Ovral Tablets

OVRAL 28 belongs to a group of medicines called combined oral contraceptives (COCs) which is used to prevent you from falling pregnant. OVRAL 28 is also used to control irregular menstruation.

Do not take OVRAL 28:

• if you are hypersensitive (allergic) to norgestrel, ethinyl estradiol, or any of the other ingredients of OVRAL 28 (listed in section 6).
• if you have a previous condition, or currently have a condition where a clot plugs a blood vessel in your body (e.g. heart attack or stroke caused by a clot blocking a blood vessel).
• if you have risk factors for developing a clot in a blood vessel. These risk factors include:
• if you smoke and are over the age of 35 years.
• if you have ever had, or currently have a clot in your leg (or a vein deep in the body), in your lung or have a family history of these blood clots.
• if you have an inherited disease where your blood clots easily (hypercoagulopathy).
• if you have an obstruction in one or more blood vessels that supply blood to the brain (cerebrovascular insufficiency) or a disease that causes a narrowing in the blood vessels to the brain (cerebrovascular disease). These conditions may lead to a stroke.
• if you have a disease causing narrowing of blood vessels supplying the heart with blood (coronary artery disease), heart rhythm diseases or problems with your heart valves. You should consult your doctor immediately if you experience unexplained chest pain.
• if you have uncontrolled high blood pressure.
• if you have diabetes mellitus with diseases of your blood vessels.
• if you have headaches or migraines with vision disturbances such as blurred or lost vision, weakness or speech difficulties. OVRAL 28 should be stopped immediately if you develop a migraine with vision loss.
• if you are over the age of 35 and you have migraine headaches.
• If you currently have or have a history of breast cancer or other cancer that is sensitive to hormones.
• if you have abnormal bleeding from your vagina.
• if you are known to have inherited genetic changes called “BRCA 1 and/or BRCA 2 genes.”
• if you started your menstrual periods before the age of 12 years.
• if you have a history of non-cancerous breast disease such as atypical hyperplasia or lobular carcinoma in situ.
• if you have had any treatment using radiation to your chest or breast.
• if you have been treated or exposed while in your mother’s womb to a medicine called diethylstilbestrol (DES).
• if you are taking medicines for hepatitis C containing ombitasvir/paritaprevir/ritonavir with or without dasabuvir.
• if you are pregnant or breastfeeding your baby.
• if you have depression, which is not well controlled with treatment.
• if you have had depression with previous use of hormonal contraceptives.

Do not share medicines prescribed for you with any other person. Always take OVRAL 28 exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The usual adult dose is one (1) tablet of OVRAL 28 daily.

1. Start by taking the white tablet in the circle on the package on the first day of your menstrual cycle (i.e. the day bleeding commences).
2. Take one white tablet each day immediately after the evening meal or at bedtime, as nearly as possible at the same time each day for 21 days, following the arrows until all 21 white tablets are finished.
3. Then start taking one red coloured tablet each day (again following the arrows) until all the red tablets are finished.
4. On the following day start a new package taking the first white tablet in the circle to commence the next course.

NOTE: There must be no interval between finishing one course and starting the next. The changes you can expect: You will probably have a menstrual period two to three days after taking the last white tablet in each package. The blood flow may be slightly less or more than you had before you started taking OVRAL 28.

If, while on OVRAL 28 you develop severe vomiting and diarrhoea the absorption of OVRAL 28 may be diminished and you should use additional methods of contraception. If vomiting or diarrhoea occurs within 3 to 4 hours after taking an active tablet of OVRAL 28, handle this as a missed tablet (see If you forget to take OVRAL 28).

If you take more OVRAL 28 than you should In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre.

If you forget to take OVRAL 28 OVRAL 28 is designed to protect you from pregnancy. It will do this as long as you follow the schedule carefully. However, should you forget to take one or more tablets, your body may not have enough hormones left to prevent pregnancy. In such cases, use an additional birth control method (other than OVRAL 28).

If you miss taking 1 tablet of OVRAL 28, take it in the morning as soon as possible, then take the next tablet at the usual time and continue the course as before. Remember to use an additional contraceptive method until you finish the package.

