Patient Information Leaflet: Instructions for Use

Divascan, 2.5 mg, tablets
iprazochromum
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

Keep this leaflet for future reference.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other people, even if their symptoms are similar.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of Contents:

What Divascan is and what it is used for
Important information before taking Divascan
How to take Divascan
Possible side effects
How to store Divascan
Contents of the package and other information

1. What Divascan is and what it is used for

Divascan contains iprazochrom as the active substance and is a medicine used for migraine prophylaxis.
It is used for the preventive treatment of migraine (with or without aura) and for treating changes in the back of the eye that may occur as a complication of diabetes (early stage diabetic retinopathy).
Divascan is intended for adults.

2. Important information before using Divascan

When not to use Divascan:

if the patient is allergic to iprazochrome or any of the other ingredients of this medicine (listed in section 6);
if the patient is pregnant;
if the patient is breastfeeding.

Divascan must not be used in children under 18 years of age.
Warnings and precautions
Before starting Divascan, consult your doctor or pharmacist.
No special precautions are required.
Children and adolescents
There is insufficient experience with the use of Divascan in children.
Divascan and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to use.
To date, no interactions between Divascan and other medicines have been observed.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
Divascan must not be used during pregnancy, as there is insufficient experience with the use of Divascan in pregnant women.
Divascan must not be used during breastfeeding.
Driving and operating machinery
No special precautions are required.
Divascan contains lactose
Patients with known intolerance to certain sugars should consult their doctor before using this medicine.

3. How to use Divascan

This medicine should always be used exactly as directed by your doctor. If in doubt, consult your doctor or pharmacist.

Recommended dosage:
Migraine:
For adult patients, the usual dose is 1–2 tablets (up to a maximum of 3 tablets) of Divascan three times daily.
Note:
Since Divascan relieves migraine symptoms but does not completely eliminate them, concomitant use of other medications for aborting migraine attacks is recommended when necessary.

Diabetic retinopathy:
For adult patients, the usual dose is 2 tablets three times daily. If, after several months of treatment with Divascan, the disease shows a favourable course, the single dose may be reduced to 1 tablet, which should still be taken three times daily.

The tablets should be swallowed whole with a small amount of liquid (e.g. a glass of water).

Use of a higher than recommended dose of Divascan
To date, no symptoms of overdose have been observed.

Missed dose of Divascan
If a dose of Divascan is missed, take the next dose at the scheduled time.
Do not take a double dose to make up for the missed dose.

Stopping Divascan
Stopping treatment may result in recurrence of symptoms.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.

Rare: may affect up to 1 in 1,000 patients
Skin allergic reactions (drug-induced allergic rash) have been observed, resolving within a few days after discontinuation of treatment.

Very rare: may affect up to 1 in 10,000 patients
At the beginning of Divascan treatment, loss of appetite may occur.
During treatment, reddish-brown discoloration of urine may appear. This indicates that the active substance of the medicine is being excreted in the urine. This is a completely harmless phenomenon.

If any of the adverse reactions worsen, or if the patient notices any adverse reaction not listed in this leaflet, they should inform their doctor or pharmacist.

Reporting of adverse reactions
If any undesirable effects occur, including any not listed in this leaflet, the patient should inform their doctor, pharmacist, or nurse.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Divascan

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the stated month.
This medicine does not require any special storage conditions.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Divascan contains
The active substance is iprazochrom.
Other ingredients are: lactose monohydrate, maize starch, gelatine, magnesium stearate.

What Divascan looks like and contents of the pack
Orange, biconvex tablets speckled with red and with bevelled edges.
The pack contains 60 tablets in a clear glass bottle (type III) closed with a PE stopper.

Marketing Authorisation Holder and Manufacturer
BERLIN-CHEMIE AG
Glienicker Weg 125
12489 Berlin, Germany

For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Berlin-Chemie/Menarini Polska Sp. z o.o.
Tel: +48 22 566 21 00
Fax: +48 22 566 21 01