Metoprolol Aurovitas 100 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Metoprolol Aurovitas 100 mg film-coated tablets EFG

Metoprolol tartrate

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 you should not give it to other people even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Metoprolol Aurovitas is and what it is used for

Metoprolol reduces the effects of stress hormones on the heart during physical and mental exertion. This causes the heart to beat more slowly (pulse rate decreases) in these situations.

Metoprolol Aurovitas is used for:

• Treatment of high blood pressure and prevention of angina symptoms.
• Treatment of certain types of palpitations.
• Treatment of certain types of irregular heart activity (arrhythmia).
• Treatment of increased metabolism (thyrotoxicosis).

In patients who have had a heart attack, metoprolol reduces the risk of death and the likelihood of a subsequent heart attack. Metoprolol Aurovitas may also be used to prevent migraines.

2. What you need to know before taking Metoprolol Aurovitas

Do not take Metoprolol Aurovitas:

• If you are allergic to metoprolol tartrate or to any of the other ingredients of this medicine (listed in section 6) or to other similar medicines (beta-blockers).
• If you have untreated heart failure.
• If you have severe heart block and/or very slow heart rate.
• If you have very low blood pressure.

Warnings and precautions

Talk to your doctor or pharmacist before taking metoprolol if you have any of the following conditions:

• Asthma.
• Significant bronchospasm conditions.
• Acute severe disorders with high levels of acidic substances in the body.
• Vasospastic angina (Prinzmetal's angina).
• Severe renal impairment.
• Intermittent claudication. Symptoms in these patients may worsen when blood pressure is reduced by treatment with metoprolol.

Taking Metoprolol Aurovitas with other medicines

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

Some medicines may affect or be affected by treatment with metoprolol, for example:

• Propafenone, amiodarone, quinidine, verapamil, diltiazem, clonidine, disopyramide, and hydralazine, digitalis/digoxin (medicines for cardiovascular disease).
• Barbituric acid derivatives (antiepileptic medicines).
• Anti-inflammatory medicines (e.g., indomethacin and celecoxib).
• Adrenaline (medicine for acute shock and severe allergic reactions).
• Phenylpropanolamine (medicine for nasal mucosa swelling).
• Diphenhydramine (medicine for allergy treatment).
• Terbinafine (medicine for treatment of fungal skin infections).
• Rifampicin (medicine for treatment of tuberculosis).
• Other beta-blockers (e.g., eye drops).
• Monoamine oxidase inhibitors (medicines used to treat depression and Parkinson's disease).
• Inhaled anaesthetics (medicines for anaesthesia).
• Tablets for treating diabetes (oral antidiabetics). Metoprolol may increase the risk of severe hypoglycaemia when used with certain types of antidiabetic drugs called sulfonylureas (for example: gliquidone, gliclazide, glibenclamide, glipizide, glimepiride or tolbutamide).
• Cimetidine (medicine for treating acidity and acid reflux).
• Antidepressants (paroxetine, fluoxetine and sertraline).

Taking Metoprolol Aurovitas with food and drinks

Metoprolol should be taken on an empty stomach.

Pregnancy and breast-feeding

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

Metoprolol will be administered during pregnancy and breast-feeding only if absolutely necessary.

Beta-blockers, including metoprolol, may cause harm to the fetus and premature delivery.

Metoprolol may cause a slower heart rate in the fetus and newborn. Metoprolol is excreted in breast milk and may potentially affect the baby.

Driving and using machines

Metoprolol may make you feel tired or dizzy, therefore your level of attention may be affected.

You are solely responsible for deciding whether you are fit to drive a motor vehicle or perform other tasks requiring a high level of concentration. Due to its effects or adverse reactions, one of the factors that may reduce your ability to safely perform these activities is the use of medicines.

Descriptions of these effects can be found in other sections. Read all the information in this leaflet for guidance. If in doubt, consult your doctor or pharmacist.

Metoprolol Aurovitas contains sodium:

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

3. How to take Metoprolol Aurovitas

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

The tablets should be taken on an empty stomach and should be swallowed with at least half a glass of water.

If you take more Metoprolol Aurovitas than you should

If you have taken more Metoprolol Aurovitas than you should, or if a child has accidentally taken this medicine, please contact the nearest emergency service or consult your doctor. In cases of overdose or accidental ingestion, contact the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Metoprolol Aurovitas

Do not take a double dose to make up for missed doses.

If you stop taking Metoprolol Aurovitas

Do not stop taking metoprolol suddenly without first consulting your doctor, as this may worsen certain symptoms (for example, palpitations or angina pectoris).

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.

Very common (may affect more than 1 in 10 people): tiredness.

Common (may affect up to 1 in 10 people): headache, dizziness, cold hands and feet, slow heartbeat, palpitations, abdominal pain, nausea, vomiting, diarrhoea, constipation, difficulty breathing.

Uncommon (may affect up to 1 in 100 people): chest pain, weight gain, difficulty sleeping, skin tingling, worsening of respiratory symptoms, skin hypersensitivity reactions, fluid retention, temporary worsening of heart failure symptoms, nightmares, depression. During a heart attack, blood pressure may drop severely.

Rare (may affect up to 1 in 1,000 people): increased sweating, hair loss, taste disturbances, transient sexual dysfunction, memory loss, confusion, restlessness, anxiety, hallucinations, worsening of psoriasis, photosensitivity, decrease in platelet count (thrombocytopenia), reduced cardiac function, heart rhythm disorders, fainting, liver problems, vision disorders, tinnitus.

The following reactions have been reported in isolated cases: joint pain, muscle cramps, dry mouth, eye irritation and dryness, allergic rhinitis, poor concentration, tissue death in patients with serious circulatory problems (gangrene). Dry mouth may increase the risk of dental caries. Therefore, it is important to maintain regular and thorough tooth brushing, as well as regular dental check-ups.

Reporting of adverse effects

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

5. Storage of Metoprolol Aurovitas

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

Do not use this medicine after the expiry date stated on the blister and carton after EXP. The expiry date is the last day of the month indicated.

Store in the original packaging to protect from light.

Medicines should not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Metoprolol Aurovitas

• The active substance is metoprolol tartrate. Each film-coated tablet contains 100 mg of metoprolol tartrate.
• The other components are:

Tablet core: microcrystalline cellulose, corn starch, sodium carboxymethyl starch (type A) (from potato), anhydrous colloidal silica, sodium lauryl sulfate, talc, magnesium stearate.

Tablet coating: hypromellose, titanium dioxide (E171), macrogol, polysorbate 80, talc, indigo carmine and aluminium lake (E132).

Appearance of the product and contents of the pack

Film-coated tablet.

Light blue, round film-coated tablets (10.6 mm in diameter), marked with “C 75” on one side and with a score line on the other side.

The tablet can be divided into equal doses.

Metoprolol tablets are available in:

PVC/PVdC-aluminum foil blister packs containing 20, 28, 30, 40, 50, 60, 84 and 90 tablets.

HDPE bottles with polypropylene closure containing 30 and 500 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Or

Arrow Génériques

26 avenue Tony Garnier

69007 Lyon

France

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Spain: Metoprolol Aurovitas 100 mg film-coated tablets EFG

France: METOPROLOL ARROW LAB 100 mg, scored film-coated tablet

Netherlands: Metoprololtartraat Aurobindo 100 mg, filmomhulde tabletten

Portugal: Metoprolol Aurovitas

Date of the most recent revision of this leaflet: April 2026

Detailed 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)