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Allevia 120 mg tablets

Presentation: Allevia (fexofenadine hydrochloride) 120mg film-coated tablets, containing equivalent to 112mg of fexofenadine. Indications: Relief of symptoms associated with seasonal allergic rhinitis in adults and children 12 years and older. Dose and administration: Adults and Children ≥ 12 years: The recommended dose is one tablet (120mg) once daily taken before a meal. Children (<12 years old): Allevia should not be used in children under 12 years of age. Elderly; Renally or Hepatically impaired patients: studies indicate that dose adjustment is not necessary, but Allevia should only be administered with care in these patients on the advice of a doctor. Contraindication: Hypersensitivity to the active substance or to any of the excipients. Warnings and precautions: Patients with a history of or ongoing cardiovascular disease should be warned that antihistamines as a medicine class have been associated with adverse reactions such as tachycardia and palpitations, and should use Allevia 120 mg only on the advice of their doctor. Interactions: Coadministration of fexofenadine hydrochloride with erythromycin or ketoconazole has been found to increase the level of fexofenadine in plasma. The changes were not accompanied by any effects on the QT interval or an increase in adverse reactions compared to the medicinal products given singly. It is advisable to leave 2 hours between administration of fexofenadine hydrochloride and aluminium and magnesium hydroxide containing antacids. Pregnancy: Allevia should not be used during pregnancy unless on the advice of a doctor. Breast-feeding: Allevia 120 mg is not recommended for mothers breast-feeding their babies. Breast-feeding women should only use Allevia 120 mg if advised to do so by a doctor. Adverse Reactions: The following undesirable effects have been reported in clinical trials, with an incidence similar to that observed with placebo. Headache, drowsiness, dizziness, nausea. Uncommon (≥1/1,000 and <1/100): Fatigue. The following undesirable effects have been reported in postmarketing surveillance. Frequency not known: Hypersensitivity reactions with manifestations such as angioedema, chest tightness, dyspnoea, flushing and systemic anaphylaxis, insomnia, nervousness, sleep disorders or nightmares/excessive dreaming (paroniria), tachycardia, palpitations, diarrhoea, rash, urticaria, pruritus. RRP (ex VAT): 30 tablets pack: £8.74, 15 tablets pack: £4.91, 7 tablets pack: £2.91. Legal category: GSL.

Product Licence Number: PL 53886/0065.

Product licence holder: Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK.

Further information is available from Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT.

Email: uk-medicalinformation@sanofi.com Document number: MAT-GB-2104889 (v1.0) Date of preparation: November 2021.

Opticrom® Hayfever 2% w/v Eye Drops, Solution

Presentation: Eye drops containing sodium cromoglicate 2.0% w/v. Indications: For the relief and treatment of the eye symptoms of hayfever. Dosage and administration: Adults and children over 6 years: One or two drops to be administered into each eye four times daily. Contraindications: Hypersensitivity to any of the ingredients. Warnings and precautions: Soft contact lenses should not be worn during the treatment period as the drops contain benzalkonium chloride. Remove contact lenses prior to application and reinsert 15 mins after instillation. Benzalkonium chloride may cause eye irritation and therefore should be used with caution in dry eye patients and in patients where the cornea may be compromised. Instillation of these eye drops may cause a transient blurring of vision. Affected patients should not drive or operate machinery until their vision returns to normal. Discard the contents four weeks after first opening. Medical advice should be sought if symptoms do not improve within 48 hours. Should not be used continuously for more than 14 days except on the advice of a doctor or pharmacist. Pregnancy and lactation: Caution should be exercised especially during the first trimester of pregnancy. Cumulative experience with sodium cromoglicate suggests that it has no adverse effects on fetal development. It should be used in pregnancy only where there is a clear need. It is not known whether sodium cromoglicate is excreted in human breast milk. There is no information to suggest it has any undesirable effects on the baby. Side effects: Transient stinging and burning may occur after instillation. Other symptoms of local irritation have been reported rarely. RRP (ex VAT): 10ml £4.99. Legal category: GSL.

PL number: PL 35533/0031.

PL holder: Aspire Pharma Limited, Unit 4, Rotherbrook Court. Bedford Road. Petersfield, Hampshire GU32 3QG, UK.

Further information is available from Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK.

Email: ukmedicalinformation@sanofi.com Document number: MAT-GB-2104907 (v1.0). Date of preparation: November 2021

Nasacort® Allergy Relief for Adults 55 micrograms/dose, Nasal Spray, suspension

Presentation: Nasal Spray suspension containing 55 micrograms of triamcinolone acetonide in each actuation. Indications: Treatment of the symptoms of seasonal allergic rhinitis (such as sneezing, itchy/runny nose, itchy/red/watery eyes, nasal congestion or associated sinus discomfort), including hay fever. Dosage: Patients aged 18 years and over: The recommended dose is 220 micrograms as 2 sprays in each nostril once daily. Once symptoms are controlled patients can be maintained on 110 micrograms (1 spray in each nostril once daily). The minimum effective dose should be used to ensure continued control of symptoms. The maximum daily dose should not exceed two sprays into each nostril. Not recommended for children or adolescents under 18 years of age. Contraindications: Hypersensitivity to any of the ingredients, infection in the nose. Concomitant use with HIV medicines. Warnings and precautions: Advise patients to stop treatment or seek doctor advice if an improvement is not seen within 7 days. Doctor advice should also be sought if symptoms have improved but are not adequately controlled. Advise patients that treatment should not be used continuously for longer than 1 month without consulting a doctor. Advise patients that medical advice should be sought before using this medicine in the case of: concomitant use of other corticosteroid products, an infection in the nasal passages or sinuses or recent injury or surgery to the nose, or problems with ulceration in the nose. If adrenal function is impaired, proceed with caution when transferring patients from systemic steroid treatment to nasal. Localised infections of the nose and pharynx with Candida albicans may require local therapy and discontinuation of treatment. Systemic effects of nasal corticosteroids may occur, particularly at high doses prescribed for prolonged periods. Treatment with higher than recommended doses may result in clinically significant adrenal suppression and additional systemic corticosteroid cover should be considered during periods of stress or elective surgery. Close monitoring is warranted in patients with a change in vision or with a history of increased intraocular pressure, glaucoma and/or cataracts. Contains benzalkonium chloride, long term use may cause oedema of the nasal mucosa. Visual disturbance may be reported with systemic and topical corticosteroid use and the patient should be considered for referral to an ophthalmologist for evaluation. Interactions: Co-treatment with CYP3A inhibitors, including cobicistat-containing products, is expected to increase the risk of systemic side-effects. The combination should be avoided unless the benefit outweighs the risk. Pregnancy and lactation: Treatment should only be used in pregnancy and lactation on medical advice. Side effects: Common: flu syndrome, pharyngitis, rhinitis, headache, bronchitis, epistaxis, cough, dyspepsia, tooth disorder. Rare: nasal septum perforations. Frequency not known: hypersensitivity (including rash, urticaria, pruritus and facial oedema), insomnia, dizziness, alterations of taste and smell, chorioretinopathy, cataract, glaucoma, increased ocular pressure, blurred vision, nasal irritation, dry mucous membrane, nasal congestion, sneezing, dyspnoea, nausea, fatigue, decreased blood cortisol. RRP (ex VAT): 30 doses £5.49 Legal category: GSL.

PL number: PL 53886/0048.

PL holder: Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK.

Further information is available from Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT.

Email: uk-medicalinformation@sanofi.com Document number: MAT-GB-2104909 (v1.0). Date of preparation: November 2021.