DEVICIUS 2 mg Film-Coated Tablets

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

Devicius 2 mg film-coated tablets

Generic medicine

Read this leaflet carefully before taking this medicine as 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 is Devicius and what is it used for?

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

2. What you need to know before you take Devicius

Do not take Devicius

• if you have a blood clotin the veins (thromboembolic disorder). This can occur, for example, in a blood vessel in the legs (deep vein thrombosis) or in the lungs (pulmonary embolism). See also “ Deviciusand venous thrombosis” below;
• if you have or have ever had a serious arterial disease,including cardiovascular disease, such as a heartattack,a strokeor a heart diseasethat causes a reduction in blood supply (angina pectoris). See below “ Deviciusand arterial thrombosis”;
• if you have diabeteswith damage to blood vessels;
• if you have or have ever had a serious liver disease(and liver function values have not returned to normal);
• if the symptoms of liver disease may be yellowing 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 suspect you have a malignant tumordependent on sex hormones such as breast cancer or cancer of the genital organs;
• if you have vaginal bleedingthat is unexplained;
• if you are allergicto dienogest or any of the other ingredients of this medicine ( listed insection 6).

If any of these conditions occur for the first time during the use of Devicius, stop
treatment immediately and consult your doctor.

Warnings and precautions
Talk to your doctor or pharmacist before taking Devicius.
You should not use hormonal contraceptives in any form (tablet, patch, intrauterine device)
while taking Devicius.
Devicius is NOT a contraceptive. If you want to avoid pregnancy, you should use a condom or other
non-hormonal contraceptive precautions.
In some situations you need to be particularly careful while using Devicius, and you may need to be visited
regularly by your doctor. Tell your doctor if any of the conditions listed here apply to you:
If:

• you have ever had a blood clot(venous thromboembolism) or if one of your close relatives has had a blood clot at a relatively young age;
• you have a close relative who has had breast cancer;
• you have ever suffered from depression;
• you have high blood pressureor this condition occurs during the use of Devicius;
• you develop a liver diseaseduring the use of Devicius. Symptoms may include yellowing of the skin or eyes or itching all over the body. Tell your doctor even if these symptoms occurred during a previous pregnancy;
• you have diabetesor had it during a previous pregnancy;
• you have ever had chloasma(patchy brown skin pigmentation, especially on the face); if so, avoid excessive exposure to the sun or ultraviolet rays;
• you suffer from lower abdominal painduring the use of Devicius. During treatment with Devicius, the possibility of pregnancy is reduced as Devicius can affect ovulation. If a pregnancy occurs during the use of Devicius there is a slightincreasein riskof ectopic pregnancy (the embryo develops outside the uterus). Tell your doctor before taking Devicius if you have had an ectopic pregnancy in the past or if you have reduced function of the fallopian tubes.

Devicius and severe uterine bleeding
Uterine bleeding, for example in women with a disease characterized by the growth of the uterine lining
(endometrium) inside the muscular layer of the uterus, called internal uterine adenomyosis or

benign uterine tumorsalso called uterine fibroids (uterine leiomyomas), may worsen with the use
of Devicius. If the bleeding is heavy and continuous over time, this can lead to a decrease
in red blood cell levels (anemia), which can sometimes be severe. In case of anemia, you should discuss with
your doctor whether to stop treatment with Devicius.

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

Devicius and venous blood clots
Some studies suggest that there may be a slight, but not statistically significant, increase in the
risk of a blood clot in the legs( venous thromboembolism) associated with the use of medicines
based on progestin alone, such as Devicius. Very rarely, blood clots can cause serious
permanent damage or can even be fatal.
The risk of having a venous blood clotincreases:

• with increasing age;
• if you are overweight;
• if you or one of your close relatives has had a blood clot in the leg (thrombosis), in the lung (pulmonary embolism), or in other organs at a young age;
• if you are going to have surgery, if you have had a serious accident or a prolonged stay in bed. It is important that you inform your doctor in advance that you are taking Devicius as treatment may need to be stopped. Your doctor will tell you when to start taking Devicius again. Generally this will be possible about 2 weeks after you have fully regained your mobility.

Deviciusand arterial blood clots
There is little evidence of an association between the use of medicines based on progestin alone such as Devicius and an
increased risk of a blood clot, for example, in the blood vessels of the heart (heart attack) or the
brain (stroke). In women with hypertension, the risk of stroke may be slightly increased by the use of these
medicines.
The risk of having an arterial blood clotincreases:

• if you smoke. It is strongly recommended to stop smoking during the use of Devicius, especially if you areover 35 years old;
• if you are overweight;
• if one of your close relatives 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 consult your doctor immediately if you notice any
possible sign of thrombosis, such as:

