Alipalmtin 10 mg zachte capsules

Country: নেদারল্যান্ডস

ভাষা: ডাচ

সূত্র: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

সক্রিয় উপাদান:

ALITRETINOÏNE 10 mg/stuk

থেকে পাওয়া:

Regiomedica GmbH Spitalstrasse 22 79539 LÖRRACH (DUITSLAND)

এটিসি কোড:

D11AH04

INN (International Name):

ALITRETINOÏNE 10 mg/stuk

ফার্মাসিউটিকাল ফর্ম:

Capsule, zacht

রচনা:

GELATINE (E 441) ; GLYCEROL (E 422) ; GLYCEROLMONOSTEARAAT (E 471) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; IJZEROXIDE ZWART (E 172) ; PLANTAARDIGE OLIE, GEHYDREERD ; SOJABOONOLIE, GEDEELTELIJK GEHYDREERD (E 479b) ; SOJAOLIE, GEZUIVERD ; SORBITOL, VLOEIBAAR, NIET-KRISTALLISEERBAAR (E 420) ; TITAANDIOXIDE (E 171) ; TOCOFEROL, DL-ALFA (E 307) ; TRIGLYCERIDEN MIDDELLANGE KETEN ; WATER, GEZUIVERD, GELATINE (E 441) ; GLYCEROL (E 422) ; GLYCEROLMONOSTEARAAT (E 471) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; IJZEROXIDE ZWART (E 172) ; PLANTAARDIGE OLIE, GEHYDREERD ; SOJABOONOLIE, GEDEELTELIJK GEHYDREERD ; SOJAOLIE, GEZUIVERD ; SORBITOL, VLOEIBAAR, NIET-KRISTALLISEERBAAR (E 420) ; TITAANDIOXIDE (E 171) ; TOCOFEROL, DL-ALFA (E 307) ; TRIGLYCERIDEN MIDDELLANGE KETEN ; WATER, GEZUIVERD

প্রশাসন রুট:

Oraal gebruik

Therapeutic area:

Alitretinoin

অনুমোদন তারিখ:

1900-01-01

তথ্য লিফলেট

PACKAGE LEAFLET: INFORMATION FOR THE USER
ALIPALMTIN 10 MG ZACHTE CAPSULES
ALIPALMTIN 30 MG ZACHTE CAPSULES
Alitretinoïne
WARNING
CAN SERIOUSLY HARM AN UNBORN BABY
Women must use effective contraception
Do not use if you are pregnant or you think you may be pregnant
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Alipalmtin is and what it is used for
2.
What you need to know before you take Alipalmtin
3.
How to take Alipalmtin
4.
Possible side effects
5.
How to store Alipalmtin
6.
Contents of the pack and other information
1. WHAT ALIPALMTIN IS AND WHAT IT IS USED FOR
The active substance in Alipalmtin is alitretinoin. It belongs to a
group of medicines known as
_retinoids, _which are related to Vitamin A. Alipalmtin capsules come
in two strengths, containing 10
mg or 30 mg of alitretinoin.
Alipalmtin is used to treat adults with severe chronic hand eczema
that has not got better after any
other topical treatments, including steroids. Treatment with
Alipalmtin must be supervised by a
specialist skin doctor (a dermatologist).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ALIPALMTIN
DO NOT TAKE ALIPALMTIN:
•
If you are PREGNANT or BREAST-FEEDING.
•
If there is any chance you could become pregnant, you must follow the
precautions under
“Pregnancy and prevention programme, see section on “Warnings and
precautions”.
•
If you have LIVER DISEASE.
•
If you have SEVERE KIDNEY DISEASE.
•
If you have HIGH BLOOD FATS (such as high cholesterol or raised
triglycerides).
•
If you have THYROID DISE

পণ্য বৈশিষ্ট্য

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAAM VAN HET GENEESMIDDEL
Alipalmtin 10 mg zachte capsules
Alipalmtin 30 mg zachte capsules
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule, soft contains 10 mg of alitretinoin
Each capsule, soft contains 30 mg of alitretinoin
Excipients with known effect
Soya-bean oil.
Each 10 mg capsule contains 92.94 mg soya-bean oil.
Each 30 mg capsule contains 278.83 mg soya-bean oil.
Sorbitol.
Each 10 mg capsule contains 13.28 mg sorbitol.
Each 30 mg capsule contains 25.55 mg sorbitol.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FROM
Capsule, soft
Alipalmtin 10 mg capsules are light brown, oval, soft-gelatin
capsules, 10 mm x 6 mm, containing a
yellow to orange, opaque, viscous suspension.
Alipalmtin 30 mg capsules are yellow, oval, soft-gelatin capsules, 13
mm x 8 mm, containing a yellow
to orange, opaque, viscous suspension.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Alipalmtin is indicated for use in adults who have severe chronic hand
eczema that is unresponsive to
treatment with potent topical corticosteroids.
Patients in whom the eczema has predominantly hyperkeratotic features
are more likely to respond to
treatment than in those in whom the eczema predominantly presents as
pompholyx (see section 5.1).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Alipalmtin should only be prescribed by dermatologists, or physicians
with experience in the use of
systemic
retinoids
who
have
full
understanding
of
the
risks
of
systemic
retinoid
therapy
and
monitoring requirements. Prescriptions of Alipalmtin for women of
childbearing potential should be
limited to 30 days of treatment and continuation of treatment requires
a new prescription. Ideally,
pregnancy testing, issuing a prescription and dispensing of Alipalmtin
should occur on the same day.
Dispensing of Alipalmtin should occur within a maximum of 7 days of
the prescription.
Posology
The recommended dose for alitretinoin is 10 mg or 30 mg once daily.
The recommended starting dose for alitretinoin is 30