Limetic

Package Leaflet: Information for the Patient

Limetic, 75 micrograms, film-coated tablets

Desogestrel

Read this leaflet carefully before taking this medicine, as it contains important information for you.

• You should keep this leaflet, so you can read it again later.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Contents of the pack

• 1. What is Limetic and what is it used for
• 2. Important information before taking Limetic
• 3. How to take Limetic
• 4. Possible side effects
• 5. How to store Limetic
• 6. Contents of the pack and other information

1. What is Limetic and what is it used for

Limetic is used to prevent pregnancy.
Limetic contains a small amount of one type of female sex hormone, the progestogen desogestrel. For this reason, Limetic is called a progestogen-only pill (POP).
Unlike the combined pill, the progestogen-only pill does not contain an oestrogen. Most progestogen-only pills work primarily by preventing sperm from entering the womb. They do not always prevent the release of an egg from the ovary, which is the main way that combined hormonal contraceptives work. Limetic is different from most progestogen-only pills in that it usually prevents the release of an egg, making it a very effective contraceptive. Unlike combined hormonal contraceptives, Limetic can be used by women who cannot tolerate oestrogens and by breastfeeding women.
A disadvantage of taking Limetic is that it can cause irregular vaginal bleeding during tablet-taking. Bleeding may also not occur at all.

2. Important information before taking Limetic

Like other hormonal contraceptives, Limetic does not protect against HIV infection (AIDS) or other sexually transmitted diseases.

When not to take Limetic

• if you are allergic to desogestrel, soya, peanuts or any of the other ingredients of this medicine (listed in section 6);
• if you have a blood clot. A blood clot is a clot that forms in the blood vessels, for example in the legs (deep vein thrombosis) or in the lungs (pulmonary embolism);
• if you have or have had jaundice (yellowing of the skin) or severe liver disease and liver function has not returned to normal;
• if you have or are suspected to have a hormone-dependent tumour (e.g. certain types of breast cancer);
• if you have vaginal bleeding of unknown cause. If any of these conditions apply to you, tell your doctor before starting to take Limetic. Your doctor may recommend a non-hormonal method of contraception.

If any of these conditions occur for the first time while taking Limetic, you should contact your doctor immediately.

Warnings and precautions

Before taking Limetic, you should discuss this with your doctor:

• if you have ever had breast cancer;
• if you have liver cancer, as the effect of Limetic on liver cancer is unknown;
• if you have ever had a blood clot;
• if you have diabetes;
• if you have epilepsy (see section "Limetic and other medicines");
• if you have tuberculosis (see section "Limetic and other medicines");
• if you have high blood pressure;
• if you have or have had chloasma (yellowish-brown pigmentation on the skin, especially on the face); in this case, you should avoid exposure to the sun or ultraviolet radiation.

If you take Limetic in any of these situations, you may need close medical supervision. Your doctor will explain what to do.

Breast cancer

You should regularly check your breasts and contact your doctor as soon as possible if you notice any lump in your breasts. Breast cancer has been found slightly more often in women who take hormonal contraceptives than in women of the same age who do not take them. After stopping hormonal contraceptives, the risk gradually decreases, and 10 years after stopping, the risk is the same as for women who have never taken hormonal contraceptives. Breast cancer is rare in women under 40 years of age, but the risk increases with age. Therefore, the number of additional breast cancers diagnosed is higher in older women who take hormonal contraceptives. The difference in breast cancer risk between ever-users and never-users of hormonal contraceptives increases with the duration of use. On each 10,000 women who take hormonal contraceptives for 5 years in their early twenties, there will be about 4 additional cases of breast cancer (more than the 14 cases usually expected over 5 years). On each 10,000 women who take hormonal contraceptives for 5 years in their early thirties, there will be about 5 additional cases of breast cancer (more than the 44 cases usually expected over 5 years). On each 10,000 women who take hormonal contraceptives for 5 years in their early forties, there will be about 20 additional cases of breast cancer (more than the 160 cases usually expected over 5 years). It is thought that the risk of breast cancer in women taking progestogen-only pills, such as Limetic, is similar to that in women taking combined hormonal contraceptives, but the evidence is not conclusive. It appears that the breast cancers found in women who take hormonal contraceptives are less advanced than those found in women who do not take them. It is not known whether this is because the hormone causes the cancer to be discovered earlier or because the hormone causes the cancer to grow more slowly. If you are taking hormonal contraceptives and notice any changes in your breasts, you should make an appointment to see your doctor as soon as possible.

