Rubaz 3 mg/0,02 mg Film-Coated Tablets

RUBAZ is a combined oral contraceptive (“the combined pill”) and is used to prevent pregnancy. It consists of 24 pink active tablets with a small amount of two different female hormones, namely drospirenone (3 mg) and ethinylestradiol (0,02 mg) and 4 white inactive (placebo) tablets. It can also be used to treat moderate acne and premenstrual dysphoric disorder (a health problem that is similar to premenstrual syndrome (PMS), which causes severe depression, irritability, or anxiety before menstruation in women).

Before you start using RUBAZ, you should read the information on blood clots below. It is particularly important to read the symptoms of a blood clot, see Blood clots below. Before you can begin taking RUBAZ, your doctor will ask you some questions about your personal health history and that of your close relatives. The doctor will also measure your blood pressure and, depending upon your personal situation, may also carry out some other tests.

In this leaflet, several situations are described where you should stop using RUBAZ, or where the reliability of RUBAZ may be decreased. In such situations you should either not have sex or you should take extra non-hormonal contraceptive precautions, e.g. use a condom or another barrier method. Do not use rhythm or temperature methods. These methods can be unreliable because RUBAZ alters the monthly changes of body temperature and cervical mucus. RUBAZ does not protect against HIV infection (AIDS) or any other sexually transmitted disease.

Do not take RUBAZ: Do not take RUBAZ if you have any of the conditions listed below. If you do have any of the conditions listed below, you must tell your doctor. Your doctor will discuss with you what other form of birth control would be more appropriate.

• if you are hypersensitive (allergic) to ethinylestradiol or drospirenone, or any of the other ingredients of RUBAZ (listed in section 6). This may cause itching, rash or swelling
• if you have (or have ever had) a blood clot in a blood vessel of your leg (deep vein thrombosis, DVT), or an increased tendency to form clots (Thrombophilia) your lungs (pulmonary embolus, PE) or other organs
• if you know you have a disorder affecting your blood clotting – for instance, protein C deficiency, protein S deficiency, antithrombin III deficiency, activated protein C-resistance (Factor V Leiden) or antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant)
• if you need an operation or if you are off your feet for a long time
• if you have ever had a heart attack or stroke
• if you have (or have ever had) angina pectoris (a condition that causes severe chest pain and may be a first sign of a heart attack) or transient ischaemic attack (TIA – temporary stroke symptoms)
• if you have any of the following diseases that may increase your risk of a clot in the arteries:
• severe diabetes with blood vessel damage
• very high blood pressure
• a very high level of fat in the blood (cholesterol or triglycerides)
• a condition known as hyperhomocysteinaemia (high level of homocysteine in blood which can lead to blood clots in your blood vessels)
• if you ever had migraine accompanied by visual symptoms, speech disability or weakness or numbness in any part of your body
• if you have (or have ever had) active liver disease and your liver function is still not normal
• if your kidneys are not working well (kidney failure)
• if you have (or have ever had) had a tumour in the liver
• if you have (or have ever had) or if you are suspected of having breast cancer or cancer of the genital organs
• if you have inherited genetic mutations: BRCA1 and BRCA 2 genes, as you have a higher risk of developing cancer
• early menstrual periods (before the age of 12 years)
• if you have ever had other non-cancerous breast diseases such as atypical hyperplasia (a precancerous condition that affects cells in the breast) or lobular carcinoma in situ (abnormal cells growing in the lining of the milk glands)
• if you have ever had treatment using radiation therapy to the chest or breast
• if you have ever been exposed to diethylstilbestrol (DES), a synthetic oestrogen medicine
• if you have any unexplained bleeding from the vagina
• if you are pregnant or you think you might be pregnant
• if you are taking medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir.

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

Take RUBAZ every day for 28 days RUBAZ comes in a blister strip containing 24 pink active film-coated tablets and 4 white inactive (placebo) film-coated tablets, each marked with a day of the week.

Take your tablet at the same time every day.

• start by taking a tablet marked with the correct day of the week
• follow the direction of the arrows on the strip. Take one tablet each day, until you have finished all 24 pink active tablets
• swallow each tablet whole, with water if necessary. Do not chew the tablet.

Then have 4 white inactive (placebo) tablets After you have taken all 24 pink active tablets in the strip, you have 4 days when you take the white inactive (placebo) tablets. Within a few days of starting the white inactive (placebo) tablets from the strip, you should have a withdrawal bleed like a period. This bleed may not have finished before the next pack is started.

Start taking your next strip of RUBAZ after the 4 days of white inactive (placebo) tablets – even if you are still bleeding. Always start the new strip on time. You don’t need to use extra contraception during these 4 white inactive tablet days as long as you have taken your tablets correctly.

When you can start with the first strip? If you have not used a contraceptive with hormones in the previous month Begin with RUBAZ on the first day of the cycle (that is, the first day of your period). If you start RUBAZ on the first day of your menstruation you are immediately protected against pregnancy. You may also begin on day 2 – 5 of the cycle, but then you must use extra protective measures (for example, a condom) for the first 7 days.

