ZINNIA-F Tablet

Indication

Oral contraception and the recognised gynaecological indications for such eostrogen-progestogen combinations. 

Posology and method of administration

- First treatment cycle: 1 tablet daily for 28 days, starting on the first day of the menstrual cycle. 21 active tablets are taken followed by 7 Ferrous Fumarated (placebo) tablet. Contraceptive protection begins immediately.

- Subsequent cycles: Tablet-taking is continuous, which means that the next pack of Zinnia-F follows immediately without a break. A withdrawal bleed usually occurs when the Ferrous Fumarate tablets are being taken.

- Changing from 21-day combined oral contraceptives: The first tablet of Zinnia-F 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 pill): Zinnia-F should be started after taking the last active tablet from the previous Every Day pill back. The first Zinnia-F tablet is taken the next day. Additional contraceptive precautions are not then required.

- Changing from a progestogen-only pill (POP): The first tablet of Zinnia-F 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, oral contraception 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 tablet taking to ensure adequate contraceptive cover if early ovulation has occurred. Since the first post-partum ovulation may precede the first bleeding, another method of contraception should be used in the interval between childbirth and the first course of tablets. After a first-trimester abortion, oral contraception may be started immediately in which case no additional contraceptive precautions are required.

For further information related to Incorrect administration, and in the case of Gastro-intestinal upset, please refer to the attached Package insert.

Contraindication:

1. Pregnancy

2. Severe disturbances of liver function, jaundice or persisten itching during a previous pregnancy, Dubin-Johnson syndrome, Rotor syndrome, previous or existing liver tumours

3. Existing or a history of confirmed venous thromboembolism (VTE), family history of idiopathic VTE and other known isk factors for VTE.

4. Existing or previous arterial thrombotic or embolic processes.

5. Conditions which predispose to thromboembolism e.g. disorders of the clotting processes, valvular heart disease and atrial fibrillation.

6. Sickle-cell anaemia

7. Mammary or endometrial carcinoma, or a history of these conditions

8. Severe diabetes mellitus with vascular changes

9. Disorders of lipid metabolism

10. History of herpes gestationis

11. Deterioration of otosclerosis during pregnancy

12. Undiagnosed abnormal vaginal bleeding

13. Hypersensitivity to any of the components of Zinnia-F.

Undesirable effects:

- In rare cases, headaches, gastric upsets, nausea, vomiting, breast tenderness, changes in body weight, changes in libido, depressive moods can occur.

- In predisposed women, use of Zinnia-F can sometimes cause chloasma which is exacerbated by exposure to sunlight. Such wmen shoul avoid prolonged exposure to sunlight.

- Individual cases of poor tolerance of contac lenses have been reported with use of oral contraceptives. Contact lens wearers who develop changes in lens tolerance should be assessed by an ophthalmologist.

- Mentrual changes: Reduction of menstrual flow, missed menstration.

- Intermenstrual bleeding

- Effect on blood chemistry.

- Overdose may cause nausea, vomiting and, in females, withdrawal bleeding.

・Hepatic enzyme inducers such as barbiturates, primidone, phenobarbitone, phenytoin, phenylbutazone, rifampicin, carbamazpepine and griseofulvin can impair the efficacy of Zinnia-F.

・The requirement for ral antidiabetics or insulin can change as a result of the effect on glucose tolerance.

・The herbal remedy St John's wort (Hypericum perforatum) should not be taken concomitantly with Zinnia-F as this could potentially lead to a loss of contraceptive effect.

・Zinnia-F is not indicated during pregnancy. If pregnacy occurs during treatment with Zinnia-F, further intake must be stopped. However, extensive epidemiological studies have revealed neither an increased risk of birth defects in children born to women who used COCs prior to pregnancy, nor a teratogenic effect when COCs were taken inadvertently during early pregnancy.

・The use of Zinnia-F during lactation may lead to a reduction in the volume of milk produced and to a change in its composition. Minute amounts of the active substances are excreted with the milk. Mothers who are breast-feeding may be advised instead to use another method of contraception.

Warnings:

The use of any combined oral contraceptive carries an increased risk of venous thromboembolism (VTE) compared with no use.

The risk of venous and/or arterial thrombosis associated with combined oral contraceptives increases with:

- age

- smoking

- a positive family history (i.e. venous or arterial thromboembolism ever in a sibling or parent at a relatively early age). If a hereditary predispositon is suspected, the woman should be referred to a specialist for advice before deciding about any COC use

- obesity (body mass index over 30kg/m2)

- dyslipoproteinaemia

- hypertension

- valvular heart disease

- atrial fibrillation

- prolonged immobilisation, major surgery, any surgery to the legs, or major trauma. In these situations, it is advisable to discntinue COC use (in the case of elective surgery at least six weeks in advance) and not to resume until two weeks after complete remobilisation.

- There is no consensus about the possible role of varicose veins and superficial thrombophlebitis in venous thromboembolism.

- The increased risk of thromboembolism in the puerperium must be considered.

- Other medical conditions which have been associated with adverse circulatory events include diabetes mellitus, systemic lupus erythematosus, haemolytic uraemic syndrome, chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis), sickle cell disease and subarachnoid haemorrhage.

- An increase in frequency of severity of migrain during COC use (which may be prodromal of a cerebrovascular event) may be a reason for immediate discontivation of the COC.

- Biochemical factors that may be indication of hereditary or acquired predisposition of venous or arterial thrombosis include Activated Protein C (APC) resistance, hyperhomocysteinaemia, antithrombin-III deficiencey, protein C deficiency, protein S deficiency, antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant).

Reasons for stopping oral contraception immediately:

1. Occurrence for the first time, or exacerbation, of migrainous headaches or unusually frequent or unusually severe headaches.

2. Sudden disturbances of vision or hearing or other perceptual disorders

3. First signs of thrombophlebitis or thromboembolic symptoms (e.g. unusual pains in or swelling of the leg(s), stabbing pains on breathing or coughing for no apparent reason). Felling of pain and tightness in the chest.

4. Six weeks before an elective major operation (e.g. abdominal, orthopaedic), any surgery to the legs, medical treatment for varicose veins or prolonged immobilisation, e.g. after accidents or surgery. Do not restart until 2 weeks after full ambulation. In case of emergency surgery, thrombotic prophylaxis is usually indicated e.g. subcutaneous heparin

5. Onset of jaundice, hepatitis, itching of the whole body

6. Increase in epileptic seizures

7. Significant rise in blood pressure

8. Onset of severe depression

9. Severe upper abdominal pain or liver enlargement

10. Clear exacerbation of conditions known to be capable of deteriorating during oral contraception or pregnancy

11. Pregnancy is a reason for stopping immediately because it has been suggested by some investigations that oral contraceptives taken in early pregnancy may slightly increase the risk of foetal malformations. Other investigations have failed to support these findings. The possibility therefore cannot be excluded, but it is certain that if a risk exists at all, it is very small.

Zinnia-F is an oestrogen-progestogen combination which acts by inhibiting ovulation by suppression of the mid-cycle surge of luteinizing hrmone, the inspissation of cervical mucus so as to constitute a barrier to sperm, and the rendering of the endometrium unreceptive to implantation.