Indications & Uses
Dinogest 1 is indicated for:
Pharmacology
Dienogest acts as an agonist at the progesterone receptor (PR). Its affinity for the receptor is weak and comparable to that of progesterone, but its progestagenic effect in the endometrium is very potent, and after prolonged use it causes endometrial atrophy. It has antiproliferative, immunologic and antiangiogenic effects on endometrial tissue.
Dienogest lowers the body's own production of oestradiol, so the trophic effects of oestradiol on both the eutopic and ectopic endometrium are suppressed. When dienogest is given continuously, it creates a hyperprogestogenic and moderately hypoestrogenic endocrine environment, and this leads to initial decidualization of the endometrial tissue. It also acts as an antagonist at androgen receptors, which improves androgenic symptoms such as acne and hirsutism [A16570].
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
You can start taking the tablets on any day of the menstrual cycle. The dose of Dienogest is 2 mg daily, with no break, and it's best to take it at about the same time each day with a little liquid if needed. Keep taking the tablet whether or not there is vaginal bleeding. When one pack is finished, start the next one straight away without any gap.
If a tablet is missed, the woman should take one 2 mg tablet as soon as she remembers, and then go on the next day to take her tablet at the usual time. If a tablet is not absorbed because of vomiting or diarrhea, it should likewise be replaced by 2 mg.
Side Effects
Undesirable effects are more common during the 1st months after you start taking Dienogest, and they ease as treatment continues. The following have been reported in people using Dienogest. The ones reported most often during treatment, and considered at least possibly related to the medicine, were headache (9%), breast discomfort (5.4%), depressed mood (5.1%) and acne (5.1%). Nervous system disorders: headache and migraine. Cardiac disorders: unspecified circulatory system disorder and palpitations, both uncommon. Vascular disorders: hypotension, which is uncommon. Gastrointestinal disorders: nausea, abdominal pain and flatulence, which are common. Metabolism and nutrition disorders: weight increase (3.6%). Psychiatric disorders: depressed mood, irritability, nervousness and altered mood.
Cautions & Contraindications
Warnings & Precautions
Pregnancy must be excluded before Dienogest treatment is started. While you are on treatment, use a nonhormonal method of contraception (for example, a barrier method) if you need contraception. Dienogest is a progestogen-only preparation, so the special warnings and precautions that apply to other progestogen-only preparations can be assumed to apply to Dienogest too. Changes in Bleeding Pattern Dienogest treatment affects the menstrual bleeding pattern in the majority of women. Hepatic Impairment Dienogest is contraindicated in patients with present or past severe hepatic disease. Impairment of Fertility Based on the data available, ovulation is inhibited in the majority of patients during treatment with Dienogest. Even so, Dienogest is not a contraceptive. If contraception is required, a nonhormonal method should be used.
Contraindications
Don't use Dienogest if you are hypersensitive to dienogest or to any of the excipients in Dienogest. It should also not be used if you have any of these conditions: active venous thromboembolic disorder, arterial and cardiovascular disease (for example myocardial infarction, cerebrovascular accident or ischemic heart disease), or diabetes mellitus with vascular involvement. The same applies if you have, or have had, severe hepatic disease, as long as your liver function values have not returned to normal, and if you have, or have had, liver tumors (benign or malignant). Known or suspected sex hormone-dependent malignancies and undiagnosed vaginal bleeding are also reasons not to use it.
Pregnancy & Breastfeeding
There isn't much data on the use of Dienogest in pregnant women. Animal studies, and data from women who were exposed to Dienogest during pregnancy, show no special risks for the pregnancy, for the development of the embryo or fetus, for the birth, or for the child's development after birth. Even so, Dienogest should not be given to pregnant women, because endometriosis doesn't need to be treated during pregnancy.
Treatment with Dienogest is not recommended during breastfeeding. Its physicochemical properties and animal data point to Dienogest passing into breast milk. A decision has to be made either to stop breastfeeding or to stay off Dienogest therapy, weighing the benefit of breastfeeding for the child against the benefit of the treatment for the woman.
⚠️ Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
Use in Special Populations
Use in Children: Dienogest is not indicated in children before menarche. Its safety and efficacy in adolescents (from menarche to 18 years) have not been established yet.
Use in the Elderly: There is no relevant indication for Dienogest in the geriatric population.
Overdose
Acute toxicity studies with Dienogest did not show any risk of acute adverse effects if someone accidentally takes a multiple of the daily therapeutic dose. There is no specific antidote. Dienogest at 20-30 mg/day (10-15 times higher than the usual dose of Dienogest) was very well tolerated over 24 weeks of use.
⚠️ In an emergency call 999 or go to the nearest hospital emergency department.
Storage
Store Dienogest below 30°C, and keep it away from light and moisture. Keep it out of the reach of children.
Drug Interactions
Common questions about Dinogest 1 1 mg
What is Dinogest 1 1 mg Tablet?
Dinogest 1 1 mg Tablet is a medicine that contains Dienogest. It is made by Nuvista Pharma PLC. It belongs to the Female Sex hormones group of medicines.
What is Dinogest 1 used for?
Dinogest 1 is used for: Pain.
What are the side effects of Dinogest 1?
Undesirable effects are more common during the 1st months after you start taking Dienogest, and they ease as treatment continues. The following have been reported in people using Dienogest.
Can I take Dinogest 1 during pregnancy or while breastfeeding?
There isn't much data on the use of Dienogest in pregnant women. Animal studies, and data from women who were exposed to Dienogest during pregnancy, show no special risks for the pregnancy, for the development of the embryo or fetus, for the birth, or for the child's development after birth. Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
What happens if I take too much Dinogest 1?
Acute toxicity studies with Dienogest did not show any risk of acute adverse effects if someone accidentally takes a multiple of the daily therapeutic dose. There is no specific antidote. In an emergency call 999 or go to the nearest hospital emergency department.
How should I store Dinogest 1?
Store Dienogest below 30°C, and keep it away from light and moisture. Keep it out of the reach of children.
Can I take other medicines with Dinogest 1?
Some medicines can interact with Dienogest, for example: Erythromycin, Fluconazole, Clarithromycin, Itraconazole, Roxithromycin, Cimetidine. Tell your doctor or pharmacist about every medicine you take.
Do I need a prescription for Dinogest 1?
Dinogest 1 is a prescription (Rx) medicine. Take it as your doctor advises.