Leaflet:information for the user

Amlodipino/Valsartán/Hidroclorotiazida Combix 5 mg/160 mg/12,5 mg film-coated tablets

Amlodipino/Valsartán/Hidroclorotiazida Combix 10 mg/160 mg/12,5 mg film-coated tablets

Amlodipino/Valsartán/Hidroclorotiazida Combix 5 mg/160 mg/25 mg film-coated tablets

Amlodipino/Valsartán/Hidroclorotiazida Combix 10 mg/160 mg/25 mg film-coated tablets

Amlodipino/Valsartán/Hidroclorotiazida Combix 10 mg/320 mg/25 mg film-coated tablets

amlodipino/valsartán/hidroclorotiazida

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask yourdoctor or pharmacist.
• This medicine has been prescribedonlyfor you, and do not give it to other people althoughtheymay havethe same symptomsas you,as it may harm them.
• If you experience any side effects,consult your doctor or pharmacist,eveniftheyare not listed in this leaflet. See section 4.

1.What is Amlodipino/Valsartán/Hidroclorotiazida Combix and for what it is used

2.What you need to knowbeforestarting totake Amlodipino/Valsartán/Hidroclorotiazida Combix

3.How to take Amlodipino/Valsartán/Hidroclorotiazida Combix

4.Possible side effects

5Storage of Amlodipino/Valsartán/Hidroclorotiazida Combix

6.Contents of the pack and additional information

Amlodipino/Valsartán/Hidroclorotiazida Combixtablets contain three substances called amlodipino, valsartán and hidroclorotiazida. All these substances help to control high blood pressure.

• Amlodipino belongs to a group of substances called «calcium channel blockers». Amlodipino prevents calcium from entering the blood vessel wall, which prevents the narrowing of blood vessels.
• Valsartán belongs to a group of substances called «angiotensin II receptor antagonists». Angiotensin II is produced by the body and causes blood vessels to narrow, thereby increasing blood pressure. Valsartán acts by blocking the effect of angiotensin II.
• Hidroclorotiazida belongs to a group of substances known as «thiazide diuretics». Hidroclorotiazida increases urine production, which also decreases blood pressure.

As a result of the three mechanisms, blood vessels relax and blood pressure decreases.

Amlodipino/Valsartán/Hidroclorotiazida Combixis used to treat high blood pressure in adult patients whose blood pressure is already controlled while taking amlodipino, valsartán and hidroclorotiazida and who may benefit from taking a tablet that contains the three substances.

Do not take Amlodipino/Valsartán/Hidroclorotiazida Combix

• if you are more than 3 months pregnant. (In any case, it is recommended to avoid taking this medication also at the beginning of your pregnancy - see Pregnancy section).
• if you are allergic to amlodipino or to any other calcium channel blocker, valsartán, hidroclorotiazida, sulfonamide-derived medications (medications used to treat chest or urinary tract infections), or to any of the other components of this medication (included in section 6).

If you think you may be allergic, do not take this medication and inform your doctor.

• if you have liver disease, destruction of the small bile ducts inside the liver (biliary cirrhosis) that leads to the accumulation of bile in the liver (cholestasis).
• if you have severe kidney problems or if you are undergoing dialysis.
• if you are unable to urinate (anuria).
• if your blood potassium or sodium levels are too low despite treatment to increase potassium or sodium levels in the blood.
• if your blood calcium levels are too high despite treatment to reduce calcium levels in the blood.
• if you have gout (uric acid crystals in the joints).
• if you have severe low blood pressure (hypotension).
• if you have aortic stenosis (narrowing of the aortic valve) or cardiogenic shock (a situation in which your heart cannot supply enough blood to the body).
• if you have heart failure after a heart attack.
• if you have diabetes or kidney insufficiency and are being treated with a medication to reduce blood pressure that contains aliskireno.

