Olmesartan/amlodipine/hydrochlorothiazide Pensal 40 mg/10 mg/25 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Olmesartan/Amlodipine/Hydrochlorothiazide pensa 40 mg/10 mg/25 mg film-coated tablets EFG

Olmesartan medoxomil / Amlodipine / Hydrochlorothiazide

Read the entire 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, tell your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Package leaflet contents

1. What Olmesartán/Amlodipino/Hidroclorotiazida Pensa is and what it is used for
2. What you need to know before taking Olmesartán/Amlodipino/Hidroclorotiazida Pensa
3. How to take Olmesartán/Amlodipino/Hidroclorotiazida Pensa
4. Possible side effects
5. Storage of Olmesartán/Amlodipino/Hidroclorotiazida Pensa
6. Contents of the pack and other information

1. What Olmesartán/Amlodipino/Hidroclorotiazida Pensa is and what it is used for

Olmesartán/Amlodipino/Hidroclorotiazida contains three active substances: olmesartán medoxomilo, amlodipino (as amlodipino besilato), and hidroclorotiazida. These three substances help control high blood pressure.

• Olmesartán medoxomilo belongs to a group of medicines called “angiotensin II receptor antagonists”, which lower blood pressure by relaxing blood vessels.

• Amlodipino belongs to a group of medicines called “calcium channel blockers”. Amlodipino also lowers blood pressure by relaxing blood vessels.

• Hidroclorotiazida belongs to a group of medicines called thiazide diuretics. It lowers blood pressure by helping the body get rid of excess fluid, increasing urine production by the kidneys.

The combined action of these substances helps reduce your blood pressure. Olmesartán/Amlodipino/Hidroclorotiazida is used to treat high blood pressure:

• in adult patients whose blood pressure is not adequately controlled with the combination of olmesartán medoxomilo and amlodipino taken as a fixed-dose combination, or
• in adult patients who are already taking a fixed-dose combination of olmesartán medoxomilo and hidroclorotiazida, together with tablets containing only amlodipino, or a fixed-dose combination of olmesartán medoxomilo and amlodipino, together with tablets containing only hidroclorotiazida.

2. What you need to know before starting to take Olmesartán/Amlodipino/Hidroclorotiazida Pensa

Do not take Olmesartán/Amlodipino/Hidroclorotiazida Pensa:

• If you are allergic to olmesartán medoxomilo, to amlodipino, or to a special group of calcium channel blockers (dihydropyridines), to hydrochlorothiazide or to 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 Olmesartán/Amlodipino/Hidroclorotiazida.

• If you have severe kidney problems.
• If you have diabetes or renal failure and are being treated with a blood pressure-lowering medicine containing aliskiren.
• If you have low levels of potassium or sodium in the blood, high levels of calcium or uric acid (with symptoms of gout or kidney stones) in the blood, which do not improve with treatment.
• If you are more than 3 months pregnant. (It is also advisable to avoid Olmesartán/Amlodipino/Hidroclorotiazida at the beginning of pregnancy – see section “Pregnancy and breastfeeding”).
• If you have severe liver problems, biliary secretion disorders, or obstruction of bile drainage from the gallbladder (e.g., due to gallstones), or have jaundice (yellowing of the skin and eyes).
• If you have inadequate blood supply to your tissues, with symptoms such as low blood pressure, weak pulse, rapid heartbeat, or shock (including cardiogenic shock, meaning shock due to serious heart problems).
• If you have very low blood pressure.
• If blood flow from your heart is slow or blocked. This may occur if blood vessels or valves collecting blood from the heart are narrowed (aortic stenosis).
• If you have low cardiac output following a heart attack (acute myocardial infarction). Low cardiac output may make you feel short of breath or cause swelling in your feet and ankles.

Do not take Olmesartán/Amlodipino/Hidroclorotiazida if any of these apply to you.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Olmesartán/Amlodipino/Hidroclorotiazida.

