OLMESARTAN/AMLODIPINE/HYDROCHLOROTHIAZIDE PENSA 40 mg/10 mg/12.5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Olmesartan/Amlodipine/Hydrochlorothiazide Pensa 40 mg/10 mg/12.5 mg film-coated tablets EFG

Olmesartan medoxomil / Amlodipine / Hydrochlorothiazide

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

• Keep this leaflet, as 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Olmesartan/Amlodipine/Hydrochlorothiazide Pensa and what is it used for
2. What you need to know before you take Olmesartan/Amlodipine/Hydrochlorothiazide Pensa
3. How to take Olmesartan/Amlodipine/Hydrochlorothiazide Pensa
4. Possible side effects
5. Storage of Olmesartan/Amlodipine/Hydrochlorothiazide Pensa
6. Contents of the pack and further information

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

Olmesartan/Amlodipine/Hydrochlorothiazide contains three active substances called olmesartan medoxomil, amlodipine (as amlodipine besylate), and hydrochlorothiazide. These 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 the kidneys to remove excess fluid from the body, increasing urine production.

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 you take Olmesartan/Amlodipine/Hydrochlorothiazide Pensa

Do not take Olmesartan/Amlodipine/Hydrochlorothiazide Pensa:

• If you are allergic to olmesartan medoxomil, amlodipine, 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 medicine (listed 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 impairment and are being treated with a blood pressure-lowering medicine that contains aliskiren.
• If you have low potassium or sodium levels in your blood, high calcium or uric acid levels (with symptoms of gout or kidney stones) in your blood, which do not improve with treatment.
• If you are more than 3 months pregnant. (It is also recommended to avoid Olmesartan/Amlodipine/Hydrochlorothiazide at the start of pregnancy - see section “Pregnancy and breast-feeding”).
• If you have severe liver problems, liver disease, or obstruction of the bile duct (e.g., due to gallstones), or 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 capture blood from 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 apply to you.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Olmesartan/Amlodipine/Hydrochlorothiazide.

Tell your doctorif you are taking any of the following medicines used to treat high blood pressure (hypertension):

• An angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g., enalapril, lisinopril, ramipril), especially 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 Pensa”.

Tell 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 diuretics, or if you are on a low-salt diet.
• High potassium levels 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 using a sunbed.
• 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 Olmesartan/Amlodipine/Hydrochlorothiazide.
• 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, seek medical attention immediately.

Contact your doctor if 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 blood pressure treatment.

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 can occur within hours to a week after taking Olmesartan/Amlodipine/Hydrochlorothiazide. This can lead to permanent vision impairment if not treated.

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

As with any other blood pressure-lowering medicine, excessive lowering of blood pressure in patients with impaired 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 increased levels of lipids and uric acid (which causes gout - painful swelling of the joints) in the blood. Your doctor will likely want to perform a blood test from time to time to monitor these possible changes.

There may be a change in the levels of certain chemicals in the blood called electrolytes. Your doctor will likely want to perform a blood test from time to time to monitor this possible change. Some signs of electrolyte changes are: thirst, dry mouth, muscle pain or cramps, tired muscles, low blood pressure (hypotension), feeling of weakness, slowness, tiredness, drowsiness, or restlessness, nausea, vomiting, decreased need to urinate, rapid heartbeat. 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.

Athletes are informed that this medicine contains a component that may result in a positive doping test.

You should inform your doctor if you are pregnant (or think you might be). Olmesartan/Amlodipine/Hydrochlorothiazide is not recommended during the first trimester of pregnancy, and it must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if taken during this stage (see section “Pregnancy and breast-feeding”).

Children and adolescents (under 18 years)

Olmesartan/Amlodipine/Hydrochlorothiazide is not recommended for use in children and adolescents under 18 years.

Using Olmesartan/Amlodipine/Hydrochlorothiazide Pensa with other medicines:

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any of the following medicines:

• Other blood pressure-lowering medicines, 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 ACE inhibitor or aliskiren (see also the information under the headings “Do not take Olmesartan/Amlodipine/Hydrochlorothiazide Pensa” and “Warnings and Precautions”).

