Clormetin

Leaflet accompanying the packaging: information for the user

Clormetin, 0.03 mg + 2 mg, coated tablets

Ethinylestradiol+ Chlormadinone acetate
This medicinal product is subject to additional monitoring. This will allow for quick identification of new safety information. The user of the medicinal product can also help by reporting any adverse reactions that occur after taking the medicinal product. To find out how to report adverse reactions, see section 4.

Important information about combined hormonal contraceptives

• If used correctly, they are one of the most reliable, reversible methods of contraception.
• They slightly increase the risk of blood clots in veins and arteries, especially in the first year of use or when resuming use after a break of 4 weeks or more.
• Caution should be exercised and a doctor should be consulted if the patient suspects that symptoms of a blood clot have occurred (see section 2 "Blood clots").

You should carefully read the contents of the leaflet before taking the medicinal product, as it contains important information for the patient.

• You should keep this leaflet so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicinal product has been prescribed specifically for you. Do not pass it on to others. The medicinal product may harm others, even if their symptoms are the same as yours.
• If the patient experiences any adverse reactions, including those not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What Clormetin is and what it is used for
• 2. Important information before taking Clormetin
• 3. How to take Clormetin
• 4. Possible adverse reactions
• 5. How to store Clormetin
• 6. Contents of the packaging and other information

1. What Clormetin is and what it is used for

Clormetin is a hormonal contraceptive for oral use. An oral contraceptive that contains two hormones, like Clormetin, is also called a combined hormonal contraceptive. Each of the 21 coated tablets in the packaging for one cycle contains the same amount of both hormones, and therefore Clormetin is also called a monophasic preparation. Hormonal contraceptives, such as Clormetin, do not protect against AIDS (HIV infection) and other sexually transmitted diseases. Only condoms can protect against these diseases.

2. Important information before taking Clormetin

General notes

Before starting to take Clormetin, you should read the information about blood clots in section 2. It is especially important to read about the symptoms of a blood clot (see section 2 "Blood clots").
Before starting to take Clormetin, your doctor will perform a general and gynecological examination, rule out pregnancy, and decide, taking into account contraindications and precautions, whether you can take Clormetin. During the use of Clormetin, such an examination should be repeated once a year.

When not to take Clormetin

You should not take Clormetin if you have any of the conditions listed below. If you have any of the conditions listed below, you should inform your doctor. Your doctor will discuss with you which other contraceptive method will be more suitable for you.

• if you are allergic to ethinylestradiol, chlormadinone acetate, or any of the other ingredients of this medicinal product (listed in section 6);
• if you currently have (or have had) a blood clot in the deep veins of the legs (deep vein thrombosis), lungs (pulmonary embolism), or other organs;
• if you have symptoms that may indicate a blood clot, such as a sharp stabbing pain, pain, or feeling of pressure in the chest;
• if you know that you have blood coagulation disorders, such as protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies;
• if you need to undergo surgery or will be immobilized for a long time (see section "Blood clots");
• if you have diabetes and your blood sugar levels are not well controlled;
• if you have high blood pressure that is difficult to control or if your blood pressure has risen significantly (blood pressure values persistently above 140/90 mmHg);
• if you have had a heart attack or stroke;
• if you have had angina pectoris (a disease that causes severe chest pain and may be the first symptom of a heart attack) or transient ischemic attacks (transient symptoms of a stroke);
• if you have any of the following diseases that may increase the risk of a blood clot in an artery:
• severe diabetes with blood vessel damage,
• very high blood pressure,
• very high levels of fats in the blood (cholesterol or triglycerides),
• a disease called hyperhomocysteinemia.
• if you have had (or have) a type of migraine called "migraine with aura";
• if you have liver inflammation (e.g., viral) or jaundice, and liver function tests have not returned to normal;
• if you have itching all over your body or bile flow disorders, especially if such disorders occurred during a previous pregnancy or during previous estrogen treatment;
• if you have elevated bilirubin levels in the blood (a breakdown product of the blood pigment) due to congenital bilirubin excretion disorders (Dubin-Johnson syndrome or Rotor syndrome);
• if you have had (or have) liver cancer;
• if you have severe abdominal pain, liver enlargement, or symptoms of bleeding into the abdominal cavity;
• if you have had (or have) a porphyria attack (a disorder of blood pigment metabolism);
• if you have had (or have) hormone-dependent malignant tumors, such as breast or uterine cancer, or if such tumors are suspected;
• if you have severe lipid metabolism disorders;
• if you have had (or have) pancreatitis with high levels of fats in the blood (triglycerides);
• if you have sudden vision or hearing disturbances;
• if you have sudden movement disturbances (especially symptoms of paresis);
• if you have had (or have) epilepsy;
• if you have severe depression;
• if you have a certain type of hearing loss (otosclerosis) that worsened during a previous pregnancy;
• if you have unexplained absence of menstruation;
• if you have been diagnosed with abnormal growth of the uterine lining (endometrial hyperplasia);
• if you have vaginal bleeding of unknown cause.
• Do not take Clormetin if you have hepatitis C and are taking medicinal products containing ombitasvir/paritaprevir/ritonavir and dasabuvir or glecaprevir/pibrentasvir (see also section "Clormetin and other medicinal products").