Do not take Amlodipino/Valsartán/Hidroclorotiazida Combix and inform your doctor if you are affected by any of the above cases.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medication

• if you have low levels of potassium or magnesium in the blood (with or without symptoms such as muscle weakness, muscle spasms, abnormal heart rhythm).
• if you have low levels of sodium in the blood (with or without symptoms such as fatigue, confusion, muscle contractions, seizures).
• if you have high levels of calcium in the blood (with or without symptoms such as nausea, vomiting, constipation, stomach pain, frequent urination, thirst, muscle contractions, and muscle weakness).
• if you have kidney problems, have undergone a kidney transplant, or if you have been informed that you suffer from narrowing of the kidney arteries.
• if you have liver problems.
• if you have or have had heart failure or coronary artery disease, particularly if you have been prescribed the maximum dose of Amlodipino/Valsartán/Hidroclorotiazida Combix (10 mg/320 mg/25 mg).
• if you have had a heart attack. Follow your doctor's instructions to start treatment carefully. Your doctor may also check your renal function.
• if you have been informed that you suffer from narrowing of the heart valves (known as "aortic or mitral stenosis") or that your heart muscle has abnormally increased in thickness (known as "hypertrophic obstructive cardiomyopathy").
• if you suffer from aldosteronism. A disease in which the adrenal glands produce too much aldosterone hormone. In this case, the use of this medication is not recommended.
• if you suffer from systemic lupus erythematosus (also known as "lupus" or "LES").
• if you have diabetes (high blood sugar levels).
• if you have high levels of cholesterol or triglycerides in the blood.
• if you experience skin reactions such as sunburn after exposure to the sun.
• if you have had an allergic reaction to other medications for high blood pressure or diuretics, especially if you suffer from asthma and allergies.
• if you have been ill (with vomiting or diarrhea).
• if you have experienced swelling, particularly in the face and throat, while taking other medications (including ACE inhibitors). If you have these symptoms, stop taking this medication and contact your doctor immediately. You should never take this medication again.
• if you experience dizziness and/or fainting during treatment with this medication, inform your doctor as soon as possible.
• if you experience a decrease in vision or eye pain. These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal hemorrhage) or increased pressure in the eye and may occur between hours and weeks after taking this medication. If not treated, this can cause permanent vision loss. You may be at greater risk of developing this if you have previously had an allergy to penicillin or sulfonamides.
• if you are taking any of the following medications used to treat high blood pressure:

• an ACE inhibitor (such as enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
• aliskireno.

• 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 certain types of skin cancer and lip cancer (non-melanoma skin cancer). Protect your skin from exposure to the sun and UV rays while taking this medication.
• 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 Amlodipino/Valsartán/Hidroclorotiazida Combix, see your doctor immediately.

Your doctor may monitor your renal function, blood pressure, and electrolyte levels (such as potassium) in the blood at regular intervals.

See also the information under the heading "Do not take Amlodipino/Valsartán/Hidroclorotiazida Combix".

Inform your doctor if you are affected by any of the cases mentioned.

Children and adolescents

This medication is not recommended for use in children or adolescents under 18 years old.

Older adults (65 years and older)

This medication may be used in people 65 years and older at the same dose as used in other adults and in the same way as they have already taken the three substances called amlodipino, valsartán, and hidroclorotiazida. Renal pressure should be monitored regularly in elderly patients, particularly those taking the maximum dose of Amlodipino/Valsartán/Hidroclorotiazida Combix (10 mg/320 mg/25 mg).

Use of Amlodipino/Valsartán/Hidroclorotiazida Combix with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication. Your doctor may need to adjust your dose and/or take other precautions. In some cases, you may need to stop taking one of the medications. This is especially important if you are taking any of the medications listed below:

Do not take with:

• lithium (a medication used to treat certain types of depression);
• medications or substances that may increase the amount of potassium in the blood. These include potassium supplements or salt substitutes that contain potassium, potassium-sparing medications, and heparin;
• an ACE inhibitor or aliskireno (see also the information under the headings "Do not take Amlodipino/Valsartán/Hidroclorotiazida Combix" and "Warnings and precautions").

