Dimetrio 2 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Dimetrio 2 mg film-coated tablets EFG

dienogest

Read the entire leaflet carefully before starting to take this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Package leaflet contents

1. What Dimetrio is and what it is used for

2. What you need to know before taking Dimetrio

3. How to take Dimetrio

4. Possible side effects

5. Storage of Dimetrio

6. Contents of the container and additional information

1. What Dimetrio is and what it is used for

Dimetrio is a preparation used for the treatment of endometriosis (painful symptoms caused by atypical localization of uterine lining tissue). Dimetrio contains a hormone, the progestogen dienogest.

2. What you need to know before starting to take Dimetrio

Do not take Dimetrio:

• if you have a blood clot (thromboembolic disorder) in the veins. This may, for example, occur in blood vessels of the legs (deep vein thrombosis) or the lungs (pulmonary embolism). See further on “Dimetrio and blood clots in the veins”
• if you suffer or have ever suffered from a serious arterial disease, including cardiovascular disease, such as a heart attack, stroke, or heart disease causing reduced blood flow (e.g. angina pectoris). See further on “Dimetrio and blood clots in the arteries”
• if you have diabetes with blood vessel damage
• if you suffer or have ever suffered from a serious liver disease (and your liver function values have not returned to normal). Symptoms of liver disease may include yellowing of the skin and/or generalized itching
• if you suffer or have ever suffered from a benign or malignant liver tumor
• if you suffer or have ever suffered from, or it is suspected that you have, a malignant tumor dependent on sex hormones, such as breast cancer or genital organ cancer
• if you have vaginal bleeding of unknown cause
• if you are allergic to dienogest or to any of the other ingredients of this medicine (listed in section 6 and at the end of section 2).

If any of these conditions occurs for the first time while you are taking dienogest, stop taking it immediately and consult your doctor.

Warnings and precautions

Consult your doctor before starting to take dienogest.

You must not take any oral contraceptives (in tablet form, patch, or intrauterine system) while taking dienogest.

Dienogest is NOT a contraceptive. If you wish to prevent pregnancy, you must use condoms or other non-hormonal contraceptive methods.

In some cases, you should take special care while taking dienogest, and your doctor may need to examine you periodically. Inform your doctor if any of the following conditions affect you:

• if you have ever had a blood clot (venous thromboembolism) or if a close family member has had a blood clot at a relatively young age
• if a close family member has had breast cancer
• if you have ever had depression
• if you have high blood pressure or develop hypertension while taking dienogest
• if you develop liver disease while taking dienogest. Symptoms may include yellowing of the skin or eyes, or itching all over the body. Inform your doctor if any of these symptoms occurred during a previous pregnancy
• if you have diabetes or had gestational diabetes temporarily during a previous pregnancy
• if you have ever had chloasma (golden-brown patches on the skin, especially on the face); if so, avoid excessive exposure to sunlight or ultraviolet rays
• if you experience pain in the lower abdomen while taking dienogest.

While taking dienogest, your chance of becoming pregnant is reduced because dienogest may affect ovulation.

If you become pregnant while taking dienogest, there is a slightly higher risk of having an ectopic pregnancy (the embryo develops outside the uterus). Inform your doctor before starting dienogest if you have previously had an ectopic pregnancy or if you have any impairment of fallopian tube function.

Dienogest and severe uterine bleeding

Uterine bleeding may worsen with the use of dienogest, for example in women who have a condition in which the uterine lining (endometrium) grows into the muscular layer of the uterus, known as adenomyosis, or benign uterine tumors, sometimes called uterine fibroids (uterine leiomyomas). If bleeding is heavy and prolonged, this may lead to a decrease in the number of red blood cells (anemia), which in some cases can be severe. If you have anemia, you should consult your doctor about whether you should stop taking dienogest.

Dienogest and changes in bleeding patterns

Most women treated with dienogest experience changes in menstrual bleeding patterns (see section 4, Possible adverse effects).

Dienogest and blood clots in the veins

Some studies suggest there may be a slight, although not statistically significant, increased risk of blood clots in the legs (venous thromboembolism) associated with the use of preparations containing progestogens such as dienogest. Very rarely, blood clots may cause serious permanent disabilities or even be fatal.

The risk of venous blood clots increases:

• with age
• if you are overweight
• if you or a close family member has had a blood clot in the leg (thrombosis), lungs (pulmonary embolism), or another organ at a young age
• if you require surgery, have suffered a serious accident, or need to remain immobile for a prolonged period. It is important to inform your doctor in advance that you are taking dienogest, as treatment may need to be interrupted. Your doctor will advise you when to restart dienogest. This usually occurs about two weeks after you regain mobility.

