Midiana

1. What is Midiana and what is it used for

• Midiana is a contraceptive pill used to prevent pregnancy.
• Each tablet contains a small amount of two different female hormones, called drospirenone and ethinylestradiol.
• Contraceptive pills that contain two hormones are called combined contraceptive pills.

2. Important information before using Midiana

General notes

Before starting to use Midiana, you should read the information about blood clots (thrombosis) in section 2. It is especially important to read about the symptoms of blood clots (see section 2 "Blood clots").
Before you can start using Midiana, your doctor will ask you a few questions about your health and the health of your close relatives. Your doctor will also measure your blood pressure and, depending on the individual case, may also perform some other tests.
This leaflet describes several situations in which you should stop using Midiana or in which the effectiveness of Midiana may be reduced. In such situations, you should either not have sexual intercourse or use additional non-hormonal contraceptive methods, such as condoms or other mechanical methods. You should not use the observation method or the temperature measurement method. These methods may be unreliable because Midiana modifies the monthly changes in body temperature and cervical mucus.

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

When not to use Midiana

You should not use Midiana 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 drospirenone and ethinylestradiol or any of the other ingredients of this medicine (listed in section 6). This may cause itching, rash, or swelling.
• if you currently have (or have ever had) a blood clot in the blood vessels of the legs (deep vein thrombosis), lungs (pulmonary embolism), or other organs.
• 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 have surgery or will be immobilized for a long time (see section 2 "Blood clots").
• if you have had a heart attack or stroke.
• if you have (or have had in the past) angina pectoris (a disease that causes severe chest pain and may be the first symptom of a heart attack) or transient ischemic attack (temporary stroke symptoms).
• if you have any of the following diseases, which 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 (or have had in the past) a type of migraine called "migraine with aura".
• if you have (or have had in the past) liver disease, and liver function disorders still persist.
• if you have kidney function disorders (renal insufficiency).
• if you have (or have had in the past) liver tumors.
• if you have (or have had in the past) or suspect breast or genital cancer.
• if you have any unexplained vaginal bleeding.
• Midiana contains soya lecithin. If you are allergic to peanuts or soya, do not use this medicine.

You should not use Midiana if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also section "Midiana and other medicines").

Children and adolescents

Midiana is not indicated for use in patients who have not yet had their first menstrual period.

Warnings and precautions

Before starting to use Midiana, you should discuss it with your doctor or pharmacist .
When should you contact your doctor?
You should contact your doctor immediately

• -if you notice possible symptoms of a blood clot, which may indicate that you have a blood clot in your leg (deep vein thrombosis), a blood clot in your lungs (pulmonary embolism), a heart attack, or a stroke (see below "Blood clots (thrombosis)"). To get a description of these serious side effects, see "How to recognize a blood clot".

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

In certain situations, you should be particularly careful when using Midiana or any other combined contraceptive pill. You may also need to be regularly examined by your doctor. If any of the following conditions occur, you should inform your doctor before starting to use Midiana.
If these symptoms occur or worsen while using Midiana, you should also tell your doctor.
If you:

• experience symptoms of angioedema, such as swelling of the face, tongue, and/or throat, and/or difficulty swallowing or hives potentially with difficulty breathing, you should contact your doctor immediately. Products containing estrogens may cause or worsen symptoms of hereditary and acquired angioedema;
• have a close relative who has had breast cancer;
• have liver or gallbladder disease;
• have diabetes;
• have depression or mood changes;
• have epilepsy (see "Midiana and other medicines");
• have a disease that first appeared during pregnancy or during previous use of sex hormones (e.g., hearing loss, a blood disease called porphyria, jaundice, itching all over the body, a skin rash with blisters during pregnancy, a neurological disorder characterized by involuntary movements of the body, called Sydenham's chorea);
• or if you have ever had skin discolorations, especially on the face or neck, called chloasma. In this case, you should avoid direct exposure to sunlight or ultraviolet radiation;
• have Crohn's disease or ulcerative colitis (chronic inflammatory bowel diseases);
• have systemic lupus erythematosus (a disease that affects the body's natural defense system);
• have hemolytic uremic syndrome (a blood clotting disorder that causes kidney failure);
• have sickle cell anemia (a hereditary disease of red blood cells);
• have elevated levels of triglycerides in the blood (hypertriglyceridemia) or a positive family history for this disease. Hypertriglyceridemia is associated with an increased risk of developing pancreatitis;
• need to have surgery or will be immobilized for a long time (see section 2 "Blood clots");
• have just given birth, in which case you are at increased risk of blood clots. You should consult your doctor to find out how soon you can start using Midiana after giving birth;
• have superficial thrombophlebitis (inflammation of veins under the skin);
• have varicose veins.

