Each film-coated tablet contains: Dienogest 2 mg

Donnagest is a preparation for the treatment of endometriosis (painful symptoms due to displaced tissue of the lining of the womb). Donnagest contains a hormone, the progestogen dienogest.

You can start treatment with Donnagest on any day of your natural cycle. Adults: take one tablet every day, preferably at the same time with some liquid as needed. When a pack is finished the next one should be started without interruption. Continue to take the tablets also on days of menstrual bleeding. There is no experience with Donnagest treatment > 15 months in patients with endometriosis. If you take more Donnagest than you should: There have been no reports of serious harmful effects from taking too many Donnagest tablets at one time. If you forget to take Donnagest or suffer from vomiting or diarrhea: Donnagest will be less effective if ycu miss a tablet. If you miss one or more tablets, take one tablet only as soon as you remember, and then continue next day taking the tablet at your usual time. If you vomit within 3-4 hours of taking Donnagest or you have severe diarrhea, there is a risk that the active substance in the tablet will not be taken up by your body. The situation is almost the same as forgetting a tablet. After vomiting or diarrhea within 3-4 hours of taking Donnagest, 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 Donnagest: If you stop taking Donnagest, your original endometriosis symptoms may return. Do not take Donnagest if you:
  • are suffering from a blood clot (thromboembolic disorder) in your veins. This may occur, for example, in the blood vessels of the legs (deep vein thrombosis) or the lungs (pulmonary embolism).
  • have or have ever had a severe arterial disease, including cardiovascular disease, such as a heart attack, stroke or heart disease which causes a reduced blood supply (angina pectoris).
  • have diabetes with blood vessel damage
  • have or have ever had severe liver diseases (and your liver function values have not returned to normal). symptoms of liver disease may be yellowing of the skin and/or itching of the whole body
  • have or have ever had a benign or malignant liver tumor suffer or have ever suffered, or if it is suspected that you suffer from a malignant sex-hormone dependent tumor such as cancer of the breast or the genital organs
  • have any unexplained vaginal bleeding
  • are allergic (hypersensitive) to dienogest or any of the other ingredients of this medicine
If any of these conditions appear for the first time while using Donnagest, stop taking it at once and consult your doctor.
Like all medicines, this medicine can cause side effects, although not everybody gets them. These effects are more common during the first months after start of intake of Donnagest and usually disappear with continued use. You may also experience changes in your bleeding pattern, such as spotting, irregular bleeding or your periods may stop completely. Common:
  • Weight gain
  • Depressed mood, problems sleeping, nervousness, loss of interest in sex, or changed mood
  • Headache or migraine
  • Nausea, abdominal pain, wind, swollen tummy or vomiting
  • Acne or hair loss
  • back pain
  • Breast discomfort, ovarian cyst or hot flushes
  • Uterine/vaginal bleeding including spotting
  • Weakness or irritability
  • severe pain and/or swelling in one of your legs
  • sudden severe pain in the chest which may reach the left arm
  • sudden breathlessness
  • sudden cough without an obvious cause
  • any unusual, severe or long-lasting headache or worsening of migraine
  • partial or complete blindness or double vision
  • difficulty in speaking or inability to speak
  • giddiness or fainting
  • weakness, strange feeling, or numbness in any part of the body

Always tell your doctor which medicines or herbal products you are already using. Also tell any other doctor or dentist who prescribes another medicine (or the pharmacist) that you are taking Donnagest.
Some medicines can have an influence on the blood levels of Donnagest and can make it less effective, or can cause undesirable 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 infections (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors such as
    ritonavir, nevirapine, efavirenz)
  • Fungal infections (griseofulvin, ketoconazole)
  • The herbal remedy St. John’s wort
You must not use hormonal contraceptives of any form (tablet, patch, intrauterine system) while taking Donnagest. Donnagest is NOT a contraceptive. If you want to prevent pregnancy, you should use condoms or other non- hormonal contraceptive precautions. In some situations, you need to take special care while using donnagest, and your doctor may need to examine you regularly. Tell your doctor if any of the following conditions applies to you: If you:
  • have ever had a blood clot (venous thromboembolism) or anyone in your immediate family has had a blood clot at a relatively early age
  • have a close relative who has had breast cancer
  • have ever suffered from depression
  • have high blood pressure or develop high blood pressure while taking donnagest
  • develop a liver disease while taking donnagest . Symptoms may include yellowing of the skin or eyes or itching all over your
body. Inform your doctor also if such symptoms occurred during a previous pregnancy
  • have diabetes or had diabetes temporarily during previous pregnancy
  • have ever had chloasma (golden-brown patches on the skin, particularly of the face); if so, avoid too much exposure to the sun
or ultraviolet radiation
  • suffer from pain in your lower abdomen while taking donnagest. While taking donnagest your chance of becoming pregnant is reduced because donnagest may affect ovulation.
If you become pregnant while taking donnagest you are at a slightly increased risk of having an extra uterine pregnancy (the embryo develops outside the womb). Tell your doctor before you start taking donnagest, if you had an extra uterine pregnancy in the past or have an impaired function of the Fallopian tubes. During Donnagest treatment, you should avoid drinking grapefruit juice, because this may increase the levels of Donnagest in your blood. This may increase the risk of getting side effects. If you cannot tolerate certain sugars, please contact your doctor before you take Donnagest. Children and adolescents: Donnagest is not for use in girls before menarche (first menstrual bleeding). The use of Donnagest may affect the strength of the bone of adolescents (12 to under 18 years). If you are under 18 your doctor will, therefore, carefully weigh the benefits and risks of using Donnagest for you as an individual patient, taking into account possible risk factors for bone loss (osteoporosis).

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

Store below 30° C and protect from light and moisture.

Donnagest is supplied in a blister pack containing 28 film-coated tablets

Haupt Pharma Münster, Germany

Farnoush Darou Teb Co.