If any of the above conditions occur during the use of Clormetin, you should stop taking Clormetin immediately.
You should not take Clormetin or stop taking it immediately if you have one or more serious risk factors for blood clots.

Warnings and precautions

Before starting to take Clormetin, you should discuss it with your doctor or pharmacist.
When should you contact your doctor?

• if you notice possible symptoms of a blood clot, which may indicate that you have a blood clot in your leg (deep vein thrombosis), blood clot in your lungs (pulmonary embolism), heart attack, or stroke (see section below "Blood clots". To find out what the symptoms of these serious adverse reactions are, see "How to recognize a blood clot".

You should tell your doctor if you have any of the following conditions.

• if you smoke. Smoking during the use of hormonal contraceptives increases the risk of serious adverse reactions related to the heart and blood vessels. This risk increases with age and the number of cigarettes smoked. This applies especially to women over 35 years old. Women over 35 years old who smoke should use other contraceptive methods.

If these symptoms occur or worsen during the use of Clormetin, you should also tell your doctor.

• if you have high blood pressure, abnormal high levels of fats in the blood, overweight, or diabetes (see also section 2). In these cases, the risk of serious adverse reactions (such as heart attack, embolism, stroke, or liver tumor) during the use of combined hormonal contraceptives is higher;
• if you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel diseases);
• if you have systemic lupus erythematosus (a disease that affects the body's natural defense system);
• if you have hemolytic uremic syndrome (a blood clotting disorder that causes kidney failure);
• if you have sickle cell anemia (a hereditary disease of red blood cells);
• if you have been diagnosed with high levels of fats in the blood (hypertriglyceridemia) or have a positive family history for this disease. Hypertriglyceridemia is associated with an increased risk of developing pancreatitis;
• if you need to undergo surgery or will be immobilized for a long time (see section 2 "Blood clots");
• if you have recently given birth, as you are at increased risk of blood clots. You should ask your doctor how soon you can start taking Clormetin after giving birth;
• if you have superficial thrombophlebitis (blood clots in the veins under the skin);
• if you have varicose veins;
• if you experience symptoms of angioedema, such as swelling of the face, tongue, and/or throat, and/or difficulty swallowing or breathing, you should contact your doctor immediately. Estrogen-containing medicinal products may cause or worsen symptoms of hereditary or acquired angioedema.

BLOOD CLOTS

The use of combined hormonal contraceptives, such as Clormetin, is associated with an increased risk of blood clots, compared to when these medicinal products are not used. In rare cases, a blood clot can block a blood vessel and cause serious complications.
Blood clots can occur

• in veins (also called "venous thromboembolism" or "deep vein thrombosis"),
• in arteries (also called "arterial thromboembolism").

Not all patients who have a blood clot will recover fully. In rare cases, the effects of a blood clot can be permanent or, very rarely, fatal.

Remember that the overall risk of having a harmful blood clot due to Clormetin is small.

HOW TO RECOGNIZE A BLOOD CLOT

You should contact your doctor immediately if you notice any of the following symptoms.

BLOOD CLOTS IN VEINS

What can happen if a blood clot forms in a vein?

• The use of combined hormonal contraceptives is associated with an increased risk of blood clots in the veins (venous thromboembolism). However, these adverse reactions are rare. They most often occur in the first year of use of combined hormonal contraceptives.
• If blood clots form in the veins in the leg or foot, it can lead to the development of deep vein thrombosis.
• If a blood clot breaks loose from the leg and settles in the lungs, it can cause a pulmonary embolism.
• In very rare cases, a blood clot can form in another organ, such as the eye (retinal vein thrombosis).

When is the risk of blood clots in a vein highest?

