RB Updates

Nurofen Joint & Muscular Pain Relief 200mg Medicated Plaster PL 00063/0733

Active Ingredient: Each medicated plaster contains 200 mg of ibuprofen. Indications: Nurofen Joint & Muscular Pain Relief 200mg Medicated Plaster is indicated for the short-term symptomatic treatment of local pain in acute muscular strains, or sprains in benign traumas close to the joint of the upper or lower limb in adults or adolescents aged 16 years and older. Dosage & Administration: Adults or adolescents aged 16 years and over: One dose is equal to one medicated plaster. The maximum dose for a single 24 hour period is one medicated plaster. The plaster can be applied at any time during the day or night but should be removed and a new plaster re-applied at the same time on the following day. The medicated plaster should be used for the shortest duration necessary to control symptoms. The treatment duration should not exceed 5 days. The therapeutic benefit of treatment longer than 5 days has not been established. If there is no improvement, during the recommended duration of treatment or a worsening of symptoms, a healthcare professional should be consulted. Elderly patients: No special dose adjustment is necessary. Paediatric population: The safety and efficacy of Nurofen Joint & Muscular Pain Relief 200mg Medicated Plaster in children or adolescents under 16 years of age has not yet been established. Method of administration: For cutaneous use and short-term use only. The medicated plaster should be used whole and not be cut. The medicated plaster should not be used together with an occlusive dressing. It is recommended to carefully wash and dry the area to be treated before applying the medicated plaster. Apply to intact skin only. Tear or cut the sachet along the dotted line to remove a medicated plaster. First remove the central portion of the release liner used to protect the adhesive surface and apply this surface to the painful area, once securely in place remove the remaining release liner at the edges of the plaster. The medicated plaster is flexible and conformable, and if necessary can be applied on or near a joint and will allow for normal movement. Avoid getting the medicated plaster wet. Contraindications: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. In patients who have previously shown hypersensitivity reactions (e.g. asthma, bronchospasm, rhinitis, angioedema or urticaria) in response to ibuprofen, acetylsalicylic acid or other non-steriodal anti-inflammatory drugs (NSAIDs). Application on broken or damaged skin Third trimester of pregnancy. Use on the eyes, lips or the mucous membranes. Warnings & Precautions: If symptoms persist for longer than 5 days or worsen, a healthcare professional should be consulted. Undesirable effects can be reduced by reducing the duration of treatment. Bronchospasm can occur in patients using ibuprofen who suffer or have previously suffered from bronchial asthma or allergies. The treatment should be discontinued immediately if a skin rash develops after applying the medicated plaster. Patients should be warned against exposure of the treated area to strong sources of natural and/or artificial light (e.g. tanning lamps) during treatment and for one day after removal of the medicated plaster, in order to reduce the risk of photosensitivity. Although the systemic availability of topically applied ibuprofen is significantly less than for oral dosage forms, complications may occur in rare cases. For these reasons, patients with: an impaired renal, cardiac or hepatic function; active or a history of peptic ulcer, intestinal inflammation or haemorrhagic diathesis should seek medical advice before using this medicinal product. Non-steroidal anti-inflammatory drugs should be used with caution in elderly patients, as they are more likely to experience undesirable effects. Pregnancy: The systemic concentration of ibuprofen is lower after topical administration, compared to oral formulations. With reference to experience from treatment with systemically applied NSAIDs, the following is recommended: Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or the embryo/foetal development. Data from epidemiological studies suggest an increased risk of miscarriage and of cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The risk is believed to increase with dose and duration of therapy. In animals, administration of a prostaglandin synthesis inhibitor has been shown to result in increased pre- and post-implantation loss and embryo-foetal lethality. In addition, increased incidences of various malformations, including cardiovascular, have been reported in animals given a prostaglandin synthesis inhibitor during the organogenetic period. During the first and second trimester of pregnancy, Nurofen Joint & Muscular Pain Relief 200mg Medicated Plaster should not be given unless clearly necessary. If Nurofen Joint & Muscular Pain Relief 200mg Medicated Plaster is used during the first and second trimester of pregnancy, the dose should be kept as low and duration of treatment as short as possible. During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may expose the foetus to: - cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension); - renal dysfunction, which may progress to renal failure with oligo-hydroamniosis; the mother and the neonate, at the end of pregnancy, to: - possible prolongation of bleeding time, an anti-aggregating effect which may occur even at very low doses - inhibition of uterine contractions resulting in delayed or prolonged labour. Consequently, ibuprofen is contraindicated during the third trimester of pregnancy. Breast-feeding: After systemic application, only small amounts of ibuprofen and its metabolites pass into the breast milk. As no harmful effects to infants are known to date, it is not usually necessary to interrupt breast-feeding during short-term treatment with this medicated plaster at the recommended dose. However, as a precautionary measure, this medicated plaster should not be applied directly onto the breast area of women who are breast-feeding. Side effects: Systemic availability of topical ibuprofen is very low compared to orally administered NSAIDs. Adverse events, particularly those affecting the gastrointestinal tract, are less common with the use of topical ibuprofen. The list of the following adverse events relates to those experienced with topical ibuprofen at OTC (dose maximum 500 mg per day), in short term use. The following frequency conventions are used in the rating of undesirable effects: 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). Within each frequency grouping, adverse events are presented in order of decreasing seriousness.

