OVOPLEX 0.15 MG/0.030 MG FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

OVOPLEX 0.15 mg/0.03 mg Coated Tablets

Levonorgestrel and Ethinylestradiol

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

• Keep this package 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, even if they have the same symptoms, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet:

1. What is Ovoplex and what is it used for
2. What you need to know before taking Ovoplex
3. How to take Ovoplex
4. Possible side effects
5. Storing Ovoplex
6. Package Contents and Additional Information

1. What is Ovoplex and what is it used for

Ovoplex is an oral contraceptive medicine.

It is prescribed for the following indications: hormonal oral contraception, menstrual cycle disorders, and ovarian rest.

In addition, the use of oral contraceptives may have beneficial effects on conditions such as dysmenorrhea (menstrual pain) and to reduce the incidence of some breast and reproductive organ disorders.

2. Before taking Ovoplex coated tablets

Do not takeOvoplex

• If you are allergic to levonorgestrel, ethinylestradiol, or any of the other components of this medicine (included in section 6).
• If you are pregnant or think you may be pregnant.
• If you have severe liver function disorders.
• If you have had blood clots in the veins of the lower limbs that have broken loose and affected other areas of the body, even if it happened a long time ago.
• If you have had tumors in the breasts, liver, cervix, uterus, or vagina.
• If you have diabetes associated with heart or circulatory problems.
• If you have disorders of the arteries of the brain or heart.
• If you have valve diseases of the heart (valvulopathies).
• If you have heart rhythm disorders (arrhythmias) with the possibility of forming blood clots.
• If you have inherited or acquired disorders that predispose to the formation of blood clots (thrombophilias).
• If you have migraines (migraines) associated with symptoms such as loss of strength or sensitivity in a part of the body, or vision disturbances (aura).
• If you have high blood pressure.
• If you have vaginal bleeding of unknown cause.
• If you have pancreatitis (inflammation of the pancreas) due to a severe increase in triglycerides.
• If you have hepatitis C and are taking medications that contain ombitasvir/paritaprevir/ritonavir and dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also the section "Other medicines and Ovoplex").

Warnings and precautions

Before taking Ovoplex, you will need to go to your doctor for a physical examination. It is essential that you inform them if you have or have had any of the diseases listed below in the past. If so, your doctor may need to monitor you more frequently. You should also go to your doctor if any of these diseases worsen or appear while using this medicine:

• Heart disease (chest pain, certain types of heart rhythm disorders, heart diseases).
• Family or personal history of high fat levels (triglycerides) in the blood.
• High blood pressure, particularly if it worsens or does not improve with antihypertensive medications.
• Severe and recurrent migraines or those associated with vision disturbances (aura).
• Diabetes.
• Depression or history of depression, as it could worsen or reappear when using hormonal contraceptives.
• Epilepsy.
• Inflammatory bowel disease (Crohn's disease or ulcerative colitis).
• Jaundice (yellowing of the whites of the eyes and skin) or liver function disorders.
• Itching, especially if it occurred during a previous pregnancy.
• Brown spots on the skin of the face, especially if you have had them during a previous pregnancy. If this is the case, avoid sunlight and ultraviolet radiation (e.g., sunlamp).
• 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 can cause or worsen symptoms of hereditary and acquired angioedema.

Psychiatric disorders:

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

Also, contact your doctor if you think you may be pregnant.

Potentially serious diseases:

Blood clots (thrombosis)

The use of contraceptive medications can increase the chances of developing blood clots (blood clots). This risk is higher during the first year of using oral contraceptives.

Blood clots can block major blood vessels and can cause: pulmonary embolism, myocardial infarction, angina pectoris, cerebral thrombosis, etc.

If you notice the appearance of any of the following signs, inform your doctor, as they could be forming blood clots:

• Pain and swelling in one leg.
• Severe chest pain and sometimes also in the arm.
• Sudden loss of breath
• Sudden onset of cough.
• Severe headache.
• Visual problems (loss of vision, double vision).
• Difficulty speaking clearly.
• Dizziness.
• Seizures.
• Weakness or numbness affecting one part of the body.
• Difficulty walking or holding things.
• Severe stomach pain.