• severe pain and/or swelling in a leg;
• sudden severe chest pain that may radiate to the left arm;
• sudden shortness of breath;
• sudden cough without an apparent cause;
• unusual, severe or prolonged headache or worsening of migraine;
• partial or total 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
From the data currently available, it is not clear whether Devicius increases or decreases the risk of breast cancer. Breast cancer has been observed with a slightly higher frequency in women
who use hormonal medicines compared to those who do not use them, but it is not known whether this is due to the
treatment. For example, it is possible that tumors are diagnosed more frequently and earlier in women who use hormonal medicines because they undergo more frequent medical checks. The occurrence of
breast tumors decreases gradually after stopping hormonal treatment. It is important
that you check your breasts regularly andif you feel any lump you should contact your doctor.
In women taking hormones, benign liver tumors and, even
more rarely, malignant liver tumors have been observed. 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 the strength of bones in adolescents (aged 12 and under 18 years). If you
are under 18 years of age, your doctor will therefore carefully assess the benefits and risks associated with the use of
Devicius for you as a patient, taking into account possible risk factors for bone loss
(osteoporosis).
If you use Devicius, adequate intake of calcium and vitamin D through
diet and supplements will be helpful 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 assess the risks and benefits of treatment with Devicius because Devicius has a
moderate suppressive effect on the production of estrogens (another type of female hormone) by
the body.

Children and adolescents
Devicius should not be used in girls before menarche (first menstrual bleeding).
The use of Devicius may interfere with the strength of bones in adolescents (aged 12 and under 18
years). If you are under 18 years of age, your doctor will carefully assess the risks and benefits of using
Devicius for you as an individual patient, taking into account possible risk factors associated with
bone loss (osteoporosis).

Other medicines and Devicius
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines. Also tell any other doctor or dentist who prescribes you other medicines (or the
pharmacist) that you are taking Devicius.
Some medicines can affect the levels of Devicius in the blood and may make it less effective, or
may cause unwanted effects. These include:

• medicines used for the treatment of:
• epilepsy(e.g. phenytoin, barbiturates, primidone, carbamazepine, oxcarbazepine, topiramate, felbamate);
• tuberculosis(e.g. rifampicin);
• HIV and Hepatitis C virus infection(called protease inhibitors and non-nucleoside reverse transcriptase inhibitors such as ritonavir, nevirapine, efavirenz);
• fungal infections(griseofulvin, ketoconazole);
• Medicines containing St. John's Wort.

Devicius with food and drinkDuring treatment with Devicius you should avoid drinking grapefruit juice,
because it can increase the levels of Devicius in the blood. This may increase the risk of having
undesirable effects.

Laboratory tests
If you are going to have a blood test, tell your doctor or laboratory staff that you are taking
Devicius, as Devicius may affect the result of some tests.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Do not take Devicius if you are pregnant, or if you are breastfeeding.

Driving and using machines
No effects on the ability to drive or use machines have been observed in women taking Devicius.

3. How to take Devicius

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

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

If you forget to takeDevicius or suffer from vomiting or diarrhea
The effectiveness of Devicius is reduced if you forget a tablet. If you forget one or more tablets, take one
tablet as soon as you remember, and then continue the next day to take the tablet at the
usual time.
In case of vomiting within 3-4 hours of taking Devicius or in case of severe diarrhea, there is a risk that the
active substance of the tablet is not absorbed by your body. The situation is comparable to
that which occurs when you forget to take a tablet.
After vomiting or 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 the forgotten tablet.

If you stop taking Devicius
If you stop taking Devicius, the symptoms of endometriosis may reappear.
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 everybody gets them.
These effects are most commonly experienced during the first few months of treatment
with Devicius and usually disappear with continued use. Changes in bleeding patterns may also occur, such as spotting, irregular bleeding, or cessation of the menstrual cycle.

Common (may affect up to 1 in 10 people)

• weight increase;
• 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, irritability.

Uncommon (may affect up to 1 in 100 people)

• anemia
• weight loss or increased appetite;
• anxiety, depression, or mood swings;
• imbalance of the autonomic nervous system (which controls unconscious bodily functions, for example sweating) or attention disorders;
• dry eyes;
• tinnitus;
• non-specific circulatory problems or uncommon palpitations;
• low blood pressure;
• shortness of breath;
• 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, appearance of visible hair in typically male areas (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, hands, or legs and feet;
• urinary tract infection;
• vaginal candidiasis, dryness in the genital area, vaginal discharge, pelvic pain, atrophic inflammation of the genitals with discharge (atrophic vulvovaginitis), or a lump or lumps in the breast;
• fluid retention edema. Further side effects in adolescents (12 years and under 18 years): loss of bone density.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through 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 which is stated on the packaging after “EXP”.
The expiry date refers to the last day of the month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

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

Description of Devicius and contents of the pack
Devicius tablets are white, round, with a diameter of 7.1 mm, a thickness of 3.4 mm and
film-coated.
14 film-coated white tablets are packaged in PVC (250 µm)-Aluminum (20 µm) blisters.
Two blisters of 14 tablets are then packaged in a PET (Polyethylene terephthalate) / Aluminum
/ PE (Polyethylene) sachet, which protects the tablets from moisture.
One or three sachets are then packaged in a cardboard box.
Packs containing 28 and 84 film-coated tablets are available.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer
Stragen Nordic A/S
Helsingørsgade 8C
3400 Hillerød
Denmark

Manufacturer
Haupt Pharma Münster GmbH
Schleebrüggenkamp 15
48159 Münster
Germany

This medicinal product is authorized in the Member States of the European Economic Area with the
following denominations:
This leaflet was last updated in 09/2019