About Bimizza®
Your healthcare provider has prescribed Bimizza® as your combined oral contraceptive.
If you are starting Bimizza® for the first time, please carefully read the Patient Information Leaflet (PIL) provided inside the pack.
Understanding how to take Bimizza® correctly and what might make it less effective is essential to prevent an unwanted pregnancy.
If you received Mercilon® previously
Changing your prescription to Bimizza® is as simple as getting used to the new packaging – you’ll take the same number of tablets each month, and request repeat prescriptions in the same way as when you took Mercilon®.1,2 When taken correctly, Bimizza® is just as effective at preventing pregnancy as Mercilon®.3
Bimizza® contains the same active ingredients in the same amounts as Mercilon®, and is therefore considered to work in the same way.1—3
If you still have any concerns about your change of brand, please talk to the healthcare provider who prescribed you this product.
Other Concerns?
Only your healthcare provider knows your full medical history, so if there is any information in the Patient Information Leaflet that you want to know more about or worries you, please talk to your doctor or healthcare provider for advice and guidance.
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:
- Stop the ovary from releasing an egg each month (ovulation).
- Also thicken the fluid (at the neck of the womb making it more difficult for the sperm to reach the egg).
- Alter the lining of the womb to make it less likely to accept a fertilised egg.
- 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.
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.
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.
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.
Marketing Authorisation Holder
Morningside Healthcare Ltd
115 Narborough Road
Leicester, LE3 0PA
United Kingdom
References
- Morningside Healthcare Ltd. Bimizza 150 microgram/20 microgram Tablets. Summary of Product Characteristics. Available at: https://www.medicines.org.uk/emc/product/9567 (accessed January 2024);
- Organon Pharma (UK) Ltd. Mercilon Tablets. Summary of Product Characteristics. Available at: https://www.medicines.org.uk/emc/product/1360 (accessed January 2024);
- MHRA. UK PAR Bimizza 150 microgram/20 microgram tablets. February 2015. Available at: https://mhraproductsproduction.blob.core.windows.net/docs/33446c8282edba466bfd797be04735e72eb54bca (accessed January 2024).