The following conditions can increase the risk of blood clot formation, so you should inform your doctor if you have any of them:

• Obesity.
• If you are a smoker and over 35 years old.
• If you have had a severe injury to your legs or hips.
• If you have just given birth or had an abortion in the second trimester of pregnancy.
• If you need to be in bed for many days. In these cases, if possible, treatment should be suspended.
• If you are going to undergo major surgery. In these cases, whenever possible, treatment should be suspended four weeks before and two weeks after surgery.
• Advanced age.

Do not start treatment with oral contraceptives until 28 days have passed after childbirth, provided you are not breastfeeding or have had an abortion in the second trimester, as the chances of venous thromboembolism increase immediately after childbirth.

Blood pressure

If you have high blood pressure or suffer from any disease related to high blood pressure (including certain kidney diseases), it is preferable to use other contraceptive methods. If you decide to use oral contraceptives, your blood pressure should be monitored, but if it increases and cannot be controlled with medication, treatment should be interrupted.

Tumors

There have been cases of breast tumors with a slightly higher frequency in women using oral contraceptives, but it is not known if this is due to treatment. For example, it could be that more tumors are detected in women using oral contraceptives because they go to the doctor more frequently. This increased frequency decreases gradually after stopping treatment. After ten years, the chances of having breast tumors will be the same as for women who have never used oral contraceptives.

Similarly, tumors of the cervix (cervix) occur more frequently in women who use the contraceptive pill. However, the appearance of this tumor is associated with increased sexual activity and sexually transmitted diseases, so it is not clear if the contraceptive pill plays a direct role in this risk.

Rarely, cases of liver tumors have been reported in women using the contraceptive pill. In these cases, internal bleeding can occur, leading to severe abdominal pain. If this happens, you should contact your doctor immediately.

Women who have suffered from cholestasis (obstruction of bile flow) during treatment with oral contraceptives in the past or during pregnancy are more likely to develop it again if they use oral contraceptives. These women should be monitored, and if cholestasis appears, oral contraceptive treatment should be suspended.

There have been reports of severe liver damage with the use of oral contraceptives. If your doctor determines that you develop severe liver damage while taking oral contraceptives, they will suspend treatment with oral contraceptives and recommend the use of non-hormonal contraceptives.

Migraines

The onset or worsening of a migraine, or the appearance of a migraine with different characteristics than usual, recurrent, persistent, or intense, requires the suspension of treatment with contraceptives and evaluation of the cause.

Women with migraines (particularly those associated with symptoms such as loss of strength or sensitivity in a part of the body, or vision disturbances (aura)) who take oral contraceptives may suffer an increased risk of cerebral infarction.

Immune system

The use of oral contraceptives can worsen the symptoms of angioedema (inflammation similar to urticaria, but which occurs under the skin instead of on the surface) particularly in women with hereditary angioedema (a problem of the immune system that is transmitted from parents to children).

Genital bleeding

It may happen that you do not have your "period" during the week of rest. If the contraceptive pill has been taken correctly, it is very unlikely that you are pregnant. However, if you have two missed periods, you should consult your doctor, as pregnancy should be ruled out. If you have not taken the contraceptive pill according to the instructions indicated in the section "3. How to take Ovoplex" and you have a missed period, you should interrupt treatment and use a non-hormonal contraceptive method until pregnancy is ruled out.

This medicine can cause vaginal bleeding or spotting between periods. If this happens to you, continue treatment, and if the bleeding continues after the first three cycles, consult your doctor immediately. Errors in using the pill can also cause spotting and light bleeding.

When you stop using this medicine, you may experience irregular, scarce, or no bleeding, especially in the first 3 months, and especially if your periods were already irregular before starting to take hormones.

