Levonorgestrel/ethinylestradiol diario Stada 0.1 mg/0.02 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Levonorgestrel/Ethinylestradiol Daily Stada 0.1 mg/0.02 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or your pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Levonorgestrel/Ethinylestradiol Daily Stada is and what it is used for

2. What you need to know before taking Levonorgestrel/Ethinylestradiol Daily Stada

   • Do not use Levonorgestrel/Ethinylestradiol Daily Stada
   • Warnings and precautions
   • Levonorgestrel/Ethinylestradiol Daily Stada and thrombosis
   • Levonorgestrel/Ethinylestradiol Daily Stada and cancer
   • Bleeding between periods
   • What to do if you do not have a withdrawal bleed during the placebo week
   • Taking Levonorgestrel/Ethinylestradiol Daily Stada with other medicines
   • Laboratory tests
   • Pregnancy
   • Breast-feeding
   • Driving and using machines
   • Levonorgestrel/Ethinylestradiol Daily Stada contains lactose

3. How to take Levonorgestrel/Ethinylestradiol Daily Stada

   • When you may start the first blister pack
   • If you take more Levonorgestrel/Ethinylestradiol Daily Stada than you should
   • If you forget to take Levonorgestrel/Ethinylestradiol Daily Stada
   • What to do in case of vomiting or severe diarrhoea
   • Delayed menstrual period: what you should know
   • Change in the first day of your menstrual period: what you should know
   • If you wish to stop taking Levonorgestrel/Ethinylestradiol Daily Stada

4. Possible side effects

5. How to store Levonorgestrel/Ethinylestradiol Daily Stada

6. Contents of the pack and other information

1. What Levonorgestrel/Ethinylestradiol Diario Stada is and what it is used for

• Levonorgestrel/ethinylestradiol is a contraceptive pill used to prevent pregnancy.
• Each pink tablet contains a small amount of two different female hormones, called levonorgestrel and ethinylestradiol.
• The white tablets do not contain any active ingredients and are also known as placebo tablets.
• Contraceptive pills containing two hormones are known as "combined pills".

2. What you need to know before taking Levonorgestrel/Ethinylestradiol Daily Stada

General notes

Before you can start taking levonorgestrel/ethinylestradiol, your doctor will ask you questions about your medical history and that of your close relatives. Your doctor will also measure your blood pressure and, depending on your personal situation, may carry out other tests.

This leaflet describes several situations in which you must stop using levonorgestrel/ethinylestradiol or in which its effectiveness may be reduced. In these situations, you should not have sexual intercourse or, if you do, you must use additional non-hormonal contraceptive precautions, e.g., use a condom or another barrier method. Do not use rhythm or temperature methods. These methods are unreliable because levonorgestrel/ethinylestradiol alters the monthly changes in body temperature and cervical mucus.

Like other hormonal contraceptives, levonorgestrel/ethinylestradiol does not protect against HIV (AIDS) infection or any other sexually transmitted disease.

Do not use Levonorgestrel/Ethinylestradiol Daily Stada

• If you have (or have had in the past) a blood clot (thrombosis) in a blood vessel of the leg, lungs (embolism), or other organs.
• If you have (or have had in the past) a heart attack or stroke.
• If you have (or have had in the past) a condition that may predict a heart attack (e.g., angina pectoris, which causes severe chest pain) or stroke (e.g., transient ischemic attack without residual effects).
• If you have a disease that may increase the risk of arterial thrombosis. These warnings apply to the following situations:
  • diabetes with blood vessel damage
  • very high blood pressure
  • very high levels of fat in the blood (cholesterol or triglycerides)
• If you have a blood clotting disorder (e.g., protein C deficiency)
• If you have (or have had) a specific type of migraine (with so-called neurological focal symptoms)
• If you have (or have had) inflammation of the pancreas (pancreatitis)
• If you have (or have had) liver disease and your liver function is still not normal
• If you have (or have had) a liver tumor
• If you have (or have had) or if there is suspicion of breast cancer or cancer of the genital organs
• If you have vaginal bleeding of unknown cause
• If you have not had a period for several months without a known cause
• If you are allergic to levonorgestrel or ethinylestradiol, or to any of the other components of this medicine (listed in section 6). This allergy may manifest as itching, rash, or swelling.
• If you have Hepatitis C and are taking medications containing ombitasvir/paritaprevir/ritonavir and dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also section "Taking Levonorgestrel/Ethinylestradiol Daily Stada with other medicines").

