Zafrilla

Package Leaflet: Information for the Patient

Zafrilla, 2 mg, tablets

Dienogest

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Zafrilla and what is it used for
• 2. Important information before taking Zafrilla
• 3. How to take Zafrilla
• 4. Possible side effects
• 5. How to store Zafrilla
• 6. Contents of the pack and other information

1. What is Zafrilla and what is it used for

Zafrilla is used to treat endometriosis (painful symptoms caused by abnormal placement of the uterine lining). Zafrilla contains a hormone, a progestogen called dienogest.

2. Important information before taking Zafrilla

When not to take Zafrilla

Do not take Zafrilla if:

• you have a blood clot (thromboembolic disease) in the veins. This can occur, for example, in the blood vessels of the legs (deep vein thrombosis) or lungs (pulmonary embolism). See also “Zafrilla and venous blood clots”below;
• you have or have had severe arterial disease, including cardiovascular disease, such as heart attack, stroke, or heart diseasecausing reduced blood flow (angina pectoris). See also “Zafrilla and arterial blood clots”below;
• you have diabetes with blood vessel damage;
• you have or have had severe liver disease (and liver function tests have not returned to normal). Symptoms of liver disease may include yellowing of the skin and (or) itching all over the body;
• you have or have had a benign or malignant liver tumor;
• you have or have had, or are suspected of having, a hormone-dependent malignant tumor, such as breast cancer or genital organ cancer;
• you have unexplained vaginal bleeding;
• you are hypersensitive (allergic) 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 while taking Zafrilla, stop taking it and consult a doctor immediately.

Warnings and precautions

Before starting Zafrilla, discuss it with your doctor or pharmacist. While taking Zafrilla, do not use hormonal contraceptives in any form (pill, patch, intrauterine system). Zafrilla is nota contraceptive. To prevent pregnancy, use condoms or other non-hormonal contraceptives. In some situations, you need to be extra careful when taking Zafrilla. Regular medical check-ups may be necessary. Tell your doctor if any of the following apply to you:

• if you have ever had a blood clot (venous thromboembolic disease) or a close family member has had a blood clot at a relatively young age;
• if a close family member has breast cancer;
• if you have ever had depression;
• if you have high blood pressure or develop high blood pressure while taking Zafrilla;
• if you develop liver disease while taking Zafrilla. Symptoms may include yellowing of the skin, eyes, or itching all over the body. Tell your doctor if you have had such symptoms during a previous pregnancy;
• if you have diabetes or had gestational diabetes during a previous pregnancy;
• if you have ever had chloasma (brown patches on the skin, especially on the face). In this case, avoid prolonged sun exposure or ultraviolet radiation;
• if you experience abdominal pain while taking Zafrilla.

While taking Zafrilla, the chance of becoming pregnant is reduced, as Zafrilla may affect ovulation. If you become pregnant while taking Zafrilla, there is a slightly increasedriskof ectopic pregnancy (the embryo develops outside the uterus). Before starting Zafrilla, tell your doctor if you have had an ectopic pregnancy or have tubal dysfunction.

Zafrilla and severe uterine bleeding

While taking Zafrilla, uterine bleeding may increase, for example, in women with a disease in which the uterine lining (endometrium) grows into the uterine muscle layer, known as adenomyosis or uterine fibroids, and sometimes uterine myomas. If the bleeding is heavy and prolonged, it may lead to a decrease in red blood cells (anemia), which can be severe in some cases. If you have anemia, discuss with your doctor whether to stop taking Zafrilla.

Zafrilla and changes in bleeding pattern

In most women treated with Zafrilla, changes in menstrual bleeding pattern occur (see section 4).

Zafrilla and venous blood clots

Some studies suggest that there may be a slightly increased risk of blood clots in the legs (venous thromboembolic disease)associated with the use of progestogen-containing medicines, such as Zafrilla. Very rarely, blood clots can cause severe, permanent disability or even death. The risk of venous blood clotincreases:

• with age;
• if you are overweight;
• if you or a close family member have had a blood clot in the leg (deep vein thrombosis), lung (pulmonary embolism), or other organ at a young age;
• if you are scheduled for surgery, have had a serious accident, or are immobilized for a long time. It is essential to tell your doctor about taking Zafrilla as soon as possible, as treatment may need to be stopped. Your doctor will tell you when you can restart Zafrilla. This is usually about two weeks after getting out of bed.

