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PARTICULARS to APPEAR on <THE OUTER PACKAGING> <AND 1.3.1 Doxylamine SPC, Labeling and Package Leaflet DE SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET SmPCPIL090533_9 23.05.2017 – Updated: 11.09.2018 Page 1 of 22 1.3.1 Doxylamine SPC, Labeling and Package Leaflet DE SUMMARY OF PRODUCT CHARACTERISTICS SmPCPIL090533_9 23.05.2017 – Updated: 11.09.2018 Page 2 of 22 1.3.1 Doxylamine SPC, Labeling and Package Leaflet DE 1. NAME OF THE MEDICINAL PRODUCT <Invented name> 25 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 25 mg doxylamine hydrogen succinate. Excipients with known effect Each film-coated tablet contains 158.34 mg lactose (as monohydrate) and 0.61 mg – 1.36 mg sodium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet White to almost white, oval, biconvex, one side scored film-coated tablets. Tablet dimension: 12 mm x 6 mm. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Short-term symptomatic treatment of occasional insomnia (problems with falling asleep and midnight awakenings) in adults. 4.2 Posology and method of administration Posology Adults: 25 mg doxylamine hydrogen succinate daily 50 mg doxylamine hydrogen succinate daily as the maximum dose in severe sleep disturbances The tablets should be taken about half an hour to one hour before bedtime. In acute sleep disturbances, treatment should be limited to single doses, if possible. The duration of treatment should be as short as possible. In general, the length of treatment can vary from a few days to one week. Treatment should be discontinued at the latest after two weeks of daily use. Special populations In patients with reduced kidney or liver function, elderly or weakened patients, who are more sensitive to the effects of doxylamine, the dose should be reduced. For doses not feasible with this medicinal product, other products are available. Paediatric population The safety and efficacy of doxylamine as a night time sleep aid in children and adolescents under 18 SmPCPIL090533_9 23.05.2017 – Updated: 11.09.2018 Page 3 of 22 1.3.1 Doxylamine SPC, Labeling and Package Leaflet DE years of age has not been established. Therefore doxylamine should not be used in children and adolescents under 18 years of age. Method of administration Oral use. The tablet should be taken with a glass of water. 4.3 Contraindications - Hypersensitivity to the active substance, other antihistamines or to any of the excipients listed in section 6.1 - Acute asthma attack - Angle-closure glaucoma - Phaeochromocytoma - Prostatic hypertrophy with urinary retention - Acute intoxication with alcohol, sleep or pain medicinal products and psychotropic medicinal products (neuroleptics, tranquillizers, antidepressants, lithium) - Epilepsy - Concomitant treatment with MAO inhibitors (see section 4.5) 4.4 Special warnings and precautions for use <Invented name> should be used with caution in: - Hepatic impairment - Renal impairment - Pre-existing cardiac impairment and hypertension - Chronic respiratory problems and asthma - Gastroesophageal reflux - Stenosing peptic ulcer - Pyloroduodenal obstruction Particular caution should be exercised in patients with neurologically apparent cerebral injuries in the cerebral cortex and a history of convulsions, because already by taking small doses of doxylamine grand mal seizures can be triggered. EEG controls are recommended. An existing treatment of seizures should not be discontinued during treatment with <Invented name>. During treatment with antihistamines, ECG changes, in particular repolarization disorders, have been reported, so regular monitoring of the heart function is recommended. This is especially true for elderly patients and patients with pre-existing cardiac impairment. Special care should also be taken in patients with arterial hypertension, as antihistamines may cause an increase in blood pressure. Caution is required in patients over 65 years of age, due to their greater sensitivity to the appearance of adverse reactions to this medication (see section 4.2). Increased risk for fall has also been described in older patients (see section 4.8). Patients must ensure a sufficient sleep time (a period of at least 8 hours) after taking <Invented name> so that their ability to react is not impaired the following morning. Interference with diagnostic tests Doxylamine may interfere with allergen tests: - Inhalation-challenge testing with histamine or antigen: Possible suppression of test response - Antigen skin testing: Possible suppression of wheal and flare reactions It is advisable to suspend this medication three days before undergoing such tests. SmPCPIL090533_9 23.05.2017 – Updated: 11.09.2018 Page 4 of 22 1.3.1 Doxylamine SPC, Labeling and Package Leaflet DE <Invented name> contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose- galactose malabsorption should not take this medicinal product. This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’. 