Warnings and precautions

In certain situations, you must take special precautions when using levonorgestrel/ethinylestradiol or any other combined hormonal contraceptive, and you may need to see your doctor regularly. If you are in any of the following situations, inform your doctor before starting levonorgestrel/ethinylestradiol. Additionally, you must consult your doctor if any of the following conditions appear or worsen while using levonorgestrel/ethinylestradiol:

• If a close relative has or has had breast cancer.
• If you have liver or gallbladder disease.
• If you have diabetes.
• If you have depression.
• If you have Crohn's disease or ulcerative colitis (inflammatory bowel disease).
• If you have HUS (hemolytic uremic syndrome), a blood disorder causing kidney damage.
• If you have sickle cell anemia (an inherited blood disorder affecting red blood cells).
• If you have epilepsy.
• If you have SLE (systemic lupus erythematosus, an immune system disorder).
• If you have a condition that first appeared during pregnancy or previous use of sex hormones (e.g., hearing loss, porphyria [a blood disorder], herpes gestationis [a blistering skin rash occurring during pregnancy], Sydenham's chorea [a nerve disorder causing sudden body movements]).
• If you have or have ever had chloasma (golden-brown pigmented patches known as "pregnancy mask," especially on the face). If so, avoid direct exposure to sunlight or ultraviolet light.
• If you experience symptoms of angioedema such as swelling of the face, tongue and/or throat, and/or difficulty swallowing or hives with possible breathing difficulty, contact a doctor immediately. Products containing estrogens may cause or worsen symptoms of hereditary or acquired angioedema.

Levonorgestrel/Ethinylestradiol Daily Stada and thrombosis

Venous thrombosis

Using any combined oral contraceptive, including levonorgestrel/ethinylestradiol, increases a woman's risk of developing venous thrombosis (formation of a blood clot in a blood vessel) compared to a woman who does not take any contraceptive pill.

The risk of venous thrombosis increases in users of combined pills:

• With age,
• If overweight,
• If a close relative had a blood clot (thrombosis) in the leg, lung, or another organ at an early age,
• If undergoing surgery, prolonged immobilization, or after a serious accident. It is important to inform your doctor that you are taking levonorgestrel/ethinylestradiol, as you may need to stop treatment. Your doctor will advise when to restart levonorgestrel/ethinylestradiol. Usually, this will be within two weeks after recovery.

Arterial thrombosis

The use of combined oral contraceptives has been associated with an increased risk of arterial thrombosis (blockage of an artery), for example, in blood vessels of the heart (heart attack) or brain (stroke).

The risk of arterial thrombosis increases in users of combined pills:

• If you smoke. You are strongly advised to stop smoking while using levonorgestrel/ethinylestradiol, especially if you are over 35 years of age.
• If you have high levels of fat in your blood (cholesterol or triglycerides).
• If you are overweight.
• If a close relative had a heart attack or stroke at an early age.
• If you have high blood pressure.
• If you have migraines.
• If you have heart problems (a valvular disorder or an irregular heartbeat).

Stop taking levonorgestrel/ethinylestradiol and contact your doctor immediately if you notice signs of possible thrombosis, such as:

• Severe pain or swelling in one of your legs
• Sudden, severe chest pain, possibly radiating to the left arm
• Sudden shortness of breath
• Sudden cough without an obvious cause
• Unusual, severe, or prolonged headache, or worsening of a migraine
• Partial or complete blindness, or double vision
• Difficulty or inability to speak
• Dizziness or fainting
• Weakness, unusual sensation, or numbness in any part of the body.