BLOOD CLOTS

The use of combined hormonal contraceptives, such as Midiana, is associated with an increased risk of blood clots, compared to not using them. 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 "venous thrombotic events")
• -in arteries (also called "arterial thromboembolism" or "arterial thrombotic events").

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

It is essential to remember that the overall risk of having a harmful blood clot due to Midiana is small.

HOW TO RECOGNIZE A BLOOD CLOT

You should contact your doctor immediately if you notice any of the following symptoms.
Are you experiencing any of these symptoms?
Why is the patient likely to be suffering from
these symptoms?

• -swelling of the leg or swelling along a vein in the leg or foot, especially if it is accompanied by:
• -pain or tenderness in the leg, which may only be felt when standing or walking
• -increased temperature in the affected leg
• -change in skin color of the leg, such as pallor, redness, or cyanosis Deep vein thrombosis
• -sudden unexplained shortness of breath or rapid breathing;
• -sudden unexplained cough, which may be accompanied by coughing up blood;
• -sharp chest pain, which may worsen with deep breathing;
• -severe dizziness or fainting;
• -rapid or irregular heartbeat;
• -severe abdominal pain.

If you are unsure, you should contact your doctor,
as some of these symptoms, such as coughing or shortness of breath, may be mistaken for milder conditions, such as a respiratory infection (e.g., a cold).
Pulmonary embolism
Symptoms usually occur in one eye:

• -sudden loss of vision or;
• -painless vision disturbances, which may progress to loss of vision. Retinal vein thrombosis (blood clot in the eye)
• -chest pain, discomfort, or a feeling of pressure or heaviness. Heart attack

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). Although these side effects are rare, they can occur. Most often, they occur in the first year of using 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 moves 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 using 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 medicine) after a break of 4 weeks or more.
After the first year, the risk decreases, but it is always higher compared to not using combined hormonal contraceptives.
If you stop using Midiana, the risk of blood clots returns to normal within a few weeks.

What factors increase the risk of blood clots in veins?

The risk of blood clots associated with Midiana 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/m);
• -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 coagulation disorders;
• -if you need to have surgery or will be immobilized for a long time due to injury or illness, or have a leg in a cast. It may be necessary to stop using Midiana for a few weeks before surgery or immobilization. If you need to stop using Midiana, you should ask your doctor when you can resume using 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.
Air travel (>4 hours) may temporarily increase the risk of blood clots, especially if you have another risk factor.
It is essential to tell your doctor if any of these risk factors apply to you, even if you are not sure. Your doctor may decide to stop using Midiana.
You should inform your doctor if any of the above conditions change while using Midiana, e.g., if you start smoking, 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 arteries 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 a heart attack or stroke associated with Midiana is very small, but it may increase:

• -with age (over approximately 35 years old);
• -if you smoke. If you are using a hormonal contraceptive like Midiana, you are advised to stop smoking. If you are unable to stop 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 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 a blood clot may be even higher.
You should inform your doctor if any of the above conditions change while using Midiana, e.g., if you start smoking, if someone in your immediate family is diagnosed with a blood clot without a known cause, or if you gain significant weight.

Midiana and cancer

Breast cancer occurs slightly more often in women who use combined contraceptive pills, but it is not known if this is caused by their use. For example, it may be that more tumors are detected in women who use combined contraceptive pills because they are examined by doctors more often. The risk of breast cancer gradually decreases after stopping the use of combined hormonal contraceptives. You should regularly examine your breasts and contact your doctor if you feel any lump.
Benign liver tumors, and in rare cases, malignant liver tumors, have been reported in women who use contraceptive pills. If you experience severe abdominal pain, you should contact your doctor.

Psychiatric disorders

Some women who use hormonal contraceptives, including Midiana, have reported depression or mood changes. Depression can be severe and sometimes lead to suicidal thoughts. If symptoms of depression occur, you should contact your doctor as soon as possible to receive further medical advice.