4.5 Interaction with other medicinal products and other forms of interaction Contraindicated combinations During concomitant use of doxylamine and monoamine oxidase inhibitors, hypotension and increased depression of the central nervous system and respiratory function may occur. Therefore, concomitant treatment with MAO inhibitors is contraindicated (see also section 4.3). Combinations which require precautions for use When used together, the CNS depressant effects of doxylamine and other medicinal products can be increased (e.g. some neuroleptics, tranquilizers, antidepressants, hypnotics, analgesics, anaesthetics, antiepileptics, muscle relaxants, other antihistamines). Alcohol can change the effect of doxylamine unpredictably and should be avoided. When used together, the effects of doxylamine and other medicinal products with anticholinergic activity (e.g. atropine, biperiden, tricyclic antidepressants), can be increased, which could lead to e.g. paralytic ileus, urinary retention or acute glaucoma. The efficacy of the following medicinal products can be decreased - Phenytoin, - Neuroleptics. During concomitant use of doxylamine - and antihypertensives with centrally active effects, such as guanabenz, clonidine, alpha-methyldopa, increased sedation may occur. - the symptoms of an incipient inner ear damage caused by ototoxic medicinal products (e.g. aminoglycosides, salicylates, diuretics) may be decreased. - false negative skin test results may be obtained. - epinephrine should not be administered, as it may lead to a paradoxical further drop in blood pressure (adrenaline reversal). Severe shock conditions can be treated with norepinephrine (see section 4.9). Therefore, concomitant treatment with epinephrine should be avoided. 4.6 Fertility, pregnancy and lactation Pregnancy Epidemiological studies with doxylamine succinate did not provide evidence for congenital malformations in humans. Animal studies are insufficient with respect to reproductive toxicity (see section 5.3). As a precautionary measure, it is preferable to avoid the use of <Invented name> during pregnancy. Breastfeeding Since the active substance is excreted into breast milk, breast-feeding should be discontinued during treatment with <Invented name>. Fertility No data are available on the possible effects of doxylamine on human fertility. Studies in animals have SmPCPIL090533_9 23.05.2017 – Updated: 11.09.2018 Page 5 of 22 1.3.1 Doxylamine SPC, Labeling and Package Leaflet DE demonstrated no effects upon fertility even at doses far higher than those recommended in clinical practice (see section 5.3). 4.7 Effects on ability to drive and use machines <Invented name> has major influence on the ability to drive and use machines. Even when used as recommended, this medicinal product may alter the ability to react to such an extent that the ability to participate actively in road traffic or to operate machinery is impaired. This applies even more in combination with alcohol. Therefore, driving, operating machinery or engaging in other dangerous activities – at least during the first phase of the treatment – should be completely omitted. 4.8 Undesirable effects Adverse reactions are listed below in frequency using the following conventions: 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). Blood and lymphatic system disorders Very rare: Blood count changes in the form of leukopenia, thrombocytopenia, haemolytic anaemia, aplastic anaemia and agranulocytosis Endocrine disorders Not known: In patients with phaeochromocytoma, the administration of antihistamines can lead to catecholamine release. Metabolism and nutrition disorders Not known: loss of appetite or increased appetite Psychiatric disorders Not known: Impaired concentration, depression, prolonged reaction time. There is also the possibility of "paradoxical" reactions, such as restlessness, excitement, tension, insomnia, nightmares, confusion, hallucinations, tremor. After prolonged daily use, intensified sleep disturbances may reoccur in case of abrupt discontinuation of treatment. Nervous system disorders Rare: seizures Not known: Dizziness, drowsiness, headache Eye disorders Not known: difficulty focusing, increased intraocular pressure Ear and
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