Vidagest: detailed information

Package leaflet: Information for the patient

Dienogest Sandoz 2 mg tablets
Equivalent medicine
Please read all of 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 other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Dienogest Sandoz is and what it is used for
What you need to know before taking Dienogest Sandoz
How to take Dienogest Sandoz
Possible side effects
How to store Dienogest Sandoz
Contents of the pack and other information

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

Dienogest Sandoz is a medication used to treat endometriosis (painful symptoms caused by
displacement of the tissue lining the inside of the uterus). Dienogest Sandoz contains a hormone called the
progestin dienogest.

2. What you need to know before taking Dienogest Sandoz

Do not take Dienogest Sandoz if:

you have a blood clot in a vein (thromboembolic disorder). This may occur, for example, in a blood vessel of the legs (deep vein thrombosis) or lungs (pulmonary embolism). See also “Dienogest Sandoz and venous blood clots”
you have or have ever had a severe arterial disease, including cardiovascular disease such as heart attack or stroke, or heart disease causing reduced blood supply (angina pectoris). See also “Dienogest Sandoz and arterial blood clots”
you have diabetes with vascular complications
you have or have ever had a severe liver disease (and liver function values have not returned to normal). Symptoms of liver disease may include yellowing of the skin and/or generalized itching
you have or have ever had a benign or malignant liver tumour
you have or have ever had, or suspect you may have, a malignant tumour dependent on sex hormones, such as breast or genital organ cancer
you have unexplained vaginal bleeding
you are allergic to dienogest or any of the other ingredients of this medicine (see section 6 and the end of section 2).

If any of these conditions occur for the first time while you are taking dienogest, stop treatment
immediately and consult your doctor.
Warnings and precautions
Talk to your doctor or pharmacist before taking Dienogest Sandoz.
You must not use hormonal contraceptives in any form (tablet, patch, intrauterine system)
while taking Dienogest Sandoz.
Dienogest is not a contraceptive. If you wish to avoid pregnancy, you must use a condom or
other non-hormonal contraceptive methods.
In certain situations, you should be particularly cautious while using Dienogest Sandoz, and
your doctor may need to examine you regularly. Inform your doctor if any of the following
conditions apply to you.
If:

you have ever had a blood clot (venous thromboembolism), or if a close relative has had a blood clot at a relatively young age
a close relative has had breast cancer
you have ever suffered from depression
you have high blood pressure or this develops during treatment with Dienogest Sandoz
you develop liver disease while taking Dienogest Sandoz. Symptoms may include yellowing of the skin or eyes or generalized itching. Inform your doctor even if these symptoms occurred during a previous pregnancy
you have diabetes or had it temporarily during a previous pregnancy
you have ever had chloasma (patchy brown skin pigmentation, especially on the face). In this case, avoid excessive exposure to sunlight or ultraviolet rays
you experience lower abdominal pain while taking Dienogest Sandoz.

During treatment with Dienogest Sandoz, the possibility of pregnancy is reduced because
dienogest may affect ovulation.
If pregnancy occurs while taking Dienogest Sandoz, there is a slight increase in the risk of
ectopic pregnancy (the embryo develops outside the uterus). Inform your doctor before taking
Dienogest Sandoz if you have previously had an ectopic pregnancy or if you have reduced
function of the Fallopian tubes.
Dienogest and severe uterine bleeding
Uterine bleeding, for example in women with a condition characterized by growth of the uterine
lining (endometrium) into the muscular layer of the uterus, called adenomyosis, or benign uterine tumours, also known as uterine fibroids (uterine leiomyomas), may worsen with the use of dienogest. If bleeding is heavy and persistent, this may lead to a decrease in red blood cell levels (anaemia), which may in some cases be severe. If you develop anaemia, you and your doctor should consider 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 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 progestogen-only preparations such as dienogest. Very rarely, blood clots can cause serious permanent damage or may even be fatal.
The risk of developing a venous blood clot increases:

with increasing age
if you are overweight
if you or a close relative has had a blood clot in the leg (thrombosis), lung (pulmonary embolism), or other organ at a young age
if you are undergoing 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 stopped. Your doctor will tell you when to restart taking Dienogest Sandoz. This is generally possible about 2 weeks after you have regained full mobility.

Dienogest and arterial blood clots
There is limited evidence of an association between the use of progestogen-only preparations such as dienogest and an increased risk of arterial blood clots, for example in blood vessels of the heart (heart attack) or brain (stroke). In women with hypertension, the risk of stroke may be slightly increased by using these preparations.
The risk of developing an arterial blood clot increases:

if you smoke. It is strongly recommended that you stop smoking while taking Dienogest Sandoz, especially if you are over 35 years old
if you are overweight
if a close relative 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 contact your doctor immediately if you notice any possible signs of thrombosis, such as:

