Country: Israel
Language: English
Source: Ministry of Health
DOXYLAMINE SUCCINATE
CTS CHEMICAL INDUSTRIES LTD, ISRAEL
R06AA09
TABLETS
DOXYLAMINE SUCCINATE 25 MG
PER OS
Not required
CTS CHEMICAL INDUSTRIES LTD
DOXYLAMINE
DOXYLAMINE
An aid to the relief of temporary sleep disturbance.
2020-03-31
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986 This medicine is dispensed without a doctor’s prescription TONIGHT TABLETS 25 MG Each tablet contains 25 mg Doxylamine Succinate For a list of inactive ingredients in the preparation - see section 6 and the section “Important information about some ingredients of the medicine” in this leaflet. READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have any other questions, refer to the doctor or the pharmacist. Take the product according to the instructions in the dosage section of this leaflet. Consult the pharmacist if you have further questions. If the insomnia persists for more than ten consecutive days despite using this medicine, stop using the medicine and refer to the doctor. The insomnia may be a symptom of another underlying disease. THE MEDICINE IS NOT INTENDED FOR CHILDREN UNDER THE AGE OF 12. Below this age – contact the doctor. 1. WHAT IS THE MEDICINE INTENDED FOR? This medicine is indicated as an aid for relief of temporary sleep disorder. THERAPEUTIC CLASS: anti-histamines. The mechanism of action of this medicine: Blocking the action of histamine and other substances produced by the body to provide relief from allergic symptoms. In addition, this medicine slows down the activity of the central nervous system, which relieves insomnia. There is no evidence that this medicine is addictive. 2. BEFORE USING THE MEDICINE: DO NOT USE THIS MEDICINE IF: • You are sensitive (allergic) to the active ingredient doxylamine succinate or to any of the additional components this medicine contains (see section 6). Symptoms of an allergic reaction may include: cough, shortness of breath, wheezing or breathing difficulty; swelling of the face, lips, tongue, throat or other parts of the body; rash, itching or skin hives; fainting or hay fever-like symptoms. If you think you are having an allergic reaction, stop taking the medicine and refer imm Read the complete document
1 PRODUCT INFORMATION-TONIGHT (DOXYLAMINE SUCCINATE) 1. NAME OF THE MEDICINE Doxylamine succinate 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 25mg doxylamine succinate. For the full list of excipients, see Section 6.1 List of excipients 3. PHARMACEUTICAL FORM Oval cream-white tablets with score line on one side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS An aid to the relief of temporary sleep disturbance. 4.2 DOSE AND METHOD OF ADMINISTRATION ADULTS: Half a tablet to one tablet about an hour before bedtime. Tonight should not be used for more than ten days consecutively. CHILDREN: Do not give to children under 12 years of age IMPAIRED HEPATIC AND RENAL FUNCTION : Dosage reduction may be necessary. 4.3 CONTRAINDICATIONS Patients with hypersensitivity to doxylamine, other antihistamines in the ethanolamine class, or any of the excipients listed in Section 6.1 should not use this product. Doxylamine should not be given to premature or new born infants due to their heightened susceptibility to antimuscarinic effects. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Avoid concurrent use with alcohol and medications which suppress the CNS as the effects of both may be enhanced. A risk-benefit approach should be adopted for patients with glaucoma. Increased ocular pressure could precipitate an attack of angle closure glaucoma. Use with caution in patients with asthma, bladder neck obstruction, urinary retention, chronic bronchitis, stenosing peptic ulcer, pyloroduodenal obstruction, symptomatic prostatic hypertrophy and epilepsy. USE IN HEPATIC IMPAIRMENT: Use with caution. 2 USE IN RENAL IMPAIRMENT Use with caution. USE IN THE ELDERLY: Use with caution as studies indicate a longer duration of action especially for elderly men. This and enhanced susceptibility to antimuscarinic side effects suggest dosage reduction may be necessary. PAEDIATRIC USE: Do not give to children under 12 years of age due to heightened sensitivity towards paradoxical stimulation. EFFECTS ON LABORATORY TESTS: Antihista Read the complete document