Package Insert: Information for the Patient

Lisinopril/Hydrochlorothiazide Sandoz Pharmaceutical 20 mg/12.5 mg Tablets EFG

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Lisinoprilbelongs to a group of medicines called angiotensin-converting enzyme (ACE) inhibitors and reduces blood pressure by widening blood vessels.

Hidroclorotiazidabelongs to a group of medicines called diuretics and reduces blood pressure by increasing urine elimination.

Lisinopril/Hidroclorotiazida Sandoz Pharmaceutical contains a combination of lisinopril and hidroclorotiazida and is used as a treatment for high blood pressure when treatment with lisinopril as a single agent is insufficient.

Your doctor may also prescribe lisinopril/hidroclorotiazida instead of separate tablets of the same doses of lisinopril and hidroclorotiazida. This fixed combination of doses is not suitable for the beginning of treatment.

Do not take Lisinopril/Hidroclorotiazida Sandoz Farmacéutica:

• if you are allergic to lisinopril, hidroclorotiazida or any of the other components of this medication (listed in section 6),
• if you are allergic to other ACE inhibitors, for example ramipril or medications derived from sulfonamides (most antibiotics, e.g., sulfametoxazol),
• if you have ever experienced itching, blisters, sudden drop in blood pressure, sudden swelling of the hands, feet, ankles, face, lips, tongue, or throat (angioedema) especially after treatment with medications in the group of ACE inhibitors (angiotensin-converting enzyme inhibitors). Difficulty swallowing or breathing may also occur.
• if you have hereditary angioedema (a condition that makes you more prone to the swelling described above). If you are unsure if this condition applies to you, consult your doctor,
• if you have taken or are currently taking sacubitril/valsartán, a medication used for the treatment of a type of chronic heart failure in adults, as the risk of angioedema (rapid swelling under the skin in an area such as the throat) is high,
• if among your relatives someone has ever experienced swelling of the extremities, face, mouth, throat, tongue, or lips (angioedema),
• if you have severe kidney problems,
• if you have severe liver problems,
• if you have difficulty producing urine (anuria),
• if you are more than 3 months pregnant. (It is also best to avoid lisinopril/hidroclorotiazida at the beginning of pregnancy, see the pregnancy section),
• if you have diabetes or kidney insufficiency and are being treated with a medication to lower blood pressure that contains aliskirén.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Lisinopril/Hidroclorotiazida Sandoz Farmacéutica:

• if you have narrowing of the arteries (arteriosclerosis), cerebrovascular problems such as a heart attack or a transient ischemic attack (TIA, a small stroke),
• if you have heart failure,
• if you have low blood pressure, are on a low-sodium diet, or are taking diuretics,
• if you have abnormal levels of water and minerals in your body (fluid/electrolyte imbalance),
• if you have hypertrophic cardiomyopathy, a narrowing of the main artery that carries blood from the heart, the aorta (aortic stenosis), or other forms of a cardiac problem called outflow tract obstruction,
• if you are undergoing LDL apheresis (removal of cholesterol from the blood through a machine),
• if you are undergoing a treatment for desensitization to some insect stings, such as bee or wasp stings,
• if you have diabetes,
• if you have had respiratory or pulmonary problems (such as inflammation or fluid in the lungs) after taking hidroclorotiazida in the past. If you experience shortness of breath or severe difficulty breathing after taking lisinopril/hidroclorotiazida, seek medical attention immediately,
• if you are taking any of the following medications used to treat high blood pressure (hypertension):

• an angiotensin II receptor antagonist (ARA) (also known as "sartanes", e.g., valsartán, telmisartán, irbesartán), particularly if you have kidney problems related to diabetes.
• aliskirén.

