Document: Cyklo-f film-coated tablet ENG PL change

• Cyklo-f film-coated tablet PL
• Cyklo-f film-coated tablet ENG PL

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Package leaflet: Information for the user

Cyklo-f 500 mg film-coated tablets

tranexamic acid

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Always take this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you.

• Keep this leaflet. You may need to read it again.

• Ask your pharmacist if you need more information or advice.

• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

• You must talk to a doctor if you do not feel better or if you feel worse.

What is in this leaflet:

Cyklo-f is used for heavy menstrual bleedings.

Cyklo-f is a drug that prevents bleeding. It contains tranexamic acid, which prevents the enzyme which dissolves blood clots to act. This causes less blood loss and quicker cure rate.

Please note that Cyklo-f should only be used if your periods are regular and heavy. To be sure you should answer yes to both the following questions:

Do not take Cyklo-f if:

• You are treated for blood clot e.g in legs, lungs or brain

• You have reduced kidney function

• You have a history of convulsions

• You are allergic to tranexamic acid or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor before taking Cyklo-f if you have any of the following :

• Your periods are irregular

• You have ever had a blood clot and your parents and/or brothers or sisters have had a blood clot

• You have had blood in your urine in between your periods

Heavy menstrual bleedings can occur due to diseases in the womb such as myoma or polyps. If they are taken care of, the heavy menstrual bleeding decreases. If anything is unclear, you should ask your gynaecologist.

Continued gynaecological health controls are recommended.

Children and adolescents

Ask your doctor before starting treatment if you are under 15 years old.

Pregnancy and breast-feeding

Cyklo-f is indicated for regular heavy menstrual bleedings and is not intended for use during pregnancy and breast-feeding.

Driving and using machines

Side effects that can affect the ability to drive and use machines have been reported. If you feel dizzy or have problems with your eyesight you should not drive or use machines until the symptoms have passed.

Always take this medicine exactly as described in this leaflet or as your doctor has told you. Check with your doctor if you are not sure.

Treatment should start when your period has started. Take 2 tablets 3 times daily as long as needed, for a maximum of 4 days. The dosage can be increased if the bleedings are very heavy. Do not use more than 8 tablets per day. Your doctor may prescribe a different dose.

If effect (decreased bleeding) has not occurred after the first day, stop treatment and discuss with your doctor.

If you take more Cyklo-f than you should

If you have taken more Cyklo-f than you should, or if children have been taking medicine by accident, contact your doctor or hospital to get an opinion of the risk and advice on action to be taken. Signs of an overdose may include dizziness, headache, low blood pressure and convulsions.

If you forget to take Cyklo-f

Do not take a double dose to make up for a forgotten dose.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Common(may affect up to 1 in 10 patients): Nausea, vomiting, diarrhoea, stomach pain, headache, dizziness. These side effects are often mild and transient.

Uncommon(may affect up to 1 in 100 patients): Allergic skin reactions.

Not known (frequency cannot be estimated from the available data):Rare cases of blood clots, changes in colour vision and other problems with the eyesight, convulsions.

If Cyklo-f does not have sufficient effect or if you do not tolerate Cyklo-f, there are other methods to treat heavy menstrual bleedings. Contact gynaecologist who can give information about those methods.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse.This includes any possible side effects not listed in this leaflet.You can also report side effects directly via the national reporting system listed in Appendix V.*By reporting side effects you can help provide more information on the safety of this medicine.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after EXP.

The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information

What Cyklo-f contains

The active substance is:Tranexamic acid. Each tablet contains 500 mg tranexamic acid.

The other ingredients are:

Tablet core:Microcrystalline cellulose, hyprolose, talc, magnesium stearate, colloidal anhydrous silica, povidone

Coating:Methacrylate copolymer, titanium dioxide (E 171), talc, magnesium stearate, macrogol 8000, vanillin.

What Cyklo-f looks like and contents of the pack

Carton containing 18 tablets in a blister. The tablets are white, capsule shaped, engraved with a score and with arcs above and below the letters CY.

Marketing authorisation holder and manufacturer

Marketing authorisation holder:

Meda AB

Box 906

170 09 Solna

Manufacturer:

Pfizer Italia S.R.L

Localita Marino del Tronto

Ascoli Piceno

Italy

Meda Manufacturing GmbH

Neurather Ring 1

51063 Cologne

Germany

The leaflet was last revised in 2016-08-29