Rovulum 2 mg Film-Coated Tablets

ROVULUM belongs to a group of medicines called progestogens. ROVULUM contains a hormone, the progestogen dienogest. ROVULUM is a medicine used for the treatment of endometriosis (painful symptoms due to displaced tissue of the lining of the womb).

Do not take ROVULUM:

• if you are hypersensitive (allergic) to dienogest or any of the other ingredients of ROVULUM (listed in section 6),
• if you are pregnant or think you might be pregnant,
• if you are breastfeeding,
• if you are suffering from a blood clot (thromboembolic disorder) in your veins,
• if you 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),
• if you have diabetes with blood vessel damage,
• if you have or have ever had severe liver disease (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,
• if you have or have ever had a benign (non-cancerous) or malignant (cancerous) liver tumour,
• if you suffer or have ever suffered, or if it is suspected that you suffer from a malignant sex-hormone dependent tumour such as cancer of the breast or the genital organs,
• if you have any unexplained vaginal bleeding.

Do not share medicines prescribed for you with any other person. Always take ROVULUM exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The usual dose of ROVULUM is 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. Your doctor will tell you how long your treatment with ROVULUM will last. Do not stop treatment early. If you have the impression that the effect of ROVULUM is too strong or too weak, tell your doctor or pharmacist.

If you take more ROVULUM than you should

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre.

If you forget to take ROVULUM

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

ROVULUM can have side effects. Not all side effects reported for ROVULUM are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking ROVULUM, please consult your healthcare provider for advice. If any of the following happens, stop taking ROVULUM and tell your doctor immediately or go to the casualty department at your nearest hospital:

• Swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing,
• rash or itching.

These are all very serious side effects. If you have them, you may have had a serious reaction to ROVULUM. You may need urgent medical attention or hospitalisation. Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• Chest pain (angina), changes in the way your heart beats (heart palpitations), for example, if you notice it beating faster,
• difficulty in breathing,
• breast cancers,
• blood clots that can lead to a stroke,
• blood disorders that lead to tiredness,
• suicidal behaviour or thoughts of harming or killing yourself.

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

Frequent side effects:

• 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.

Less frequent side effects:

• Anemia,
• weight loss or increase in appetite,
• anxiety, depression or mood swings,
• imbalance in the autonomic nervous system (controls unconscious bodily functions, e.g. perspiration) or disturbed attention,
• dry eye,
• tinnitus (ringing in the ears),
• unspecific circulatory problems,
• low blood pressure,
• shortness of breath,
• diarrhoea, constipation, abdominal discomfort, inflammation of the stomach and intestines (gastrointestinal inflammation),
• inflammation of the gums (gingivitis),
• dry skin, excessive sweating, severe itching of the whole body, male pattern hair growth (hirsutism),
• brittle nails, dandruff, dermatitis, abnormal hair growth, hypersensitive response to light or problems with skin pigmentation,
• pains in your bones, muscle spasms, pains and/or a sensation of heaviness in your arms and hands or legs and feet,
• urinary tract infection,
• vaginal thrush, dryness of the genital area, vaginal discharge, pelvic pain, atrophic inflammation of the genitals with discharge (atrophic vulvovaginitis), or a lump or lumps in the breast,
• swelling due to fluid retention,
• additional side effects in adolescents (ages 12 to under 18 years): loss of bone density.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Store all medicines out of reach of children. Store at or below 25 °C. Do not store in a bathroom. Do not use after the expiry date stated on the label. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).