Prospecto: information for the user

MINESSE0,06mg/0,015 mg coated tablets

Gestodeno/Ethinylestradiol

Important things you should know about combined hormonal contraceptives (CHCs):

• They are one of the most reliable reversible contraceptive methods if used correctly.
• They slightly increase the risk of suffering a blood clot in the veins and arteries, especially in the first year or when restarting use of a combined hormonal contraceptive after a pause of 4 weeks or more.
• Be alert and consult your doctor if you think you may have symptoms of a blood clot (see section 2 “Blood clots”).

Read this prospectus carefully before starting to take this medicine, because it contains important information for you.

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist or nurse.
• This medicine has been prescribed only to you, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor, pharmacist or nurse, even if they are adverse effects that do not appear in this prospectus.

1.What isMINESSEand for what it is used

2.What you need to know before starting to takeMINESSE

3.How to takeMINESSE

4.Possible adverse effects

5.Storage ofMINESSE

6.Contents of the package and additional information

• MINESSE is an oral contraceptive pill, used to prevent pregnancy.
• Each of the 24 pale yellow tablets contains a small amount of two different female hormones, called gestodeno and ethinylestradiol.
• The 4 white tablets do not contain active ingredients and are called placebo tablets.
• Contraceptive pills that contain two hormones are called "combined" pills.

.

Do not take

Do not use MINESSE if you have any of the conditions listed below. Inform your doctor if you have any of the conditions listed below. Your doctor will discuss with you what other form of contraception would be more suitable.

• If you are allergic to gestodene or ethinylestradiol or to any of the other components of this medication (including in section 6).

• Si you have (or have had at any time) a blood clot in a leg vein (deep vein thrombosis, DVT), in the lungs (pulmonary embolism, PE) or in other organs.
• Si you know that you have a disorder that affects blood clotting: for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden or antiphospholipid antibodies.
• Si you need surgery or if you spend a lot of time without standing up (see section “Blood Clots”).
• Si you have ever had a heart attack or a stroke.
• Si you have (or have had at any time) angina pectoris (a condition that causes severe chest pain and may be the first sign of a heart attack) or a transient ischemic attack (TIA, symptoms of a stroke).
• Si you have any of the following diseases that may increase your risk of forming a blood clot in the arteries:
• • severe diabetes with vascular damage
  • very high blood pressure
  • very high levels of fat in the blood (cholesterol or triglycerides)
  • a condition called hyperhomocysteinemia.
• Si you have (or have had at any time) a type of migraine called “migraine with aura”.
• Si you have (or have had at any time) a benign tumor (called focal nodular hyperplasia or hepatic adenoma) or malignant tumor of the liver or if you have recently had liver disease. In these cases, your doctor will order you to stop taking the tablets until your liver is functioning normally.
• Si you have unexplained vaginal bleeding.
• Si you have breast cancer or uterine cancer or any cancer that is sensitive to female sex hormones or if you suspect that you may have it.
• Si you have Hepatitis C and are taking certain antiviral medications such as ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir or sofosbuvir/velpatasvir/voxilaprevir (see also the section “Other Medications and MINESSE”).

Warnings and Precautions

Inform your doctor if you suffer from any of the following conditions.

Si the condition develops or worsens while you are using MINESSE, you should also inform your doctor.

