Package Insert: Information for the User

Emcoretic 10 mg/25 mg Film-Coated Tablets

Bisoprolol Fumarate / Hydrochlorothiazide

Read this package insert carefully before taking this medicine, as it contains important information for you.

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

Emcoretic 10 mg/25 mg film-coated tablets contain a combination of two active ingredients: bisoprolol fumarate and hydrochlorothiazide.

This combination is used for the treatment of essential hypertension (high blood pressure), particularly when this condition cannot be adequately controlled with a single active ingredient.

Do not take Emcoretic

If you are allergicto bisoprolol, hydrochlorothiazide, to other medications in the same group (thiazides, sulfonamides) or to any of the other components of this medication (listed in section 6)

If you have any of the following conditions:

• Severe bronchial asthma.
• Severe circulatory problems in the extremities (such as Raynaud's syndrome), which can cause tingling in the fingers and toes or make them pale or blue.
• Untreated phaeochromocytoma, a rare tumor of the adrenal gland.
• Metabolic acidosis, a condition that occurs when there is too much acid in the blood.
• Severe kidney failure
• Severe liver failure
• Low levels of potassium in the blood
• Low levels of sodium in the blood
• High levels of calcium in the blood
• Gout

If you have one of the following heart problems:

• Acute heart failure.
• Worsening heart failure that requires intravenous medication to increase the heart's contraction force.
• Determined cardiac conditions that produce a very slow or irregular heart rate (second- or third-degree atrioventricular block without a pacemaker, sick sinus syndrome, sinoatrial block).
• Cardiogenic shock, a severe and acute cardiac disease that causes a drop in blood pressure and circulatory failure.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Emcoretic:

• If you have had skin cancer or if you develop an unexpected skin lesion during treatment. The treatment with hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of skin and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking Emcoretic

If you have any of the following problems, inform your doctor before taking Emcoretic:

• Diabetes.
• Strict fasting.
• Determined heart conditions such as heart failure, arrhythmias, or severe chest pain at rest (Prinzmetal's angina).
• Liver problems.
• Decreased blood volume (hypovolemia)
• Circulatory problems in the legs.
• Asthma or chronic respiratory disease. Your doctor may need to change your asthma medication doses.
• Chronic respiratory obstruction.
• History of psoriasis (scaly skin rash)
• Adrenal gland tumor (pheochromocytoma).
• If you have had respiratory or pulmonary problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you experience severe shortness of breath or difficulty breathing after taking Emcoretic, seek medical attention immediately.

Also, inform your doctor if you are going to:

• Undergo desensitization treatment (e.g., for hay fever prevention), as Emcoretic may make it more likely that you will experience an allergic reaction, or that such a reaction may be more severe.
• Anesthesia (e.g., for surgery), as Emcoretic may affect how your body reacts to this situation.

You should also be aware that:

• This medication may increase your sensitivity to sunlight or UVA radiation. Avoid exposure to the sun (even on cloudy days) and UVA lamps while taking this medication.
• In long-term treatments, your doctor may perform regular blood checks for certain substances (electrolytes, creatinine, urea, lipids, uric acid, and glucose).
• If you have high levels of uric acid in your blood, the risk of a gout attack may increase.

If you experience a decrease in vision or eye pain, it may be a symptom of fluid accumulation in the eye's vascular layer (choroidal effusion) or increased eye pressure, which can occur within a few hours to a week after taking Emcoretic. Your doctor will inform you if you need to stop or change treatment. If you are allergic to penicillin or sulfonamides, the risk of developing this type of alteration is higher.

Use in athletes

This medication contains hydrochlorothiazide, which can produce a positive result in doping control tests.

Taking Emcoretic with other medications

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

Do not take the following medications with Emcoretic without special advice from your doctor:

• Lithium, used to treat mood disorders and severe depression, as it may increase its toxicity.
• Determined medications used to treat high blood pressure, angina, or irregular heartbeats (such as verapamil and diltiazem).
• Determined medications used to treat high blood pressure, such as clonidine, methyldopa, and moxonidine. However,do not stop taking these medicationswithout consulting your doctor first.

Consult your doctor before taking the following medications with Emcoretic; your doctor may need to monitor your condition more frequently:

• Determined medications used to treat irregular or abnormal heartbeats.
• Medications used to treat high blood pressure or angina.
• Some eye drops for glaucoma (containing beta-blockers).
• Some medications used to treat Alzheimer's disease, dementia, or glaucoma.
• Medications used to treat acute heart problems.
• Insulin and other medications for diabetes.
• Anesthetics (e.g., during surgery).
• Medications used to treat heart failure (such as digoxin).
• Non-steroidal anti-inflammatory drugs (NSAIDs) used to treat arthritis, pain, or inflammation.
• Any medication that can lower blood pressure, such as antihypertensives, certain antidepressants.
• Medications that can cause potassium loss (e.g., corticosteroids, diuretics, laxatives…)
• Methyldopa, used to lower blood pressure
• Medications to lower uric acid levels, which may be less effective.
• Colestiramine, colestipol (used to remove cholesterol): may reduce the effectiveness of Emcoretic.
• Mefloquine, used to prevent or treat malaria.
• Corticosteroids, which may reduce the effect of Emcoretic.

Pregnancy and breastfeeding

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

Emcoretic is not recommended during pregnancy.

There is a risk that using Emcoretic during pregnancy may harm the baby.

If you are pregnant or planning to become pregnant, inform your doctor. Your doctor will decide if you can take Emcoretic during pregnancy.

The components of Emcoretic may pass into breast milk, so it is not recommended to breastfeed while taking Emcoretic.

Driving and operating machinery

Your ability to drive or operate machinery may be affected depending on how you tolerate the medication. Be especially careful at the start of treatment and with changes in dosage or treatment, and also in combination with alcohol.

