Ciclonamine

Package Leaflet: Information for the Patient

CYCLONAMINE

250 mg, tablets

Etamsylate

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

• 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 symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Cyclonamine and what is it used for
• 2. Important information before taking Cyclonamine
• 3. How to take Cyclonamine
• 4. Possible side effects
• 5. How to store Cyclonamine
• 6. Contents of the pack and other information

1. What is Cyclonamine and what is it used for

Cyclonamine is a medicine with anti-haemorrhagic and angioprotective (protective of blood vessels) action. It acts selectively on the walls of blood vessels, sealing them and preventing their fragility and brittleness. By improving platelet adhesion and restoring the strength of capillary walls, it reduces bleeding time and minimizes blood loss.

Indications for use of the medicine

In surgery: prevention and treatment of preoperative or postoperative capillary bleeding in all types of operations with good tissue perfusion: in otolaryngology, gynaecology, obstetrics, urology, dentistry, ophthalmology, plastic and reconstructive surgery.
In internal diseases: prevention and treatment of capillary bleeding of various aetiologies and locations: haematuria, haematemesis, blood in stool, epistaxis, bleeding gums.
In gynaecology: spotting (bleeding outside the menstrual cycle), excessive menstrual bleeding, primary or secondary, caused by an intrauterine device, after excluding organic causes.

2. Important information before taking Cyclonamine

When not to take Cyclonamine

Warnings and precautions

Before starting treatment with Cyclonamine, discuss it with your doctor.
In case of fever, the medicine should be discontinued immediately.
If Cyclonamine is used to reduce excessive and/or prolonged menstrual bleeding, and improvement does not occur, you should contact your doctor to find and exclude possible pathological causes.

Cyclonamine and other medicines

Tell your doctor about all medicines you are taking, or have recently taken, and any medicines you plan to take.
Cyclonamine may be combined with other anticoagulant medicines. If dextran infusion is necessary, Cyclonamine should be administered first.

Cyclonamine with food and drink

The medicine can be taken with food, with a small amount of liquid.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Due to insufficient clinical data on the safety of Cyclonamine, it is not recommended during pregnancy.
Breastfeeding
Cyclonamine is excreted in breast milk. It is not recommended during breastfeeding.

Driving and using machines

The medicine, when taken as recommended, does not affect psychophysical fitness, ability to drive vehicles, or operate machinery.

Cyclonamine contains sodium metabisulfite

The medicine may rarely cause severe hypersensitivity reactions and bronchospasm.

Information on sodium content in Cyclonamine

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to take Cyclonamine

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Adults
Before surgery: 1 to 2 tablets (i.e., 250 mg to 500 mg) 1 hour before surgery.
After surgery: 1 to 2 tablets (i.e., 250 mg to 500 mg) every 4 to 6 hours, as long as there is a risk of bleeding.
Internal diseases: usually 2 tablets 2 to 3 times a day (i.e., 1000 mg to 1500 mg), taken with food, with a small amount of liquid; the duration of treatment depends on the results achieved.
Gynaecology, spotting, and excessive menstrual bleeding: 2 tablets 3 times a day (i.e., 1500 mg) with food, with a small amount of liquid. Treatment lasts 10 days and starts 5 days before the expected start of menstruation.
Children
Recommended dose: half of the adult dose.

Overdose of Cyclonamine

In case of overdose, contact your doctor immediately.

Missed dose of Cyclonamine

Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Cyclonamine can cause side effects, although not everybody gets them.
Rarely (in less than 1 in 1000 people, but more than 1 in 10,000 people) the following may occur:

• abdominal pain,
• nausea,
• headache,
• rash.

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. 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
Tel.: +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 authorisation holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Cyclonamine

Store in a temperature below 30°C. Store in the original package.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the package .The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Cyclonamine contains

• The active substance is 250 mg of etamsylate.
• The other ingredients are: potato starch, microcrystalline cellulose, sodium carboxymethylcellulose type A, colloidal anhydrous silica, magnesium stearate, sodium metabisulfite.

What Cyclonamine looks like and contents of the pack

Cyclonamine is available in tablet form. The tablet is white, round, and slightly convex on both sides.
Pack sizes:
30 tablets
60 tablets
Blister packs of aluminium foil and orange PVC film in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Pharmaceutical Cooperative "GALENA"
ul. Dożynkowa 10
52-311 Wrocław
Poland
Tel.: +48 71 71 06 201
Date of last revision of the leaflet:14.04.2023