The risk of forming a blood clot in a vein is highest during the first year of use of combined hormonal contraceptives for the first time. The risk may also be higher when resuming the use of combined hormonal contraceptives (the same or a different medicinal product) after a break of 4 weeks or more.
After the first year, the risk decreases, but it is always higher compared to when combined hormonal contraceptives are not used.
If you stop taking Clormetin, the risk of blood clots returns to normal within a few weeks.

What factors increase the risk of blood clots in veins?

The risk depends on the natural risk of venous thromboembolism and the type of combined hormonal contraceptive used.
The overall risk of blood clots in the legs or lungs associated with Clormetin is small.

• In a year, about 2 out of 10,000 women who do not use combined hormonal contraceptives and are not pregnant will develop blood clots.
• In a year, about 5-7 out of 10,000 women who use combined hormonal contraceptives containing levonorgestrel, norethisterone, or norgestimate will develop blood clots.
• It is not yet known what the risk of blood clots associated with Clormetin is compared to the risk associated with combined hormonal contraceptives containing levonorgestrel.
• The risk of blood clots depends on the patient's individual medical history (see "Factors that increase the risk of blood clots", below).

If a woman notices an increased frequency or severity of migraine attacks during the use of Clormetin (which may indicate disturbances in the brain's blood supply), she should consult her doctor as soon as possible. The doctor may recommend stopping the use of Clormetin.

Factors that increase the risk of blood clots in veins

The risk of blood clots associated with Clormetin is small, but some factors can increase this risk. The risk is higher:

• if you are significantly overweight (body mass index (BMI) over 30 kg/m²);
• if someone in your immediate family has had blood clots in the legs, lungs, or other organs at a young age (e.g., under 50 years old). In this case, you may have hereditary blood coagulation disorders;
• if you need to undergo surgery, are immobilized for a long time due to injury or illness, or have a leg in a cast. It may be necessary to stop taking Clormetin for a few weeks before surgery or immobilization. If you need to stop taking Clormetin, you should ask your doctor when you can resume taking it;
• with age (especially over 35 years old);
• if you have recently given birth.

The risk of blood clots increases with the number of risk factors present in the patient.
Long-haul flights (>4 hours) may temporarily increase the risk of blood clots, especially if the patient has another risk factor.
It is essential to tell your doctor if any of the above risk factors apply to you, even if you are not sure. Your doctor may decide to stop the use of Clormetin.
You should inform your doctor if any of the above conditions change during the use of Clormetin, e.g., if someone in your immediate family is diagnosed with a blood clot without a known cause or if you gain significant weight.

BLOOD CLOTS IN ARTERIES

What can happen if a blood clot forms in an artery?

Similarly to blood clots in veins, blood clots in an artery can cause serious consequences, such as a heart attack or stroke.

Factors that increase the risk of blood clots in arteries

It is essential to note that the risk of heart attack or stroke associated with Clormetin is very small, but it may increase:

• with age (over about 35 years old);
• if you smoke.During the use of combined hormonal contraceptives, such as Clormetin, it is recommended to quit smoking. If you cannot quit smoking and are over 35 years old, your doctor may recommend using a different type of contraception;
• if you are overweight;
• if you have high blood pressure;
• if someone in your immediate family has had a heart attack or stroke at a young age (under 50 years old). In this case, you may also be at increased risk of having a heart attack or stroke;
• if you or someone in your immediate family has had high levels of fats in the blood (cholesterol or triglycerides);
• if you have migraines, especially migraines with aura;
• if you have heart disease (valve damage, arrhythmia called atrial fibrillation);
• if you have diabetes.

If you have more than one of the above conditions or if any of them are severe, the risk of blood clots may be even higher.
You should inform your doctor if any of the above conditions change during the use of Clormetin, e.g., if you start smoking, someone in your immediate family is diagnosed with a blood clot without a known cause, or if you gain significant weight.
Cancer
In several studies, an increased risk of cervical cancer has been found in women infected with a specific sexually transmitted virus (human papillomavirus) and long-term users of contraceptives. However, it has not been clarified what other factors may influence the development of cervical cancer (e.g., different numbers of sexual partners and the use of barrier methods of contraception).
Studies have shown a slightly increased risk of breast cancer in women taking combined hormonal contraceptives. Within 10 years after stopping the use of these medicinal products, the risk returns to the level of risk associated with age. Since breast cancer is rare in women under 40 years old, the increase in the number of diagnosed cases of this disease in women currently or previously using hormonal contraceptives is small compared to the risk of breast cancer over a lifetime.
In rare cases, the use of hormonal contraceptives has led to the development of benign or, even more rarely, malignant liver tumors. They can cause life-threatening internal bleeding. If you experience severe, persistent abdominal pain, you should contact your doctor.

