2 mg tablets 
dienogest

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

  • Save this information, 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 give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet you will find information about: 
1. What Endovelle® is and what it is used for 
2. What you need to know before you use Endovelle® 
3. How to use Endovelle® 
4. Possible side effects 
5. How to store Endovelle® 
6. Contents of the packaging and other information 

1. What Endovelle® is and what it is used for

Endovelle is a preparation for the treatment of endometriosis (painful symptoms due to uterine lining occurring outside the uterus). Endovelle contains a hormone, the progestogen dienogest.

Dienogest contained in Endovelle may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.

2. What you need to know before using Endovelle®

Do not use Endovelle®

  • if you have a blood clot (thromboembolism) in a friend. This can occur, for example, in the blood vessels in the legs (deep vein thrombosis ) or the lungs ( pulmonary embolism ). See also ” Endovelle and venous blood clots ” below.
  • if you have or have had a severe arterial disease, including cardiovascular diseases such as myocardial infarction, stroke, or heart disease that results in decreased blood supply to the heart ( angina pectoris ). See also ” Endovelle and arterial blood clots ” below.
  • if you have diabetes with vascular damage.
  • if you have or have had severe liver disease (and your liver function values ​​have not returned to normal). Symptoms of liver disease may include yellowing of the skin and/or itching all over the body.
  • if you have or have had a benign or malignant liver tumor.
  • if you have or have had or if you suspect you have a malignant tumor that is dependent on sex hormones, such as breast or genital cancer.
  • if you have unexplained vaginal bleeding.
  • if you are allergic (hypersensitive) to dienogest or any of the other ingredients of this medicine (listed in section 6 and at the end of section 2).

If any of these conditions occur for the first time during the use of Endovelle, stop using Endovelle immediately and consult a doctor.

Warnings and cautions

You must not use hormonal contraceptives of any kind (tablets, patches, IUD ) while you are taking Endovelle.

Endovelle is NOT a contraceptive. If you want to avoid getting pregnant, use condoms or other non-hormonal contraceptives.

In some situations, you need to be especially careful when using Endovelle, and your doctor may need to examine you regularly. Tell your doctor if any of the following conditions apply to you:

If you:

  • have ever had a blood clot (venous thromboembolism) or someone in your immediate family has had a blood clot at a relatively young age.
  • has a close relative who has had breast cancer.
  • have ever had depression.
  • have high blood pressure or get high blood pressure while taking Endovelle.
  • get the liver disease while taking Endovelle. The symptoms may be yellowing of the skin or eyes or itching all over the body. Also, tell your doctor if such symptoms have occurred during a previous pregnancy.
  • have diabetes or had temporary diabetes during a previous pregnancy.
  • have ever had chloasma (yellow-brown spots on the skin, especially on the face). In this case, avoid exposing yourself to too much sun or ultraviolet radiation.
  • get pain in the lower abdomen while taking Endovelle.

While you are taking Endovelle, the chance of you getting pregnant is reduced, as Endovelle may affect your ovulation.

If you become pregnant while taking Endovelle, the risk of ectopic pregnancy (the embryo develops outside the uterus) is slightly increased. Tell your doctor before taking Endovelle if you have previously had an ectopic pregnancy or have impaired fallopian tube function.

Endovelle and severe bleeding from the uterus

Bleeding from the uterus, for example in women with a disease where the uterine lining (endometrium) grows into the uterine muscle tissue, so-called uterine adenomyosis or benign uterine tumor, sometimes also called uterine fibroid (uterine leiomyoma), can be aggravated when using Endovelle. If the bleeding is profuse and prolonged, this can lead to low levels of red blood cells ( anemia ) which can be severe in some cases. If you get anemia, talk to your doctor about stopping Endovelle.

Endovelle and changes in the bleeding pattern

Most women treated with Endovelle experience changes in their bleeding patterns (see section 4, Possible side effects ).

Endovelle and venous blood clots

Some studies show that there may be a slightly, but not statistically significant, increased risk of a blood clot in the bone (venous thromboembolism) in connection with the use of preparations such as Endovelle, which contain progestogen. In very rare cases, blood clots can cause serious permanent damage or be fatal.

