Label: information for the user

Dimetrio 2 mg film-coated tablets EFG

dienogest

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

• Keep this label, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, 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 any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

Label content

1. What Dimetrio is and for what it is used
2. What you need to know before starting to take Dimetrio
3. How to take Dimetrio
4. Possible adverse effects
5. Storage of Dimetrio

6. Contents of the pack and additional information

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

Do not take Dimetrio:

• if you have ablood 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 had aserious arterial disease, even a cardiovascular disease, such as a heart attack, stroke, or heart disease that causes a decrease in blood flow (for example, angina pectoris). Consultlater “Dimetrio and blood clots in the arteries”
• if you havediabeteswith vascular damage
• if you have or have had aserious liver disease(and your liver function values have not returned to normal). The symptoms of liver disease can be a yellow color of the skin and/or itching all over the body
• if you have or have had abenign or malignant liver tumor
• if you have or have had, or are suspected of having amalignant tumor, dependent on sex hormones, such as breast cancer or genital organs
• if you have avaginal bleedingof unknown cause
• if you areallergicto dienogest or to any of the other components of this medication (listed in section 6 and 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 tablet, 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 your doctor may need to examine you periodically. Inform your doctor if you are affected by any of the following disorders:

• if you have ever had ablood clot(thromboembolism) or if a close relative has had a blood clot at a relatively early age
• if you have a close relative who has hadbreast cancer
• if you have ever haddepression
• if you have high blood pressure or havehypertensionwhile taking dienogest
• if you have aliver diseasewhile taking dienogest. The 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 havediabetesor have had temporary diabetes in a previous pregnancy
• if you have ever hadmelasma(brownish-yellow patches on the skin, especially on the face); if so, avoid exposure to too much sun or ultraviolet rays
• if you have pain in the lower part of yourabdomenwhile taking dienogest.

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

If you become pregnant while taking dienogest, you have aslightly higher riskof having an ectopic pregnancy (the embryo develops outside the uterus). Inform your doctor before starting to take dienogest, if you have already had an ectopic pregnancy or if you have a fallopian tube dysfunction.

Dimetrio and severe uterine bleeding

Severe 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 muscle layer of the uterus, known as adenomyosis uteri or benign uterine tumors, sometimes called uterine fibroids (leiomyomas uteri). If the bleeding is intense and prolonged, it 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.

Dimetrio and changes in menstrual 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 suggest that there may be a slight, but not statistically significant, increase in the risk ofblood clots in the legs (thromboembolism), in relation to the use of preparations containing progestogens such as dienogest. Very rarely, blood clots can cause permanent and severe disabilities or even be fatal.

The risk ofblood clots in the veinsincreases:

Dimetrio and blood clots in the arteries

There is little evidence of a relationship between progestogen-containing preparations such as 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 ablood clot in the arteriesincreases:

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

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:

Dimetrio and cancer

Currently available data do not clearly show whether dienogest increases or decreases 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 their doctor. The appearance of breast tumors decreases after interrupting hormone treatment.It is essential to regularly check your breastsand consult your doctor if you feel any lump.

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

Dimetrio and osteoporosis

Bone mineral density (BMD) changes

The use of dienogest may affect the bone strength of adolescents (12 to less than 18 years old). If you are under 18 years old, your doctor will carefully weigh the benefits and risks of using dienogest for you as a patient, 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 food and dietary supplements.

If you have a higher risk of developing osteoporosis (bone weakening 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 the bone strength of adolescents (12 to less than 18 years old). If you are under 18 years old, your doctor will carefully weigh the benefits and risks of using dienogest for you as a patient, taking into account possible risk factors for bone loss (osteoporosis).

Other medications and Dimetrio

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including herbal preparations you are taking. Also, inform any other doctor or dentist who prescribes another medication (or pharmacist) that you are taking dienogest.

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

These include:

Consult your doctor or pharmacist before using any medication.

Dimetrio with food and drinks

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

Laboratory tests

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consultyour doctor before using this medication.

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

Driving and operating machines

No effects have been observed on the ability to drive and use machines in dienogest users.

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 1 mmol of sodium (23 mg) pertablet; it is essentially “sodium-free”.

Follow exactly the administration instructions for this medication 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 dienogest treatment.

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

Adults: Take one tablet every day, preferably at the same time, with some liquid if necessary. After finishing one package, start the next one without interruption. Continue taking the tablets on menstrual bleeding days as well.

There is no experience with dienogest treatment for a period exceeding 15 months in patients with endometriosis.

If You Take More Dimetrio Than You Should

No serious adverse effects have been reported from taking too many dienogest tablets at once. Consult your doctor or pharmacist immediately or the Toxicological Information Service, phone 91-562.04.20. Do not forget to bring the medication package.

If You Forget to Take Dimetrio or Experience Vomiting or Diarrhea

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

If you experience vomiting within 3-4 hours after taking a dienogest tablet or have intense diarrhea, there is a risk that the active ingredient in the tablet will not be fully absorbed by your body. This situation is similar to forgetting 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 compensate for missed doses.

If You Interrupt Treatment with Dimetrio

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

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

Like all medications, this medication may cause side effects, although not everyone will experience them. Side effects are more common in the first few months after starting dienogest and usually disappear with continued use. You may also experience changes in your bleeding pattern, for example, spotting, irregular bleeding, or your menstrual period may stop completely.

Frequent (affects between 1 and 10 in 100 users))

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

Rare (affects between 1 and 10 in 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)
• unspecified circulatory problems or irregular heartbeats
• low blood pressure
• difficulty breathing
• diarrhea, constipation, abdominal discomfort, gastrointestinal inflammation, gingivitis
• dry skin, excessive sweating, intense itching all over the body, male-type hair growth (hirsutism), brittle nails, dandruff, dermatitis, abnormal hair growth, light sensitivity, or skin pigmentation problems
• bone pain, muscle spasms, pain, or heaviness in the arms and hands, or the legs and feet
• urinary tract infection
• vaginal candidiasis, vaginal dryness, vaginal discharge, pelvic pain, atrophic vaginal inflammation, or breast lump(s)
• swelling due to fluid retention.

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

bone density loss.

Reporting side effects:

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medication.

This medication does not require special storage conditions.

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

Do not use this medication after the expiration date that appears on the packaging after “CAD:”. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medications. By doing so, you will help protect the environment.

Composition of Dimetrio

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

The other components are lactose monohydrate, cornstarch, 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 content of the container

The film-coated Dimetrio tablets are white, round, biconvex, with a “2” in relief on one face and approximate diameters and thicknesses 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 container sizes may be commercially marketed.

Marketing authorization holderandmanufacturer

Marketing authorization holder

Cinfa Laboratories, S.A.

Carretera Olaz-Chipi, 10. Areta Industrial Estate

31620 Huarte (Navarra) – Spain

Manufacturer

Haupt Pharma Münster GmbH

Schleebrüggenkamp 15

48159 Münster

Germany

Cinfa Laboratories, S.A.

Carretera Olaz-Chipi, 10. Areta Industrial Estate

31620 Huarte (Navarra) – Spain

This medicine is authorized in the member states of the European Economic Area with the following names:

Spain: Dimetrio

Last review date of this leaflet:May 2023

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

You can access detailed and updated information about this medicine by scanning with your 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