Changing from a combined hormonal contraceptive, or combined contraceptive vaginal ring or patch You can start RUBAZ preferably on the day after the last pink active tablet (the last tablet containing the active substances) of your previous pill, but at the latest on the day after the white inactive tablet days of your previous oral contraceptive finish (or after the last inactive tablet of your previous oral contraceptive). When changing from a combined contraceptive vaginal ring or patch, follow the advice of your doctor.

Changing from a progestogen-only method (progestogen-only pill, injection, implant or a progestogen-releasing intrauterine system (IUS)) You may switch any day from the minipill (from an implant or an IUS on the day of its removal, from an injectable when the next injection would be due) but in all of these cases use extra protective measures (for example, a condom) for the first 7 days of taking RUBAZ.

After a miscarriage or abortion If you have had a miscarriage or abortion during the first three months of pregnancy, your doctor may tell you to start taking RUBAZ immediately. This means that you will have contraceptive protection with your first pill.

After miscarriage in the second 3 months or after having a baby You can start taking RUBAZ between 21 and 28 days after having a baby or miscarriage in the second 3 months. If you start later than day 28, use a so-called barrier method (for example, a condom) during the first seven days of taking RUBAZ. If, after having a baby, you have had sex before starting RUBAZ (again), you must first be sure that you are not pregnant or wait until your next period.

If you are breastfeeding and want to start RUBAZ after having a baby Use of RUBAZ is generally not advisable when a woman is breastfeeding. If you want to take the pill while you are breastfeeding you should contact your doctor.

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

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

• swelling of your hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing
• rash, hives or itching
• fainting.

These are all very serious side effects. If you have them, you may have had a serious reaction to RUBAZ. 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:

• tachycardia (fast heartbeat)
• inflammation of vein, vascular disorder, nosebleed, fainting
• enlarged, swollen or twisting veins
• asthma (tightness in the chest, wheezing and difficulty breathing)
• increased blood pressure, decreased blood pressure.

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:

• headache, migraine (throbbing headache, usually affecting one side of the head and often accompanied by nausea, vomiting and sensitivity to light)
• nausea (feeling sick)
• breast pain, menstrual problems, bleeding between periods, thick whitish vaginal discharge, vaginal yeast infection.

Less frequent side effects:

• increased appetite
• anorexia (obsession of what they eat)
• increased potassium level in blood
• decreased sodium level in blood
• fluid retention, changes in body weight
• changes in sexual drive
• nervousness, drowsiness, inability to fall asleep
• failure to experience an orgasm
• dizziness, ‘pins and needles’, spinning sensation, shaking
• hearing impairment
• dyspepsia (indigestion), flatulence (intestinal gas), gastritis (inflammation of the stomach, symptoms include pain, nausea, vomiting, vomiting blood, blood in the bowel motions), diarrhoea
• enlargement of abdomen (stomach), gastrointestinal disorder, abdominal fullness (due to excessive gas build up in the digestive tract)
• hiatus hernia (protrusion of upper part of stomach into the chest)
• fungal infection in mouth and throat
• constipation, dry mouth
• acne, severe itching, rash, chloasma (discolouration of the skin especially of the face or neck known as “pregnancy patches”), alopecia (hair loss), dermatitis acneiform (skin rash with a flat discoloured area or raised bumps like acne), dry skin, erythema nodosum (skin condition characterised by painful reddish skin nodules), excessive hair growth in a defined area, skin disorder, white markings on skin, contact dermatitis (local skin reaction characterised by skin redness, swelling and itching, pain or burning sensation), light-sensitive skin inflammation, skin nodules
• inflammation of the vagina, breast discharge, breast enlargement, pelvic pain, benign breast lumps, uterine/vaginal bleeding (which usually subsides during continued treatment), genital discharge, hot flushes, painful periods, reduced periods, very heavy periods, vaginal dryness, abnormal cervical smear, decreased interest in sex
• eye disorders, e.g. inflammation of the eyelid/pink eye or red eye, dry eyes
• candidiasis (fungal infection)
• anaemia (decrease in the number of red blood cells), increase in the number of platelets in the blood
• endocrine disorder (problem with the glands that secrete hormones internally into the blood stream)
• abnormally rapid heartbeat
• dull pain in the middle to upper right area of the abdomen, inflammation of the gallbladder (symptoms may include pain in the upper right abdomen, fever, nausea, yellowing of the skin and eyes (jaundice)
• aches and pains, e.g. back pain, limb pain, muscle cramps
• lack of energy, increased sweating, feeling generally unwell.

Frequency not known (cannot be estimated from available data):

• altered mood
• urticaria (nettle rash)
• intolerance to contact lenses.

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 any side effects to SAHPRA via the online service for adverse drug reaction reporting by following the link: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of RUBAZ. You can also send an email directly to the company, [email protected] to ensure safety of the product.

Store at or below 25 °C. Keep the blister strip in the outer carton until required for use. STORE ALL MEDICINES OUT OF REACH OF CHILDREN. Do not use after the expiry date printed on the carton / blister. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains and sewerage systems (e.g. toilets).