Blood clots

You should contact your doctor as soon as possible if you notice any of the following symptoms of a blood clot (see also section "Regular check-ups"): a blood clot is a clot that forms in the blood vessels, which can block a blood vessel. A blood clot in the deep veins of the legs (deep vein thrombosis) can move to the lungs and block the blood vessels there (pulmonary embolism), which can be fatal. Blood clots can occur in women who are not taking hormonal contraceptives, but the risk is higher in women who take hormonal contraceptives. The risk is higher in women who take hormonal contraceptives that contain oestrogen and progestogen (combined hormonal contraceptives) than in women who take progestogen-only pills like Limetic.

Mental health

Some women who take hormonal contraceptives, including Limetic, have reported depression or a worsening of their mood. Depression can be severe and, in rare cases, lead to suicidal thoughts. If you experience mood changes or symptoms of depression, you should contact your doctor as soon as possible for further medical advice.

Children and adolescents

There are no clinical data on the efficacy and safety of Limetic in adolescents below 18 years of age.

Limetic and other medicines

Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription, herbal products, and other non-prescription products. You should also tell any other doctor or dentist who prescribes another medicine (or pharmacist) that you are taking Limetic. Your doctor will tell you whether you need to use an additional barrier method of contraception (e.g. a condom) and for how long, or whether the dose of your other medicines needs to be adjusted. Some medicines may affect the levels of Limetic in your blood, which may lead to:

Examples of medicines that may affect the levels of Limetic in your blood are:

• medicines used to treat epilepsy (e.g. primidone, phenytoin, carbamazepine, oxcarbazepine, felbamate, topiramate, and phenobarbital),
• medicines used to treat tuberculosis (e.g. rifampicin, rifabutin),
• medicines used to treat HIV infections (e.g. ritonavir, nelfinavir, nevirapine, efavirenz),
• medicines used to treat hepatitis C virus infections (e.g. boceprevir, telaprevir),
• other infectious diseases (e.g. griseofulvin),
• high blood pressure in the blood vessels of the lungs (bosentan),
• depression (St. John's Wort),
• certain bacterial infections (e.g. clarithromycin, erythromycin),
• fungal infections (e.g. ketoconazole, itraconazole, fluconazole),
• high blood pressure, angina pectoris, or certain heart rhythm disorders (e.g. diltiazem).

If you are taking any of these medicines, you should use a barrier method of contraception (e.g. a condom) in addition to Limetic. Because the effect of another medicine on Limetic may last up to 28 days after stopping the other medicine, you should use a barrier method of contraception for that long. Your doctor will tell you whether you need to use an additional barrier method of contraception and for how long. Limetic may also affect the efficacy of other medicines, such as:

• ciclosporin (an immunosuppressant),
• lamotrigine (an antiepileptic medicine).

Before taking any other medicine, you should consult your doctor or pharmacist.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Do not take Limetic if you are pregnant or think you may be pregnant.

Breastfeeding

Limetic can be used during breastfeeding. It does not seem to affect milk production or the quality of the milk. However, small amounts of the active substance of Limetic may pass into the breast milk. The health of children whose mothers took desogestrel during breastfeeding was studied for up to 2.5 years. No effects on the growth and development of the children were found. If you are breastfeeding and want to take Limetic, you should consult your doctor.

