Dienterna 2 mg Tablets

DIENTERNA 2 is a hormone preparation indicated for the treatment of endometriosis (painful disorder in which tissue similar to the tissue that normally lines the inside of your womb grows outside your womb). DIENTERNA 2 contains a hormone, the progestogen, dienogest. DIENTERNA 2 tablets cause the shrinking of the endometrial tissue (tissue of the womb) and reduces symptoms associated with endometriosis such as pelvic pain and painful monthly bleedings.

Do not take DIENTERNA 2:

• If you are allergic to dienogest or to any of the components listed in section 6.
• If you are pregnant or think you might be pregnant (see “Pregnancy and breastfeeding”).
• If you are breastfeeding (see “Pregnancy and breastfeeding”).
• If you are suffering from or have a history of having blood clots (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 had arterial diseases, including cardiovascular diseases such as a heart attack, stroke or heart diseases which cause reduced blood supply to the heart (ischaemic heart disease).
• If you have diabetes mellitus (disease causing high blood sugar) and associated diseases of blood vessels.
• If you suffer or have ever suffered from severe liver disease (this applies for as long as it takes for your liver function values to return to normal).
• If you have or ever had a liver cancer.
• If you suffer from or if it is suspected that you have a sex hormone-dependent malignant (harmful) cancer of the breast or the sex organs.
• If you have unexplained vaginal bleeding.

Do not share medicines prescribed for you with any other person. Always use DIENTERNA 2 exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Tablet - taking from the very first pack must start on day one of the menstrual cycle (i.e. the first day of menstrual bleeding/period).

The dosage of DIENTERNA 2 is one tablet daily without any break, taken preferably at the same time each day. 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. You can take DIENTERNA 2 with or without food and with some liquid as needed. Your doctor will tell you how long your treatment with DIENTERNA 2 will last. Do not stop treatment early without discussing it with your doctor. If you have the impression that the effect of DIENTERNA 2 is too strong or too weak, tell your doctor or pharmacist.

If you use more DIENTERNA 2 than you should: In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre.

If you forget to take/missed a dose of DIENTERNA 2: If you forget to take your tablets or missed a dose, DIENTERNA 2 may not work properly and you may not receive the full benefit from it. If you missed a dose(s), take one tablet as soon as you remember and continue the next day to take the tablet at your usual time. Do not take a double dose to make up for forgotten individual doses. A tablet not absorbed due to vomiting or diarrhoea should likewise be replaced by one tablet. If you stop taking/using DIENTERNA 2: Don’t stop taking DIENTERNA 2 without talking to your doctor first.

DIENTERNA 2 can have side effects. Not all side effects reported for DIENTERNA 2 are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking DIENTERNA 2, please consult your health care provider for advice. You may experience changes in your bleeding patterns (menstrual cycle), such as infrequent or frequent bleeding, irregular bleeding, prolonged bleeding, or your periods may stop completely. Tell your doctor if you notice any of the following:

Frequent side effects:

• Weight gain.
• Depressed mood, problems sleeping, nervousness, decreased sex drive and mood changes.
• Headaches and migraine (intense headaches often accompanied by nausea and sensitivity to light and sound).
• Nausea, stomach pain, gassiness, bloating and vomiting.
• Acne and hair loss.
• Back pain.
• Breast discomfort, ovarian cyst (fluid filled sack in or on the surface of an ovary that may cause menstrual irregularities or pain), hot flushes and vaginal bleeding.
• Asthenic conditions, irritability.

Less frequent side effects:

• Anaemia (low red blood cell count).
• Weight loss or increased appetite.
• Anxiety, depression, mood swings.
• Autonomic nervous system imbalance (condition affecting the functioning of the heart, bladder, intestines, sweat glands, pupils, and blood vessels), trouble with attention.
• Dry eyes.
• Tinnitus (ringing or buzzing noise in one or both ears that may be constant or come and go).
• Undetermined circulatory system (blood vessel system) disorder/sickness and rapid and irregular heartbeat (palpitations).
• Low blood pressure (hypotension).
• Difficulty breathing (dyspnoea).
• Diarrhoea, constipation, abdominal discomfort such as stomach pain), gastrointestinal inflammation (inflammation of the digestive system including stomach, intestines), and inflammation of the gums (gingivitis).
• Dry skin, excessive sweating, itchy skin, hirsutism (unwanted male-pattern hair growth on a woman's face, chest and back), breaking nails, dry and flaking scalp (dandruff), skin rash, abnormal hair growth, light sensitivity reaction, pigmentation disorder (affecting skin colour, i.e. development of blotchy, darker or lighter skin or patches of skin).
• Bone pain, muscle cramp, pain in extremity (such as arms, hands legs and feet), heaviness in extremities.
• Urinary tract infection (i.e. kidney-, bladder infection, etc.).
• Vaginal candidiasis (thrush), vaginal dryness or discharge, pain in pelvis, atrophic vulvovaginitis (thinning, drying and inflammation of the vaginal walls), breast mass (lump), fibrocystic breast diseases (fluid filled sacks or scar-like tissue developing in breast causing lumpy or tender breasts), breast hardening.
• Oedema (swelling caused by the accumulation of fluid in a part of the body).

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

Reporting of side effects: If you get 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 to SAHPRA via the 6.04 Adverse Drug Reaction Reporting Form, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of DIENTERNA 2.

Store all medicines out of reach of children. Store at or below 25 °C. Store in the original packaging to protect from light. Do not use after the expiry date stated on the blister pack and the carton. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewage systems (e.g. toilets).