Package leaflet: Information for the patient

CYCLOREG
500 mg, hard capsules
Etamsylate
Please read carefully all the information in this leaflet 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 further questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, 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

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

1. What Cycloreg is and what it is used for

Cycloreg is a haemostatic agent that shortens bleeding time and reduces blood loss.
Cycloreg is used for the prevention and treatment of capillary bleeding (bleeding from small vessels), regardless of the cause or site of bleeding.
Cycloreg is used in the treatment of intermenstrual spotting (bleeding occurring outside the menstrual cycle) and excessive or prolonged menstrual bleeding, associated with or independent of the use of intrauterine devices.

2. Important information before using Cycloreg

When not to use Cycloreg

if the patient is allergic to ethamsylate or any of the other ingredients of this medicine (listed in section 6).
if the patient has porphyria (a disorder characterized by disturbances in hemoglobin synthesis). In such a case, this fact should be reported to the physician, who will decide on further treatment.

Warnings and precautions
Before starting to use Cycloreg, discuss it with your doctor or pharmacist.
Before laboratory tests: during treatment with Cycloreg, blood samples (e.g. blood samples) should be taken before the first dose of the medicine to minimize any potential influence of Cycloreg on laboratory test results.
A woman must be examined by a gynecologist before using Cycloreg for treatment related to menstrual bleeding.
If Cycloreg is used to reduce excessive and (or) prolonged menstrual bleeding and no improvement occurs, possible pathological causes should be identified and ruled out. In such a case, immediate consultation with a doctor is necessary; the doctor will perform appropriate examinations and determine further treatment.

Children and adolescents
Cycloreg is not intended for use in children and adolescents under 18 years of age.

Cycloreg with other medicines
Inform your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.

Cycloreg with food and drink
The medicine should be taken with food, drinking water (except when administered before surgery, when the medicine should be taken on an empty stomach).

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.

Pregnancy
There are insufficient data on the use of Cycloreg in pregnant women. As a precautionary measure, the use of Cycloreg during pregnancy is not recommended.

Breastfeeding
Due to insufficient data on the passage of the drug into human milk, breastfeeding is not recommended during treatment. Otherwise, if breastfeeding is continued, treatment should be discontinued.

Fertility
No data available.

Driving and operating machinery
Cycloreg has no effect on the ability to drive or operate machinery.

3. How to use Cycloreg

This medicine should always be used as directed by a physician. In case of doubt, consult a doctor or pharmacist.
Cycloreg is intended for use in adults. The medicine is administered orally.
Internal medicine: usually 1 capsule 2-3 times daily (1000-1500 mg). Take the medicine with food, drinking water. The duration of treatment depends on the results achieved.
Before surgical procedure: 1 capsule (500 mg) 1 hour before surgery.
After surgical procedure: 1 capsule (500 mg) every 4-6 hours, as long as there is a risk of bleeding.
Gynecology: 1 capsule 3 times daily (1500 mg), taken with food and water. Treatment lasts 10 days and begins 5 days before the expected onset of menstruation.
Cycloreg should be used with caution in patients with impaired liver or kidney function.
Use in children and adolescents
Cycloreg is not intended for use in children and adolescents under 18 years of age.
Inform your doctor or pharmacist if you have any concerns about the medicine's effect being too strong or too weak.
Do not discontinue use of this medicine without consulting a doctor or pharmacist.
Use of a higher than recommended dose of Cycloreg
If more medicine has been taken than recommended, contact a doctor or pharmacist immediately. In case of overdose, symptomatic treatment should be initiated.
Missed dose of Cycloreg
Do not take a double dose to make up for a missed capsule.
If a dose has been missed, contact your doctor or pharmacist.
Stopping use of Cycloreg
The effects of stopping treatment are not known.
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.

Common (occur in no more than 1 in 10 people)

headache,
rash,
abdominal pain, nausea, diarrhoea, vomiting, discomfort in the abdominal cavity,
weakness.

Uncommon (occur in no more than 1 in 1,000 people)

joint pain.

Rare (occur in no more than 1 in 10,000 people)

fever,
coagulation disorders with formation of blood clots in vessels (thromboembolic disease),
a marked decrease in the number of white blood cells, increasing the likelihood of infection,
a decrease in the number of platelets, increasing the risk of bleeding or bruising,
hypersensitivity reaction.

The adverse reactions listed above are transient in nature and resolve after discontinuation of treatment. If any adverse skin reactions or fever occur, treatment must be stopped immediately and the physician must be informed, as these may be the first signs of a hypersensitivity reaction. Treatment should also be discontinued in case of recurrent vomiting persisting for at least 2 days.

Reporting of adverse reactions

If any symptoms of adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of 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 authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Cycloreg

Store 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the package and other information

What Cycloreg 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 Cycloreg looks like and contents of the pack
Cycloreg is available as hard capsules. The capsule is cylindrical-oval, closed, two-part, orange in colour. The capsule contents are white or almost white powder.
Available pack sizes:
30 pieces, 60 pieces, 90 pieces.
PVC/PVDC/Aluminium blisters in a cardboard box.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Pharmaceutical Labour Cooperative "GALENA"
Dożynkowa Street 10
52-311 Wrocław
Poland
Tel. +48 71 71 06 201