Martaviva 21 tablet

Trade Name:

Martaviva

Dienogest 2 mg

Ethinylestradiol 0.03 mg

21 film coated tablet

Composition:

Dienogest 2 mg

Ethinylestradiol 0.03 mg

Inactive ingredients:

Lactose monohydrate, maize starch, hypromellose, talc, polacrilin potassium, magnesium stearate, titanium dioxide, macrogol

Properties:

-Martaviva is a combined contraceptive pill, that protects you against getting pregnant in three ways:

1.stop the ovary from releasing an egg each month (ovulation)

2.thicken the fluid (at the neck of the womb) making it more difficult for the sperm to reach the egg.

3.alter the lining of the womb to make it less likely to accept a fertilized egg.

-Martaviva 2 mg/0.03 mg film-coated tablets belongs to the group of drugs often referred to as micro pills due to its low hormone content, “combined pills” due to the two types of hormone in the pill and

monophasic oral contraceptives due to the identical composition of each tablet.

-Martaviva 2 mg/0.03 mg film-coated tablets alleviates pimples (acne) in women caused by the excessive quantity of male sex hormones called “androgens” that are present in every woman.

Indications:

Martaviva is a medicinal product used for: 

-prevention of pregnancy (contraception)

-treatment of moderate acne in women, if suitable local or oral antibiotic treatments failed.

Dosage and administration:

-Always take this medicine exactly as your doctor has told you. 

-The blister pack has been designed to help you remember to take your pills.

The strip contains 21 tablets. Next to each tablet is printed the day of the week that it is easier for you to remember to take pills.

You should try to take your pill at about the same time each day; if necessary with a little liquid, in the order shown on the blister pack. 

-One tablet is to be taken daily until you have finished all 21 pills in the pack. Then you have 7 days when you do not take a pill. During the 7 pill-free days, on day 2 or 3, you will have menstruation-like withdrawal bleeding, i.e. your monthly period.

-Start your next pack on the 8th day (following the 7 pill-free days) – even if the bleeding has not yet ended. 

-As long as you takeMartaviva 2 mg/0.03 mg film-coated tablets correctly, you will always start each new pack on the same day of the week, and you will always have your monthly period on the same day of the month.

• If no oral contraception has been used during the preceding cycle:

Take the first pill on the first day of your period. This is the first day of your cycle – the day when bleeding starts. Take a pill marked for that day of the week.

You may also begin on day 2-5 of the cycle, but then you must use extra protective measures (for example, a condom) for the first 7 days.

• Changing from another combined hormonal contraceptive:

Start takingMartaviva 2 mg/0.03 mg film-coated tablets on the day after you take the last pill from the strip of your previous contraceptive, but at the latest on the day after the tablet-free days of your previous pill.

• When changing from a vaginal ring or transdermal patch, follow the advice of your doctor.
• If you are less than 12 hours late taking the pill:

You are still protected against pregnancy if you take the late pill as soon as you remember, and keep taking your next pills at the usual time. This may mean taking two pills in one day.

• If you are more than 12 hours late taking the pill your protection against pregnancy might be reduced.

The risk of a pregnancy is higher if you forget to take the pill at the start of a pack or before the end of a pack. Ask your doctor’s advice.

Side effects:

Common: headache, breast pain including breast discomfort and breast tenderness.

Uncommon: inflammation of genitals (vaginitis/vulvovaginitis), fungal infections in the vagina (candidiasis, vulvovaginal infections), increased appetite, depressed mood, dizziness, migraine, high or low blood pressure, abdominal pain (including pain in the upper and lower abdomen, discomfort/bloating, nausea, vomiting, diarrhea, acne, hair loss (alopecia), skin rash (including spotty skin rash), itching (in some cases of the whole body), irregular withdrawal bleedings including strong bleedings (menorrhagia), weak bleedings (hypomenorrhea), rare bleedings (oligomenorrhea) and absence of withdrawal bleeding (amenorrhea), intermenstrual bleeding (vaginal haemorrhagia and metrorrhagia), menstrual pain (dysmenorrhea), pelvic pain, breast enlargement including swelling of the breast, vaginal secretion ovarian cysts, exhaustion including weakness, tiredness and general indisposition, weight gain.

