Ruby 3 mg/0,03 mg Film-Coated Tablets

RUBY contains two different female hormones - drospirenone and ethinylestradiol. RUBY, containing specific hormones is used to prevent pregnancy.

Do not take RUBY :

• if you are hypersensitive (allergic) to drospirenone, ethinylestradiol or any of the other ingredients of RUBY (see section 6)
• if you know you have a disorder affecting your blood clotting – for instance, protein C deficiency, protein S deficiency, antithrombin - III deficiency, Factor V Leiden or antiphospholipid antibodies
• if you have thrombosis (formation of blood clots in the vessels leading to deep venous thrombosis, pulmonary embolism, heart attack or stroke), are at risk of thrombosis or have previously had thrombosis or an increased tendency to form clots (thrombophilia)
• if you have any of the following diseases which 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 (high cholesterol)
• if you are a heavy smoker
• if you have jaundice (yellowing of the skin), active liver disease or a severe liver disorder or a liver tumour
• if you have a kidney disorder
• if you have any malignant tumours of the breast or womb or if you have a family history of breast cancer or non-cancerous breast disease
• if you inherited gene (BRCA1 and BRCA2) that may change and increase the likelihood to get breast, ovarian, and other cancers
• if you have vaginal bleeding of unknown origin
• if you had early menstrual periods (before the age of 12 years)
• if you previously received a cancer treatment that uses high doses of radiation to kill cancer cells and shrink tumours
• if you previously used a medicine containing Diethylstilbestrol (a synthetic form of the female hormone estrogen) which is prescribed for related to complications during pregnancy
• if you suffer from migraine headaches
• if you are pregnant or suspecting pregnancy or breastfeeding your baby (see Pregnancy and breastfeeding)
• if you need an operation or are off your feet for a long time.

If any of these conditions appear for the first time whilst using RUBY, stop taking it at once and consult your healthcare provider.

Do not share medicines prescribed for you with any other person. Always take/use RUBY exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Taking RUBY for the first time: The first tablet should be started on the first day of the menstrual cycle (day 1 of the cycle) by selecting the appropriate tablet for that day of the week (e.g. MON for Monday). One tablet should be taken daily (preferably after the evening meal or at bedtime) for 28 consecutive days. The tablet is swallowed whole with some liquid. Withdrawal bleeding usually starts on day 2 to 3 after starting on the inactive white tablets and may not have finished before the next pack is started. Each subsequent pack is started the day after the last tablet of the current pack. If RUBY is started during the last part of the week, the very first cycle may be slightly shortened.

How to start RUBY No preceding hormonal contraceptive uses (in the past month): Tablet - taking has to start on day 1 of natural cycle (i.e. the first day of the menstrual bleeding). An additional barrier method is recommended for the first 7 days of tablet - taking during the first cycle.

Changing from another combined oral contraceptive, or combination contraceptive vaginal ring or patch to RUBY: The first RUBY tablet should be taken on the day after the last active tablet of the previous combined oral contraceptive, but at the latest on the day following the usual tablet - free or inactive tablet interval of the previous combined oral contraceptive. In case a vaginal ring or transdermal patch has been used, the woman should start using RUBY preferably on the day of removal, but at the latest when the next application would have been due.

Changing from a Progestogen - only - Pill (POP or mini - pill, injection, implant or a progestogen - releasing intrauterine system IUS): From mini - pills it can be changed to RUBY on any day, from an implant or intrauterine system on the day of its removal and from an injectable when the next injection would be due. In all these cases additional contraceptive precautions are required for the first 7 days of tablet - taking.

Following 1st trimester abortion or miscarriage: Oral contraception may be started immediately. Additional contraceptive precautions are not required.

Following delivery or 2nd trimester abortion or miscarriage: For use in lactation – see section 2 Pregnancy and breastfeeding. Oral contraception can be started by non - lactating women 21 to 28 days after a delivery or 2nd trimester abortion. If oral contraception is started later, one of the barrier methods as additional contraceptive precaution is also required for the first 7 days.

If intercourse has already taken place, pregnancy should be excluded before tablet intake is started, or it should be delayed until the first menstrual bleeding.

What to do if you start vomiting or have severe diarrhoea: If you start vomiting within 3 to 4 hours of taking RUBY, the medicine may be less effective as this is like missing a tablet. Speak to your doctor or pharmacist on how to continue taking RUBY.

You want to delay a period: You can delay your period if you start with your next pack of RUBY tablets immediately after finishing the active yellow tablets of your current pack (do not take the inactive white tablets). You can continue with this pack for as long as you wish, e.g., until this pack is empty, to get a period approximately 3 weeks later than usual. While using the second pack, you may have some breakthrough bleeding or spotting on active tablet - taking days.

You have unexpected bleeding: With all pills, for the first few months, you can have irregular vaginal bleeding (spotting or breakthrough bleeding) outside the 7 - day pill - free days. If this bleeding lasts longer than a few months, or if it begins after some months, your doctor must investigate the cause.

Your doctor will tell you how long your treatment with RUBY will last. Do not stop treatment early because the risk of unwanted pregnancy is increased. If you have the impression that the effect of RUBY is too strong or too weak, tell your doctor or pharmacist.

