ZAFRILLA 2 mg Coated Tablet

Содержание инструкции

1. Zafrilla 2 mg tablets
   1. What is Zafrilla and what is it used for?
   2. What you need to know 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

Zafrilla 2 mg tablets

Dienogest
Generic medicine

Read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Zafrilla is and what it is used for
• 2. What you need to know before you take 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 a preparation for the treatment of endometriosis (painful symptoms due to displacement of the internal lining tissue of the uterus). Zafrilla contains a hormone, the progestin dienogest.

2. What you need to know before taking Zafrilla

Do not take Zafrilla

• you have a blood clotin the veins (thromboembolic disorder). This can occur, for example, in a blood vessel in the legs (deep vein thrombosis) or in the lungs (pulmonary embolism). See also “ Zafrillaand venous blood clots” below;
• you have or have ever had a serious arterial disease, including cardiovascular disease such as a heart attackor a strokeor a heart conditionthat causes a reduction in blood supply (angina pectoris). See “ Zafrillaand arterial blood clots” below;
• you have diabeteswith vascular damage;
• you have or have ever had a serious liver disease(and liver function values have not returned to normal). Symptoms of liver disease may be yellowing of the skin and/or itching all over the body;
• you have or have ever had a benign or malignant liver tumor;
• you have or have ever had, or suspect you have, a malignanttumor dependent on sex hormones, such as breast cancer or cancer of the genital organs;
• you experience vaginal bleedingof unknown cause;
• 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 during the use of Zafrilla, stop treatment immediately and consult your doctor.

Warnings and precautions
Consult your doctor or pharmacist before taking Zafrilla.
You should not use hormonal contraceptives in any form (tablet, patch, intrauterine system) while taking Zafrilla.
Zafrilla is nota contraceptive. If you want to avoid pregnancy, you must use a condom or other non-hormonal contraceptive precautions.
In some situations you need to be particularly careful while using Zafrilla and you may need to be visited regularly by your doctor. Tell your doctor if any of the conditions listed below apply to you:
if:

• you have ever had a blood clot(thromboembolism) or if one of your close relatives has had a blood clot at a relatively young age;
• you have a close relative who has had breast cancer;
• you have ever suffered from depression;
• you have high blood pressureor this condition occurs during the use of Zafrilla;
• you develop a liver diseaseduring the use of Zafrilla. Symptoms may include yellowing of the skin or eyes or itching all over the body. Also inform your doctor if these symptoms occurred during a previous pregnancy;
• you have diabetesor had it during a previous pregnancy;
• you have ever had chloasma(patchy brown pigmentation of the skin, especially on the face). If so, avoid excessive exposure to the sun or ultraviolet rays;
• you suffer from lower abdominal painduring the use of Zafrilla.

During treatment with Zafrilla, the possibility of pregnancy is reduced as Zafrilla may have an effect on ovulation.
If a pregnancy occurs during the intake of Zafrilla there is a slight increase in the riskof ectopic pregnancy (the embryo develops outside the uterus). Inform your doctor before taking Zafrilla if you have had an ectopic pregnancy in the past or if you have reduced function of the fallopian tubes.

Zafrilla and heavy uterine bleeding
Uterine bleeding, for example in women with a disease characterized by the growth of the uterine lining (endometrium) within the muscle layer of the uterus, called internal endometriosis, or benign uterine tumors, also called uterine fibroids (uterine leiomyomas), may worsen with the use of Zafrilla. If the bleeding is heavy and continuous, this can lead to a lowering of red blood cell levels (anemia), which can be severe in some cases. In case of anemia, you should discuss with your doctor whether to discontinue treatment with Zafrilla.

Zafrilla and changes in bleeding pattern
Most women treated with Zafrilla experience changes in their menstrual bleeding pattern (see section 4, “Possible side effects”).

Zafrilla and venous blood clots
Some studies suggest that there may be a slight, but not statistically significant, increased risk of a blood clot in the legs (venous thromboembolism)associated with the use of progestin-only preparations, such as Zafrilla. Very rarely, blood clots can cause serious permanent damage or can even be fatal.
The risk of having a venous blood clotincreases:

• with increasing age;
• if you are overweight;
• if you or one of your close relatives has had a blood clot in the leg (thrombosis), in the lung (pulmonary embolism), or in other organs at a young age;
• if you are to undergo surgery, prolonged bed rest, or have had a serious accident. It is important to inform your doctor in advance that you are taking Zafrilla, as it may be necessary to stop treatment. Your doctor will tell you when to resume taking Zafrilla. Generally this will be possible about 2 weeks after you have fully regained your mobility.