Other diseases

Psychiatric disorders:
Some women using hormonal contraceptives, including Clormetin, have reported depression or low mood. Depression can be severe and sometimes lead to suicidal thoughts. If mood changes and symptoms of depression occur, you should contact your doctor as soon as possible for further medical advice.
Many women taking hormonal contraceptives experience a slight increase in blood pressure. If your blood pressure increases significantly during the use of Clormetin, your doctor will recommend stopping the use of Clormetin and prescribe a medicinal product to lower your blood pressure. You can resume taking Clormetin when your blood pressure returns to normal.
Women who have had impetigo herpetiformis (a skin condition) during a previous pregnancy may experience it again while taking hormonal contraceptives.
If you or a family member has a disorder of fat metabolism (hypertriglyceridemia), there is an increased risk of pancreatitis. If you experience acute or chronic liver function disorders, your doctor may recommend stopping the use of Clormetin until liver function tests return to normal. If you have had jaundice during a previous pregnancy or while taking hormonal contraceptives and it recurs, your doctor will recommend stopping the use of Clormetin.
If you are taking Clormetin and have diabetes, and your blood sugar levels are well controlled, your doctor should carefully monitor your condition while you are taking Clormetin.
A change in your antidiabetic treatment may be necessary.
Brown spots on the skin (chloasma) may occur, especially if they occurred during a previous pregnancy. If you are prone to chloasma, you should avoid direct exposure to sunlight and ultraviolet radiation while taking Clormetin.
Unfavorable effect on existing diseases
Special medical supervision may be necessary if you have:

• epilepsy;
• multiple sclerosis;
• severe muscle spasms (tetany);
• migraine (see also section 2);
• asthma;
• heart or kidney function disorders (see also section 2);
• Sydenham's chorea (a minor chorea);
• diabetes (see also section 2);
• liver function disorders (see also section 2);
• fat metabolism disorders (see also section 2);
• immune system diseases (including systemic lupus erythematosus);
• significant overweight;
• high blood pressure (see also section 2);
• endometriosis (when the tissue lining the uterus, called the endometrium, occurs outside the uterine cavity) (see also section 2);
• varicose veins or phlebitis (see also section 2);
• blood coagulation disorders (see also section 2);
• a history of uterine fibroids (myomas);
• breast disease (mastopathy);
• a history of pustular psoriasis (impetigo herpetiformis) during a previous pregnancy;
• depression (see also section 2);
• chronic inflammatory bowel disease (Crohn's disease, ulcerative colitis).

You should tell your doctor if any of the above diseases have occurred in the past, are present, or occur while taking Clormetin.
Efficacy
The contraceptive effect may be affected if the contraceptive is taken irregularly, if vomiting or diarrhea occurs after taking the medicinal product (see section 3), or if you are taking certain other medicinal products (see section 2). In very rare cases, the contraceptive effect may be affected by metabolic disorders.
Even if hormonal contraceptives are taken correctly, they do not guarantee complete protection against pregnancy.
Irregular bleeding
During the use of hormonal contraceptives, irregular vaginal bleeding (bleeding and/or spotting) may occur, especially during the first few months of use. You should inform your doctor if irregular bleeding persists after 3 months of use or if it occurs after previously regular menstrual cycles.
Spotting may also indicate a decrease in contraceptive efficacy.
In some patients, withdrawal bleeding may not occur after 21 days of taking Clormetin. If Clormetin has been taken according to the instructions in section 3 below, pregnancy is unlikely. However, if Clormetin was not taken according to the instructions before the first missed withdrawal bleeding, you should ensure that you are not pregnant before continuing to take Clormetin.

