VIDAGEST 2 mg Coated Tablet

Содержание инструкции

1. What is Dienogest Sandoz and what is it used for
2. What you need to know before you take Dienogest Sandoz
3. How to take Dienogest Sandoz
4. Possible side effects
5. How to store Dienogest Sandoz
6. Contents of the pack and other information

Dienogest Sandoz 2 mg tablets
Generic medicine

Read this leaflet carefully before you start taking this medicine as 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 they have the same symptoms as you, as it may 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 Dienogest Sandoz is and what it is used for
• 2. What you need to know before you take Dienogest Sandoz
• 3. How to take Dienogest Sandoz
• 4. Possible side effects
• 5. How to store Dienogest Sandoz
• 6. Contents of the pack and other information

1. What is Dienogest Sandoz and what is it used for

Dienogest Sandoz is a medicine for the treatment of endometriosis (painful symptoms due to displacement of the tissue lining the inside of the uterus). Dienogest Sandoz contains a hormone, the progestin dienogest.

2. What you need to know before you take Dienogest Sandoz

Do not take Dienogest Sandoz if:

• 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 “ Dienogest Sandoz and venous blood clots”
• 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 also “ Dienogest Sandoz and arterial blood clots”
• 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 unexplained vaginal bleeding
• you are allergicto dienogest or any of the other ingredients of this medicine ( seesection 6, and the end of section 2).

If any of these conditions occur for the first time during the use of dienogest, stop treatment immediately and consult your doctor.

Warnings and precautions
Talk to your doctor or pharmacist before taking Dienogest Sandoz
You should not use hormonal contraceptives in any form (tablet, patch, intrauterine system) while taking Dienogest Sandoz.
Dienogest is NOT a contraceptive. If you want to avoid pregnancy, you should use a condom or other non-hormonal contraceptive precautions.
In some situations you need to be particularly careful while using Dienogest Sandoz and, your doctor may need to examine you regularly. 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 Dienogest Sandoz
• you develop a liver diseaseduring the use of Dienogest Sandoz. Symptoms may include yellowing of the skin or eyes or itching all over the body. Tell your doctor even if these symptoms occurred during a previous pregnancy
• you have diabetesor have had it temporarily 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 Dienogest Sandoz.

During treatment with Dienogest Sandoz the possibility of pregnancy is reduced as dienogest may have an effect on ovulation.
In the event of a pregnancy occurring during the intake of Dienogest Sandoz there is a slight increase in the riskof ectopic pregnancy (the embryo develops outside the uterus). Tell your doctor before taking Dienogest Sandoz if you have had an ectopic pregnancy in the past or if you have reduced function of the fallopian tubes.

Dienogest and severe 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 dienogest. If the bleeding is heavy and continuous, this can lead to a decrease in 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 Dienogest Sandoz.

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

Dienogest and venous blood clots
Some studies suggest that there may be a slight, but not statistically significant, increase in the risk of a blood clot in the legs (venous thromboembolism)associated with the use of progestin-only preparations, such as dienogest. 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 Dienogest Sandoz, as treatment may need to be suspended. Your doctor will tell you when to restart taking Dienogest Sandoz. Generally this will be possible about 2 weeks after you have fully regained your mobility.

Dienogest and arterial blood clots
There is little evidence of an association between the use of progestin-only preparations, such as dienogest, 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 these preparations.
The risk of having an arterial blood clotincreases:

• if you smoke. It is strongly recommended to quit smoking during the use of Dienogest Sandoz, 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 Dienogest Sandoz

Stop taking Dienogest Sandoz and consult your doctor immediately if you notice any possible sign 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 an apparent 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

Dienogest and cancer
From the data currently available, it is not clear whether dienogest 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 regularly and you should contact your doctor if you feel any lump.
In women taking hormones, benign and, more rarely, malignant liver tumors have been observed in rare cases. Contact your doctor if you experience unusually severe stomach pain.

