Country: Нови Зеланд
Језик: Енглески
Извор: Medsafe (Medicines Safety Authority)
Doxylamine succinate 25mg;
Wilson Foods Limited
Doxylamine succinate 25 mg
25 mg
Liquid filled capsule
Active: Doxylamine succinate 25mg Excipient: Amaranth Butylated hydroxyanisole Gelatin Macrogol 400 Patent blue V Propylene glycol Purified water Sorbitol
Blister pack, 10 capsules
Restricted
Restricted
Corden Pharma Bergamo SpA
Temporary use in the relief of insomnia
Package - Contents - Shelf Life: Blister pack, - 10 capsules - 24 months from date of manufacture stored at or below 25°C
1994-06-15
Medsafe Logo INFORMATION FOR CONSUMERS Home | Consumers | Health Professionals | Regulatory | Other | Hot Topics | Search Consumer Medicine Information DOZILE ® Doxylamine succinate 25mg capsules What is in this leaflet Please read this leaflet carefully before you start taking DOZILE. This leaflet answers some common questions about DOZILE. It does not contain all the available information. It does not take the place of talking to your pharmacist or doctor. All medicines have risks and benefits. Your pharmacist or doctor has weighed the risks of you taking DOZILE against the benefits they expect it will have for you. Use DOZILE as instructed and follow the advice given in this leaflet. If you have any concerns about taking this medicine, ask your pharmacist or doctor. Keep this leaflet with the medicine. You may need to read it again. What DOZILE is used for DOZILE is used to help in the temporary relief of sleeplessness. If you have trouble falling asleep, your doctor or pharmacist will advise you if DOZILE may help. Ask your doctor or pharmacist if you have any questions about why DOZILE has been recommended for you. How DOZILE works DOZILE capsules contain doxylamine succinate. Doxylamine succinate is a type of antihistamine called an ethanolamine derivative antihistamine. It has a sedating effect. Before taking DOZILE Before taking DOZILE When you must not take it Do not take DOZILE if: you have an allergy to doxylamine succinate, other ethanolamine derivative antihistamines or any of the ingredients listed at the end of this leaflet. If you are not sure if you have such an allergy to DOZILE, check with your pharmacist or doctor. the expiry date (EXP) printed on the pack has passed. If you take this medicine after the expiry date Прочитајте комплетан документ
NEW ZEALAND DATASHEET 1 PRODUCT NAME DOZILE 25 mg capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Doxylamine Succinate 25 mg Capsules 3 PHARMACEUTICAL FORM Liquid filled soft gel capsules, purple, containing 25 mg doxylamine succinate. 4 CLINICAL PARTICULARS 4.1 Therapeutic indications Temporary use in the relief of insomnia. 4.2 Dose and method of administration Adults: 1 capsule 30 minutes before retiring, or as directed by a pharmacist or physician. Maximum stated dose should not be exceeded. Dozile is recommended for occasional use only i.e. for periods of no longer than a week at a time. If sleeplessness persists, consult your doctor. Note: Dozile is not recommended for children under 12 years of age. 4.3 Contraindications Hypersensitivity to doxylamine, other ethanolamine derivative antihistamines or to any other ingredient in the product. 4.4 Special warnings and precautions for use Caution should be used if taken with alcohol. Due to the anticholinergic properties of antihistamines, caution should be used when Dozile is taken concurrently with other medications. (See section 4.5) Caution should be taken by those with narrow angle or open-angle glaucoma, urinary retention, prostate enlargement, pyloroduodenal obstruction, epilepsy or severe cardiovascular disorders. Doxylamine may suppress positive skin test results. USE IN CHILDREN Dozile is not recommended for children under 12 years of age. The safety and efficacy of doxylamine as a night time sleep aid in children younger than 12 years of age have not been established. In addition, children may be more prone than adults to experience paradoxical CNS stimulation rather than sedation when antihistamines are used as night time sleep aids. USE IN THE ELDERLY The elderly may be more sensitive to the effects of the usual adult dose. 4.5 Interaction with other medicines and other forms of interaction Dozile produces an additive effect when administered with other CNS depressants such as opioid analgesics, neuroleptics, alcohol, hypnotics and psychotherape Прочитајте комплетан документ