CARE MAX STRENGTH COLD & FLU RELIEF

Posology For short-term use only. One tablet every 8 hours. Leave at least 4 hours between doses and do not exceed three tablets in any 24 hour period. 4). The patient should consult a doctor if symptoms persist or worsen, or if the medicinal product is required for more than 10 days.

Children Not to be given to children under 12 years. Method of administration For oral use

Summary of the safety profile The most commonly observed adverse events are gastrointestinal in nature. Hypersensitivity reactions have been reported following treatment with ibuprofen and these may consist of: (a) Non-specific allergic reaction and anaphylaxis.

g. asthma, aggravated asthma, bronchospasm or dyspnoea. g. pruritis, urticaria, angioedema and, more rarely, exfoliative and bullous dermatoses (including epidermal necrolysis and erythema multiforme). The following list of adverse effects relates to those experienced with ibuprofen at OTC doses, for short-term use.

In the treatment of chronic conditions, under long- term treatment, additional effects may occur. Tabulated summary of adverse reactions The incidences of undesirable effects are tabulated below.

They are listed by system organ class and frequency defined as follows:

Very common (≥ 1/10) Common (≥ 1/100 to < 1/10) Uncommon (≥1/1,000 to < 1/100) Rare (≥ 1/10,000 to < 1/1,000) Very rare (< 1/10,000) Not known (cannot be estimated from the available data) Ibuprofen Blood and lymphatic system disorders Very rare: 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. 4).

Hypersensitivity reactions Uncommon:

Hypersensitivity reactions with urticaria and pruritus.

Very rare:

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

Nervous system disorders Uncommon:

Headache, dizziness and tinnitus.

Very rare:

Aseptic meningitis - single cases have been reported very rarely. Cardiac disorders Oedema, hypertension and cardiac failure have been reported in association with NSAID treatment. 4).

Gastrointestinal disorders Uncommon:

Abdominal pain, nausea and dyspepsia.

Rare:

Diarrhoea, flatulence, constipation and vomiting.

Very rare:

Peptic ulcer, perforation and gastrointestinal haemorrhage, melaena, haematemesis, sometimes fatal, particularly in the elderly. Ulcerative stomatitis, gastritis and mouth ulceration. 4).

Hepatobiliary disorders Very rare:

Liver disorders.

Skin and subcutaneous tissue disorders Uncommon:

Various skin rashes.

Very rare:

Severe forms of skin reactions such as bullous reactions, including Stevens-Johnson Syndrome, erythema multiforme and toxic epidermal necrolysis, can occur.

Not known:

Drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), acute generalised exanthematous pustulosis (AGEP), photosensitivity reactions.

Renal and urinary disorders Very rare:

Acute renal failure, papillary necrosis, especially in long-term use, associated with increased serum urea and oedema. Phenylephrine High blood pressure with headache and vomiting, probably only in overdose. Rarely, palpitations. Also, rare reports of allergic reactions and occasionally urinary retention in males.

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.

Ibuprofen Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see gastrointestinal and cardiovascular risks below). Elderly The elderly are at increased risk of consequence of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation which may be fatal.

Respiratory Bronchospasm may be precipitated in patients suffering from or with a previous history of bronchial asthma or allergic disease. 5). 8). 8). 8). Cardiovascular and cerebrovascular effects Caution (discussion with doctor or pharmacist) is required prior to starting treatment in patients with a history of hypertension and/or heart failure as fluid retention, hypertension and oedema have been reported in association with NSAID therapy.

Clinical studies suggest that use of ibuprofen, particularly at a high dose (2,400 mg/day) may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke). g. ≤ 1,200 mg/day) is associated with an increased risk of arterial thrombotic events.

Patients with uncontrolled hypertension, congestive heart failure (NYHA II-III), established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should only be treated with ibuprofen after careful consideration and high doses (2,400 mg/day) should be avoided.

g. hypertension, hyperlipidaemia, diabetes mellitus, smoking), particularly if high doses of ibuprofen (2,400 mg/day) are required. Impaired female fertility There is limited evidence that drugs which inhibit cyclo-oxygenase/prostaglandin synthesis may cause impairment of female fertility by an effect on ovulation.

This is reversible on withdrawal of treatment. 8). GI bleeding, ulceration or perforation, which can be fatal, has been reported with all NSAIDs at any time during treatment, with or without warning symptoms or a previous history of serious GI events.

3), and in the elderly. These patients should commence treatment on the lowest dose available. Patients with a history of GI toxicity, particularly the elderly, should report any unusual abdominal symptoms (especially GI bleeding), particularly in the initial stages of treatment.

5). When GI bleeding or ulceration occurs in patients receiving ibuprofen, the treatment should be withdrawn. 8). Patients appear to be at highest risk of these reactions early in the course of therapy, the onset of the reaction occurring in the majority of cases within the first month of treatment.

Acute generalised exanthematous pustulosis (AGEP) has been reported in relation to ibuprofen-containing products. This medicinal product should be discontinued at the first appearance of skin rash, mucosal lesions or any other sign of hypersensitivity.

Masking of symptoms of underlying infections This product can mask symptoms of infection, which may lead to delayed initiation of appropriate treatment and thereby worsening the outcome of the infection. This has been observed in bacterial community acquired pneumonia and bacterial complications to varicella.

When this product is administered for fever or pain relief in relation to infection, monitoring of infection is advised. In nonhospital settings, the patient should consult a doctor if symptoms persist or worsen. Phenylephrine Phenylephrine should be used with care in patients with cardiovascular disease, diabetes mellitus, closed angle glaucoma, prostatic enlargement and hypertension.

Paediatric population There is a risk of renal impairment in dehydrated adolescents. This medicine contains sodium This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

1. • Hypertension and severe coronary heart disease. g. asthma, rhinitis, angioedema or urticaria) in response to acetylsalicylic acid or other non- steroidal anti-inflammatory drugs (NSAIDs). • Active or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes or proven ulceration or bleeding).

• History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy. 4). • Last trimester of pregnancy. 5). • Hyperthyroidism. • Contraindicated in patients currently receiving or within two weeks of stopping therapy with monoamine oxidase inhibitors.