Levonorgestrel/Ethinylestradiol Daily Stada and cancer

A slightly increased frequency of breast cancer has been observed in women taking oral contraceptives, but it is unknown whether this is due to the treatment. For example, more tumors may be detected in women taking combined pills because they are examined by their doctor more frequently. The occurrence of breast tumors gradually decreases after stopping combined hormonal contraceptives. It is important to regularly examine your breasts, and you should contact your doctor if you notice any lump.

Rarely, benign liver tumors and even more rarely, malignant liver tumors, have been reported in users of oral contraceptives. Contact your doctor if you experience unusual, severe abdominal pain.

Psychiatric disorders

Some women using hormonal contraceptives such as levonorgestrel/ethinylestradiol have reported depression or depressed mood. Depression can be severe and may sometimes lead to suicidal thoughts. If you experience mood changes or depressive symptoms, contact your doctor for medical advice as soon as possible.

Bleeding between periods

During the first months of treatment with levonorgestrel/ethinylestradiol, you may experience unexpected bleeding (bleeding outside the placebo week). If this bleeding lasts for more than a few months, or if it starts after several months, your doctor should investigate the cause.

What to do if there is no bleeding during the placebo week

If you have taken all the pink active tablets correctly, have not vomited or had severe diarrhea, and have not taken other medicines, it is very unlikely that you are pregnant.

If the expected bleeding does not occur in two consecutive cycles, you may be pregnant. Contact your doctor immediately. Do not start the next pack until you are sure you are not pregnant.

Taking Levonorgestrel/Ethinylestradiol Daily Stada with other medicines

Always consult the doctor who prescribed levonorgestrel/ethinylestradiol about any other medicines or herbal remedies you are already using. Also, inform any other doctor or dentist who prescribes you medicines (or the pharmacist dispensing them) that you are using levonorgestrel/ethinylestradiol. They will advise whether you need to use additional contraceptive measures (e.g., condoms) and, if so, for how long.

Some medicines reduce the effectiveness of levonorgestrel/ethinylestradiol in preventing pregnancy or may cause unexpected bleeding.

These include medicines used to treat epilepsy (e.g., primidone, phenytoin, barbiturates, carbamazepine, or oxcarbazepine), tuberculosis (e.g., rifampicin), or HIV infection (ritonavir), other infectious diseases (such as griseofulvin, ampicillin, or tetracycline), drugs that increase intestinal motility (such as metoclopramide), and the herbal remedy St. John's wort.

If you wish to use herbal remedies containing St. John's wort while taking levonorgestrel/ethinylestradiol, you must consult your doctor first.

Levonorgestrel/ethinylestradiol may reduce the effectiveness of other medicines, such as those containing cyclosporine or the antiepileptic lamotrigine (which could increase the frequency of seizures).

Do not take levonorgestrel/ethinylestradiol if you have Hepatitis C and are taking medications containing ombitasvir/paritaprevir/ritonavir and dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as these may cause increases in liver test results (elevation of the liver enzyme ALT).

Your doctor will prescribe another type of contraceptive before starting treatment with these medicines.

Levonorgestrel/ethinylestradiol can be restarted approximately 2 weeks after completing this treatment. See the section "Do not use Levonorgestrel/Ethinylestradiol Daily Stada".

Consult your doctor or pharmacist before using any medicine.

Analytical tests

If you require a blood test, inform your doctor or laboratory staff that you are taking the pill, as oral contraceptives may affect the results of certain tests.

Pregnancy

If you are pregnant or breastfeeding, or think you might be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medicine.

If you are pregnant, you must not take levonorgestrel/ethinylestradiol. If you become pregnant while taking levonorgestrel/ethinylestradiol, you must stop taking it immediately and contact your doctor.

Breastfeeding

If you are pregnant or breastfeeding, or think you might be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medicine.

