Metoprolol Krka

Metoprolol Krka

metoprolol

Manufacturer:

Krka

Distributor:

Hind Wing
/
Agencia Lei Va Hong
Full Prescribing Info
Contents
Metoprolol succinate.
Description
Each Metoprolol KRKA 25mg Prolonged-Release Tablets contains 23.75 mg metoprolol succinate equivalent to 25 mg metoprolol tartrate.
Each Metoprolol KRKA 50mg Prolonged-Release Tablets contains 47.5 mg metoprolol succinate equivalent to 50 mg metoprolol tartrate.
Each Metoprolol KRKA 100mg Prolonged-Release Tablets contains 95 mg metoprolol succinate equivalent to 100 mg metoprolol tartrate.
Each Metoprolol KRKA 200mg Prolonged-Release Tablets contains 190 mg metoprolol succinate equivalent to 200 mg metoprolol tartrate.
Excipients/Inactive Ingredients: Tablet core: colloidal anhydrous silica, microcrystalline cellulose, hypromellose, sodium laurilsulfate, polysorbate 80, glycerol, hydroxypropylcellulose, ethylcellulose, sodium stearyl fumarate.
Film coating: hypromellose, titanium dioxide (E171), talc, propylene glycol.
Action
Metoprolol succinate belongs to a group of medicines called beta-blockers.
Indications/Uses
In Adults, Metoprolol Krka is used to treat: high blood pressure (hypertension); a tight pain in the chest caused by insufficient oxygen to the heart (angina pectoris); irregular heart rhythm (arrhythmia); stable heart failure with symptoms (such as shortness of breath or swollen ankles), when taken together with other medicines for heart failure; palpitations (feeling the heart beat) due to non-organic (functional) heart disorders.
Metoprolol Krka is used to prevent: further heart attacks or damage to the heart after a heart attack; migraine.
Dosage/Direction for Use
Always take this medicine exactly as advised by the doctor or pharmacist. Check with the doctor or pharmacist if not sure.
Take once daily with a glass of water in the morning. Swallow the tablet whole or divided. Do not chew or crush before swallowing.
Adults: Usual doses: High blood pressure: Metoprolol Krka 50 mg prolonged-release tablet once daily. The dose may be increased to 100 to 200mg once daily if necessary.
Tight chest pain (angina pectoris): Metoprolol Krka 100 to 200mg prolonged-release tablet once daily.
Irregular heart beats (arrhythmia): Metoprolol Krka 100 to 200mg prolonged-release tablet once daily.
Preventive therapy following a heart attack: Metoprolol Krka 200mg prolonged-release tablet once daily.
Palpitations due to heart disease: Metoprolol Krka 100mg prolonged-release tablet once daily. The dose may be increased to 200mg once daily if necessary.
Prevention of migraine: Metoprolol Krka 100 to 200mg prolonged-release tablet once daily.
Patients with stable heart failure: Always follow the doctor's advice.
Patients with impaired liver function: If liver function is severely impaired, the doctor may adjust the dose. Always follow the doctor's advice.
If the patient forgets to take Metoprolol Krka: If forgotten to take a dose, take it as soon as remembered, then go on as before.
Do not take a double dose to make up for a forgotten tablet.
If the patient stops taking Metoprolol Krka: Do not suddenly stop taking Metoprolol Krka 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 the doctor.
If there are any further questions on the use of this medicine, ask the doctor or pharmacist.
Overdosage
If more than the prescribed dose is accidentally taken, contact the nearest hospital or tell the doctor or pharmacist at once. Symptoms of overdose are low blood pressure (fatigue and dizziness), slow pulse, irregular heart rhythm, cardiac arrest, shortness of breath, deep unconsciousness, nausea, vomiting and blue colouring of the skin.
Contraindications
Do not take Metoprolol Krka and tell the doctor if: Allergic to active substance, other beta-blockers or any of the other ingredients of this medicine (listed in Description).
Heart conduction problems (2nd or 3rd degree atrioventricular block) or heart rhythm problems (sick sinus syndrome) are present.
Untreated heart failure is present, receiving treatment to increase heart contractions, or in shock caused by heart problems.
Suffering from severe blood circulation problems (severe peripheral arterial disease).
Having a slow heart rate (less than 50 beats/min) or low blood pressure.
Suffering from increased acidity of the blood (metabolic acidosis).
Severe asthma or COPD (chronic obstructive pulmonary disease) is present.
Untreated phaeochromocytoma (high blood pressure due to a rare tumour in one of the adrenal glands) is present.
Heart failure is present and the blood pressure keeps falling below 100 mmHg.
Taking any of the following medicines (see also Interactions): Monoamine Oxidase Inhibitors (MAOIs) (for depression); verapamil and diltiazem (to lower the blood pressure); an antiarrhythmic such as disopyramide.
Special Precautions
Talk to the doctor or pharmacist before taking Metoprolol Krka if: Asthma is present.
Prinzmetal's angina (tight chest pain usually occurring during the night) is present.
Diabetes mellitus is present (low blood sugar levels may be hidden by this medicine).
Phaeochromocytoma (high blood pressure due to a rare tumour in one of the adrenal glands) is present.
Having treatment to reduce allergic reactions. Metoprolol Krka may increase the hypersensitivity to the substances the patient is allergic to and increase the severity of allergic reactions.
An overactive thyroid is present (symptoms such as increased heart rate, sweating, tremor, anxiety, increased appetite or weight loss may be hidden by this medicine).
Suffering or have suffered from psoriasis (severe skin rashes).
Suffering from blood circulation problems which may cause the fingers and toes to tingle or turn pale or blue.