Effects on carbohydrates and lipids

In users of oral contraceptives, cases of glucose intolerance have been reported. Women with glucose intolerance or diabetes mellitus should be carefully monitored.

A small proportion of women who take oral contraceptives may experience changes in their lipid profile (analysis of fat content in the blood). Non-hormonal contraceptive methods should be considered in women with uncontrolled lipid disorders. In a small proportion of women who take oral contraceptives, persistent hypertriglyceridemia (increase in triglycerides in the blood) can occur. A significant increase in plasma triglycerides can lead to pancreatitis and other complications.

Women who have been treated for hyperlipidemias (increased cholesterol and/or triglycerides) should be monitored if they decide to take oral contraceptives.

Eye injuries

With the use of oral contraceptives, cases of retinal vascular thrombosis have been reported, which can lead to partial or complete loss of vision. If you experience signs or symptoms such as visual changes, proptosis (bulging eyes), or diplopia (double vision), papilledema (eye inflammation), or retinal vascular injury, you should suspend treatment with oral contraceptives, and the cause should be evaluated immediately.

Depression

If a severe depression occurs, the medication should be suspended, and an alternative contraceptive method should be used.

Women with a history of depression should be monitored.

Others

The contraceptive pill does not protect against HIV (AIDS) infection or any other sexually transmitted disease (e.g., chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, and syphilis). It is necessary to use a condom to protect against these diseases.

Other medicines and Ovoplex

Inform your doctor or pharmacist if you are using or have recently used other medicines, including those purchased without a prescription.

Never take another medicine on your own initiative without your doctor's recommendation, as some combinations should be avoided.

Note that these instructions may also apply to medicines that you have taken/used before or may take/use after.

The following medicines may prevent hormonal contraceptives from working well, and if this happens, you could become pregnant:

• Some treatments against viral infections and HIV (ritonavir, indinavir).
• Some antibiotics (rifampicin, rifabutin, griseofulvin, and troleandomycin).
• Some antiepileptics (topiramate, barbiturics (phenobarbital), phenytoin, carbamazepine, primidone, oxcarbazepine, felbamate).
• Some anti-inflammatory drugs (phenylbutazone, dexamethasone).
• Antacids.
• Purgatives.
• Certain substances to improve mood (modafinil).
• Medicines that reduce triglyceride and/or cholesterol levels (atorvastatin).
• Antifungals (fluconazole).
• Vitamin C.
• Analgesics (paracetamol).

The herbal medicine St. John's Wort (Hypericum perforatum) also reduces the effect of oral contraceptives, and cases of pregnancy have been reported in women who take the contraceptive pill and some St. John's Wort preparation at the same time. The decrease in contraceptive effect lasts up to two weeks after stopping the St. John's Wort preparation.

It is advisable to use another reliable contraceptive method if you take any of the medicines that can make oral contraceptives less effective. Women being treated with antibiotics should use a non-hormonal contraceptive method during antibiotic use and up to 7 days after discontinuation (except rifampicin and griseofulvin, which should be used for 28 days after discontinuation, as well as liver enzyme-inducing drugs: antiepileptics).

If treatment with the drug lasts longer than the number of tablets in the Ovoplex package, the next Ovoplex package should be started without the usual tablet-free interval.

There are other substances that can increase etinilestradiol concentrations

• Medicines that reduce triglyceride and/or cholesterol levels (atorvastatin).
• Antifungals (fluconazole).
• Vitamin C.
• Analgesics (paracetamol).

Troleandomycin can increase the risk of intrahepatic cholestasis

Ovoplex can decrease the effect of other medicines, such as:

• Oral anticoagulants (acenocoumarol).
• Analgesics (such as paracetamol and salicylates).
• Oral antidiabetics and insulin.
• Lamotrigine (for treating epilepsy and some psychiatric disorders).

