Limetic

Patient Information Leaflet

Limetic, 75 micrograms, coated tablets
Desogestrel
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are similar.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of Contents

1. What Limetic is and what it is 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 Limetic is and what it is used for

Limetic is used for contraception (to prevent pregnancy).
Limetic contains a small amount of one type of female sex hormone called a progestogen –
desogestrel. For this reason, Limetic is known as a 'progestogen-only pill'.
Unlike combined oral contraceptives, the progestogen-only pill does not contain oestrogen.
Most progestogen-only pills work primarily by preventing sperm from entering the womb. They do not always prevent the release of an egg (ovulation), which is the main mechanism of action of combined oral contraceptives. Limetic differs from most progestogen-only pills in that its dose is sufficient in most cases to prevent ovulation. As a result, Limetic has high contraceptive efficacy.
Unlike combined oral contraceptives, Limetic can be used by women who cannot tolerate oestrogens and by breastfeeding women.
A disadvantage of using Limetic is the occurrence of irregular vaginal bleeding while taking the tablets. Bleeding may also not occur at all.

2. Important information before using Limetic

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

When not to use Limetic

• if the patient is allergic to desogestrel, soy, peanuts or any of the other ingredients of this medicine (listed in section 6);
• if the patient has thrombosis. Thrombosis is the formation of blood clots in blood vessels, for example in the legs (deep vein thrombosis) or in the lungs (pulmonary embolism);
• if the patient has or has previously had jaundice (yellowing of the skin) or serious liver disease and liver function has not yet returned to normal;
• if the patient has or there is suspicion of a hormone-dependent tumour (e.g. certain types of breast cancer);
• if the patient has vaginal bleeding of unknown cause.

If any of the conditions listed above apply, the patient should inform her doctor before starting to use Limetic. The doctor may recommend using a non-hormonal method of contraception.

If any of the conditions listed above occur for the first time while taking Limetic, medical advice should be sought immediately.

Warnings and precautions

Before starting to use Limetic, discuss the following with your doctor:

• if the patient has ever had breast cancer;
• if the patient has liver cancer, as a potential effect of Limetic on liver cancer cannot be excluded;
• if the patient has ever had thrombosis;
• if the patient has diabetes;
• if the patient has epilepsy (see section "Limetic and other medicines");
• if the patient has tuberculosis (see section "Limetic and other medicines");
• if the patient has high blood pressure;
• if the patient has or has previously had chloasma (yellowish-brown patches or skin discoloration, especially on the face); in such cases, excessive exposure to sunlight or ultraviolet radiation should be avoided.

If Limetic is used in any of these cases, close monitoring of the patient may be necessary. The doctor will advise on how to proceed.

Breast cancer

Women should regularly examine their breasts and contact their doctor immediately if they detect any lump. Breast cancer occurs slightly more frequently in women using contraceptive pills than in women of the same age who do not use them. After stopping contraceptive pills, the risk gradually decreases, and 10 years after stopping, the risk is the same as in women who have never used contraceptive pills. Breast cancer is rare in women under 40 years of age, but the risk increases with age. Therefore, the number of additional diagnosed cases of breast cancer increases with the age at which women stop taking contraceptive pills. The duration of contraceptive pill use is of lesser significance.

Among 10,000 women who used contraceptive pills for 5 years and stopped before age 20, there are fewer than 1 additional case of breast cancer after 10 years compared to the 4 cases normally diagnosed in women of the same age group who did not use contraceptive pills. Similarly, among 10,000 women who used contraceptive pills for 5 years and stopped before age 30, there are 5 additional cases compared to 44 cases normally diagnosed. Among 10,000 women who used contraceptive pills for 5 years and stopped before age 40, there are 20 additional cases compared to 160 cases normally diagnosed.

It is believed that the risk of breast cancer in women using progestogen-only pills, such as Limetic, is similar to that in women using combined pills, but the data are not conclusive.

It appears that breast cancer detected in women using contraceptive pills is usually less advanced than in women who do not use them. It is not known whether this difference is caused by the use of contraceptive pills. It may be due to earlier detection, as women using contraceptive pills tend to be examined more frequently.

Thrombosis

Seek immediate medical advice if potential symptoms of thrombosis occur (see also section "Regular check-ups"). Thrombosis is the formation of blood clots that may block a blood vessel. Thrombosis sometimes occurs in the deep veins of the legs (deep vein thrombosis). If such a clot detaches from the vein where it formed, it may travel to the lungs and block the arteries, causing a so-called "pulmonary embolism," which may lead to death. Deep vein thrombosis is rare and may occur regardless of whether contraceptive pills are used or not. It may also occur during pregnancy. The risk is higher in women using contraceptive pills than in women who do not use them. It is believed that the risk is lower in women using progestogen-only pills, such as Limetic, compared to women using combined pills containing oestrogens.

Psychiatric disorders

Some women using hormonal contraceptives, including Limetic, have reported depression or low mood. Depression can be severe and may sometimes lead to suicidal thoughts. If mood changes or symptoms of depression occur, contact your doctor as soon as possible for further medical advice.