Irregular bleeding

During the first few months of using Midiana, you may experience unexpected bleeding (bleeding outside the 7-day break from taking pills). If such bleeding persists for more than a few months or starts after a few months, you should contact your doctor to investigate the cause.

What to do if you do not experience withdrawal bleeding during the 7-day break without taking pills

If you have taken all the pills correctly, have not vomited, or have not had severe diarrhea, and you have not taken any other medicines, the likelihood of pregnancy is very low.
If you do not experience the expected withdrawal bleeding twice in a row, you may be pregnant. You should contact your doctor immediately. You should not start the next pack of Midiana until you are sure you are not pregnant.

Midiana and other medicines

You should tell your doctor or pharmacist about all the medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
You should also inform other doctors or your dentist that you are taking Midiana if they prescribe other medicines. Your doctor will tell you if there is a need to use additional contraceptive methods (e.g., condoms) and if so, for how long.
You should not use Midiana if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as these medicines may cause abnormal liver function test results (elevated liver enzymes).
Before starting to take these medicines, your doctor will prescribe a different contraceptive method.
You can start taking Midiana again about 2 weeks after finishing the above-mentioned treatment. See section "When not to use Midiana".
Certain medicines may affect the level of Midiana in your blood and may reduce its effectiveness in preventing pregnancy or cause unexpected bleeding. These include:

• medicines used to treat:
• epilepsy (e.g., barbiturates, carbamazepine, phenytoin, primidone, felbamate, oxcarbazepine, topiramate),
• tuberculosis (e.g., rifampicin),
• HIV and hepatitis C virus infections (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors, such as nevirapine, ritonavir, efavirenz) or other infections (griseofulvin),
• high blood pressure in the blood vessels of the lungs (bosentan),
• fungal infections (e.g., griseofulvin, ketoconazole),
• symptomatic treatment of osteoarthritis (etoricoxib),
• a herbal product containing St. John's Wort ( Hypericum perforatum). If you want to use herbal products containing St. John's Wort while taking Midiana, you should consult your doctor first.

Midiana may affect the effectiveness of other medicines, such as:

• cyclosporin (a medicine used to prevent rejection of transplanted organs),
• an antiepileptic medicine - lamotrigine (may increase the frequency of seizures),
• tizanidine (a medicine used to treat muscle spasticity),
• theophylline (a medicine used to treat asthma).

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

Midiana with food and drink

Midiana can be taken with or without food, if necessary with a small amount of water.

Lab tests

If a blood test is necessary, you should tell your doctor or laboratory staff that you are taking contraceptive pills, as hormonal contraceptives may affect the results of some tests.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, you should consult your doctor or pharmacist before taking this medicine.
Pregnancy
Midiana should not be taken by pregnant women. If you become pregnant while using Midiana, you should stop taking it immediately and contact your doctor.
If you want to become pregnant, you can stop using Midiana at any time (see also "Stopping Midiana").
Before taking any medicine, you should consult your doctor or pharmacist.
Breastfeeding
Midiana is not recommended for use during breastfeeding. If you want to take contraceptive pills while breastfeeding, you should contact your doctor.
Before taking any medicine, you should consult your doctor or pharmacist.

Driving and using machines

There is no data on the effect of Midiana on the ability to drive and use machines.

Midiana contains lactose and soya lecithin

Midiana contains 48.17 mg of lactose monohydrate. If you have intolerance to some sugars, you should consult your doctor before taking this medicine.
Midiana contains 0.070 mg of soya lecithin. If you are allergic to soya or peanuts, you should not use this medicine.

3. How to use Midiana

This medicine should always be taken as directed by your doctor or pharmacist. In case of doubt, you should consult your doctor or pharmacist.

Midiana should be taken every day for 21 days.

Each Midiana blister pack contains 21 tablets, each marked with a day of the week.

• You should take a tablet at the same time every day.
• You should start taking the tablets from the one marked with the corresponding day of the week.
• You should move in the direction of the arrows on the blister pack. You should take one tablet every day until all 21 tablets have been taken.
• The tablet should be swallowed whole, if necessary with a little water. You should not chew the tablets.

