Diva Tablets

DIVA 35 is used as an oral contraceptive which is known also as the Pill, OC’s, or birth control pills. They usually contain two types of female hormones, estrogens and progestins. When taken by mouth on a regular schedule, they change the hormone balance of the body, which prevents pregnancy.

This medicine is also used in the treatment of other conditions that are helped by added hormones, such as androgen-dependent acne, androgen-dependent hair loss or abnormal hairiness. This medicine is available only on your doctor’s prescription.

Important information about some of the ingredients of DIVA 35

DIVA 35 contains lactose. Patients with the rare hereditary conditions of lactose or galactose intolerance should not take DIVA 35.

Allergies - Tell your doctor if you have ever had any unusual or allergic reaction to estrogens or progestins. Also tell your doctor and pharmacist if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy - This medicine is not recommended for use during pregnancy.

Do not take DIVA 35

• If you are hypersensitive (allergic) to cyproterone acetate OR ethinylestradiol or any of the other ingredients of DIVA 35 listed above.
• You have depression, which is not well controlled with treatment.
• You have had depression with previous use of hormonal contraceptives.
• If you have moderately impaired liver function or cholestasis, the Dubin-Johnson or Rotor syndromes, hepatic adenomas, estrogen-dependent neoplasms (cancers) such as breast or endometrial cancer, cardiovascular disease including previous or current thrombo-embolic disorders, or high risk of them and arterial disease or multiple risk factors for it.
• If you suffer from - Disorders of fat metabolism, undiagnosed vaginal bleeding, jaundice with less flow of bile, involuntary movements of the limbs of facial muscles, herpes (inflammatory skin disease caused by a virus (herpes simplex or varicella zoster), pemphigoid gestationis, or worsening hearing loss.
• If you suffer from - Severe or focal migraine, cerebrovascular conditions, advanced diabetes mellitus (high blood sugar) with vascular changes, sickle-cell disease (abnormal shaped red blood cells) and porphyria.
• If you are a male or a child

Other medicines and DIVA 35

Always tell your health care provider if you are taking any other medicine. (This includes all complementary or traditional medicines.) Reduced DIVA 35 plasma levels have been obtained with concomitant use of certain antibiotics (e.g. ampicillin, tetracycline) and oral contraceptive failure may occur. Spotting and breakthrough bleeding are possible signs of diminished effectiveness. For maximal protection, additional non-hormonal contraception should be recommended for the duration of antibiotic therapy and for seven days afterwards. Those on long-term antibiotic therapy need only take extra precautions for the first two weeks of antibiotic therapy.

An impaired action of DIVA 35 is noted with enzyme inducers such as:

• anti-epileptic agents,
• griseofulvin
• barbiturates
• phenylbutazone and rifampicin.
• modafinil and some antiviral agents, such as nelvinavir, ritonavir and nevirapine.

Reduced effectiveness was observed when DIVA 35 was administered with:

• anticoagulants
• antidepressants
• antidiabetics
• antihypertensives
• beta blockers and diuretics.

The plasma concentrations of cyclosporine and theophylline may be increased with concomitant use. Large supplements of vitamin C have been reported to increase serum ethinylestradiol concentrations. Withdrawal of high doses of vitamin C may lead to breakthrough bleeding. Mild laxatives do not impair the action of DIVA 35.

Do not share medicines prescribed for you with any other person. Always take DIVA 35 exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Take this medicine only as directed by your doctor. This medicine must be taken exactly on schedule to prevent pregnancy. Try to take the medicine at the same time each day, not more than 24 hours apart to reduce the possibility of side effects and to provide the best protection.

Initial course: One tablet daily for 28 days, starting on the first day of the menstrual cycle (the first day of menstruation counting as Day 1).

Subsequent course: After the last tablet has been taken from the first pack, tablet-taking is continued from a new pack the very next day.

Length of use: The length of use depends on the severity of the clinical picture. In general, treatment should be carried out over several months. It is recommended that DIVA 35 be taken for at least another 3 to 4 cycles after the signs have subsided. Should there be a recurrence weeks or months after discontinuation, treatment with DIVA 35 may be resumed.

When changing from an oral contraceptive and relying on the contraceptive action of DIVA 35, the instructions given below should be followed:

Changing from 21-day combined oral contraceptives: The first tablet of DIVA 35 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): The first DIVA 35 tablet should be taken the day after the last active tablet from the Every Day Pill pack. Additional contraceptive precautions are not then required.

Changing from a progesterone-only pill (POP): The first tablet of DIVA 35 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 required. The remaining progesterone-only pills should be discarded.

Other Precautions

• It is very important that your doctor check your progress at regular visits to make sure this medicine does not cause unwanted effects. These visits will usually be every 6 to 12 months, but some doctors require them more often.
• When you begin to use oral contraceptives, your body will require at least 7 days to adjust before pregnancy will be prevented; therefore, you should use a second method of birth control for the first cycle (or 3 weeks) to ensure full protection.
• Tell the medical doctor or dentist in charge that you are taking this medicine before any kind of surgery (including dental surgery) or emergency treatment, since this medicine may cause serious blood clots, heart attack, or stroke.
• Certain medicines may reduce the effectiveness of this medicine. You should use a second method of birth control during each cycle in which any of the medicines listed under “What you need to know before you take DIVA 35” are used. Check with your doctor if you have any questions about this.
• Vaginal bleeding of various amounts may occur between your regular menstrual periods during the first 3 months of use. This is sometimes called spotting when slight, or breakthrough bleeding when heavier. If this should occur:

1. Continue with your regular dosing schedule.
2. The bleeding usually stops within 1 week.
3. Check with your doctor if the bleeding continues for more than 1 week.
4. After you have been taking this medicine on schedule and for more than 3 months, check with your doctor.