Driving and using machines

There are no reports of any effect of Limetic on the ability to drive and use machines.

Limetic contains lactose and soya oil

Limetic contains lactose (a sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
If you are allergic to peanuts or soya, do not take this medicinal product.

Regular check-ups

While taking Limetic, your doctor will tell you to have regular check-ups. The frequency and nature of these check-ups will depend on your individual situation.

Contact your doctor immediately if:

• you notice any signs of a blood clot, such as severe pain or swelling in one of your legs, unexplained chest pain, or difficulty breathing (see section "Blood clots");
• you have severe abdominal pain or yellowing of the skin (which may be signs of liver problems);
• you have a breast lump (which may be a sign of breast cancer);
• you have severe pain in your lower abdomen (which may be a sign of an ectopic pregnancy);
• you are to be immobilised or are to have surgery (tell your doctor at least four weeks in advance);
• you have unusual or heavy vaginal bleeding;
• you suspect that you are pregnant.

3. How to take Limetic

Take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

When and how to take the tablets

The pack contains 28 tablets. The blister pack is marked with the days of the week. Each day corresponds to one tablet. When starting a new pack of Limetic, take a tablet from the top row, following the direction of the arrows. Do not start with just any tablet. For example, if you start taking Limetic on a Wednesday, take the tablet marked "WED" (Wednesday). Continue taking one tablet every day, following the direction of the arrows, until the pack is empty. You can check that you have taken a tablet by looking at the blister pack.

Take one tablet every day, at about the same time.

Swallow the tablet whole, with water. You may experience vaginal bleeding during tablet-taking, but you should continue to take the tablets as usual. After finishing a pack, start a new pack the next day - without a break and without waiting for a period.

Starting the first pack of Limetic

If you are not using hormonal contraception at the moment
Wait until your period starts. Take the first tablet on the first day of your period. You do not need to use any additional contraception.
You can also start taking the tablets between day 2 and 5 of your cycle, but you will need to use an additional method of contraception (such as a condom) for the first 7 days of tablet-taking.
Changing from a combined pill, vaginal ring, or transdermal patch
You can start taking Limetic the day after you take the last tablet from your current pill pack, or the day after you remove the vaginal ring or patch (this means that there is no break between the different methods). If your current pill pack also contains placebo tablets, you can start taking Limetic the day after you take the last active tablet (if you are not sure which this is, ask your doctor or pharmacist). If you follow these instructions, you do not need to use any additional contraception.
You can start taking Limetic after a break from hormonal contraception, but you will need to use an additional method of contraception (such as a condom) for the first 7 days of tablet-taking.
Changing from a progestogen-only pill
You can stop taking your current progestogen-only pill at any time and start taking Limetic immediately. You do not need to use any additional contraception.
Changing from an injection, implant, or intrauterine system (IUS) that releases progestogen
You can start taking Limetic on the day that your next injection is due or on the day that your implant or IUS is removed. You do not need to use any additional contraception.
After childbirth
Limetic can be started between 21 and 28 days after childbirth. If you start later than this, you will need to use an additional method of contraception for the first 7 days of tablet-taking. However, if you have already had sex, you should make sure you are not pregnant before starting Limetic. For more information, see section 2 "Pregnancy and breastfeeding". You should also consult your doctor.
After a miscarriage or abortion
You should consult your doctor.

Missing a tablet

If you are less than 12 hours late with a tablet, the contraceptive effect of Limetic is maintained. Take the missed tablet as soon as you remember, and then take the next tablet at the usual time.
If you are more than 12 hours late with a tablet, the contraceptive effect of Limetic may be reduced. The more tablets you miss, the greater the risk that the contraceptive effect will be reduced. Take the most recently missed tablet as soon as you remember, and then take the next tablet at the usual time. You should also use an additional method of contraception (such as a condom) for the next 7 days. If you miss one or more tablets in the first week of tablet-taking and have sex in the week before missing the tablets, you may be at risk of becoming pregnant. You should consult your doctor.