In general, the use of levonorgestrel/ethinylestradiol is not recommended while breastfeeding. You should consult your doctor if you wish to take the pill while breastfeeding.

Driving and use of machines

There is no information indicating that the use of levonorgestrel/ethinylestradiol affects the ability to drive or operate machinery.

Levonorgestrel/Ethinylestradiol Diario Stada contains lactose

This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Levonorgestrel/Ethinylestradiol Daily Stada

If you were previously taking another contraceptive before starting levonorgestrel/ethinylestradiol, you already know that most contraceptives contain 21 tablets. With those contraceptives, you take one pill for 21 days, followed by a week without taking any tablets (a drug-free interval).

The regimen when using levonorgestrel/ethinylestradiol is different. After taking the 21 pink tablets, you must continue and take the 7 placebo tablets; that is, there is no drug-free interval, but instead a week of "placebo" (the week when you take the white tablets in row 4). Since you must take one tablet every day and there is no drug-free interval between packs, taking the pills becomes a routine habit, thereby reducing the risk of missing a dose.

The two different types of colored tablets in levonorgestrel/ethinylestradiol are arranged in order. One pack contains 28 tablets.

Take one levonorgestrel/ethinylestradiol tablet daily, if necessary with a small amount of water. You must take the tablets every day, preferably at approximately the same time.

Do not confuse the tablets: take one pink tablet daily for the first 21 days, then one white tablet daily for the last 7 days. After this, you must start a new pack (21 pink tablets and 7 white tablets). Consequently, there is no drug-free interval between packs.

The blister pack contains 28 tablets. Taking one tablet daily for 28 consecutive days is important to maintain contraceptive effectiveness.

Adhesive labels with the days of the week are included alongside the blisters. Select the label corresponding to the day you start taking the pill. Place the label on the blister over the words “Apply label here.” Each day will then align with a row of tablets. It is important that you take your pill every day. Take the first tablet from the first row, where the word “START” is indicated.

Follow the direction of the arrow shown on the blister: first take the pink tablets for 21 days, then the white tablets for 7 days, until all 28 tablets are taken. After this, you must start the next blister pack. This means there is no drug-free interval between packs.

During the 7 days of white tablets, bleeding should begin (usually on the 2nd or 3rd day). This is known as withdrawal bleeding and may continue when you start the next blister pack.

You must start the next blister pack on the same day of the week, and the withdrawal bleeding should occur on the same days each month.

When to start the first blister pack

• If you have not used a hormonal contraceptive in the previous month

Start levonorgestrel/ethinylestradiol on the first day of your cycle (the first day of your menstruation). If you start taking levonorgestrel/ethinylestradiol on the first day of your period, you are immediately protected against pregnancy. You may also start on days 2–5 of the cycle, but in this case, you must use additional contraceptive measures (e.g., a condom) during the first 7 days.

• Switching from another combined hormonal contraceptive, a vaginal ring, or a combined contraceptive patch

You may start taking levonorgestrel/ethinylestradiol the day after the tablet-free interval of the contraceptive you are finishing (or after the last inactive tablet of your previous pill).

When switching from a vaginal ring or a combined contraceptive patch, follow your doctor’s advice.

• Switching from a progestogen-only method (progestogen-only pill or injection, implant, or progestogen-releasing IUD)

You may switch on any day from the progestogen-only pill (if you were using an implant or IUD, on the day of removal, and if you were receiving progestogen by injection, on the date when the next injection would have been due), but in all cases, you must use additional contraceptive protection (e.g., a condom) during the first 7 days of taking the new pills.

• After an abortion or miscarriage

Follow your doctor’s instructions.

• After giving birth

After giving birth, you may start taking levonorgestrel/ethinylestradiol between 21 and 28 days later. If you start after day 28, you must use a barrier method (e.g., a condom) during the first seven days of using levonorgestrel/ethinylestradiol.

If you had intercourse after giving birth before starting levonorgestrel/ethinylestradiol (again), you must first confirm that you are not pregnant or wait until your next menstrual bleeding.

