OLMESARTAN/AMLODIPINE/HYDROCHLOROTHIAZIDE VISO FARMACEUTICA 20 mg/5 mg/12.5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Olmesartan/Amlodipine/Hydrochlorothiazide Viso Pharmaceutical 20 mg/5 mg/12.5 mg Film-Coated Tablets EFG

olmesartan medoxomil/amlodipine/hydrochlorothiazide

Read the entire 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. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Olmesartan/Amlodipine/Hydrochlorothiazide Viso Pharmaceutical and what is it used for
2. What you need to know before you start taking Olmesartan/Amlodipine/Hydrochlorothiazide Viso Pharmaceutical
3. How to take Olmesartan/Amlodipine/Hydrochlorothiazide Viso Pharmaceutical
4. Possible side effects
5. Storage of Olmesartan/Amlodipine/Hydrochlorothiazide Viso Pharmaceutical
6. Package Contents and Additional Information

1. What is Olmesartan / Amlodipine / Hydrochlorothiazide Viso Pharmaceutical and what is it used for

This medicinal product contains three active substances called olmesartan medoxomil, amlodipine (as amlodipine besylate), and hydrochlorothiazide. The three substances help control high blood pressure.

• Olmesartan medoxomil belongs to a group of medicines called “angiotensin II receptor antagonists”, which lower blood pressure by relaxing blood vessels.
• Amlodipine belongs to a group of medicines called “calcium channel blockers”. Amlodipine also lowers blood pressure by relaxing blood vessels.
• Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics. It lowers blood pressure by helping to remove excess fluids, increasing urine production by the kidneys.

The action of these substances contributes to lowering your blood pressure.

Olmesartan/amlodipine/hydrochlorothiazide is used to treat high blood pressure:

• in adult patients whose blood pressure is not adequately controlled with the combination of olmesartan medoxomil and amlodipine, taken as a fixed-dose combination, or
• in patients who are already taking a fixed-dose combination of olmesartan medoxomil and hydrochlorothiazide, along with tablets containing only amlodipine, or a fixed-dose combination of olmesartan medoxomil and amlodipine, along with tablets containing only hydrochlorothiazide.

2. What you need to know before taking Olmesartan / Amlodipine / Hydrochlorothiazide Viso Farmacéutica

Do not take Olmesartan/Amlodipine/Hydrochlorothiazide Viso Farmacéutica

• If you are allergic to olmesartan medoxomil, amlodipine besylate, or a special group of calcium channel blockers (dihydropyridines), hydrochlorothiazide, or substances similar to hydrochlorothiazide (sulfonamides), or to any of the other components of this medication (included in section 6). If you think you may be allergic, inform your doctor before taking olmesartan/amlodipine/hydrochlorothiazide.
• If you have severe kidney problems.
• If you have diabetes or kidney failure and are being treated with a blood pressure medication that contains aliskiren.
• If you have low levels of potassium or sodium in your blood, high levels of calcium or uric acid (with symptoms of gout or kidney stones) in your blood, which do not improve with treatment.
• If you are pregnant for more than 3 months. (It is also best to avoid olmesartan/amlodipine/hydrochlorothiazide at the start of pregnancy - see section "Pregnancy and breastfeeding").
• If you have severe liver problems, bile secretion problems, or obstruction of bile drainage from the gallbladder (e.g., due to gallstones), or if you have jaundice (yellowing of the skin and eyes).
• If you have insufficient blood supply to your tissues, with symptoms such as low blood pressure, weak pulse, rapid heart rate, or shock (including cardiogenic shock, which means shock due to severe heart problems).
• If you have very low blood pressure.
• If the blood flow to your heart is slow or blocked. This can happen if the blood vessels or valves that carry blood out of the heart become narrowed (aortic stenosis).
• If you have poor heart function after suffering a heart attack (acute myocardial infarction). Poor heart function can make you feel short of breath or have swelling in your feet and ankles.

Do not take olmesartan/amlodipine/hydrochlorothiazide if any of these cases apply to you.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Olmesartan/Amlodipine/Hydrochlorothiazide Viso Farmacéutica:

Contact your doctorif you are taking any of the following medications used to treat high blood pressure:

• An angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g., enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
• Aliskiren.

Your doctor may monitor your kidney function, blood pressure, and blood electrolyte levels (e.g., potassium) at regular intervals.

See also the information under the heading "Do not take Olmesartan/Amlodipine/Hydrochlorothiazide Viso Farmacéutica".

