DIENOGEST ADALVO 2 mg TABLETS

Introduction

Package Leaflet: Information for the User

Dienogest Adalvo 2 mg film-coated tablets EFG

dienogest

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

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the package leaflet

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

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

Dienogest Adalvo is a medicine for the treatment of endometriosis (painful symptoms due to the presence of uterine wall tissue located outside its normal place).

This medicine contains a hormone, the progestogen dienogest.

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

Do not take Dienogest Adalvo:

• if you are allergic to dienogest or any of the other ingredients of this medicine (listed in section 6).
• if you have a blood clot (thromboembolism) in the veins. This can happen, for example, in the blood vessels of the legs (deep vein thrombosis) or the lungs (pulmonary embolism). See also the section on Dienogest Adalvo and blood clots that follows.
• if you have or have ever had a severe arterial disease, which includes cardiovascular disease, such as a heart attack, stroke, or heart disease that causes a reduction in blood supply (angina pectoris). See also the section on Dienogest Adalvo and arterial blood clots that follows.
• if you have diabetes with blood vessel damage.
• if you have or have ever had a severe liver disease (and liver enzyme values have not yet returned to normal). Symptoms of liver disease may include yellowing of the skin or itching all over the body.
• if you have or have ever had a malignant or benign liver tumor.
• if you have, have ever had, or are suspected of having a hormone-dependent malignant tumor, such as breast cancer or genital cancer.
• if you experience unexplained vaginal bleeding.

If any of these conditions appear for the first time while taking this medicine, stop taking it immediately and inform your doctor.

Warnings and precautions

You must not use hormonal contraceptives of any kind (pill, patch, intrauterine device, etc.) while taking this medicine.

This medicine is NOT a contraceptive. If you want to avoid getting pregnant, you must use condoms or other non-hormonal contraceptive methods.

In some cases, it may be necessary to take special precautions while taking this medicine, and your doctor may need to monitor you periodically. If you have any of the following conditions, inform your doctor:

• If you have ever had a blood clot (venous thromboembolism) or a close relative has had a blood clot at a relatively young age.
• If you have a close relative who has had breast cancer.
• If you have ever had depression.
• If you have high blood pressure or experience high blood pressure while taking this medicine.
• If you have liver disease while taking this medicine. Symptoms may include yellowing of the skin or eyes or itching all over the body. Inform your doctor if any of these symptoms also appeared in a previous pregnancy.
• If you have diabetes or have had temporary diabetes in a previous pregnancy.
• If you have ever had chloasma (brown pigmented patches on the skin, especially on the face); if so, avoid excessive sun exposure or ultraviolet radiation.
• If you experience lower abdominal pain while taking this medicine.

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

If you become pregnant while taking this medicine, you have a slightly increased riskof having an ectopic pregnancy (the embryo develops outside the uterus). Consult your doctor before starting Dienogest Adalvo, if you have had an ectopic pregnancy in the past or if you have a fallopian tube function disorder.

Dienogest Adalvo and severe uterine bleeding

Uterine bleeding may worsen with the use of this medicine, for example, in women who have a condition in which the uterine mucosa (endometrium) grows into the muscular layer of the uterus, known as uterine adenomyosisor benign uterine tumors, sometimes also called uterine fibroids(uterine leiomyomas). If the bleeding is intense and prolonged, it can cause low red blood cell counts (anemia) that can be severe in some cases. If you have anemia, you should consult your doctor about whether you should stop taking this medicine.

Dienogest Adalvo and changes in bleeding pattern

Most women treated with this medicine experience changes in menstrual bleeding pattern (see section 4).

Dienogest Adalvo and blood clots

Some studies indicate that there may be a slight increase in the risk of blood clots in the legs (venous thromboembolism)related to the use of progestogen-containing medicines like Dienogest Adalvo, although this risk is not statistically significant. In very rare cases, blood clots can cause severe permanent disability or even be fatal.