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

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

Your doctor may monitor your kidney function, blood pressure, and blood levels of electrolytes (for example, potassium) at regular intervals.

See also the information under the heading “Do not take Olmesartán/Amlodipino/Hidroclorotiazida Pensa”.

Tell your doctor if you have any of the following health conditions:

• Kidney problems or a kidney transplant.
• Liver disease.
• Heart failure or problems with heart valves or heart muscle.
• Severe vomiting, diarrhoea, treatment with high doses of medicines that increase urine elimination (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 sun exposure or use of sunbeds.
• 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 non-melanoma skin cancer and lip cancer. Protect your skin from exposure to sunlight and UV rays while taking Olmesartán/Amlodipino/Hidroclorotiazida.
• If you have previously experienced breathing or lung problems (such as lung inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop shortness of breath or severe difficulty breathing after taking Olmesartán/Amlodipino/Hidroclorotiazida, seek medical attention immediately.

Contact your doctor if you experience any of the following symptoms:

• Severe, persistent diarrhoea causing significant weight loss. Your doctor will assess your symptoms and decide how to proceed with your blood pressure treatment.

Reduced vision or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure, and may occur within hours to a week after taking Olmesartán/Amlodipino/Hidroclorotiazida. This may lead to permanent worsening of vision if not treated.

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhoea after taking Olmesartán/Amlodipino/Hidroclorotiazida Pensa. Your doctor will decide whether to continue treatment. Do not stop taking Olmesartán/Amlodipino/Hidroclorotiazida Pensa on your own.

As with any other medicine that lowers blood pressure, excessive lowering of blood pressure in patients with impaired blood flow to the heart or brain may lead to heart attack or stroke. Therefore, your doctor will carefully monitor your blood pressure.

Olmesartán/Amlodipino/Hidroclorotiazida may cause an increase in blood levels of lipids and uric acid (which causes gout – painful joint swelling). Your doctor may wish to carry out blood tests from time to time to monitor these possible changes.

Changes in blood levels of certain chemicals called electrolytes may occur. Your doctor may wish to carry out blood tests periodically to monitor this possible change. Some signs of electrolyte imbalances are: thirst, dry mouth, muscle pain or cramps, tired muscles, low blood pressure (hypotension), feeling weak, sluggish, tired, drowsy or restless, nausea, vomiting, reduced need to urinate, rapid heartbeat. Tell your doctor if you notice any of these symptoms.

If you are scheduled for tests of parathyroid function, you must stop taking Olmesartán/Amlodipino/Hidroclorotiazida before the tests are performed.

Athletes should be aware that this medicine contains a component that may result in a positive analytical finding in doping control tests.

Inform your doctor if you are pregnant (or think you might be). Use of Olmesartán/Amlodipino/Hidroclorotiazida is not recommended at the beginning of pregnancy, and should not be taken after the third month of pregnancy, as it may cause serious harm to your baby if taken during this period (see section “Pregnancy and breastfeeding”).

Children and adolescents (under 18 years of age)

Use of Olmesartán/Amlodipino/Hidroclorotiazida is not recommended in children and adolescents under 18 years of age.

Use of Olmesartán/Amlodipino/Hidroclorotiazida Pensa with other medicines:

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

• Other blood pressure-lowering medicines, as they may enhance the effect of Olmesartán/Amlodipino/Hidroclorotiazida.

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 Olmesartán/Amlodipino/Hidroclorotiazida Pensa” and “Warnings and precautions”).

