MINULET

0.075 / 0.03 MG / MG · comprime enrobe · box 21 tablets

Reference dated : 2017-12-18. Confirm price and availability with a pharmacist.

Public price

76,60 MAD

Composition and presentation

MINULET — GESTODENE / ETHINYLESTRADIOL. Listed presentation: 0.075 / 0.03 MG / MG · COMPRIME ENROBE · 1 BOITE 21 COMPRIME.

Full clinical reference

Additional sections are available in French. Read the original document; the information concerns the French reference product.

Uses

Oral hormonal contraception.

The decision to prescribe GESTODENE/ETHINYLESTRADIOL EG must be made taking into account the patient's risk factors, in particular her risk factors for venous thromboembolism (VTE), as well as the risk of VTE associated with GESTODENE/ETHINYLESTRADIOL EG in comparison to other CHCs (Combined Hormonal Contraceptives) (see sections 4.3 and 4.4).

Pregnancy and breastfeeding

Pregnancy

GESTODENE/ETHINYLESTRADIOL EG is not indicated during pregnancy. In case of discovery of a pregnancy while taking this medicine, its use must immediately be interrupted.

Many epidemiological studies have not revealed an increase in the risk of congenital anomalies in children born to women who used an oral contraceptive before pregnancy.

No teratogenic effect has been observed when a combined oral contraceptive was taken by mistake at the beginning of pregnancy.

The increased risk of TEV in the postpartum period must be taken into account when resuming GESTODENE/ETHINYLESTRADIOL EG (see sections 4.2 and 4.4).

Breastfeeding

In case of breastfeeding, the use of this medicine is not recommended due to the passage of estroprogestogens into breast milk.

If the woman wishes to breastfeed, another method of contraception must be offered.

Driving

No study on the ability to drive and use machines has been conducted. No effects on the ability to drive and use machines have been observed in COC users.

Adverse effects

Description of particular adverse effects

An increase in the risk of arterial and venous thrombotic and thrombo-embolic events, including myocardial infarction, stroke, transient ischemic attacks, venous thrombosis and pulmonary embolism, has been observed in women using CHCs; this is addressed in more detail in section 4.4.

The following adverse effects have been observed during treatment with oral estrogen-progestogen contraceptives:

For serious adverse effects, such as venous and arterial thromboembolic accidents, cervical cancers, breast cancers and malignant hepatic tumours, see section 4.4.

	Common (≥1/100 and <1/10)	Uncommon (≥1/1000 and <1/100)	Rare (≥1/10 000 and <1/1000)	Very rare (<1/10 000)		Frequency unknown
Benign, malignant and unspecified tumours (incl. cysts and polyps)				Hepatocellular carcinoma, benign hepatic tumours (e.g.: focal nodular hyperplasia, hepatic adenoma)
Infections and infestations	Vaginitis including vaginal candidiasis
Immune system disorders			Anaphylactic reactions with very rare cases of urticaria, angioedema, severe circulatory and respiratory disorders	Exacerbation of systemic lupus erythematosus		Worsening of symptoms of hereditary or acquired angioedema
Metabolism and nutrition disorders		Change in appetite (increase or decrease)	Glucose intolerance	Exacerbation of porphyria
Psychiatric disorders	Mood change including depression, change in libido
Nervous system disorders	Nervousness, dizziness			Exacerbation of chorea
Eye disorders			Irritation by contact lenses	Optic neuritis
Vascular disorders		Hypertension	Venous thromboembolism and arterial thromboembolism	Worsening of varices
Gastrointestinal disorders	Nausea, vomiting, abdominal pain	Abdominal cramps, bloating		Ischaemic colitis		Inflammatory bowel disease (Crohn's disease, ulcerative colitis)
Hepatobiliary disorders			Cholestatic jaundice	Pancreatitis biliary lithiasis, cholestasis		Hepatocellular damage (e.g.: hepatitis, abnormal liver function)
Skin and subcutaneous tissue disorders	Acne	Rashes, chloasma (melasma) with risk of persistence, hirsutism, alopecia	Erythema nodosum	Erythema multiforme
Renal and urinary tract disorders					Haemolytic uraemic syndrome
Reproductive system and breast disorders	Pain, tension, swelling and breast secretions, dysmenorrhoea, change in menstruation, change in ectropion and vaginal secretions, amenorrhoea
General disorders and administration site conditions	Water retention/oedema Change in weight (increase or decrease)
Investigations		Change in plasma lipids, including hypertriglyceridemia, increase in blood pressure		Decrease in serum folate levels

Reporting of suspected adverse effects

Reporting suspected adverse effects after medicinal product authorization is important. It allows for continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare professionals report any suspected adverse effect via the national reporting system: French National Agency for Medicines and Health Products Safety (ANSM) and the network of Regional Pharmacovigilance Centres - Website: https://signalement.social-sante.gouv.fr/

Read the French reference

Hospital price

50,70 MAD

Type

Originator

References and update dates

CNOPS Referentiel des medicaments · 2017-12-18

Product and price reference

This information is informational and must be confirmed by a pharmacist or doctor. Do not change medicine or dosage based only on this page.

Price history

Reference price recorded since 2017-12-18: 76,60 MAD

Referenced presentations and strengths

MINULET

0,075 MG / 0,03 MG · comprime enrobe · box of 21

76,60 MAD

Same ingredient, strength and form

This grouping does not establish interchangeability.

MONEVA

0.075 / 0.03 MG / MG · comprime enrobe · box 21 tablets enrobe

62,90 MAD

Other strengths and forms

Routes and instructions may differ.