Clormetin and other medicinal products

You should tell your doctor or pharmacist about all medicinal products you are currently taking or have recently taken, as well as any medicinal products you plan to take.
Do not take Clormetin if you have hepatitis C and are taking medicinal products containing ombitasvir/paritaprevir/ritonavir and dasabuvir or glecaprevir/pibrentasvir, as this may cause abnormal liver function test results in the blood (elevated liver enzyme alanine aminotransferase (ALT) activity).
Before starting to take these medicinal products, your doctor will prescribe a different contraceptive method.
You can resume taking Clormetin after about 2 weeks after stopping these medicinal products. See section "When not to take Clormetin".
Certain medicinal products may affect the blood levels of Clormetin and cause a decrease in its efficacy in preventing pregnancy or cause unexpected bleeding. These include medicinal products used to treat:

• epilepsy (such as barbiturates, carbamazepine, phenytoin, topiramate, felbamate, oxcarbazepine, barbexaclone, primidone),
• tuberculosis (e.g., rifampicin, rifabutin),
• sleep disorders (modafinil),
• HIV and hepatitis C virus infections (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors, such as ritonavir, nevirapine, efavirenz),
• fungal infections (griseofulvin),
• high blood pressure in the blood vessels of the lungs (bosentan),
• herbal products containing St. John's Wort ( Hypericum perforatum). If you want to take herbal products containing St. John's Wort while taking Clormetin, you should consult your doctor first.

Medicinal products that stimulate bowel movements (e.g., metoclopramide) and activated charcoal may change the absorption of the active substances of Clormetin.
During treatment with the above-mentioned medicinal products, you should use additional mechanical methods of contraception (e.g., condoms). Additional mechanical methods of contraception should be used throughout the time of concurrent use of these medicinal products and for 28 days after stopping their use.
If concurrent use of medicinal products will continue until the end of the tablets in the current pack of the combined hormonal contraceptive, you should start the next pack of Clormetin without the usual break in tablet-taking.
If long-term treatment with the above-mentioned medicinal products is necessary, you should use non-hormonal methods of contraception. You should ask your doctor or pharmacist for advice.
Interactions between Clormetin and other medicinal products may increase or worsen the adverse reactions of Clormetin. The following medicinal products may have an unfavorable effect on the tolerance of Clormetin:

• ascorbic acid (a preservative, also known as vitamin C),
• paracetamol (a pain reliever and antipyretic),
• atorvastatin (a medicinal product that lowers elevated cholesterol levels),
• troleandomycin (an antibiotic),
• imidazole antifungal medicinal products - e.g., fluconazole (used to treat fungal infections),
• indinavir (a medicinal product used to treat HIV infection).

Clormetin may affect the efficacy of other medicinal products. The efficacy or tolerance of the following medicinal products may be reduced by the use of Clormetin:

• certain benzodiazepines, e.g., diazepam (used to treat sleep disorders),
• cyclosporin (used to suppress the immune system),
• theophylline (used to treat asthma symptoms),
• corticosteroids, e.g., prednisolone (known as steroids, anti-inflammatory medicinal products used to treat, e.g., lupus, arthritis, psoriasis),
• lamotrigine (used to treat epilepsy),
• clofibrate (a medicinal product that lowers elevated cholesterol levels),
• paracetamol (a pain reliever and antipyretic),
• morphine (a specific strong pain reliever),
• lorazepam (used to treat anxiety disorders).

You should also read the package leaflets of other medicinal products prescribed by your doctor.
You should inform your doctor if you are taking insulin or other medicinal products that lower blood sugar levels. A change in the dosage of these medicinal products may be necessary.
You should remember that this information also applies to situations where one of these active substances was used shortly before starting to take Clormetin.
During the use of Clormetin, the results of some tests that determine liver, adrenal, and thyroid function, certain blood proteins, carbohydrate metabolism parameters, and blood coagulation parameters may change. Therefore, before having blood tests, you should tell your doctor that you are taking Clormetin.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before taking this medicinal product.
The use of Clormetin is not recommended during pregnancy.
If you become pregnant while taking Clormetin, you should stop taking it immediately. However, previous use of Clormetin is not a reason to terminate the pregnancy.
Remember that during breastfeeding, while taking Clormetin, milk production may decrease, and the composition of the milk may change. Very small amounts of the active substances may pass into the milk. Hormonal contraceptives, such as Clormetin, should only be used after weaning.

Driving and using machines

There is no known unfavorable effect of combined hormonal contraceptives on the ability to drive and use machines.

Clormetin contains lactose

If you have been diagnosed with an intolerance to some sugars, you should consult your doctor before taking this medicinal product.

3. How to take Clormetin

This medicinal product should always be taken exactly as prescribed by your doctor. If you are unsure, you should consult your doctor or pharmacist.

Method of administration

For oral use.