• Si any blood test has shown that you have high levels of sugar, high levels of cholesterol and fats or high levels of prolactin (a hormone that stimulates milk production).
• Si you are obese.
• Si you have a benign tumor of the breast or if any close relative has ever had breast cancer.
• Si you have a uterine disease (uterine dystrophy).
• Si you suffer from epilepsy (see also ‘Use of other medications’).
• Si you suffer from migraine.
• Si you suffer from hearing loss due to a condition called otosclerosis.
• Si you suffer from asthma.
• Si you have Crohn’s disease or ulcerative colitis (chronic inflammatory bowel disease).
• Si you have systemic lupus erythematosus (SLE, a disease that affects your natural defense system).
• Si you have hemolytic-uremic syndrome (HUS, a disorder of blood clotting that causes kidney failure).
• Si you have sickle cell anemia (a hereditary disorder of red blood cells).
• Si you have high levels of fat in the blood (hypertriglyceridemia) or known family history of this condition. Hypertriglyceridemia has been associated with an increased risk of pancreatitis (inflammation of the pancreas).
• Si you need surgery or spend a lot of time without standing up (see section “Blood Clots”).
• Si you are at greater risk of blood clots after giving birth. Ask your doctor when you can start taking MINESSE after delivery.
• Si you have superficial thrombophlebitis.
• Si you have varicose veins.
• Si you or any close relative (parents, grandparents, brothers, sisters, etc.) has ever had any disease that tends to produce blood clots (in the leg, lung, or other, heart attacks, strokes).
• Si during any pregnancy, or while using another contraceptive pill, you have had any skin disease that causes itching, red patches, and blisters (gestational herpes).
• Si you have had melasma (skin discoloration) during pregnancy or while using another contraceptive pill. In this case, avoid direct sun exposure while using MINESSE.
• Si you suffer from gallstones.
• Si you suffer from any heart, liver, or kidney disease.
• Si you suffer from depression.
• Si you have high blood pressure.
• Si you suffer from a condition called chorea, characterized by involuntary, irregular, and sudden movements.
• Si you experience symptoms of angioedema such as facial swelling, tongue, and/or throat swelling, and/or difficulty swallowing or urticaria with possible difficulty breathing, contact a doctor immediately. Products containing estrogens can cause or worsen the symptoms of hereditary and acquired angioedema.

Mental Disorders:

Some women who use hormonal contraceptives like MINESSE 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 additional medical advice as soon as possible.

Do not hesitate to ask your doctor or pharmacist if you have any doubts about using MINESSE.

BLOOD CLOTS

The use of a combined hormonal contraceptive like MINESSE increases your risk of suffering a blood clot compared to not using it.

Blood clots can form in veins (called “deep vein thrombosis”, “thromboembolism”, or TEV) or in arteries (called “arterial thrombosis”, “thromboembolism”, or TEA).

The recovery of blood clots is not always complete. In rare cases, there may be serious and lasting effects, or even fatal ones.

It is essential to remember that the overall risk of a blood clot that can cause harm due to MINESSE is small.

HOW TO RECOGNIZE A BLOOD CLOT

Seek immediate medical attentionif you notice any of the following signs or symptoms.

BLOOD CLOTS IN A VEIN

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

• The use of combined hormonal contraceptives has been associated with an increased risk of blood clots in veins (thrombosis venosa). However, these side effects are rare. They occur more frequently in the first year of use of a combined hormonal contraceptive.
• Si a blood clot forms in a vein in the leg or foot, it may cause deep vein thrombosis (DVT).
• Si a blood clot breaks loose from the leg and lodges in the lung, it may cause a pulmonary embolism (PE).
• In very rare cases, a blood clot may form in a vein in another organ, such as the eye (retinal vein thrombosis).

When is the risk of a blood clot in a vein higher?

The risk of a blood clot in a vein is higher during the first year of taking a combined hormonal contraceptive for the first time. The risk may be higher if you start taking a combined hormonal contraceptive again (the same medication or a different one) after a break of 4 weeks or more.

After the first year, the risk decreases, but it is always slightly higher than if you were not taking a combined hormonal contraceptive.

When you stop taking MINESSE, your risk of a blood clot returns to normal in a few weeks.

What is the risk of a blood clot?

The risk depends on your natural risk of TEV and the type of combined hormonal contraceptive you are taking.

The overall risk of a blood clot in the leg or lung (DVT or PE) with MINESSE is small.

• Of every 10,000women who do not use a combined hormonal contraceptive and are not pregnant, about 2 will develop a blood clot in a year.
• Of every 10,000women who use a combined hormonal contraceptive containing levonorgestrel, noretisterone, or norgestimato, about 5-7women will develop a blood clot in a year.
• Of every 10,000women who use a combined hormonal contraceptive containing gestodene like MINESSE, about 9-12women will develop a blood clot in a year.

