Dienogest 2 mg Tablets

DIENOGEST 2 mg PHARMC contains a hormone, the progestogen dienogest. DIENOGEST 2 mg PHARMC is a hormone preparation indicated for the treatment of the painful symptoms of endometrial lesions (displaced tissue of the lining of the womb). DIENOGEST 2 mg PHARMC tablets cause the shrinking of the endometrial tissue and reduces associated complaints such as pelvic pain and painful monthly bleedings. Safety and efficacy beyond 24 months have not been established.

Do not take DIENOGEST 2 mg PHARMC:

• if you are hypersensitive (allergic) to dienogest or any of the other ingredients of DIENOGEST 2 mg PHARMC (listed in section 6),
• if you are pregnant or think you might be pregnant,
• if you are breastfeeding,
• if you are suffering from blood clot (thromboembolic disorder) in your veins. Thrombosis is the formation of a blood clot which may block a blood vessel. Thrombosis sometimes occurs in the deep veins of the legs (deep vein thromboembolism). If this blood clot breaks away from the veins where it is formed, it may reach and block arteries of the lungs, causing a so-called “pulmonary embolism”. This may occur for example in the blood vessels of the legs (deep vein thrombosis) and the lungs (pulmonary embolism),
• if you have or have ever had several arterial diseases, including cardiovascular diseases such as a heart attack, stroke or heart diseases which cause reduced blood supply to the heart (angina pectoris),
• if you have diabetes mellitus (a group of diseases that affect how your body uses blood sugar),
• if you suffer or have ever suffered from severe liver disease (as long as your liver function values have not returned to normal). Symptoms of liver diseases may be, for instances, yellowing of the skin and/or itching of the whole body,
• if you have or have ever had a non-invasive or invasive cancer of the liver,
• if you suffer or have ever suffered from invasive sex hormone-dependent tumour such as cancer of the breast or the genital organs,
• if you have unexplained vaginal bleeding.

Warnings and precautions

You must not use hormonal contraceptives of any form (tablet, patch, intrauterine system) while taking DIENOGEST 2 mg PHARMC. DIENOGEST 2 mg PHARMC 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 taking DIENOGEST 2 mg PHARMC, 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;
• If you have a close relative who has had breast cancer;
• If you have ever suffered from depression;
• If you have high blood pressure or develop high blood pressure while taking DIENOGEST 2 mg PHARMC;
• If you develop a liver disease while taking DIENOGEST 2 mg PHARMC. 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;
• If you have diabetes or had diabetes temporarily during previous pregnancy;
• If you 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;
• If you suffer from pain in your lower abdomen while taking DIENOGEST 2 mg PHARMC.

Do not share medicines prescribed for you with any other person. Always take DIENOGEST 2 mg PHARMC exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure.

The following statement applies to DIENOGEST 2 mg PHARMC unless otherwise prescribed by your doctor. Please observe these instructions for use, otherwise you will not fully benefit from DIENOGEST 2 mg PHARMC.

Tablet-taking from the very first pack has to start on day 1 of the natural cycle (i.e. the first day of your menstrual bleeding). The dosage of DIENOGEST 2 mg PHARMC is one tablet daily without any break, taken preferably at the same time each day with some liquid as needed. Tablets must be taken throughout 28 days without regard to bleeding. This means that after the first pack has been finished, the next should be started without interruptions.

If you take more DIENOGEST 2 mg PHARMC than you should you should not take more than your doctor tells you to. In the event of overdose, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre.

If you forget to take DIENOGEST 2 mg PHARMC /If you suffer from vomiting and/or diarrhoea: The efficacy of DIENOGEST 2 mg PHARMC may be reduced in the event of missed tablets, vomiting and/or diarrhoea (if occurring within 3 to 4 hours after tablet taking). In the event of missed tablet(s), you should take one tablet only, as soon as you remember, and should then continue the next day to take the tablet at your usual time. A tablet not absorbed due to vomiting or diarrhoea should likewise be replaced by one tablet. Do not take a double dose to make up for forgotten individual doses.

If you stop taking DIENOGEST 2 mg PHARMC: If you stop taking DIENOGEST 2 mg PHARMC, your original endometriosis complaints may re-occur.

DIENOGEST 2 mg PHARMC can have side effects. Not all side effects reported for DIENOGEST 2 mg PHARMC are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking DIENOGEST 2 mg PHARMC, please consult your health care provider for advice.

If any of the following happens, stop taking DIENOGEST 2 mg PHARMC 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 DIENOGEST 2 mg PHARMC. You may need urgent medical attention or hospitalisation.

Stop taking DIENOGEST 2 mg PHARMC and see your doctor immediately if you notice possible signs of thrombosis which include:

• breathelessness;
• an unusual cough;
• severe pain in the chest which may reach the left arm;
• any unusual, severe or prolonged headache or migraine attack;
• partial or complete loss of vision, or double vision;
• slurring or speech disability;
• sudden changes to your hearing, sense of smell or taste;
• dizziness or fainting;
• weakness or numbness in any part of your body;
• severe pain in your abdomen;
• severe pain or swelling in either of your legs.

It is also important to immediately tell your doctor if you notice any of the following:

• a lump in your breast;
• unusual, heavy vaginal bleeding;
• other abdominal complaints that are different to the symptoms you commonly experience from your endometriosis.

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

Tell your doctor if you notice any of the following:

• Frequent weight gain;
• depressed mood, problems sleeping, nervousness, loss on 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 (asthenic conditions) or irritability.

Less frequent:

• anaemia;
• weight loss or increased appetite;
• anxiety, depression or mood swings;
• imbalance in the autonomic nervous system (controls unconscious bodily functions e.g. perspiration) or disturbed attention;
• dry eyes;
• tinnitus;
• unspecified circulatory problems or palpitations (e.g. transient feeling of fatigue or dizziness);
• 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, itching of the whole body, male pattern hair growth (hirsutism), brittle nails, dandruff, dermatitis, abnormal hair growth, hypersensitive response to light or problem with skin pigmentation (e.g. patches of darker pigmentation in the facial area);
• pain in your bones, muscle spasm, pains and/or 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 (breast mass, fibrocystic breast disease, breast induration);
• swelling due to fluid retention.

Additional side effects in adolescents (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.
• Store in the original package in order to protect from light.
• Do not use after the expiry date stated on the carton or label.
• Return all unused medicine to your pharmacist.
• Do not dispose of unused medicine in drains or sewerage systems (e.g., toilets).