• Lithium (a medicine used to treat mood disorders and certain types of depression) may have increased toxicity when used together with Olmesartán/Amlodipino/Hidroclorotiazida Pensa. If you need to take lithium, your doctor will monitor lithium blood levels.
• Diltiazem, verapamil, used for heart rhythm disorders 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 used to treat depression.
• Cisapride, used to increase movement of food through the stomach and intestine.
• Difemanil, used to treat slow heart rate or to reduce sweating.
• Halofantrine, used for malaria.
• Vincamine IV, used to improve blood circulation in the nervous system.
• Amantadine, used for Parkinson’s disease.
• Potassium supplements, potassium-containing salt substitutes, medicines that increase urine elimination (diuretics), heparin (to thin the blood and prevent blood clots), angiotensin-converting enzyme (ACE) inhibitors (to lower blood pressure), laxatives, steroids, adrenocorticotropic hormone (ACTH), carbenoxolone (a medicine used to treat mouth and stomach ulcers), sodium penicillin G (an antibiotic also known as sodium benzylpenicillin), some painkillers such as acetylsalicylic acid (“aspirin”) or salicylates. Taking these medicines together with Olmesartán/Amlodipino/Hidroclorotiazida may alter blood potassium levels.
• Non-steroidal anti-inflammatory drugs (NSAIDs) (medicines used to relieve pain, swelling and other symptoms of inflammation, including arthritis), when used together with Olmesartán/Amlodipino/Hidroclorotiazida, may increase the risk of kidney failure. The effect of Olmesartán/Amlodipino/Hidroclorotiazida may be reduced by NSAIDs. High doses of salicylates may increase the toxic effect on the central nervous system.
• Sleep-inducing medicines, sedatives and antidepressants, when used together with Olmesartán/Amlodipino/Hidroclorotiazida, may cause a sudden drop in blood pressure upon standing.
• Colesevelam hydrochloride, a medicine that lowers blood cholesterol levels, as it may reduce the effect of Olmesartán/Amlodipino/Hidroclorotiazida. Your doctor may advise you to take Olmesartán/Amlodipino/Hidroclorotiazida at least 4 hours before colesevelam hydrochloride.
• Certain antacids (remedies for indigestion and heartburn), as they may slightly reduce the effect of Olmesartán/Amlodipino/Hidroclorotiazida.
• Some muscle relaxants, such as baclofen and tubocurarine.
• Anticholinergic medicines, such as atropine and biperidene.

Calcium supplements.

• Dantrolene (administered by infusion for severe abnormalities in body temperature).
• Simvastatin, used to lower cholesterol and fat (triglyceride) levels in the blood.
• Medicines used to control the body's immune response (e.g., tacrolimus, cyclosporine), which help the body accept a transplanted organ.

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

• To treat certain mental disorders, such as thioridazine, chlorpromazine, levomepromazine, trifluoperazine, cyamemazine, sulpiride, amisulpride, pimozide, sultopride, tiapride, droperidol, or haloperidol.
• To treat low blood sugar (e.g., diazoxide) or high blood pressure (e.g., beta-blockers, methyldopa), since Olmesartan/Amlodipine/Hydrochlorothiazide may affect the action of these medicines.
• To treat heart rhythm problems, such as mizolastine, pentamidine, terfenadine, dofetilide, ibutilide, or erythromycin injections.
• To treat HIV/AIDS (e.g., ritonavir, indinavir, nelfinavir).
• To treat fungal infections (e.g., ketoconazole, itraconazole, amphotericin).
• To treat heart problems, such as quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, bepridil, or digitalis.
• To treat cancer, such as amifostine, cyclophosphamide, or methotrexate.
• To increase blood pressure and decrease heart rate, such as noradrenaline.
• To treat gout, such as probenecid, sulfinpyrazone, and allopurinol.
• To lower blood fat levels, such as cholestyramine and colestipol.
• To lower blood sugar levels, such as metformin or insulin.

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicine.

Taking Olmesartan/Amlodipine/Hydrochlorothiazide Pensa with food, drinks, and alcohol:

Olmesartan/Amlodipine/Hydrochlorothiazide may be taken with or without food.

Patients taking Olmesartan/Amlodipine/Hydrochlorothiazide should not consume grapefruit or grapefruit juice. This is because grapefruit and grapefruit juice may increase blood levels of the active ingredient amlodipine, which could lead to an unpredictable increase in the blood pressure-lowering effect of Olmesartan/Amlodipine/Hydrochlorothiazide.

