Devicius

Package leaflet: Information for the user

Devicius 2 mg film-coated tablets

Equivalent medicine
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Devicius is and what it is used for

Devicius is a medicine used for the treatment of endometriosis (painful symptoms caused by displacement of the tissue lining the inside of the uterus). Devicius contains a hormone, the progestin dienogest.

2. What you should know before taking Devicius

Do not take Devicius

• if you have a blood clot in your veins (thromboembolic disorder). This may, for example, occur in a blood vessel in the legs (deep vein thrombosis) or in the lungs (pulmonary embolism). See also “Devicius and venous thrombosis” below;
• if you have or have ever had a severe arterial disease, including cardiovascular disease, such as a heart attack, stroke, or heart disease causing reduced blood supply (angina pectoris). See further “Devicius and arterial thrombosis” below;
• if you have diabetes with blood vessel damage;
• if you have or have ever had severe liver disease (and liver function values have not returned to normal);
• if symptoms of liver disorders include yellowing of the skin and/or generalized itching;
  • if you have or have ever had a benign or malignant liver tumour;
  • if you have or have ever had, or suspect you may have, a malignant tumour dependent on sex hormones, such as breast or genital organ cancer;
  • if you have unexplained vaginal bleeding;
  • if you are allergic to dienogest or any of the other ingredients of this medicine (listed in section 6).

If any of these conditions occurs for the first time while you are using Devicius, stop treatment immediately and consult your doctor.

Warnings and precautions

Talk to your doctor or pharmacist before taking Devicius.

You must not use hormonal contraceptives in any form (tablet, patch, intrauterine device) while taking Devicius.

Devicius is NOT a contraceptive. If you wish to avoid pregnancy, you must use a condom or other non-hormonal contraceptive methods.

In certain situations, you should be particularly careful while using Devicius, and your doctor may need to examine you regularly. Inform your doctor if any of the following conditions apply to you:

If:

• you have ever had a blood clot (venous thromboembolism) or if a close relative has had a blood clot at a relatively young age;
• a close relative has had breast cancer;
• you have ever suffered from depression;
• you have high blood pressure or this develops during treatment with Devicius;
• you develop liver disease while taking Devicius. Symptoms may include yellowing of the skin or eyes or generalized itching. Also inform your doctor if these symptoms occurred during a previous pregnancy;
• you have diabetes or had diabetes during a previous pregnancy;
• you have ever had chloasma (patchy brown skin pigmentation, especially on the face); in this case, avoid excessive exposure to sunlight or ultraviolet radiation;
• you experience lower abdominal pain while taking Devicius. During treatment with Devicius, the likelihood of pregnancy is reduced because Devicius may affect ovulation. However, if pregnancy occurs while taking Devicius, there is a slight increase in the risk of ectopic pregnancy (the embryo develops outside the uterus). Inform your doctor before taking Devicius if you have had an ectopic pregnancy in the past or if you have impaired function of the Fallopian tubes.

Devicius and severe uterine bleeding

Uterine bleeding, for example in women with a condition characterized by the growth of the uterine lining (endometrium) into the muscular layer of the uterus, called adenomyosis, or benign uterine tumours also known as uterine fibroids (uterine leiomyomas), may worsen with the use of Devicius. If bleeding is heavy and prolonged, this may lead to a decrease in red blood cell levels (anaemia), which in some cases may be severe. If anaemia occurs, your doctor should evaluate whether treatment with Devicius should be discontinued.

Devicius and changes in bleeding pattern

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

Devicius and venous blood clots

Some studies suggest there may be a slight, but not statistically significant, increased risk of a blood clot in the legs (venous thromboembolism) associated with the use of progestogen-only medicines such as Devicius. Very rarely, blood clots can cause serious permanent damage or may even be fatal.

The risk of developing a venous blood clot increases:

• with increasing age;
• if you are overweight;
• if you or a close relative have had a blood clot in the leg (thrombosis), lung (pulmonary embolism), or other organs at a young age;
• if you are scheduled for surgery, have had a serious accident, or prolonged bed rest. It is important to inform your doctor in advance that you are taking Devicius, as treatment may need to be stopped. Your doctor will advise you when to restart taking Devicius. This is generally possible about 2 weeks after you have regained full mobility.

