nervousness.

• Reye's syndrome.

  • Metabolic acidosis (serious condition that can make blood more acidic, see Section 2).

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 theYellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRAYellow Card in the Google Play orAppleApp Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store your medicine

• Do not use this medicine after the expiry date shown on the end of the carton.
• Do not store above 25ºC.
• Keep out of sight and reach of children.

6. Further Information What does this medicine contain?

The active substances are aspirin, paracetamol and caffeine. Your medicine contains 300 mg ofAspirin, 200 mg of Paracetamol and 45 mg of Caffeine.

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially "sodium free". Each tablet also contains: citric acid (E330), calcium carbonate (E170), lactose, microcrystalline cellulose (E460), potato starch, colloidal silicon dioxide, maize starch, hydrogenated vegetable oil, lemon flavour, saccharin sodium, aspartame (E951), dioctyl sodium sulfosuccinate, pregelatinised starch and povidone.

Your medicine is available in packs containing 12 tablets.

Manufacturer: Haleon Italy Manufacturing S.r.l.,Via Nettunense, 90 - 04011Aprilia (LT), Italy. MarketingAuthorisation Holder: Haleon UKTrading Limited,Weybridge, KT13 0NY, U.K.

This leaflet was last revised inAugust 2026.

Trademarks are owned by or licensed to the Haleon group of companies.

•

10 mm

186,26 mm

117,0 mm

Rear side

8,5 mm

1,5 mm

Step cutting notch

18 mm max

8,0 mm

2,0 mm

1,5 mm

Material Code

XXXXX

XXXXX

Reel unwind:

cm

0 1 2 3 4 5 Scale 1:1

Cross Cutting