If you take more RUBY 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. Symptoms of overdose may include: nausea, vomiting and slight vaginal bleeding in young girls.

If you forget to take RUBY: Management of missed tablets: Tablet - taking must never be discontinued for longer than 7 days. Uninterrupted tablet - taking for 7 days are required to attain adequate suppression of the hypothalamic - pituitary - ovarian axis. If you are less than 12 hours late taking a tablet, the protection against pregnancy is not reduced. Take the tablet as soon as you remember and then take the following tablets again at the usual time. If you are more than 12 hours late taking a tablet, the protection against pregnancy may be reduced. The greater the number of tablets you have forgotten, the greater is the risk of becoming pregnant. The risk of incomplete protection against pregnancy is greatest if you forget a tablet at the beginning or at the end of the strip. Therefore, you should keep to the following rules:

• More than one tablet forgotten in this strip: Contact your doctor.
• One tablet forgotten between days 1 - 7: Take the forgotten tablet as soon as you remember, even if that means that you have to take two tablets at the same time. Continue taking the tablets at the usual time and use extra precautions for the next 7 days, for example, a condom. If you have had sex in the week before forgetting the tablet you may be pregnant. In that case, contact your doctor.
• One tablet forgotten between days 8 – 14: Take the forgotten tablet as soon as you remember, even if that means that you have to take two tablets at the same time. Continue taking the tablets at the usual time. The protection against pregnancy is not reduced, and you do not need to take extra precautions. If you forget more than one tablet use an additional barrier method such as a condom for 7 days.
• One tablet forgotten between days 15 - 21: You can choose between two possibilities: 1. Take the forgotten tablet as soon as you remember, even if that means that you have to take two tablets at the same time. Continue taking the tablets at the usual time. Instead of having seven pill - free days start the next strip as soon as you have taken the last tablet. Most likely, you will have a period at the end of the second strip – but you may also have light or menstruation - like bleeding during the second strip. 2. You can also stop the tablets and go directly to the tablet - free period (record the day on which you forgot your tablet). If you want to start a new strip on the day you always start, make the tablet - free period less than 7 days. If you follow one of these two recommendations, you will remain protected against pregnancy.

If you have forgotten any of the tablets in a strip, and you do not have a bleeding during the first tablet - free period, you may be pregnant. Contact your doctor before you start the next strip.

RUBY can have side effects. Not all side effects reported for RUBY are included in this leaflet. Should your general health worsen, or if you experience any untoward effects while using RUBY, please consult your doctor, pharmacist or other healthcare professional for advice.

If any of the following happens, stop using RUBY 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

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

• tight chest or wheezing
• breast pain or tenderness, any lumps you can see or feel
• signs of a thrombosis such as severe pain in the chest which may reach the left arm, unusually severe pain in the legs, weakness or numbness in any part of your body, breathlessness, unusual cough, especially if you cough up blood, dizziness or fainting, visual disturbances, disturbed hearing or speech, sensory defect, migraine for the first time or your migraine gets worse, unusual, recurrent or constant headache
• if you experience a heart attack or stroke
• jaundice (yellowing of the skin)
• sudden severe stomach pains
• unusual heavy vaginal bleeding or if you miss your period twice in a row
• if you suspect you are pregnant
• high or low 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:

• mood disturbances, depression, uncontrollable laughing or crying at inappropriate times
• decrease and loss of interest in sexual intercourse
• depressed mood and depression are well - known undesirable effects of hormonal contraceptive use. Depression can be serious and is a well - known risk factor for suicidal behaviour and suicide. You should contact your doctor or pharmacist in case of mood changes and depressive symptoms, including shortly after you have started the treatment
• headache, migraine
• nausea, drowsiness, stomach pain
• menstrual disorders, bleeding between menstrual cycles, breakthrough bleeding or spotting, breast tenderness, breast pain, vaginal discharge.

Less frequent side effects:

• asthma
• increase of interest in sexual intercourse
• contact lens intolerance (pain, irritation, or significant discomfort from using contact lenses)
• vomiting, diarrhoea
• acne, eczema, painful red skin rash or sores, hair loss, abnormal hair growth on the face and body
• vaginal (yeast) infection
• unusual breast enlargement
• fluid retention, weight gain or weight loss, fatigue, fever.

The following side effects have been reported but the frequency for them to occur is not known:

• inflammation of the pancreas, gallstones, how well your body’s cells absorb glucose (changes in glucose tolerance), inflammatory bowel disease (Crohn’s disease, ulcerative colitis)
• darker skin patches that primarily affect the face and other sun - exposed areas (chloasma)
• liver tumours or changes in liver function tests
• hearing impairment
• harmful blood clots in a vein or artery for example, in a leg or foot (i.e. DVT), heart attack stroke, mini stroke or temporary stroke - like symptoms, known as transient ischaemic attack (TIA).

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 or pharmacist or nurse. You can also report side effects to SAHPRA via the online service for adverse drug reaction reporting by following the link: https://www.sahpra.org.za/document/adverse-drug-reactions-and-quality-problem-reporting-form/ https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of RUBY. You can also send an email directly to the company, [email protected], to ensure safety of the product.

Store all medicines out of reach of children. Store at or below 25 ºC. Keep in outer container until required for use. Do not use after the expiry date stated on the carton. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).