Also, Ovoplex can increase the effect of other drugs such as:

• Beta-blockers like metoprolol (for treating high blood pressure).
• Theophylline (for treating asthma).
• Corticosteroids (such as prednisolone).
• Cyclosporine (immunosuppressant), increasing the risk of liver toxicity.
• Flunarizine (for treating migraines), increasing the risk of milk secretion.

Do not take OVOPLEX 150/30 if you have hepatitis C and are taking medications that contain ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as these medications can cause increases in liver test results (increase in liver enzyme ALT).

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

OVOPLEX 150/30 can be used again approximately 2 weeks after the end of this treatment. See the section "Do not take OVOPLEX 150/30".

Laboratory tests

The use of oral contraceptives can affect the results of certain laboratory tests. If you are prescribed any laboratory test, inform your doctor that you are using oral contraceptives.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

Do not use this medicine if you are pregnant or think you may be pregnant (for information on the use of Ovoplex after pregnancy, see the section "3. How to take Ovoplex").

If you become pregnant, you should stop taking this medicine immediately and consult your doctor.

This medicine should not be used until the end of the breastfeeding period.

Children and adolescents

The efficacy and safety of oral contraceptives have been established in women of childbearing age.

It is not indicated for use before the first menarche (menstruation).

Older adults

It is not indicated for use in postmenopausal women.

Driving and using machines

No effects on the ability to drive or use machinery have been observed.

Ovoplex contains lactose and sucrose

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

This medicine contains sucrose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

3. How to Take Ovoplex

Follow the administration instructions for Ovoplex 150/30 exactly as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

This medication is for oral administration.

Remember to take your medication, as forgetting Ovoplex 150/30 can decrease the effectiveness of the preparation.

Before starting treatment with this medication, your doctor should perform a detailed medical history and thorough medical examination, including blood pressure, and rule out the existence of pregnancy. You should also undergo a breast, liver, extremities, and pelvic organs (urinary bladder, vagina, uterus, and rectum) examination. Your doctor may also need to perform a cervical cytology (painless scraping of the cervix to take cells from the area for analysis). Your doctor will repeat this review 3 months after starting treatment and then annually.

See the section "2. Before Taking Ovoplex".

Instructions for Correct Administration of the Medication

You should take the tablets orally, in the order indicated on the blister pack, approximately at the same time, every day, with some liquid if necessary. You should take one tablet daily for 21 consecutive days and then be without tablets for 7 days. Each subsequent pack will start after the 7-day interval without tablets, during which bleeding usually occurs. This bleeding, similar to menstruation, usually begins between days 2 and 3 after taking the last tablet and may not have finished before starting the next pack.

Your doctor will indicate the duration of your treatment with this medication.

If you think the action of this medication is too strong or too weak, inform your doctor or pharmacist.

Starting the First Pack of Ovoplex

• When no hormonal contraceptive has been used in the previous month

Treatment starts on the first day of the menstrual cycle (i.e., the first day of bleeding).

For example, if bleeding appears on a Monday, you should start taking the medication on the same day, with the coated tablet marked "Lu", and follow the indicator arrow for subsequent intakes.

It is also allowed to start on days 2-7 of the menstrual cycle; in this case, a non-hormonal contraceptive method (e.g., condoms or spermicide) is recommended for birth control during the first 7 days of tablet intake.

• When switching from another contraceptive to Ovoplex

You can start taking Ovoplex the day after taking the last active tablet of your current pack of pills (this means there is no tablet-free interval). If your current pack of pills also contains inactive tablets, you can start taking Ovoplex the day after taking the last activetablet. Never delay more than the day after finishing the usual tablet-free interval or inactive tablet interval of your previous contraceptive.

• When switching from a progestogen-only method (minipill, implant, intrauterine device (IUD), or injection)

You can stop taking the progestogen pill (minipill) on any day and start taking Ovoplex the next day, at the same time.

Start using this medication when your next injection is due or on the day your implant or intrauterine device (IUD) is removed.

In all these situations, also make sure to use an additional barrier method when having sexual intercourse (e.g., condoms or spermicides) during the first 7 days of tablet intake.

• After a first-trimester abortion

You can start taking the tablets immediately. If you do so, you do not need to take other contraceptive measures.

• Postpartum

If you are breastfeeding, you should not take this medication; see the section "Pregnancy, Breastfeeding, and Fertility".

Tablet intake starts 28 days after delivery in non-breastfeeding women or after a second-trimester abortion. If you start later, you should use an additional barrier method during the first 7 days of tablet intake. However, if you have already had sexual intercourse, you should rule out pregnancy before taking the contraceptive or wait for your next menstrual period.

Subsequent Cycles

After the 7-day tablet-free interval, a new pack of Ovoplex is started, beginning on the same day of the week as the first pack.

What to do if bleeding occurs during the 21 days of taking coated tablets

The occurrence of bleeding during the 3 weeks of taking coated tablets is not a reason to interrupt treatment. Mild bleeding usually disappears on its own. If bleeding reaches the intensity of a normal menstrual period and lasts for more than 3 cycles, you should consult your doctor.

Absence of Bleeding

If vaginal bleeding does not occur during the tablet-free interval, it is advisable to consult your doctor immediately to rule out the possibility of pregnancy if the coated tablets were not taken regularly or if you experienced vomiting or diarrhea during the cycle.

If You Forget to Take Ovoplex

Contraceptive protection may be reduced if you forget to take tablets. In particular, if you forget during the first week of treatment and had sexual intercourse in the previous week, you may be at risk of becoming pregnant.

• If you have delayed taking a tablet by less than 12 hours, the efficacy of the pill is maintained. Take it as soon as you remember and take the next tablets at the usual time.

• If you have delayed taking a tablet by more than 12 hours, the efficacy of the contraceptive may be reduced.

• Always take the last forgotten tablet as soon as you remember, even if it means taking two tablets in one day. Continue taking the next tablets at the usual time, but use an additional barrier method (such as condoms or spermicides) for the next 7 days.
• • If you take the last tablet before the 7 days that require the use of an additional contraceptive method, start a new pack immediately without a break between them. You will not have menstruation until the end of the new pack, although you may experience spotting or bleeding on the days you take the tablets.
  • If you do not have menstruation at the end of the new pack, contact your doctor, who must rule out pregnancy before starting the next pack.

Advice in case of vomiting and/or diarrhea

If vomiting or diarrhea occurs within 4 hours after taking a tablet, follow the advice for forgetting to take a tablet. If you do not want to change your usual tablet intake schedule, you should take the additional tablets needed from another pack.

How to delay a period

To delay a period, start a new pack immediately after finishing the current pack, without any break. Periods can be delayed for as long as you want, but not beyond the end of the second pack. During this time, you may experience bleeding or spotting. Afterward, regular intake of this medication will resume after the usual 7-day tablet-free interval.

If You Take More Ovoplex Than You Should

You may experience nausea, vomiting, drowsiness, breast pain, dizziness, and vaginal bleeding; treatment consists of suspending administration of this medication. Contact your doctor or pharmacist as soon as possible.

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service. Phone 915 620 420, indicating the medication and the amount used.

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

4. Possible Side Effects

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 "Warnings and Precautions" section).

Like all medications, Ovoplex can cause side effects, although not everyone will experience them.

The use of oral contraceptives has been associated with an increased risk of:

• Venous and arterial thrombotic and thromboembolic events, including stroke, transient ischemic attack, myocardial infarction, venous thrombosis, and pulmonary embolism (see Warnings and Precautions).
• Cervical intraepithelial neoplasia (abnormal cells on the surface of the cervix) and cervical cancer (cancer of the cervix).
• Breast cancer diagnosis (see Warnings and Precautions).
• Benign hepatic tumors (e.g., focal nodular hyperplasia, hepatic adenomas).