Use with caution with:

• alcohol, sleeping pills, and anesthetics (medications for patients undergoing surgery and other procedures);
• amantadine (treatment for Parkinson's disease, also used to treat or prevent certain diseases caused by viruses);
• anticholinergic medications (medications used to treat various disorders such as gastrointestinal upset, bladder spasms, asthma, motion sickness, muscle spasms, Parkinson's disease, and as an aid in anesthesia);
• anticonvulsants and mood stabilizers used to treat epilepsy and bipolar disorder (e.g. carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone);
• colestiramine, colestipol, or other resins (substances used mainly to treat high levels of lipids in the blood);
• simvastatin (a medication used to control high cholesterol levels);
• ciclosporina (a medication used in transplants to prevent organ rejection or for other conditions, e.g. rheumatoid arthritis or atopic dermatitis);
• cytotoxic medications (used to treat cancer), such as methotrexate or cyclophosphamide;
• digoxin or other digitalis glycosides (medications used to treat heart problems);
• verapamil, diltiazem (heart medications);
• contrast agents and iodinated substances (agents used in imaging tests);
• medications used to treat diabetes (oral medications such as metformin or insulin);
• medications used to treat gout, such as allopurinol;
• medications that may increase blood sugar levels (beta-blockers, diazoxide);

medications that may induce "torsades de pointes" (irregular heart rhythm), such as antiarrhythmics (medications used to treat heart problems) and some antipsychotics;

• medications that may reduce the amount of sodium in the blood, such as antidepressants, antipsychotics, antiepileptics;

medications that may reduce the amount of potassium in the blood, such as diuretics, corticosteroids, laxatives, amphotericin, or penicillin G;

• medications used to increase blood pressure, such as adrenaline or noradrenaline;
• medications used to treat HIV/AIDS (e.g. ritonavir, indinavir, nelfinavir);
• medications used to treat fungal infections (e.g. ketoconazole, itraconazole);
• medications used to treat esophageal inflammation and ulceration (carbenoxolone);
• medications used to relieve pain or inflammation, especially nonsteroidal anti-inflammatory drugs (NSAIDs), including selective COX-2 inhibitors;
• muscle relaxants (medications used to relax muscles during surgery);
• nitroglycerin and other nitrates, or other substances called "vasodilators";
• other medications used to treat high blood pressure, including methyldopa;
• rifampicin (used, for example, to treat tuberculosis), erythromycin, clarithromycin (antibiotics);

St. John's Wort;

• dantrolene (in perfusion for severe temperature abnormalities);
• vitamin D and calcium salts.

Take Amlodipino/Valsartán/Hidroclorotiazida Combix with food, drinks, and alcohol

People who have been prescribed this medication should not consume grapefruit or grapefruit juice.

This is because grapefruit and grapefruit juice may cause an increase in the blood levels of the active ingredient amlodipino, which may cause unpredictable reductions in blood pressure. Consult your doctor before drinking alcohol. Alcohol may significantly lower your blood pressure and/or increase the risk of dizziness or fainting.

Pregnancy and breastfeeding

Pregnancy

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medication.. Your doctor will usually advise you to stop taking this medication before becoming pregnant or as soon as you become pregnant, and recommend taking another antihypertensive medication instead. This medication is not recommended for use at the beginning of pregnancy and should not be administered after the third month of pregnancy as it may cause serious harm to your baby when administered from that point onwards.

Breastfeeding

Inform your doctorif you plan to start or are breastfeeding. It has been shown that amlodipino passes into breast milk in small amounts. This medication is not recommended for use during this period. Your doctor may decide to administer a treatment that is more suitable if you want to breastfeed, especially in newborns or premature babies.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

As with other medications used to treat high blood pressure, this medication may cause you to feel dizzy, drowsy, nauseous, or experience headaches. If you experience these symptoms, do not drive or operate tools or machinery.

Use in athletes

This medication containshidroclorotiazidawhich may produce a positive result in doping control tests

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor again. This will help you obtain the best results and reduce the risk of adverse effects.