Your doctor may monitor your renal function, blood pressure, and electrolyte levels in the blood (e.g., potassium) at regular intervals. See also the information under the heading “Do not take Lisinopril/Hidroclorotiazida Sandoz Farmacéutica”

• if you are taking any of the following medications, the risk of angioedema may increase (rapid swelling under the skin in an area such as the throat):
• sirolimus, temsirolimus, everolimus, and other medications belonging to the class called mTOR inhibitors (used to prevent rejection in organ transplants and for cancer),
• racecadotrilo, a medication used for the treatment of diarrhea,
• vildagliptina, a medication used for the treatment of diabetes,
• activator of tissue plasminogen (ATP) used to dissolve blood clots formed in the blood vessels,
• if you are taking other medications, such as salt substitutes or potassium supplements,
• if you have gout, high levels of uric acid in the blood, or are being treated with alopurinol or procainamida,
• if you are undergoing surgery (including dental surgery) and will receive anesthetics,
• if you have recently experienced prolonged vomiting and/or severe diarrhea,
• if you are undergoing a test of the function of your parathyroid gland,
• if you have or have had liver or kidney problems, or have narrowing of the arteries in your kidneys (renal artery stenosis), or only have one kidney, or are undergoing dialysis,
• if you have a vascular disease of collagen, such as systemic lupus erythematosus (SLE) or scleroderma, which may be associated with skin rashes, joint pain, and fever,
• if you have had skin cancer or if you develop an unexpected skin lesion during treatment. The treatment with hidroclorotiazida, particularly its long-term use at high doses, may increase the risk of some types of skin cancer and lip cancer (non-melanoma skin cancer). Protect your skin from exposure to the sun and UV rays while taking Lisinopril/Hidroclorotiazida Sandoz Farmacéutica,
• if you have allergies or asthma,
• if you are taking lithium, used for the treatment of some psychiatric disorders
• if you think you are (or may become) pregnant. Lisinopril/hidroclorotiazida is not recommended at the beginning of pregnancy, and should not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used during this period (see the pregnancy section),
• if you are being treated with other diuretics.

Lisinopril/Hidroclorotiazida is not generally recommended in the following cases, so you should consult with your doctor before taking this medication:

• if you have recently undergone a kidney transplant,
• if you have high levels of potassium in your blood.

See also the section “Other medications and Lisinopril/Hidroclorotiazida Sandoz Farmacéutica”

Consult your doctor if you are an athlete, as this medication contains a component that may result in a positive analytical result for doping control.

Patients who are elderly or malnourished should be especially careful when taking lisinopril/hidroclorotiazida.

Lisinopril/hidroclorotiazida may be less effective in black patients.

Children

This medication is not recommended for use in children.

While taking Lisinopril/Hidroclorotiazida Sandoz Farmacéutica:

Consult your doctor immediately if you develop any of the following symptoms:

• if you feelgiddyafter your first dose. Some people react to the first dose or when it is increased with a feeling of dizziness, weakness, fainting, and nausea,
• suddenswelling of the lips and neck, possibly also hands and feet or wheezing or hoarseness. This condition is called angioedema. This can occur at any time during treatment. ACE inhibitors produce angioedema more frequently in black patients than in patients of other races,
• hightemperatures, sore throat, or ulcers in the mouth (these may be symptoms of an infection caused by a decrease in white blood cells),
• yellowingof the skin and white of the eyes (jaundice) that may be a symptom of liver disease,
• drycough that persists for a long time. A cough has been detected with the use of ACE inhibitors, but it may also be a symptom of another respiratory tract disease,
• slightmyopiaor glaucoma. Talk to your doctor or pharmacist if you experience a decrease in vision or eye pain. They may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or an increase in eye pressure and may occur within a few hours to a week after taking lisinopril/hidroclorotiazida. If left untreated, it may lead to permanent vision loss. If you have had an allergy to penicillins or sulfonamides, you may have a higher risk of developing them.