Devicius and arterial blood clots

There is little evidence of an association between the use of progestogen-only medicines such as Devicius and an increased risk of arterial blood clots, for example, in blood vessels of the heart (heart attack) or brain (stroke). In women with hypertension, the risk of stroke may be slightly increased by the use of these medicines.

The risk of developing an arterial blood clot increases:

• if you smoke. It is strongly recommended that you stop smoking while taking Devicius, especially if you are over 35 years of age;
• 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.

Talk to your doctor before taking Devicius.

Stop taking Devicius and contact your doctor immediately if you notice any possible signs of thrombosis, such as:

• severe pain and/or swelling in one leg;
• sudden severe chest pain that may radiate to the left arm;
• sudden shortness of breath;
• sudden cough without apparent 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 sensations, or numbness in any part of the body.

Devicius and cancer

Current data do not clearly indicate whether Devicius increases or decreases the risk of breast cancer. Breast cancer has been observed slightly more frequently in women using hormonal medicines compared to those who do not, but it is not known whether this is due to the treatment. For example, it is possible that more tumours are detected earlier in women using hormonal medicines because they undergo more frequent medical check-ups. The occurrence of breast tumours gradually decreases after stopping hormonal treatment. It is important that you regularly examine your breasts and contact your doctor if you notice any lumps.

Benign liver tumours have been observed rarely in women taking hormones, and malignant liver tumours even more rarely. Contact your doctor if you experience unusual, severe stomach pain.

Devicius and osteoporosis

Changes in bone mineral density (BMD)

The use of Devicius may affect bone strength in adolescents (aged 12 to under 18 years). If you are under 18 years of age, your doctor must therefore carefully evaluate the benefits and risks associated with using Devicius for you as an individual patient, taking into account possible risk factors for bone loss (osteoporosis).

If you are taking Devicius, adequate intake of calcium and vitamin D through diet and/or supplements will be beneficial for your bones.

If you have an increased risk of osteoporosis (weakening of the bones due to loss of bone minerals), your doctor will carefully evaluate the risks and benefits of treatment with Devicius, because Devicius has a moderate suppressive effect on the body's production of oestrogens (another type of female hormone).

Children and adolescents

Devicius must not be used in girls before menarche (first menstrual bleeding).

The use of Devicius may interfere with bone strength in adolescents (aged 12 to under 18 years). If you are under 18 years of age, your doctor will therefore carefully evaluate the risks and benefits of using Devicius for you as an individual patient, taking into account possible risk factors related to bone loss (osteoporosis).

Other medicines and Devicius

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Also inform any other doctor or dentist who prescribes medicines for you (or the pharmacist) that you are taking Devicius.

Some medicines may affect the levels of Devicius in your blood and may make it less effective, or may cause side effects. These include:

• medicines used to treat:
  • epilepsy (e.g. phenytoin, barbiturates, primidone, carbamazepine, oxcarbazepine, topiramate, felbamate);
  • tuberculosis (e.g. rifampicin);
  • HIV infection and Hepatitis C virus (known as protease inhibitors and non-nucleoside reverse transcriptase inhibitors such as ritonavir, nevirapine, efavirenz);
  • fungal infections (griseofulvin, ketoconazole);
• Medicines containing St. John’s wort (Hypericum perforatum).

Devicius with food and drink

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

Laboratory tests

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

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Do not take Devicius if you are pregnant or breastfeeding.

Driving and using machines

No effects on the ability to drive or operate machinery have been observed in users of Devicius.

3. How to take Devicius

Take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
For adults, the recommended dose is 1 tablet per day.
Unless otherwise prescribed by your doctor, the following instructions apply to the use of Devicius. Follow these instructions carefully; otherwise, you may not get the full benefit from treatment with Devicius.
You may start treatment with Devicius on any day of the cycle.
Adults: take one tablet daily, preferably at the same time each day, if necessary with a small amount of liquid. When you finish a pack, start the next one the following day without interruption. Continue taking the tablets even during menstrual bleeding.
There is no experience with treatment using Devicius for periods longer than 15 months in patients with endometriosis.