Description of Selected Adverse Reactions: 1 Hypersensitivity reactions have been reported following treatment with oral ibuprofen. These may consist of (a) non-specific allergic reaction and anaphylaxis, (b) respiratory tract reactions comprising asthma, aggravated asthma, bronchospasm or dyspnoea, or (c) skin reactions, including rashes of various types, urticaria, purpura, angioedema and, more rarely, exfoliative and bullous dermatoses (including toxic epidermal necrolysis, Stevens-Johnson Syndrome and erythema multiforme), and pruritus. 2 Renal impairment may occur following the use of topical ibuprofen, particularly in those with pre-existing renal dysfunction. 3 The most common undesirable effects are application site reactions. Recommended retail price: £7.99 (pack of 2s); £12.99 (pack of 4s). Pack sizes available: 2,4,6,8 or 10 medicated plasters. Not all pack sizes may be marketed. Marketing Authorisation number: PL 00063/0733 Marketing Authorisation Holder: Reckitt Benckiser Healthcare UK Limited, 103-105 Bath Road, Slough, SL1 3UH, UK. Date of prep: May 18.

Adverse events should be reported. Reporting forms can be found at www.mhra.gov.uk/yellowcard.

Adverse events should also be reported to Reckitt Benckiser (0333 2005 345).

Name and actives: Strefen Honey & Lemon contains Flurbiprofen BP 8.75mg per lozenge.

Indication: Symptomatic relief of sore throat. Dosage and administration: Adults and children over the age of 12 years: One lozenge sucked/dissolved slowly in the mouth every 3 - 6 hours as required. Maximum 5 lozenges in a 24 hour period. The lowest effective dose should be used for the shortest duration necessary to relieve symptoms. The patient should consult a doctor if symptoms persist or worsen, or if the product is required for more than 3 days. It is recommended that this product should be used for a maximum of three days. Children: Not indicated for children under 12 years. Elderly: No dose modification is required. As with all lozenges, to avoid local irritation, Strefen Honey and Lemon should be moved around the mouth whilst sucking. Contraindications: Hypersensitivity to flurbiprofen or any of the excipients in the product. Patients who have previously shown hypersensitivity reactions (e.g. asthma, rhinitis, angioedema, or urticaria) in response to aspirin or other non-steroidal anti-inflammatory drugs. Active or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding). History of gastrointestinal bleeding or perforation, related to previous NSAIDS therapy. Severe heart failure, renal failure or hepatic failure. Last trimester of pregnancy. Special warnings and precautions for use: Pregnancy and lactation: Whilst no teratogenic effects have been demonstrated in animal experiments, the use of Strefen Honey and Lemon should, if possible, be avoided during the first 6 months of pregnancy. During the 3rd trimester, flurbiprofen is contraindicated as there is a risk of premature closure of the foetal ductus arteriosus with possible persistent pulmonary hypertension. The onset of labour may be delayed and the duration increased with an increased bleeding tendency in both mother and child. Flurbiprofen appears in the breast milk in very low concentration and is unlikely to affect the breast-fed infant adversely. Undesirable effects: Strefen Honey and Lemon have the potential for inducing transient local irritation of the buccal mucosa. The most frequently reported adverse event in clinical trials was taste perversion. Hypersensitivity reactions have been reported and these may consist of (a) non-specific allergic reactions and anaphylaxis (b) respiratory tract reactivity e.g. asthma, aggravated asthma, bronchospasm, dyspnoea (c) various skin reactions e.g. pruritus, urticaria, angioedema and more rarely exfoliative and bullous dermatoses (including epidermal necrolysis and erythema multiforme). The list of the following adverse effects relates to those experienced with NSAIDS at doses available over the counter for short-term use. In the treatment of chronic conditions, under long-term treatment, additional adverse effects may occur. Hypersensitivity reactions: Uncommon: Hypersensitivity reactions with urticaria and pruritis. 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. Gastrointestinal: The most commonly observed adverse events are gastrointestinal in nature. Uncommon: abdominal pain, nausea, dyspepsia. Rare: Diarrhoea, flatulence, constipation and vomiting. Very rare: peptic ulcer, perforation or gastrointestinal haemorrhage, melaena, haematemesis, sometimes fatal, particularly in the elderly. Ulcerative stomatitis, gastritis. Exacerbation of colitis and Crohn’s disease. Nervous System: Uncommon: Headache. Very rare: Aseptic meningitis – single cases have been reported very rarely. Renal: Very rare: Acute renal failure, papillary necrosis, especially in long-term use, associated with increased serum and oedema. Hepatic: Very rare: liver disorders. Haematological: 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. Dermatological: 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. Immune System: 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 section 4.4). Cardiovascular and Cerebrovascular Oedema, hypertension and cardiac failure, have been reported. In association with NSAID treatment. Clinical trial and epidemiological data suggest that the use of NSAIDS (particularly at high doses 2400 mg daily) and in long-term treatment may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke).