Contact your doctorif you have any of the following health problems:

• Kidney problems or a kidney transplant.
• Liver disease.
• Heart failure or problems with the heart valves or heart muscle.
• Severe vomiting, diarrhea, treatment with high doses of medications that increase urine production (diuretics), or if you are on a low-salt diet.
• High levels of potassium in the blood.
• Problems with the adrenal glands (hormone-producing glands located above the kidneys).
• Diabetes.
• Lupus erythematosus (an autoimmune disease).
• Allergy or asthma.
• Skin reactions such as sunburn or rash after being in the sun or in a solarium.
• If you have had skin cancer or if you develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, particularly 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 sun exposure and UV rays while taking this medication.
• If you have had respiratory or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you experience shortness of breath or severe difficulty breathing after taking Olmesartan/Amlodipine/Hydrochlorothiazide Viso Farmacéutica, seek medical attention immediately.

Contact your doctorif you experience any of the following symptoms:

• Severe, persistent diarrhea that causes significant weight loss. Your doctor will assess your symptoms and decide how to proceed with your treatment for high blood pressure.
• Decreased vision or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in the eye, and may occur from a few hours to a few weeks after taking olmesartan/amlodipine/hydrochlorothiazide. This can lead to permanent vision impairment if left untreated.

As with any other medication that lowers blood pressure, an excessive decrease in blood pressure in patients with altered blood flow to the heart or brain may cause a heart attack or stroke. Therefore, your doctor will carefully monitor your blood pressure.

Olmesartan/amlodipine/hydrochlorothiazide may cause an increase in lipid and uric acid levels in the blood. Your doctor will likely want to perform a blood test from time to time to monitor these potential changes.

A change in blood levels of certain chemicals called electrolytes may occur. Your doctor will likely want to perform a blood test from time to time to monitor this potential change. Some signs of electrolyte changes are: thirst, dry mouth, muscle pain or cramps, tired muscles, low blood pressure (hypotension), feeling of weakness, slowness, fatigue, drowsiness or restlessness, nausea, vomiting, decreased need to urinate, rapid heart rate. Tell your doctor if you notice any of these symptoms.

If you are going to have parathyroid function tests, you should stop taking olmesartan/amlodipine/hydrochlorothiazide before these tests are performed.

You should inform your doctor if you are pregnant (or think you may be pregnant). It is not recommended to use olmesartan/amlodipine/hydrochlorothiazide at the start of pregnancy, and it should not be taken if you are pregnant for more than 3 months, as it may cause serious harm to your baby if taken at this stage (see section "Pregnancy and breastfeeding").

If you become pregnant while taking olmesartan/amlodipine/hydrochlorothiazide, inform and consult your doctor immediately.

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking olmesartan/amlodipine/hydrochlorothiazide. Your doctor will decide whether to continue treatment. Do not stop taking olmesartan/amlodipine/hydrochlorothiazide on your own.

Children and adolescents (under 18 years)

The use of olmesartan/amlodipine/hydrochlorothiazide is not recommended in children and adolescents under 18 years of age.

Other medications and Olmesartan/Amlodipine/Hydrochlorothiazide Viso Farmacéutica

Tell your doctor or pharmacist if you are taking, have recently taken, or may need to take any of the following medications:

• Other blood pressure-lowering medications, as they may increase the effect of olmesartan/amlodipine/hydrochlorothiazide. Your doctor may need to adjust your dose and/or take other precautions:

If you are taking an angiotensin-converting enzyme inhibitor (ACE inhibitor) or aliskiren (see also the information under the headings "Do not take Olmesartan/Amlodipine/Hydrochlorothiazide Viso Farmacéutica" and "Warnings and precautions").

