DIMETRIO 2 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Dimetrio 2 mg Film-Coated Tablets EFG

dienogest

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

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

Contents of the Package Leaflet

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

1. Contents of the pack and further information

1. What Dimetrio is and what it is used for

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

2. What you need to know before taking Dimetrio

Do not take Dimetrio

• if you have a blood clot(thromboembolic disorder) in the veins. This can occur, for example, in the blood vessels of the legs (deep vein thrombosis) or lungs (pulmonary embolism). See later “Dimetrio and blood clots in the veins”
• if you have or have ever had a severe arterial disease, including cardiovascular disease, such as a heart attack, stroke, or heart disease that causes a decrease in blood flow (e.g., angina pectoris). See later “Dimetrio and blood clots in the arteries”
• if you have diabeteswith blood vessel damage
• if you have or have ever had a severe liver disease(and your liver function values have not returned to normal). Symptoms of liver disease can be a yellow color of the skin and/or itching all over the body
• if you have or have ever had a benign or malignant liver tumor
• if you have or have ever had, or are suspected of having, a malignant tumorthat is dependent on sex hormones, such as breast cancer or cancer of the genital organs
• if you have vaginal bleedingof unknown cause
• if you are allergicto dienogest or any of the other components of this medication (listed in section 6 and at the end of section 2).

If any of these disorders appear for the first time while taking dienogest, stop taking it immediately and consult your doctor.

Warnings and Precautions

Consult your doctor before starting to take dienogest.

You should not take oral contraceptives in any form (in pill, patch, intrauterine system) while taking dienogest.

Dienogest is NOT a contraceptive. If you want to prevent pregnancy, you should use condoms or other non-hormonal contraceptive precautions.

In some cases, you should be particularly careful while taking dienogest, and it may be necessary for your doctor to examine you periodically. Inform your doctor if you are affected by any of the following conditions:

• 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 develop hypertensionwhile taking dienogest
• if you have liver diseasewhile taking dienogest. Symptoms can include a yellow color of the skin or eyes, or itching all over the body. Inform your doctor if any of these symptoms have appeared in a previous pregnancy
• if you have diabetesor have had temporary diabetes in a previous pregnancy
• if you have ever had chloasma(brownish patches on the skin, especially on the face); if so, avoid excessive sun exposure or ultraviolet radiation
• if you experience abdominal painwhile taking dienogest.

While taking dienogest, the likelihood of becoming pregnant decreases because dienogest can affect ovulation.

If you become pregnant while taking dienogest, you have a slightly higher riskof having an ectopic pregnancy (the embryo develops outside the uterus). Inform your doctor before starting to take dienogest if you have had an ectopic pregnancy or if you have a malfunction of the Fallopian tubes.

Dimetrio 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 uterine fibroids (leiomyomas). If the bleeding is intense and prolonged, it can lead to a decrease in the number of red blood cells (anemia), which in some cases can be severe. In case of anemia, you should consult your doctor about whether you should stop taking dienogest.

Dimetrio and Changes in Bleeding Pattern

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

Dimetrio and Blood Clots in the Veins

Some studies indicate that there may be a slight, although not statistically significant, increase in the risk of blood clots in the legs (venous thromboembolism)associated with the use of preparations containing progestogens like dienogest. Very rarely, blood clots can cause permanent and severe disabilities or even be fatal.

The risk of blood clots in the veinsincreases:

• with age
• if you are overweight
• if you or a close relative have had a blood clot in the leg (thrombosis), lungs (pulmonary embolism), or other organ at a young age.
• if you need to undergo surgery, have had a serious accident, or need to be immobilized for a prolonged period. It is essential that you inform your doctor in advance that you are taking dienogest, as treatment may need to be interrupted. Your doctor will tell you when to start taking dienogest again. This usually occurs about two weeks after regaining mobility.

Dimetrio and Blood Clots in the Arteries

There is little evidence of a relationship between progestogen preparations like dienogest and an increased risk of having a blood clot, for example, in the 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 having a blood clot in the arteriesincreases:

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• 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 to take dienogest.

Stop taking Dimetrio and contact your doctor immediately if you notice possible signs of a blood clot, such as

• severe pain and/or swelling in one of your legs
• severe and sudden chest pain that may radiate to the left arm
• sudden difficulty breathing
• sudden cough without an obvious 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 sensation, or numbness in any part of the body.