Vomiting or diarrhoea

Follow the same procedure as when you miss a tablet (see above). If you vomit or have severe diarrhoea within 3-4 hours of taking a tablet, the active substance may not have been completely absorbed. You should follow the same procedure as when you miss a tablet.

Overdose

No serious harmful effects have been reported when too many Limetic tablets are taken at the same time. Symptoms that have been reported include nausea, vomiting, and, in young girls, slight vaginal bleeding. If you have taken too many tablets, you should consult your doctor.

Stopping Limetic

You can stop taking Limetic at any time. From the day you stop, you will not be protected against pregnancy.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Severe side effects that have been reported with the use of Limetic are described in the sections "Breast cancer" and "Blood clots" in section 2 "Important information before taking Limetic". You should read these sections to find out more and to find out what to do if you are affected by any of these conditions.
In addition to these side effects, the following may also occur:

• allergic reactions (hypersensitivity), including swelling of the face, lips, tongue, and/or throat, causing difficulty in swallowing or breathing (angio-oedema and anaphylactic reactions),

During tablet-taking, vaginal bleeding may occur at irregular intervals. This may be in the form of light bleeding or heavier bleeding, which may be like a light period and require sanitary protection. Bleeding may also not occur at all. Irregular bleeding is not a sign of a reduced contraceptive effect. In general, no action is needed, and you should continue to take Limetic as usual. However, if the bleeding is heavy or prolonged, you should consult your doctor.
Women taking Limetic have reported the following side effects:

Common(may affect up to 1 in 10 people):

• mood changes, depression, decreased sex drive, headaches, nausea, acne, breast tenderness, irregular periods or absence of periods, weight gain.

Uncommon(may affect up to 1 in 100 people):

• vaginal infections, difficulties with contact lenses, vomiting, hair loss, painful periods, ovarian cysts, fatigue.

Rare(may affect up to 1 in 1,000 people):

• rash, hives, painful red lumps on the skin (erythema nodosum) (these are skin conditions).

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

• allergic reactions.

In addition to these side effects, breast discharge has been reported.

Reporting of side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in the "Further information" section. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Limetic

Keep this medicine out of the sight and reach of children.
There are no special storage instructions for this medicine.
Do not use this medicine after the expiry date, which is stated on the packaging after "EXP". The expiry date refers to the last day of the month stated.
The packaging is marked with "EXP" (expiry date) and "Lot" (batch number).
The active substance may pose a risk to aquatic organisms. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Limetic contains

• The active substance is desogestrel. Each tablet contains 75 micrograms of desogestrel.
• The other ingredients are maize starch, povidone K30, d-alpha-tocopherol, colloidal anhydrous silica, colloidal hydrated silica, stearic acid, hypromellose 2910, macrogol, titanium dioxide (E 171), lactose monohydrate, soya oil.

What Limetic looks like and contents of the pack

One blister pack of Limetic contains 28 film-coated tablets. Each pack contains 1, 3, or 6 blisters. Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19
83-200 Starogard Gdański
tel.: + 48 22 364 61 01
Manufacturer
Laboratorios León Farma, S.A.
C/ La Vallina s/n
Pol. Ind. Navatejera
24193, Villaquilambre, León
Spain
Zakłady Farmaceutyczne POLPHARMA S.A.
Production Plant in Nowa Dęba
ul. Metalowca 2, 39-460 Nowa Dęba

This medicine is authorised in the Member States of the European Economic Area under the following names:

Austria: Grystella 75 Mikrogramm Filmtabletten
Spain: Kerizet 75 microgramos comprimidos recubiertos con pelicula EFG
Poland: Limetic
United Kingdom (Northern Ireland): Desogestrel 75 microgram film-coated tablets
Date of last revision of the leaflet: February 2024