Country: Israel
Language: English
Source: Ministry of Health
HOP CONES DRY EXTRACT; VALERIAN ROOT DRY EXTRACT
NEOPHARM (ISRAEL)1996 LTD
N05CM09
FILM COATED TABLETS
HOP CONES DRY EXTRACT 42 MG; VALERIAN ROOT DRY EXTRACT 187.5 MG
PER OS
Not required
MAX ZELLER SOHNE AG, SWITZERLAND
VALERIAN
VALERIAN
Herbal medicinal product for problems falling asleep and staying asleep, as well as restless sleep.
2018-02-28
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986 The dispensing of this medicine does not require a physician’s prescription DORMINOL NIGHT FILM COATED TABLETS COMPOSITION: Each tablet contains: Valerian root dry extract 187.5 mg Hop cones dry extract 42 mg NON ACTIVE INGREDIENTS AND ALLERGENS: see paragraph 6: “FURTHER INFORMATION” . READ THIS PACKAGE INSERT CAREFULLY IN ITS ENTIRETY BEFORE USING THIS MEDICINE. This insert is a synopsis of the product information. In case you have any additional questions, please ask a doctor or a pharmacist. This medicine is intended for use in adolescents and adults over the age of 12 years. You should use the drug according to the instructions in the dosage section of this leaflet. Consult a pharmacist in case you need farther information. You should refer to the physician in case your sleeping disorder gets worse or do not get better following a period of one month. 1. WHAT THIS MEDICINE IS USED FOR? Inducing sleep in cases of problems falling asleep and staying asleep, as well as in cases of sleep disorders and restless sleep. THERAPEUTIC GROUP: Sleep-inducing substances. 2. BEFORE USING THE MEDICINE THIS MEDICINE SHOULD NOT BE USED IF: SPECIAL WARNING RELATED TO THE MEDICINE USE: Do not use this medicine without consulting a doctor before starting treatment: - if you suffer from other illnesses - If you are sensitive to any type of food or medicine - if you take other medication - if you are pregnant or breast-feeding DRUG-DRUG INTERACTIONS IF YOU ARE TAKING OR WERE TAKING LATELY OTHER MEDICINES INCLUDING MEDICINES THAT CAN BE BOUGHT WITHOUT A PRESCRIPTION AND FOOD SUPPLEMENTS, TELL A DOCTOR OR A PHARMACIST. You should consult your doctor if you are taking other medications to induce sleep. PREGNANCY AND LACTATION: There is not enough data available considering the use of the medicine in pregnancy and lactation, therefore it is recommended to avoid using this medicine. If you are pregnant or breast-feeding you should cons Read the complete document
SUMMARY OF PRODCUT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Dorminol Night film coated tablet 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Fixed combination of _Valeriana officinalis _L., radix (Valerian Root Dry Extract ) and _Humulus lupulus _L., flos (Hop Cones Dry Extract ). 1 film coated tablet contains: 42 mg Hop Cones Dry Extract 187.5 mg Valerian Root Dry Extract For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film coated tablet 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Herbal medicinal product for problems falling asleep and staying asleep, as well as restless sleep . ( 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults _ -1 2 film coated tablets should be taken half to one hour before bed time. _Adolescents over 12 years of age _ 1 film coated tablet should be taken half to one hour before bed time _Elderly _ Posology is the same as for adults.1- 2 film coated tablets should be taken half to one hour before bed time. The use in children below the age of 12 years is not recommended (see section 4.4). Duration of use Because of its gradual onset of efficacy Dorminol Night is not suitable for acute interventional treatment of mild nervous tension or sleep disorders. To achieve optimal treatment effect, the continued use over 4 weeks is recommended. If symptoms persist or worsen after 4 weeks of continued use, a doctor should be consulted. Method of administration Oral use. Crushing of the tablets is permissible but it may be difficult to crush the film coating. 4.3 CONTRAINDICATION Hypersensitivity to the active substance(s) or to any of the excipients of Dorminol Night. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE The use of Dorminol Night is not recommended in children below the age of 12 years, due to lack of adequate data. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION Only limited data on pharmacological interactions with other medicinal products are available. Clinically relevant interaction with drugs metabolised by the CY Read the complete document