The usual dose ofAmlodipino/Valsartán/Hidroclorotiazida Combixisone tablet per day.

• It is best to take the tablet at the same time every day. The best time is in the morning.
• Swallow the tablet whole with a glass of water.
• You can takethis medicationwith or without food. Do not takethis medicationwith grapefruit or grapefruit juice.

Depending on your response to treatment, your doctor may suggest a higher or lower dose.

Do not exceed the prescribed dose.

If you take moreAmlodipino/Valsartán/Hidroclorotiazida Combixthan you should

If you have accidentally taken too many tablets ofthis medication, consult your doctor immediately. You may need medical attention.

Excess fluid may accumulate in the lungs (pulmonary edema) causing difficulty breathing that may develop within 24-48 hours after ingestion.

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 takeAmlodipino/Valsartán/Hidroclorotiazida Combix

If you forget to take a dose of this medication, take it as soon as you remember and then take the next dose at the usual time. If it is almost time for the next dose, you should only take the next tablet at the usual time.Do nottake a double dose (two tablets at once) to make up for the missed doses.

If you interrupt treatment withAmlodipino/Valsartán/Hidroclorotiazida Combix

Stopping your treatment withthis medicationmay cause your condition to worsen. Do not stop taking the medication unless your doctor tells you to.

Always take this medication, even if you feel well

People with hypertension often do not notice any symptoms of their problem. Many feel well. It is very important that you take this medication exactly as your doctor has instructed to obtain the best results and reduce the risk of adverse effects. Keep your appointments with your doctor even if you feel well.

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

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

As with any combination that contains three active principles, it cannot be ruled out that side effects associated with each individual component may occur. The side effects observed with this medicine or one of its three active principles (amlodipine, valsartan, and hydrochlorothiazide) are listed below and may occur with the use of this medicine.

Some side effects can be severe and require immediate medical attention.

Consult your doctor immediately if, after taking this medicine, you experience any of the following severe side effects:

Frequent (may affect up to 1 in 10 patients):

• dizziness
• low blood pressure (sensation of fainting, dizziness, sudden loss of consciousness)

Infrequent (may affect up to 1 in 100 patients):

• reduced urine production (reduced kidney function)

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

• spontaneous bleeding
• irregular heartbeat
• liver disorder

Very rare (may affect up to 1 in 10,000 patients):

• sudden wheezing while breathing (sudden wheezing), chest pain, shortness of breath, or difficulty breathing
• swelling of the eyelids, face, or lips
• swelling of the tongue and throat that causes severe difficulty breathing
• severe skin reactions that include intense skin rash, blisters, skin redness all over the body, severe itching, blistering, peeling, skin inflammation, mucous membrane inflammation (Stevens-Johnson syndrome, toxic epidermal necrolysis), or other allergic reactions
• heart attack
• pancreatitis that can cause severe abdominal pain and back pain accompanied by severe discomfort
• weakness, bruises, fever, and frequent infections
• stiffness
• acute respiratory difficulty (signs include severe breathing difficulty, fever, weakness, and confusion)

Other side effects may include:

Very frequent (may affect more than 1 in 10 patients)

• low potassium levels in the blood
• increased levels of lipids in the blood

Frequent (may affect up to 1 in 10 patients)

• drowsiness
• palpitations (feeling the heartbeat)
• angina
• swelling of the ankles (edema)
• abdominal pain
• stomach discomfort after eating
• fatigue
• headache
• frequency of urination
• high uric acid levels in the blood
• low magnesium levels in the blood
• low sodium levels in the blood
• dizziness, dizziness when standing up
• decreased appetite
• nausea and vomiting
• skin rash with itching and other types of rash
• inability to achieve or maintain an erection

Infrequent (may affect up to 1 in 100 patients)