Use alcohol cautiously while taking Olmesartan/Amlodipine/Hydrochlorothiazide, as some people may experience dizziness or fainting. If this occurs, avoid alcohol.

Elderly patients:

If you are over 65 years of age, your doctor will regularly monitor your blood pressure each time your dose is increased, to ensure that your blood pressure does not drop too low.

Pregnancy and breastfeeding:

Pregnancy

You must inform your doctor if you are pregnant, or think you might be pregnant. 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 recommend an alternative medicine. Olmesartan/Amlodipine/Hydrochlorothiazide is not recommended during pregnancy, and must not be taken after the first 3 months of pregnancy, as it may cause serious harm to your unborn baby if used beyond the third month of pregnancy.

If you become pregnant while taking Olmesartan/Amlodipine/Hydrochlorothiazide, inform your doctor immediately and seek medical advice.

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. Olmesartan/Amlodipine/Hydrochlorothiazide is not recommended for breastfeeding mothers, and your doctor may choose an alternative treatment if you wish to breastfeed.

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

Driving and use of machines:

You may feel drowsy, nauseous, dizzy, or experience headache while being treated for high blood pressure. If this occurs, do not drive or operate machinery until these symptoms have resolved. Consult your doctor.

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

3. How to take Olmesartán/Amlodipino/Hidroclorotiazida Pensa

Follow exactly the instructions for using this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

• The recommended dose of Olmesartán/Amlodipino/Hidroclorotiazida is one tablet daily.
• The tablets can be taken with or without food. Take the tablets with some 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, with breakfast.

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

If you take more tablets than you should, you are likely to experience a drop in blood pressure, accompanied by symptoms such as dizziness, and fast or slow heartbeat.

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

If you take more tablets than prescribed or if a child accidentally swallows any tablets, contact your doctor immediately or go to the nearest emergency room, and take the medicine 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 at telephone number 91 562 04 20.

If you forget to take Olmesartan/Amlodipine/Hydrochlorothiazide Pensa:

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

If treatment with Olmesartan/Amlodipine/Hydrochlorothiazide Pensa is interrupted:

It is important to continue taking Olmesartan/Amlodipine/Hydrochlorothiazide, unless your doctor tells you to stop treatment.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them. If they do occur, they are often mild and do not require discontinuation of treatment.

The following adverse effects can be serious, although they affect only a small number of people:

During treatment with Olmesartan/Amlodipine/Hydrochlorothiazide, allergic reactions may occur, with swelling of the face, mouth and/or larynx (vocal cords), together with itching and skin rash. If this happens to you, stop taking Olmesartan/Amlodipine/Hydrochlorothiazide and consult your doctor immediately.

Olmesartan/Amlodipine/Hydrochlorothiazide may cause a marked decrease in blood pressure in susceptible patients. This may lead to fainting or severe dizziness. If this happens to you, stop taking Olmesartan/Amlodipine/Hydrochlorothiazide, consult your doctor immediately, and remain lying down in a horizontal position.

Frequency not known: If you experience yellowing of the whites of the eyes, dark urine, or skin itching, even if you started treatment with Olmesartan/Amlodipine/Hydrochlorothiazide some time ago, contact your doctor immediately, who will evaluate your symptoms and decide how to proceed with your blood pressure treatment.

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

To give you an idea of the number of patients who may experience adverse effects, these have been classified as common, uncommon, rare, and very rare.

These are other known adverse effects reported so far with Olmesartan/Amlodipine/Hydrochlorothiazide:

If these effects occur, they are often mild and you do not need to stop treatment.

Frequent

(may affect up to 1 in 10 people)

Upper respiratory tract infection, sore throat and nose, urinary tract infection, dizziness, headache, awareness of heartbeat, low blood pressure, nausea, diarrhea, constipation, cramps, joint swelling, feeling of urgency to urinate, weakness, ankle swelling, fatigue, abnormal laboratory test results.