• The risk of a blood clot will depend on your personal history (see “Factors that increase your risk of a blood clot” below).

Factors that increase your risk of a blood clot in a vein

Your risk of a blood clot is higher:

• Si you are overweight (body mass index (BMI) of 30 kg/m2or higher).
• Si any close relative has had a blood clot in the leg, lung, or other, heart attack, or stroke at a young age (before about 50 years). In this case, you may have a hereditary disorder of blood clotting.
• Si you need surgery or spend a lot of time without standing up due to an injury or disease or if you have your leg immobilized. You may need to stop using MINESSE for several weeks before the operation or while you have less mobility. If you need to stop using MINESSE, ask your doctor when you can start using it again.
• Si you are older (especially over about 35 years).
• Si you have given birth recently.

Your risk of a blood clot increases the more conditions you have.

Long flights (over 4 hours) may temporarily increase your risk of a blood clot, especially if you have any of the other risk factors listed.

It is essential to inform your doctor if you suffer from any of the conditions above, even if you are unsure. Your doctor may decide that you should stop using MINESSE.

Si any of the conditions above change while you are using MINESSE, for example, a close relative experiences a blood clot without a known cause or you gain a lot of weight, inform your doctor.

BLOOD CLOTS IN AN ARTERY

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

Like a blood clot in a vein, a blood clot in an artery can cause serious problems. For example, it can cause a heart attack or a stroke.

Factors that increase your risk of a blood clot in an artery

It is essential to note that the risk of a heart attack or stroke due to MINESSE is very small, but it may increase:

• With age (over about 35 years).
• Si you smoke.When using a combined hormonal contraceptive like MINESSE, you are advised to stop smoking. If you are unable to stop smoking and are over 35 years, your doctor may advise you to use a different type of contraceptive.
• Si you are overweight.
• Si you have high blood pressure.
• Si any close relative has had a heart attack or stroke at a young age (before about 50 years). In this case, you may also be at higher risk of a heart attack or stroke.
• Si you or any close relative has high levels of fat in the blood (cholesterol or triglycerides).
• Si you suffer from migraines, especially migraines with aura.
• Si you have a heart problem (valve disorder, irregular heart rhythm called atrial fibrillation).
• Si you have diabetes.

Si you have one or more of these conditions or if any of them are particularly severe, your risk of a blood clot may be increased even further.

Si any of the conditions above change while you are using MINESSE, for example, you start smoking, a close relative experiences a blood clot without a known cause, or you gain a lot of weight, inform your doctor.

MINESSE and Cancer

The detection of breast cancer is slightly higher in women who use combined pills, but it is not known if it is caused by the pill. It is possible that these women are simply examined more thoroughly and more frequently, or that breast cancer is detected earlier.

Studies indicate cases of cervical cancer in women who use combined pills for a relatively long time. Currently, it is unknown if it is caused by the pill or if it is related to sexual behavior (e.g., frequent changes of partner) and other factors.

In rare cases, benign liver tumors and, even more rarely, malignant liver tumors have been reported in users of the pill. Consult your doctor if you experience unusual abdominal pain.

Menstrual Bleeding

During the first few months of taking MINESSE, you may experience unexpected bleeding (bleeding outside of the placebo days). If these bleeding persists beyond a few months or starts after a few months, your doctor should investigate the cause.

What to do if you do not have your period during the placebo days

Si you have taken all the active yellowish tablets correctly, have not had severe vomiting or diarrhea, and have not taken other medications, it is very unlikely that you are pregnant.

Si you miss your period twice in a row, you may be pregnant. Go to your doctor immediately. Do not start the next pack until you are sure you are not pregnant.

Si you do not have your period after stopping MINESSE

After stopping MINESSE, it may take some time for your period to return. If this continues for a prolonged period, consult your doctor.

Other Medications and MINESSE

Some medications may affect the levels of MINESSE in the blood, making itless effective in preventing pregnancyand may cause unexpected bleeding.