Children and adolescents

There are no available clinical data on the efficacy and safety of use in adolescents under 18 years of age.

Limetic and other medicines

Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, including herbal medicines, and any medicines you plan to take. You should also inform other doctors or dentists (or pharmacists) who prescribe other medicines (or the pharmacist) that you are using Limetic. The doctor will advise whether you need to use an additional method of contraception (e.g. a condom) and, if so, for how long, and whether the dosage of other medicines you are taking needs to be changed.

Some medicines:

• may affect the blood concentration of Limetic,
• may reduce contraceptive effectiveness,
• may cause unexpected bleeding.

These include medicines used to treat:

• epilepsy (e.g. primidone, phenytoin, carbamazepine, oxcarbazepine, felbamate, topiramate and phenobarbital),
• tuberculosis (e.g. rifampicin, rifabutin),
• HIV infection (e.g. ritonavir, nelfinavir, nevirapine, efavirenz),
• hepatitis C virus infection (e.g. boceprevir, telaprevir),
• other infectious diseases (e.g. griseofulvin),
• pulmonary hypertension (bosentan),
• depressive states (herbal St John's wort),
• certain bacterial infections (e.g. clarithromycin, erythromycin),
• fungal infections (e.g. ketoconazole, itraconazole, fluconazole),
• high blood pressure (hypertension), angina pectoris or certain heart rhythm disorders (e.g. diltiazem).

If you are taking medicines or herbal products that may reduce the effectiveness of Limetic, you should also use an additional barrier method of contraception. As the effect of another medicine on Limetic may last up to 28 days after discontinuation, prolonged use of an additional barrier method of contraception may be necessary. Your doctor will advise whether additional contraceptive methods are needed and, if so, for how long.

Limetic may also affect the mechanism of action of other medicines in the body, either increasing their effect (e.g. medicines containing cyclosporine) or reducing their effectiveness (e.g. lamotrigine).

Before taking any medicine, 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, you should consult your doctor or pharmacist before using this medicine.

Pregnancy

Do not use Limetic if you are pregnant or suspect you may be pregnant.

Breastfeeding

Limetic may be used during breastfeeding. It does not appear to affect the production or quality of breast milk. However, a decrease in milk production has occasionally been reported during use of Limetic. Small amounts of the active substance in Limetic pass into breast milk.

The health of children breastfed for 7 months by mothers taking desogestrel was monitored up to the age of 2.5 years. No effect on children's growth and development was observed.

If you are breastfeeding and wish to use Limetic, consult your doctor.

Driving and operating machinery

There are no reports on the effect of Limetic on alertness and concentration.

Limetic contains lactose and soya oil

Limetic contains lactose (milk sugar). If you have been previously diagnosed with an intolerance to certain sugars, consult your doctor before taking this medicine.

If you are allergic to peanuts or soya, do not take this medicine.

Regular check-ups

While using Limetic, your doctor will recommend regular check-up visits. The frequency and type of check-ups will depend on your health status.

Contact your doctor immediately if:

• you experience severe pain or swelling in either lower limb, unexplained chest pain, shortness of breath, unusual cough, especially coughing up blood (indicating possible thrombosis);
• you experience sudden, severe stomach pain or yellowing of the skin (indicating possible liver dysfunction);
• you detect a lump in your breast (indicating possible breast cancer);
• you experience sudden or severe pain in the lower abdomen or stomach area (indicating possible ectopic pregnancy);
• you are to be immobilized or undergo surgery (consult your doctor at least four weeks in advance);
• you experience unusual, heavy vaginal bleeding;
• you suspect you are pregnant.