Consult your doctor if you are unsure about when to start.

• If you are breastfeeding and wish to start (or restart) taking levonorgestrel/ethinylestradiol after giving birth

Read the section on “Breastfeeding.”

If you take more Levonorgestrel/Ethinylestradiol Daily Stada film-coated tablets than you should

There are no published reports of harmful effects from taking too many levonorgestrel/ethinylestradiol tablets. If you take several tablets at once, you may experience symptoms such as nausea and vomiting. Young girls may experience vaginal bleeding.

If you have taken too many levonorgestrel/ethinylestradiol tablets, or if you discover that your child has taken some, consult your doctor or pharmacist.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Levonorgestrel/Ethinylestradiol Daily Stada film-coated tablets

The tablets in the fourth row of the pack are placebo tablets. If you forget to take one of these placebo tablets, it will not affect the effectiveness of levonorgestrel/ethinylestradiol. You should remove the forgotten placebo tablet to avoid prolonging the placebo week, which could negatively affect the efficacy of levonorgestrel/ethinylestradiol.

If you forget to take a tablet from rows 1, 2, or 3, follow the instructions below:

• If less than 12 hours have passed since you missed the tablet, contraceptive protection remains intact. You can take the missed tablet as soon as you remember and continue taking the following tablets at your usual time.

• If more than 12 hours have passed since you missed the tablet, contraceptive protection may be reduced. The more tablets you miss, the greater the risk of reduced protection against pregnancy.

The risk of incomplete contraceptive protection is higher if you miss a tablet at the beginning of a blister pack (first row) or at the end of week 3 (third row of the blister).

Therefore, you must follow the rules below (see also the diagram below):

• More than 1 tablet missed from the blister pack

Consult your doctor.

• One tablet missed in week 1

Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time. Then continue taking the tablets at your usual time and use additional contraceptive precautions for the next 7 days, for example, use a condom. If you had sexual intercourse in the week before the missed tablet, or if you forgot to start a new blister pack after the active tablet-free interval, be aware that there is a risk of pregnancy. In this case, consult your doctor.

• One tablet missed in week 2

Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time. Then continue taking the tablets at your usual time. Contraceptive protection is not reduced, and you do not need to take additional precautions.

• One tablet missed in week 3

You have two options:

1. Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time.

Instead of taking the 7 white placebo tablets, go directly to the next blister pack.

You will most likely have a period (withdrawal bleeding) at the end of the second blister pack, but you may also experience spotting or breakthrough bleeding during the second blister.

2. Alternatively, you may stop taking the active pink tablets and immediately start taking the 7 white placebo tablets (note the day on which you missed the tablet). Then continue with the next blister pack. If you wish to start a new blister pack on a specific day, take fewer than 7 placebo tablets.

If you follow either of these two recommendations, you will remain protected against pregnancy.

• If you missed one or more tablets from a blister pack and do not have bleeding during the placebo week, this could mean you are pregnant. You must contact your doctor before starting the next blister pack.

What to do in case of vomiting or severe diarrhea

If you vomit within 3–4 hours after taking the active pink tablet or if you have severe diarrhea, there is a risk that the active ingredients are not completely absorbed into your body. The situation is similar to missing a tablet. After vomiting or experiencing severe diarrhea, take another tablet from your reserve blister pack as soon as possible. If possible, take it within 12 hours of when you would normally take your tablet. If this is not possible, or if more than 12 hours have passed, follow the advice given under “If you forget to take Levonorgestrel/Ethinylestradiol Daily Stada”.

Delayed menstrual period: what you should know

Although not recommended, it is possible to delay your menstrual period (withdrawal bleeding) until the end of a new pack by not taking the white placebo tablets and instead starting a second pack of levonorgestrel/ethinylestradiol. You may experience spotting (drops or spots of blood) or breakthrough bleeding while using the second blister pack. After the 7 days of taking the placebo tablets from the second blister pack*, continue with the next blister pack.*

You may need to consult your doctor before deciding to delay your menstrual cycle.