These include:

• medications used to treat:

• infections caused by HIV and hepatitis C (inhibitors of protease and non-nucleoside reverse transcriptase inhibitors)
• epilepsy (e.g., phenobarbital, phenytoin, primidone, carbamazepine, topiramate, felbamate)
• tuberculosis (e.g., rifabutin, rifampicin)
• fungal infections (griseofulvin, azole antifungals, e.g., itraconazole, voriconazole, fluconazole)
• bacterial infections (macrolide antibiotics, e.g., clarithromycin, erythromycin)
• heart disease, high blood pressure (calcium channel blockers, e.g., verapamil, diltiazem)
• arthritis, osteoarthritis (etoricoxib)
• sleep disorders (modafinil)

or

• the herbal remedy St. John’s Wort, used to treat certain types of depression
• grapefruit juice

The troleandomycin may increase the risk of intrahepatic cholestasis (retention of bile in the liver) during administration with combined oral contraceptives (COCs).

MINESSE mayinfluence the effectof other medications, for example:

• lamotrigine
• ciclosporin
• theophylline
• tizanidine

Do not take MINESSE if you have Hepatitis C and are taking certain medications for Hepatitis C such as ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as these medications may cause increases in liver test results (elevated ALT levels).

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

MINESSE can be restarted approximately 2 weeks after the completion of this treatment. See the section “Do not take MINESSE”.

Consult your doctor or pharmacist before using any medication.

Pregnancy

Si you are pregnant, there is no reason for your doctor to prescribe contraceptives.

Si you discover that you are pregnant while taking MINESSE, stop taking the pill and consult your doctor.

Si you plan to become pregnant, consult your doctor.

Consult your doctor or pharmacist before using any medication.

Lactation

MINESSE is not recommended for use during breastfeeding.

Si you wish to breastfeed, your doctor will recommend the suitable form of contraception.

Consult your doctor or pharmacist before using any medication.

Driving and Operating Machines

There is no information on the effect of MINESSE on the ability to drive and operate machines. It is unlikely that MINESSE will affect your ability to drive or operate machines. Dizziness has been reported as a side effect. If you experience dizziness, do not drive or operate machines until it has passed.

MINESSE contains lactose

This medication contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Dosage

• Start taking MINESSE with the tablet number 1, located next to the word "INITIO".
• Pierce the empty compartment in the center of the blister that corresponds to the day of the week when you took the first tablet. This will be the initial day for any new blister. Similarly, it will be the day of the week when you should take the tablets number 8, 15, and 22, which have a colored edge. This will help you check that you are taking the tablets correctly.
• Each blister contains 28 tablets. Take one tablet at the same time every day for 28 consecutive days, following the direction indicated by the arrows, without skipping any, as follows: take one active yellowish tablet every day for the first 24 days, and then one white placebo tablet every day for the last 4 days.
• After taking the last tablet, continue takingMinessethe next day, starting a new blister without leaving an interval of rest between the blisters. Each blister should be started on the same day of the week. Since there is no pause in taking the medication, it is essential that you already have the next blister before finishing the previous one.
• Menstruation usually starts two or three days after taking the last yellowish tablet from the blister, and may not have finished before starting the next blister.

Method and route of administration

Swallow each tablet with a large glass of water.

If you have not taken any hormonal contraceptive in the previous month

Take the first tablet on the first day of your menstruation.

If you are changing from a hormonal contraceptive

Finish the blister you have started (if your current contraceptive pill blister also contains hormone-free tablets, do not take them). Start the MINESSE blister the next day, without leaving any day without taking a pill.

If you were using a method based exclusively on progestogens (only progestogen pill, injectable method, or implant)

• change from an only progestogen pill: you can start MINESSE at any time during the menstrual cycle, the day after stopping the only progestogen pill
• change from an implant: start MINESSE on the day of the implant removal
• change from an injectable contraceptive: start MINESSE on the day corresponding to the next injection

In any case, it is necessary to use a barrier contraceptive method (e.g. condom) during the first 7 days of taking the pill.

If you are starting MINESSE after a pregnancy interruption in the first trimester

Normally, you can start immediately, but follow your doctor's advice before doing so.