Missed menstrual periods may occur:

• If you have not taken the medicine exactly as scheduled. Pregnancy must be considered a possibility.
• If the medicine is not properly adjusted for your needs.
• If you have taken oral contraceptives for a long time, usually 2 or more years, and stop their use. Check with your doctor if you miss any menstrual periods so that the cause may be determined.

Some people who take this medicine may become more sensitive to sunlight than they are normally. When you begin taking this medicine, avoid too much sun and do not use a sunlamp until you see how you react to the sun, especially if you tend to burn easily. If you have a severe reaction, check with your doctor. Some people may develop brown, blotchy spots on exposed areas. These spots usually disappear gradually when the medicine is stopped.

If you wear contact lenses and notice a change in vision or are not able to wear them, check with your doctor.

If you suspect that you may have become pregnant, stop taking this medicine immediately and check with your doctor.

If you are scheduled for any laboratory tests, tell your doctor that you are taking birth control pills.

If you take more DIVA 35 than you should

Call your doctor, pharmacist, poison centre or go to the nearest hospital emergency unit immediately. Take your box of DIVA 35 capsules with you.

If you forget to take DIVA 35

Missed dose and special circumstances requiring additional contraception: If a patient forgets to take her tablet at the usual time, she must take it within the next 12 hours at the latest. If more than 12 hours elapse from the time that she normally takes her tablet, and also in the case of vomiting or diarrhoea, she must continue to take the other tablets in the pack at the usual time in order to avoid premature withdrawal bleeding during the cycle. At the same time, however, an additional, non-hormonal method of contraception (with the exception of the rhythm and temperature methods) must be employed in order to prevent a pregnancy which would be a compelling reason for the discontinuation of DIVA 35.

If tablet(s) have been missed during the last 7 days of a pack, there should be no break before the next pack is started. In this situation, a withdrawal bleed should not be expected until the end of the second pack. Some breakthrough bleeding may occur on tablet taking days, but this is not clinically significant. If the patient does not have a withdrawal bleed during the tablet-free interval following the end of the second pack, the possibility of pregnancy must be ruled out before starting the next pack.

DIVA 35 can have side effects. Not all side effects reported for DIVA 35 are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking DIVA 35, please consult your health care provider for advice.

Cyproterone acetate:

• Neoplasms (abnormal tissue growth) benign (not cancerous) and malignant (cancerous): Less frequent: Liver cancer
• Blood and lymphatic system disorders: Less frequent: Thrombosis (clotting within a blood vessel)
• Endocrine (internal or hormonal secretion of a ductless gland) disorders: Less frequent: Weight gain
• Psychiatric disorders: More frequent: Changes in conscious and unconscious sexual desire; Less frequent: Depression
• Gastrointestinal disorders: Less frequent: Nausea (inclination to vomit or feeling sick), vomiting (being sick)
• Hepato-biliary (Liver & gall) disorders: Less frequent: Altered liver function, inflammation of the liver, jaundice, enlargement of the liver, liver failure, liver carcinoma, gall bladder disease
• Skin and subcutaneous tissue disorders: Less frequent: loss of hair, abnormal sensitivity to light, allergic rash or skin eruption
• Reproductive system and breast disorders: More frequent: Breast tenderness

Ethinylestradiol:

• Infections and infestations: More frequent: Vaginal candidiasis or yeast-like infection
• Blood and lymphatic system disorders: Less frequent: Thromboembolic (clotting within blood vessel, resulting in a plug) disorders, thrombosis (clotting within a blood vessel)
• Metabolic and nutritional disorders: Incidence unknown: Reduced tolerance towards sugars, changes in fat metabolism
• Psychiatric disorders: More frequent: Changes in appetite, depression; Less frequent: Mood or mental changes, changes in conscious or unconscious sexual desire
• Nervous system disorders: More frequent: Dizziness (mild), headache, migraine (severe complex type of headache together with other symptoms)
• Eye disorders: Less frequent: Intolerance to contact lenses
• Vascular disorders: More frequent: Water retention; Less frequent: Hypertension/High blood pressure
• Gastrointestinal disorders: More frequent: Gastrointestinal irritation, abdominal cramps, nausea (inclination to vomit or feeling sick); Less frequent: Vomiting (being sick)
• Hepato-biliary (Liver & gall) disorders: Less frequent: Poor liver function, gall bladder disease, inflammation of the liver, jaundice with less flow of bile
• Skin and subcutaneous tissue disorders: More frequent: itchy skin, skin rash; Incidence unknown: pigmented facial patches, patchy pigmentation of sun-exposed skin, a breakout bleeding of the skin
• Reproductive system and breast disorders: Incidence unknown: Change in cervical secretions

Ethinylestradiol/cyproterone cyclical:

• Neoplasms (abnormal tissue growth) benign (not cancerous) and malignant (cancerous): Incidence unknown: Increased risk of cervical or breast cancer
• Reproductive system and breast disorders: More frequent: Menstrual irregularities, spotting (slight bleeding), breakthrough bleeding, amenorrhoea (absence of menstruation); Incidence unknown: Anovulation post-treatment (to treat the condition where the patient does not ovulate after being on DIVA - 35 treatment)

Reported post marketing: Suicidal thoughts/behavior and suicide

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist or nurse.

Reporting of side effects

If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to SAHPRA via the Med Safety App (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on the SAHPRA website https://www.sahpra.org.za/Publications/Index/8. Side effects can also be reported to Unicorn Pharmaceuticals (Pty) Ltd to [email protected]. By reporting side effects, you can help provide more information on the safety of DIVA 35.

Store in original packs below 25 ºC. Store all medicines out of reach of children. Store away from heat and direct light. Do not store in bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down. Do not keep outdated or medicines no longer needed. Be sure that any discarded medicine is out of reach of children.