Zafrilla 2 mg. 28 tablets

What Zafrila is and what it is used for

Zafrila is a medicine used to treat endometriosis (pain symptoms due to the transfer of tissue to an unusual place from the inner surface of the uterus). Zafrila contains one hormone
- progestogen dienogest.

2. What you need to know before you take Zafrila

Do not take Zafrila:
- If you have an increased tendency to form clots in your veins (thromboembolic disorder). This can happen, for example, in the blood vessels of the legs (deep vein thrombosis) or in the lungs (pulmonary embolism). See also 'Zafrila and venous clots' below;
- If you have or have ever had severe arterial disease, including cardiovascular disease such as a heart attack, stroke or heart disease that results in a reduced blood supply (angina pectoris). See also "Zafrila and arterial clots" below;
- If you have diabetes with damage to blood vessels;
- If you have or have had severe liver disease in the past (and the values ​​of laboratory parameters reflecting liver function have not returned to the reference range). Symptoms of liver disease may include yellowing of the skin and / or itching all over the body;
- If you have or have had malignant or benign liver tumors in the past;
- If you suffer or have suffered in the past, or are thought to be suffering from a malignant tumor whose growth is favored by sex hormones, such as breast or genital cancer;
- If you have any unusual vaginal bleeding;
- If you are allergic (hypersensitive) to dienogest or any of the other ingredients of this medicine (listed in section 6).
- If any of these conditions occur for the first time when taking Zafrila, stop taking it immediately and consult a doctor.

Warnings and precautions

Talk to your doctor or pharmacist before taking Zafrila.

You should not use hormonal contraceptives in any form (tablets, patches, intrauterine systems) while taking Zafrila.

Zafrila is not a contraceptive. If you want to avoid pregnancy, you should use condoms or other non-hormonal contraceptive precautions.

In some situations, you need to pay special attention to the use of Zafrila and your doctor may need to see you regularly. Tell your doctor if any of the following conditions apply to you:

If you:
- you have ever had a blood clot (venous thromboembolism) or one of your closest blood relatives has had a blood clot forming at a relatively young age;
- you have a close relative with breast cancer; have you ever suffered from depression;
- you have high blood pressure or if you develop high blood pressure while taking Zafrila;
- develop liver disease while taking Zafrila. Symptoms may include yellowing of the skin or whites of the eyes or itching all over the body. Also tell your doctor if you have experienced such symptoms in previous pregnancies;
- you have or have had diabetes temporarily in previous pregnancies; - you have ever had chloasma (golden brown spots on the skin, especially on the face); in this case, avoid excessive sun exposure or ultraviolet radiation;
- you suffer from lower abdominal pain while taking Zafrila.

While taking Zafrila, the likelihood of becoming pregnant is reduced because Zafrila can affect ovulation.

If you become pregnant while taking Zafrila, you have a slightly increased risk of ectopic pregnancy (the fetus develops outside the uterus). Tell your doctor before taking Zafrila if you have a history of ectopic pregnancy or have fallopian tube dysfunction.

Zafrila and profuse uterine bleeding
Uterine bleeding may worsen during the use of Zafrila, for example in women with a condition in which the lining of the uterus (endometrium) grows into the muscular layer of your uterus, called uterine adenomyosis or benign uterine tumors, sometimes called uterine fibroids. (uterine leiomyomas). If the bleeding is heavy and prolonged over time, this can lead to a decrease in the number of red blood cells (anemia), which can sometimes be severe. In case of anemia, you should discuss with your doctor whether you should stop taking Zafrila.

Zafrila and changes in the characteristics of bleeding
The majority of women treated with Zafrila have changes in the characteristics of their menstrual bleeding (see section 4, “Possible side effects”).
Zafrila and venous clots
Some studies show that there may be a slightly increased, but without statistical reliability, risk of blood clots forming in the blood vessels in your legs (venous thromboembolism), which may be related to the use of progestogen-containing medicines such as Zafrila. Very rarely, clots can lead to severe permanent disability or even be fatal.

The risk of developing a venous blood clot increases:
- with advancing age;
- if you are overweight;
- if you or any of your close relatives have had clots in the blood vessels of the legs (thrombosis), pulmonary embolism or embolism in other organs at an early age;
- if you are about to have surgery, if you have had a severe injury or if you need to be immobilized for a long time. It is important that you tell your doctor in advance that you are using Zafrila, as treatment may need to be stopped. Your doctor will tell you when to start taking Zafrila again. This is usually two weeks after you get back on your feet.

Zafrila and clots in arterial vessels
There is little evidence of a link between medicines that contain progestogens such as Zafrila and an increased risk of blood clots, for example in the blood vessels of the heart (heart attack) or the brain (stroke). In women with hypertension, the risk of stroke may be slightly increased by such drugs.

The risk of blood clot formation in an arterial vessel increases:
- if you smoke. It is strongly recommended that you stop smoking when using Zafrila, especially if you are over 35 years of age;
- if you are overweight;
- if any of your close relatives had a heart attack or stroke when you were your age;
- if you have high blood pressure.

Talk to your doctor before taking Zafrila Stop taking Zafrila and contact your doctor immediately if you notice signs of blood clots, such as:
- acute pain and / or swelling of one leg;
- sudden sharp pain in the chest, which may spread to the left arm;
- sudden shortness of breath;
- sudden onset of cough for no apparent reason;
- any unusual, severe or prolonged headache or worsening of migraine;
- partial or complete blindness or double vision;
- difficulty speaking or inability to speak;
- dizziness or fainting;
- weakness, strange sensation or tingling in any part of the body.

