Dienogest Stragen 2mg Prescribing Information

Please refer to the Summary of Product Characteristics (SmPC) before prescribing. 

Name and active ingredient: Dienogest Stragen 2mg Film-Coated Tablets.

Each tablet contains 2mg dienogest.

Indications: Treatment of endometriosis.

Posology and method of administration: One tablet daily without any break, taken preferably at the same time each day with some liquid as needed.

The tablet can be taken with or without food.

Tablets must be taken continuously without regard to vaginal bleeding.

When a pack is finished the next one should be started without interruption.

Treatment can be started on any day of the menstrual cycle.

Any hormonal contraception needs to be stopped prior to initiation of Dienogest Stragen 2mg Film-Coated Tablets.

If contraception is required, non-hormonal methods of contraception should be used (e.g. barrier method). (see SmPC section 4.2).

Contraindications: Dienogest Stragen 2mg Film-Coated Tablets should not be used in the presence of any of the conditions listed and should any of the conditions appear during the use of Dienogest Stragen 2mg Film-Coated Tablets, treatment must be discontinued immediately: active venous thromboembolic disorder, arterial and cardiovascular disease, past or present (e.g. myocardial infarction, cerebrovascular accident, ischemic heart disease), diabetes mellitus with vascular involvement, presence or history of severe hepatic disease as long as liver function values have not returned to normal, presence or history of liver tumours (benign or malignant), known or suspected sex hormone-dependent malignancies, undiagnosed vaginal bleeding or hypersensitivity to the active substance or to any of the excipients listed (see section 6.1 of the SmPC).

Special warnings and precautions for use: Precautions should be taken regarding serious uterine bleeding: If bleeding is heavy and continuous over time, this may lead to anemia (severe in some cases).

In the event of anemia, discontinuation of Dienogest Stragen 2mg Film-Coated Tablets should be considered.

Changes in bleeding pattern: (see SmPC section 4.8). Circulatory disorders: Treatment should be stopped at once if there are symptoms of an arterial or venous thrombotic event or suspicion thereof., tumours: The risk of having breast cancer diagnosed in users of progestogen-only preparations is possibly of similar magnitude to that associated with combined oral contraceptives (COC).

However, for progestogen-only preparations, the evidence is based on much smaller populations of users and so is less conclusive than that for COCs.

These studies do not provide evidence for causation. osteoporosis: In patients who are at an increased risk of osteoporosis a careful risk-benefit assessment should be performed before starting Dienogest Stragen 2mg Film-Coated Tablets because endogenous estrogen levels are moderately decreased during treatment with Dienogest Stragen 2mg Film-Coated Tablets (see section 5.1).

Other conditions (see SmPC section 4.4).

Interactions: Inducers or inhibitors of CYP3A4 may affect the progestogen drug metabolism.

An increased clearance of sex hormones due to enzyme induction may reduce the therapeutic effect of Dienogest Stragen 2mg Film-Coated Tablets and may result in undesirable effects e.g. changes in the uterine bleeding profile.

A reduced clearance of sex hormones due to enzyme inhibition may increase the exposure to dienogest and may result in undesirable effects.

Substances increasing the clearance of sex hormones (diminished efficacy by enzyme-induction), e.g.: phenytoin, barbiturates, primidone, carbamazepine, rifampicin, and possibly also oxcarbazepine, topiramate, felbamate, griseofulvin, and products containing St. John’s wort (Hypericum perforatum). (see SmPC section 4.5).

Fertility, pregnancy and lactation: Dienogest Stragen 2mg Film-Coated Tablets must not be administered to pregnant women because there is no need to treat endometriosis during pregnancy.

Treatment with Dienogest Stragen 2mg Film-Coated Tablets during lactation is not recommended.

Based on the available data, ovulation is inhibited in the majority of patients during treatment with Dienogest Stragen 2mg Film-Coated Tablets.

However, Dienogest Stragen 2mg Film-Coated Tablets is not a contraceptive.

Based on the available data, the menstrual cycle returns to normal within 2 months after cessation of Dienogest Stragen 2mg Film-Coated Tablets treatment. (see SmPC section 4.6).

Adverse reactions: Undesirable effects are more common during the first months after the start of treatment with Dienogest Stragen 2mg Film-Coated Tablets, and subside with continued treatment.

The most commonly reported adverse reactions of Dienogest Stragen 2mg Film-Coated Tablets are (≥1/100 to <1/10): weight increase, depressed mood, sleep disorder, nervousness, loss of libido, altered mood, headache, migraine, nausea, abdominal pain, flatulence, abdominal distension, vomiting, acne, alopecia, back pain, breast discomfort, ovarian cyst, hot flushes, uterine / vaginal bleeding including spotting, asthenic conditions and irritability.

Uncommon (≥1/1000 to <1/100): anemia, weight decrease, increased appetite, anxiety, depression, mood swings, autonomic nervous system imbalance, disturbance in attention, dry eye, tinnitus, unspecific circulatory system disorder palpitations, hypotension, dyspnoea, diarrhoea, constipation, abdominal discomfort, gastrointestinal inflammation, gingivitis, dry skin, hyperhidrosis, pruritus, hirsutism, onychoclasis, dandruff, dermatitis, abnormal hair growth, photosensitivity reaction pigmentation disorder, bone pain, muscle spasms, pain in extremity, heaviness in extremities, urinary tract infection, vaginal candidiasis, vulvovaginal dryness, genital discharge, pelvic pain, atrophic vulvovaginitis, breast mass, fibrocystic breast disease, breast induration, Oedema.

Presentation: 14 white film-coated tablets packed in PVC (250 μm)- Aluminium (20 μm) push-through-blister.

Two blisters of 14 tablets are then packed in a PET (Polyethylene Terephthalate)/Aluminium/PE (Polyethylene) pouch, which protects tablets from humidity.

1 or 3 pouches are packed in a carton box.

Pack Size: 28 and 84 film-coated tablets.

NHS Cost: £20.50 (28 pack), £61.50 (84 pack).

Legal Classification: POM.

MA Number: PL 21844/0037.

Distributed by Kent Pharma UK Ltd.

Date of preparation: Dec 2024.

UK24/012/01 SmPC June 2024.

Adverse events should be reported: Reporting forms and information can be found at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to Kent Pharma UK Ltd on 01233 506574 or medical@kent-athlone.com. For a copy of the SmPC or further medical information, please contact: medical@kent-athlone.com. Additional information available on request.