The risk of a venous blood clot increases:

  • with increasing age
  • if you are overweight
  • if you or any of your closest relatives have had a blood clot in the leg ( thrombosis), lung ( pulmonary embolism ), or other organs at a young age
  • if you have to have surgery, have had a serious accident, or become immobile for a long time. You must tell your doctor in advance that you are using Endovelle, as treatment may need to be stopped. Your doctor will tell you when to start Endovelle again. This usually happens about two weeks after you get back on your feet.

Endovelle and arterial blood clots

There is limited evidence for a link between preparations containing progestogen, such as Endovelle, and an increased risk of blood clots, for example in the heart’s blood vessels (heart attack) or the brain ( stroke ). In women with high blood pressure, the risk of stroke may increase slightly when using these drugs.

The risk of an arterial blood clot increases:

  • if you smoke. It is strongly recommended that you stop smoking when using Endovelle, especially if you are older than 35 years.
  • if you are overweight.
  • if any of your closest relatives have had a heart attack or stroke at a young age.
  • if you have high blood pressure.

Talk to your doctor before taking Endovelle

Stop taking Endovelle and contact your doctor immediately if you notice any signs of a blood clot, such as:

  • severe pain and/or swelling in one leg
  • sudden severe pain in the chest, possibly with radiance in the left arm
  • sudden shortness of breath
  • sudden cough for no apparent reason
  • unusual, severe, or prolonged headache or worsening of migraine
  • partial or complete vision loss or double vision
  • difficulty speaking or inability to speak
  • dizziness or fainting
  • weakness, unusual feeling, or numbness in any part of the body.

Endovelle and cancer

Based on the data currently available, it is not clear whether Endovelle increases the risk of breast cancer. Breast cancer has been observed slightly more often in women taking hormones than in women not taking hormones, but it is not known if this is caused by treatment. For example, it may be that more tumors are detected and that they are detected earlier in women who take hormones because they are examined by doctors more often. The incidence of breast tumors gradually decreases when the hormone treatment has been completed. It is important that you regularly examine your breasts and you should contact a doctor if you feel any lump.

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

Endovelle and osteoporosis

Changes in bone density

The use of Endovelle may affect skeletal strength in adolescents (12 up to 18 years of age). If you are under 18, your doctor will therefore carefully consider the risks and benefits of using Endovelle for you as an individual patient, taking into account the possible risk factors for osteoporosis ( osteoporosis ).

If you use Endovelle, a sufficient intake of calcium and vitamin D, either through your food or through supplements, will help your skeleton.

If you are at increased risk of developing osteoporosis (weakening of the skeleton due to decreased bone density), your doctor will carefully consider the risks and benefits of treatment with Endovelle, as Endovelle provides a moderate reduction in estrogen production (another type of female hormone ) in your body.

Children and young people

Endovelle should not be used by girls before menarche (first menstrual bleeding).

The use of Endovelle may affect skeletal strength in adolescents (12 up to 18 years of age). If you are under 18, your doctor will therefore carefully weighing the benefits against the risks from the use of Endovelle for you as an individual patient, taking into account the possible risk factors for osteoporosis ( osteoporosis ).

Other medicines and Endovelle®

Always tell your doctor which medicines or herbal remedies you are already taking. Also, tell other doctors or dentists who prescribe other medicines (or pharmacists) that you are taking Endovelle.

Some medicines can affect the level of Endovelle in the blood and may make it less effective, or cause side effects.

These include:

  • medicines used to treat
    • epilepsy (eg phenytoin , barbiturate , primidone, carbamazepine, oxcarbazepine, topiramate, felbamate)
    • tuberculosis (eg 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 )
  • (traditional) herbal medicines containing St. John’s wort.

Ask your doctor or pharmacist for advice before taking any medicine.

Endovelle with food and drink

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

Laboratory tests

If you need to take a blood sample, tell your doctor or laboratory staff that you are taking Endovelle, as Endovelle may affect the results of some tests.

Pregnancy and breastfeeding

Do not take Endovelle if you are pregnant or breast-feeding.

Driving and using machines

There is no information to suggest that the use of Endovelle affects the ability to drive or use machines.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Endovelle contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to use Endovelle®

Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure. For adults, the usual dose is 1 tablet daily.

The following advice applies to Endovelle unless your doctor prescribes otherwise. Follow these instructions, otherwise, you will not get the best effect from Endovelle.