Zafrila and cancer
It is not clear from the current data whether Zafrila increases the risk of breast cancer or not. Breast cancer is slightly more common in women who take hormones than in women who do not take hormones, but it is not known if this is due to treatment. For example, it is possible for more tumors to be detected earlier in women who take hormones because they are more likely to be examined by their doctors. The incidence of breast tumors gradually decreases after discontinuation of hormonal treatment. It is important to check your breasts regularly and you should contact your doctor if you feel lumps.

There are rare reports of benign liver tumors and even less frequently of malignant liver tumors in women taking hormones. Contact your doctor if you have unusually severe abdominal pain.

Zafrila and osteoporosis
Changes in bone mineral density (BMD)

The use of Zafrila can affect the strength of the bones in girls (from 12 to under 18 years of age). If you are under 18 years of age, your doctor will evaluate the benefits against the risks of using Zafrila in you, taking into account the possible risk factors for bone loss (osteoporosis).

Proper intake of calcium and vitamin D, whether through food or as a dietary supplement, will help your bone health if you take Zafrila.

If you are at increased risk of developing osteoporosis (decreased bone strength due to loss of minerals), your doctor will carefully consider the risks and benefits of treatment with Zafrila, because Zafrila has a moderate suppressive effect on the production of estrogen (a type of female hormone) in the body. You.
Children and adolescents
Zafrila should not be used in girls before menarche (first menstrual bleeding).

The use of Zafrila can affect bone strength in adolescents (12 to under 18 years of age). If you are under 18 years of age, your doctor will evaluate the benefits against the risks of using Zafrila in you, taking into account the possible risk factors for bone loss (osteoporosis).

Zafrila and use of other drugs
Please tell your doctor if you are taking or have recently taken any other medicines.

Some medicines can affect the levels of Zafrila in your blood and make it less effective or cause side effects.

They include:
- medicines used to treat:
- epilepsy (eg phenytoin, barbiturates, primidone, carbamazepine, oxcarbazepine, topiramate, felbamate);
- tuberculosis (eg rifampicin);
- HIV infections and hepatitis C infection (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors such as ritonavir, nevirapine, efavirenz);
- fungal infections (griseofulvin, ketoconazole).
- medicine based on the herb St. John's wort.

Ask your doctor or pharmacist for advice before taking any medicine.

Taking Zafrila with food and drinks
During treatment with Zafrila, you should avoid consuming grapefruit juice, as it may increase the levels of Zafrila in your blood. This may increase the risk of side effects.

Laboratory researches
If you need laboratory blood tests, tell your doctor or laboratory staff that you are taking Zafrila, as Zafrila may affect the results of some laboratory tests.

Pregnancy, lactation and fertility
Do not take Zafrila if you are pregnant or breast-feeding.

Driving and using machines
No effects on the ability to drive and use machines have been observed in women using Zafrila.

Zafrila contains lactose.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Zafrila.

3. How to take Zafrila

Always take Zafrila exactly as your doctor has told you. If you are not sure, talk to your doctor or pharmacist.

For adults, the usual dose is one tablet a day.

The following statements apply to Zafrila unless your doctor tells you otherwise. Please follow these instructions, otherwise you will not achieve the full effect of Zafrila,

You can start treatment with Zafrila on any day of your natural cycle.

Adults: take one tablet each day, preferably at the same time with some liquid as needed. When one pack is finished, you must continue with the next without interruption. Continue to take the tablets on the days of menstrual bleeding.

There is no experience with Zafrila in patients with endometriosis lasting more than 15 months.

If you take more Zafrila than you should
No serious adverse effects have been reported as a result of taking too many Zafrila tablets at one time. However, if this happens to you, tell your doctor.

If you forget to take Zafrila or have vomiting or diarrhea
Zafrila is less effective if you miss a tablet. If you miss one or more tablets, take only one tablet as soon as you remember and then continue to take it at the usual time.

If you vomit or have severe diarrhea within 3-4 hours of taking Zafrila, there is a risk that the active substance in the tablet will not be taken by your body. The situation is almost the same as with a forgotten tablet. After vomiting or diarrhea within 3-4 hours of taking Zafrila, you should take another tablet as soon as possible.

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

If you stop taking Zafrila
If you stop taking Zafrila, the initial symptoms of endometriosis may return.

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

4. Possible side effects

Like all medicines, Zafrila can cause side effects, although not everybody gets them. These effects are more common during the first months after starting Zafrila and usually disappear with long-term use. You may also have changes in bleeding characteristics, such as light spotting, irregular bleeding or complete cessation of the cycle.

Common (affects between 1 and 10 in every 100 patients):
- weight gain;
- depressed mood, sleep problems, nervousness, loss of sexual desire or mood swings;
- headache or migraine;
- nausea, abdominal pain, flatulence, bloating or vomiting;
- acne or hair loss;
- back pains;
- chest discomfort, ovarian cysts or hot paroxysmal redness;
- uterine / vaginal bleeding, including lightly spotting extramenstrual bleeding;
How to store Zafrila

Keep out of reach of children.

Store in the original package in order to protect from light.

This medicinal product does not require any special storage conditions.

Do not use Zafrila after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month.

Do not throw away any medicines 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 package and additional information

What Zafrila contains

The active substance is: dienogest. Each tablet contains 2 mg of dienogest.

The other ingredients are: lactose monohydrate, maize starch, pregelatinised, microcrystalline cellulose, povidone K-25, crospovidone (type A), talc, magnesium stearate.

What Zafrila looks like and contents of the pack
Zafrila 2 mg tablets are white or off-white, round, flat tablets with bevelled edges engraved with “G 93” on one side and “RG” on the other, with a diameter of 7 mm.

28, 84 and 168 Zafrila 2 mg tablets are packed in green, PVC // A1 blisters, in a cardboard box. Not all pack sizes may be marketed.

 

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