Dienogest and osteoporosis
Changes in bone mineral density (BMD)
The use of dienogest may affect the strength of bones in adolescents (aged 12 or under 18 years).
If you are under 18 years of age, your doctor will need to carefully evaluate the benefits and risks associated with the use of Dienogest Sandoz for you as a patient, taking into account possible risk factors for reduced bone mass (osteoporosis).
If you use dienogest, 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 mineral loss), your doctor will carefully evaluate the risks and benefits of treatment with Dienogest Sandoz, because dienogest has a moderate suppressive effect on the production of estrogens (another type of female hormone) by the body.

Other medicines and Dienogest Sandoz
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Always inform your doctor of any medicine or herbal product you are taking. Also, inform any doctor or dentist who prescribes you other medicines (or the pharmacist) that you are taking Dienogest Sandoz.
Some medicines can affect the levels of dienogest 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 preparations.

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

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

Laboratory tests
If you are to have a blood test, tell your doctor or laboratory staff that you are taking Dienogest Sandoz, as dienogest can affect the results of some tests.

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

Driving and using machines
No effects on the ability to drive or operate machinery have been observed in women taking dienogest.

Dienogest Sandoz contains lactose
If you have been diagnosed with intolerance to certain sugars, contact your doctor before taking this medicine.

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

3. How to take Dienogest Sandoz

Take this medicine always exactly as your doctor or pharmacist has told you. If you
have any doubts, ask your doctor or pharmacist.
For adults, the usual dose is 1 tablet a day.
The following instructions apply to dienogest, unless otherwise prescribed by your doctor. Follow these
instructions carefully, otherwise you may not benefit adequately from treatment with Dienogest Sandoz.
You can start treatment with Dienogest Sandoz on any day of your cycle.

Adults:take one tablet preferably at the same time each day, with the amount of liquid
needed. When you finish one pack, start the next without interruption. Continue to
take the tablets even during your menstrual period.
There is no experience in the treatment of patients with endometriosis with dienogest for periods longer than
15 months.

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

If you forget to take Dienogest Sandoz or if you suffer from vomiting or diarrhoea
The effectiveness of Dienogest Sandoz 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 to
take the tablet at the usual time.
In case of vomiting within 3-4 hours of taking Dienogest Sandoz, or in case of severe diarrhoea, it is
possible that the active substance of the tablet is not completely absorbed by your body.
The situation is comparable to that which occurs when you forget to take a tablet.
After vomiting or diarrhoea within 3-4 hours of taking Dienogest Sandoz, 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 Dienogest Sandoz
If you stop taking Dienogest Sandoz, the symptoms of endometriosis may return.

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 dienogest 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 increase
• 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

• 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
• 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 sensation 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 nodule or nodules in the breast
• swelling from fluid retention.

Additional side effects in adolescents(12 to less than 18 years): loss of bone density.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly through the national reporting system at, https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Dienogest Sandoz

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and the pack after
Exp. The expiry date refers to the last day of that month.
Store in the original package to protect the medicine from light.
Do not dispose of any medicine in waste water 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 Dienogest Sandoz contains
The active ingredient is dienogest. Each tablet contains 2 mg of dienogest.
The other ingredients are lactose monohydrate, corn starch, povidone K-30 and magnesium stearate
vegetable. See section 2 “Dienogest Sandoz contains lactose”.

Description of the appearance of Dienogest Sandoz and contents of the pack
Dienogest Sandoz 2 mg tablets are white, round and flat with a diameter of approximately 5 mm.
Dienogest Sandoz is available in PVC/PVDC/Alu blisters
Packs
Blisters: 28, 84 and 168 tablets
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Sandoz S.p.A., L.go U. Boccioni 1, 21040 Origgio (VA), Italy

Manufacturers
Laboratorios León Farma, S.A.
Calle La Vallina s/n. Polígono Industrial Navatejera Villaquilambre,
24008 León
Spain
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben
Germany

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Germany Verybel HEXAL
Italy Dienogest Sandoz
Czech Republic Dienogest Sandoz