Other medications and Lisinopril/Hidroclorotiazida Sandoz Farmacéutica

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

This applies particularly if you are also taking:

• potassium supplements (including salt substitutes), or diuretics that save potassium and other medications that increase the amount of potassium in your body (such as heparin, a medication used to dilute the blood to prevent clots, cotrimoxazol and trimetoprim, for bacterial infections; and ciclosporina, an immunosuppressant used to prevent organ rejection after transplantation),
• other medications used to treat high blood pressure. Your doctor may need to change your dose and/or take other precautions. If you are taking an angiotensin II receptor antagonist (ARA) or aliskirén (see also the information under the headings “Do not take Lisinopril/Hidroclorotiazida Sandoz Farmacéutica” and “Warnings and precautions”),
• anestheticsand medications for mental disorders or depression (e.g., tricyclic antidepressants), medications for psychosis, medications for seizures, or sedatives. Low blood pressure may be exacerbated. You may feel dizzy when standing up.
• litio (medication for depression),
• analgesicsand anti-inflammatory medications (used for the treatment of muscle pain or arthritis), such as acetylsalicylic acid, ibuprofen, or indometacina,
• aurousmalatosódico (gold), an injectable medication for rheumatoid arthritis,
• medications such as ephedrine, noradrenaline, or adrenaline used for thetreatmentof hypotensive shock, heart failure, asthma, or allergies,
• medications to lower blood sugar, such as insulin or those taken orally (including vildagliptina). See also the section “Warnings and precautions”,
• cholesterol-lowering medications, such as resins of colestiramina and colestipol,
• corticosteroids, hormonal anti-inflammatory medications,
• corticotropina (ACTH), used to check if your adrenal glands are functioning correctly,
• diuretics,
• muscle relaxants (e.g., cloruro de tubocurarina, medications to relax muscles used in operations),
• alopurinol, medications used for the treatment of gout,
• medications for the treatment of cancer, such as ciclofosfamida or metotrexato,
• medications that inhibit the immune system, medications to prevent rejection after an organ transplant or bone marrow transplant,
• procainamida, a medication for irregular heartbeats,
• cardiac glycosides (e.g., digoxina, medications to strengthen the heart),
• medications that, as a side effect, produce abnormalities in the conduction of stimuli in the heart, such as medications for arrhythmias, some medications for psychosis, and other medications such as the treatment of bacterial infections,
• calcium salts, increase levels of calcium in the blood,
• vitamin D,
• anfotericina B, an antifungal medication,
• laxatives, medications to promote defecation,
• carbenoxolona, a medication for the treatment of gastrointestinal diseases,
• medications that are often used to prevent rejection after organ transplantation (sirolimus, everolimus, and other medications belonging to the class of mTOR inhibitors). See the section “Warnings and precautions”,
• medications called NEP inhibitors, such as racecadotrilo used for the treatment of diarrhea. See section “Warnings and precautions”,
• sacubitril/valsartán (used for the treatment of heart failure). See section “Do not take Lisinopril/Hidroclorotiazida Sandoz Farmacéutica”,
• activator of tissue plasminogen (ATP), used to dissolve blood clots formed in the blood vessels. See section “Warnings and precautions”,
• lovastatina, a medication for high cholesterol,
• sotalol (a beta blocker), as it increases the risk of arrhythmias,
• diazóxido (a medication for the treatment of blood sugar),
• amantadina (a medication for the treatment of Parkinson's disease or severe viral infections).

Lisinopril/Hidroclorotiazida Sandoz Farmacéutica and alcohol

Low blood pressure may be exacerbated by alcohol. You may feel dizzy when standing up.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

Consult your doctor if you think you are (or may become) pregnant. Your doctor will recommend stopping lisinopril/hidroclorotiazida before becoming pregnant or as soon as possible after becoming pregnant and will recommend taking another medication instead of lisinopril/hidroclorotiazida. Lisinopril/hidroclorotiazida is not recommended during pregnancy, and should not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used during this period.

Breastfeeding

Consult your doctor if you are breastfeeding or plan to start breastfeeding. Lisinopril/hidroclorotiazida is not recommended for breastfeeding mothers, and your doctor may choose another treatment for you if you want to breastfeed, especially if your baby is newborn or premature.

