PACKAGE LEAFLET: INFORMATION FOR THE USER
Cyklonova 500 mg film-coated tablet
tranexamic acid
Read all of this leaflet carefully before you start using this medicine.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
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 any of the side effects gets serious, or if you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.
In this leaflet:
1.
What Cyklonova is and what it is used for
2.
Before you use Cyklonova
3.
How to use Cyklonova
4.
Possible side effects
5.
How to store Cyklonova
6.
Further information
1.
WHAT CYKLONOVA IS AND WHAT IT IS USED FOR
Ask your doctor, pharmacist or other health care professional if you have further questions and
always follow their instructions.
Cyklonova is a medicine that reduces bleeding. Cyklonova contains tranexamic acid which inhibits
the enzyme that dissolves clotted blood (clots). This leads to less blood loss.
Cyklonova is used for heavy menstrual bleeding.
2.
BEFORE YOU USE CYKLONOVA
Do not use Cyklonova
if you are allergic (hypersensitive) to tranexamic acid or any of the other ingredients of
Cyklonova.
if you are treated for a blood clot e.g. in your legs, lungs or brain.
if you are treated for a kidney disease.
Take special care with Cyklonova
if you have irregular menstrual bleeding the cause should be established before using
Cyklonova
if you have had a blood clot and if any of your parents and/or siblings have had blood clots
if you have had blood in your urine (between menstrual periods)
if you have impaired renal function
There is little information on the use of Cyklonova in heavy menstrual bleeding in children and
adolescents under 15 years of age. Ask your doctor for advice whether it may be appropriate for
you.
1
If Cyklonova does not have adequate effect there are other ways to treat heavy menstrual bleeding,
contact your doctor for more information.
Using other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines,
including medicines obtained without a prescription.
If you are taking medicines that reduce the blood’s ability to clot (anticoagulants such as Warfarin
for example), concurrent treatment with Cyklonova should only be made under the supervision of a
doctor who specialises in coagulation.
Pregnancy and breast-feeding
Cyklonova should be used for regular heavy menstrual bleeding and is not intended to be used
during pregnancy or breast feeding.
Driving and using machines
No effects on the ability to drive and use machines has been observed.
3.
HOW TO USE CYKLONOVA
Always use Cyklonova exactly as your doctor has told you. Always follow the doctors orders and
the instructions on the label on the package. You should check with your doctor or pharmacist if
you are not sure.
The usual dosage is 2-3 tablets 3-4 times daily for 3-4 days. If used for very heavy menstrual
bleeding, the dosage may be increased up to 2 tablets 6 times daily. Treatment with Cyklonova
should not be initiated until menstrual bleeding has started.
If you take more Cyklonova than you should
If you have taken more Cyklonova than you should, always contact a doctor, a hospital or the
poison information centre for an assessment of the risk and consultation.
Symptoms of overdose include the following:
Nausea, diarrhoea, dizziness, headache. Light-headedness, faintness, low blood pressure and
muscle weakness may occur. There is a risk of thrombosis (blood clots) in predisposed individuals.
4.
POSSIBLE SIDE EFFECTS
Like all medicines, Cyklonova can cause side effects, although not everybody gets them.
The most common side effects are mild and transient.
Common side effects (occur in more than 1 in 100 patients, but in less than 1 in 10): Nausea,
vomiting, diarrhoea, abdominal pain, headache and dizziness.
Uncommon side effects (occur in more than 1 in 1000 patients, but in less than 1 in 100 patients):
Allergic skin reactions may occur.
Rare side effects (occur in more than 1 in 10000 patients but in less than 1 in 1000 patients):
Rare cases of blood clots, disturbances of the colour vision and other visual disturbances have
been reported.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
5.
HOW TO STORE CYKLONOVA
Keep out of the reach and sight of children.
Do not store above 30C.
2
Do not use this medicine after the expiry date which is stated on the carton after “Utg. Dat.:”.
The expiry date refers to the last day of that 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.
FURTHER INFORMATION
What Cyklonova contains
-
The active substance is tranexamic acid 500 mg
The other ingredients are microcrystalline cellulose, povidone, croscarmellose sodium,
colloidal anhydrous silica, talc and magnesium stearate.
The film-coating contains methacrylate polymer (Eudragit E100), titanium dioxide (E 171),
talc, magnesium stearate, macrogol and vanillin.
What Cyklonova looks like and contents of the pack
Blister packs with 18, 20, 30, 50, 60 and 100 tablets.
The tablets are white, capsule shaped and scored.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Alternova A/S, Lodshusvej 11, DK-4230 Skælskør, Denmark
Manufacturer
Viminco A/S, Lodshusvej 11, 4230 Skælskør, Denmark
This leaflet was last approved in 2011-06-01
3