You can start treatment with Endovelle any day during the natural menstrual cycle.

Adults: Take one tablet daily, preferably at the same time each day, with some liquid as needed. When one tablet map is finished, the next should be started without interruption. Continue to take the tablets even on the days when you have menstrual bleeding.

There is no experience of treatment with Endovelle for more than 15 months in patients with endometriosis.

If you take more Endovelle then you should

There are no reports of serious adverse effects after taking too many Endovelle tablets at the same time.

If you have ingested too much medicine or if e.g. If a child has inadvertently ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

If you forget to take Endovelle or suffer from vomiting or diarrhea

Endovelle will have a worse effect if you forget to take a tablet. If you forget to take one or more tablets, take one tablet as soon as you remember. Then continue taking a tablet at the usual time the next day.

If you vomit within 3-4 hours after taking Endovelle or have severe diarrhea, there is a risk that the active substance in the tablet will not be absorbed by your body. This situation is almost like forgetting to take a tablet. After vomiting or diarrhea within 3-4 hours after taking Endovelle, you should take a new tablet as soon as possible.

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

If you stop taking Endovelle

If you stop taking Endovelle, the original symptoms of endometriosis may return.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. These side effects are more common in the first few months after you start taking Endovelle, and they usually go away with continued use. You may also experience changes in your bleeding pattern, such as spotting, irregular bleeding, or the complete cessation of your period.

Common (affects between 1 and 10 users in 100)

  • weight gain
  • depression, sleep problems, nervousness, loss of sex drive, or mood swings
  • headache or migraine
  • nausea, abdominal pain, gas, bloating, or vomiting
  • acne or hair loss
  • back pain
  • breast discomfort, ovarian cysts, or hot flashes
  • bleeding from the uterus/vagina including spotting
  • weakness or irritability.

Uncommon (affects between 1 and 10 users in 1,000)

  • anemia
  • weight loss or increased appetite
  • anxiety, depression, or mood swings
  • imbalance in the autonomic nervous system (controls unconscious bodily functions, eg sweating) or impaired attention span
  • dry eyes
  • tinnitus
  • non-specific circulatory problems or unusual palpitations
  • low blood pressure
  • shortness of breath
  • diarrhea, constipation, stomach upset, inflammation of the stomach and intestines ( gastrointestinal inflammation ), gingivitis ( gingivitis )
  • dry skin, heavy sweating, severe itching all over the body, male hair growth ( hirsutism ), brittle nails, dandruff, dermatitis (skin inflammation), abnormal hair growth, hypersensitivity to light, or problems with skin pigmentation
  • skeletal pain, muscle cramps, pain and/or heaviness in arms and hands or legs and feet
  • urinary tract infection
  • fungal infection of the vagina, dryness of the abdomen, discharge from the vagina, pelvic pain, inflammation of the genitals with discharge (atrophic vulvovaginitis), or one or more nodules in the breasts
  • swelling due to fluid retention.

Additional side effects in children and adolescents

Additional side effects in adolescents (12 up to 18 years): decreased bone density.

5. How to store Endovelle®

Store in the outer carton. Sensitive to light.

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 carton or blister after “EXP”. The expiration date is the last day of the specified month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

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

The other ingredients are lactose monohydrate, corn starch, povidone K 30, vegetable magnesium stearate.

What the medicine looks like and the contents of the pack

Endovelle tablets are round, white tablets, 5 mm in diameter.

They are supplied in a blister pack containing 28 tablets.

The cartons contain blister packs with

1 x 28 tablets ( calendar pack )

3 x 28 tablets ( calendar pack )

6 x 28 tablets ( calendar pack )

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Exeltis Healthcare SL

Avenida Miralcampo 7

Poligono Industrial Miralcampo

19200 Azuqueca de Henares, Guadalajara

Spain

Manufacturer

Laboratories León Farma, SA

C / La Vallina s / n, Pol. Ind. Navatejera

24008 – Navatejera, León.

Spain

Contact the representative of the marketing authorization holder to find out more about this medicine.

This medicinal product is authorized under the European Economic Area under the names:

Finland Endovelle 2 mg tablets
France Endomila 2 mg compressEndobella 2 mg compressEndosana 2 mg compress
Portugal Endovelle
Spain Endovelle 2mg compressed

Muhammad Nadeem

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