PACKAGE LEAFLET: INFORMATION FOR THE USER
Metoprolol Succinate retard 100 A, modified release tablet 95 mg Metoprolol retard Succinate 200 A, modified release tablet 190 mg
electric metoprolol
Read all of this leaflet carefully before you start taking this medicine.
- Keep this leaflet, you may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- The prescription for this medicine was written for you personally. Do not give this medicine to other people. This medicine can harm you, even if your symptoms match those for which you were given the medicine.
- If any side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this brochure:
1. What metoprolol retard succinate is and what it is used for
2. Before using metoprolol retard succinate
3. How to use extended-release metoprolol succinate
4. Possible side effects
5. How to store extended-release metoprolol succinate
6. Additional Information
1. WHAT METOPROLOL SUCCINATE RETARD IS AND WHAT IT IS USED FOR
Metoprolol Succinate Retardant belongs to a group of medicines called beta-blockers. This medicine affects the functioning of the heart and lowers blood pressure
Metoprolol retarder is prescribed for:
- Increased blood pressure (hypertension).
- Feeling of tightness and pain in the chest (angina pectoris).
- cardiac arrhythmia?
- After a heart attack, to prevent another heart attack.
- Increased thyroid function (hyperthyroidism).
- To prevent migraine attacks.
- Mild to severe persistent heart failure (the heart does not pump properly) together with other medicines
2. BEFORE TAKING METOPROLOL SUCCINATO RETARD
Não use succinato de metoprolol retard
- if you are allergic (hypersensitive) to metoprolol succinate or any of the other ingredients of metoprolol succinate retard.
- if you suffer from certain cardiac conduction disorders (2nd and 3rd degree AV block).
- if you have acute heart failure or heart failure that cannot be controlled by fluid in the lungs (pulmonary oedema) or low blood pressure (hypotension).
- if you are receiving continuous or intermittent therapy with medicines that increase the heart's ability to contract, e.g. B. Beta receptor agonists.
- if you are in “shock” caused by the heart not pumping enough (cardiogenic shock).
- if you suffer from severe circulatory disorders in your arms and legs (peripheral circulatory disorders).
- if you suffer from a severely slow heart rate (bradycardia).
- if you suffer from cardiac arrhythmia (weak sinus syndrome).
- if you are having a heart attack (myocardial infarction) in combination with a slow heartbeat, low blood pressure and/or severe heart failure (insufficient heart pumping ability).
Special care is required when using metoprolol retard succinate
- if you want to stop. This is because you cannot stop suddenly, as it can worsen chronic heart failure (the heart's ability to not pump properly) and increase your risk of heart attack (myocardial infarction) and sudden death. For tips on tapering off, see What happens if you suddenly stop taking your medicine?
- if you are going to undergo major or minor surgery. This is because extended-release metoprolol succinate treatment may need to be stopped temporarily.
- if you are taking other medicines to support heart function. This is because heart function can deteriorate.
- if you suffer from cold fingers and feet (Raynaud's syndrome) or clubfoot (intermittent claudication). The use of metoprolol retard succinate may worsen symptoms.
- if you suffer from untreated heart failure (reduced pumping ability of the heart). This must first be remedied before starting metoprolol retard succinate.
- if you are being treated with digitalis (medicine to increase the pumping capacity of the heart) at the same time. It may be necessary to adjust the dose or gradually stop taking it.
- if you suffer from an increased slow heart rate (bradycardia). It may be necessary to adjust the dose or gradually stop taking it.
- if you have an attack of shortness of breath due to muscle spasms and swelling of the lining of the airways, often with cough and phlegm (bronchial asthma) and if you have e.g. B. be treated with drugs. terbutaline. If symptoms get worse. Dose adjustment may be necessary.
- if you suffer from severe liver dysfunction. If necessary, the dose should be reduced.
- if you have a tumor in the adrenal medulla associated with a sudden and severe increase in blood pressure, severe headaches, sweating and rapid heartbeat (pheochromocytoma).
- if you suffer from severe hypersensitivity to certain substances. Shock (sudden drop in blood pressure, pallor, restlessness, weak and rapid pulse, smooth skin, decreased consciousness) caused by sudden strong vasodilation as a result (anaphylactic shock) can be more serious.
if you have diabetes.
Consult your doctor if any of the above warnings apply to you or have applied to you in the past.
There is no experience in the treatment of heart failure in patients:
- over 80 years
- with restrictive and enlarged heart muscle
- with a certain disease of the heart valve
- with severe liver and kidney failure
- who had a heart attack less than 3 months ago
- with a congenital heart defect
Use in combination with other drugs
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This also applies to medications that you can take without a prescription.
Delaying taking metoprolol succinate can make some medications less effective. On the other hand, some medicines can also affect the way Metoprolol Delay works. If you combine metoprolol retard succinate with the drugs listed below, you should consult your doctor:
Calcium channel blockers such as verapamil and diltiazem. Because these drugs can negatively affect heart contraction (cardiac contractility) and heart conduction (AV conduction).