Changing the first day of your menstrual period: what you should know

If you take the tablets as instructed, your menstrual period or withdrawal bleeding will begin during the placebo tablet week. If you need to change this day, do so by shortening the placebo interval—that is, when taking the white placebo tablets (but never by extending it). For example, if your placebo week starts on a Friday and you wish to change it to Tuesday (3 days earlier), you should start the new blister pack 3 days earlier than usual. If you shorten the placebo interval significantly (e.g., 3 days or less), you may not have any bleeding during this placebo period. Afterwards, you may experience spotting or breakthrough bleeding.

If you are unsure what to do, consult your doctor.

If you wish to stop taking Levonorgestrel/Ethinylestradiol Daily Stada film-coated tablets

You may stop taking levonorgestrel/ethinylestradiol at any time. If you do not wish to become pregnant, consult your doctor about other reliable methods of contraception.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Always inform your doctor if you experience any side effects, especially if the side effect is severe or persistent, or if you notice any changes in your health that you think may be due to the pill.

Serious adverse effects:

Contact a 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 with possible breathing difficulties (see also section “Warnings and precautions”).

Several side effects related to the use of the pill are described in the sections “Levonorgestrel/Ethinylestradiol Daily Stada and thrombosis” and “Levonorgestrel/Ethinylestradiol Daily Stada and cancer”. Please read these paragraphs for further information and consult your doctor immediately if necessary.

• Common side effects (may affect up to 1 in 10 women): headache, mood changes (including depression), nausea, abdominal pain, breast pain, breast tenderness, weight gain, skin rash.

• Uncommon side effects (may affect up to 1 in 100 women): vomiting, diarrhoea, fluid retention or oedema, migraine, loss of libido, breast enlargement, urticaria.

• Rare side effects (may affect up to 1 in 1,000 women): eye irritation when wearing contact lenses, hypersensitivity, weight loss, galactorrhoea, vaginal discharge, increased libido, erythema nodosum (nodules on the legs), erythema multiforme (skin lesions).

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines, website: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Levonorgestrel/Ethinylestradiol Diario Stada

Keep this medicine out of the sight and reach of children.

Do not store above 30 °C.

Do not use this medicine after the expiry date stated on the outer packaging and on the blister after EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Levonorgestrel/Ethinylestradiol Diario Stada

• The active substances are levonorgestrel and ethinylestradiol.

Levonorgestrel/Ethinylestradiol Diario Stada contains tablets of 2 colours:

• Each pink tablet contains 0.1 mg of levonorgestrel and 0.02 mg of ethinylestradiol. The other components (excipients) are lactose, povidone K-30 (E1201), magnesium stearate (E572) and Opadry II pink [polyvinyl alcohol, talc (E553b), titanium dioxide (E171), polyethylene glycol 3350, red aluminium lake (E129), lecithin (E322), red iron oxide (E172) and blue aluminium lake (E132)].
• Each white tablet (inactive tablet or placebo tablet) contains only excipients (no active substances), which are lactose, povidone K-30 (E1201), magnesium stearate (E572) and Opadry II white [polyvinyl alcohol, talc (E553b), titanium dioxide (E171), polyethylene glycol 3350].

Appearance of the product and contents of the pack

Each active film-coated tablet is round and pink in colour.

Each placebo film-coated tablet is round and white in colour.

Levonorgestrel/Ethinylestradiol Diario Stada is marketed in blister packs of 28 tablets: 21 active pink tablets and 7 white placebo tablets.

Pack sizes are 1, 3 or 6 blisters, each blister containing 28 tablets.

Only some pack sizes may be commercially available.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

[email protected]

Manufacturer

Laboratorios León Farma, S.A.

Pol. Ind. Navatejera

La Vallina s/n

24193-Villaquilambre (León)

Spain

Date of the most recent review of this leaflet: September 2022

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.