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METOPROLOL TARTRATE 50MG FILM-COATED TABLETS

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Package leaflet: Information for the user
Metoprolol 50 mg film-coated tablets
Metoprolol 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.

What is in this leaflet
1.
2.
3.
4.
5.
6.

What Metoprolol is and what it is used for
What you need to know before you take Metoprolol
How to take Metoprolol
Possible side effects
How to store Metoprolol
Contents of the pack and other information

1.

What Metoprolol is and what it is used for

Metoprolol 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

Do not take Metoprolol 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 ”
are using antiarrrhythmics such as disopyramide. See also “Other medicines and Metoprolol

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 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 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:
- had a heart attack or angina attack in the last 28 days
- reduced kidney or liver function
- are under 40 years old or over 80 years old
- diseases of the heart valves
- enlarged heart muscle
- had heart surgery in the last 4 months
- have unstable heart failure .
If are going to have an anaesthetic, please tell your doctor or dentist that you are taking Metoprolol
.
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
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
Metoprolol tablets can affect how some other medicines work, and some medicines an also affect how
metoprolol work. If Metoprolol 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 with alcohol
You are advised to avoid alcohol whilst taking this medicine. Alcohol may increase the blood pressure
lowering effect of Metoprolol .
Pregnancy, breast-feeding and fertility
Metoprolol 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 may make you feel tired and dizzy. Make sure you are not affected before you drive or
operate machinery.

3.

How to take Metoprolol

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 should be taken without food and on an empty stomach.
Metoprolol tablets can 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 heart beats (arrhythmia):
100-200 mg daily.
• Preventive theray after a heart attack:
The usual maintenance dose is 100 mg twice daily.
• Prevention of migraine:
50-100 mg twice daily.
If you take more Metoprolol 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
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
Do not suddenly stop taking Metoprolol 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:
• an allergic reaction such as itchy skin 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 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):
• feeling faint on standing due to low blood pressure, tiredness.
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.
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed
in this leaflet.

5.

How to store Metoprolol

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, 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 contains
• The active substance is metoprolol tartrate. Each film-coated tablet contains 50 mg or 100 mg of
metoprolol tartrate.


The other ingredients are:
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 looks like and contents of the pack
Metoprolol 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 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
Pack sizes: 20, 28, 30, 40, 50, 56, 60, 90, 98, 100, 250 tablets
HDPE bottle pack with polypropylene closure: 250 tablets
Not all pack sizes may be marketed
Marketing Authorisation Holder and Manufacturer
Amneal Pharma Europe Limited
70 Sir John Rogerson’s Quay
Dublin 2
Ireland
Manufacturer
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate,
Hal Far, Birzebbugia, BBG 3000
Malta

This leaflet was last revised in 07/2014

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Further information

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