Zafrilla and arterial blood clots
There is little evidence of an association between the use of progestin-only preparations, such as Zafrilla, and an increased risk of a blood clot, 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 the use of progestin-only preparations.
The risk of having an arterial blood clotincreases:

• if you smoke. It is strongly recommended that you quit smoking while using Zafrilla, especially if you are over 35 years old;
• if you are overweight;
• if one of your close relatives has had a heart attack or stroke at a young age;
• if you have high blood pressure.

Talk to your doctor before taking Zafrilla Stop taking Zafrilla and consult your doctor immediately if you notice any possible signs of thrombosis, such as:

• severe pain and/or swelling in a leg;
• sudden and severe chest pain, which may radiate to the left arm;
• sudden shortness of breath;
• sudden cough without a known cause;
• unusual, severe or prolonged headache or worsening of migraine;
• partial or total loss of vision or double vision;
• difficulty or inability to speak;
• dizziness or fainting;
• weakness, unusual sensations or numbness in any part of the body.

Zafrilla and cancer
From the currently available data, it is not clear whether Zafrilla increases or decreases the risk of breast cancer. Breast cancer has been observed with a slightly higher frequency in women who use hormonal preparations compared to those who do not use them, but it is not known whether this is due to the treatment. For example, it is possible that, in women who use hormonal preparations, more tumors are diagnosed, and earlier, because they undergo more frequent medical check-ups. The occurrence of breast cancer decreases gradually after discontinuation of hormonal treatment. It is important that you check your breasts regularlyand you should contact your doctor if you feel any lump.
In women taking hormones, benign liver tumors and, more rarely, malignant liver tumors have been observed. Contact your doctor if you experience unusually severe stomach pain.

Zafrilla and osteoporosis
Changes in bone mineral density (BMD)
The use of Zafrilla may affect the robustness of the bones in adolescents (12 years and under 18 years). If you are under 18 years of age, your doctor will carefully assess the benefits and risks associated with the use of Zafrilla for you as a patient, taking into account possible risk factors for reduced bone mass (osteoporosis).
If you use Zafrilla, adequate intake of calcium and vitamin D through diet and supplements will be helpful for your bones.
If you have an increased risk of osteoporosis (fragile bones due to loss of minerals), your doctor will carefully assess the risks and benefits of treatment with Zafrilla, as the medicine has a moderate suppressive effect on the production of estrogens (another type of female hormone) by the body.

Children and adolescents
Zafrilla should not be used in girls before menarche (first menstrual bleeding).
The use of Zafrilla may affect the robustness of the bones in adolescents (12 years and under 18 years). If you are under 18 years of age, your doctor will carefully assess the benefits and risks associated with the use of Zafrilla for you as a patient, taking into account possible risk factors for reduced bone mass (osteoporosis).

Other medicines and Zafrilla
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Some medicines can affect the levels of Zafrilla in the blood and can make it less effective or can cause unwanted effects.
These include:

• medicines used for the treatment of:
• epilepsy(e.g. phenytoin, barbiturates, primidone, carbamazepine, oxcarbazepine, topiramate, felbamate);
• tuberculosis(e.g. rifampicin);
• HIV and Hepatitis C virus infection(known as protease inhibitors and non-nucleoside reverse transcriptase inhibitors such as ritonavir, nevirapine, efavirenz);
• other fungal infections(griseofulvin, ketoconazole).
• St. John's Wort-containing preparations.

Ask your doctor or pharmacist before taking any medicine.

Zafrilla with food and drink
During treatment with Zafrilla you should avoid drinking grapefruit juice as it can increase the levels of Zafrilla in the blood. This may increase the risk of side effects.

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

Pregnancy, breastfeeding and fertility
Do not take Zafrilla if you are pregnant or if you are breastfeeding.

Driving and operating machinery
No effects on the ability to drive or operate machinery have been observed in women taking Zafrilla.

Zafrilla contains lactose
If your doctor has diagnosed you with lactose intolerance, contact him before taking this medicine.

3. How to take Zafrilla

Take this medicine following the instructions of your doctor exactly. If you have any doubts, consult your
doctor or pharmacist.
For adults, the usual dose is 1 tablet a day.
The following instructions apply to Zafrilla, unless otherwise prescribed by your doctor. Follow these
instructions carefully, otherwise you may not benefit adequately from treatment with Zafrilla.
You can start treatment with Zafrilla on any day of your cycle.
Adults: take one tablet preferably at the same time each day, with the amount of liquid
necessary. When you finish one pack, you should start the next without interruption. Continue to
take the tablets even during your menstrual period.
There is no experience in treating patients with endometriosis with Zafrilla for periods longer than 15
months.

If you take more Zafrilla than you should
There are no reports of serious adverse effects following the intake of an excessive number of
Zafrilla tablets at once. However, if you are concerned, contact your doctor.

