50 mg prolonged-release tablets, 100 mg prolonged-release tablets, 200 mg prolonged-release tablets are
metoprolol succinate
What Metomylan is and what it is used for
The active substance in Metomylan, metoprolol, belongs to a group of medicines called selective beta-blocker blockers, which have a special effect on the heart. The drug affects the body’s response to certain nerve signals, especially in the heart. The result is that blood pressure is lowered at the same time as the heart’s pumping power increases.
Methomylan is used to:
- treat high blood pressure .
- treat insufficient blood supply to the coronary arteries of the heart (coronary heart disease, angina).
- treat arrhythmias where the heart beats too fast ( tachycardia ), especially if they start in the atrium of the heart ( supraventricular tachycardia ).
- help prevent a new heart attack after a previous heart attack (maintenance treatment).
- treat functional cardiovascular disease (such as when it feels like the heart is overworking, eg it beats very fast).
- help prevent migraine attacks.
- treat mild to moderate, stable, chronic heart failure (with impaired left ventricular pump function) in addition to standard treatment.
Methomylan can also be used to treat high blood pressure in children aged six years and adolescents.
Metoprolol contained in Metomylan may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professionals if you have any further questions, and always follow their instructions.
What you need to know before you take Metomylan
Do not take Metomylan
- if you are allergic to metoprolol , other beta-blocker blockers or any of the other ingredients of this medicine (see section 6).
- if you have certain types of arrhythmias ( grade II or III AV block or high grade SA block).
- if you have a slow heart rate (below 50 beats / minute).
- if you have sinus node dysfunction in the heart (diseased sinus node) unless you have a permanent pacemaker.
- if you have suffered from circulatory collapse , mainly due to insufficient heart function.
- if you have severe circulatory disorders in your arms and / or legs.
- if you have morbidly low blood pressure , ie when the systolic pressure (hypertension) is lower than 90 mmHg.
- if you have an untreated, hormone-producing tumor in the adrenal medulla ( pheochromocytoma ).
- if you have high acid levels in your blood caused by metabolic disorder.
- if you have severe asthma or chronic lung disease that makes your airways narrow.
- if you are also being treated with MAOIs (medicines used to treat depression, however, MAO-B inhibitors do not apply).
- in case of suspected myocardial infarction and heart rate one is below 45 beats per minute, the overpressure is less than 100 mmHg and some heart rhythm disorders occur.
- You should not be given certain medicines to treat cardiac arrhythmia , e.g. calcium channel blockers such as verapamil and diltiazem or class 1 antiarrhythmics (eg diopyramide) intravenous (exception: intensive care medicine).
If you have chronic heart failure, you must not take metoprolol if:
- you have unstable, uncompensated heart failure (which can manifest itself in the form of fluid accumulation in the lungs, poor blood circulation or low blood pressure ), unless the condition has stabilized with the help of medication.
- you are continuously or temporarily on drug treatment that increases the heart’s pumping power, e.g. dobutamine .
- your systolic blood pressure (hypertension) is always below 100 mmHg or has lowered heart rate (less than 68 beats / min).
Warnings and cautions
Talk to your doctor or pharmacist before taking Metomylan:
- if you have asthma : metoprolol may worsen the symptoms of asthma . The effect of some asthma medications may be impaired. Methomylane should not be used if you have severe asthma .
- if you have severe liver problems.
- if you have diabetes : metoprolol may mask low blood sugar symptoms. Regular checks of blood sugar levels are required.
- if you have a mild form of certain cardiac arrhythmias (1st degree AV block ).
- if you have a type of angina called Prinzmetal’s angina.
- if you have mild to moderate circulatory disorders in your arms and / or legs.
- if you have a hormone-producing tumor in the adrenal medulla ( pheochromocytoma ): you must be treated with an alpha-receptor blocker before starting Metomylan.
- if you have an overactive thyroid gland .
- if you are going to have surgery. Before the operation, tell your anesthetist that you are using Metomylan.
- if you have psoriasis .
- if you are prone to allergic reactions , as metoprolol may increase both the sensitivity to allergens ( allergens ) and the severity of an allergic reaction . Methomylan may also reduce the effect of medicines used to treat severe allergic reactions, such as adrenaline
The use of metoprolol may lead to positive results in doping tests.
Other medicines and Metomylan
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription.
Careful medical attention is required if any of the following medicines are taken with Metomylan:
- Drugs for the treatment of cardiac arrhythmias , e.g. calcium channel blockers such as verapamil and diltiazem or class I antiarrhythmics (eg disopyramide ). You must not be given this type of medicine intravenously (except in intensive care).
- If you are taking other beta -blocker blockers (eg eye drops containing timolol ).
Other interactions:
Inhaled anesthetics enhance the heart rate lowering effect of metoprolol.
Metoprolol may potentiate the effect of antihypertensive drugs e.g. nifedipine, prazosin, reserpine, alpha methyldopa, clonidine, guanfacine, and cardiac glycosides. This can, for example, lead to a sharply reduced pulse.
If you are being treated with clonidine (a medicine used to treat high blood pressure ) at the same time and treatment needs to be stopped, treatment with Metomylan should be stopped several days before clonidine treatment.
The following substances may increase the concentration of metoprolol in the blood and thus enhance the effect of Metomylan:
- alcohol
- drugs used to treat high levels of stomach acid , e.g. cimetidine
- blood pressure lowering drugs e.g. hydralazine
- certain drugs used in depression , e.g. paroxetine , fluoxetine and sertraline
- drugs used to treat insomnia, e.g. diphenhydramine
- certain drugs used to treat joint problems , e.g. hydroxychloroquine and celecoxib
- certain drugs used to treat fungal infections, e.g. terbinafine
- neuroleptics used in psychotic illness, e.g. chlorpromazine, triflupromazine and chlorprotixen
- certain drugs used to treat cardiac arrhythmias , e.g. amiodarone , quinidine and possibly propafenone
If you also use anti-inflammatory drugs, e.g. indomethacin or other prostaglandin synthesis inhibitors, the antihypertensive effect of metoprolol may be reduced.
Rifampicin (an antibiotic used to treat tuberculosis ) and barbituric acid derivatives (used as sedatives or hypnotics) reduce the antihypertensive effect of metoprolol.
Beta-receptor blockers may inhibit the release of insulin in patients with type II diabetes or affect medicines taken to lower blood sugar. You should check your blood sugar regularly. If necessary, your doctor will adjust the dosage of one of your blood sugar-lowering medicines ( insulin and oral antidiabetic medicines).
Your blood pressure may increase significantly if you take Metomylan at the same time as norepinephrine or adrenaline (neurotransmitters that occur naturally in the body and which increase blood pressure due to its stimulating effect on the heart and vessels ) or other drugs with a similar effect (eg cough medicines, nasal drops or eye drops ).
The effect of adrenaline in the treatment of hypersensitivity reactions may be impaired.
Metoprolol may reduce the body’s ability to secrete other medicines (eg lidocaine which is a topical anesthetic).
If you are also being treated with medicines containing guanidine (a substance that blocks sympathetic ganglion ), which are used to prevent the release of adrenaline and norepinephrine into your body, you may need to be closely monitored by your doctor while taking Metomylan.
Methomylane with alcohol
Metoprolol may make you tired / lethargic and this effect may be exacerbated by consuming alcohol. Alcohol can also increase the concentration of Metomylan in the blood. Therefore, you should not drink alcohol while using Metomylan.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Metoprolol should only be used during pregnancy if there are special reasons and after careful risk-benefit assessment by the treating physician. There is evidence that metoprolol reduces the blood supply to the placenta and can thereby cause growth disorders in the fetus.