Suppose you forget to take 2 tablets of OVRAL 28 in a row; take the 2 missed tablets when you remember, and the tablet for that day at the regular time. In this case you take 3 tablets on the day you remember. Continue your schedule until the package is finished. An additional contraceptive method is necessary until you finish the package.

If you forget 3 or more tablets in a row, do NOT take them when you remember and do NOT finish the package. Wait 4 more days. This makes 1 week without tablets. Then begin a new package on DAY 8, even if you are still bleeding. During the 7 days without tablets, and until you have taken a tablet daily for seven days from the new OVRAL 28 package, use an additional birth control method.

If you omit any of the tablets in a package and do not menstruate when you expect to, see your doctor or healthcare provider. Do not take any more tablets until the doctor says you can.

If you stop taking OVRAL 28 You should not stop taking OVRAL 28 without talking to your healthcare provider first. You may need to use other contraceptive methods.

OVRAL 28 can have side effects, Not all side effects reported for OVRAL 28 are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking OVRAL 28, please consult your healthcare provider for advice.

If any of the following happens, stop taking OVRAL 28 and tell your doctor immediately or go to the casualty department at your nearest hospital:

• Swelling of the hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing,
• rash or itching,
• fainting.

These are all very serious side effects. If you have them, you may have had a serious reaction to OVRAL 28. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• Cancer of the reproductive organs, breasts or liver,
• bleeding of the brain, a clot in the brain or a stroke with symptoms such as numbness of the face and limbs on one side of the body,
• a clot in the blood vessel that supplies the eye with blood with symptoms such as sudden onset of vision loss generally only in one eye,
• inflammation of the eye nerve which could lead to partial or complete loss of vision,
• heart attack with symptoms such as tightness or pain in the chest, abnormal heartbeat, anxiety, shortness of breath and light-headedness,
• a clot in a blood vessel (arterial or venous thromboembolism),
• a clot in the lung (pulmonary embolism) with symptoms such as shortness of breath, chest pain and cough,
• inflammation of the pancreas (pancreatitis) with symptoms such as severe nausea and stomach pain,
• a clot in the blood vessels supplying the small intestines with blood with symptoms such as severe stomach pain, nausea and vomiting,
• liver and gallbladder problems with symptoms such as yellowing of the skin and whites of the eyes (jaundice) or a very rare liver condition called Budd-Chiari syndrome that effects

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

• Frequent side effects
• Increased appetite,
• depression, nervousness,
• headache,
• worsening of varicose veins,
• nausea, stomach pain, cramps and bloating,
• acne, brown patches on the face,
• backache,
• vaginal infection, vaginal discharge, painful menstruation, breast discomfort, changes in menstrual flow,
• fatigue.

Side effects with an unknown frequency

• Unwanted male-pattern hair growth in women (hirsutism),
• fluid retention, decreased appetite, effects on the carbohydrates and fats (lipids),
• porphyria (an inherited blood disorder) or a worsening of existing porphyria,
• mood changes, mood swings, changes in sex drive (libido),
• migraine,
• lesions in the eye, change in the curve of your eye, intolerance to contact lenses,
• high blood pressure,
• irritation in the stomach and gut, inflammation of the inner lining of the colon,
• skin pigmentation, bull’s-eye-shaped lesions on the skin, nodules or tender bumps under the skin,
• unscheduled menstrual bleeding (spotting or breakthrough bleeding), absence of menstrual flow, breast changes including tenderness, pain, enlargement and secretion from the breast, premenstrual syndrome (PMS), temporary infertility after discontinuation of treatment, thrush,
• mass gain, change in weight.

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

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 “6.04 Adverse Drug Reactions Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8 Aspen Pharmacare: E-mail: [email protected] Tel: 0800 118 088 / +27 (0) 11 239 - 6200 By reporting side effects, you can help provide more information on the safety of OVRAL 28.

Store all medicines out of reach of children. Store at or below 25 °C, in a cool dry place. Protect from light. Keep in the original packaging until required for use. Do not store in a bathroom. Do not use after the expiry date stated on the label. The expiry date refers to the last day of that month. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).