Dimetrio and Cancer

Based on currently available data, it is not clear whether dienogest increases or does not increase the risk of breast cancer. It has been observed that breast cancer is slightly more common in women taking hormones compared to those not taking them, but it is unknown whether this is caused by the treatment. For example, tumors may be detected more frequently and earlier in women taking hormones because they are examined more frequently by the doctor. The occurrence of breast tumors decreases after stopping hormonal treatment. It is essential that you regularly check your breastsand consult your doctor if you feel any lump.

In rare cases, in women taking hormones, benign liver tumors and, in more exceptional cases, malignant liver tumors have been reported. 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 (12 to less than 18 years). If you are under 18 years old, your doctor will carefully weigh the benefits and risks of using dienogest for you as a patient on an individual basis, considering 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 food and dietary supplements.

If you are at higher risk of suffering from osteoporosis (weakening of bones due to loss of bone minerals), your doctor will carefully weigh the risks and benefits of your treatment with dienogest because dienogest causes 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 (12 to less than 18 years). If you are under 18 years old, your doctor will carefully weigh the benefits and risks of using dienogest for you as a patient on an individual basis, considering possible risk factors for bone loss (osteoporosis).

Other Medicines and Dimetrio

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including herbal preparations that you are taking. Also, inform any other doctor or dentist who prescribes you another medicine (or pharmacist) that you are taking dienogest.

Some medicines may influence dienogest blood levels and make it less effective or cause unwanted effects.

These include:

• medicines used to treat:
• • epilepsy (e.g., phenytoin, barbiturates, primidone, carbamazepine, oxcarbazepine, topiramato, felbamato)
  • 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)
• herbal preparations.

Consult your doctor or pharmacist before using any medicine.

Taking Dimetrio with Food and Drinks

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

Laboratory Tests

If you need a blood test, inform your doctor or laboratory personnel that you are taking dienogest, as dienogest can affect the results of some tests.

Pregnancy, Breastfeeding, and Fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medication.

Do not take dienogest 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 dienogest.

Dimetrio Contains Lactose

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

Dimetrio Contains Sodium

This medication contains less than 1mmol of sodium (23 mg) per tablet; this is essentially “sodium-free”.

3. How to Take Dimetrio

Follow the instructions for administration of this medication exactly as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again. The usual dose for adults is one tablet per day.

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

You can start treatment with dienogest 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, the next one should be started without interruption. Continue taking the tablets even on days of menstrual bleeding.

There is no experience with treatment with dienogest for more 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. Consult your doctor or pharmacist immediately or the Toxicology Information Service, phone 91-562.04.20. Do not forget to take the medication package with you.

If You Forget to Take Dimetrio or If You Have Vomiting or Diarrhea

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

If you vomit within 3-4 hours after taking a dienogest tablet or have severe diarrhea, there is a risk that the active substance of the tablet may not be fully absorbed by your body. This situation is similar to when you forget a tablet. After vomiting or diarrhea within 3-4 hours after taking dienogest, you should take another tablet as soon as possible.

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

If You Stop Taking Dimetrio

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

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

4. Possible Side Effects

Like all medicines, this medication can cause side effects, although not everyone gets them. The effects are more frequent in the first few months after starting to take 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 stop completely.

Common (affect 1 to 10 users in 100)

• weight gain
• depressive 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/vaginal bleeding, including spotting
• weakness or irritability.

Uncommon (affect 1 to 10 users in 1,000)

• anemia
• weight loss or increased appetite
• anxiety, depression, or mood changes
• imbalance of the autonomic nervous system (which controls unconscious body functions, e.g., sweating) or attention disorders
• dry eyes
• tinnitus (ringing in the ears)
• non-specific circulatory problems or unusual palpitations
• low blood pressure
• breathing difficulties
• 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, hypersensitive reaction 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 candida infection, genital dryness, vaginal discharge, pelvic pain, atrophic vulvovaginitis, or breast lumps
• swelling due to fluid retention.

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

loss of bone density.

Reporting Side Effects:

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are side effects not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Dimetrio

This medication does not require special storage conditions.

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date shown on the packaging after "CAD:". The expiration date is the last day of the indicated month.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and unused medicines at the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Dimetrio

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

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

Appearance of the Product and Package Contents

The Dimetrio film-coated tablets are white, round, biconvex, with a "2" in relief on one face and 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.

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

Only some package sizes may be marketed.

Marketing Authorization Holderand 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 medication is authorized in the Member States of the European Economic Area under the following names:

Spain: Dimetrio

Date of Last Revision of this Leaflet:May 2023

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

You can access detailed and updated information on this medication by scanning the QR code included in the leaflet and packaging with your mobile phone (smartphone). 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