Dienogest 2 mg Tablets

DIENOGEST 2 mg DYNA contains a hormone, the progestogen dienogest, which is a hormone preparation indicated for the long-term treatment of endometriosis (painful symptoms of displaced tissue of the lining of the womb) in adolescents after their first menstrual bleeding from 12 years of age onward and in adults. DIENOGEST 2 mg DYNA tablets cause the shrinking of the endometrial tissue and reduces associated complaints such as pelvic pain and painful monthly bleedings.

Do not take DIENOGEST 2 mg DYNA :

• if you are hypersensitive (allergic) to dienogest, or to any of the other ingredients of DIENOGEST 2 mg DYNA (see section 6)
• if your blood can form blood clots easily (thrombophilia) or if you suffer from blood clot(s) (thromboembolic disorder) in your veins. . If a 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 ever had several arterial diseases, including cardiovascular diseases such as a heart attack, stroke (such as transient ischaemic attack or small reversible stroke) or heart diseases which cause reduced blood supply to the heart (angina pectoris)
• if you have diabetes mellitus with blood vessel damage
• if you suffer or have ever suffered from any liver disease (and 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.

If any of these conditions appear for the first time while taking DIENOGEST 2 mg DYNA, stop taking it at once and consult your doctor.

Warnings and precautions

Take special care with DIENOGEST 2 mg DYNA: Because DIENOGEST 2 mg DYNA is not supposed to be used in pregnancy, you are advised to use non-hormonal method for contraception (barrier contraception e.g. condom) to prevent an unwanted pregnancy. You must not use sex-hormone containing contraceptives of any form (tablet, patch, intrauterine system) while taking DIENOGEST 2 mg DYNA. Do not use the rhythm or temperature methods. These methods can be unreliable because DIENOGEST 2 mg DYNA alters the usual changes in temperature and cervical mucus that occur during the menstrual cycle.

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

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 DYNA 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. Your doctor will tell you how long your treatment with DIENOGEST 2 mg DYNA will last. Do not stop treatment early because your original endometriosis complaints may re-occur.

If you have the impression that the effect of DIENOGEST 2 mg DYNA is too strong or too weak, tell your doctor or pharmacist.

If you take more DIENOGEST 2 mg DYNA 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 DIENOGEST 2 mg DYNA

The efficacy of DIENOGEST 2 mg DYNA 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 DYNA

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

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

If any of the following happens, stop using DIENOGEST 2 mg DYNA and tell your doctor immediately or go to the casualty department at your nearest hospital:

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

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to DIENOGEST 2 mg DYNA. 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:

• possible signs of thrombosis (occurs when blood clots block veins or arteries) which include breathlessness, 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.
• unspecified circulatory problems or palpitations (e.g. transient feeling of fatigue or dizziness).

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
• feeling depressed, problems sleeping, nervousness, loss of interest in sex, changed mood, irritability
• headache, migraine
• nausea, abdominal pain, farting, swollen tummy or vomiting
• acne, hair loss
• back pain
• breast discomfort, ovarian cyst, hot flushes, vaginal bleeding or spotting
• lack of strength, feeling weak.

Less frequent side effects:

• 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 (ringing or buzzing in the ears)
• low blood pressure
• shortness of breath
• diarrhoea, constipation, stomach ache, 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)

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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects to SAHPRA via Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on SAHPRA website.By reporting side effects, you can help provide more information on the safety of DIENOGEST 2 mg DYNA. An email can be sent directly to the company, [email protected] to ensure safety of the product.

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. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).