Core Safety Profile Active substance: Acrivastine + Pseudoephedrine Pharmaceutical form(s)/strength: Hard capsules; acrivastine 8 mg + pseudoephedrine HCI 60 mg P RMS: DK/H/PSUR/0027/001 Date of FAR: 04.10.2010 4.2 Posology and method of administration Children aged less than 12 years: The safety and efficacy of acrivastine + pseudoephedrine in children less than 12 years has not been established. Elderly: It has been shown in clinical studies with a total daily dosage of 24 mg acrivastine plus 180 mg pseudoephedrine that no special precautions are required, although it may be advisable to monitor renal function (see section 4.3). 4.3 Contraindications Acrivastine + pseudoephedrine is contra-indicated in individuals with known hypersensitivity to acrivastine, triprolidine or pseudoephedrine. Acrivastine+ pseudoephedrine is contra-indicated in patients with severe hypertension or severe coronary artery disease. The concomitant use of a pseudoephedrine-containing product and monoamine oxidase inhibitors can occasionally cause a rise in blood pressure. Acrivastine + pseudoephedrine is therefore contra-indicated in patients who are taking or have taken monoamine oxidase inhibitors within the preceding two weeks. The antibacterial agent furazolidone is known to cause a dose-related inhibition of monoamine oxidase. Although there are no reports of hypertensive crises caused by the concurrent administration of acrivastine + pseudoephedrine and furazolidone, they should not be taken together. Renal excretion is the main route of elimination of the active ingredients of acrivastine + pseudoephedrine. Until specific studies have been carried out acrivastine+ pseudoephedrine should not be given to patients with significant renal impairment (creatinine clearance less than 50 ml/min or serum creatinine greater than 150 micromol/litre). 4.4 Special warnings and precautions for use Although pseudoephedrine has virtually no pressor effects in normotensive patients, acrivastine + pseudoephedrine should be used with caution in patients taking antihypertensive agents, tricyclic antidepressants or other sympathomimetic agents such as decongestants, appetite suppressants and amphetamine-like psychostimulants. The effects of a single dose of acrivastine + pseudoephedrine on the blood pressure of these patients should be observed before recommending repeated or unsupervised treatment. As with other sympathomimetic agents, acrivastine + pseudoephedrine should be used with caution in patients with hypertension, heart disease, tachyarrhythmia, pre-existing cerebrovascular disease or at high risk of cerebrovascular disease, diabetes, hyperthyroidism, elevated intraocular pressure and prostatic enlargement. Caution should be exercised also when treating patients who are simultaneously using vasoconstrictive agents such as bromocriptine, pergolide, lisuride, cabergoline, ergotamine or dihydroergotamine.Acute perioperative hypertension may occur if evaporating halogenated anesthetics are used simultaneously with sympathomimetics with an indirect effect. When planning an operation, it is recommended that acrivastine + pseudoephedrine treatment is stopped 24 hours before anesthesia.Pseudoephedrine contained in the capsules gives a positive result in doping tests.Special caution in patients > 60 years. Patients in this 2/5 age group are more likely to experience unwanted reactions by use of sympatomimetic agents. 4.5 Interactions with other medicinal products and other forms of interaction Concomitant use of acrivastine + pseudoephedrine with other sympathomimetic agents, such as decongestants, tricyclic antidepressants, appetite suppressants and amphetamine-like psychostimulants or with monoamine oxidase inhibitors, which interfere with the catabolism of sympathomimetic amines, may occasionally cause a rise in blood pressure (see sections 4.3 and 4.4). The effect of antihypertensive agents that interfere with sympathetic activity may be partially reversed by acrivastine + pseudoephedrine, e.g. bretylium, bethanidine, guanethidine, debrisoquine, methyldopa, and adrenergic blocking agents. (See section 4.4 Special Warnings and Special Precautions for Use). Linezolide may decrease the metabolism of pseudoephidrine. The treatment with acrivastine + pseudoephedrine should be discontinued 48 hours before skin prick test to avoid influencing the results. 4.6 Fertility, pregnancy and lactation Teratogenicity: Systemic administration of acrivastine and pseudoephedrine, either alone or in combination, did not produce any teratogenic effects in animal reproductive studies. Fertility: Systemic administration of acrivastine and pseudophedrine, either alone or in combination, did not impair fertility in animal reproductive studies. There is no experience of the effect of acrivastine + pseudoephedrine on human fertility. Pregnancy: No information is available on the effects of administration of acrivastine + pseudoephedrine during human pregnancy. Acrivastine + pseudephedrine should not be used during pregnancy unless the potential benefit of treatment to the mother outweighs any possible risk to the developing foetus. Lactation: There is no information on the levels of acrivastine which may appear in human breast milk following administration of Acrivastine + pseudoephedrine. Pseudoephedrine is excreted in breast milk in small amounts but the effect of this on breast-fed infants is not known. It has been estimated that approximately 0.5 to 0.7% of a single dose of pseudoephedrine ingested by a mother will be excreted in the breast milk over 24 hours. A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with acrivastine + pseudoephedrine should be made taking into account the benefit of breast-feeding to the child and the benefit of acrivastine + pseudoephedrine therapy to the woman. 3/5 4.7 Ability to perform tasks that require judgement, motor or cognitive skills There is individual variation in response to all medication, it is sensible to caution all patients about engaging in activities requiring mental alertness, such as driving a car or operating machinery, until patients are familiar with their own response to the drug. It is usual to advise patients not to undertake tasks requiring mental alertness whilst under the influence of alcohol or other central nervous sytem depressants. Concomitant administration of acrivastine + pseudoephedrine may, in some individuals, produce additional impairment. 4.8 Undesirable effects The following convention has been used for the classification of frequencies: Very common ≥1/10; Common ≥1/100 to <1/10; Uncommon ≥1/1000 to <1/100; Rare ≥1/10,000 to <1/1000; Very rare <1/10,000. Immune System disorders Uncommon: Hypersensitivity reactions ranging from skin rash to anaphylaxis Nervous System disorders Very common: Somnolence Common: Sleep disturbance including insomnia Uncommon: Hallucinations Skin and subcutaneous disorders Uncommon: Acute generalised exanthematous pustulosis Renal and urinary disorders Uncommon: Urinary retention 4.9 Overdose Symptoms and signs: There is no experience of overdosage with acrivastine + pseudoephedrine. As with other sympathomimetic-containing products, symptoms and signs of overdosage may include irritability, restlessness, tremor, convulsions, palpitations, hypertension and difficulty with micturition. Twenty-five patients have received daily doses up to and including 1200 mg acrivastine. Symptoms and signs (gastrointestinal disturbance, headache and drowsiness) were absent or mild. 4/5 Treatment: The treatment of overdosage is likely to be symptomatic and supportive. Management of overdose should be as clinically indicated or as recommended by the national poison centre, where available. 5/5 .
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