Driving and operating machinery

You may feel dizzy or tired while taking this medication. If this occurs, do not drive or operate machinery(see the section “Possible side effects”).

Lisinopril/Hidroclorotiazida Sandoz Farmacéutica contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet, which is essentially sodium-free.

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

Adults

The usual dose is one tablet once a day.

The maximum dose is 40 mg of lisinopril and 25 mg of hydrochlorothiazide per day.

Use in children

The safety and efficacy profile has not been established in children.

Advanced age

No special dose adjustments are required.

Renal problems

Do not take this medication if you have severe kidney problems.

If you have a kidney disorder, your doctor will prescribe a lower dose and monitor your renal function.

Previous treatment with diuretics

If you change from a diuretic to lisinopril/hydrochlorothiazide, your doctor should instruct you to stop taking the diuretic 2 or 3 days before starting this medication.

How to take the tablet

Take the tablet or half tablet with plenty of water. Try to take your medication at the same time every day.

Tablet division

Place the tablet on a hard surface with the dividing line facing upwards. Press with your finger in the middle of the tablet, and the tablet divides into two parts.

If you take more Lisinopril/Hidroclorotiazida Sandoz Farmacéutica than you should

If you (or someone) take multiple tablets at once or think a child has swallowed some tablets, consult your doctor immediately.

Overdose may cause decreased blood pressure, dizziness, circulatory shock, electrolyte imbalance, renal failure, hyperventilation (rapid breathing, feeling of illness), excessive rapid or slow heart rate, palpitations (feeling of irregular heart rhythm), anxiety, and cough. Bring this leaflet and any remaining tablets to the hospital or doctor so they can know what you have taken.

If you have taken more Lisinopril/Hidroclorotiazida Sandoz Farmacéutica than you should, consult your doctor, pharmacist, or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount used..

If you forgot to take Lisinopril/Hidroclorotiazida Sandoz Farmacéutica

Do not take a double dose to compensate for the missed doses, take your next dose at the planned time.

If you interrupt treatment with Lisinopril/Hidroclorotiazida Sandoz Farmacéutica

High blood pressure treatment is a long-term treatment, and interrupting treatment should be discussed with your doctor. Stopping or abandoning treatment may cause an increase in blood pressure.

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

Like all medications, this medication may cause side effects, although not everyone will experience them.

If you experience any of the following side effects, stop taking this medication and consult your doctor immediately or visit the emergency department of your nearest hospital.

• Severe allergic reaction called angioedema (rash, itching, swelling of the extremities, face, lips, mouth, or throat that may cause difficulty breathing or swallowing).

This is a rare and severe side effect (may affect up to 1 in 1,000 people). You may need urgent medical attention or hospitalization..

• Severe allergic reaction called anaphylactoid reaction that causes difficulty breathing or dizziness. The frequency of this side effect isunknown.
• Severe skin disorders with severe skin rash or itching, skin peeling, or blisters on the skin, redness of the skin all over the body, eye pain, mouth, or genital organ pain, fever, (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, pemphigus). These side effects are severe and very rare (may affect up to 1 in 10,000 people).
• Heart attack or stroke (mainly in patients with low blood pressure). This is a severe andinfrequentside effect (may affect up to 1 in 100 people).
• Difficulty breathing, wheezing (bronchospasm). This is a severe andvery rareside effect (may affect up to 1 in 10,000 people).
• Acute respiratory distress (symptoms include severe difficulty breathing, fever, weakness, and confusion). This is a very rare side effect (may affect up to 1 in 10,000 people),
• Jaundice (yellowing of the skin and white of the eyes).

This is a potentially severe butvery rareside effect (may affect up to 1 in 10,000 people) that indicates liver inflammation that may progress to liver failure. You may need urgent medical attention or hospitalization.