• Lithium(a medication used to treat mood changes and some types of depression) may have its toxicity increased if taken with olmesartan/amlodipine/hydrochlorothiazide. If you need to take lithium, your doctor will monitor your lithium levels in the blood.
• Diltiazem, verapamil, used for heart rhythm problems and high blood pressure.
• Rifampicin, erythromycin, clarithromycin, tetracyclines, or sparfloxacin, antibiotics used for tuberculosis and other infections.
• St. John's Wort(Hypericum perforatum), a herbal medicine for the treatment of depression.
• Cisapride, used to increase food movement in the stomach and intestines.
• Difemanil, used to treat slow heart rate or to decrease sweating.
• Halofantrine, used for malaria.
• Vincamine IV, used to improve blood circulation in the nervous system.
• Amantadine, used for Parkinson's disease.
• Potassium supplements, salt substitutes that contain potassium, medications that increase urine production(diuretics), heparin(to thin the blood and prevent blood clots), angiotensin-converting enzyme inhibitors (ACE inhibitors) (to lower blood pressure), laxatives, steroids, adrenocorticotropic hormone (ACTH), carbenoxolone (a medication for the treatment of mouth and stomach ulcers), sodium penicillin G (an antibiotic also known as sodium benzylpenicillin), and some pain relievers such as acetylsalicylic acid ("aspirin") or salicylates. The use of these medications at the same time as olmesartan/amlodipine/hydrochlorothiazide may alter potassium levels in the blood.
• Non-steroidal anti-inflammatory medications(NSAIDs) (medications used to relieve pain, swelling, and other symptoms of inflammation, including arthritis), used at the same time as olmesartan/amlodipine/hydrochlorothiazide, may increase the risk of kidney failure. The effect of olmesartan/amlodipine/hydrochlorothiazide may be decreased by NSAIDs. If high doses of salicylates are used, the toxic effect on the central nervous system may increase.
• Sedatives, sleep-inducing medications, and antidepressants, used with olmesartan/amlodipine/hydrochlorothiazide, may cause a sudden drop in blood pressure when standing.
• Colesevelam hydrochloride, a medication that lowers cholesterol levels in the blood, as it may decrease the effect of olmesartan/amlodipine/hydrochlorothiazide. Your doctor may advise you to take olmesartan/amlodipine/hydrochlorothiazide at least 4 hours before colesevelam hydrochloride.
• Certain antacids(remedies for indigestion and acidity), as they may slightly decrease the effect of olmesartan/amlodipine/hydrochlorothiazide.
• Certain muscle relaxants, such as baclofen and tubocurarine.
• Anticholinergic medications, such as atropine and biperiden.
• Calcium supplements.
• Dantrolene(in infusion for severe body temperature abnormalities).
• Simvastatin, used to lower cholesterol and fat (triglyceride) levels in the blood.
• Medications used to control the body's immune response(e.g., tacrolimus, sirolimus, temsirolimus, everolimus, and cyclosporine), which make it possible for your body to accept a transplanted organ.

Tell your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.

Tell your doctor or pharmacist if you are taking, have recently taken, or may need to take any of the following medications for:

• Treating certain mental disorders, such as thioridazine, chlorpromazine, levomepromazine, trifluoperazine, ciamemazine, sulpiride, amisulpride, pimozide, sultoprida, tiaprida, droperidol, or haloperidol.
• Treating low blood sugar(e.g., diazoxide) or high blood pressure(e.g., beta-blockers, methyldopa), as olmesartan/amlodipine/hydrochlorothiazide may affect the mechanism of action of these medications.
• Treating heart rhythm problems, such as mizolastine, pentamidine, terfenadine, dofetilide, ibutilide, or erythromycin injections.
• Treating HIV/AIDS(e.g., ritonavir, indinavir, nelfinavir).
• Treating fungal infections(e.g., ketoconazole, itraconazole, amphotericin).
• Treating heart problems, such as quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, bepridil, or digitalis.
• Treating cancer, such as amifostine, cyclophosphamide, or methotrexate.
• Increasing blood pressureand decreasing heart rate, such as noradrenaline.
• Treating gout, such as probenecid, sulfinpyrazone, and allopurinol.
• Lowering blood fat levels, such as colestyramine and colestipol.
• Lowering blood sugar levels, such as metformin or insulin.

Tell your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.

Taking Olmesartan/Amlodipine/Hydrochlorothiazide Viso Farmacéutica with food, drinks, and alcohol

Olmesartan/amlodipine/hydrochlorothiazide can be taken with or without food.

People taking olmesartan/amlodipine/hydrochlorothiazide should not consume grapefruit or grapefruit juice. This is because grapefruit and grapefruit juice can lead to an increase in the levels of the active ingredient amlodipine in the blood, which can cause an unpredictable increase in the blood pressure-lowering effect of olmesartan/amlodipine/hydrochlorothiazide.

Be careful when drinking alcohol while taking olmesartan/amlodipine/hydrochlorothiazide, as some people may feel dizzy or lightheaded. If this happens, do not drink any alcohol.

Elderly patients

If you are over 65 years old, your doctor will regularly monitor your blood pressure whenever your dose is increased, to ensure that your blood pressure does not drop too much.