• rapid heartbeat
• sensation that everything is spinning
• vision disorder
• stomach discomfort
• chest pain
• increased levels of urea, creatinine, and uric acid in the blood
• high levels of calcium, lipids, or sodium in the blood
• low potassium levels in the blood
• bad breath
• diarrhea
• dry mouth
• weight gain
• loss of appetite
• altered sense of taste
• back pain
• swelling of the joints
• muscle cramps/weakness/pain
• pain in the extremities
• inability to stand or walk normally
• weakness
• abnormal coordination
• dizziness when standing up or after exercise
• lack of energy
• sleep disturbances
• tingling or numbness
• neuropathy
• sudden and transient loss of consciousness
• low blood pressure when standing up
• cough
• shortness of breath
• throat irritation
• excessive sweating
• itching
• swelling, redness, and pain along a vein
• skin redness
• shaking
• mood changes
• anxiety
• depression
• drowsiness
• altered sense of taste
• syncope
• loss of pain sensation
• visual disturbances
• visual deterioration
• tinnitus in the ears
• runny nose/secretion caused by inflammation of the nasal mucosa (rhinitis)
• alteration of bowel habits
• indigestion
• hair loss
• itching of the skin
• skin discoloration
• urination disorder
• increased need to urinate at night
• increased frequency of urination
• breast discomfort in men
• pain
• discomfort
• weight loss

Rare (may affect up to 1 in 1,000 patients)

• low platelet count in the blood (sometimes with bleeding or hematoma under the skin)
• glucose in the urine
• high blood sugar levels
• worsening of diabetic metabolic state
• abdominal discomfort
• constipation
• liver disorders that may be accompanied by yellow skin and eyes, or dark-colored urine (hemolytic anemia)
• increased skin sensitivity to the sun
• purplish patches on the skin
• kidney disorders
• confusion

Very rare (may affect up to 1 in 10,000 patients)

• decrease in white blood cell count
• decrease in platelet count in the blood that may cause unusual bruises or easy bleeding (damage to red blood cells)
• gingivitis
• abdominal swelling (gastritis)
• hepatitis
• yellow discoloration of the skin (jaundice)
• increase in liver enzymes that may affect some medical tests
• muscle tension
• inflammation of blood vessels often with skin eruptions
• light sensitivity
• disorders combining stiffness, shaking, and/or movement disorders
• fever, sore throat, or ulcers in the mouth, increased frequency of infections (low or very low white blood cell count)
• pale skin, fatigue, shortness of breath, dark-colored urine (hemolytic anemia, abnormal decrease in red blood cells due to rupture in blood vessels and other parts of the body)
• confusion, fatigue, muscle contractions and spasms, rapid breathing (hypochloremic alkalosis)
• severe abdominal pain (inflammation of the pancreas)
• difficulty breathing with fever, cough, wheezing, shortness of breath (respiratory distress, pulmonary edema, pneumonitis)
• facial rash, joint pain, muscle alteration, fever (lupus erythematosus)
• inflammation of blood vessels with symptoms such as rash, purplish patches, fever (vasculitis)
• severe skin disease that causes skin rash, skin redness, blisters on the lips, eyes, or mouth, skin peeling, fever (toxic epidermal necrolysis)

Frequency unknown (the frequency cannot be estimated from available data)

• alteration of kidney function test results in blood, increase in potassium levels in the blood, low red blood cell count in the blood
• abnormal red blood cell count
• low count of a certain type of white blood cell and platelets in the blood
• increase in creatinine levels in the blood
• abnormal liver function test
• important decrease in urine production
• inflammation of blood vessels
• weakness, bruises, and frequent infections (aplastic anemia)
• decrease in vision or eye pain due to high intraocular pressure (possible signs of accumulation of fluid in the vascular layer of the eye (choroidal hemorrhage) or acute angle-closure glaucoma)
• shortness of breath
• severe decrease in urine production (possible signs of renal impairment or renal insufficiency)
• severe skin disease that causes rash, red skin, blisters on the lips, eyes, or mouth, skin peeling, fever (erythema multiforme)
• muscle spasm
• fever (pyrexia)
• bullous skin disease (sign of a disease called bullous dermatitis)
• skin cancer and lip cancer (non-melanoma skin cancer)

Reporting of side effects

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

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. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C

Do not use any packaging that is damaged or shows signs of manipulation.