• Pancreatitis, an inflammation of the pancreas that produces severe abdominal and back pain. This is a severe andvery rareside effect (may affect up to 1 in 10,000 people).
• Weakness and fatigue, loss of appetite, feeling of dizziness, vomiting, tremors, inability to urinate (decreased urine output) may also appear with high temperature (fever), side pain, swelling of legs, ankles, feet, face, and hands or blood in the urine. These are severe side effects due to kidney problems such as uremia (high levels of urea in the blood), sudden kidney failure side effectsare rare(may affect up to 1 in 1,000 people) or interstitial nephritis, a side effect ofunknown frequency.
• Sudden myopia. This is a severe side effect whose frequency isunknown.
• Decreased vision or eye pain due to high pressure (possible signs of accumulation of fluid in the vascular layer of the eye (choroidal hemorrhage) or acute angle-closure glaucoma). These are severe side effects withunknown frequency.
• Systemic lupus erythematosus, an allergic condition that produces joint pain, skin rash, and fever. The frequency of this severe adverse reaction isunknown.
• Pneumonia, an inflammation of the lungs that causes cough, feeling of lack of breathing, and elevated temperature. This is a severe andvery rareside effect (may affect up to 1 in 10,000 people).
• Difficulty breathing. You may feel short of breath if your lungs become inflamed or have fluid inside (pneumonitis, pulmonary edema). These are severe side effects withunknown frequency.

Lisinopril/hidroclorotiazidafrequently(may affect up to 1 in 10 people) causes a decrease in blood pressure that may be associated with a mild headache and weakness. In some patients, this may occur after the first dose or when the dose is increased. If you experience these symptoms, consult your doctor immediately.

Lisinopril/hidroclorotiazida may causevery rarely(may affect up to 1 in 10,000 people) a reduction in the number of white blood cells or red blood cells or platelets and may decrease your resistance to infections. If you suffer from an infection with symptoms such as fever and severe deterioration of your general condition, pale skin, fatigue, shortness of breath, or fever with local symptoms of infection such as throat pain/pharynx/ulcers in the mouth, dark urine, bleeding or spontaneous hematomas or urinary problems, consult your doctor immediately. A blood sample will be taken to check for possible reduction in white blood cells (agranulocytosis). It is essential to inform your doctor about your medication.

It has been detectedfrequently(may affect up to 1 in 10 people) dry cough, which may persist for a long period of time with the use of lisinopril/hidroclorotiazida and other ACE inhibitors, but it may also be a symptom of another respiratory tract disease. Consult your doctor if you suffer from this symptom.

The following side effects have also been detected:

Frequent(may affect up to 1 in 10 people)

• dizziness, headache, sudden loss of consciousness,
• decrease in blood pressure associated with changes in posture (such as feeling dizzy or weak when standing up after lying down),
• diarrhea, feeling of dizziness,
• kidney problems.

Infrequent(may affect up to 1 in 100 people)

• mood changes,
• tingling or numbness (paresthesia), feeling of spinning, alterations in taste, difficulty breathing,
• palpitations (feeling of rapid or very strong heart rhythm),
• rapid heart rate (tachycardia),
• Raynaud's syndrome, a disorder of blood vessels that may cause fingers of the hand and feet to become pale, blue, and then red,
• inflammation of the nasal mucosa that produces rhinitis,
• feeling of dizziness, abdominal pain, and indigestion,
• increase in liver enzymes and waste products,
• skin rash or itching,
• inability to achieve or maintain an erection (impotence)
• fatigue, general weakness,
• increase in urea levels in the blood,
• high levels of potassium in the blood, which may cause abnormal heart rhythm and increase in creatinine levels in the blood.

Rare(may affect 1 in 1,000 people)

• decrease in hemoglobin in the blood and number of red blood cells (hematocrit),
• confusion,
• changes in the smell of things
• dry mouth,
• itching, hair loss, red or silver skin patches (psoriasis),
• breast enlargement in men (gynecomastia),
• low sodium levels in the blood, which may cause fatigue and confusion, muscle spasms, convulsions, or coma, also leading to dehydration and low blood pressure that makes you feel dizzy when standing up,
• syndrome of inadequate secretion of antidiuretic hormone (SIADH). Symptoms include weight gain, nausea, vomiting, muscle cramps, confusion, and seizures (convulsions).