If you are starting MINESSE after giving birth or pregnancy interruption in the second trimester

Like any other contraceptive pill, MINESSE should not be started before21 to28 days after giving birth or pregnancy interruption, due to an increased risk of blood clots. If you start later, it is recommended to use a barrier contraceptive method during the first 7 days of taking the pill. If you have had sex before starting to take MINESSE, make sure you are not pregnant or wait until the next menstruation.

Always ask your doctor for advice.

Duration of use

Your doctor will tell you for how long you should use this pill.

If you take moreMINESSEthan you should

Overdose may cause gastrointestinal problems (e.g. nausea, vomiting, abdominal pain), mastalgia, dizziness, somnolence/fatigue, and menstrual cycle disturbances (bleeding). Ask your doctor for advice.

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

If you forget to take MINESSE

If you realize you have forgotten a yellowish tablet within 12 hours of the time you normally take it, take the forgotten tablet immediately and continue normally, taking the next one at the usual time until you finish the blister.

If you realize you have forgotten a yellowish tablet after more than 12 hours of the time you normally take itthere is a risk of becoming pregnant. In this case:

• take the last forgotten tablet as soon as possible, even if this means taking 2 tablets on the same day
• continue taking the contraceptive until you finish the blister
• in addition, use a barrier contraceptive method (condom, spermicides...) during the next 7 days
• if this 7-day period ends after the last yellowish tablet, discard all remaining tablets and start the next blister.

If you have forgotten one or more yellowish tablets in a blister and you do not get the bleeding that should occur when taking the white tablets, you may be pregnant.

If you have forgotten one or more white tablets, you are still protected as long as no more than 4 days pass between the last yellowish tablet of the current blister and the first yellowish tablet of the next blister.

Ask your doctor for advice.

If you experience vomiting or acute diarrhea within 4 hours of taking the tablet, a situation similar to forgetting a tablet occurs. After vomiting or diarrhea, you should take another tablet from a reserve blister as soon as possible. If possible, take itwithin 12 hours after the usual time you take your contraceptive. If this is not possible or more than 12 hours have passed, follow the advice in the section “If you forget to take MINESSE”.

If these episodes of vomiting or acute diarrhea recur over several days, you should use a barrier contraceptive method (condom, spermicide...) until the start of the next blister. Ask your doctor for advice.

Like all medications,MINESSEmay cause side effects, although not everyone will experience them.If you experience any side effect, especially if it is severe and persistent, or if you have any health change that you think may be related to MINESSE, consult your doctor.

All women taking combined hormonal contraceptives are at a higher risk of developing blood clots in the veins (venous thromboembolism (VTE)) or blood clots in the arteries (arterial thromboembolism (ATE)). For more detailed information on the different risks of taking combined hormonal contraceptives, see section2 “What you need to know before starting to take MINESSE”.

If you experience any of the following severe side effects, seek medical attention immediately:

• Severe allergic reaction– frequency unknown

Symptoms include sudden wheezing, difficulty breathing or dizziness, swelling of the eyelids, face, lips or throat, skin rash and urticarial hives.

• Angioedema– frequency unknown

Symptoms include swelling of the face, tongue and/or throat and/or difficulty swallowing or urticaria with possible difficulty breathing (also see section “Warnings and precautions”).

• Retinal vein thrombosis– frequency unknown
• Symptoms appear more frequently in one eye.
• Painless blurry vision that may progress to loss of vision.
• Immediate loss of vision.

• Sickle cell hemolytic syndrome (a condition affecting the blood and kidneys) –frequency unknown

Symptoms include vomiting, diarrhea (which may be bloody), fever, feeling weak and urinating less frequently than usual.

• Pancreatitis –occurs rarely(may affect 1 to 10 of every 10,000 people)

Symptoms include severe upper abdominal pain that may radiate to the back.

• Erythema multiforme –frequency unknown

Symptoms include skin rash with pinkish-red patches, especially on the palms of the hands or soles of the feet, which may form blisters. They may also appear ulcers in the mouth, eyes or genitals, as well as fever.