Contraindications:

-Allergy to dienogest or ethinylestradiol or any of the other ingredients of this

medicine;

-blood clot in a blood vessel of your legs (deep vein thrombosis, DVT), your lungs (pulmonary embolism, PE) or other organs;

-a disorder affecting your blood clotting- for instance protein C deficiency, protein S deficiency, antithrombin-III-deficiency, Factor V Leiden, antiphospholipid-antibodies;

-if you need an operation or if you are off your feet for a long time;

-if you have ever had a heart attack or a stroke;

-if you have (or have ever had) angina pectoris (a condition that causes severe chest pain and may be a first sign of a heart attack) or transient ischaemic attack;

-if you have any of the following diseases that may increase your risk of a clot in the arteries: severe diabetes with blood vessel damage, very high blood pressure, a very high level of fat in the blood (cholesterol or triglycerides), hyperhomocysteinemia;

if you have or ever had severe liver disease, liver disease, liver tumors, breast cancer or other cancer, for example ovarian cancer, cervical cancer, or cancer of the uterus (womb); unusual bleeding from your vagina; pancreatitis, migraine with aura, hepatitis C.

Warnings and precautions:

• Tell your doctor if any of the following conditions apply to you:

-if you have diabetes;

-if you are very overweight (obese);

-if you have high blood pressure:

-if you have a heart valve disorder or a certain heart rhythm disorder;

-if you have an inflammation in the veins under the skin (superficial thrombophlebitis);

-if you have varicose veins;

-if you or any member of your close family have any medical condition which makes you more at risk of developing blood clots;

-if you have migraine:

-if you have the movement disorder called Sydenham’s chorea;

-if you or any member of your close family have a disorder of blood-fat (lipid) metabolism, or other very rare blood disorders;

-if you have liver and/or gallbladder disease (yellowing of the skin, gallstones);

if you have Crohn’s disease or ulcerative colitis (chronic inflammatory bowel diseases);

-if you have jaundice or itching of your whole body;

-if you have systemic lupus erythematosus;

-if you have a haemolytic uraemic syndrome;

-if you have sickle cell anemia (an inherited disease of the red blood cells);

-if you have elevated levels of fat in the blood (hypertriglyceridemia) or a positive family history for this condition;

-if you have the inherited disease called porphyria;

-if you have had the rash known as herpes gestationis;

-if you have the inherited form of deafness known as otosclerosis;

-if you have brown patches on your face and body (chloasma), which you can reduce by staying out of the sun and not using sunbeds or sunlamps;

-if you are smoking: in smokers combined oral contraceptives increase the risk of severe cardiovascular conditions;

-if you experience symptoms of angioedema such as swollen face, tongue and/or throat and/or difficulty swallowing or hives potentially with difficulty breathing 

• Using a combined hormonal contraceptive such asMartaviva 2 mg/0.03 tablets increases your risk of developing a blood clot compared with not using one. In rare cases a blood clot can block blood vessels and cause serious problems.
• Martaviva 2 mg/0.03 mg film-coated tablets and cancer:

Breast cancer has been observed slightly more often in women using combination pills, but it is not known whether this is caused by the treatment. It is important to regularly check your breasts and you should contact your doctor if you feel any lump.

• Psychiatric disorders:

Some women using hormonal contraceptives includingMartaviva 2 mg/0.03 mg film-coated tablets have reported depression or depressed mood. Depression can be serious and may sometimes lead to suicidal thoughts. If you experience mood changes and depressive symptoms contact your doctor for further medical advice as soon as possible.

• Children and adolescents:

Martaviva 2 mg/0.03 mg film-coated tablets are not indicated for use before the first menstrual bleeding (menarche).

• Elderly women:

Martaviva 2 mg/0.03 mg film-coated tablets are not indicated after menopause.

• Drug interactions:

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

• Before you have any blood tests

Tell your doctor or the laboratory staff that you are taking the pill, because oral contraceptives can affect the results of some tests.

• Pregnancy and breast-feeding:

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.

It is not recommended to takeMartaviva tablets during pregnancy or breastfeeding, as it affects the baby.

• Driving and using machines:

Martaviva 2 mg/0.03 mg film-coated tablet has no influence on the ability to drive and use machines.

• Keep out of reach of children.

Storage:

Store at a temperature not exceeding 25°C

Package:

Carton box holds a strip of 21 tablet and paper instructions.