ANADIN LIQUIFAST

For oral administration and short-term use only. 4).

Adults, the elderly, and children and adolescents over 12 years of age:

If in children and adolescents, between the age of 12 and 18 years, this medicinal product is required for more than 3 days, or if symptoms worsen, a doctor should be consulted. For adults aged 18 years or older the minimum effective dose should be used for the shortest time necessary to relieve symptoms.

The patient should consult a pharmacist or a doctor if symptoms persist or worsen, or if the product is required for more than 10 days. One or two capsules up to three times per day as required. The respective dosing interval should be chosen in line with the observed symptoms and the maximum recommended daily dose.

Doses should be given approximately every 6-8 hours, with a minimum interval of 4 hours between each dose. A total dose of 1200 mg of ibuprofen [6 capsules] should not be exceeded in any 24 hour period. 4). The capsules should be taken with water.

Not to be used for children under 12 years of age

Adverse reactions reported from extensive post-marketing experience are tabulated below by System Organ Class and frequency. The following convention has been utilised for the classification of undesirable effects: very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1000, <1/100), rare (≥1/10000, <1/1000), very rare (<1/10000), not known (cannot be estimated from available data).

The following list of adverse effects relates to those experienced with ibuprofen at OTC doses, for short term use. In treatment of chronic conditions, under long-term treatment, additional adverse effects may occur. Body System Undesirable effect Frequency Nausea, dyspepsia, diarrhoea, vomiting Common Abdominal pain, flatulence, constipation Uncommon Intestinal diaphragm disease Rare Gastrointestinal disorders Peptic ulcer, perforation or gastrointestinal haemorrhage, sometimes fatal, particularly in the elderly.

Exacerbation of ulcerative colitis and Crohn’s disease (see Warnings and Precautions). Very rare Psychiatric disorders Nervousness Rare Nervous system disorders Headache, drowsiness, dizziness Common Metabolism and Nutrition Disorders Decreased appetite and Hypokalaemia* Not known Tubulointerstitial nephritis, nephrotic syndrome, haematuria, proteinuria RareRenal and urinary disorders Acute renal failure, papillary necrosis, especially in long-term use, associated with increased serum urea and oedema.

Very rare Uretic colic, dysuria and renal tubular acidosis* Not known Hepatobiliary disorders Liver disorders. Very rare Blood and lymphatic system disorders Haematopoietic disorders (anaemia, leucopenia, thrombocytopenia, pancytopenia, agranulocytosis).

First signs are: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe exhaustion, unexplained bleeding and bruising. g. myocardial infarction or stroke Not known General disorders and administration site conditions Oedema (see Warnings and Precautions) Rare Skin rashes Uncommon Severe cutaneous adverse reactions (SCARs) (including Erythema multiforme, exfoliative dermatitis, Stevens-Johnson Syndrome, and toxic epidermal necrolysis) Very rare Skin and subcutaneous tissue disorders Drug reaction with eosinophilia and systemic symptoms (DRESS) Very rare Photosensitivity reactions Not known Acute generalized exanthematous pustulosis (AGEP) Not known Immune system disorders Hypersensitivity reactions including: • Urticaria and pruritus Uncommon • In patients with existing auto- immune disorders (such as systemic lupus erythematosus, mixed connective tissue disease) during treatment with ibuprofen, single cases of symptoms of aseptic meningitis, such as stiff neck, headache, nausea, vomiting, fever or disorientation have been observed (see Warnings and Precautions).

Rare Immune system disorders • Severe hypersensitivity reactions. Symptoms could be: facial, tongue and laryngeal swelling, dyspnoea, tachycardia, hypotension (anaphylaxis, angioedema or severe shock). • Exacerbation of asthma and bronchospasm.

Very rare Eye disorder Visual disturbances Rare Tinnitus UncommonEar and labyrinth disorders Vertigo Rare Description of Selected Adverse Reactions *Renal tubular acidosis and hypokalaemia have been reported in the post-marketing setting typically following prolonged use of the ibuprofen component at higher than recommended doses.

4). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

4 Special Warnings and Precautions. g. asthma, rhinitis, angiodema or urticaria) in response to aspirin or other non-steroidal anti-inflammatory drugs. Active or previous peptic ulcer (two or more distinct episodes of proven ulceration or bleeding).

History of upper gastrointestinal bleeding or perforation, related to previous NSAID therapy. 4). Use in last trimester of pregnancy (See section

Hypersensitivity to ibuprofen or any of the constituents in this product (see Section