Very common (may affect more than 1 in 10 people):

• headache, including migraine
• abdominal pain
• breast pain
• breast tenderness
• very light or absent menstrual bleeding

Common (may affect up to 1 in 10 people):

• vaginal infection including vaginal candidiasis
• intermenstrual bleeding
• mood changes including depression and changes in sexual appetite
• nervousness or dizziness
• nausea, vomiting
• feeling of swelling
• acne
• menstrual cramps
• changes in menstrual flow
• changes in vaginal discharge or cervical changes (ectropion)
• acute fluid retention in tissues or edema
• weight gain or loss
• skin rash
• hair loss

Uncommon (may affect up to 1 in 100 people):

• increased appetite
• decreased appetite
• excessive body hair
• skin discoloration on the face (melasma)
• changes in laboratory test results: increased levels of cholesterol, triglycerides or blood pressure
• breast secretion
• breast enlargement
• emergence of varicose veins

Rare (may affect up to 1 in 1,000 people):

• harmful blood clots in a vein or artery, for example:

The risk of having a blood clot may be higher if you have any other condition that increases this risk (see section2 for more information on conditions that increase the risk of blood clots and symptoms of a blood clot).

• liver or bile duct disorders (such as hepatitis or abnormal liver function)
• gallbladder disease, including gallstones and worsening of this condition

Frequency unknown (cannot be estimated from available data):

• benign liver tumor (called focal nodular hyperplasia or hepatocellular adenoma) or malignant liver tumor
• worsening of an autoimmune disease (lupus), a liver disease (porphyria) or a disease called chorea characterized by involuntary, sudden and irregular movements
• obstruction of bile flow in the liver or worsening of this condition
• inflammatory or ischemic intestinal disease, symptoms include cramps and abdominal pain, diarrhea (which may be bloody) or weight loss
• glucose intolerance
• contact lens intolerance
• abdominal cramps
• jaundice (yellowing of the skin or eyes)
• red, painful lumps under the skin (erythema nodosum)
• inflammation of the optic nerve that may lead to partial or total loss of vision

If you consider that any of the side effects you are experiencing are severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting of side effects

If you experienceany type of side effect, consult your doctor or pharmacist, even if it is apossibleside effect not listed in this leaflet.You can also report them directly to theSpanish Medicines Agency’s Pharmacovigilance System for Human Use:www.notificaRAM.es.By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

Do not use this medication after the expiration date that appears on the packaging and on the blister pack after “CAD”. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition ofMINESSE

Yellowish pale tablet:

The active principles are:0.06 mgof gestodeno and 0.015 mgof ethinylestradiol.

The other components are: lactose monohydrate, microcrystalline cellulose, magnesium stearate, potassium polacrilex, polyethylene glycol 1450, purified water, glycolated montan wax, Opadry Yellow [hydroxypropylmethylcellulose, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172)].

White tablet:

It does not contain active principle (placebo).

The other components are:lactose monohydrate, microcrystalline cellulose, magnesium stearate, potassium polacrilex, polyethylene glycol 1500, purified water, glycolated montan wax, Opadry White [hydroxypropylmethylcellulose, hydroxypropylcellulose, titanium dioxide (E171), polyethylene glycol].

Appearance of the product and contents of the package

MINESSE is presented in the form of coated tablets.

Each package contains1.3 or 6 blisters,eachone with28 tablets (24 active yellowish pale tablets with “60”on one face and “15”on the other face of the tablet and 4 inactive white tablets). Each blister is packaged in an aluminum bag that contains a sachet with silica gel desiccant. After opening each bag, which contains the blister, the desiccant sachet must be discarded.

Only some package sizes may be marketed.

Marketing Authorization Holder

Wyeth Farma, S.A.

Burgos Road, Km.23

San Sebastián de los Reyes

28700-Madrid

Responsible for manufacturing

Pfizer Ireland Pharmaceuticals Unlimited Company,

Little Connell,

Newbridge,

Co. Kildare,

Ireland

Local Representative

Pfizer, S.L.

Avda. de Europa, 20-B

Parque Empresarial La Moraleja

28108 Alcobendas (Madrid)

Last review date of this leaflet: February 2023

Other sources of information

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