METOPROLOL AUROVITAS 100 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Metoprolol Aurovitas 100 mg Film-Coated Tablets EFG

Metoprolol Tartrate

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

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

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

Metoprolol Aurovitas is used for:

• Treatment of high blood pressure and to prevent symptoms of angina pectoris.
• 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 possibility of another heart attack. Metoprolol Aurovitas can also be used to prevent migraines.

2. What you need to know before you take Metoprolol Aurovitas

Do not take Metoprolol Aurovitas:

• If you are allergic to metoprolol tartrate or 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 a very slow heart rate.
• If you have very low blood pressure.

Warnings and Precautions

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

• Asthma.
• Notable problems with bronchial narrowing.
• Severe acute conditions with high concentrations of acidic substances in the body.
• Vasospastic angina (Prinzmetal's angina).
• Severe kidney dysfunction.
• Intermittent claudication. The symptoms of these patients may worsen when blood pressure decreases with metoprolol treatment.

Taking Metoprolol Aurovitas with other medicines

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

Some medicines may affect or be affected by treatment with metoprolol, such as:

• Propafenone, amiodarone, quinidine, verapamil, diltiazem, clonidine, disopyramide, and hydralazine, digitalis/digoxin (medicines for the treatment of 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 fungal skin infections).
• Rifampicin (medicine for tuberculosis treatment).
• Other beta-blockers (e.g., eye drops).
• Monoamine oxidase inhibitors (medicines used to treat depression and Parkinson's disease).
• Inhaled anesthetics (medicines for anesthesia).
• Tablets for diabetes treatment (oral antidiabetics).
• Cimetidine (medicine for 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 have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Metoprolol will only be given during pregnancy and breast-feeding if it is absolutely necessary.

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

Metoprolol may cause slower heart activity 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, so your attention may be affected.

You are the only person responsible for deciding whether you are fit to drive a motor vehicle or perform other tasks that require a high level of concentration. Due to its effects or side effects, one of the factors that can reduce your ability to do these things safely is the use of medicines.

In other sections, you can find descriptions of these effects. Read all the information in this leaflet as advice. If you are in doubt, consult your doctor or pharmacist.

Metoprolol Aurovitas contains sodium:

This medicine contains less than 23 mg of sodium (1mmol) per tablet; this is essentially "sodium-free".

3. How to take Metoprolol Aurovitas

Follow exactly the administration instructions of this medicine given by your doctor. If you are in doubt, consult your doctor or pharmacist again.

The tablets should be taken on an empty stomach and 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 taken this medicine accidentally, please contact the nearest emergency service or consult your doctor. In cases of overdose or accidental ingestion, consult the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Metoprolol Aurovitas

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

If you stop taking Metoprolol Aurovitas

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

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

4. Possible side effects

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

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

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

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

Rare(may affect up to 1 in 1,000 people):increased sweating, hair loss, changes in taste, transient alteration of sexual function, memory loss, confusion, nervousness, anxiety, hallucinations, worsening of psoriasis, hypersensitivity to sunlight, decrease in platelet count (thrombocytopenia), decreased cardiac function, alterations in heart rhythm, fainting, liver problems, vision disorders, ringing in the ears.

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 severe circulatory problems (gangrene). Dry mouth may increase the risk of caries. Therefore, it is important to maintain regular and meticulous brushing as well as dental care.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side 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 which is stated on the blister and carton after EXP. The expiry date is the last day of the month stated.

Store in the original package to protect from light.

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 Metoprolol Aurovitas

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

Core of the tablet:microcrystalline cellulose, maize starch, sodium carboxymethylcellulose (type A) (from potato), anhydrous colloidal silica, sodium lauryl sulfate, talc, magnesium stearate.

Coating of the tablet:hypromellose, titanium dioxide (E171), macrogol, polysorbate 80, talc, carmine indigo and aluminum lacquer (E132).

Appearance of the product and pack contents

Film-coated tablet.

Light blue film-coated tablets, round (diameter of 10.6 mm), marked with "C 75" on one face and with a score line on the other face of the tablet.

The tablet can be divided into equal doses.

Metoprolol tablets are available in:

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

HDPE bottles with polypropylene caps of 30 and 500 tablets.

Not all 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

Phone: 91 630 86 45

Fax: 91 630 26 64

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 medicine 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, film-coated tablet, scored

Netherlands: Metoprololtartraat Aurobindo 100 mg, film-coated tablets

Portugal: Metoprolol Aurovitas

Czech Republic: Metoprolol Aurovitas 100 mg film-coated tablets

Date of last revision of this leaflet: August 2021

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