Ciclonamine 12,5%

Package Leaflet: Information for the Patient

Cyclonamine 12.5%

125 mg/ml, Solution for Injection

Etamsylate

Read the package leaflet carefully before using 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.
• 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 12.5% and what is it used for
• 2. Important information before using Cyclonamine 12.5%
• 3. How to use Cyclonamine 12.5%
• 4. Possible side effects
• 5. How to store Cyclonamine 12.5%
• 6. Contents of the pack and other information

1. What is Cyclonamine 12.5% and what is it used for

Cyclonamine 12.5% shortens prolonged bleeding time, reduces bleeding intensity, and strengthens and seals blood vessels.
Indications for use
Prevention of vascular bleeding before, during, and after surgical procedures on highly vascularized tissues or those requiring caution:

• in otolaryngology,
• in gynecology and obstetrics: before and after surgery, after childbirth and abortion,
• in urology: in bleeding from the urinary tract,
• in dentistry: after tooth extraction with subsequent heavy bleeding,
• in ophthalmology: before corneal transplantation, cataract removal, and before retinal detachment surgery,
• in plastic or reconstructive surgery.

Treatment of vascular bleeding, regardless of its location and cause.
Prevention of periventricular hemorrhages (bleeding into the brain in the immediate vicinity of the brain ventricles) in newborns with low birth weight (below 1.5 kg).

2. Important information before using Cyclonamine 12.5%

When not to use Cyclonamine 12.5%

• if you are allergic to etamsylate or any of the other ingredients of this medicine (listed in section 6),
• if you have acute porphyria,
• in patients with asthma.

Warnings and precautions

Before starting treatment with Cyclonamine 12.5%, discuss it with your doctor.
Particular caution should be exercised when using Cyclonamine 12.5%:

• in patients with unstable blood pressure or hypotension, due to the risk of sudden decrease in blood pressure after parenteral administration,
• in patients with known hypersensitivity to sulfites, as their presence in the medicine may cause allergic reactions, nausea, and diarrhea in sensitive individuals; allergic reactions may take the form of anaphylactic shock and lead to life-threatening asthma attacks; the frequency of such reactions in the population is unknown, but it is likely to be low.

Cyclonamine 12.5% and other medicines

Tell your doctor about all medicines you are taking, or have recently taken, and about medicines you plan to take.
The antioxidants contained in the medicine, sodium sulfite and sodium pyrosulfite, may inactivate vitamin B (thiamine).
High molecular weight volume substitutes (e.g., dextran) should be used after, not before, administration of Cyclonamine 12.5%.

Using Cyclonamine 12.5% in patients with kidney or liver disorders

There are no data available on the use of etamsylate in patients with renal or liver failure, therefore, when using Cyclonamine 12.5% in these patients, particular caution should be exercised.

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 for advice before taking this medicine.
There are no data on the safety of using the medicine in pregnant women. The medicine may be used during pregnancy if, in the doctor's opinion, it is absolutely necessary.
There are no data on the safety of using the medicine in breastfeeding women, therefore, breastfeeding is not recommended during treatment with Cyclonamine 12.5%. If breastfeeding continues, treatment should be discontinued.

Driving and using machines

There are no data available on the effect of etamsylate on the ability to drive and use machines.

Cyclonamine 12.5% contains sodium sulfite and sodium pyrosulfite

The medicine may rarely cause severe hypersensitivity reactions and bronchospasm.
The medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., the medicine is considered "sodium-free".
See also: "Warnings and precautions".

3. How to use Cyclonamine 12.5%

This medicine should always be used as directed by your doctor. If you are unsure, ask your doctor.
Doses of the medicine may vary for different patients.
The medicine is administered intramuscularly or intravenously.
Recommended dose
Adults and adolescents
Surgical procedures:

• 1 hour before surgery 250 to 500 mg (1 to 2 ampoules) - intravenously or intramuscularly,
• during surgery 250 to 500 mg (1 to 2 ampoules) - intravenously, repeat as needed,
• after surgery 250 to 500 mg (1 to 2 ampoules) every 4 to 6 hours, as long as there is a risk of bleeding.

In emergency situations, depending on the degree of risk: 250 to 500 mg (1 to 2 ampoules) intravenously or intramuscularly, repeat every 4 to 6 hours, until the risk of bleeding has passed.
For local use
Saturate a compress with the contents of the ampoule and apply to the bleeding site or tooth socket after tooth extraction. Repeat as needed. Oral and parenteral treatment can be used simultaneously.
Children
Half of the recommended dose for adults.
In neonatology (in preterm infants)
Usually, 10 mg per kg of body weight (0.1 ml = 12.5 mg) is administered intramuscularly within 2 hours of birth, and then every 6 hours for the first 4 days of life.
Use in patients with impaired kidney or liver function
There are no data available on the use of etamsylate in patients with renal or liver failure, therefore, when using Cyclonamine 12.5% in these patients, particular caution should be exercised.
If you feel that the effect of the medicine is too strong or too weak, consult your doctor.

Using a higher dose of Cyclonamine 12.5% than recommended

If you have used a higher dose of the medicine than recommended, contact your doctor.

Missing a dose of Cyclonamine 12.5%

If you miss a dose, take it as soon as possible. However, if it is almost time for the next dose, do not take the missed dose. Do not take a double dose.

Stopping treatment with Cyclonamine 12.5%

If you have any further questions about the use of this medicine, ask your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The frequency of possible side effects listed below is defined as:

• very common (affects more than 1 in 10 people),
• common (affects 1 to 10 people in 100),
• uncommon (affects 1 to 10 people in 1,000),
• rare (affects 1 to 10 people in 10,000),
• very rare (affects less than 1 in 10,000 people),
• not known (frequency cannot be estimated from the available data).

Rare: headaches, bitter taste, nausea, vomiting, rash, lower back pain.
Very rare: risk of arterial thrombosis, acute porphyria, allergic reactions.
Unknown: hypotension.

Reporting side effects

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

5. How to store Cyclonamine 12.5%

Keep this 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 month.
Store in a temperature below 25°C. Store in the original packaging to protect from light.
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 12.5% contains

• The active substance is etamsylate. 1 ampoule (2 ml solution) contains 250 mg of etamsylate.
• The other ingredients are: sodium pyrosulfite, sodium sulfite, water for injections.

What Cyclonamine 12.5% looks like and contents of the pack

The medicine is a colorless, clear solution. The immediate packaging is a glass ampoule containing 2 ml of solution. The outer packaging is a cardboard carton.
Pack sizes:
5 or 50 ampoules.

Marketing authorization holder and manufacturer

Marketing authorization holder

Pharmaceutical Cooperative "GALENA"
ul. Dożynkowa 10
52-311 Wrocław
Poland
Phone: +48 71 710 62 01

Manufacturer

Polpharma S.A.
ul. Pelplińska 19
83-200 Starogard Gdański
Poland

Date of last revision of the leaflet: