Metoprolol Aurobindo

Package leaflet: Information for the user

Metoprolol Aurobindo 100 mg film-coated tablets

Generic medicine
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. 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 their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Metoprolol Aurobindo contains metoprolol tartrate, which belongs to a group of medicines called
beta-blockers. Metoprolol tartrate reduces the effect of stress hormones on the heart related to
physical and mental exertion. This causes a slowing of the heartbeat (pulse rate is reduced).
It is used to treat:

• high blood pressure
• angina pectoris (chest pain caused by lack of oxygen to the heart)
• irregular heart rhythm (arrhythmia) in adults.

It is used to prevent:

• migraine
• heart damage, cardiac death, or further heart attacks after a heart attack in adults.

2. What you need to know before taking Metoprolol Aurobindo

Do not take Metoprolol Aurobindo if:

• you are allergic to metoprolol tartrate, to other beta-blockers, or to any of the other ingredients of this medicine (listed in section 6)
• you have heart conduction problems (severe atrioventricular block or sinoatrial block)
• you suffer from sick sinus syndrome
• you have untreated heart failure, are receiving treatment to increase heart contractions, or are in shock due to heart problems
• you have severely blocked blood vessels, including circulation problems (which may cause tingling in the fingers and toes or make them pale or blue)
• you have a slow heart rate (less than 50 beats/min)
• you have low blood pressure
• you suffer from increased blood acidity (metabolic acidosis)
• you have severe asthma or chronic obstructive pulmonary disease
• you are taking other medicines to lower blood pressure such as verapamil and diltiazem administered intravenously. See also “Other medicines and Metoprolol Aurobindo”
• you are using antiarrhythmics such as disopyramide. See “Other medicines and Metoprolol Aurobindo”
• you have untreated high blood pressure due to a tumour of the adrenal medulla (pheochromocytoma).

Warnings and precautions
Talk to your doctor or pharmacist before taking Metoprolol Aurobindo if:

• you have asthma
• you have diabetes mellitus (low blood sugar levels may be masked by this medicine)
• you have high blood pressure due to a tumour of the adrenal medulla (treated pheochromocytoma)
• you are undergoing treatment to reduce allergic reactions. Metoprolol Aurobindo may increase your hypersensitivity to substances you are allergic to and increase the severity of allergic reactions
• you have an overactive thyroid (symptoms such as increased heart rate, sweating, tremor, anxiety, increased appetite, or weight loss may be masked by this medicine)
• you have or have had skin rashes called psoriasis
• you suffer from circulation problems (in the fingers and toes, arms and legs)
• you have a heart conduction disorder (atrioventricular block)
• you have a type of chest pain called Prinzmetal's angina
• you have heart failure and one of the following conditions:
• you have had a heart attack or an episode of angina within the last 28 days
• reduced kidney or liver function
• you are under 40 years or over 80 years of age
• heart valve diseases
• enlarged heart muscle
• you have had heart surgery within the last 4 months
• you have unstable heart failure If you are about to receive an anaesthetic, inform your doctor or dentist that you are taking Metoprolol Aurobindo.

For athletes: Using this medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.
Children and adolescents
There is limited data on the use of metoprolol in children and adolescents; therefore, the use of metoprolol is not recommended.

Other medicines and Metoprolol Aurobindo
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Metoprolol Aurobindo tablets may affect how some other medicines work, and some medicines may, in turn, affect how metoprolol works. If Metoprolol Aurobindo tablets are taken together with the medicines listed below, you must consult your doctor before taking this medicine:

The following combinations with metoprolol should be avoided:

• barbituric acid derivatives, e.g. phenobarbital (used to treat epilepsy)
• propafenone, quinidine, verapamil, diltiazem, nifedipine, and amlodipine (used to treat cardiovascular diseases)

The following combinations with metoprolol may require dose adjustment:

• amiodarone, disopyramide (for irregular heart rhythm)
• indomethacin, sulindac, diclofenac, and floctafennine (medicines used to reduce inflammation, fever, and pain)
• fluoxetine, paroxetine, and bupropion (medicines used to treat depression)
• thioridazine (antipsychotic)
• ritonavir (antiretroviral)
• diphenhydramine (antihistamine)
• hydroxychloroquine, mefloquine (used for malaria)
• terbinafine (for fungal skin infections)
• cimetidine (for ulcers)
• digitalis glycosides such as digoxin (used in heart failure)
• epinephrine (medicines used in acute shock and severe allergic reactions)
• phenylpropanolamine (used to treat nasal mucosa thickening)
• other beta-blockers, e.g. eye drops
• monoamine oxidase inhibitors (MAOIs) (used to treat depression and Parkinson's disease)
• clonidine, guanfacine, moxonidine, methyldopa, rilmenidine (medicines to lower blood pressure)
• ergotamine (used for migraine)
• nitrates such as nitroglycerin (used for angina)
• general anaesthetics
• insulin and oral antidiabetic medicines (to reduce blood sugar levels)
• prazosin, tamsulosin, terazosin, doxazosin (alpha-blockers, used to treat hypertension and benign prostatic hyperplasia)
• lidocaine (local anaesthetic)
• rifampicin (used to treat tuberculosis)
• antacids (used for stomach problems).

Metoprolol Aurobindo and alcohol
It is recommended to avoid alcohol while taking this medicine. Alcohol may increase the blood pressure-lowering effect of Metoprolol Aurobindo.

Pregnancy, breastfeeding, and fertility
The use of Metoprolol Aurobindo is not recommended during pregnancy and breastfeeding. If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Driving and using machines
Metoprolol Aurobindo may cause tiredness and dizziness. Make sure you are not affected by these symptoms before driving or operating machinery.