4. Possible side effects

Like all medicines, Clormetin can cause side effects, although not everybody gets them.
If side effects occur, especially severe and persistent ones, or changes in health that the woman considers related to the use of Clormetin, a doctor should be consulted.
All women using combined hormonal contraceptives are at an increased risk of blood clots in veins (venous thromboembolism) or blood clots in arteries (arterial thrombosis). For detailed information on the various risk factors associated with the use of combined hormonal contraceptives, see point 2 "Important information before using Clormetin".
The frequency of side effects is defined as follows:
Very common:may occur in more than 1 in 10 women
Nausea, discharge, painful menstruation, absence of menstruation.
Common:may occur in up to 1 in 10 women
Depression, nervousness, irritability, dizziness, migraine (and/or worsening of migraine), vision disturbances, vomiting, acne, feeling of heaviness, abdominal pain, fatigue, water retention in the body, weight gain, increased blood pressure.
Uncommon:may occur in up to 1 in 100 women
Vaginal fungal infection, mild changes in breast tissue, hypersensitivity to the medicine, including skin allergic reactions, changes in blood lipid levels, including increased triglyceride levels, decreased libido, abdominal pain, bloating, diarrhea, pigmentation changes, brown spots on the face, hair loss, dry skin, excessive sweating, back pain, muscle discomfort, breast discharge.
Rare:may occur in up to 1 in 1000 women
Vaginitis, increased appetite, conjunctivitis, discomfort when wearing contact lenses, deafness, tinnitus, high blood pressure, low blood pressure, circulatory collapse, hives, rash, skin inflammation, itching, worsening of psoriasis, excessive hair growth on the body or face, prolonged and/or severe menstrual bleeding, premenstrual syndrome (physical and emotional problems before the start of menstruation).
Harmful blood clots in a vein or artery, for example:

• in the leg or foot (e.g., deep vein thrombosis),
• in the lungs (e.g., pulmonary embolism),
• heart attack,
• stroke,
• mini-stroke or transient stroke-like symptoms, known as a transient ischemic attack,
• blood clots in the liver, stomach/intestine, kidneys, or eye. The likelihood of blood clots may be higher if the patient has any other risk factors (see point 2 for more information on risk factors for blood clots and symptoms of blood clots).

Very rare:may occur in up to 1 in 10,000 women
Erythema nodosum.
Additionally, after the marketing of Clormetin, the following side effects have been reported in relation to the active substances, ethinylestradiol and chlormadinone acetate: weakness and allergic reactions.
The use of combined hormonal contraceptives has also increased the risk of serious diseases and side effects:

• venous or arterial thrombosis (see point 2);
• biliary disorders (see point 2);
• the occurrence of tumors (such as liver tumors, which in individual cases can cause life-threatening bleeding into the abdominal cavity, cervical cancer, and breast cancer; see point 2);
• worsening of chronic inflammatory bowel diseases (Crohn's disease, ulcerative colitis; see point 2).

A doctor should be consulted immediately if the patient experiences symptoms of angioedema, such as facial swelling, tongue and/or throat swelling, and/or difficulty swallowing, as well as skin rash and breathing problems (see "Warnings and precautions").
The information in point 2 should be read carefully, and if necessary, a doctor should be consulted for advice.

Reporting side effects

If any side effects occur, including any side effects not listed in this leaflet, a doctor or pharmacist should be informed. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of 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 will help gather more information on the safety of the medicine.

5. How to store Clormetin

The medicine should be stored out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging and blister pack after: "EXP". The expiry date refers to the last day of the given month. The batch number is stated on the packaging after "Lot".
There are no special precautions for storing the medicinal product.
Medicines should not be disposed of via wastewater or household waste. A pharmacist should be asked how to dispose of unused medicines. This will help protect the environment.

6. Package contents and other information

What Clormetin contains

The active substances of Clormetin are ethinylestradiol and chlormadinone acetate.
One coated tablet contains 0.03 mg of ethinylestradiol and 2 mg of chlormadinone acetate.
The other ingredients are:
Tablet core: lactose monohydrate, cornstarch, povidone K-30, magnesium stearate.
Tablet coating: hypromellose, macrogol 6000, talc, titanium dioxide (E 171), and iron oxide red (E 172).

What Clormetin looks like and what the package contains

Clormetin is available in calendar packages containing 1x21, 3x21, and 6x21 pink, round, biconvex coated tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Exeltis Poland Sp. z o.o.
Szamocka 8
01-748 Warsaw

Manufacturer

Laboratorios León Farma, S.A.
Calle La Vallina s/n
Polígono Industrial Navatejera
24008 Villaquilambre, León
Spain

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Date of last revision of the leaflet:19.11.2021