Leaflet: information for the user

Metoprolol Aurovitas 100 mg film-coated tablets EFG

Metoprolol tartrate

Read 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only; do not give it 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 leaflet. See section 4.

1. What isMetoprolol Aurovitasand what it is used for

2. What you need to know before you start takingMetoprolol Aurovitas

3. How to takeMetoprolol Aurovitas

4. Possible side effects

5. Storage ofMetoprolol Aurovitas

6. Contents of the pack and additional information

Metoprolol reduces the effect of hormones produced by stress on the heart during physical and mental effort. This leads to the heart beating slower (pulse rate decreases) in these situations.

Metoprolol Aurovitas is used for:

• The treatment of high blood pressure and to prevent symptoms of angina pectoris.
• The treatment of some types of palpitations.
• The treatment of some types of irregular heart activity (arrhythmia).
• The treatment of increased metabolism (thyrotoxicosis).

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

Do not take Metoprolol Aurovitas:

• If you are allergic to metoprolol tartrate or to any of the other ingredients of this medication (listed in section 6) or to other similar medications (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

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

• Asthma.
• Notable problems with bronchial constriction.
• Severe acute conditions with high acid concentrations in the body.
• Variant angina (Prinzmetal's angina).
• Severe renal dysfunction.
• Intermittent claudication. Symptoms of these patients may worsen when blood pressure decreases with metoprolol treatment.

Metoprolol Aurovitas with other medications

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

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

• Propafenone, amiodarone, quinidine, verapamil, diltiazem, clonidine, disopyramide, and hydralazine (cardiovascular disease medications).
• Barbiturate derivatives (antiepileptic medications).
• Anti-inflammatory medications (e.g., indomethacin and celecoxib).
• Adrenaline (medication for acute shock and severe allergic reactions).
• Phenylpropanolamine (medication for nasal mucosa swelling).
• Diphenhydramine (medication for allergy treatment).
• Terbinafine (medication for fungal skin infections).
• Rifampicin (medication for tuberculosis treatment).
• Other beta-blockers (e.g., eye drops).
• Monamine oxidase inhibitors (medications used to treat depression and Parkinson's disease).
• Inhaled anesthetics (medications for anesthesia).
• Oral diabetes medications (antidiabetic medications).
• Cimetidine (medication for acid reflux and heartburn).
• Antidepressants (paroxetine, fluoxetine, and sertraline).

Metoprolol Aurovitas with food and drinksand beverages

Metoprolol should be taken on an empty stomach.

Pregnancy and breastfeeding

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

Metoprolol will only be administered during pregnancy and breastfeeding if absolutely necessary.

Beta-blockers, including metoprolol, may cause fetal damage 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 operating machinery

Metoprolol may make you feel tired or dizzy, so your level of attention may be impaired.

You are the only one responsible for deciding if you are fit to drive a motor vehicle or perform other tasks that require high concentration. Due to its effects or adverse reactions, one of the factors that may reduce your ability to do these things safely is the use of medications.

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

Metoprolol Aurovitas contains sodium:

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

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

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 accidentally taken this medication, please contact the nearest emergency service or consult your doctor. In cases of overdose or accidental ingestion, consult the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Metoprolol Aurovitas

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Metoprolol Aurovitas

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

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

Like all medications, this medication may produce adverse effects, although not all people will experience them.

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

Frequent(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.

Infrequent(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, 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, light sensitivity, decreased platelet count (thrombocytopenia), decreased cardiac function, cardiac rhythm alterations, fainting, liver problems, vision disturbances, 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, concentration difficulties, death of tissues in patients with severe circulatory problems (gangrene). Dry mouth may increase the risk of tooth decay. Therefore, it is essential to maintain regular and meticulous brushing and dental assistance.

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting adverse effects, you 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 blister and carton after CAD. The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from light.

Medications should not be disposed of through drains or trash. Dispose of containers and medications you no longer need at the SIGRE collection point at the pharmacy.Ask your pharmacist how to dispose of containers and medications you no longer need if you are unsure. By doing so, you will help protect the environment.

Composition of Metoprolol Aurovitas

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

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

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

Appearance of the product and contents of the package

Film-coated tablet.

Blue-colored, clear film-coated, round tablets (diameter of 10.6 mm), marked with “C 75” on one face and with a notch on the other face of the tablet.

The tablet can be divided into equal doses.

Metoprolol tablets are available in:

PVC/PVdC blister packs with aluminum foil backing in 20, 28, 30, 40, 50, 60, 84, and 90 tablet sizes.

HDPE bottles with polypropylene closures in 30 and 500 tablet sizes.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Tel.: 91 630 86 45

Fax: 91 630 26 64

Responsible manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

O

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, breakable tablet

Netherlands:Metoprololtartraat Aurobindo 100 mg, film-coated tablets

Portugal:Metoprolol Aurovitas

Czech Republic:Metoprolol Aurovitas 100 mg coated tablets

Last review date of this leaflet: August 2021

More detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es)