3. How to use Limetic

This medicine should always be taken exactly as directed by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
When and how to take the tablets
The Limetic pack contains 28 tablets. The packaging (blister) is marked with the days of the week
and arrows indicating the order in which the tablets should be taken. Each day corresponds to one tablet.
Each time you start a new pack of Limetic, you should take the tablet from the top row. Do not start
with any tablet at random. For example, if starting treatment on Wednesday, take the tablet from the top row marked "WED" (Wednesday). Continue taking one tablet daily until the pack is empty, always following
the direction of the arrows. By looking at the tablet packaging, you can easily check whether you have
already taken the tablet for a given day.
Tablets should be taken every day, approximately at the same time.
Swallow the tablet whole with water. Bleeding may occur while taking Limetic, but you should
continue taking the tablets as before. After finishing one pack, start taking tablets from a new
pack of Limetic the next day—without interruption and without waiting for bleeding to occur.
Starting the first pack of Limetic
If you have not used hormonal contraceptives during the past month
Wait for your menstrual period to begin. Take the first tablet of Limetic on the first day of your period.
There is no need to use additional contraceptive methods.
You may also start taking the tablets between day 2 and day 5 of your cycle, but in this case,
you should use an additional contraceptive method (barrier method) for the first 7 days of tablet use.
Switching from a combined oral contraceptive, vaginal ring, or transdermal patch
You may start taking Limetic the day after taking the last active tablet of your current contraceptive
product, or on the day of removal of the vaginal ring or transdermal patch (meaning no break between
the tablet, ring, or patch and Limetic). If your current contraceptive pack also contains inactive tablets,
you may start Limetic the day after taking the last active tablet (if in doubt about which tablet is meant,
consult your doctor or pharmacist). If the above instructions are followed, there is no need to use
an additional contraceptive method.
You may start taking Limetic no later than the day after the break from tablets, ring, patch, or after
taking the last inactive tablet of your current contraceptive. In this case, you must use an additional
contraceptive method (barrier method) for the first 7 days of tablet intake.
Switching from another progestogen-only pill
You may stop taking the other progestogen-only pill on any day and immediately start taking Limetic.
There is no need to use additional contraceptive methods.
Switching from an injection, implant, or intrauterine device (IUD) releasing progestogen
Start taking Limetic on the day the next injection would have been administered, or on the day of
removal of the implant or intrauterine device. There is no need to use additional contraceptive methods.
After childbirth
You may start taking Limetic 21 to 28 days after childbirth. If the time since childbirth is longer,
you should use an additional contraceptive method for the first 7 days of tablet intake.
However, if you have already had sexual intercourse, pregnancy must be ruled out before starting Limetic.
Additional information for breastfeeding women is provided in section 2, "Pregnancy and breastfeeding".
You may also consult your doctor.
After premature delivery or miscarriage
Consult your doctor.
Missed dose of Limetic
If the delay in taking a tablet is less than 12 hours, the contraceptive effectiveness of the medicine
is maintained. Take the missed tablet as soon as you remember, and take the next tablet at the usual time.
If the delay in taking a tablet is more than 12 hours, the contraceptive effectiveness may be reduced.
The greater the number of tablets missed, the higher the risk of reduced contraceptive effectiveness.
Take the last missed tablet as soon as you remember, and take the next tablet at the usual time.
You should also use an additional contraceptive method (barrier method) for the next 7 days.
If one or more tablets were missed during the first week of use and you had sexual intercourse
in the week before the missed tablets, there is a possibility of pregnancy. Consult your doctor.
Gastrointestinal disturbances (e.g., vomiting, severe diarrhoea)
Follow the instructions for missed doses (above). If vomiting occurs within 3–4 hours after taking
a Limetic tablet, or if severe diarrhoea occurs, there is a risk that the active substance has not been
fully absorbed.
Taking more than the recommended dose of Limetic
No serious harmful effects have been observed after taking too many Limetic tablets at the same time.
Symptoms such as nausea, vomiting, and slight vaginal bleeding in young girls may occur.
For further information, consult your doctor.
Stopping the use of Limetic
You may stop taking Limetic at any time. From the day you stop, you are no longer protected
against pregnancy.
If you have any further doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Serious side effects associated with the use of Limetic are described in the sections
"Breast cancer" and "Thrombosis" in section 2 "Important information before taking Limetic" of this leaflet.
Please read these sections for additional information and consult your doctor if necessary.
If allergic reactions (hypersensitivity) occur, including swelling of the face, lips, tongue and/or throat,
causing difficulty in breathing or swallowing (angioedema and/or anaphylactic reactions), seek immediate
medical advice.
Vaginal bleeding at irregular intervals may occur during treatment. This may be in the form of light spotting,
which may not even require the use of sanitary pads, or heavier bleeding resembling a light menstrual period
requiring the use of hygiene products. Bleeding may also not occur at all. Irregular bleeding is not a sign of
reduced contraceptive effectiveness of the medicine. Usually, no action is required and you should continue
taking Limetic. However, if bleeding is heavy or prolonged, consult your doctor.
The following side effects have been reported by women taking Limetic:
Common (may affect up to 1 in 10 women):
mood changes, depressed mood, decreased sexual drive (libido), headache, nausea, acne, breast tenderness,
irregular menstrual bleeding or absence of periods, weight gain.
Uncommon (may affect up to 1 in 100 women):
vaginal infections, difficulty wearing contact lenses, vomiting, hair loss, painful menstruation, ovarian cyst,
fatigue.
Rare (may affect up to 1 in 1,000 women):
rash, urticaria, painful red or purple nodules on the skin (erythema nodosum) (these are skin disorders).
Frequency not known (frequency cannot be estimated from the available data):
allergic reactions.
In addition to the side effects listed above, breast discharge may occur.
Reporting of side effects
If any side effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Side effects
can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Medicinal
Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Limetic

Keep this medicine out of sight and reach of children.
Store below 30°C. Keep in the original packaging to protect from light.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
The label on the packaging shows the expiry date after the abbreviation EXP, and the batch number after the abbreviation Lot.
The active substance poses an environmental risk to fish.
Medicines must 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 packaging and other information

What Limetic contains

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

What Limetic looks like and contents of the pack
One blister of Limetic contains 28 film-coated tablets. Each package 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 Site in Nowa Dęba
ul. Metalowca 2, 39-460 Nowa Dęba

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Austria: Grystella 75 Micrograms Film-coated Tablets
Spain: Kerizet 75 micrograms film-coated tablets EFG
Poland: Limetic