País: Austràlia
Idioma: anglès
Font: Department of Health (Therapeutic Goods Administration)
clomipramine hydrochloride, Quantity: 25 mg
Pharmaco Australia Ltd
Tablet, sugar coated
Excipient Ingredients: lactose monohydrate; maize starch; microcrystalline cellulose; povidone; purified talc; glycerol; titanium dioxide; hypromellose; magnesium stearate; stearic acid; colloidal anhydrous silica; sucrose; macrogol 8000; iron oxide yellow; copovidone
Oral
50
Medicine Registered
(S4) Prescription Only Medicine
Major depression. Obsessive-compulsive disorders and phobias in adults. Cataplexy associated with narcolepsy
Visual Identification: light yellow round biconvex sugar-coated tablet; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
1991-08-02
Anafranil® Consumer Medicine Information 2021-11 v1.0 1 ANAFRANIL® CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. 1. WHY AM I USING ANAFRANIL®? Anafranil® contains the active ingredient clomipramine hydrochloride. Anafranil® is used to treat: depression that is longer lasting and/or more severe than the "low moods" that everyone has from time to time due to the stress of everyday life; obsessive- compulsive disorders (OCD) and phobias in adults; and, muscle weakness in people with a sleep disorder called narcolepsy. For more information, see Section 1. Why am I using Anafranil®? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE ANAFRANIL®? Do not use if you have ever had an allergic reaction to Anafranil® or any of the ingredients listed at the end of the CMI. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2. What should I know before I use Anafranil®? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Anafranil® and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I USE ANAFRANIL®? • The dose, frequency and length of treatment will be determined by your doctor. Follow all directions given to you by your doctor or pharmacist carefully. • Swallow the tablets with a full glass of water. More instructions can be found in Section 4. How do I use Anafranil®? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING ANAFRANIL®? THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist you visit that you are using Anafranil®. • Tell your doctor immediately if you become pregnant. • Call your doctor straight away if you or someone you know has thoughts about or attempts to commit suicide. • Call your doctor straight Llegiu el document complet
2022-02 v0.2 1 AUSTRALIAN PRODUCT INFORMATION – ANAFRANIL (CLOMIPRAMINE HYDROCHLORIDE) TABLETS 1 NAME OF THE MEDICINE Clomipramine hydrochloride 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 25 mg clomipramine hydrochloride. EXCIPIENTS WITH KNOWN EFFECT Sugars as lactose and sucrose For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Tablet Anafranil tablets are light yellow, round and biconvex and sugar-coated. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Major depression. Obsessive-compulsive disorders and phobias in adults. Cataplexy associated with narcolepsy. 4.2 D OSE AND METHOD OF ADMINISTRATION GENERAL The dosage should be determined individually and adapted to the patient's condition. Doses should be kept as low as possible and increased cautiously. Note that the plasma concentrations of the drug and active metabolite do not stabilise for 7 to 14 days after commencing treatment and after a dosage change. During treatment, the efficacy and tolerability of Anafranil must be judged by keeping the patients under close surveillance. DEPRESSION, OBSESSIVE-COMPULSIVE DISORDERS AND PHOBIAS: Start treatment with one tablet of 25 mg 2 or 3 times daily. Raise the daily dosage stepwise, e.g. 25 mg every few days, (depending on how the medication is tolerated) to 4 to 6 tablets of 25 mg. Once a distinct improvement has set in, adjust the daily dosage to a maintenance level averaging 2 to 4 tablets of 25 mg. 2022-02 v0.2 2 CATAPLEXY ACCOMPANYING NARCOLEPSY: Anafranil should be given orally in a daily dose of 25 to 75 mg. Nocturnal medication should only be given in cases where Anafranil does not appear to exacerbate insomnia. ELDERLY PATIENTS Elderly patients generally show a more marked response to Anafranil than patients belonging to intermediate age groups. Anafranil should be used with caution in elderly and doses should be increased cautiously. Start treatment with one tablet of 25 mg daily. Gradually raise the dosage to an optimum leve Llegiu el document complet