Morningside Healthcare Contraceptives

Bimizza^® tablets are a combined oral contraceptive, also called the pill. Each tablet contains a small amount of two types of female hormones, namely, a progestogen, desogestrel and an oestrogen, ethinylestradiol.
These help to stop you from getting pregnant, just as your natural hormones would stop you conceiving again when you are already pregnant.
The combined contraceptive pill protects you against getting pregnant in three ways. These hormones:

1. Stop the ovary from releasing an egg each month (ovulation).
2. Also thicken the fluid (at the neck of the womb making it more difficult for the sperm to reach the egg).
3. Alter the lining of the womb to make it less likely to accept a fertilised egg.

There are several situations where you should stop using Bimizza^® tablets if a problem arises, or where the reliability of the pill may be decreased, and so it is important that you read the Patient Information Leaflet carefully. 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 Bimizza^® tablets alter the monthly changes of body temperature and of cervical mucus.Do not take Bimizza tablets

• if you have (or have ever had) a blood clot in a blood vessel of the leg (thrombosis), lung (pulmonary embolism) or other organs
• if you have (or have ever had) a heart attack or stroke
• if you have (or have ever had) a disease that can be an indicator of a heart attack in the future (for example, angina pectoris, which causes severe pain in the chest) or of a stroke (for example, a passing slight stroke with no residual effects)
• if you have a disease that may increase the risk of a clot in the arteries. This applies to the following diseases:
• diabetes with damaged blood vessels
• very high blood pressure
• a very high level of fat in the blood (cholesterol or triglycerides)
• if you have a disturbance of blood clotting (for example, protein C deficiency)
• if you have (or have ever had) a certain form of migraine (with so-called focal neurological symptoms)
• if you have (or have ever had) an inflammation of the pancreas (pancreatitis)
• if you have (or have ever had) a liver disease and your liver function is still not normal
• if you have (or have ever 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 any unexplained bleeding from the vagina
• if you are allergic to ethinylestradiol or desogestrel, or any of the other ingredients of this medicine (listed in section 6 of the Patient Information Leaflet)

Stop taking Bimizza tablets and contact your doctor immediately if you notice possible signs of blood clot, such as:

• severe pain and/or swelling in one of your legs
• sudden severe pain in the chest which may reach the left arm
• sudden breathlessness
• sudden cough without an obvious cause
• any unusual, severe or long-lasting headache or worsening of migraine
• partial or complete blindness or double vision
• difficulty in speaking or inability to speak
• giddiness or fainting
• weakness, strange feeling, or numbness in any part of the body

You should take the necessary time to read the full information on precautions and warnings contained in Section 2 of your Patient Information Leaflet. If you have any questions or concerns these should be discussed with your healthcare provider.

Bimizza^® tablets, like other hormonal contraceptives, do not protect against HIV infection (AIDS) or any other sexually transmitted disease.

Take one Bimizza^® tablet every day, if necessary with a small amount of water. You may take the tablets with or without food, but you should take the tablets every day around the same time. The strip contains 21 tablets. Next to each tablet is printed the day of the week that it should be taken. If, for example you start on a Wednesday, take a tablet with “WED” next to it. Follow the direction of the arrow on the strip until all 21 tablets have been taken. Then take no tablets for 7 days. In the course of these 7 tablet-free days (otherwise called a stop or gap week) bleeding should begin. This is so-called “withdrawal bleeding” usually starts on the 2^nd or 3^rd day of the gap week. On the 8^th day after the last tablet of Bimizza^® (that is, after the 7-day gap week), you should start with the following strip, whether your bleeding has stopped or not. This means that you should start every strip on the same day of the week and that the withdrawal bleed should occur on the same days each month.
If you use Bimizza^® tablets in this manner, you are also protected against pregnancy during the 7 days when you are not taking a tablet.Please consult your Patient Information Leaflet for more information about what to do if you miss a pill or download one here.When can you start with the first strip?

• If you have not used a contraceptive with hormones in the previous month
  Begin with Bimizza^® on the first day of the cycle (that is the first day of your period). If you start Bimizza^® on the first day of your period 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 combination hormonal contraceptive, or combination contraceptive vaginal ring or patch
  You can start Bimizza^® preferably on the day after the last active tablet (the last tablet containing active substances) of your previous pill, but at the latest on the day after the tablet-free days of your previous pill (or after the last inactive tablet of your previous pill). When changing from a combination 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 IUD)
  You may switch any day from the progestogen-only pill (from an implant or an IUD 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 tablet-taking
• After a miscarriage
  Follow the advice of your doctor
• After having a baby
  You can start Bimizza^® between 21 and 28 days after having a baby. If you start later than day 28, use a so-called barrier method (for example, a condom) during the first seven days of Bimizza^® use. If, after having a baby, you have had sex before starting Bimizza (again), be sure that you are not pregnant or wait until your next period

Ask your doctor what to do if you are not sure when to start.

Bleeding between periods

During the first few months that you are taking Bimizza tablets, you may have unexpected bleeding (bleeding outside the gap week). If this bleeding occurs for more than a few months, or if it begins after some months, your doctor must find out what is wrong.