Uncommon

(may affect up to 1 in 100 people)

Dizziness upon standing, vertigo, rapid heartbeat, feeling faint, facial flushing and sensation of warmth, cough, dry mouth, muscle weakness, inability to achieve or maintain an erection.

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

These may be adverse effects due to Olmesartan/Amlodipine/Hydrochlorothiazide, even if they have not yet been observed with Olmesartan/Amlodipine/Hydrochlorothiazide.

Very common

(may affect more than 1 in 10 people)

Edema (fluid retention).

Common

(may affect up to 1 in 10 people)

Bronchitis, stomach and intestinal infection, vomiting, increased blood sugar, sugar in urine, confusion, drowsiness, visual disturbances (including double vision and blurred vision), nasal discharge 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.

Uncommon

(may affect up to 1 in 100 people)

Reduction in the number of a type of blood cells called platelets, which may lead to easy bruising or prolonged bleeding time, anaphylactic reactions, abnormal decrease in appetite (anorexia), difficulty sleeping, irritability, mood changes including anxiety, feeling of depression, chills, sleep disorders, disturbance of taste sensation, loss of consciousness, decreased sense of touch, tingling sensation, worsening of myopia, ringing in the ears (tinnitus), angina (pain or discomfort in the chest, known as angina pectoris), irregular heartbeat, rash, hair loss, allergic skin inflammation, redness of the skin, purple spots or patches on the skin due to small hemorrhages (purpura), skin discoloration, itchy red welts (urticaria), increased sweating, pruritus, skin rash, skin reactions to light such as sunburn or skin eruption, muscle pain, problems urinating, feeling of need to urinate during the night, enlargement of the breasts in men, decreased sexual desire, swelling of the face, feeling of malaise, weight gain or weight loss, exhaustion.

Rare

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

Inflammation and pain of the salivary glands, decreased number of white blood cells in the blood, which could increase the risk of infections, decreased number of red blood cells (anemia), bone marrow damage, restlessness, feeling of loss of interest (apathy), seizures, 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, inflammation of the pancreas, yellowing of the skin and eyes, acute inflammation of the gallbladder, lupus erythematosus-like symptoms such as skin rash, joint pain, and coldness in hands and fingers, severe skin reactions including severe skin rash, hives, redness of the skin, severe itching, blisters, skin peeling and inflammation, inflammation of mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis), sometimes very severe, impaired movement, acute kidney failure, non-infectious inflammation of the kidney, reduced kidney function, fever.

Intestinal angioedema: swelling in the intestine causing 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 overgrowth, intestinal obstruction, liver inflammation.

Acute breathing difficulty (signs include severe shortness of breath, fever, weakness, and confusion).

Adverse reactions of unknown frequency (cannot be estimated from available data): Decreased vision or eye pain due to increased 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 unbalanced gait with dragging of the feet, skin and lip cancer (non-melanoma skin cancer).

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it involves possible adverse reactions not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaram.es. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of Olmesartan/Amlodipine/Hydrochlorothiazide Pensa

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging and blister after "EXP.". The expiry date refers to the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Olmesartán/Amlodipino/Hidroclorotiazida Pensa

The active substances 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 25 mg of hydrochlorothiazide.

The other components are:

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

Appearance of the product and contents of the container

Olmesartán/Amlodipino/Hidroclorotiazida Pensa 40 mg/10 mg/25 mg film-coated tablets are pink, oblong, biconvex tablets, with a score line and the logo “t1” on the other side. The score line is intended only to facilitate breaking for ease of swallowing and is not intended to divide the tablet into equal doses.

Olmesartán/Amlodipino/Hidroclorotiazida Pensa film-coated tablets are supplied in blister packs containing 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 - Areta Industrial Estate

31620 Huarte (Navarre)

Spain

Date of the most recent review of this leaflet: January 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/