Pregnancy and breastfeeding

Pregnancy

If you are pregnant, breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication. Your doctor will advise you to stop taking olmesartan/amlodipine/hydrochlorothiazide before becoming pregnant or as soon as you know you are pregnant, and will advise you to take another medication instead of olmesartan/amlodipine/hydrochlorothiazide. The use of olmesartan/amlodipine/hydrochlorothiazide is not recommended during pregnancy, and it should not be taken when pregnant for more than 3 months, as it may cause serious harm to your baby if taken at this stage.

If you become pregnant while taking olmesartan/amlodipine/hydrochlorothiazide, inform and consult your doctor immediately.

Breastfeeding

Tell your doctor if you are breastfeeding or about to start breastfeeding. It has been shown that amlodipine and hydrochlorothiazide pass into breast milk in small amounts. Olmesartan/amlodipine/hydrochlorothiazide is not recommended in breastfeeding mothers, and your doctor may choose another treatment if you wish to breastfeed your baby.

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

Driving and using machines

You may feel drowsy, sick, or dizzy, or have a headache while taking this medication for high blood pressure. If this happens, do not drive or use machines until the symptoms have disappeared. Consult your doctor.

This medication contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per film-coated tablet; i.e., it is essentially "sodium-free".

3. How to take Olmesartan / Amlodipine / Hydrochlorothiazide Viso Farmacéutica

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

• The recommended dose is one tablet per day.
• The tablet can be taken with or without food. Take the tablet with a little liquid (such as a glass of water). Do not chew the tablet. Do not take the tablets with grapefruit juice.
• If possible, take your daily dose at the same time every day, for example, at breakfast time.

If you take more Olmesartan/Amlodipine/Hydrochlorothiazide Viso Farmacéutica than you should

If you take more tablets than you should, you will likely experience a drop in blood pressure, accompanied by symptoms such as dizziness, and rapid or slow heart rate.

If you take more tablets than you should or if a child accidentally ingests some tablets, contact your doctor or go to the nearest emergency center immediately and bring the medication package or this leaflet with you.

Excess fluid may accumulate in the lungs (pulmonary edema) causing difficulty breathing, which can develop up to 24-48 hours after ingestion.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20.

If you forget to take Olmesartan/Amlodipine/Hydrochlorothiazide Viso Farmacéutica

If you forget to take a dose, take the usual dose the next day. Do not take a double dose to make up for forgotten doses.

If you interrupt treatment with Olmesartan/Amlodipine/Hydrochlorothiazide Viso Farmacéutica

It is important to continue taking this medication, unless your doctor tells you to stop treatment.

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

4. Possible Adverse Effects

Like all medications, this medication may produce adverse effects, although not all people suffer from them. If they occur, they are often mild and do not require interrupting treatment.

The following two adverse effects may be serious, although they affect only a small group of people:

During treatment with olmesartan/amlodipine/hydrochlorothiazide, allergic reactions with inflammation of the face, mouth, and/or larynx (vocal cords), along with itching and skin rash, may occur. If this happens to you, stop taking this medication and consult your doctor immediately.

Olmesartan/amlodipine/hydrochlorothiazide may cause a pronounced decrease in blood pressure, in susceptible patients. This can cause fainting or severe dizziness. If this happens to you, stop taking this medication, consult your doctor immediately, and remain lying down in a horizontal position.

Olmesartan/amlodipine/hydrochlorothiazide is a combination of three active substances. The following information first describes the adverse effects reported so far with the olmesartan/amlodipine/hydrochlorothiazide combination (in addition to those already mentioned) and, secondly, the known adverse effects of each of the active substances separately, or when two of the substances are taken together.

To give you an idea of the number of patients who may have adverse effects, they have been classified as frequent, infrequent, rare, and very rare.

These are other known adverse effects of olmesartan/amlodipine/hydrochlorothiazide so far:

If these effects occur, they are often mild and do not require interrupting treatment.

Frequent(may affect up to 1 in 10 people)

Upper respiratory tract infection, sore throat and nose, urinary tract infection, dizziness, headache, perception of heartbeats, low blood pressure, nausea, diarrhea, constipation, cramps, joint swelling, urge to urinate, weakness, ankle swelling, fatigue, abnormal laboratory test values.

Infrequent(may affect up to 1 in 100 people)

Dizziness when standing up, vertigo, rapid heartbeat, feeling of fainting, flushing and feeling of heat in the face, cough, dry mouth, muscle weakness, inability to have or maintain an erection.

These are the known adverse effects for each of the active substances separately or when two of the substances are taken together:

They may be adverse effects due to olmesartan/amlodipine/hydrochlorothiazide, even if they have not been observed so far with olmesartan/amlodipine/hydrochlorothiazide.

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

Edema (fluid retention).