Side effects are listed below, classified according to their frequency, as follows:

Side effectsvery common (more than 1 in 10 patients)

?unexpected vaginal bleeding or spotting

?headache, including migraines

Side effectscommon (at least 1 in 100 patients)are:

?vaginitis (vaginal inflammation), including candidiasis (fungal infection in the vagina)

• mood changes, including depression; changes in libido (sexual desire)
• nervousness, dizziness
• nausea, vomiting, abdominal pain
• acne
• breast pain or tenderness, breast swelling, nipple discharge, dysmenorrhea (painful menstruation), changes in menstrual flow, changes in vaginal discharge, and cervical ectopia (alteration of the cervical mucosa), amenorrhea (absence of menstruation)
• fluid retention, edema (swelling)
• weight changes (increase or decrease)

Side effects uncommon (at least 1 in 1,000 patients)are:

• changes in appetite, increased or decreased
• colic, bloating, diarrhea
• rash (skin eruption), chloasma (skin discoloration) that may persist, hirsutism (excessive hair growth), alopecia (hair loss)
• increased blood pressure; changes in blood lipid levels, including hypertriglyceridemia (high levels of fatty acids in the blood)

Side effectsrare (at least 1 in 10,000 patients)are:

• intolerance to contact lenses
• allergic reactions such as urticaria (hives), angioedema (swelling of the face, lips, mouth, and, in rare cases, difficulty breathing, dizziness, and loss of consciousness)

?glucose intolerance

• venous thrombotic events (blood clots in veins)
• cholestatic jaundice (yellowing of the skin and eyes due to bile buildup)
• erythema nodosum (a type of skin inflammation with nodules on the legs)
• vaginal discharge
• decreased folate levels in the blood

Side effectsvery rare (less than 1 in 10,000 patients)are:

• hepatocellular carcinomas (malignant liver tumors)
• worsening of systemic lupus erythematosus (an autoimmune disease)
• worsening of porphyria (a familial metabolic disorder)
• worsening of chorea (involuntary movements)
• eye abnormalities and visual disturbances
• worsening of varices
• pancreatitis (inflammation of the pancreas); ischemic colitis (a type of colon inflammation)
• cholecystopathy (bile duct disorders) including gallstones
• erythema multiforme (a type of skin inflammation)
• hemolytic uremic syndrome (a kidney disease with blood abnormalities)

Side effects of unknown frequencyare:

• inflammatory bowel disease (Crohn's disease, ulcerative colitis) (certain types of intestinal inflammation)

Do not be alarmed by these side effects, as it is very likely that none of them will occur.

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

Reporting Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for human use medications, https://www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Ovoplex 150/30 Coated Tablets

Do not store above 30°C.

Keep out of the reach and sight of children.

Do not use OVOPLEX 150/30 after the expiration date stated on the packaging. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Additional Information

Composition of Ovoplex Coated Tablets

The active ingredients of Ovoplex are: 0.15 mg of levonorgestrel and 0.03 mg of ethinylestradiol.

The other ingredients (excipients) are: sucrose, lactose, cornstarch, povidone K-25, magnesium stearate, povidone K-90, macrogol 6,000, calcium carbonate, talc, white wax, carnauba wax, and purified water.

Appearance of the Product and Packaging Contents

It is presented in a calendar pack containing 1 blister pack with 21 coated tablets.

The blister pack is packaged in an aluminum bag containing a sachet with desiccant (silica gel).

After opening the aluminum bag, the desiccant can be removed.

Marketing Authorization Holder

WYETH FARMA, S.A.

Ctra. Burgos, Km 23. Desvío Algete, Km 1.

San Sebastián de los Reyes – Madrid

SPAIN

Manufacturer

Pfizer Ireland Pharmaceuticals Unlimited Company

Little Connell

Newbridge,

Co. Kildare

W12 HX57

Ireland

Local Representative

Pfizer, S.L.

Avda. de Europa, 20-B

Parque Empresarial La Moraleja

28108 Alcobendas (Madrid)

Date of the Last Revision of this Leaflet: November 2022

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