Zafrilla and arterial blood clots

There is limited evidence of a link between the use of progestogen-containing medicines, such as Zafrilla, and an increased risk of blood clots, for example, in the blood vessels of the heart (heart attack) or brain (stroke). In women with high blood pressure, the risk of stroke may be slightly increased by such medicines. The risk of arterial blood clotincreases:

• in women who smoke - it is strongly recommended to quit smoking when taking Zafrilla

Zafrilla, especially if you are over 35 years old;

• if you are overweight;
• if a close family member has had a heart attack or stroke at a young age;
• if you have high blood pressure.

Consult your doctor before taking Zafrilla.

Stop taking Zafrilla and contact your doctor immediately if you notice any possible signs of a blood clot, such as:

• severe pain and (or) swelling in one leg;
• sudden severe chest pain, which may also radiate to the left arm;
• sudden shortness of breath;
• sudden cough without an obvious cause;
• 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 feeling, or numbness in any part of the body.

Zafrilla and cancer

Currently available data do not clearly indicate whether Zafrilla increases the risk of breast cancer or not. Breast cancer has been observed slightly more frequently in women taking hormones compared to women not taking hormones, but it is not known if this is caused by the treatment. This may be due to the fact that women taking hormones are more frequently examined by a doctor, and more tumors are detected and detected earlier. The frequency of breast tumors becomes gradually lower after stopping hormonal treatment. Regular breast examination is important, and you should consult your doctor if you feel a lump. In rare cases, women taking hormones have reported benign liver tumors, and in even rarer cases, malignant liver tumors. You should consult your doctor if you experience severe abdominal pain.

Zafrilla and osteoporosis Bone Mineral Density (BMD) changes

Taking Zafrilla may affect bone strength in young people (12 to under 18 years old). If you are under 18 years old, your doctor will individually weigh the benefits and risks of taking Zafrilla, considering possible risk factors for bone loss (osteoporosis). If you take Zafrilla, you should ensure adequate calcium and vitamin D intake from your diet or supplements for bone health. If you are at increased risk of osteoporosis (bone weakness due to loss of bone mineral substances), your doctor will carefully weigh the benefits and risks of Zafrilla treatment, as Zafrilla has a moderate estrogen-suppressing effect.

Children and adolescents

Zafrilla should not be used in girls before their first menstrual period. Taking Zafrilla may affect bone strength in young people (12 to under 18 years old). Therefore, if you are under 18 years old, your doctor will individually weigh the benefits and risks of taking Zafrilla, considering possible risk factors for bone loss (osteoporosis).

Zafrilla and other medicines

Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take. You should also tell any other doctor or dentist prescribing another medicine (or pharmacist) that you are taking Zafrilla. Some medicines may affect the level of Zafrilla in your blood and reduce its effectiveness or cause side effects. These include:

• medicines used for:
• epilepsy(e.g., phenytoin, barbiturates, primidone, carbamazepine, oxcarbazepine, topiramate, felbamate);
• tuberculosis(e.g., rifampicin);
• HIV and hepatitis C infections(protease inhibitors and non-nucleoside reverse transcriptase inhibitors, such as ritonavir, nevirapine, efavirenz);
• fungal infections(griseofulvin, ketoconazole).
• St. John's Wort (Hypericum perforatum);

Before taking any medicine, consult your doctor or pharmacist.

Zafrilla with food and drink

While taking Zafrilla, you should avoid drinking grapefruit juice, as it may increase the level of Zafrilla in your blood, which may increase the risk of side effects.

Lab tests

If you need to have a blood test, tell your doctor or laboratory staff that you are taking Zafrilla, as Zafrilla may affect the results of some tests.

Pregnancy, breastfeeding, and fertility

Zafrilla should not be used during pregnancy or breastfeeding.

Driving and using machines

No effect on the ability to drive and use machines has been observed in people taking Zafrilla.

Zafrilla contains lactose.

If you have been diagnosed with intolerance to some sugars, consult your doctor before taking this medicine.

3. How to take Zafrilla

This medicine should always be taken exactly as directed by your doctor. If you are unsure, consult your doctor or pharmacist. The usual dose for adults is one tablet per day. The following information is about how to take Zafrilla when your doctor has not prescribed otherwise. You should follow the instructions below, as otherwise, you will not get the full benefit of Zafrilla. Treatment with Zafrilla can be started on any day of the natural cycle. Adults: Take one tablet daily, preferably at the same time, with a small amount of liquid if necessary. After finishing one pack, start the next one without a break. Continue taking tablets during menstrual bleeding days.

