Cyclonamine

Package leaflet: Information for the patient

CYCLONAMINE
250 mg, tablets
Etamsylatum
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

1. What Cyclonamine is and what it is 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 package and other information

1. What Cyclonamine is and what it is used for

Cyclonamine is a haemostatic and angioprotective (vessel-protecting) medicine. It acts selectively on the walls of blood vessels, strengthening and sealing them, thereby counteracting their fragility and permeability. By improving platelet adhesion and restoring capillary wall resistance, it shortens bleeding time and reduces blood loss.

Indications for use of the medicine
Surgery: Prevention and pre- or postoperative treatment of capillary bleeding in all types of surgery involving well-perfused tissue areas:
in otorhinolaryngology, gynaecology, obstetrics, urology, dentistry, ophthalmology, plastic and reconstructive surgery.
Internal medicine: Prevention and treatment of capillary bleeding of various aetiologies and localizations: haematuria, haematemesis, blood in stool, epistaxis, gingival bleeding.
Gynaecology: Spotting (bleeding outside the menstrual cycle), primary or secondary excessive menstrual bleeding caused by an intrauterine device, after exclusion of organic causes.

2. Important information before using Cyclonamine

When not to use Cyclonamine

• if the patient is allergic to etamsylate or any of the other ingredients of this medicine (listed in section 6),
• if the patient has acute porphyria.

Warnings and precautions
Before starting Cyclonamine, discuss it with your doctor.
If fever occurs, the medicine should be discontinued immediately.
If Cyclonamine is used to reduce excessive and (or) prolonged menstrual bleeding and no improvement occurs, contact your doctor to identify and exclude possible pathological causes.

Cyclonamine with other medicines
Tell your doctor about all medicines you are currently taking, have recently taken, or plan to take.
Cyclonamine may be used together with other anticoagulant medicines. If dextran infusion is required, Cyclonamine should be administered first.

Cyclonamine with food and drink
The medicine may be taken with food, accompanied by a small amount of liquid.

Pregnancy and breastfeeding
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy
Due to insufficient clinical data on safety, Cyclonamine is not recommended for use in pregnant women.

Breastfeeding
Cyclonamine is excreted in breast milk. Use of the medicine during breastfeeding is not recommended.

Driving and operating machinery
When used according to recommendations, Cyclonamine does not affect psychophysical performance, ability to drive vehicles or operate machinery.

Cyclonamine contains sodium metabisulfite
This 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, meaning the medicine is considered "sodium-free".

3. How to use Cyclonamine

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

Adults
Before surgery: 1 to 2 tablets (i.e. 250 mg to 500 mg) one hour before the surgical procedure.
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 daily (i.e. 1000 mg to 1500 mg), taken with food and a small amount of liquid. The duration of treatment depends on the achieved results.
Gynecology, spotting and excessive menstrual bleeding: 2 tablets three times daily (i.e. 1500 mg) with food, taken with a small amount of liquid. Treatment lasts 10 days, starting 5 days before the expected onset of menstruation.

Children
Recommended dose: half the adult dose.

Use of a higher than recommended dose of Cyclonamine
In case of ingestion of a dose higher than recommended, seek immediate medical advice from a doctor.

Missed dose of Cyclonamine
Do not take a double dose to make up for a missed dose.

If you have any further questions regarding 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.
Rarely (in less than 1 in 1,000 people but more than 1 in 10,000 people) the following occur:

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

If any of the adverse reactions worsen or if any adverse reactions not listed in this leaflet occur, inform a doctor or pharmacist.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, tell a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Cyclonamine

Store below 30ºC. Keep in the original packaging.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines must 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 packaging and other information

What Cyclonamine contains

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

What Cyclonamine looks like and contents of the pack
Cyclonamine is available as tablets. The tablet is white, round, and slightly convex on both sides.
Pack sizes available:
30 tablets
60 tablets
Aluminium foil and orange PVC foil blisters in a cardboard box.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Farmaceutyczna Spółdzielnia Pracy „GALENA”
ul. Dożynkowa 10
52-311 Wrocław
Poland
Tel.: +48 71 71 06 201