Seven days without taking pills

After taking all 21 tablets from the blister pack, there is a 7-day break without taking pills. So, if the last tablet from one pack was taken on a Friday, you can take the first tablet from the next pack on the following Saturday.
Within a few days of taking the last tablet from the blister pack, you should experience withdrawal bleeding similar to a menstrual period. This bleeding may not have stopped by the time you start the next pack of pills.
There is no need to use additional contraceptive methods during these 7 days without taking pills, provided that you have taken the pills correctly and started the next pack of pills on time.

When to start the next pack

You should start taking the pills from the next pack of Midiana after a 7-day break without taking pills, even if you are still bleeding. You should always start a new pack on time.
During this 7-day break without taking pills, you should experience withdrawal bleeding (also called "withdrawal bleeding"). Withdrawal bleeding usually starts on the 2nd or 3rd day after taking the last tablet of Midiana. You should start taking the pills from the next pack on the 8th day after the last tablet, even if you are still bleeding.

When can you start the first pack

• -If you have not used a hormonal contraceptive in the previous month.You should start using Midiana on the first day of your menstrual cycle (i.e., the first day of your period). If you start using Midiana on the first day of your period, you are immediately protected against pregnancy. You can also start using Midiana on days 2-5 of your cycle, but in this case, you will need to use an additional contraceptive method (e.g., condoms) for the first 7 days.
• -Changing from another combined hormonal contraceptive or a combined hormonal contraceptive vaginal ring or transdermal patchYou can start using Midiana the day after taking the last active tablet (the last tablet containing active substances) of your previous contraceptive, but no later than the day after the end of the break from taking pills of your previous contraceptive (or after the last inactive tablet of your previous contraceptive). When changing from a combined hormonal contraceptive vaginal ring or transdermal patch, you should follow your doctor's advice.
• -Changing from a progestogen-only method (progestogen-only pill, injection, implant, or intrauterine system releasing progestogen)You can switch on any day from a progestogen-only pill (from an implant or intrauterine system on the day of its removal, or from injections when the next injection is scheduled). In these cases, you should always use an additional non-hormonal contraceptive method (e.g., condoms) for the first 7 days of using Midiana tablets.
• -After a miscarriage or abortionAfter a miscarriage or abortion in the first three months of pregnancy, your doctor may advise you to start using Midiana immediately. This means that contraceptive protection occurs after taking the first tablet.
• -After childbirthYou can start using Midiana from 21 to 28 days after giving birth. If you start using Midiana later than 28 days, you should use a so-called mechanical method (e.g., condoms) for the first 7 days of using Midiana. If you have had sexual intercourse after giving birth before starting to use Midiana, you should first make sure you are not pregnant or wait for your next menstrual period.
• -If you are breastfeeding and want to start using Midiana after childbirthYou should read the section "Breastfeeding".

If you are unsure when to start using Midiana, you should consult your doctor.

What to do if you take more Midiana than you should

No serious harmful effects have been reported after taking too many Midiana tablets.
Taking several tablets of Midiana at once may cause nausea or vomiting or vaginal bleeding. Also, in young girls before their first menstrual period, vaginal bleeding may occur if they accidentally take this medicine.
If you have taken too many Midiana tablets or if a child has taken Midiana, you should consult your doctor or pharmacist.

What to do if you forget to take Midiana

• If it has been less than 12 hourssince the scheduled time for taking the tablet, contraceptive protection is not reduced. You should take the tablet as soon as you remember, and the next tablet at the usual time.
• If it has been more than 12 hourssince the scheduled time for taking the tablet, contraceptive protection may be reduced. The more tablets you have missed, the higher the risk of becoming pregnant.

The risk of reduced contraceptive protection is highest if you miss tablets at the beginning or end of the pack. Therefore, you should follow these rules (see also the scheme below):

• If you have missed more than one tablet from one packYou should contact your doctor.
• -If you have missed one tablet in the 1st weekYou should take the tablet as soon as you remember, even if it means taking two tablets at the same time. You should take the next tablets at the usual time and use additional protection, e.g., condoms, for the next 7 days. If you have had sexual intercourse in the week before missing the tablet, you may be pregnant. In this case, you should contact your doctor.
• -If you have missed one tablet in the 2nd weekYou should take the tablet as soon as you remember, even if it means taking two tablets at the same time. You should take the next tablets at the usual time. Contraceptive protection is not reduced, and you do not need to use additional protection. If you have missed more than one tablet, you should use additional mechanical contraceptive methods, such as condoms, for 7 days.
• -If you have missed one tablet in the 3rd weekYou can use one of the two following options:
• 1. You should take the missed tablet as soon as you remember, even if it means taking two tablets at the same time. You should take the next tablets at the usual time. You should skip the 7-day break without taking pills and start the next pack of Midiana immediately. You will probably experience withdrawal bleeding at the end of the second pack - but you may experience spotting or breakthrough bleeding during the second pack.
• 2. You can also stop taking the pills and go directly to the break without taking pills (you should note the day you missed the tablet, so that the number of days without taking pills does not exceed the maximum of 7 days).If you