Very rare(may affect 1 in 10,000 people)

• lymph node disease, autoimmune disease, in which the body attacks itself,
• hypoglycemia (low blood sugar) (see "Warnings and precautions"),
• inflammation of the nasal sinuses,
• swelling of the intestinal lining (intestinal angioedema). This may cause sudden stomach pain, diarrhea, or feeling of dizziness (vomiting),
• excessive sweating (diaphoresis),
• aggregation of mature lymphocytes or abnormal-looking lymphocytes in the dermis (pseudolymphoma cutaneus). A complex side effect has been reported that may include any or all of the following: elevated temperature, inflammation of blood vessels, muscle and joint pain, blood abnormalities found by blood tests, rash, hypersensitivity to sunlight, and other skin effects**,
• inability to urinate or urinate less (decreased urine output).

Unknown frequency(cannot be estimated from available data)

• skin cancer and lip cancer (non-melanoma skin cancer),
• inflammation of salivary glands,
• loss of appetite, weight loss,
• increase in blood sugar (glucose) levels (hyperglycemia),
• sugar in the urine,
• increase in uric acid levels in the blood,
• elevated or high levels of fats in the blood (including cholesterol),
• low levels of potassium in the blood, which may cause muscle weakness, spasms, or abnormal heart rhythm,
• joint pain or swelling (gout),
• decrease in magnesium and chloride levels in the blood,
• stomach irritation,
• constipation,
• anxiety,
• seeing, feeling, or hearing things that are not real (hallucinations),
• vision disorders (yellow color in vision, blurred vision),
• damage to blood vessels that cause red or purple spots on the skin,
• inflammatory condition of blood vessels that produce red or purple spots on the skin,
• sensitivity of the skin to light, skin disorders with red patches on the nose and cheeks (lupus erythematosus), which may worsen in patients who already have it,
• muscle cramps, muscle weakness,
• fever,
• depression,
• seizures.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Like all medications, this medication may cause side effects, although not everyone will experience them.

.

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 blister after CAD/EXP. 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 the packaging and medications you no longer need at 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. By doing so, you will help protect the environment.

Composition of Lisinopril/Hidroclorotiazida Sandoz Pharmaceutical

• The active principles are lisinopril and hidroclorotiazida.Each tablet contains 20 mg of lisinopril (as dihydrate) and 12.5 mg of hidroclorotiazida.
• The other components are: calcium dihydrogen phosphate dihydrate, croscarmelosa sodium, manitol, cornstarch, magnesium stearate and red iron oxide (E172).

Appearance of the product and content of the container

Pink, round, biconvex and scored on one face.

The tablets are packaged in a PVC/Aluminum blister inside a cardboard box.

Lisinopril/Hidroclorotiazida Sandoz Pharmaceutical is available in containers of 14, 28, 30, 50, 56, 98, 100 and 400 tablets.

Only some sizes of containers may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Sandoz Pharmaceutical, S.A.

Business Park North Center

Roble Building

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible for manufacturing

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1

39179 Barleben

Germany

or

ROWA Pharmaceuticals Limited

Newtown, Bantry, Co.Cork

Ireland

This medicine is authorized in the member states of the European Economic Area with the following names:

Bélgica:Co-Lisinopril Sandoz 20 mg/12.5 mg tablets

Irlanda:Lispril-Hydrochlorothiazide 20 mg/12.5 mg tablets

Italia:LISINOPRIL IDROCLOROTIAZIDE SANDOZ

Portugal:Lisinopril + Hidroclorotiazida Sandoz 20 mg + 12,5 mg tablets

Date of the last review of this prospectus:February 2022

The detailed and updated information of this medicine is available on the website of the Spanish Agency of Medicaments and Health Products (AEMPS)

http://www.aemps.gob.es/