• Lithium(a medicine used to treat mood changes and some types of depression) may have its toxicity increased if taken with Olmesartan/Amlodipine/Hydrochlorothiazide. If you have to take lithium, your doctor will measure lithium levels in your 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 remedy for the treatment of depression.
• Cisapride, used to increase the movement of food 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, diuretics, heparin(to thin the blood and prevent blood clots), ACE inhibitors(to lower blood pressure), laxatives, steroids, adrenocorticotropic hormone (ACTH), carbenoxolone(a medicine for the treatment of mouth and stomach ulcers), sodium penicillin G(an antibiotic also called benzylpenicillin sodium), and some painkillers like acetylsalicylic acid(“aspirin”) or salicylates. The use of these medicines at the same time as Olmesartan/Amlodipine/Hydrochlorothiazide may alter potassium levels in the blood.
• Non-steroidal anti-inflammatory drugs (NSAIDs)(medicines 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 reduced by NSAIDs. If high doses of salicylates are used, it may increase the toxic effect on the central nervous system.
• Sleep-inducing medicines, sedatives, and antidepressants, used with Olmesartan/Amlodipine/Hydrochlorothiazide, may cause a sudden drop in blood pressure when standing up.
• Colesevelam hydrochloride, a medicine that lowers cholesterol levels in the blood, as it may reduce 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 heartburn), as they may slightly reduce the effect of Olmesartan/Amlodipine/Hydrochlorothiazide.
• Certain muscle relaxants, such as baclofen and tubocurarine.
• Anticholinergic medicines, such as atropine and biperiden.

Introductionto Olmesartán/Amlodipino/Hidroclorotiazida Pensa

• Dantrolene(in infusion for severe body temperature anomalies).
• Simvastatin, used to decrease cholesterol and fat (triglycerides) levels in the blood.
• Medicines used to control the body's immune response(e.g., tacrolimus, cyclosporine), which makes it possible for your body to accept the transplanted organ.

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, sultopride, tiapride, droperidol, or haloperidol.
• Treating low blood sugar levels(e.g., diazoxide) or high blood pressure(e.g., beta-blockers, methyldopa), as Olmesartán/Amlodipino/Hidroclorotiazida 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.
• Decreasing blood fat levels, such as colestyramine and colestipol.
• Decreasing 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 Olmesartán/Amlodipino/Hidroclorotiazida Pensa with food, drinks, and alcohol:

Olmesartán/Amlodipino/Hidroclorotiazida can be taken with or without food.

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

Be careful when drinking alcohol while taking Olmesartán/Amlodipino/Hidroclorotiazida, as some people may feel faint or dizzy. If this happens, do not drink any alcohol.

Elderly patients:

If you are over 65 years old, your doctor will regularly check your blood pressure each time your dose is increased to ensure that your blood pressure does not decrease too much.

Pregnancy and breastfeeding:

Pregnancy

You should inform your doctor if you are pregnant, or if you think you may be pregnant. Your doctor will advise you to stop taking Olmesartán/Amlodipino/Hidroclorotiazida before becoming pregnant or as soon as you know you are pregnant and will advise you to take another medication instead of Olmesartán/Amlodipino/Hidroclorotiazida. The use of Olmesartán/Amlodipino/Hidroclorotiazida is not recommended during pregnancy, and it should not be taken when pregnant for more than 3 months, as it can cause serious harm to your baby if used from the third month of pregnancy onwards.

If you become pregnant while being treated with Olmesartán/Amlodipino/Hidroclorotiazida, inform and consult your doctor immediately.

Breastfeeding

Inform 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. Olmesartán/Amlodipino/Hidroclorotiazida is not recommended for breastfeeding mothers, and your doctor may choose another treatment if you wish to breastfeed.

If you are pregnant or 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 being treated for high blood pressure. If this happens, do not drive or use machines until the symptoms have disappeared. Consult your doctor.

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

3. How to take Olmesartán/Amlodipino/Hidroclorotiazida Pensa

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 of Olmesartán/Amlodipino/Hidroclorotiazida is one tablet per day.
• The tablets can be taken with or without food. Take the tablets 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 each day, for example, at breakfast time.

If you take more Olmesartán/Amlodipino/Hidroclorotiazida Pensa than you should:

If you take more tablets than you should, you will likely suffer from low blood pressure, accompanied by symptoms such as dizziness, and rapid or slow heartbeat.