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor again.

Treatment with Emcoretic may require individual dose adjustment at the start of treatment and during dose increase.

If you have renal or hepatic insufficiency, you may need a lower dose.

Take the tablet with a little water in the morning, with or without food. Do not crush or chew the tablet.

The tablet can be split into two equal doses.

Treatment with Emcoretic is usually long-term.

Normally, if you have to stop treatment completely, your doctor will advise you to gradually reduce the dose, as otherwise your condition may worsen.

Children

Emcoretic is not recommended for use in children.

If you take more Emcoretic than you should

The symptoms of an overdose may include a reduced heart rate, low blood pressure, severe difficulty breathing, dizziness, nausea, or tremors (due to decreased blood sugar).

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

If you forgot to take Emcoretic

Do not take a double dose to compensate for the missed doses. Take your usual dose the next morning.

If you interrupt treatment with Emcoretic

Never stop taking Emcoretic except on the advice of your doctor. Otherwise, your condition may worsen significantly.

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

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

To prevent serious adverse reactions, talk to a doctor immediately if a side effect is severe, occurs suddenly, or worsens quickly.

Below, other side effects are mentioned according to the organ or system affected and their possible frequency of occurrence:

Very frequent:can affect more than 1 in 10 patients

Frequent:can affect up to 1 in 10 patients.

Infrequent:can affect up to 1 in 100 patients.

Rare:can affect up to 1 in 1,000 patients.

Very rare:can affect up to 1 in 10,000 patients.

Unknown frequency:cannot be estimated from available data.

Benign, malignant, and unspecified neoplasms (including cysts and polyps):

Unknownskin and lip cancer (non-melanoma skin cancer)

Blood and lymphatic system disorders:

Rare: decrease in white blood cells and platelets in the blood.

Very rare: decrease in white blood cells in the blood.

Metabolism and nutrition disorders:

Frequent: elevation of blood sugar and uric acid levels, fluid and electrolyte imbalance.

Infrequent: loss of appetite.

Very rare: alkalosis (metabolic alkalosis) of the blood.

Psychiatric disorders:

Infrequent: depression, sleep disorders.

Rare: nightmares, hallucinations.

Nervous system disorders:

Frequent: dizziness, headache.

Eye disorders:

Rare: decreased tear production (to be taken into account for contact lens wearers), vision disorders.

Very rare: conjunctivitis.

Unknown: decreased vision or eye pain due to increased pressure [possible signs of fluid accumulation in the vascular layer of the eye (choroidal hemorrhage) or acute angle-closure glaucoma].

Ear and labyrinth disorders:

Rare: hearing disorders.

Cardiac disorders:

Infrequent: decrease in heart rate, disorders of heart stimulus transmission, worsening of heart failure.

Vascular disorders:

Frequent: sensation of coldness or numbness in the extremities.

Infrequent(can affect up to 1 in 100 people): orthostatic hypotension (dizziness upon standing).

Rare: fainting.

Respiratory, thoracic, and mediastinal disorders

Infrequent: bronchial constriction in patients with asthma or chronic obstructive pulmonary disease.

Rare: allergic rhinitis.

Very rare: acute respiratory distress (symptoms include severe respiratory distress, fever, weakness, and confusion).

Unknowna: interstitial lung disease.

Gastrointestinal disorders:

Frequent: nausea, vomiting, diarrhea, constipation.

Infrequent: abdominal pain, pancreatitis.

Liver disorders:

Rare: liver inflammation, yellowing of the skin and mucous membranes (jaundice).

Skin and subcutaneous tissue disorders:

Rare: hypersensitivity reactions (allergies) such as itching, redness, hives, irritation, urticaria. Consult a doctor immediately if you experience more severe allergic reactions, which may include swelling of the face, neck, tongue, mouth, or throat, or difficulty breathing.

Very rare: hair loss, lupus erythematosus, appearance or worsening of psoriasis (skin scaly disorder).

Musculoskeletal and connective tissue disorders:

Infrequent: muscle weakness, muscle cramps.

Reproductive and breast disorders:

Rare: impotence.

General disorders:

Frequent: fatigue.

Infrequent: exhaustion.

Very rare: chest pain.

Complementary examinations:

Frequent: elevation of cholesterol and triglyceride levels, glucose in the urine.

Infrequent:elevation of amylase, reversible increase in creatinine and urea.

Rare: elevation of liver enzymes.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is not listed in this prospectus.

You can also report them directly through the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es

Reporting adverse effects can contribute to providing more information on the safety of this medication.

• 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 after CAD. The expiration date is the last day of the month indicated.
• Do not store at a temperature above 86°F (30°C).

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

Composition of Emcoretic

The active principles are bisoprolol fumarate and hydrochlorothiazide. Each coated tablet contains 10 mg of bisoprolol fumarate and 25 mg of hydrochlorothiazide.

The other components are:

• Core of the tablet:anhydrous colloidal silica, magnesium stearate, cornstarch, microcrystalline cellulose, anhydrous calcium hydrogen phosphate.
• Coating film: red iron oxide (E172), black iron oxide (E172), dimethicone, macrogol 400, titanium dioxide (E171), hypromellose.

Appearance of the product and contents of the packaging

Emcoretic tablets are coated heart-shaped tablets of a pinkish grey color with a groove on both faces.

Each package contains 28 or 56 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder:

Merck, S.L.

María de Molina, 40

28006 Madrid

Spain

Manufacturing responsible:

Merck Healthcare KGaA

Frankfurter Strasse 250

64293 Darmstadt

Germany

Or

Merck, S.L.

Merck Industrial Estate

Mollet del Vallés 08100

Spain

Last review date of this leaflet:12/2021

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/