Dienogest and blood clots in arteries

There is limited evidence of an association between progestogen-containing preparations such as dienogest and an increased risk of developing a blood clot, for example, in blood vessels of the heart (heart attack) or brain (stroke). In women with hypertension, these preparations may slightly increase the risk of stroke.

The risk of experiencing a blood clot in the arteries increases:

?If you smoke. You are strongly advised to stop smoking while taking dienogest, especially if you are over 35 years old

• if you are overweight
• if one of your close family members has had a heart attack or stroke at an early age
• if you have high blood pressure.

Consult your doctor before starting to take dienogest.

Stop taking Dimetrio and contact your doctor immediately if you notice possible signs of a blood clot, for example:

• severe and/or swelling in one of your legs
• sudden, severe chest pain, which may extend to your left arm
• sudden difficulty breathing
• sudden cough without an obvious cause
• unusual, severe, or prolonged headache, or worsening of a migraine
• partial or complete loss of vision, or double vision
• difficulty or inability to speak
• dizziness or fainting
• weakness, abnormal sensation, or numbness in any part of the body.

Dienogest and cancer

Based on currently available data, it is not clear whether dienogest increases the risk of breast cancer or not. Breast cancer has been observed to be slightly more frequent in women taking hormones compared to women who do not, but it is unknown whether this is caused by the treatment. For example, more tumors may be detected, and at an earlier stage, in women taking hormones because they are examined more frequently by their doctor. The occurrence of breast tumors decreases after stopping hormonal treatment. It is important that you regularly examine your breasts and consult your doctor if you feel any lump.

In rare cases, benign liver tumors have been reported in women taking hormones, and in even more exceptional cases, malignant liver tumors. Contact your doctor if you experience unusually severe stomach pain.

Dimetrio and osteoporosis

Changes in bone mineral density (BMD)

The use of dienogest may affect bone strength in adolescents (from 12 to less than 18 years of age). If you are under 18 years old, your doctor will therefore carefully evaluate the benefits and risks of using dienogest for you on an individual basis, taking into account possible risk factors for bone loss (osteoporosis).

If you use dienogest, it will be helpful for your bones to have an adequate intake of calcium and vitamin D, both through diet and dietary supplements.

If you have an increased risk of developing osteoporosis (weakening of the bones due to loss of bone minerals), your doctor will carefully weigh the risks and benefits of your treatment with dienogest, because dienogest causes a moderate suppression of estrogen production (another type of female hormone) by your body.

Children and adolescents

Dienogest is not indicated in girls before menarche (first menstruation).

The use of dienogest may affect bone strength in adolescents (aged 12 to less than 18 years). If you are under 18 years of age, your doctor will therefore carefully evaluate the benefits and risks of using dienogest for you on an individual basis, taking into account possible risk factors for bone loss (osteoporosis).

Other medicines and Dimetrio

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including herbal preparations. Likewise, inform any other doctor or dentist who prescribes you a medicine (or your pharmacist) that you are taking dienogest.

Some medicines may affect the blood levels of dienogest and make it less effective, or may cause unwanted effects.

These include:

• medicines used to treat:
  • epilepsy (for example, phenytoin, barbiturates, primidone, carbamazepine, oxcarbazepine, topiramate, felbamate)
  • tuberculosis (for example, rifampicin)
  • HIV and Hepatitis C virus infections (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors, such as ritonavir, nevirapine, efavirenz)
  • fungal infections (griseofulvin, ketoconazole)
• herbal preparations containing St. John's wort.

Consult your doctor or pharmacist before using any medicine.

Taking Dimetrio with food and beverages

During treatment with dienogest, you should avoid drinking grapefruit juice, as it may increase the levels of dienogest in your blood. This could increase the risk of experiencing adverse effects.

Laboratory tests

If you require a blood test, inform your doctor or laboratory staff that you are taking dienogest, as dienogest may affect the results of certain tests.

Pregnancy, lactation, and fertility

If you are pregnant or breastfeeding, think you might be pregnant, or are planning to become pregnant, consult your doctor before using this medicine.

Do not take dienogest if you are pregnant or during breastfeeding.

Driving and operating machinery

No effect on the ability to drive or operate machinery has been observed in women taking dienogest.

