Metoprolol Succinate Extended-Release Tablets USP 12.5mg

Metoprolol Succinate Extended-Release Tablets USP 12.5mg
Metoprolol Succinate Extended-Release Tablets USP 25mg
Metoprolol Succinate Extended-Release Tablets USP 50mg
Metoprolol Succinate Extended-Release Tablets USP 100mg

Patient Information Leaflet

Read this entire 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 Metoprololsuccinate is and what it is used for

2. What you need to know before you take Metoprololsuccinate

3. How to take Metoprololsuccinate

4. Possible side effects

5. How to store Metoprololsuccinate

6. Contents of the pack and other information

1. What Metoprololsuccinate is and what it is used for

Metoprolol succinate contains metoprolol succinate, which belongs to a group of medicines called beta-blockers. Metoprolol succinate 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.

2. What you need to know before you take Metoprololsuccinate

Do not take Metoprololsuccinate if you:

  • Are allergic to metoprolol succinate, 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 diltiazem by intravenous injection. See also ?Other medicines and Metoprololsuccinate?
  • Are using antiarrhythmics such as disopyramide. See also ?Other medicines and Metoprololsuccinate?
  • Have untreated high blood pressure due to tumour of the adrenal medulla (pheochromocytoma).

Warnings and precautions

Talk to your doctor or pharmacist before taking

Metoprolol succinate 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 succinate 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 succinate.

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

Metoprolol succinate tablets can affect how some other medicines work, and some medicines can also affect how metoprolol works. If Metoprololsuccinate 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 Floctafenine (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 the skin)

Cimetidine (for ulcers)

Digitalis glycosides such as digoxin (used in heart failure)

Epinephrine (a 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, guanfacine, moxonidine, methyldopa, cimetidine (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

Prazosin, tamsulosin, terazosin, doxazosin (alpha-blockers, used to treat high blood pressure and benign prostatic hyperplasia)

Lidocaine (local anaesthetic)

Rifampicin (used to treat tuberculosis)

Antacids (used for stomach upsets).

Metoprolol succinate with alcohol

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

Pregnancy, breast-feeding and fertility Metoprololsuccinate 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 succinate may make you feel tired and dizzy. Make sure you are not affected before you drive or operate machinery.

3. How to take Metoprololsuccinate

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 succinate should be taken without food

High blood pressure:

Initially 100mg daily

Angina pectoris:

Usually, 50-100mgTwice daily.

Irregular heartbeats:

100-200mg daily.

Preventive therapy after a heart attack:

The usual maintenance done is 100mg twice daily.

Prevention of migraine:

50-100mg twice daily.

If you take more Metoprololsuccinate 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 an 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 Metoprololsuccinate

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 Metoprololsuccinate

Do not suddenly stop taking Metoprololsuccinate as this may cause worsening of heart failure and increase the risk of a 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 effect

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 10people):

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,




feeling sick,



stomach pain,

shortness of breath with strenuous physical activity.

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

chest pain,

weight gain,


concentration problems

inability to sleep (insomnia)



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),



increased sweating

fluid retention

muscle cramps

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

worsening of diabetes,



visual disturbances,

dry or irritated eyes,


impotence, other sexual dysfunctions,

Peyronie?s syndrome (bending of penis on erection),

irregular heartbeat,

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



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.

5. How to store Metoprololsuccinate

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 Metoprololsuccinate contains

The active substance is metoprolol succinate. Each film-coated tablet contains 12.5mg metoprolol succinate.

The other ingredients are:

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

Pack: Available in Blister Pack.
Aceclofenac Tablets are available in boxes of 10, 20, 30, 40, 60, 100 and 500 tablets.

Not all pack sizes may be marketed.

7. Manufactured By:
Unit No. 214, Old Bake House, 
Bake House Lane, Fort,
at: Ahmedabad- Gujarat, INDIA.
Ho.NO.+91 8448 444 095
Toll Free Phone: (1800-222-434 / 1800-222-825)