Taking more than the recommended dose of Zafrilla

There are no reports of serious harmful effects after taking more than the recommended dose of Zafrilla. However, if you are unsure, consult your doctor.

Missing a dose of Zafrilla or experiencing vomiting or diarrhea

The effect of Zafrilla will be less if you miss a dose. If you miss one or more tablets, take only one tablet as soon as possible and continue with the next tablet at the usual time the next day. If you vomit within 3-4 hours of taking Zafrilla or experience severe diarrhea, there is a risk that the active substance will not be absorbed into your body. These situations are similar to missing a dose. After vomiting or diarrhea within 3-4 hours of taking Zafrilla, take the next tablet as soon as possible. Do not take a double dose to make up for a missed tablet.

Stopping Zafrilla

If you stop taking Zafrilla, your previous endometriosis symptoms may return. If you have any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Zafrilla can cause side effects, although not everybody gets them. Such effects are more common during the first few months after starting Zafrilla and usually disappear with continued treatment. Changes in bleeding pattern, such as spotting, irregular bleeding, or absence of menstruation, may also occur. Common(occurring in up to 1 in 10 patients)

• weight gain;
• low mood, sleep disturbances, nervousness, loss of interest in sex, or mood changes;
• headache or migraine;
• nausea, abdominal pain, gas, bloating, or vomiting;
• acne or hair loss;
• back pain;
• breast discomfort, ovarian cyst, or hot flashes;
• uterine or vaginal bleeding, including spotting;
• weakness or irritability.

Uncommon(occurring in up to 1 in 100 patients)

• anemia;
• weight loss or increased appetite;
• anxiety, depression, or sudden mood changes;
• autonomic nervous system imbalance (controls unconscious body functions, e.g., sweating) or attention disturbances;
• dry eye;
• tinnitus;
• non-specific circulatory disorders or palpitations;
• low blood pressure;
• shortness of breath;
• diarrhea, constipation, abdominal discomfort, gastroenteritis, or gingivitis;
• dry skin, excessive sweating, severe itching all over the body, hirsutism, nail brittleness, dandruff, skin inflammation, abnormal hair growth, photosensitivity, or pigmentation disorders;
• bone pain, muscle cramps, pain, or feeling of heaviness in the arms or legs;
• urinary tract infection;
• vaginal thrush, vaginal dryness, discharge, pelvic pain, or breast lump;
• edema due to fluid retention.

Additional side effects in adolescents (12 to under 18 years old): bone density loss.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. You can report side effects directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl. You can also report side effects to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Zafrilla

Keep the medicine out of the sight and reach of children. Store in the original package to protect from light. There are no special storage temperature recommendations for this medicine. Do not use this medicine after the expiry date stated on the package after “EXP”. The expiry date refers to the last day of the month. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Zafrilla contains

The active substance is dienogest. Each tablet contains 2 mg of dienogest. The other ingredients are lactose monohydrate, maize starch, microcrystalline cellulose, povidone K-25, crospovidone (type A), talc, magnesium stearate.

What Zafrilla looks like and contents of the pack

Zafrilla, 2 mg, is a white or almost white, round, flat tablet with beveled edges, with the inscription G93 on one side and RG on the other. The tablet diameter is 7 mm. Green PVC/Aluminum blisters with the days of the week marked, in a cardboard box containing 28, 84, or 168 tablets. Not all pack sizes may be marketed.

Marketing authorization holder:

GEDEON RICHTER POLSKA Sp. z o.o., ul. Ks. J. Poniatowskiego 5, 05-825 Grodzisk Mazowiecki

Manufacturer:

Gedeon Richter Plc., Gyömrői út 19-21, 1103 Budapest, Hungary. For more information on this medicine and its names in other EU member states, contact GEDEON RICHTER POLSKA Sp. z o.o., Medical Department, ul. Ks. J. Poniatowskiego 5, 05-825 Grodzisk Mazowiecki, Tel.: +48 (22) 755 96 48, [email protected], fax: +48 (22) 755 96 24

Date of last revision of the leaflet: April 2021

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