Suffering from a heart conduction disorder (heart block).
Heart failure and one of the following is present: unstable heart failure (NYHA IV); heart attack or angina attack in the last 28 days; reduced kidney or liver function; under 40 years old or over 80 years old; diseases of the heart valves; enlarged heart muscle; heart surgery in the last 4 months.
If having an anaesthetic, please tell the doctor or dentist that metoprolol tablets are being taken.
Driving and using machines: Metoprolol Krka may make the patient feel tired and dizzy. Make sure to not be affected before driving or operating machinery, particularly after changing to another medicine or if taken with alcohol.
Use In Pregnancy & Lactation
Metoprolol Krka is not recommended during pregnancy or breastfeeding. If pregnant or breast-feeding, may be pregnant or planning to have a baby, ask the doctor or pharmacist for advice before taking this medicine.
Side Effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop treatment and contact the doctor at once if having symptoms of 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. The patient may need urgent medical attention or hospitalisation.
Tell the doctor if any of the following side effects or any other effects not listed are noticed: 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 heartbeat; difficulty in maintaining balance (very rarely with fainting); cold hands and feet; palpitations; dizziness, headache; feeling sick, diarrhoea, constipation, abdominal pain; shortness of breath with strenuous physical activity.
Uncommon (may affect up to 1 in 100 people): temporary worsening of symptoms of heart failure; fluid retention (swelling); chest pain; pins and needles; muscle cramps; vomiting (being sick); weight gain; depression; reduced concentration; difficulty in sleeping (insomnia); drowsiness; nightmares; shortness of breath; skin rash; increased sweating.
Rare (may affect up to 1 in 1,000 people): worsening of diabetes; nervousness, anxiety; visual disturbances; dry or irritated eyes; conjunctivitis (a kind of eye infection); impotence (inability to obtain an erection); 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 counts (thrombocytopenia, leukopenia); forgetfulness; confusion; hallucinations; mood changes; ringing in the ears; hearing problems; taste changes; inflammation of the liver (hepatitis); sensitivity to light; worsening or new psoriasis (a type of skin disease); muscle weakness; joint pain; tissue death in patients with severe blood circulation problems.
If getting any side effects, talk to the doctor or pharmacist. This includes any possible side effects not listed in this monograph.
Drug Interactions
Other medicines and Metoprolol Krka: Do not take Metoprolol Krka if already taking: Monoamine Oxidase Inhibitors (MAOIs) for depression (can increase the effect on lowering blood pressure); other blood pressure lowering medicines such as verapamil and diltiazem (can cause slow heart beat or an increased drop in blood pressure); antiarrhythmics such as disopyramide (may increase the risk of irregular or slow heart beat and reduce heart function).
Tell the doctor or pharmacist if taking, have recently taken or might take any other medicines.
The following medicines can increase the effect on lowering blood pressure: cimetidine (for ulcers); hydralazine and clonidine (blood pressure lowering medicines); terbinafine (for fungal infection); paroxetine, fluoxetine, and sertraline (for depression); hydroxychloroquine (for malaria); chlorpromazine, triflupromazine, chlorprothixene (antipsychotic medications); amiodarone, quinidine and propafenone (for irregular heart rhythm); diphenhydramine (antihistamine); celecoxib (for pain).
The following medicines can reduce the effect on lowering blood pressure: indomethacin (for pain); rifampicin (antibiotics).
Other medicines that may affect or can be affected by metoprolol: other beta-blockers, e.g. eye drops; adrenaline (epinephrine), noradrenaline (norepinephrine) or other sympathomimetics; medicines used to treat diabetes, the symptoms of low blood sugar may be hidden; lidocaine; reserpine, alpha-methyldopa, guanfacine, cardiac glycosides.
Metoprolol Krka with food, drink and alcohol: Alcohol may increase the blood pressure lowering effect of Metoprolol Succinate tablets.
Caution For Usage
Do not throw away any medicines via wastewater or household waste. Ask the pharmacist how to throw away medicines no longer used. These measures will help protect the environment.
Storage
Do not store above 30°C.
MIMS Class
ATC Classification
C07AB02 - metoprolol ; Belongs to the class of selective beta-blocking agents. Used in the treatment of cardiovascular diseases.
Presentation/Packing
PR tab 25 mg (white to almost white, oval, biconvex, film coated, with score line on one side of the tablet; on one side of the score line mark C is engraved, on the other side of the score line mark 1 is engraved) x 100's. 50 mg (white to almost white, oval, slightly biconvex, film coated, with score line on one side of the tablet; on one side of the score line mark C is engraved, on the other side of the score line mark 2 is engraved) x 100's. 100 mg (white to almost white, oval, biconvex, film coated, with score line on one side of the tablet; on one side of the score line mark C is engraved, on the other side of the score line mark 3 is engraved) x 100's. 200 mg (white to almost white, biconvex, capsule shaped, film coated, with score line on both sides of the tablet; on one side of the tablet on one side of the score line mark C is engraved, on the other side of the score line mark 4 is engraved) x 100's.
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