If you forget to take Zafrilla or suffer from vomiting or diarrhea
The effectiveness of Zafrilla is reduced if you miss a tablet. If you forget to take one or more tablets,
take one tablet as soon as you remember and then continue the next day taking the
tablet at the usual time.
In case of vomiting within 3-4 hours of taking Zafrilla, or in case of severe diarrhea, it is possible that the
active ingredient of the tablet is not completely absorbed by your body. The situation is
comparable to what happens when you forget to take a tablet. After vomiting or
diarrhea within 3-4 hours of taking Zafrilla, you should take another tablet as soon as
possible.
Do not take a double dose to make up for a missed tablet.

If you stop taking Zafrilla
If you stop taking Zafrilla, the symptoms of endometriosis may recur.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
These effects are most common during the first few months of treatment with
Zafrilla and usually disappear with continued use. Changes in bleeding patterns may also occur, such as spotting, irregular bleeding or cessation of the menstrual cycle.

Common(may affect up to 1 in 10 people)

• weight gain;
• depressed mood, sleep disorders, nervousness, loss of interest in sex, mood swings;
• headache or migraine;
• nausea, abdominal pain, flatulence, abdominal bloating or vomiting;
• acne or hair loss;
• back pain;
• breast discomfort, ovarian cyst or hot flushes;
• uterine/vaginal bleeding, including spotting;
• weakness, irritability.

Uncommon(may affect up to 1 in 100 people)

• low number of red blood cells in the blood (anemia);
• weight loss or increased appetite;
• anxiety, depression or mood swings;
• imbalance of the autonomic nervous system (which controls unconscious bodily functions such as sweating) or attention disorders;
• dry eyes;
• ringing in the ears (tinnitus);
• non-specific circulatory problems or unusual palpitations;
• low blood pressure;
• shortness of breath;
• diarrhea, constipation, abdominal discomfort, inflammation of the stomach and intestines (gastrointestinal inflammation), inflammation of the gums (gingivitis);
• dry skin, excessive sweating, intense itching all over the body, appearance of visible hair in typically male areas (hirsutism), brittle nails, dandruff, dermatitis, abnormal hair growth, hypersensitivity to light or skin pigmentation problems;
• bone pain, muscle spasms, pain and/or feeling of heaviness in the arms, hands or legs and feet;
• urinary tract infection;
• vaginal candidiasis, vaginal dryness, vaginal discharge, pelvic pain, atrophic inflammation of the genitals with discharge (atrophic vulvovaginitis) or lump or lumps in the breast;
• swelling due to fluid retention.

Further side effects in adolescents (12 years and under 18 years): loss of bone density.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system at http://www.agenziafarmaco.gov.it/content/come-segnalare-una-
sospetta-reazione-avversa .
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Zafrilla

Keep this medicine out of the sight and reach of children.
Store in the original packaging to protect the medicine from light.
This medicine does not require any particular storage temperature
Do not use this medicine after the expiry date which is reported on the internal packaging and on the
blister after SCAD. The expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

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

Description of the appearance of Zafrilla and contents of the pack
Zafrilla 2 mg tablets are white to almost white, round, flat tablets, with bevelled edges,
with “G 93” imprinted on one side and “RG” on the other. The diameter of the tablets is 7 mm.
28, 84, 168 of Zafrilla 2 mg tablets are packaged in rigid green PVC/Aluminum blisters in
folded cardboard boxes.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer
Gedeon Richter Plc.
Gyömrői út 19-21
1103 Budapest
Hungary

This medicinal product is authorised in the Member States of the European Economic Area with
the following denominations:
Austria: Zafrilla 2 mg Tabletten
Belgium: Zafrilla 2 mg comprimés/tabletten/Tabletten
Bulgaria: Zafrilla,
Cyprus: Zafrilla,
Czech Republic: Zafrilla
Denmark: Zafrilla,
Estonia: SAWIS
Finland: Sawis
France: SAWIS 2 mg, comprimé
Germany: Zafrilla 2 mg Tabletten, Sawis 2 mg Tabletten
Greece: Zafrilla, Sawis
Croatia: ZAFRILLA 2 mg tablete,. SAWIS 2 mg tablete
Hungary: ZAFRILLA 2 mg tabletta,. SAWIS 2 mg tabletta
Ireland: Zafrilla, Sawis
Italy Zafrilla
Latvia Sawis 2 mg tabletes
Lithuania SAWIS 2 mg tabletės
Luxembourg. Zafrilla, Sawis
Malta Zafrilla, Sawis
Netherlands Zafrilla 2 mg tabletten
Poland: Zafrilla
Portugal; Zafrilla
Romania ZAFRILLA 2 mg comprimate
Slovakia ZAFRILLA 2 mg tablety, SAWIS 2 mg tablety
Slovenia: KLAAR 2 mg tablete, MINOSTA 2 mg tablete,
DIENOGEST RICHTER 2 mg tablete
Spain Zafrilla, Sawis
Sweden Sawis
United Kingdom Sawis