Dimetrio contains lactose

If your doctor has informed you that you have an intolerance to certain sugars, consult with them before taking this medicine.

Dimetrio contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; essentially, it is "sodium-free".

3. How to take Dimetrio

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again. The usual dose for adults is one tablet daily.

The following statements apply to dienogest unless your doctor has prescribed otherwise. Follow these instructions; otherwise, you may not fully benefit from treatment with dienogest.

You may start treatment with dienogest on any day of your natural cycle.

Adults: take one tablet every day, preferably at the same time each day, with some liquid if necessary. When you have finished one pack, start the next pack immediately without interruption. Continue taking the tablets also during days of menstrual bleeding.

There is no treatment experience with dienogest for periods longer than 15 months in patients with endometriosis.

If you take more Dimetrio than you should

No serious harmful effects have been reported from taking too many dienogest tablets at once. Contact your doctor or pharmacist immediately, or call the Toxicology Information Service at 91-562.04.20. Do not forget to bring the medicine package with you.

If you forget to take Dimetrio or if you experience vomiting or diarrhea

Dinogest will be less effective if you miss a tablet. If you forget one or more tablets, take a single tablet as soon as you remember; then continue the next day by taking the tablet at your usual time.

If you vomit within 3–4 hours after taking a dienogest tablet or if you have severe diarrhea, there is a risk that the active ingredient in the tablet may not be completely absorbed by your body. This situation is similar to forgetting a tablet. After vomiting or experiencing severe diarrhea within 3–4 hours of taking dienogest, you should take another tablet as soon as possible.

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

If you interrupt treatment with Dimetrio

If you interrupt treatment with dienogest, your original endometriosis symptoms may return.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may produce adverse effects, although not everyone experiences them. These effects are more frequent during the first months after starting dienogest and usually disappear with continued use. You may also experience changes in your bleeding pattern; for example, you may have spotting, irregular bleeding, or your menstruation may cease completely.

Frequent (affects between 1 and 10 out of 100 users)

• weight gain
• depressed mood, sleep disorders, nervousness, loss of interest in sex, or 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 or irritability.

Uncommon (affects between 1 and 10 out of 1,000 users)

• anemia
• weight loss or increased appetite
• anxiety, depression, or mood changes
• autonomic nervous system imbalance (which controls unconscious bodily functions, for example, sweating) or attention disorders
• dry eyes
• tinnitus (ringing in the ears)
• non-specific circulatory problems or unusual palpitations
• low blood pressure
• difficulty breathing
• 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, growth of male-pattern body hair (hirsutism), brittle nails, dandruff, dermatitis, abnormal hair growth, hypersensitivity to light, or skin pigmentation problems
• bone pain, muscle spasms, pain and/or heaviness in the arms and hands, or legs and feet
• urinary tract infection
• vaginal candidiasis, genital dryness, vaginal discharge, pelvic pain, atrophic inflammation of the genital area with discharge (atrophic vulvovaginitis), or lump(s) in the breast
• swelling due to fluid retention.

Additional adverse effects in adolescents (aged 12 to under 18 years):

loss of bone density.

Reporting of adverse reactions:

If you experience any type of adverse reaction, consult your doctor, pharmacist, or nurse, even if it is a possible adverse reaction not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of Dimetrio

This medicine does not require special storage conditions.

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

Do not use this medicine after the expiry date stated on the packaging after "EXP:". The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Dimetrio

The active substance is dienogest. Each tablet contains 2 mg of dienogest.

The other components are lactose monohydrate, corn starch, povidone, sodium starch glycolate (starch derived from potato), magnesium stearate, hypromellose (E464), hydroxypropylcellulose (E463), talc (E553b), hydrogenated cottonseed oil, titanium dioxide (E171).

Appearance of the Product and Contents of the Package

Dimetrio film-coated tablets are white, round, biconvex, with a raised "2" on one side, and have an approximate diameter and thickness of 6.1 mm and 2.7 mm, respectively.

They are presented in a blister pack containing 14 film-coated tablets.

Cartons contain blister packs with 28, 56, 84, or 168 film-coated tablets.

Some package sizes may not be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Manufacturer

Haupt Pharma Münster GmbH

Schleebrüggenkamp 15

48159 Münster

Germany

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Spain: Dimetrio

Date of most recent review of this leaflet: May 2023

Detailed information about this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the leaflet and packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/84015/P_84015.html

QR code to: https://cima.aemps.es/cima/dochtml/p/84015/P_84015.html