Land: Malta
Sprog: engelsk
Kilde: Medicines Authority
AMMONIUM CHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE, MENTHOL
SIMRU Global Holdings Limited The Black Church, St. Mary’s Place, Dublin 7, D07 P4AX , Ireland
R05FB02
AMMONIUM CHLORIDE 135 mg/5ml DIPHENHYDRAMINE HYDROCHLORIDE 14 mg/5ml MENTHOL 1.1 mg/5ml
SYRUP
AMMONIUM CHLORIDE 135 mg/5ml DIPHENHYDRAMINE HYDROCHLORIDE 14 mg/5ml MENTHOL 1.1 mg/5ml
OTC
COUGH AND COLD PREPARATIONS
Withdrawn
2006-04-13
H0155-4 PATIENT INFORMATION LEAFLET HISTALIX SYRUP Diphenhydramine Hydrochloride 14 mg / 5 ml Ammonium Chloride 135 mg / 5 ml Levomenthol 1.1 mg / 5 ml READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor or pharmacist. • You must contact a doctor if your symptoms worsen or do not improve. • If any side effect becomes more serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. WHAT HISTALIX SYRUP IS AND WHAT DOES IT DO? 2. WHAT SHOULD I KNOW BEFORE USING HISTALIX SYRUP? 3. HOW DO I USE HISTALIX SYRUP? 4. DOES HISTALIX SYRUP HAVE ANY SIDE EFFECTS? 5. HOW DO I STORE HISTALIX SYRUP? 6. FURTHER INFORMATION 1.WHAT HISTALIX SYRUP IS AND WHAT DOES IT DO? The name of your medicine is Histalix Syrup. It is for the symptomatic relief of troublesome cough associated with upper respiratory tract congestion. It may also be used to aid restful sleep. The syrup contains the active ingredients diphenhydramine hydrochloride, ammonium chloride and levomenthol. Diphenhydramine Hydrochloride is an antihistamine that is used to provide relief from the effects of an allergy. Ammonium chloride is an expectorant that helps loosen phlegm and catarrh. Levomenthol relieves the discomfort of congestion and also provides a cooling effect in mouth and throat. 2.WHAT SHOULD I KNOW BEFORE USING HISTALIX SYRUP? YOU SHOULD NOT USE THIS MEDICINE IF YOU: • Are sensitive to any of the ingredients (full list provided in Section 6). • Are taking or have taken monoamine oxidase inhibitors (MAOI) (a treatment for depression) within the previous 14 days. • Are under 12 years old. TALK TO YOUR DOCTOR OR PHARMACIST BEFORE TAKING THIS MEDICINE IF YOU: • Suffer from glaucoma. • Have difficulty urinating. • Have a cough with a lot of mucus. • Suffer from an enlarged prostate. • Have asthma. • Have any disorder of the liver. IS IT SAFE TO Læs hele dokumentet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Histalix Syrup 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5ml contains :- Diphenhydramine HCl BP 14.00 mg Ammonium Chloride BP 135.00 mg Menthol BP 1.10 mg 3 PHARMACEUTICAL FORM Oral Syrup 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the oral symptomatic relief of troublesome cough associated with upper respiratory tract congestion and aids restful sleep. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION One to two 5ml spoonfuls to be taken every 4 hours To aid sleep the patient may start with two 5ml spoonfuls at bedtime followed by two 5ml spoonfuls every 6 hours. Not suitable for children under 12 years. Do not take more than 4 doses (1 dose = two 5ml spoonfuls) in 24 hours. Do not exceed the stated dose. 4.3 CONTRAINDICATIONS • Hypersensitivity to any of the ingredients. • Children below 12 years of age. • Patients on monoamine oxidase inhibitor therapy within previous 14 days (see Section 4.5). 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Do not combine with other treatments for coughs and colds. Histalix syrup should be used with caution in patients with the following conditions: prostatic hypertrophy, urinary retention, susceptibility to ‘closed angle’ glaucoma and hepatic disease. Histalix Syrup may cause drowsiness. Seek medical advice when suffering from chronic or persistent cough and when also suffering from asthma, and acute asthmatic attack or where cough is accompanied by excessive secretions. Keep out of the reach and sight of children. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION • Additive CNS depressant effects with alcohol and other CNS depressants including barbiturates, hypnotics, opiod analgesics, anxiolytic sedatives and anti- psychotics. • Additive anti-muscarinic effects with other drugs of similar properties such as atropine and some anti-depressants. • Not to be taken in patients taking monoamine oxidase inhibitors (MAOIs) or within 14 of stopping treatment as there Læs hele dokumentet