Microval 0,03 mg Tablets

MICROVAL tablets are indicated for the control of fertility.

Contraindications

MICROVAL is contraindicated in:

• Patients with hypersensitivity to levonorgestrel or to any of the excipients in MICROVAL (see section 6.1).
• Known or suspected pregnancy.
• Presence or history of hepatic disease as long as liver function values have not returned to normal (active liver disease).
• History of or existing thromboembolic processes (e.g. stroke, myocardial infarction, previous proven deep-vein thrombosis (DVT), previous pulmonary embolism and inherited thrombophilia).
• Presence or history of liver tumours (benign or malignant).
• Depression not well controlled with treatment.
• A history of depression with the use of hormonal contraceptives.
• Undiagnosed abnormal vaginal bleeding.
• Severe diabetes with vascular changes.
• Recurrent cholestatic jaundice or markedly impaired liver-function.
• Hormone-dependent neoplasms (e.g. current or personal and family history of breast cancer).
• History of non-cancerous breast diseases (atypical hyperplasia or lobular carcinoma in situ).
• Severe migraine or cerebrovascular insufficiency.
• Patients known with inherited genetic mutations: BRCA1 and BRCA2 genes.
• Early menstrual periods (before the age of 12 years).
• Previous treatment using radiation therapy to the chest or breast.
• Previous exposure to diethylstilbestrol (DES).

Warnings and precautions

CIGARETTE SMOKING INCREASES THE RISK OF SERIOUS CARDIOVASCULAR SIDE EFFECTS FROM THE USE OF ORAL CONTRACEPTIVES, LIKE MICROVAL. THE RISK INCREASES WITH AGE AND WITH HEAVY SMOKING (15 OR MORE CIGARETTES PER DAY) AND IS MARKED IN WOMEN OVER 35 YEARS OF AGE. WOMEN WHO USE ORAL CONTRACEPTIVES SUCH MICROVAL SHOULD BE STRONGLY ADVISED NOT TO SMOKE.

MICROVAL must be taken exactly as directed and at intervals not exceeding 24 hours. Patients should be instructed to take the tablets at the same time every day, preferably after the evening meal or at bedtime. The patient begins MICROVAL on day 1 of her menstrual cycle, i.e. the first day of bleeding. One tablet is taken every day at the same time, without interruption, as long as contraception is desired. Tablets should be taken on this continuous daily regimen whether or not bleeding occurs.

Summary of the safety profile

The most commonly reported adverse reactions with progestogen-only pills including MICROVAL are uterine/vaginal bleeding including spotting, menorrhagia and/or metrorrhagia and amenorrhea. They occur in ≥ 10 % of users.

Tabulated list of adverse reactions

System organ class Frequent Less frequent Frequency unknown (cannot be estimated from the available data)

• Neoplasm benign, malignant and unspecified (including cysts and polyps) Hepatic tumours, breast tumours
• Immune system disorders Allergic reactions
• Metabolism and nutrition disorders Mass gain, increased or decreased weight
• Psychiatric disorders Severe depression with a higher risk of suicidal thoughts/behavior and suicide, mood changes, depressed mood.
• Nervous system disorders Migraine/headache, dizziness
• Vascular disorders Hypertension, venous thromboembolic disorders, arterial thromboembolic disorders, strokes (e.g. transient ischemic attack, ischemic stroke, haemorrhagic stroke)
• Gastrointestinal disorders Lower abdominal pain, nausea, vomiting, gastrointestinal irritation, fluid retention, diarrhoea
• Hepato-biliary disorders Gall bladder disease
• Skin and subcutaneous tissue disorders Rash, urticaria, pruritus, skin pigmentation
• Reproductive system and breast disorders Prolonged amenorrhea, vaginal candidiasis, changes in vaginal bleeding pattern, decreased or increased libido, pelvic pain, dysmenorrhea
• General disorders and administrative site conditions Fatigue, face oedema

Store at or below 25 °C in a cool dry place. Keep the blisters in the carton until required for use.