500 mg film-coated tablets 
tranexamic acid

1. What Cyklo-f is and what it is used for

Cyclo-f is used during heavy menstruation.

Cyclo-f is a bleeding inhibitor. It contains tranexamic acid, which prevents the effect of the enzyme that dissolves clotted blood ( clot ). This leads to less blood loss and a faster healing process.

Tranexamic acid contained in Cyklo-f may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.

2. What you need to know before taking Cyklo-f

Do not use Cyklo-f

Note that Cyklo-f may only be used if you have regular, heavy periods. For you to feel confident about this before you start the treatment, you must have answered yes to both questions as follows:

  1. Are your periods regular, ie. occurs at 21-35 day intervals?
  2. When menstruation is most abundant, do you need to use double sanitary napkins, sanitary napkins, and tampons at the same time or double napkins to prevent bleeding, or change sanitary napkins bothersome often?

Do not take Cyklo-f

  • If you are being treated for a blood clot, for example in your legs, lungs, or brain
  • If you have severe renal impairment
  • If you have had seizures in the past
  • If you are allergic to tranexamic acid or any of the other ingredients of this medicine (listed in section 6).

Warnings and cautions

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

  • Irregular periods
  • Previously had a blood clot and if a blood clot has occurred in parents and/or siblings
  • Blood in the urine (between menstrual periods)

Excessive menstruation can be due to diseases of the uterus, such as. muscle knot or polyp is. If these are remedied, the abundant menstruation usually disappears. If you feel unsure, you should contact your gynecologist.

Continued gynecological health examinations are recommended.

Children and young people

If you are under 15 years of age, you should consult a doctor before treatment.

Pregnancy and breastfeeding

Cyclo-f should be used during regular heavy periods and is not intended for use during pregnancy and lactation.

Driving and using machines

Side effects that may affect the ability to drive and use machines have been reported. If you experience dizziness or visual disturbances, do not drive or use machines until the symptoms have passed.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

3. How to take Cyklo-f

Always take this medicine exactly as described in this leaflet or as your doctor advised. Consult a doctor if you are unsure.

Treatment should be started only when the actual menstruation begins. Take 2 tablets 3 times daily for as long as needed, but for a maximum of 4 days. During very heavy periods, the dose can be increased. However, do not use more than 8 tablets per day. Other dosages may be prescribed by a doctor. If the effect (reduced bleeding) is not achieved after the first day, discontinue treatment and consult a physician.

If you take more Cyklo-f then you should

If you have ingested too much medicine or if e.g. If a child has inadvertently ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice. Signs of an overdose may include dizziness, headache, drop in blood pressure, and seizures.

If you forget to take Cyklo-f

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

4. Possible side effects

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

Common (may affect up to 1 in 10 people): Nausea, vomiting, diarrhea, abdominal pain, headache, and dizziness. However, these side effects are usually of a mild and transient nature.

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

Has been reported (occurs in unknown numbers of users): Occasional cases of blood clots, changes in color vision or other visual disturbances, seizures.

If Cyklo-f does not have sufficient effect or if you do not tolerate Cyklo-f, there are other methods to treat heavy menstruation. Contact a gynecologist who can provide information on these methods.

5. How to store Cyklo-f

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 expiration date is 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. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

The active substance is tranexamic acid. One tablet contains 500 mg of tranexamic acid.

Other ingredients are:

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

Coating: Methacrylate copolymer, titanium dioxide (E171), talc, magnesium stearate, macrogol 8000, vanillin.

What the medicine looks like and the contents of the pack

Carton containing 18 or 20 tablets in a blister pack.

The tablets are white capsule-shaped, embossed with a notch, and with CY in arcs above and below.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder:

Meda AB

Box 906

170 09 Solna

Manufacturer:

Madaus GmbH

51101 Cologne

Germany

Muhammad Nadeem

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