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PATIENT INFORMATION CARD
WHAT I NEED TO KNOW ABOUT  COMBINED HORMONAL  CONTRACEPTIVES (CHC)
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Combined hormonal contraceptives (commonly called "tablets") are not intended for treatment  no disease. Their use is intended to prevent unwanted pregnancies.

Birth control pills are one of the most reliable contraceptive methods of contraception,  if used correctly.

All combined hormonal contraceptives, including those prescribed for you,  increase the risk of blood clot formation. Overall risk of blood clot formation at  Combined hormonal contraception is low, but blood clots can be severe  and in very rare cases even fatal. It is especially important that you  Recognize when you have a higher risk of blood clots and what signs and symptoms you would have  and what steps need to be taken.

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WHEN IS THE RISK OF BLOOD CARTRIDGE THE MOST?
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  • In the first year of taking combined hormonal anticoncretion (or after  opiate use after 4 weeks or more)

  • If you are overweight or obese

  • Older than 35 years

  • If you smoke

  • If any of your relatives were relatively young (ie younger than  50 years) a blood clot, such as a blocked blood vessel in the lower limb (deep  venous thrombosis), in the lungs (pulmonary embolism) or other organs (brain  event or heart attack)

  • If you have given birth in recent weeks

  • If you smoke and you are over 35 years old, we strongly recommend that you stop smoking or use  non-hormonal contraception.

 
WHEN DO YOU LOOK FOR IMMEDIATE MEDICAL ASSISTANCE?

 

You should seek medical attention immediately if you notice any of the following  symptoms because you may suffer from deep vein thrombosis, pulmonary embolism,  heart attack or stroke.

 

Symptoms of deep vein thrombosis:

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  • Severe pain or swelling of the legs, which may be accompanied by pressure pain,  heat or discoloration of the skin, such as paleness, red skin  blue skin color.

 

Pulmonary embolism symptoms:

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  • sudden cough for no apparent reason, which can cause bleeding or bloody  mucus

  • severe chest pain, which may increase with deep breathing

  • sudden unexplained breathing, difficulty breathing or rapid breathing,  which may affect whether you are active or in the skin

 

Symptoms of heart attack:

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  • sudden chest pain or discomfort

  • increase in discomfort, pressure or exertion radiating to  one or both of the shoulders, back, neck, jaw or upper stomach  (above the navel)

  • feeling dizzy, indigestion or suffocation

  • cold sweat, nausea, vomiting or dizziness

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Stroke symptoms (defeats):

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  •   sudden weakness or numbness of the face, shoulders or legs, especially on one  body side

  • a sudden feeling of confusion

  • problems in talking or understanding

  • sudden blurred vision or loss of vision in one or both eyes

  • severe or persistent hiava / migraine bottleneck

  • loss of consciousness or fainting

 
INFORM YOUR DOCTOR AND ASK PREVENTIVELY  MEASURES:
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  • if you have recently had or will have an operation or the operation requires long term  stay in  bed

  • if you have been in bed for a long time (due to injury or illness)

  • if you flew longer (flights longer than 4 hours)

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REMEMBER TO WARNING YOUR DOCTOR THAT YOU ARE USING  COMBINED HORMONAL CONTRACEPTIVES:

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  • if you are planning a longer trip (especially if it is connected with a longer flight)

  • if you need surgery or medical treatment that requires a longer stay  in bed

  • if you are prescribed another medicine

 

SUBSCRIPTION REPORT

 

If you get any side effects, talk to your doctor. This also applies  any side effects not mentioned in the package leaflet.

You can report side effects through: State Institute for Drug Control, Clinical Trials and Pharmacovigilance Section , Kvetná 11, 825 08 Bratislava 26, tel .: 02 507  01 206, fax: 02 507 01 237,

Web page:  http://www.sukl.sk/skibezpecnost-liekov,

e-mail: neziaduce.ucinky@sukl.sk.

The report can also be sent electronically:  https: //portal.sukl.sIdeskadra/.

By reporting side effects you can help get more information about  security  of this drug.

Information about  Adverse drug reactions may be reported, depending on the type of drug  to the relevant marketing authorization holder:

Zentiva, as , Aupark  Tower, Einsteinova 24, 851 01 Bratislava,  e-mail:  BTS.SK_PHV@zentiva.com, tel .: 0915 714 757

EXELTIS Slovakia sro , Prievozská 4D, 821 09 Bratislava, tel. number: 0908 927 882,  e-mail: fannakovigilancia.sk@exeltis.com. This material is also published on the website:  http: //www.exeltis.comisk .

STADA PHARMA Slovakia, sro , Digital Park III., Einsteinova 19, 851 01 Bratislava,  phone: 0905 747 753, e-mail: neziaduceucinkygstada.sk

VALEANT Slovakia sro , Galvaniho 71B, 821 04 Bratislava, phone: 0905 747 753,  e-mail:  DL-PS-PharmacovigilanceSlovakia@valeant.com

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