What you must do if no bleeding occurs in the gap week

If you have taken all the tablets correctly, have not had vomiting or severe diarrhoea and you have not taken any other medicines, it is highly unlikely that you are pregnant. If the expected bleeding does not happen twice in succession, you may be pregnant. Contact your doctor immediately. Do not start the next strip until you are sure that you are not pregnant.

• 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 that 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 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 in week 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 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 in week 2
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.

One tablet forgotten in week 3
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 taking the tablet-free period start next strip.

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.

What to do in case of vomiting or severe diarrhoea
If you vomit within 3-4 hours of taking a tablet or you have severe diarrhoea, there is a risk that the active substances in the tablet are not fully absorbed into your body. The situation is almost the same as forgetting a tablet. After vomiting or diarrhoea, take another tablet from a reserve strip as soon as possible. If possible take it within 12 hours of when you normally take your pill. If this is not possible or 12 hours have passed, you should follow the advice given under “If you forget to take Bimizza^® tablets”.

Before you have any blood tests

Tell your doctor or the laboratory staff that you are taking the pill, because oral contraceptives can affect the results of some tests.

Other medicines and Bimizza tablets

Always tell the doctor which medicines or herbal products you are already using. Also tell any other doctor or dentist who prescribes another medicine (or the pharmacist) that you use Bimizza tablets. They can tell you if you need to take additional contraceptive precautions (for example condoms) and if so, for how long.

Some medicines can make Bimizza tablets less effective in preventing pregnancy, or can cause unexpected bleeding. These include medicines used for the treatment of

• epilepsy (e.g. primidone, phenytoin, barbiturates, carbamazepine, oxcarbamazepine)
• tuberculosis (e.g. rifampicin),
• HIV infections (ritonavir, nevirapine) or other infections (antibiotics such as griseofulvin, penicillin, tetracycline)

Additionally, the herbal remedy St. John’s wort can affect the efficacy of Bimizza.

Bimizza tablets may influence the effect of other medicines, e.g.

• medicines containing cyclosporin,
• the anti-epileptic lamotrigine (this could lead to an increased frequency of seizures)

Ask your doctor or pharmacist for advice before taking any medicine.

Like all medicines, Bimizza^® tablets can cause side effects, although not everybody gets them.
Serious reactions
More serious reactions associated with combined hormonal contraceptive pills are detailed above in section 2 under “The pill and venous and arterial blood clots (thrombosis)” and “The pill and cancer”. Please read these subsections carefully, and if you have any questions, ask your doctor.
The following serious side effects have been reported in women using the pill:
Crohn’s disease or ulcerative colitis (chronic inflammatory bowel diseases), systemic lupus erythematosus (SLE, a disease of the connective tissue), epilepsy, the rash known as herpes gestationis, chorea (a movement disease), a blood disorder called haemolytic uraemic syndrome – HUS (a disorder where blood clots cause the kidneys to fail), brown patches on the face and body (chloasma), movement disorder called Sydenham’s chorea, yellowing of the skin, gynaecological disorders (endometriosis, uterine myoma).
Other possible side effects
The following side effects have been reported in women using the pill, which can occur in the first few months after starting Bimizza^® tablets, but they usually stop once your body has adjusted to the pill. The most commonly reported side effects (more than 1 in every 10 users may be affected) are irregular bleeding and weight gain.
Common or uncommon (between 1 and 100 in every 1,000 users may be affected):
none or reduced bleeding, tender breasts, breast enlargement, breast pain, decreased sexual desire, depression, headache, nervousness, migraine, dizziness, nausea, vomiting, acne, rash, nettle-rash (urticaria), fluid retention, high blood pressure.
Rare (between 1 and 10 in every 10,000 users may be affected):
vaginal candidiasis (fungal infection), impaired hearing (otosclerosis), thromboembolism, hypersensitivity, increased sexual desire, eye irritation due to contact lens, loss of hair (alopecia), itching, skin disorders (erythema nodosum – a skin disease associated with joint pain, fever, hypersensitivity, or infection, and characterized by small, painful, pink to blue nodules under the skin and on the shins that tend to recur; erythema multiforme – a skin disease characterized by solid raised spots on the skin or fluid-filled blisters lesions and reddening or discoloration of the skin often in concentric zones about the lesions), vaginal discharge, breast discharge.
Reporting of side effects.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard By reporting side effects you can help provide more information on the safety of this medicine.

Keep this medicine out of the sight and reach of children.
Do not store above 25°C. Store in original package in order to protect from moisture and light.
Do not use this medicine after the expiry date which is stated on the package after “EXP”. The expiry date refers to the last day of that month.Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

Each tablet is round, white to off-white, uncoated, biconvex, debossed with ‘141’ on one side and other side plain.Each strip of Bimizza^® tablets contains 21 white tablets.Each box of Bimizza^® tablets contains 1, 3 or 6 strips of 21 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder
Morningside Healthcare Ltd
115 Narborough Road
Leicester, LE3 0PA
United Kingdom