500 mg film-coated tablet 
tranexamic acid

1. What Cyklonova is and what it is used for

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

Cyklonova is an anti-bleeding drug. Cyklonova contains tranexamic acid, which prevents the enzyme that dissolves clotted blood ( clot ) from working. This leads to less blood loss.

Cyklonova is used during heavy menstruation.

2. What you need to know before using Cyklonova

Do not use Cyklonova

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

Warnings and cautions

Talk to your doctor, pharmacist, or nurse before using Cyklonova:

  • if you have irregular periods, the cause should be investigated before using Cyklonova
  • if you have previously had a blood clot and if a blood clot has occurred in parents and/or siblings
  • if you have blood in your urine (between menstrual periods)
  • if you have impaired kidney function

Experience with Cyklonova in the treatment of children and adolescents under 15 years of age with heavy menstruation is lacking. If you are under 15 years of age, you should consult a doctor before treatment with Cyklonova.

If Cyklonova does not have sufficient effect, there are other methods to treat heavy menstruation, consult a doctor for more information.

Other medicines and Cyklonova

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Concomitant treatment with drugs that impair the blood’s ability to coagulate ( anticoagulants such as warfarin ) should only be performed by a physician with coagulation as a specialist.

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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

Driving and using machines

Side effects are such as dizziness has been reported, which may affect the ability to drive and use machines.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened 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.

How to use Cyklonova

Always use this medicine exactly as your doctor or pharmacist has told you. Always follow your doctor’s prescription and the instructions on the pharmacy label. Ask your doctor or pharmacist if you are unsure.

The recommended dose is 2-3 tablets 3-4 times daily for 3-4 days. For very heavy periods, the dose can be increased up to 2 tablets 6 times daily. Treatment should be started only when menstruation has begun.

The tablet can be divided into two equal doses.

Renal impairment 
It may be necessary to reduce dose one. Follow your doctor’s instructions.

If you take more Cyklonova then you should

If you have ingested too much medicine or if e.g. If a child has inadvertently ingested a medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

Symptoms of overdose may include the following: nausea, diarrhea, dizziness, headache. Dizziness, lethargy, low blood pressure , muscle weakness and cramps may occur. There is a risk of thrombosis (blood clot) in people with predisposition to blood clots.

If you forget to take Cyklonova

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

If you have any further questions on the use of this product, ask your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects , although not everybody gets them. The most common side effects are usually of a mild and transient nature.

Serious side effects are

The following side effects are very serious and may require immediate treatment. In case of serious side effects, stop taking the medicine and contact a doctor immediately.

Rare side effects are (may affect up to 1 in 1000 people):

  • Shortness of breath, chest pain with radiating arms or neck, severe pain in the abdomen, paralysis, sensory disturbances, speech difficulties, painful and possibly swollen arms or legs due to blood clots.


Has been reported
 (occurs in an unknown number of users):

  • Cramps.


Other side effects may occur

Common side effects are (may affect up to 1 in 10): 

  • Nausea, vomiting, diarrhea, abdominal pain, headache and dizziness.

Less common side effects are (may affect up to 1 in 100): 

  • Allergic skin reactions may occur.

Rare side effects are (may affect up to 1 in 1000 people):

  • Changes in color vision or other visual disturbances have also been reported.

5. How to store Cyklonova

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

Do not store above 30 ° C.

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 500 mg
  • The other ingredients are microcrystalline cellulose, povidone, croscarmellose sodium, anhydrous colloidal silica, talc and magnesium stearate.
  • The film coating contains methacrylate polymer (Eudragit E 100), titanium dioxide (E 171), talc, magnesium stearate, macrogol and vanillin.

What the medicine looks like and the contents of the pack

Appearance

White, capsule-shaped tablets with a scoreline, length 18 mm.

Pack sizes

Blister: 18, 20, 30, 50, 60 or 100 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Alternova A / S, Lodshusvej 11, 4230 Skælskør, Denmark

Manufacturer

Orifarm Generics A / S, Energivej 15, 5260 Odense S, Denmark This medicine is authorized under the European Economic Area under the names:

Muhammad Nadeem

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