Ciclonamine

Package Leaflet: Information for the Patient

CYCLONAMINE

500 mg, hard capsules

Etamsylate

Read the package 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. 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 action, which shortens bleeding time and reduces blood loss.
Cyclonamine is used to prevent and treat capillary bleeding (bleeding from small vessels), regardless of the cause and location of the bleeding.
Cyclonamine is used to treat spotting (bleeding outside the menstrual cycle) and excessive or prolonged menstrual bleeding, with or without the use of intrauterine devices.

2. Important information before taking Cyclonamine

When not to take Cyclonamine

Warnings and precautions

Before starting treatment with Cyclonamine, you should discuss it with your doctor or pharmacist.
Before laboratory tests, you should consider: during treatment with Cyclonamine, blood sampling for tests (e.g. blood tests) should be performed before the first administration of the medicine to limit the potential impact of Cyclonamine on laboratory test results.
A woman should be examined by a gynecologist before taking Cyclonamine in case of treatment related to menstrual bleeding.

Children

Cyclonamine is not intended for use in children.

Cyclonamine and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take.

Cyclonamine with food and drink

The medicine can be taken with food, with a glass of water (except before surgery, when the medicine is given on an empty stomach).

Pregnancy, breastfeeding, and fertility

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
There are no sufficient data on the use of Cyclonamine in pregnant women.
Animal studies have not shown any direct or indirect harmful effects on pregnancy, embryonic or fetal development, and (or) postnatal development.
As a precaution, it is recommended to avoid using Cyclonamine during pregnancy.
Breastfeeding
Due to the lack of sufficient data on the penetration of the medicine into human milk, breastfeeding is not recommended during treatment. If breastfeeding is continued, treatment should be discontinued.
Fertility
There are no available data.

Driving and using machines

In adults, Cyclonamine does not affect the ability to drive and use machines.

3. How to take Cyclonamine

Always take this medicine exactly as your doctor has told you.
In case of doubt, consult your doctor or pharmacist.
Cyclonamine is intended for use in adults. The medicine is taken orally.
Internal diseases:usually 1 capsule 2-3 times a day (1000-1500 mg). Take the medicine with food, with a glass of water. The duration of treatment depends on the results achieved.
Before surgery:1 capsule (500 mg) 1 hour before surgery.
After surgery:1 capsule (500 mg) every 4-6 hours, as long as there is a risk of bleeding.
Gynecology:1 capsule 3 times a day (1500 mg), take with food, with a glass of water.
Treatment lasts 10 days and starts 5 days before the expected start of menstruation.
If Cyclonamine is used to reduce excessive and (or) prolonged menstrual bleeding, and improvement does not occur, it is necessary to find and exclude possible pathological causes. In this case, you should immediately consult a doctor who will conduct tests and determine further treatment.
Cyclonamine should be used with caution in patients with liver and kidney function disorders.

Use in children

Cyclonamine is not intended for use in children.
Tell your doctor or pharmacist if you have any doubts about the too strong or too weak action of Cyclonamine.
Do not stop taking the medicine without consulting your doctor or pharmacist.

Using a higher dose of Cyclonamine than recommended

In case of taking a higher dose of the medicine than recommended, you should immediately contact your doctor or pharmacist. In case of overdose, treatment of symptoms should be started.

Missing a dose of Cyclonamine

Do not take a double dose to make up for a missed capsule.
In case of missing a dose, contact your doctor or pharmacist.

Stopping treatment with Cyclonamine

There are no known effects of stopping treatment.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common (affect 1 to 10 people in 100)

• headache,
• rash,
• abdominal pain, nausea, diarrhea, vomiting, abdominal discomfort,
• feeling tired.

Uncommon (affect 1 to 10 people in 10,000)

• joint pain.

Rare (affect less than 1 person in 10,000)

• fever,
• blood clotting disorders with the formation of blood clots in vessels (thromboembolic disease),
• significant decrease in white blood cell count, which increases the risk of infection,
• decrease in platelet count, which increases the risk of bleeding or bruising,
• allergic reaction.

The listed side effects are temporary and disappear after the end of treatment. If you experience any unwanted skin reactions or fever, you should immediately stop treatment and inform your doctor, as these may be the first symptoms of hypersensitivity. If you experience repeated vomiting lasting at least 2 days, treatment should be discontinued.

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
Poland
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 authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Cyclonamine

Store in a temperature below 30 ° C.
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 specified 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 etamsylate 500 mg.
• The other ingredients are: stearic acid, titanium dioxide (E 171), erythrosine (E 127), quinoline yellow (E 104), gelatin.

What Cyclonamine looks like and contents of the pack

Cyclonamine is available in the form of hard capsules. The capsule is cylindrical-oval, closed, two-part, orange in color. The contents of the capsule are white or almost white powder.
Pack sizes: 30, 60, 90.
PVC/PVDC/Aluminum blisters in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Pharmaceutical Cooperative "GALENA"
ul. Dożynkowa 10
52-311 Wrocław
Poland
Date of last revision of the leaflet:02.11.2023