DIANETTE

Method of Administration Oral use Dosage regimen Dianette inhibits ovulation and thereby prevents conception. Patients who are using Dianette should not therefore use an additional hormonal contraceptive, as this will expose the patient to an excessive dose of hormones and is not necessary for effective contraception.

First treatment course:

One tablet daily for 21 days, starting on the first day of the menstrual cycle (the first day of menstruation counting as Day 1).

Subsequent courses:

Each subsequent course is started after 7 tablet-free days have followed the preceding course. When the contraceptive action of Dianette is also to be employed, it is essential that the above instructions be rigidly adhered to. Should bleeding fail to occur during the tablet-free interval, the possibility of pregnancy must be excluded before the next pack is started.

When changing from an oral contraceptive and relying on the contraceptive action of Dianette, follow the instructions given below: Changing from 21-day combined oral contraceptives: The first tablet of Dianette should be taken on the first day immediately after the end of the previous oral contraceptive course.

Additional contraceptive precautions are not required.

Changing from a combined Every Day pill (28 day tablets):

Dianette should be started after taking the last hormone containing tablet from the Every Day Pill pack. The first Dianette tablet is taken the next day. Additional contraceptive precautions are not then required.

Changing from a progestogen-only pill (POP):

The first tablet of Dianette should be taken on the first day of bleeding, even if a POP has already been taken on that day. Additional contraceptive precautions are not then required. The remaining progestogen-only pills should be discarded.

Post-partum and post-abortum use:

After pregnancy, Dianette can be started 21 days after a vaginal delivery, provided that the patient is fully ambulant and there are no puerperal complications. Additional contraceptive precautions will be required for the first 7 days of pill taking.

Summary of safety profile The most commonly reported adverse reactions with Dianette are nausea, abdominal pain, increased weight, headache, depressed mood, altered mood, breast pain, breast tenderness. They occur in ≥ 1 % of users.

4). Tabulated list of adverse events Adverse events reported in clinical trials System Organ Class Common (≥ 1/100 to <1/10) Uncommon (≥ 1/1000 to <1/100) Rare (≥1/10,000 to < 1/1000) Adverse events reported post marketing Eye disorders contact lens intolerance Gastrointestinal disorders nausea, abdominal pain vomiting, diarrhea Immune system disorders hypersensitivity exacerbation of symptoms of hereditary and acquired angioedema Investigations weight increased weight decreased Metabolism fluid hypertriglyceridemia and nutrition disorders retention Nervous system disorders headache migraine exacerbation of chorea Gastrointestinal disorders Crohn’s disease, ulcerative colitis Hepatobiliary disorders liver function disturbances Psychiatric disorders depressed mood, mood altered libido decreased libido increased Reproductive system and breast disorders breast pain, breast tenderness breast hypertrophy vaginal discharge, breast discharge reduced menstrual flow, spotting, breakthrough bleeding and missed withdrawal bleeding, post pill amenorrhoea Skin and subcutaneous tissue disorders rash, urticaria erythema nodosum, erythema multiforme chloasma Vascular Disorders Thromboembolism increase in blood pressure Description of selected adverse reactions Post-marketing reports of severe depression (including very rare reports of suicidal ideation or behaviour) in patients using Dianette have been received.

However, a causal relationship between clinical depression and Dianette has not been established. 4. 4 Special warnings and precautions for use: − Venous thromboembolic disorders; − Arterial thromboembolic disorders; − Hypertension; − Liver tumours; − Occurrence or deterioration of conditions for which association with COC use is not conclusive: Crohn’s disease, ulcerative colitis, epilepsy, uterine myoma, porphyria, systemic lupus erythematosus, herpes gestationis, Sydenham's chorea, haemolytic uremic syndrome, cholestatic jaundice; − Chloasma; − Acute or chronic disturbances of liver function may necessitate the discontinuation of COC use until markers of liver function return to normal.

Medical Examination Assessment of women prior to starting oral contraceptives (and at regular intervals thereafter) should include a personal and family medical history of each woman. 4) for this product. The frequency and nature of these assessments should be based upon relevant guidelines and should be adapted to the individual woman, but should include measurement of blood pressure and, if judged appropriate by the clinician, breast, abdominal and pelvic examination including cervical cytology.

Exclude the likelihood of pregnancy before starting treatment. Undiagnosed vaginal bleeding that is suspicious for underlying conditions should be investigated.

Warnings:

Dianette is composed of the progestogen cyproterone acetate and the oestrogen ethinylestradiol and is administered for 21 days of a monthly cycle. It has a similar composition to that of a combined oral contraceptive (COC). Duration of Use Time to relief of symptoms is at least three months.

2). Women should be advised that Dianette does not protect against HIV infections (AIDS) and other sexually transmitted diseases. Conditions which require strict medical supervision If any of the conditions/risk factors mentioned below is present, the benefits of the use of Dianette should be weighed against the possible risks for each individual woman and discussed with the woman before she decides to start using Dianette.

In the event of aggravation, exacerbation or first appearance of any of these conditions or risk factors, the woman should contact her physician. The physician should then decide on whether the use of Dianette should be discontinued.

e. 4 ‘Reasons for stopping Dianette immediately’ • porphyria • clinical depression • obesity • migraine • cardiovascular diseases • chloasma Patients with a history of depression or any condition mentioned above should be monitored during treatment with Dianette.

3. Patients with renal impairment Dianette has not been specifically studied in renally impaired patients. Available data do not suggest a change in treatment in this patient population. 3 Contraindications Preparations containing oestrogen/progestogen combinations should not be used in the presence of any of the conditions listed below.

Should any of the conditions appear for the first time during their use, the product should be stopped immediately. g. g. angina pectoris and transient ischaemic attack). 4) such as: o diabetes mellitus with vascular symptoms o severe hypertension o severe dyslipoproteinaemia • Hereditary or acquired predisposition for venous or arterial thrombosis, such as activated protein C (APC) resistance, antithrombin-III-deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinaemia and antiphospholipid-antibodies (anticardiolipin-antibodies, lupus anticoagulant) • History of migraine with focal neurological symptoms.

g. active viral hepatitis and severe cirrhosis, as long as liver function values have not returned to normal. • Presence or history of liver tumours (benign or malignant). • Current or history of breast cancer. • Meningioma or history of meningioma.

6). 6). • Hypersensitivity to the active substances or to any of the excipients. 5). Relevant UK clinical guidance on COCs should also be consulted. Dianette is not for use in men.