Document: Metoprolol Aurobindo film-coated tablet ENG PL change

• Metoprolol Aurobindo film-coated tablet PL
• Metoprolol Aurobindo film-coated tablet ENG PL

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Package leaflet: Information for the user

Metoprolol Aurobindo 50 mg film-coated tablets

Metoprolol Aurobindo 100 mg film-coated tablets

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.

What is in this leaflet

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 the stress hormones on the heart in connection with physical and mental exertion. This results in the heart beating slower (pulse rate is reduced).

It is used to treat:

• high blood pressure

• angina pectoris (pain in the chest caused by lack of oxygen in the heart)

• irregular heart rhythm (arrhythmia).

in adults.

It is used to prevent:

• migraine

• heart damage, heart death or further heart attacks after a heart attack.

in adults.

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

Do not take Metoprolol Aurobindo if you:

• are allergic to metoprolol tartrate, other beta-blockers or any of the other ingredients of this medicine (listed in section 6)

• have heart conduction problems (serious AV-block or sinoatrial block)

• suffer from sick sinus syndrome

• have untreated heart failure, are receiving treatment to increase heart contractions or are in shock caused by heart problems

• suffer from severely blocked blood vessels, including blood circulation problems (which may cause your fingers and toes to tingle or turn pale or blue)

• have a slow heart rate (less than 50 beats/min)

• have low blood pressure

• suffer from increased acidity of the blood (metabolic acidosis)

• have severe asthma or COPD (chronic obstructive pulmonary disease)

• are receiving other blood pressure lowering medicines such as verapamil and diltiazam by intravenous injection. See also “Other medicines and Metoprolol Aurobindo”

• are using antiarrrhythmics such as disopyramide. See also “Other medicines and Metoprolol Aurobindo”

• have untreated high blood pressure due to tumour of the adrenal medulla (phaechromocytoma).

Warnings and precautions

Talk to your doctor or pharmacist before taking Metoprolol Aurobindo if you:

• have asthma

• have diabetes mellitus (low blood sugar levels may be hidden by this medicine)

• have high blood pressure due to tumour of the adrenal medulla (treated phaeochromocytoma)

• are having treatment to reduce allergic reactions. Metoprolol Aurobindo may increase your hypersensitivity to the substances you are allergic to and increase the severity of allergic reactions

• have an overactive thyroid, (symptoms such as increased heart rate, sweating, tremor, anxiety, increased appetite or weight loss may be hidden by this medicine)

• have or have suffered from skin rashes called psoriasis

• suffer from blood circulation problems (in the fingers, toes, arms and legs)

• suffer from a heart conduction disorder (AV block)

• have a type of chest pain called Prinzmetal’s angina.

• have heart failure and one of the following:

If are going to have an anaesthetic, please tell your doctor or dentist that you are taking Metoprolol Aurobindo.

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

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

Metoprolol Aurobindo tablets can affect how some other medicines work, and some medicines an also affect how metoprolol work. If Metoprolol Aurobindo tablets are to be combined with the medicines listed below, you must consult your doctor before taking this medicine:

The following combination 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 disease)

The following combinations with metoprolol may require dose adjustment:

• Amiodarone, disopyramide (for irregular heart rhythm)

• Indomethacin, sulindac, diclofenac and foctafenine (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 in malaria)

• Terbinafine (for fungal infection of skin)

• Cimetidine (for ulcers)

• Digitalis glycosides such as digoxin (used in heart failure)

• Epinephrine (medicine used in acute shock and severe allergic reaction)

• Phenylpropanolamine (used to reduce swelling of the nasal mucosa)

• Other beta blockers e.g. eye drops

• Monoamine oxidase inhibitors (MAOIs) (used to treat depression and Parkinson’s disease)

• Clonidine, guanfacin, moxonidine, methyldopa, rilmenidine (blood pressure lowering medicines)

• Ergotamine (used in migraine)

• Nitrates such as nitroglycerine (used in angina)

• General anaesthetics

• Insulin and oral antidiabetic (for reducing blood sugar level) medicines

• Prazosine, tamsulosin, terazosine, doxazosine (alpha blockers, used to treat high blood pressure and benign prostatic hyperplasia)

• Lidocaine (local anaesthetic)

• Rifampicine (used to treat tuberculosis)

• Antacids (used for stomach upsets).

Metoprolol Aurobindo with alcohol

You are advised to avoid alcohol whilst taking this medicine. Alcohol may increase the blood pressure lowering effect of Metoprolol Aurobindo.

Pregnancy, breast-feeding and fertility

Metoprolol Aurobindo is not recommended during pregnancy or breastfeeding. 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.

Driving and using machines

Metoprolol Aurobindo may make you feel tired and dizzy. Make sure you are not affected before you drive or operate machinery.

3. How to take Metoprolol Aurobindo

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Metoprolol Aurobindo should be taken without food and on an empty stomach.

Metoprolol Aurobindo tablets can be divided into equal doses.

The recommended dose is:

Initially 100 mg daily.

Usually 50-100 mg twice daily.

100-200 mg daily.

The usual maintenance dose is 100 mg twice daily.

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 your nearest casualty department or tell your doctor or pharmacist at once. Depending on the extent of the overdose, this can lead to excessive reduction in blood pressure and a decrease in heart rate. As a consequence of the failure of heart function, this can even lead to cardiac arrest, heart muscle weakness and shock. Other symptoms include problems in breathing, constriction of the muscles in the respiratory tract, vomiting, disturbances of consciousness and even occasionally generalised 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 nearly time for your next dose. Then go on as before. Do not take a double dose to make up for a forgotten dose.

If you stop taking Metoprolol Aurobindo

Do not suddenly stop taking Metoprolol Aurobindo as this may cause worsening of heart failure and increase the risk of heart attack. Only change the dose or stop the treatment in consultation with your doctor.

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.

Stop treatment and contact a doctor at once if you have:

This is a very serious but rare side effect. You may need urgent medical attention or hospitalisation.

Tell your doctor if you notice any of the following side effects or notice any other effects not listed:

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

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

• slow heart rate,

• difficulties in maintaining balance (very rare with fainting),

• cold hands and feet,

• palpitation,

• dizziness,

• headache,

• feeling sick,

• diarrhoea,

• constipation,

• stomach pain,

• shortness of breath with strenuous physical activity.

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

• chest pain,

• weight gain,

• depression

• concentration problems

• inability to sleep (insomnia)

• drowsinees

• nightmares

• tingling in the skin,

• temporary worsening of symptoms of heart failure

• disturbances in the conduction of the heart

• spasmodic contraction of the smooth muscle of the bronchi (causing shortness of breath),

• vomiting

• rashes

• increased sweating

• fluid retention

• muscle cramps

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

• worsening of diabetes,

• nervousness,

• anxiety,

• visual disturbances,

• dry or irritated eyes,

• conjunctivitis,

• impotence, other sexual dysfunctions,

• Peyronie’s syndrome (bending of penis on erection),

• irregular heart beat,

• heart conduction disturbances,

• 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,

• forgetfulness, memory impairment

• confusion,

• hallucinations,

• personality changes e.g. mood changes,

• ringing in the ears (tinnitus),

• hearing problems,

• taste changes,

• inflammation of the liver (hepatitis),

• sensitivity to light,

• worsening or new psoriasis, psoriasis like changes

• muscle weakness,

• joint pain,

• tissue death in patients with severe circulation disturbances.

Reporting of side effects

If you get 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 via the national reporting system listed in Appendix V. 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 medicineafter the expiry date which is stated on the blister, carton and bottle label after EXP. The expiry date refers to the last day of that month.

Store in the original package in order to protect from light.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Metoprolol Aurobindo contains

Tablet core:Cellulose microcrystalline, maize starch, sodium starch glycolate, silica colloidal anhydrous, sodium laurilsulfate, talc, magnesium stearate.

Tablet coating:

50 mg: Hypromellose, titanium dioxide (E171), polysorbate 80, talc, iron oxide red (E172).

100 mg: Hypromellose, titanium dioxide (E171), macrogol, polysorbate 80, talc, indigo carmine aluminium lake (E132).

What Metoprolol Aurobindo looks like and contents of the pack

Metoprolol Aurobindo 50 mg:

Peach coloured, round shaped [diameter 8.1 mm], film-coated tablets, debossed with ‘C over 74’ on one side and deep score line on the other side. The tablet can be divided into equal doses.

Metoprolol Aurobindo 100 mg:

Light blue coloured, round shaped [diameter 10.6 mm], film-coated tablets, debossed with ‘C over 75’ on one side and deep score line on the other side. The tablet can be divided into equal doses.

Metoprolol tablets are available in PVC/PVdC – Aluminium blister pack: 20, 28, 30, 50, 56, 60 and 100 tablets

HDPE bottle pack with polypropylene closure: 30 and 500 tablets.

Not all pack sizes may be marketed

Marketing Authorisation Holder

[To be completed nationally]

Manufacturer

[To be completed nationally]

This medicinal product is authorised in the Member States of the EEA under the following names:

Germany: Metoprolol Aurobindo 50 mg/100mgFilmtabletten

Italy: Metoprololo Aurobindo 100 mg compresse rivestite con film.

Malta: MetoprololAurobindo 50 mg/100 mgfilm-coated tablets

Poland: Selmet

Portugal: MetoprololAurobindo

Sweden: Metoprolol Aurobindo 50 mg/100 mgfilmdragerade tabletter

Romania Metoprolol tartrat Aurobindo 50 mg/100 mgcomprimate filmate

United Kingdom: Metoprololtartrate 50 mg/100 mg film-coated tablets

This leaflet was last revised in 10 Mars 2016