Divascan

Package Leaflet: Information for the Patient

Divascan, 2.5 mg, Tablets

Iprazochrome

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• This leaflet should be kept in case it needs to be read again.
• -In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for one person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

• 1. What is Divascan and what is it used for
• 2. Important information before taking Divascan
• 3. How to take Divascan
• 4. Possible side effects
• 5. How to store Divascan
• 6. Package contents and other information

1. What is Divascan and what is it used for

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

2. Important information before taking Divascan

When not to take Divascan:

Divascan should not be taken by children under 18 years of age.

Warnings and precautions

Before starting to take Divascan, discuss it with a 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 the doctor or pharmacist about all medicines the patient is taking or has recently taken, as well as any medicines the patient plans to take.
So far, no interactions between Divascan and other medicines have been found.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before taking this medicine.
Divascan should not be taken during pregnancy, as there is insufficient experience with its use in pregnant women.
Divascan should not be taken during breastfeeding.

Driving and using machines

No special precautions are required.

Divascan contains lactose

Patients who have been diagnosed with intolerance to certain sugars should consult a doctor before taking the medicine.

3. How to take Divascan

This medicine should always be taken as directed by the doctor. In case of doubts, consult a doctor or pharmacist.
The recommended dose is:
Migraine:
For adult patients, the usual dose is 1-2 tablets (up to a maximum of 3 tablets) of Divascan 3 times a day.
Note:
Since Divascan alleviates migraine symptoms but does not eliminate them completely, concurrent administration of other medicines to interrupt the attack is recommended if necessary.
Diabetic retinopathy:
For adult patients, the usual dose is 2 tablets 3 times a day. If after several months of treatment with Divascan the disease has a favorable course, the single dose can be reduced to 1 tablet, which should still be taken 3 times a day.
Tablets should be swallowed whole with a small amount of liquid (e.g., a glass of water).

Taking a higher dose of Divascan than recommended

No symptoms of overdose have been reported so far.

Missing a dose of Divascan

In case of a missed dose, the next tablet should be taken at the scheduled time.
A double dose should not be taken to make up for the missed dose.

Stopping Divascan treatment

In such a situation, a relapse of symptoms may occur.
In case of any further doubts about taking this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Divascan can cause side effects, although not everybody gets them.

Rare: may affect up to 1 in 1000 patients

Observed skin allergic reactions (drug rash) resolving after a few days of discontinuing treatment.

Very rare: may affect up to 1 in 10,000 patients

At the beginning of treatment with Divascan, loss of appetite may occur.
During treatment, a 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 symptom.
In case of intensification of any side effects or if the patient notices any side effects not listed in this leaflet, they should inform their doctor or pharmacist.

Reporting side effects

If any side effects occur, including any not listed in this leaflet, the patient should inform their doctor or pharmacist, or nurse.
Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Divascan

The medicine should be stored 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 month.
This medicine does not require special storage conditions.
Medicines should not be disposed of via wastewater or household waste. Ask a pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Divascan contains

The active substance of the medicine is iprazochrome.
The other ingredients of the medicine are: lactose monohydrate, cornstarch, gelatin, magnesium stearate.

What Divascan looks like and what the package contains

Orange, biconvex tablets with a red speck, with beveled edges.
The package contains 60 tablets in a clear glass bottle (type III) closed with a PE stopper.

Marketing authorization holder and manufacturer

BERLIN-CHEMIE AG
Glienicker Weg 125
12489 Berlin, Germany
To obtain more detailed information about this medicine, contact the local representative of the marketing authorization holder:
Berlin-Chemie/Menarini Polska Sp. z o.o.
Phone: +48 22 566 21 00
Fax: +48 22 566 21 01

Date of last revision of the leaflet: