LEVONORGESTREL/ETHINYLESTRADIOL STADA 0.1 mg/0.02 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

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

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What you need to know before you start 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 bleeding during the placebo week
   • Taking Levonorgestrel/Ethinylestradiol Daily Stada with other medicines
   • Lab tests
   • Pregnancy
   • Breast-feeding
   • Driving and using machines
   • Levonorgestrel/Ethinylestradiol Daily Stada contains lactose

1. How to take Levonorgestrel/Ethinylestradiol Daily Stada
   • When can you start with the first blister
   • 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 diarrhea
   • Delayed menstrual period: what you should know
   • Change of the first day of your menstrual period: what you should know
   • If you want to stop taking Levonorgestrel/Ethinylestradiol Daily Stada

1. Possible side effects
2. Storage of Levonorgestrel/Ethinylestradiol Daily Stada
3. Contents of the pack and other information

1. What is Levonorgestrel/Ethinylestradiol Daily Stada and what is it 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 active substances and are also known as placebo tablets.
• Contraceptive pills that contain two hormones are known as "combined pills".

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

General notes

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

This leaflet describes several situations in which you should stop using levonorgestrel/ethinylestradiol or in which the reliability of levonorgestrel/ethinylestradiol may be decreased. In such situations, you should either not have sex or take extra non-hormonal contraceptive precautions, such as using a condom or another barrier method. Do not use the rhythm or temperature methods. These methods can be unreliable because levonorgestrel/ethinylestradiol affects the monthly changes in body temperature and cervical mucus.

Like other hormonal contraceptives, levonorgestrel/ethinylestradiol does not protect against HIV infection (AIDS) 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 disease that may predict a heart attack (e.g. angina pectoris, which causes severe chest pain) or a stroke (e.g. a small, temporary stroke without any lasting effects).
• If you have a disease that may increase the risk of thrombosis in the arteries. These warnings apply to the following situations:
• • diabetes with damage to blood vessels
  • 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 certain type of migraine (with so-called focal neurological symptoms)
• If you have (or have had) inflammation of the pancreas (pancreatitis)
• If you have (or have had in the past) liver disease and if 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 a suspicion of breast cancer or cancer of the genital organs
• If you have vaginal bleeding of unknown cause
• If you have not had your period for several months without a known cause
• If you are allergic to levonorgestrel or ethinylestradiol, or to any of the other ingredients of this medicine (listed in section 6). This allergy may be recognized by the appearance of itching, rash or swelling.
• If you have Hepatitis C and are taking medicines that contain 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 some situations, you will need to take special precautions while using levonorgestrel/ethinylestradiol or any other combined hormonal contraceptive, and sometimes you will need to visit your doctor regularly. If you are in any of the following situations, you should tell your doctor before starting to use levonorgestrel/ethinylestradiol. Also, you should consult your doctor if any of the following conditions appear or worsen while using levonorgestrel/ethinylestradiol:

• If a close relative has had or has breast cancer.
• If you have a 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 hemolytic uremic syndrome (HUS), a blood disorder that causes kidney damage.
• If you have sickle cell anemia (a hereditary disease of the red blood cells).
• If you have epilepsy.
• If you have systemic lupus erythematosus (SLE, a disease of the immune system).
• If you have a disease that appeared for the first time during pregnancy or while using sex hormones (e.g. loss of hearing, porphyria [a blood disease], gestational herpes [a skin rash with blisters that appears during pregnancy], Sydenham's chorea [a nerve disease in which sudden movements of the body occur]).
• If you have or have had chloasma (brownish patches on the skin, especially on the face), 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 urticaria with possible difficulty breathing, contact a doctor immediately. Products containing estrogens may cause or worsen the symptoms of hereditary and acquired angioedema.

Levonorgestrel/Ethinylestradiol Daily Stada and thrombosis

Venous thrombosis

The use of any combined pill, including levonorgestrel/ethinylestradiol, increases the risk of a woman developing a 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 you are overweight,
• If any of your close relatives have had a blood clot (thrombosis) in the leg, lung or other organ at a young age,
• If you need to undergo surgery (surgery), a prolonged period of immobilization or if you have had a serious accident. It is important that you discuss with your doctor that you are using levonorgestrel/ethinylestradiol, as you may need to interrupt treatment. Your doctor will tell you when you can start taking levonorgestrel/ethinylestradiol again. This is usually within 2 weeks after your recovery.

Arterial thrombosis

The use of combined pills has been associated with an increased risk of arterial thrombosis (blockage of an artery), for example, in the 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 when using levonorgestrel/ethinylestradiol, especially if you are over 35 years old.
• If you have high levels of fat in your blood (cholesterol or triglycerides).
• If you are overweight.
• If one of your close relatives has had a heart attack or stroke at a young age.
• If you have high blood pressure.
• If you have migraines.
• If you have heart problems (a heart valve disorder or a heart rhythm disorder).

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

• Severe pain or swelling of one leg
• Sudden severe chest pain, which may radiate to the left arm
• Sudden shortness of breath
• Sudden cough, without an obvious cause
• An 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, feeling or numbness in any part of the body.

Levonorgestrel/Ethinylestradiol Daily Stada and cancer

There have been reports of breast cancer with a slightly higher frequency in women taking contraceptive pills, but it is not known if this is due to treatment. For example, it may be that more tumors are detected in women taking combined pills because they are examined by their doctor more frequently. The occurrence of breast tumors has been gradually lower after stopping the use of combined hormonal contraceptives. It is important to regularly check your breasts, and you should contact your doctor if you notice any lump.

In rare cases, benign liver tumors and even rarer cases of liver cancer have been reported in users of contraceptive pills. Contact your doctor if you notice any unusual severe abdominal pain.

Psychiatric disorders

Some women who use hormonal contraceptives like levonorgestrel/ethinylestradiol have reported depression or a depressed mood. Depression can be severe and sometimes may induce suicidal thoughts. If you experience mood changes and depressive symptoms, contact your doctor for further medical advice as soon as possible.

Bleeding between periods

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

What to do if you do not have bleeding during the placebo week

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

If the expected bleeding does not occur in two consecutive occasions, you may be pregnant. Contact your doctor immediately. Do not start taking the next blister 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 other medicines or herbal remedies you are already using. Also, tell any other doctor or dentist who prescribes you other medicines (or the pharmacist who dispenses them) that you are using levonorgestrel/ethinylestradiol. They may tell you if you need to use additional contraceptive precautions (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 for the treatment of epilepsy (e.g. primidone, phenytoin, barbiturates, carbamazepine or oxcarbazepine) and tuberculosis (e.g. rifampicin) or HIV infections (e.g. ritonavir) or other infectious diseases (such as griseofulvin, ampicillin or tetracycline), which increase intestinal motility (such as metoclopramide) and the herbal remedy St. John's Wort.

If you want to use herbal remedies that contain hypericum while taking levonorgestrel/ethinylestradiol, you should first consult your doctor.

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

Do not take levonorgestrel/ethinylestradiol if you have Hepatitis C and are taking medicines that contain ombitasvir/paritaprevir/ritonavir and dasabuvir, glecaprevir/pibrentasvir or sofosbuvir/velpatasvir/voxilaprevir, as these medicines may increase liver test results (increase in liver enzyme ALT).

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

Levonorgestrel/ethinylestradiol can be used again approximately 2 weeks after the end of this treatment. See the section "Do not use Levonorgestrel/Ethinylestradiol Daily Stada".

Consult your doctor or pharmacist before using any medicine.

Lab tests

If you need a blood test, tell your doctor or the laboratory staff that you are taking the pill, because oral contraceptives affect the results of some tests.

Pregnancy

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

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

Breast-feeding

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

Levonorgestrel/ethinylestradiol is not recommended for use during breast-feeding. You should consult your doctor if you wish to take the pill while breast-feeding.

Driving and using machines

There is no information that suggests the use of levonorgestrel/ethinylestradiol affects the ability to drive or use machines.

Levonorgestrel/Ethinylestradiol Daily Stada contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, contact them before taking this medicine.

3. How to Take Levonorgestrel/Ethinylestradiol Daily Stada

If you were taking another contraceptive before starting to take levonorgestrel/ethinylestradiol, you will already know that most contraceptives contain 21 tablets. With those contraceptives, you take a pill for 21 days and then there is a week when you do not take any tablets (medication-free interval).

The system to follow when using levonorgestrel/ethinylestradiol is different. After taking the 21 pink tablets, you must continue and take the 7 placebo tablets, i.e., there is no medication-free interval but a week of "placebo" (the week when you take the placebo tablets from row 4). Since you have to take one tablet every day and there is no medication-free interval between two packs, taking the tablets will become routine and, consequently, the risk of forgetting a tablet is lower.

The two distinct color classes of levonorgestrel/ethinylestradiol tablets are placed in order. One pack contains 28 tablets.

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

Do not confuse the tablets: take one pink tablet once a day for the first 21 days, and then one white tablet every day for the last 7 days. After that, you will have to start a new pack (21 pink tablets and 7 white tablets). Consequently, there is no medication-free interval between packs.

The blister pack contains 28 tablets. Daily intake for 28 consecutive days is important to maintain the contraceptive effect.

Along with the blister packs, adhesive labels with the days of the week are attached. Take the label for the day you start taking the pill. Put the label on the blister pack over the words "Stick the label with the day here". Each day will align with a row of tablets. It is essential that you take your pill every day. And take the first tablet from the first row where the word "START" is indicated.

Follow the direction of the arrow indicated on the blister pack, take the pink tablets first for 21 days and then the white tablets for 7 days, until you have taken all 28 tablets. After that, you will have to start taking the next blister pack. This means that there is no medication-free interval between packs.

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

You should start taking the next blister pack on the same day of the week, and the withdrawal bleeding should appear on the same days every month.

When can you start with the first blister pack

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

Start with levonorgestrel/ethinylestradiol on the first day of your cycle (which is the first day of your menstruation). If you start taking levonorgestrel/ethinylestradiol on the first day of your menstruation, you are immediately protected against pregnancy. You can also start on days 2-5 of your cycle, but in that case, you must use extra protection measures (e.g., a condom) during the first 7 days.

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

You can start taking levonorgestrel/ethinylestradiol the day after the tablet-free period of the pill you just finished (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 can switch any day from the progestogen-only pill (if you used an implant or IUD, on the day of its removal, and if you received the progestogen by injection, on the date the next injection was due), but in all cases, you must apply additional protection measures (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 having a child.

After having a child, you can 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 7 days of using levonorgestrel/ethinylestradiol.

If after having a child you have had sexual intercourse before starting to take levonorgestrel/ethinylestradiol again, you must first check that you are not pregnant or wait until your next menstrual period.

Ask your doctor for advice if you are not sure when to start.

• If you are breastfeeding and want to start taking levonorgestrel/ethinylestradiol again after having a child

Read the section on "Breastfeeding".

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

There are no reports of harmful effects from taking too many levonorgestrel/ethinylestradiol tablets. If you take several tablets at once, you may experience nausea and vomiting. Little girls may have 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, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Levonorgestrel/Ethinylestradiol Daily Stada tablets

The tablets in the fourthrow of the pack are placebo tablets. If you forgot to take one of those tablets, it will not affect the effect of levonorgestrel/ethinylestradiol. You should discard the forgotten placebo tablet so as not to prolong the placebo week, which could have a negative effect on the effectiveness of levonorgestrel/ethinylestradiol.

If you forgot to take a tablet from rows 1, 2, or 3, you should follow these instructions:

• If it has been less than 12 hourssince you forgot the tablet, pregnancy protection is not altered. You can still take the tablet as soon as you remember and then take the following tablets at the usual time.

• If it has been more than 12 hourssince you forgot the tablet, pregnancy protection may be reduced. The more tablets you forget to take, the greater the risk that pregnancy protection will be reduced.

The risk of incomplete pregnancy protection is greater if you forget to take a tablet at the beginning of a blister pack (1st row) or at the end of week 3 (3rd row of the blister pack).

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

• More than 1 forgotten tablet in the blister pack

Consult your doctor.

• One forgotten tablet in week 1

Take the forgotten tablet as soon as you remember, even if it means taking two tablets at the same time. Take the tablets afterwards at the usual time and take extra precautionsfor the next 7 days, for example, use a condom. If you have had sexual intercourse in the week before the missed tablet, or if you forgot to start a new blister pack after the inactive tablet period, you should be aware that there is a risk of pregnancy. In that case, consult your doctor.

• One forgotten tablet in week 2

Take the forgotten tablet as soon as you remember, even if it means taking two tablets at the same time. Take the tablets afterwards at the usual time. Pregnancy protection is not reduced, and you do not need to take extra precautions.

• One forgotten tablet in week 3

You can choose between 2 options:

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

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

It is likely that you will have a menstrual period (withdrawal bleeding) at the end of the second blister pack, but you may also have spotting or intercurrent bleeding when taking the second blister pack.

1. You can also stop taking the active tablets, the pink ones, and go directly to taking the 7 white placebo tablets (note the day you forgot to take the tablet). After that, continue with the next blister pack. If you want to start a new blister pack on a specific day, take the placebo tablets for less than 7 days.

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

• If you forgot to take some of the tablets in a blister pack and do not have bleeding during the placebo week, it could mean that you are pregnant. You must contact your doctor before continuing with 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 significant diarrhea, there is a risk that the active ingredients of the tablet will not be fully absorbed into your body. The situation is similar to when you forget to take a tablet. After vomiting or having diarrhea, you must take another tablet from the reserve blister pack as soon as possible. If possible, take it within 12 hoursof the time you would normally take your tablet. If it is not possible, or if 12 hours have already passed, you must follow the advice included in "If you forget to take Levonorgestrel/Ethinylestradiol Daily Stada".

Delayed menstrual period: what you should know

Although it is not recommended, it is possible to delay your menstrual period (withdrawal bleeding) until the end of a new pack if you do not take the white placebo tablets and start taking a second pack of levonorgestrel/ethinylestradiol. You may have spotting (drops or spots of blood) or intercurrent bleeding while using the second blister pack. After the 7 days of taking the placebo tablets from the second blister pack, continue withthe next blister pack.

You may need to ask your doctor for advice before deciding whether to delay your menstrual cycle.

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

If you take the tablets according to the instructions, your menstrual period or withdrawal bleeding will start during the week of the placebo tablets. If you need to change this day, do so by shortening the placebo period, i.e., when you take the white placebo tablets (but never lengthening it). For example, if your placebo period starts on a Friday and you want to change to a Tuesday (3 days earlier), you must start a new blister pack 3 days earlier than usual. If you shorten the placebo interval too much (e.g., 3 days or less), you may not have any bleeding during this placebo period. After that, you may have spotting (drops or spots of blood) or intercurrent bleeding.

If you are not sure what to do, ask your doctor for advice.

If you want to stop taking Levonorgestrel/Ethinylestradiol Daily Stada tablets

You can stop taking levonorgestrel/ethinylestradiol whenever you want. If you do not want to become pregnant, ask your doctor for advice on other reliable methods of birth control.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

Severe side 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 urticaria with possible difficulty breathing (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". Read those paragraphs for more 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 tenderness, breast sensitivity, weight gain, skin rash.

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

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

Reporting side effects

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

5. Storage of Levonorgestrel/Ethinylestradiol Daily 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 pack after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and additional information.

Composition of Levonorgestrel/Ethinylestradiol Daily Stada

• The active ingredients are levonorgestrel and ethinylestradiol.

Levonorgestrel/Ethinylestradiol Daily Stada contains tablets of 2 colors:

• 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, aluminum lake red (E129), lecithin (E322), iron oxide red (E172), and aluminum lake blue (E1329)].
• Each white tablet (inactive or placebo tablet) contains only excipients (without active ingredients), 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 pack contents

Each active film-coated tablet is round and pink.

Each placebo film-coated tablet is round and white.

Levonorgestrel/Ethinylestradiol Daily 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 blister packs, and each blister pack contains 28 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization 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 last revision of this leaflet: September 2022

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