Anafranil Tablets

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv ingrediens:

clomipramine hydrochloride, Quantity: 25 mg

Tilgjengelig fra:

Pharmaco Australia Ltd

Legemiddelform:

Tablet, sugar coated

Sammensetning:

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

Administreringsrute:

Oral

Enheter i pakken:

50

Klasse:

Medicine Registered

Resept typen:

(S4) Prescription Only Medicine

Indikasjoner:

Major depression. Obsessive-compulsive disorders and phobias in adults. Cataplexy associated with narcolepsy

Produkt oppsummering:

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

Autorisasjon status:

Registered

Autorisasjon dato:

1991-08-02

Informasjon til brukeren

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

Preparatomtale

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