If you take more Devicius than you should
There have been no reports of serious harmful effects following the ingestion of an excessive number of Devicius tablets at the same time. However, if you are concerned, contact your doctor.

If you forget to take Devicius or experience vomiting or diarrhea
The effectiveness of Devicius is reduced if you forget to take a tablet. If you forget one or more tablets, take a single tablet as soon as you remember, and then continue taking one tablet at the usual time the next day.
If you vomit within 3–4 hours after taking Devicius or experience severe diarrhea, there is a risk that the active substance in the tablet may not be absorbed by your body. This situation is comparable to forgetting to take a tablet.
After vomiting or severe diarrhea within 3–4 hours of taking Devicius, you should take another tablet as soon as possible.
Do not take a double dose to make up for a forgotten tablet.

If you stop taking Devicius
If you stop taking Devicius, symptoms of endometriosis may return.
If you need further clarification regarding 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 everyone gets them. These side effects most commonly occur during the first few months after starting treatment with Devicius and usually disappear with continued use. Changes in bleeding patterns may also occur, such as spotting, irregular bleeding, or cessation of menstrual periods.

Common (may affect up to 1 in 10 people)

• weight gain;
• depressed mood, sleep disturbances, nervousness, loss of interest in sex, or mood changes;
• headache or migraine;
• nausea, abdominal pain, flatulence, bloating, or vomiting;
• acne or hair loss;
• back pain;
• breast discomfort, ovarian cyst, or hot flushes;
• uterine/vaginal bleeding, including spotting;
• weakness, irritability.

Uncommon (may affect up to 1 in 100 people)

• anaemia;
• weight loss or increased appetite;
• anxiety, depression, or mood swings;
• autonomic nervous system imbalance (which controls unconscious bodily functions, for example sweating) or attention disturbances;
• dry eyes;
• tinnitus;
• non-specific circulatory problems or uncommon palpitations;
• low blood pressure;
• breathlessness;
• diarrhoea, constipation, abdominal discomfort, inflammation of the stomach and intestine (gastroenteritis), inflammation of the gums (gingivitis);
• dry skin, excessive sweating, severe itching all over the body, development of visible hair in typically male areas (hirsutism), brittle nails, dandruff, dermatitis, abnormal hair growth, photosensitivity, or skin pigmentation problems;
• bone pain, muscle spasms, pain and/or heaviness in the arms, hands, legs, or feet;
• urinary tract infection;
• vaginal candidiasis, genital dryness, vaginal discharge, pelvic pain, atrophic inflammation of the genital area with discharge (atrophic vulvovaginitis), or breast lump(s);
• fluid retention and swelling. Additional side effects in adolescents (12 to less than 18 years): loss of bone density.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Devicius

This medicine does not require any 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.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Devicius contains
The active substance is dienogest. Each tablet contains 2 mg of dienogest.
The other components are:
Tablet core: microcrystalline cellulose, pregelatinized corn starch, crospovidone, povidone K25, anhydrous colloidal silica, magnesium stearate.
Coating: aquapolish white: hypromellose, hydroxypropylcellulose, hydrogenated cottonseed oil, talc, titanium dioxide (E171).

Description of the appearance of Devicius and package contents
Devicius tablets are white, round, 7.1 mm in diameter and 3.4 mm thick, film-coated.
14 film-coated white tablets are packed in PVC (250 µm)-aluminum (20 µm) blisters.
Two blisters containing 14 tablets each are then packaged into a pouch made of PET (polyethylene terephthalate)/aluminum/PE (polyethylene), which protects the tablets from moisture.
One or three pouches are then placed into a cardboard carton.
Pack sizes containing 28 and 84 film-coated tablets are available.
It is possible that not all pack sizes are marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Stragen Nordic A/S
Helsingørsgade 8C
3400 Hillerød
Denmark

Manufacturer:
Haupt Pharma Münster GmbH
Schleebrüggenkamp 15
48159 Münster
Germany

This medicinal product has been authorized in the Member States of the European Economic Area under the following names:
This leaflet was last updated in 09/2019