severe pain and/or swelling in one leg;
sudden and severe chest pain, possibly radiating to the left arm;
sudden shortness of breath;
sudden cough without apparent cause;
unusual, severe or prolonged headache, or worsening of migraine;
partial or complete 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
Based on currently available data, it is unclear whether dienogest increases or decreases the risk of
breast cancer. Breast cancer has been observed slightly more frequently in women using hormonal preparations compared to those who do not, but it is not known whether this is due to the treatment. For example, women using hormonal preparations may have more frequent medical check-ups, leading to earlier detection and diagnosis of tumours. The occurrence of breast cancer gradually decreases after stopping hormonal treatment. It is important that you regularly examine your breasts and contact your doctor if you feel any lumps.
In rare cases, benign liver tumours and, even more rarely, malignant liver tumours have been observed in women taking hormones. 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 bone strength in adolescents (aged 12 to under 18 years).
If you are under 18 years of age, your doctor must carefully evaluate the benefits and risks associated with using Dienogest Sandoz for you as a patient, considering possible risk factors for reduced bone mass (osteoporosis).
If you are taking dienogest, adequate intake of calcium and vitamin D through diet and/or supplements will help support bone health.
If you have an increased risk of osteoporosis (bone fragility due to mineral loss), your doctor will carefully assess the risks and benefits of treatment with Dienogest Sandoz, as dienogest has a moderate suppressive effect on the body's production of oestrogens (another type of female hormone).
Other medicines and Dienogest Sandoz
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Always inform your doctor of any medicines or herbal products you are taking. Also, inform any doctor or dentist who prescribes other medicines (or the pharmacist) that you are taking Dienogest Sandoz.
Some medicines may affect dienogest levels in the blood and may make it less effective or may cause side effects.
These include:

medicines used to treat:
- 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 (Hypericum perforatum) 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 because it may
increase dienogest levels in the blood. This may increase the risk of side effects.
Laboratory tests
If you need to have a blood test, inform your doctor or laboratory staff that you are taking
Dienogest Sandoz, as dienogest may affect the results of certain tests.
Pregnancy, breastfeeding and fertility
Do not take Dienogest Sandoz if you are pregnant or breastfeeding.
Driving and using machines
No effects on the ability to drive or use machines have been observed in users of
dienogest.
Dienogest Sandoz contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this
medicine.
Children and adolescents
Dienogest Sandoz must not be used in girls before menarche (first menstrual bleeding). The use of dienogest may affect bone strength in adolescents (aged 12 to under 18 years). If you are under 18 years of age, your doctor must carefully evaluate the benefits and risks associated with using Dienogest Sandoz for you as a patient, considering possible risk factors for reduced bone mass (osteoporosis).

3. How to take Dienogest Sandoz

Take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
For adults, the usual dose is 1 tablet per day.
The following instructions apply to dienogest, unless otherwise prescribed by your doctor. Follow these instructions carefully, otherwise you may not obtain the full benefit from treatment with Dienogest Sandoz.
You may start treatment with Dienogest Sandoz on any day of the cycle.
Adults: take one tablet every day, preferably at the same time each day, with a sufficient amount of liquid. When you finish one pack, start the next pack the following day without interruption. Continue taking the tablets even during menstrual bleeding days.
There is no experience with dienogest treatment in patients with endometriosis for periods longer than 15 months.
If you take more Dienogest Sandoz than you should
There have been no reports of serious harmful effects following the ingestion of an excessive number of dienogest tablets. However, if you are concerned, contact your doctor.
If you forget to take Dienogest Sandoz or experience 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 taking one tablet per day at your usual time.
If you vomit within 3–4 hours after taking Dienogest Sandoz, or if you have severe diarrhoea, the active substance in the tablet may not be completely absorbed by your body. This situation is comparable to missing a tablet.
After vomiting or severe diarrhoea within 3–4 hours of taking Dienogest Sandoz, you must take another tablet as soon as possible.
Do not take a double dose to make up for a forgotten tablet.
If you stop taking Dienogest Sandoz
If you stop taking Dienogest Sandoz, symptoms of endometriosis may return.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
These side effects most commonly occur during the first months of treatment with dienogest and usually resolve with continued use. Changes in bleeding patterns may also occur, such as spotting, irregular bleeding, or cessation of menstruation.

Common: may affect up to 1 in 10 people

weight gain
depressed mood, sleep disturbances, nervousness, loss of interest in sex, mood changes
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

anaemia
weight loss or increased appetite
anxiety, depression, or mood swings
autonomic nervous system imbalance (which controls unconscious bodily functions such as sweating) or attention disorders
dry eyes
tinnitus
non-specific circulatory problems or uncommon palpitations
low blood pressure
shortness of breath
diarrhoea, constipation, abdominal discomfort, inflammation of the stomach and intestine (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, photosensitivity, or skin pigmentation problems
bone pain, muscle spasms, pain and/or heaviness in arms, hands, legs, or feet
urinary tract infection
vaginal candidiasis, genital dryness, vaginal discharge, pelvic pain, atrophic inflammation of the genital organs with discharge (atrophic vulvovaginitis), or breast lump(s)
fluid retention-related swelling

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

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You can also report side effects directly via 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 carton after
Exp. The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from light.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Dienogest Sandoz contains
The active substance is dienogest. Each tablet contains 2 mg of dienogest.
The other components are monohydrate lactose, maize starch, povidone K-30 and vegetable magnesium stearate.
See section 2 “Dienogest Sandoz contains lactose”.

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

Marketing Authorization 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 authorized in the Member States of the European Economic Area under the following names:
Germany Verybel HEXAL
Italy Dienogest Sandoz
Czech Republic Dienogest Sandoz