MRRP: £4.15 16 lozenges. Product license number: PL0327/0135. Product License Holder: Crookes Healthcare Ltd., Nottingham NG2 3AA. Legal category: P. Date of preparation: July 2017.

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard.

Adverse events should also be reported to Reckitt Benckiser Healthcare (UK) Ltd on: 0333 200 5345.

GAVISCON ADVANCE ANISEED contains sodium alginate 500mg and potassium bicarbonate 100mg per 5ml dose. Indications: Treatment of symptoms resulting from the reflux of acid, bile and pepsin into the oesophagus such as acid regurgitation, heartburn, indigestion (occurring due to the reflux of stomach contents), for instance, after gastric surgery, as a result of hiatus hernia, during pregnancy, accompanying reflux oesophagitis, including symptoms of laryngopharyngeal reflux such as hoarseness and other voice disorders, sore throats and cough. Can also be used to treat the symptoms of gastro-oesophageal reflux during concomitant treatment with or following withdrawal of acid suppressing therapy. Legal category: P MRRP: 150ml - £4.99; 300ml - £8.99 MAH: Reckitt Benckiser Healthcare (UK) Ltd, HU8 7DS, United Kingdom. Information about this product including adverse reactions, precautions, contra-indications and method of use can be found at: www.medicines.org.uk/emc/medicine/20571

GAVISCON DOUBLE ACTION MINT contains sodium alginate 500mg, sodium bicarbonate 213mgl and calcium carbonate 325mg per 10ml dose Indications: Treatment of symptoms of gastro-oesophageal reflux such as acid regurgitation, heartburn and indigestion, for example following meals or during pregnancy, and for symptoms of excess stomach acid (hyperacidity). Legal category: GSL MRRP: 150ml - £4.99; 300ml - £8.49; 600ml - £13.99 MAH: Reckitt Benckiser Healthcare (UK) Ltd, HU8 7DS, United Kingdom. Information about this product including adverse reactions, precautions, contra-indications and method of use can be found at: www.medicines.org.uk/emc/medicine/23351

GAVISCON INFANT contains sodium alginate 225mg and magnesium alginate 87.5mg Indications: For gastric regurgitation, gastro-oesophageal reflux and reflux associated with hiatus hernia in infant and young children where competence of the cardiac sphincter has not been fully established. Legal category: P MRRP: £8.99 (30 unit doses) MAH: Reckitt Benckiser Healthcare (UK) Ltd, HU8 7DS. Information about this product including adverse reactions, precautions, contra-indications and method of use can be found at: www.medicines.org.uk/emc/medicine/21981 

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Reckitt Benckiser Healthcare (UK) ltd on: 0333 200 5345.