Frequent(may affect up to 1 in 10 people)

Bronchitis, stomach and intestine infection, vomiting, increased blood sugar, sugar in urine, confusion, drowsiness, visual disturbances (including double vision and blurred vision), nasal secretion or congestion, sore throat, difficulty breathing, cough, abdominal pain, heartburn, stomach discomfort, flatulence, joint or bone pain, back pain, bone pain, blood in urine, flu-like symptoms, chest pain, pain.

Infrequent(may affect up to 1 in 100 people)

Reduction in the number of a type of blood cells called platelets, which can easily cause bruising or prolong bleeding time, anaphylactic reactions, abnormally decreased appetite (anorexia), sleep problems, irritability, mood changes including anxiety, feeling of depression, chills, sleep disorders, alteration of taste, loss of consciousness, decreased sense of touch, tingling sensation, worsening of myopia, ringing in the ears (tinnitus), angina (chest pain or discomfort, known as angina pectoris), irregular heartbeats, rash, hair loss, allergic skin inflammation, skin redness, purple-colored patches on the skin due to small hemorrhages (purpura), skin discoloration, red itchy hives (urticaria), increased sweating, itching, skin rash, skin reactions to light, such as sunburn or skin rash, muscle pain, urination problems, feeling of needing to urinate at night, increased breast size in men, decreased sexual desire, facial swelling, feeling of discomfort, weight gain or loss, exhaustion.

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

Inflammation and pain of the salivary glands, decrease in the number of white blood cells in the blood, which could increase the risk of infections, decrease in the number of red blood cells (anemia), bone marrow damage, restlessness, feeling of loss of interest (apathy), seizures (convulsions), yellowish perception of objects when looking at them, dry eyes, blood clots (thrombosis, embolism), fluid accumulation in the lungs, pneumonia, inflammation of blood vessels and small blood vessels in the skin, pancreatitis, yellowish discoloration of the skin and eyes, acute inflammation of the gallbladder, lupus-like symptoms such as skin rash, joint pain, and cold hands and fingers, severe skin reactions including intense skin rash, urticaria, skin redness, severe itching, blisters, peeling, and skin inflammation, inflammation of the mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis), sometimes very severe, movement impairment, acute kidney failure, non-infectious kidney inflammation, decreased kidney function, fever, intestinal angioedema: swelling in the intestine that occurs with symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

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

High muscle tension, numbness of hands or feet, heart attack, stomach inflammation, gum thickening, intestinal obstruction, liver inflammation, acute breathing difficulty (signs include severe breathing difficulty, fever, weakness, and confusion).

Adverse effects of unknown frequency(cannot be estimated from available data)

Decreased vision or eye pain (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma). Tremors, rigid posture, mask-like face, slow movements, and unsteady gait. Skin and lip cancer (non-melanoma skin cancer).

Reporting 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 Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Olmesartan/Amlodipine/Hydrochlorothiazide Viso Farmacéutica

Keep this medication out of 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.

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Olmesartan/Amlodipine/Hydrochlorothiazide Viso Farmacéutica

• The active ingredients are olmesartan medoxomil, amlodipine (as amlodipine besylate), and hydrochlorothiazide.

• Each film-coated tablet contains 20 mg of olmesartan medoxomil, 5 mg of amlodipine (as amlodipine besylate), and 12.5 mg of hydrochlorothiazide.

• The other components are:

• Core of the tablet: Pregelatinized cornstarch, sodium croscarmellose, anhydrous colloidal silica, magnesium stearate, and microcrystalline cellulose.

• Tablet coating: Polyvinyl alcohol, macrogol 4000, talc, titanium dioxide (E-171), yellow iron oxide (E-172), red iron oxide (E-172), and black iron oxide (E-172).

Appearance and package contents

White-orange film-coated tablets, round, biconvex, marked with "T21" on one side and smooth on the other (approx. diameter 8.1 mm)

The available package sizes are: 28, 56, and 98 film-coated tablets.

Marketing authorization holder and manufacturer

Marketing Authorization Holder:

Glenmark Arzneimittel GmbH

Industriestr. 31

D-82194 Gröbenzell

Germany

Manufacturer:

Glenmark Pharmaceuticals s.r.o.

Fibichova 143

56617 Vysoké Mýto

Czech Republic

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Glenmark Farmacéutica, S.L.U.

C/ Retama 7, 7th floor

28045 Madrid

Spain

This medication is authorized in EEA member states under the following names:

Date of the last revision of this prospectus:February 2025.

Other sources of information

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/