The risk of venous blood clotsincreases:

• With age.
• If you are overweight.
• If you or a close relative have had a blood clot in the legs (thrombosis), lungs (pulmonary embolism), or other organ at a young age.
• If you need to have surgery, have had a serious accident, or need to be immobilized for a prolonged period. It is important that you inform your doctor in advance that you are using this medicine, as treatment may need to be interrupted. Your doctor will tell you when you can start taking this medicine again. This usually happens about two weeks after regaining mobility.

Dienogest Adalvo and arterial blood clots

There is limited data on the relationship between progestogen-containing medicines, such as this medicine, and an increased risk of arterial blood clots, for example, in the heart (heart attack) or brain (stroke). In women with high blood pressure, these medicines may slightly increase the risk of stroke.

The risk of arterial blood clotsincreases:

• If you smoke. You are strongly advised to stop smoking while using this medicine, 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.

Consult your doctor before starting this medicine.

Stop taking this medicine and contact your doctor immediately, if you experience possible signs of a blood clot, such as:

• Severe pain or swelling in one leg.
• Sudden severe chest pain that may radiate to the left arm.
• Sudden difficulty breathing.
• Sudden unexplained cough.
• Any 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 sensation, or numbness in any part of the body.

Dienogest Adalvo and cancer

Based on currently available data, it is not clear whether this medicine increases or does not increase the risk of breast cancer. Breast cancer cases have been observed with slightly higher frequency in women using hormones than in those not taking them, but it is unknown whether this is due to treatment. For example, it could be that more tumors are detected and detected earlier in women taking hormones because they undergo more frequent medical check-ups. The incidence of breast cancer decreases gradually after stopping hormonal treatment. Regular breast examination is important, and you should contact your doctor as soon as possible if you notice any lump.

Rare cases of benign liver tumors (and even more rarely, malignant liver tumors) have been reported in women taking hormones. If you experience unusual severe abdominal pain, contact your doctor.

Dienogest Adalvo and osteoporosis

Changes in bone mineral density (BMD)

The use of this medicine may affect bone strength in adolescents (12 to less than 18 years old). Therefore, if you are under 18 years old, your doctor will carefully weigh the benefits and risks of using this medicine on an individual basis, considering potential risk factors for bone loss (osteoporosis).

If you use this medicine, it will help to have an adequate intake of calcium and vitamin D, both from food and dietary supplements.

If you are at higher risk of osteoporosis (weakening of bones due to mineral loss), your doctor will carefully weigh the risks and benefits of treatment with this medicine because this medicine has a moderate suppressive effect on estrogen production (another type of female hormone) in the body.

Other medicines and Dienogest Adalvo

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes herbal products and other medicines you have bought without a prescription.

Also, inform any other doctor or dentist prescribing you another medicine (or pharmacist) that you are taking Dienogest Adalvo.

Some medicines may affect the levels of Dienogest in your blood and make it less effective or cause side effects, including:

• Medicines used to treat:
• 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)
• Products containing St. John's Wort (Hypericum perforatum)

Consult your doctor or pharmacist before taking any medicine.

Taking Dienogest Adalvo with food and drinks

During treatment with this medicine, you should avoid consuming grapefruit juice, as it may increase the levels of Dienogest in your blood. This may increase the risk of side effects.

Lab tests

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

Pregnancy and breastfeeding

Do not take this medicine if you are pregnant or breastfeeding.

Driving and using machines

No effect on the ability to drive and use machines has been observed in users of this medicine.

Children and adolescents

The use of this medicine is not indicated in girls before menarche (first menstruation).

The use of Dienogest may affect bone strength in adolescents (12 to less than 18 years old).

Therefore, if you are under 18 years old, your doctor will carefully weigh the benefits and risks of using this medicine on an individual basis, considering potential risk factors for bone loss (osteoporosis).

