Divascan-Tabletten

देश: जर्मनी

भाषा: जर्मन

स्रोत: BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte)

सक्रिय संघटक:

Iprazochrom

थमां उपलब्ध:

Berlin-Chemie AG

INN (इंटरनेशनल नाम):

Iprazochrom

फार्मास्यूटिकल फॉर्म:

Tablette

रचना:

Iprazochrom 2.5mg

प्राधिकरण का दर्जा:

gültig

सूचना पत्रक

PACKAGE LEAFLET: INFORMATION FOR THE USER
® 2.5 MG TABLET
_iprazochrome_
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 is and what it is used for
2.
What you need to know before you take
3.
How to take
4.
Possible side effects
5.
How to store
6.
Contents of the pack and other information
1.
WHAT IS AND WHAT IT IS USED FOR
contains the active substance iprazochrome and is a
migraine prophylactic agent.
It is used for preventative treatment (reduction of the intensity of
symptoms and/or the frequency of
attack) of migraine and related forms of functional headache and for
the treatment of diabetic
retinopathy (pathological changes to the retina in diabetes) in the
early stage.
is for use in adults.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
DO NOT USE
-
if you are allergic to iprazochrome or any of the other ingredients of
this medicine (listed in
section 6).
-
If you are pregnant.
-
If you are breast-feeding.
Do not give to a child aged under 18.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking .
No special precautions are required.
CHILDREN AND ADOLESCENTS
Insufficient experience exists on the use of in children.
OTHER MEDICINES AND
Tell your doctor or pharmacist if you are taking, have recently taken
or might take any other
medicines.
No interactions of with other drugs are known to

उत्पाद विशेषताएं

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
2.5 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2.5 mg iprazochrome as the pharmacologically
active substance.
Excipient(s) with known effect
Each tablet contains 84.62 mg of lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
Orange, red spotted biplanar tablet with bevelled edges
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS

Prophylactic treatment (reduction of the intensity of symptoms and/or
of the
frequency of attack) of migraine and related forms of functional
headache

Treatment of diabetic retinopathy in the early stage.
is indicated in adults.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
MIGRAINE:
Generally 1 – 2 (up to 4) tablets 3 times daily. As
reduces the symptoms of a migraine
attack without, however, aborting it completely, combination with
another attack-aborting medicine is
recommended if required.
DIABETIC RETINOPATHY:
2 tablets 3 times daily, in favourable cases a reduction to 1 tablet 3
times daily can be carried out after
several months' treatment.
_Paediatric population_
Insufficient experience exists on the use of in children.
Method of administration
The tablets are swallowed whole with a little liquid.
is primarily intended for permanent treatment.
The duration of therapy in migraine should, depending on the frequency
of attack, be at least 6
months. There are no objections to longer use. If therapy failure is
suspected, treatment should not be
discontinued before several weeks have passed, as the action can also
start after a long interval without
effect.
4.3
CONTRAINDICATIONS

Hypersensitivity to active substance or one of the excipients listed
in section 6.1

pregnancy and lactation

children under 18 years
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Patients with rare hereditary problems of galactose intolerance, total
lactase deficiency