About Cimizt®

Your healthcare provider has prescribed Cimizt® as your combined oral contraceptive.

If you are starting Cimizt® for the first time, please carefully read the patient information leaflet (PIL) provided inside the pack.

If you misplace the PIL you can download a replacement here or read about Cimizt® on this website.

Understanding how to take Cimizt® correctly and what might make it less effective is essential to prevent an unwanted pregnancy.

cimizt
Why was I given Cimizt®?
If you want to find out more about why Cimizt® was chosen as your contraceptive pill, please talk to your doctor or other healthcare professional. They will be able to explain in greater detail why Cimizt® has been selected as the right choice for your contraception.

If you received Marvelon® previously
Changing your prescription to Cimizt® should not cause you any problems or inconvenience. Cimizt® is just as effective at preventing pregnancy as Marvelon®.

Cimizt® contains the same active ingredients in the same amounts as Marvelon®, and therefore works in the same way.

If you still have any concerns about your change of brand, please talk to a healthcare professional 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 or this website that you want to know more about or worries you, please talk to your doctor or other healthcare professional for advice and guidance.

What Cimizt® tablets are and what they are used for
Cimizt® 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. 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
Before you take Cimizt
Before you start using Cimizt®Tablets you should read all the information on blood clots and other precautions and warnings in section 2 of your Patient Information Leaflet. It is particularly important to read the symptoms of a blood clot – see Section 2 “Blood Clots”.

If there is anything in the leaflet that worries you or you would like to discuss further, please consult your healthcare provider.

When you must not take Cimizt® tablets

You should not use Cimizt® Tablets 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 have (or have ever had) a blood clot in a blood vessel of your legs (deep vein thrombosis, DVT), 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, Factor V Leiden or antiphospholipid antibodies
  • if you need an operation or if you are off your feet for a long time (see section ‘Blood Clots’)
  • if you have ever had a heart attack or a 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
  • if you have (or have ever had) a type of migraine called ‘migraine with aura
  • 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)

When should you contact your doctor?

Seek urgent medical attention if you notice possible signs of a blood clot that may mean you are suffering from a blood clot in the leg (i.e. deep vein thrombosis), a blood clot in the lung (i.e. pulmonary embolism), a heart attack or a stroke (see ‘Blood Clots’ (thrombosis) section in your patient information leaflet.

In your Patient Information Leaflet, several situations are described where you should stop using Cimizt® Tablets, or where the reliability of the pill may be decreased. Please read your 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 Cimizt® Tablets alters the monthly changes of body temperature and of cervical mucus.

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

How to take Cimizt®
Take one Cimizt® 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 so-called “withdrawal bleeding” usually starts on the 2nd or 3rd day of the gap week.

On the 8th day after the last tablet of Cimizt® (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 Cimizt® Tablets in this manner, you are also protected against pregnancy during the 7 days when you are not taking a tablet.

When can you start with the first strip?

  • If you have not used a contraceptive with hormones in the previous month
    Begin with Cimizt® on the first day of the cycle (that is the first day of your period). If you start Cimizt® 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 Cimizt® 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 Cimizt® 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 Cimizt® use. If, after having a baby, you have had sex before starting Cimizt® (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 Cimizt® 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.

Missed pills
  • 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

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
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 taking the tablet-free period start the 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.

  1. You can also stop the strip and go directly to the tablet-free period of 7 days (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 bleeding in the first tablet-free period, you may be pregnant. Contact your doctor before you start the next strip

If you are sick or taking other medications

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 “What to do if you forget to take Cimizt® 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 Cimizt® 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 Cimizt® 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 Cimizt® 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)
  • The herbal remedy St. John’s wort

Cimizt® 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.

Possible side effects
Like all medicines, Cimizt® Tablets can cause side effects, although not everybody gets them. If you get any side effect, particularly if severe and persistent, or have any change to your health that you think may be due to Cimizt®, please talk to your doctor.
An increased risk of blood clots in your veins (venous thromboembolism (VTE)) or blood clots in your arteries (arterial thromboembolism (ATE)) is present for all women taking combined hormonal contraceptives. For more detailed information on the different risks from taking combined hormonal contraceptives please see section 2 “What you need to know before you take Cimizt® tablets”.

Serious reactions
More serious reactions associated with combined hormonal contraceptive pills are detailed above in section 2 under “Blood Clots” 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 Cimizt® 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, harmful blood clots in a vein or artery for example:

  • in a leg or foot (i.e. DVT)
  • in a lung (i.e. PE)
  • heart attack
  • stroke
  • mini-stroke or temporary stroke-like symptoms, known as a transient ischaemic attack (TIA)
  • blood clots in the liver, stomach/intestine, kidneys or eye

The chance of having a blood clot may be higher if you have any other conditions that increase this risk (See section 2 for more information on the conditions that increase risk for blood clots and the symptoms of a blood clot).

Reporting side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in your Patient Information Leaflet. You can also report side effects directly via Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard By reporting side effects you can help provide more information on the safety of this medicine.

Storing your Cimizt®
Keep this medicine out of the sight and reach of children. Do not store above 25°C. Store in the original package in order to protect from moisture and light.

Expiry date
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.

Pack contents and information
Each tablet is round, white to off-white, uncoated, biconvex, debossed with ‘142’ on one side and other side plain.
Each strip of Cimizt® Tablets contains 21 white tablets.Each box of Cimizt®
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.