Ganglionic blockers (medicines for nerve disorders), MAOIs (medicines for depression), and other beta-blockers (also in eye drops), as extra monitoring is needed.
Clonidine, when combined with a beta-blocker, may increase symptoms of high blood pressure.
Medicines for heart rhythm problems (antiarrhythmics), such as amiodarone and quinidine. These drugs can prolong the conduction time of the heart (AV conduction) and adversely affect the force of contraction of the heart.
Rifampicin (antibiotic) as it decreases the amount of metoprolol in the blood. Cimetidine (antacid) as it increases the amount of metoprolol in the blood. Indomethacin (a certain group of analgesics that also have anti-inflammatory and antipyretic effects), as it may reduce the antihypertensive effect of metoprolol.
Insulin and other oral antidiabetic drugs, as the hypoglycemic effect of these drugs can be increased by beta-blockers. In this case, the dosage of these drugs must be adjusted.
Lidocaine (local anaesthetic), as metoprolol can reduce the elimination of lidocaine from the body.
period of pregnancy and breastfeeding
Consult your doctor or pharmacist before taking any medicine.
Late administration of metoprolol may have adverse effects on the pregnancy, fetus and neonate. Therefore, you should only use Metoproluccinate retard during pregnancy under the express guidance of your doctor.
Metoprolol passes into breast milk. At normal doses, the amount of metoprolol in breast milk is so small that you can also use metoproluccinate retard while breastfeeding if needed.
Drive and operate machines
As far as is known, the use of metoproluccinate retard has no influence on the ability to drive and use machines. However, the possibility of side effects such as fatigue and dizziness should be considered.
3. HOW TO USE METOPROLOL SUCCINATE RETARD?
Always follow your doctor's advice when using metoprolol retard succinate. If in doubt, consult your doctor or pharmacist.
The tablets must not be broken to get the amount of metoprolol prescribed for you. In this case, ask your pharmacist for a tablet with the desired dosage. Swallow the tablets with half a glass of water. Do not break or chew! Choose a fixed time to pick up your tablet.
The adult dose depends on the condition for which you are taking metoprolol extended-release succinate.
For high blood pressure:
Starting dose: 50 mg of metoprolol retard succinate once daily.
If the effect is insufficient, the dose can be increased to 100 mg of extended-release metoprolol succinate once a day or, in some cases, to 200 mg of extended-release metoprolol succinate once a day.
For chest pain (angina pectoris), depending on symptoms:
100 – 200 mg of metoprolol retard succinate once daily, depending on personal needs. Maximum 400 mg of delayed metoprolol succinate per day.
For cardiac arrhythmias:
Typically, 100-200 mg of extended-release metoprolol succinate is administered throughout the day. If necessary, your doctor may further increase the dose.
As protection against a subsequent heart attack.
200 mg extended-release metoprolol succinate once daily after being prescribed 50 mg extended-release metoprolol succinate two to four times daily for 2 to 3 days for the first time.
With an overactive thyroid.
100 - 200 mg of delayed metoprolol succinate distributed throughout the day. If necessary, your doctor may further increase the dose.
To prevent migraine attacks:
100 or 200 mg of metoprolol retard succinate per day.
In heart failure in combination with other drugs:
Starting dose: 12.5 - 25 mg of metoprolol retard succinate once daily for 2 weeks. The dose can then be doubled every two weeks to a maximum of 200 mg metoprolol succinate once daily.
Metoprolol Succinate Delay is usually used for a longer period of time. Never change the dose yourself and never stop using it suddenly.
What to do if you use more metoprolol succinate than usual?
If you take large amounts of metoprolol retard succinate, the following symptoms may occur:
- Severely reduced blood pressure (hypotension)
- slow heart rate (venous bradycardia)
- certain cardiac conduction disorders that lead to cardiac arrhythmias (AB block)
- Heart failure (insufficient pumping ability of the heart) (descompensatio cordis)
- a “shock” caused by the heart not pumping enough (cardiogenic shock)
- Heart attack
- Shortness of breath due to spasm of the muscles in the airways (bronchospasm)
- disturbances of consciousness (up to coma)
- Nausea, vomiting
- Blue discoloration of the lips, tongue, skin and mucous membranes due to lack of oxygen in the blood (cyanosis).
The first symptoms usually appear within 20 minutes to 2 hours after ingestion.
Call a doctor immediately. Try to find out how much metoprolol succinate retard was taken. Keep the metoprolol succinate extended-release pack near you.
Sometimes hospitalization may be necessary.
What to do if you forget to use metoprolol retard succinate?
Do not take a double dose to make up for a forgotten tablet.
If you forget to take Metoprolol Succulent delayed-release tablets and you remember within 4 hours, you should take the missed tablets as soon as possible and then take the next tablet at your "normal" time. If it has been more than 4 hours since you were supposed to take the pills, simply skip that dose and wait until your 'normal' schedule calls for the next pill.
If you stop using metoprolol retard succinate
If you have any further questions on the use of this product, ask your doctor or pharmacist.