Dienogest Adalvo contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

3. How to take Dienogest Adalvo

Follow the instructions for administration of this medicine exactly as prescribed by your doctor. If you are unsure, consult your doctor or pharmacist again.

In adults, the usual dose is 1 tablet per day.

The following statements apply to this medicine unless your doctor prescribes otherwise. Follow these instructions. If not, you will not benefit fully from treatment with this medicine.

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

Adults: Take one tablet every day, preferably at the same time, with some liquid if necessary. When you finish one pack, start the next one without interruption. Continue taking the tablets even on days of menstrual bleeding.

If you take more Dienogest Adalvo than you should

No serious harmful effects have been reported from taking too many tablets of this medicine at the same time. However, if you are concerned, contact your doctor.

In case of overdose or accidental ingestion, contact your doctor or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Dienogest Adalvo or suffer from vomiting or diarrhea

This medicine will be less effective if you miss a tablet. If you forget to take one or more tablets, take only one tablet as soon as you remember and then continue the next day taking the tablet at the usual time.

If you vomit within 3-4 hours after taking this medicine or experience severe diarrhea, there is a risk that the body has not absorbed the active substance contained in the tablet. This situation is very similar to missing a tablet. After vomiting or diarrhea within 3-4 hours after taking this medicine, you should take another tablet as soon as possible.

Do not take a double dose to make up for missed doses.

If you stop taking Dienogest Adalvo

If you stop taking this medicine, your original symptoms of endometriosis may return.

If you have any other questions 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. The effects are more frequent in the first few months after starting this medicine and usually disappear with continued use. You may also experience changes in your bleeding pattern, for example, spotting or irregular bleeding, or your menstruation may stop completely.

Common(may affect up to 1 in 10 people)

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

Uncommon(may affect up to 1 in 100 people)

• anemia
• weight loss or increased appetite
• anxiety, depression, or mood changes
• autonomic nervous system imbalance (which controls unconscious body functions, such as sweating) or attention disorders
• dry eye
• tinnitus
• non-specific circulatory problems or infrequent palpitations
• low blood pressure
• shortness of breath
• diarrhea, constipation, abdominal discomfort, gastrointestinal inflammation, gingivitis
• dry skin, excessive sweating, intense itching all over the body, male-type hair growth (hirsutism), nail fragility, dandruff, dermatitis, abnormal hair growth, photosensitivity, or skin pigmentation problems
• bone pain, muscle spasms, pain or heaviness in the arms and hands or legs and feet
• urinary tract infection
• candidiasis (vaginal yeast infection), genital dryness, vaginal discharge, pelvic pain, atrophic vulvovaginitis, or breast lump
• fluid retention

Additional side effects in adolescents (12 to less than 18 years old):

• loss of bone density

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Dienogest Adalvo

Keep this medicine out of the sight and reach of children.

Store in the original packaging to protect it from light.

Do not use this medicine after the expiration date that appears on the packaging after «EXP». The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the pharmacy's SIGRE Point. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Dienogest Adalvo

• The active ingredient is dienogest. Each tablet contains 2 mg of dienogest.
• The other excipients are lactose monohydrate, microcrystalline cellulose, potato starch, povidone (K-25), talc, crospovidone (type A), and magnesium stearate.

Appearance of the Product and Package Contents

Dienogest Adalvo are white to off-white, round tablets with flat faces, beveled edges, with the mark «NC» engraved on one face and «22» on the other, and a diameter of approximately 7 mm.

The tablets are packaged in green PVC/PVDC film and aluminum foil blisters containing 14 tablets each.

Each cardboard box contains 28, 84, or 168 tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder

Adalvo Limited

Malta Life Science Park,

Level 1, Building 4,

Sir Temi Zammit Buildings,

San Gwann, SGN 3000, Malta

Manufacturer

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park,

Paola PLA 3000, Malta

Date of the Last Revision of this Leaflet:October 2023

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/