Anadin Extra Soluble Tablets

This medicine is available without a prescription, for you to treat a mild illness without a doctor’s help.

Nevertheless, you still need to use your medicine carefully to get the best results. Keep this leaflet. You may need to read it again. Ask your pharmacist if you need more information or advice. You must see a doctor if your symptoms worsen or do not improve.

1. What your medicine is and what it is used for
2. Before you take your medicine
3. How to take your medicine
4. Possible side effects
5. How to store your medicine
6. Further information

• 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.

• suffer from asthma, allergic disease, have a history of gout, kidney or liver disease (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 with Anadin 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).

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.
• 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.

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.

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.
• Temporary hearing loss.
• Fluid retention (swelling of the limbs).
• Abdominal bleeding, abdominal discomfort, gastrointestinal ulceration, indigestion, nausea and vomiting.
• Reye's syndrome.
• Kidney dysfunction.
• Dizziness and headaches.
• Fluttering heartbeat.
• Insomnia, restlessness, anxiety, irritability and nervousness.
• Metabolic acidosis (serious condition that can make blood more acidic, see Section 2).

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 or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

The active substances are aspirin, paracetamol and caffeine. Your medicine contains 300 mg of Aspirin, 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.

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