If you suddenly stop taking Metoprolol Succinate retard, your condition may suddenly get worse. It can lead to heart arrhythmia or increased blood pressure and increases the risk of heart attack and sudden death.
Discontinuation of treatment with metoprolol retard succinate should therefore always be done gradually and always in consultation with your doctor. The dose is gradually reduced by half over at least 2 weeks to a final dose of 12.5 mg of prolonged-release metoprolol succinate. This lower dose should be taken for at least 4 days before stopping treatment completely. If you experience any discomfort during the reduction, consult your doctor.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Metoprolol Succinate can cause side effects, although not everybody gets them. These side effects are usually mild and go away on their own with time.
The following side effects have been reported as common, rare, rare or very rare:
The frequency is 1 in 10 to 1 in 100 patients.
It rarely occurs in 1 in 100 to 1 in 1000 patients.
It occurs rarely in 1 in 1000 to 1 in 10,000 patients.
very rare, less than 1 in 10,000 patients.
Often
Nervous system: fatigue.
Often
Heart: slow heartbeat (bradycardia), drop in blood pressure, for example when rising quickly from a sitting or lying position, sometimes accompanied by dizziness (orthostatic hypotension), cold hands and feet, palpitations.
Nervous system: dizziness, headache.
Gastrointestinal tract: nausea, abdominal pain, diarrhea, constipation.
Respiratory: dyspnea on exertion.
Sometimes
Heart: Worsening symptoms of heart failure (the heart does not pump enough), certain disturbances in the conduction of impulses in the heart that can lead to cardiac arrhythmia (heart block), accumulation of fluid (oedema), pain in the heart area .
Nervous system: tingling, itching or tingling without cause (paresthesia) muscle spasms.
Gastrointestinal tract: vomiting;
Metabolism: weight gain?
Mental: (severe) depressed mood (depression), reduced alertness, drowsiness or insomnia, nightmares.
Airway: Tightness caused by spasms of the muscles in the airways (bronchospasm), even in patients without airway obstruction.
Skin and Subcutaneous Tissue: Transient rash, increased sweating.
Rarely:
Heart: conduction disorders, cardiac arrhythmias.
Gastrointestinal tract: dry mouth;
Liver and bile: Liver dysfunction.
Soul; Nervousness, anxiety, impotence, decreased sexual desire.
Respiratory system: inflammation of the nasal mucosa, characterized by nasal congestion, sneezing and discharge (rhinitis).
Eyes? Visual disturbances, dry and/or irritated eyes, inflammation of the conjunctiva (conjunctivitis).
Skin and subcutaneous tissue: hair loss.
Very rare:
Heart: Tissue death in patients with severe circulatory disorders. Gastrointestinal tract: taste disorders.
Blood and lymphatic system: Blood disorders (lack of blood platelets), accompanied by bruising and tendency to bleed (thrombocytopenia).
Liver and gallbladder: Inflammation of the liver (hepatitis) accompanied by jaundice (yellowing of the skin or eyes).
Muscles and joints: joint pain (arthralgia);
Mental: memory loss, confusion, perception of things that are not there (hallucinations), alienation from self or feelings (depersonalization).
Organ and ear balance: ringing in the ears (tinnitus).
Skin and Subcutaneous Tissues: Hypersensitivity to light, worsening of a recurrent skin condition accompanied by a dry, scaly rash (psoriasis).
Sexual organs: erectile dysfunction.
If any side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Never reduce a dose or interrupt treatment (temporarily)! See "If you stop using extended-release metoprolol succinate".
5. HOW DO I STORE METOPROLOL SUCCIATE RETARD?
Store in a place that children cannot see or reach.
Store below 25°C in the original packaging.
Do not use metoprolol retard succinate after the expiry date which is stated on the carton after "Do not use after... month/year" and on the blister packs under "Use by".
Medicines should not be thrown down the drain or in the trash. Ask your pharmacist how to throw away medicines you no longer need. These measures help to protect the environment.
6. FURTHER INFORMATION What metoprolol retard succinate contains
- The active substance is metoprolol succinate
- The other ingredients are:
Microcrystalline cellulose (E460), methylcellulose (E461), glycerol (E422), maize starch, ethylcellulose (E462), magnesium stearate (E572), hypromellose (E464), macrogol stearate, titanium dioxide (E171).
Extended Release Metoprolol Succinate Appearance and Contents of the Pack
Metoprolol Succinate retard 100 A are round white tablets. Metoprolol Succinate retard 200 A are white oval tablets
Registration holders and manufacturers
record holder
Apothecon B.V.
Industriestrasse 3
3771 MIT Barneveld
Manufacturer
Sofarimex -
chemical and pharmaceutical industry,
Lda Av.das Indústrias - Alto de Colaride,
Agualva, 2735-213 Cacém
Portugal
Metoprolol succinate retard 100 A is registered under RVG 102063
Metoprolol succinate retard 200 A is registered under RVG 102323
This leaflet was last approved in May 2008