Emcoretic 10 mg/25 mg film-coated tablets

Package leaflet: Information for the user

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, 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 may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

What is in this leaflet

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

1. What Emcoretic is and what it is used for

Emcoretic contains a combination of two active substances: bisoprolol fumarate and hydrochlorothiazide.

This combination is used for the treatment of 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 taking Emcoretic

Do not take Emcoretic

If you are allergic to bisoprolol, hydrochlorothiazide, other medicines in the same group (thiazides, sulfonamides), or 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 may cause tingling in the fingers and toes or make them pale or blue.
• Untreated phaeochromocytoma, which is a rare tumor of the adrenal gland.
• Metabolic acidosis, a condition that occurs when there is too much acid in the blood.
• Severe renal insufficiency.
• Severe hepatic insufficiency.
• 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 any of the following heart problems:

• Acute heart failure.
• Worsening heart failure requiring intravenous injection of medicines that increase the strength of heart contractions.
• Certain heart conditions causing very slow heart rate or irregular pulse (second- or third-degree atrioventricular block without pacemaker, sick sinus syndrome, sinoatrial block).
• Cardiogenic shock, a severe and acute heart disease causing low 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, 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 radiation while taking Emcoretic.

If you have any of the following conditions, 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.
• Reduced blood volume (hypovolemia).
• Circulatory problems in the legs.
• Asthma or chronic respiratory disease. Your doctor may need to adjust your asthma medication doses.
• Obstructive respiratory disease.
• History of psoriasis (scaly skin rash).
• Tumor of the adrenal gland (phaeochromocytoma).
• If you have previously experienced respiratory or pulmonary problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop dyspnea or severe difficulty breathing after taking Emcoretic, seek medical attention immediately.

Additionally, inform your doctor if you are undergoing:

• Desensitization treatment (e.g., for hay fever prevention), as Emcoretic may make allergic reactions more likely or more severe.
• Anesthesia (e.g., for surgery), as Emcoretic may affect how your body responds in this situation.

You should also be aware that:

• This medicine may increase your sensitivity to sunlight or UVA radiation. Avoid exposure to sunlight (even when cloudy) and tanning lamps (UVA) while taking this medicine.
• During long-term treatment, your doctor may perform periodic checks of blood levels of certain substances (electrolytes, creatinine, urea, lipids, uric acid, and glucose).
• If you have elevated blood uric acid levels, there may be an increased risk of gout attacks.

If you experience decreased vision or eye pain, these could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure, which may occur within hours to a week after taking Emcoretic. Your doctor will advise whether you should stop or change treatment. The risk of such effects is higher if you are allergic to penicillin or sulfonamides.

Use in athletes

This medicine contains hydrochlorothiazide, which may result in a positive doping test.

Other medicines and Emcoretic

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

Do not take the following medicines with Emcoretic without specific 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, moxonidine. However, do not stop taking these medicines without first consulting your doctor.

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

• Certain medicines used to treat irregular or abnormal heartbeats.
• Medicines used to treat high blood pressure or angina.
• Some eye drops used to treat glaucoma (containing beta-blockers).
• Some medicines used to treat Alzheimer's disease, dementia, or glaucoma.
• Medicines used to treat acute heart problems.
• 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 antidepressants.
• Medicines that may cause potassium loss (e.g., corticosteroids, diuretics, laxatives...).
• Methyldopa, used to lower blood pressure.
• Medicines to reduce uric acid levels, which may be less effective.
• Cholestyramine, colestipol (used to lower cholesterol): may reduce the effectiveness of Emcoretic.
• Mefloquine, used for prevention or treatment of malaria.
• Corticosteroids, which may reduce the effect of Emcoretic.

In particular, inform your doctor if you are taking any of the following:

• Medicines for diabetes such as insulin and sulfonylureas (e.g., glibenclamide, gliquidone, gliclazide, glipizide, glimepiride, or tolbutamide). Bisoprolol may increase the risk of severe hypoglycemia when used with these medicines.

Pregnancy and breastfeeding

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

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 whether you can take Emcoretic during pregnancy.

The components of Emcoretic may pass into breast milk; therefore, breastfeeding is not recommended while being treated with Emcoretic.

Driving and using machines

Your ability to drive or operate machinery may be affected depending on how well you tolerate the medicine. Exercise particular caution at the beginning of treatment, when changing doses or treatments, and when taking alcohol.

3. How to take Emcoretic

Follow exactly the instructions given by your doctor for taking this medicine. If you are unsure, consult your doctor again.

Treatment with Emcoretic may require individual dose adjustment at the beginning of treatment and during dose escalation.

If you have renal or hepatic impairment, you may require 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 stop treatment completely, your doctor will advise you to gradually reduce the dose, as otherwise your condition may worsen.

Use in children

Emcoretic is not recommended for use in children.

If you take more Emcoretic than you should

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 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 missed doses. Take your usual dose the next morning.

If you stop taking Emcoretic

Never stop taking Emcoretic unless advised by your doctor. Otherwise, your condition could worsen significantly.

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

4. Possible adverse effects

Like all medicines, Emcoretic may produce adverse effects, although not everyone experiences them.

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

Below are other adverse effects listed by 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: decreased white blood cells and platelets in blood.

Very rare: decreased white blood cells in blood.

Metabolism and nutrition disorders:

Common: increased 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 in contact lens wearers), vision disorders.

Very rare: conjunctivitis.

Not known: decreased vision or eye pain due to elevated 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: decreased heart rate, disorders of electrical conduction in the heart, worsening of heart failure.

Vascular disorders:

Common: sensation of cold or numbness in the extremities.

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

Rare: fainting.

Respiratory, thoracic and mediastinal disorders:

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

Rare: allergic rhinitis.

Very rare: acute breathing difficulty (symptoms include severe shortness of breath, fever, weakness, and confusion).

Not known: interstitial lung disease.

Gastrointestinal disorders:

Common: nausea, vomiting, diarrhoea, constipation.

Uncommon: abdominal pain, pancreatitis.

Hepatic 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, onset or worsening of psoriasis (scaly skin disorder).

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 urine.

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

Rare: increased liver enzymes.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.

You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Emcoretic

Keep this medicine out of sight and reach of children.

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

Do not store above 30°C.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of unused medicines and their containers. This 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 coated tablet contains 10 mg of bisoprolol fumarate and 25 mg of hydrochlorothiazide.

• The other components are:

• Tablet core: anhydrous colloidal silica, magnesium stearate, corn starch, microcrystalline cellulose, calcium hydrogen phosphate (anhydrous).

• Coating: iron oxide red (E172), iron oxide black (E172), dimethicone, macrogol 400, titanium dioxide (E171), hypromellose.

Appearance of the product and contents of the pack

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

Each pack contains 28 or 56 tablets. Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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.

Polígono Merck

Mollet del Vallés 08100

Spain

Date of the most recent revision of this leaflet: 10/2025

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