Package leaflet: Information for the patient

Cyclonamine 12.5%
125 mg/ml, solution for injection
Etamsylatum
Please read carefully the entire leaflet before using this 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 questions, please consult your doctor.
This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are identical.
If the patient experiences any adverse reactions, including any not listed in this leaflet, inform a doctor or pharmacist immediately. See section 4.

Table of contents of the leaflet

What is Cyclonamine 12.5% and what is it used for
Important information before using Cyclonamine 12.5%
How to use Cyclonamine 12.5%
Possible adverse reactions
How to store Cyclonamine 12.5%
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 the intensity of bleeding,
and strengthens and seals blood vessels.

Indications for use
Prevention of vascular bleeding before, during, and after surgical procedures on tissues
that are highly vascularized or require caution:

in otorhinolaryngology,
in gynecology and obstetrics: before and after procedures, after childbirth and abortion,
in urology: in bleeding from the urinary tract,
in dentistry: after tooth extraction followed by profuse bleeding,
in ophthalmology: before corneal transplantation, cataract removal, and retinal detachment surgery,
in plastic or reconstructive surgery.

Treatment of vascular bleeding, regardless of location or cause.
Prophylaxis of periventricular hemorrhages (bleeding into the brain in the immediate vicinity
of the cerebral ventricles) in low birth weight infants (below 1.5 kg).

2. Important information before using Cyclonamine 12.5%

When not to use Cyclonamine 12.5%

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

Warnings and precautions
Before starting treatment with Cyclonamine 12.5%, discuss this with your doctor.
Special caution is required when using Cyclonamine 12.5%:

in patients with unstable blood pressure or arterial hypotension, due to the risk of sudden decrease in blood pressure following parenteral administration,
in patients with known hypersensitivity to sulfites, as their presence in the medicine may cause allergic reactions, nausea, and diarrhoea in susceptible individuals; allergic reactions may manifest as anaphylactic shock and may lead to life-threatening asthma attacks; the frequency of such reactions in the population is unknown, but is probably low.

Cyclonamine 12.5% and other medicines
Inform your doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
The antioxidant substances contained in the medicine, sodium sulfite and sodium pyrosulfite, may inactivate vitamin B (thiamine).
High-molecular-weight plasma volume expanders (e.g. dextran) should be administered after, not before, administration of Cyclonamine 12.5%.
Use of Cyclonamine 12.5% in patients with renal or hepatic impairment
There are no data available regarding the use of etamsylate in patients with renal or hepatic insufficiency; therefore, special caution should be exercised when using Cyclonamine 12.5% in these patients.
Pregnancy, breastfeeding, and effects on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor before using this medicine.
There is a lack of data on the safety of using this medicine in pregnant women. The medicine may be used during pregnancy only if, in the opinion of the doctor, it is absolutely necessary.
There is a lack of data on the safety of using this medicine in breastfeeding women; therefore, breastfeeding is not recommended during treatment with Cyclonamine 12.5%. If breastfeeding is continued, treatment should be discontinued.
Driving and operating machinery
There are no data available on the effects of etamsylate on the ability to drive or operate machinery.
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 exactly as directed by the physician. In case of doubt, consult
your doctor.
Dosage may vary for different patients.
This medicine is administered intramuscularly or intravenously.
Recommended dose
Adults and adolescents
Surgical procedures:

1 hour before surgery: 250 to 500 mg (1 to 2 vials) – intravenously or intramuscularly,
during surgery: 250 to 500 mg (1 to 2 vials) – intravenously, repeat if necessary,
after surgery: 250 to 500 mg (1 to 2 vials) every 4 to 6 hours, as long as there is a risk of bleeding.

In emergency cases, depending on the severity of the condition: 250 to 500 mg (1 to 2 vials)
intravenously or intramuscularly, repeated every 4 to 6 hours until the risk of bleeding has subsided.
Topical use
Soak a compress with the vial contents and apply to the site of bleeding or into the tooth socket after
tooth extraction. Repeat if necessary. Concomitant oral or parenteral treatment may be used.
Children
Half the adult recommended dose.
Use in neonatology (in premature infants)
Usually 10 mg per kg body weight (0.1 ml = 12.5 mg) intramuscularly within 2 hours after birth, then
every 6 hours during the first 4 days of life.
Use in patients with impaired renal or hepatic function
There are no data available on the use of etamsylate in patients with renal or hepatic insufficiency;
therefore, particular caution should be exercised when administering Cyclonamine 12.5% to these
patients.
If you feel the effect of the medicine is too strong or too weak, consult your doctor.
Use of more than the recommended dose of Cyclonamine 12.5%
If more medicine has been administered than recommended, contact your doctor immediately.
Missed dose of Cyclonamine 12.5%
If a dose has been missed, 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 of the medicine.
Stopping treatment with Cyclonamine 12.5%
In case of any further doubts concerning the use of this medicine, consult your doctor.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The frequency of the possible adverse reactions listed below is defined as follows:

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

Rare: headache, bitter taste, nausea, vomiting, rash, lumbosacral pain.
Very rare: risk of arterial embolism, acute porphyria, allergic reactions.
Unknown: hypotension.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, tell your doctor. 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
Tel.: +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 provide more information on the safety of the 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 container. The expiry date refers to the last day of the stated month.
Store below 25°C. Keep 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. One ampoule (2 ml of solution) contains 250 mg of etamsylate.
Other ingredients: sodium metabisulfite, sodium sulfite, water for injections.

What Cyclonamine 12.5% looks like and contents of the pack
The medicine is a colourless, clear solution. The immediate packaging consists of a colourless glass ampoule containing 2 ml of solution. The outer packaging is a cardboard carton.
Available pack sizes:
5 or 50 ampoules.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Farmaceutyczna Spółdzielnia Pracy „GALENA”
ul. Dożynkowa 10
52-311 Wrocław
Poland
Tel.: +48 71 710 62 01

Manufacturer
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19
83-200 Starogard Gdański
Poland