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

The active ingredients of Amlodipino/Valsartán/Hidroclorotiazidaare amlodipino (as amlodipino besilato), Valsartán and Hidroclorotiazida.

5 mg/160 mg/12,5 mgfilm-coated tablets

Each film-coated tablet contains 5 mg of amlodipino (as amlodipino besilato), 160 mg of valsartán and 12,5 mg of hidroclorotiazida

10 mg/160 mg/12,5 mgfilm-coated tablets

Each film-coated tablet contains 10 mg of amlodipino (as amlodipino besilato), 160 mg of valsartán and 12,5 mg of hidroclorotiazida

5 mg/160 mg/25 mgfilm-coated tablets

Each film-coated tablet contains 5 mg of amlodipino (as amlodipino besilato), 160 mg of valsartán and 25 mg of hidroclorotiazida

10 mg/160 mg/25 mgfilm-coated tablets

Each film-coated tablet contains 10 mg of amlodipino (as amlodipino besilato), 160 mg of valsartán and 25 mg of hidroclorotiazida

10 mg/320 mg/25 mgfilm-coated tablets

Each film-coated tablet contains 10 mg of amlodipino (as amlodipino besilato), 320 mg of valsartán and 25 mg of hidroclorotiazida

The other components are:

Microcrystalline cellulose

Crospovidona

Colloidal silicon dioxide

Estearato de magnesio

Hipromelosa 6 cPs

Macrogol 4000

Talco

Dióxido de titanio (E171)(only in 5 mg/160 mg/12,5 mg film-coated tablets, 10 mg/160 mg/12,5 mg film-coated tablets, 5 mg/160 mg/25 mg tablets)

Óxido de hierro rojo (E172) (only in 10 mg/160 mg/12,5 mg film-coated tablets)

Óxido de hierro amarillo (E172)(only in 10 mg/160 mg/12,5 mg film-coated tablets, 5 mg/160 mg/25 mg film-coated tablets, 10 mg/160 mg/25 mg film-coated tablets, 10 mg/320 mg/25 mg film-coated tablets)

Appearance of the product and contents of the package

The Amlodipino/Valsartán/Hidroclorotiazida Combix 5 mg/160 mg/12,5 mg film-coated tabletsare biconvex, oval, white, marked with “T23” on one side and smooth on the other.

The Amlodipino/Valsartán/Hidroclorotiazida Combix 5 mg/160 mg/25 mg film-coated tabletsare biconvex, oval, yellow, marked with “T25” on one side and smooth on the other.

The Amlodipino/Valsartán/Hidroclorotiazida Combix 10 mg/160 mg/12,5 mg film-coated tabletsare biconvex, oval, pale yellow, marked with “C96” on one side and smooth on the other.

The Amlodipino/Valsartán/Hidroclorotiazida Combix 10 mg/160 mg/25 mg film-coated tabletsare biconvex, oval, yellow-brown, marked with “C97” on one side and smooth on the other.

The Amlodipino/Valsartán/Hidroclorotiazida Combix 10 mg/320 mg/25 mg film-coated tabletsare biconvex, oval, yellow-brown, marked with “T98” on one side and smooth on the other.

The following pack sizes are available: boxes with blisters of 14, 28, 56 and 98 film-coated tablets.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder

Laboratorios Combix, S.L.U.

C/ Badajoz 2, Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Manufacturer responsible

Synoptis Industrial Sp. z o.o

ul. Rabowicka 15, Swarzedz,

62-020, Poland

or

Focus Care Pharmaceuticals B.V.

Westzijde 416, 1506 GM Zaandam

Netherlands

or

Heumann Pharma GmbH & Co. Generica KG

Südwestpark 50

90449 Nürnberg

Germany

or

Laboratori FUNDACIO DAU,

C/ De la letra C, 12-14,

Poligono Industrialde la Zona Franca,

08040 Barcelona,

Spain

Last revision date of thisleaflet:January 2022

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