want to start the next pack on the day you always start, the break without taking pills should be less than7 days.
If you follow one of the above recommendations, contraceptive protection will be maintained.

• If you have missed any of the tablets and you do not experience withdrawal bleeding within the first week of not taking pills, you may be pregnant. In this case, you should contact your doctor before starting the next pack.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. If you experience any side effects, especially serious or persistent ones, or changes in your health that you think may be related to the use of Midiana, you should consult a doctor.
Severe side effects
You should contact your doctor immediately if you experience any of the following symptoms of angioedema: swelling of the face, tongue, and/or throat, and/or difficulty swallowing or hives potentially with difficulty breathing (see also the section "Warnings and precautions").
In all women using combined hormonal contraceptives, there is an increased risk of blood clots in the veins (venous thromboembolism) or blood clots in the arteries (arterial thromboembolism). For more detailed information on the various risk factors associated with the use of combined hormonal contraceptives, you should refer to section 2 "Important information before taking Midiana".
The following is a list of side effects that are associated with the use of drospirenone and ethinylestradiol.

Common side effects (may occur in up to 1 in 10 patients)

• Depressed mood,
• Headache, migraine,
• Nausea,
• Menstrual disorders, intermenstrual bleeding, breast pain, breast tenderness, thick, white vaginal discharge, fungal vaginal infection.

Uncommon side effects (may occur in up to 1 in 100 patients):

• Changes in libido (interest in sex),
• High blood pressure, low blood pressure,
• Vomiting, diarrhea,
• Acne, severe itching, skin rash, hair loss (alopecia),
• Breast enlargement, vaginal infection,
• Fluid retention, changes in body weight.

Rare side effects may occur in up to 1 in 1,000 patients):

• Allergic reactions (hypersensitivity),
• Asthma,
• Hearing disorders,
• Skin disorders - erythema nodosum (characterized by painful, red nodules on the skin) or erythema multiforme (characterized by a rash of round, red patches or sores),
• Breast discharge,
• 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 section 2 for more information on risk factors for blood clots and symptoms of blood clots).

Reporting side effects

If you experience any side effects, including any not listed in the leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Midiana

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. The expiry date refers to the last day of the month.
Store below 30°C. Store in the original packaging to protect from light.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Midiana contains

• The active substances of Midiana are drospirenone and ethinylestradiol. One tablet contains 3 mg of drospirenone and 0.03 mg of ethinylestradiol.
• Other ingredients of the medicine are: Tablet core:lactose monohydrate, maize starch, corn starch, povidone K 25, magnesium stearate. Tablet coating:polyvinyl alcohol, titanium dioxide (E171), talc, macrogol 3350, soybean lecithin.

What Midiana looks like and contents of the pack

Round, biconvex, film-coated tablet, white or almost white, with "G63" engraved on one side.
Midiana, 3 mg + 0.03 mg, is packaged in PVC/PVDC/Aluminum blisters of 21 tablets.
The blisters are packaged in cardboard boxes with a pouch for storing the blisters, attached to each box.
Pack sizes:
21 film-coated tablets
3 x 21 film-coated tablets
Not all pack sizes may be marketed.
Marketing authorization holder
GEDEON RICHTER POLSKA Sp. z o.o.
ul. Ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
Poland
Manufacturer
Gedeon Richter Plc.
1103 Budapest,
Gyömrői út 19-21
Hungary
To obtain more detailed information on the medicine and its names in other European Economic Area member states, you should contact:
GEDEON RICHTER POLSKA Sp. z o.o.
Medical Department
ul. Ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
Tel. +48 (22)755 96 48
lekalert@grodzisk.rgnet.org
Date of last revision of the leaflet:January 2023
((logo of the marketing authorization holder))