EMCORETIC 10 mg/25 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Emcoretic 10 mg/25 mg Film-Coated Tablets

Bisoprolol Fumarate / Hydrochlorothiazide

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

• Keep this 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 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 Emcoretic and what is it used for
2. What you need to know before you take Emcoretic
3. How to take Emcoretic
4. Possible side effects
5. Storage of Emcoretic
6. Contents of the pack and other information

1. What is Emcoretic and what is it used for

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

This combination is used to treat essential arterial hypertension (high blood pressure), particularly when this condition cannot be adequately controlled with a single active substance.

2. What you need to know before you take Emcoretic

Do not take Emcoretic

If you are allergic to bisoprolol, hydrochlorothiazide, or other medicines of the same group (thiazides, sulfonamides) or to any of the other ingredients of this medicine (listed in section 6)

If you have any of the following conditions:

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

If you have any of the following heart problems:

• Acute heart failure.
• Deterioration of heart failure that requires intravenous injection of medicines that increase the heart's contractile force.
• Certain heart conditions that cause a very slow or irregular heartbeat (second or third degree atrioventricular block without a pacemaker, sick sinus syndrome, sinoatrial block).
• Cardiogenic shock, which is a severe and acute heart 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. Treatment with hydrochlorothiazide, in particular its 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 and UV exposure while taking Emcoretic

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

• Diabetes.
• Strict fasting.
• Certain heart diseases such as heart failure, heart rhythm disorders, 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 the doses of your asthma medications.
• Chronic obstructive pulmonary disease.
• 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.

In addition, inform your doctor if you are going to undergo:

• Desensitization treatment (e.g., for the prevention of hay fever), because Emcoretic may make you more likely to experience an allergic reaction, or such a reaction may be more severe.
• Anesthesia (e.g., for surgery), because Emcoretic may affect how your body reacts to this situation.

You should also be aware that:

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

If you experience a decrease in vision or eye pain, they 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 a few hours to a week after taking Emcoretic. Your doctor will inform you if you should 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 medicine contains hydrochlorothiazide, which may produce a positive result in doping tests.

Taking Emcoretic with Other Medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

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

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

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

• Certain medicines used to treat irregular heartbeats or arrhythmias.
• Medicines used to treat high blood pressure or angina.
• Certain eye drops used to treat glaucoma (containing beta-blockers).
• Certain medicines used to treat Alzheimer's disease, dementia, or glaucoma.
• Medicines used to treat acute heart problems.
• Insulin and other medicines for diabetes.
• Anesthetics (e.g., during surgery).
• Medicines used to treat heart failure (such as digoxin).
• Non-steroidal anti-inflammatory drugs (NSAIDs) used to treat arthritis, pain, or inflammation.
• Any medicine that may lower blood pressure as a desired or undesired effect, such as antihypertensives, certain medicines for depression.
• Medicines that may cause potassium loss (e.g., corticosteroids, diuretics, laxatives...)
• Methyldopa, used to lower blood pressure
• Medicines to lower uric acid levels, which may be less effective.
• Cholestyramine, colestipol (used to eliminate cholesterol): may decrease the effectiveness of Emcoretic.
• Mefloquine, used for the prevention or treatment of malaria.
• Corticosteroids, which may reduce the effect of Emcoretic.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Emcoretic is not recommended during pregnancy.

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

If you are pregnant or plan 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 your child while being treated with Emcoretic.

Driving and Using Machines

Your ability to drive or use machines may be affected depending on how you tolerate the medicine. Be especially careful when starting treatment and when changing doses or treatment, and also when combined with alcohol.

3. How to Take Emcoretic

Follow exactly the administration instructions of this medicine indicated by your doctor. In case of 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 divided into two equal doses.

Treatment with Emcoretic is usually long-term.

Normally, if you need to interrupt 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

Symptoms of an overdose may include a decrease in heart rate, low blood pressure, severe difficulty breathing, dizziness, nausea, or tremors (due to low 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 medicine and the amount taken.

If You Forget to Take Emcoretic

Do not take a double dose to make up for forgotten doses. Take your usual dose the next morning.

If You Stop Taking Emcoretic

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

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

4. Possible Side Effects

Like all medicines, Emcoretic can cause side effects, although not everybody gets them.

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

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

Very common: may affect more than 1 in 10 patients

Common: may affect up to 1 in 10 patients.

Uncommon: may affect up to 1 in 100 patients.

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

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

Frequency not known: cannot be estimated from the available data.

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

Not known: Skin 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:

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

Uncommon: loss of appetite.

Very rare: blood alkalization (metabolic alkalosis).

Psychiatric disorders:

Uncommon: depression, sleep disorders.

Rare: nightmares, hallucinations.

Nervous system disorders:

Common: dizziness, headache.

Eye disorders:

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

Very rare: conjunctivitis.

Not known: 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].

Ear and labyrinth disorders:

Rare: hearing disorders.

Cardiac disorders:

Uncommon: decrease in heart rate, conduction disorders, worsening of heart failure.

Vascular disorders:

Common: feeling of coldness or numbness in the limbs.

Uncommon(may affect up to 1 in 100 people): orthostatic hypotension (dizziness when standing up).

Rare: fainting.

Respiratory, thoracic, and mediastinal disorders

Uncommon: bronchial constriction in patients with bronchial asthma or obstructive airway disease.

Rare: allergic rhinitis.

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

Not known: interstitial lung disease.

Gastrointestinal disorders:

Common: nausea, vomiting, diarrhea, constipation.

Uncommon: abdominal pain, pancreatitis.

Liver disorders:

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

Skin and subcutaneous tissue disorders:

Rare: hypersensitivity reactions (allergy) such as itching, redness, rash, irritation, urticaria. You should consult your 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 (scaly skin rash).

Musculoskeletal and connective tissue disorders:

Uncommon: muscle weakness, muscle cramps.

Reproductive system and breast disorders:

Rare: impotence.

General disorders:

Common: fatigue.

Uncommon: exhaustion.

Very rare: chest pain.

Investigations:

Common: increased cholesterol and triglyceride levels, glucose in the urine.

Uncommon: increased amylase, reversible increase in creatinine and urea.

Rare: increased liver enzymes.

Reporting of Side Effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is not listed in this leaflet.

You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: www.notificaRAM.es

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Emcoretic

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of the month stated.
• Do not store above 30°C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the Pack and Other Information

Composition of Emcoretic

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

The other ingredients are:

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

Appearance of the Product and Contents of the Pack

Emcoretic tablets are film-coated, heart-shaped, pink-gray tablets with a score line on both sides.

Each pack contains 28 or 56 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Merck, S.L.

María de Molina, 40

28006 Madrid

Spain

Manufacturers:

Merck Healthcare KGaA

Frankfurter Strasse 250

64293 Darmstadt

Germany

Or

Merck, S.L.

Merck Industrial Park

Mollet del Vallés 08100

Spain

Date of Last Revision of this Leaflet:12/2021

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es/