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

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

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 Olmesartán/Amlodipino/Hidroclorotiazida Pensa:

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 stop taking Olmesartán/Amlodipino/Hidroclorotiazida Pensa:

It is important to continue taking Olmesartán/Amlodipino/Hidroclorotiazida, unless your doctor tells you to stop the treatment.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them. If they occur, they are usually mild and do not require stopping the treatment.

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

During treatment with Olmesartán/Amlodipino/Hidroclorotiazida, 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 Olmesartán/Amlodipino/Hidroclorotiazida and consult your doctor immediately.

Olmesartán/Amlodipino/Hidroclorotiazida may cause a significant drop in blood pressure in susceptible patients. This can cause fainting or severe dizziness. If this happens to you, stop taking Olmesartán/Amlodipino/Hidroclorotiazida, consult your doctor immediately, and remain lying down.

Unknown frequency: If you experience yellowing of the whites of the eyes, dark urine, itching of the skin, even if you started treatment with Olmesartán/Amlodipino/Hidroclorotiazida a long time ago, contact your doctor immediately, who will evaluate your symptoms and decide how to continue treatment for high blood pressure.

Olmesartán/Amlodipino/Hidroclorotiazida is a combination of three active substances. The following information describes the side effects reported so far with the combination Olmesartán/Amlodipino/Hidroclorotiazida (in addition to those already mentioned) and the side effects known for 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 experience side effects, they have been classified as frequent, uncommon, rare, and very rare.

These are other known side effects of Olmesartán/Amlodipino/Hidroclorotiazida:

If these effects occur, they are usually mild and do not require stopping the 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.

Uncommon

(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 side effects for each of the active substances separately or when two of the substances are taken together:

They may be side effects due to Olmesartán/Amlodipino/Hidroclorotiazida, even if they have not been observed so far with Olmesartán/Amlodipino/Hidroclorotiazida.

Very common

(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 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.

Uncommon

(may affect up to 1 in 100 people)

Decrease in the number of a type of blood cell called platelets, which can cause easy bruising or prolonged bleeding, anaphylactic reactions, abnormal decrease in 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, feeling of tingling, 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 spots or patches on the skin due to small bleeding (purpura), skin discoloration, red itchy patches (urticaria), increased sweating, itching, skin rash, skin reactions to light, such as sunburn or skin rash, muscle pain, urination problems, need to urinate at night, breast enlargement 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, yellowish vision, dry eyes, blood clots (thrombosis, embolism), fluid accumulation in the lungs, pneumonia, inflammation of blood vessels and small blood vessels in the skin, pancreatitis, yellowing of the skin and eyes, acute inflammation of the gallbladder, symptoms of lupus erythematosus such as skin rash, joint pain, and cold hands and fingers, severe skin reactions including intense skin rash, urticaria, skin redness of the body, 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 presents 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 difficulties (signs include severe breathing difficulties, fever, weakness, and confusion).

Side effects of unknown frequency(cannot be estimated from the available data): Decreased vision or eye pain due to high pressure (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 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 Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Olmesartán/Amlodipino/Hidroclorotiazida Pensa

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date shown on the package and blister after "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 wastewater or household waste. Deposit the packages and medications you no longer need at the SIGRE collection point in the pharmacy. If in doubt, ask your pharmacist how to dispose of packages and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Olmesartán/Amlodipino/Hidroclorotiazida Pensa

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

Each film-coated tablet contains 40 mg of olmesartan medoxomil, 10 mg of amlodipine (as amlodipine besylate), and 12.5 mg of hydrochlorothiazide.

The other ingredients are:

Tablet core: Pregelatinized corn starch, microcrystalline cellulose, sodium croscarmellose, and magnesium stearate. Tablet coating: Polyvinyl alcohol, macrogol, talc, titanium dioxide (E-171), red iron oxide (E-172).

Appearance of the product and package contents

Olmesartán/Amlodipino/Hidroclorotiazida Pensa 40 mg/10 mg/12.5 mg film-coated tablets are pink, cylindrical, biconvex tablets with the inscription "t3" on one side.

Olmesartán/Amlodipino/Hidroclorotiazida Pensa film-coated tablets are available in blister packs of 28 tablets.

Marketing authorization holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturer

Laboratorios CINFA, S.A.

Olaz-Chipi, 10 - Polígono Industrial Areta

31620 Huarte (Navarra)

Spain

Date of the last revision of this leaflet:January 2025

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/