3. How to take Metoprolol Aurobindo

Take this medicine exactly as directed by your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
Metoprolol Aurobindo should be taken without food and on an empty stomach.
Metoprolol Aurobindo tablets may be divided into equal doses.
The recommended dose is:

• High blood pressure: Initially 100 mg daily.
• Angina pectoris: Usually 50–100 mg twice daily.
• Irregular heartbeat (arrhythmia): 100–200 mg daily.
• Preventive treatment after a heart attack: The usual maintenance dose is 100 mg twice daily.
• Migraine prevention: 50–100 mg twice daily.

If you take more Metoprolol Aurobindo than you should
If you have accidentally taken more than the prescribed dose, contact the nearest emergency department, or inform
your doctor or pharmacist immediately. Depending on the severity of the overdose, this may lead to
excessive lowering of blood pressure and reduced heart rate. As a consequence
of heart failure, this may also lead to cardiac arrest, weakening of the heart muscle, and
shock. Other symptoms include breathing difficulties, constriction of the respiratory tract muscles, vomiting,
disturbances of consciousness, and occasionally generalized seizures.
If you forget to take Metoprolol Aurobindo
If you forget to take a dose, take it as soon as you remember, unless it is almost time for the
next dose. Then continue as usual. Do not take a double dose to make up for
the missed dose.
If you stop taking Metoprolol Aurobindo
Do not stop taking Metoprolol Aurobindo suddenly, as this may worsen heart failure and increase the risk of a heart attack. Only adjust the dose or stop treatment after consulting your doctor.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking the medicine and contact your doctor immediately if you experience:

• an allergic reaction such as itchy rash, flushing, swelling of the face, lips, tongue or throat, or difficulty breathing or swallowing. This is a very serious but rare side effect. You may require urgent medical attention or hospitalisation.

Tell your doctor if you notice any of the following side effects or any other side effect not listed below:
Very common (may affect more than 1 in 10 people):

• feeling faint when standing due to low blood pressure, tiredness.

Common (may affect up to 1 in 10 people):

• slow heart rate
• difficulty maintaining balance (very rarely with fainting)
• cold hands and feet
• palpitations
• dizziness
• headache
• feeling unwell
• diarrhoea
• constipation
• stomach ache
• shortness of breath following strenuous physical activity.

Uncommon (may affect up to 1 in 100 people):

• chest pain
• weight gain
• depression
• difficulty concentrating
• inability to sleep (insomnia)
• drowsiness
• nightmares
• skin tingling
• temporary worsening of heart failure symptoms
• heart conduction disorders
• spasmodic contraction of the smooth muscles of the bronchi (causing shortness of breath)
• vomiting
• skin rashes
• increased sweating
• fluid retention
• muscle cramps.

Rare (may affect up to 1 in 1,000 people):

• worsening of diabetes
• restlessness
• anxiety
• visual disturbances
• dry or irritated eyes
• conjunctivitis
• impotence, other sexual dysfunction
• Peyronie's syndrome (bending of the penis during erection)
• irregular heartbeat
• cardiac conduction disorders
• dry mouth
• runny nose
• hair loss
• changes in liver function tests.

Very rare (may affect up to 1 in 10,000 people):

• changes in blood cells
• loss or impairment of memory
• confusion
• hallucinations
• changes in personality, e.g. mood changes
• ringing in the ears (tinnitus)
• hearing problems
• taste disturbances
• liver inflammation (hepatitis)
• light sensitivity
• worsening of existing psoriasis or new onset of psoriasis, psoriasis-like skin changes
• muscle weakness
• joint pain
• tissue death in patients with severe circulatory disorders.

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at:
www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Metoprolol Aurobindo

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister, the carton, and the label of the
bottle after EXP. The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from light.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Metoprololo Aurobindo contains
The active substance is metoprolol tartrate. Each film-coated tablet contains 100 mg of
metoprolol tartrate.
The other components are:
Tablet core: microcrystalline cellulose, maize starch, sodium starch glycolate, anhydrous colloidal silica, sodium lauryl sulfate, talc, magnesium stearate.
Tablet coating: hypromellose, titanium dioxide (E171), macrogol, polysorbate 80, talc, indigo carmine aluminium lake (E132).

Description of the appearance of Metoprololo Aurobindo and pack contents
Metoprololo Aurobindo 100 mg:
Blue, round film-coated tablets [diameter 10.6 mm], marked with 'C on 75' on one side and a deep score line on the other side. The tablets can be divided into equal doses.
Metoprolol tablets are available in PVC/PVdC – aluminium foil blisters: 20, 28, 30, 50, 56, 60 and 100 tablets.
HDPE bottle with polypropylene closure: 30 and 500 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Aurobindo Pharma (Italia) s.r.l.
via San Giuseppe, 102
21047 - Saronno (VA)
Italy

Manufacturers responsible for batch release
APL Swift Services (Malta) Limited,
HF26, Hal Far Industrial Estate, Hal Far, Birzebbugia, BBG 3000
Malta
Milpharm Limited
Ares Block, Odyssey Business Park, West End Road,
Ruislip HA4 6QD
United Kingdom

This medicinal product is authorized in the European Economic Area Member States under the following names:
Italy: Metoprololo Aurobindo
Malta: Metoprolol Aurobindo 50 mg/100 mg film-coated tablets
Poland: Selmet
Portugal: Metoprolol Aurobindo
Sweden: Metoprolol Aurobindo 50 mg/100 mg filmdragerade tabletter
Romania: Metoprolol tartrat Aurobindo 50 mg/100 mg comprimate filmate
United Kingdom: Metoprolol tartrate 50 mg/100 mg film-coated tablets