If Metomylan has been used during pregnancy, treatment should be stopped 48-72 hours before the expected date of delivery. If this is not possible, the newborn should be closely monitored for the first 48-72 hours after delivery.
Breast-feeding
Metoprolol accumulates (stores) in breast milk.
No side effects are expected when metoprolol is used in regular treatment doses, but breastfed infants should still be observed regarding the effects of the drug.
Driving and using machines
Dizziness and fatigue may occur during treatment with Metomylan. Your ability to react can be affected to such an extent that your ability to drive, operate machinery and work without safety equipment is impaired. This is especially true in combination with alcohol, at the beginning of treatment, or if the dose of metoprolol is increased.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Methomylan contains glucose and sucrose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption, or glucose-isomaltase deficiency should not take this medicine.
How to take Metomylan
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Administration
The prolonged-release tablets should be taken once daily, with or without food, preferably in the morning. The prolonged-release tablets should be swallowed whole or divided, but must not be chewed or crushed. They should be taken with at least half a glass of water.
Please note that doses lower than 25 mg are not available for this product!
Unless otherwise specified by your doctor, the recommended dose is:
| Therapeutic indication | The recommended dose, once daily | If necessary, the dose can be increased as follows: |
| High blood pressure | 1 prolonged-release tablet of 50 mg½ 100 mg prolonged-release tablet there are more strengths to use initially for treating the condition | Maximum dose:4 prolonged-release tablets are 50 mg each2 prolonged-release tablets are 100 mg1 prolonged-release tablet of 200 mg Your doctor may also prescribe additional treatment with other antihypertensive drugs |
| Insufficient blood supply to the coronary arteries (coronary heart disease, angina) | 1-4 prolonged-release tablets are 50 mg½-2 prolonged-release tablets are 100 mg½-1 prolonged-release tablet of 200 mg | Maximum dose:4 prolonged-release tablets are 50 mg each2 prolonged-release tablets are 100 mg1 prolonged-release tablet of 200 mg l Your doctor may also prescribe additional treatment with other antihypertensive drugs |
| Fast heartbeat | 1-4 prolonged-release tablets are 50 mg½-2 prolonged-release tablets are 100 mg½-1 prolonged-release tablet of 200 mg | Maximum dose:4 prolonged-release tablets are 50 mg each2 prolonged-release tablets are 100 mg1 prolonged-release tablet of 200 mg |
| Functional cardiovascular disease | 1-4 prolonged-release tablets are 50 mg½-2 prolonged-release tablets are 100 mg½-1 prolonged-release tablet of 200 mg | Maximum dose:4 prolonged-release tablets are 50 mg each2 prolonged-release tablets are 100 mg1 prolonged-release tablet of 200 mg |
| Maintenance treatment after a heart attack | 2-4 prolonged-release tablets are 50 mg1-2 prolonged-release tablets are 100 mg½-1 prolonged-release tablet of 200 mg | Maximum dose:4 prolonged-release tablets are 50 mg each2 prolonged-release tablets of 100 mg1 prolonged-release tablet of 200 mg |
| Prevention of migraines | 2 prolonged-release tablets are 50 mg1 prolonged-release tablet of 100 mg | Maximum dose:2 prolonged-release tablets are 50 mg1 prolonged-release tablet is 100 mg |
| Treatment of heart failure NYHA class II The treating physician must have experience in treating stable heart failure | Starting dose during the first two weeks:½ 50 mg prolonged-release tablet The patient’s condition should be closely monitored after each dose increase | From week three onwards:1 prolonged-release tablet of 50 mg½ 100 mg prolonged-release tablet Dose one is doubled every two weeks up to the maximum dose if4 prolonged-release tablets are 50 mg each2 prolonged-release tablets are 100 mg1 prolonged-release tablet is 200 mg or to the highest dose tolerated by the patient. 200 mg Metomylan is also the recommended dose for long-term treatment of heart failure. |
| Treatment of heart failure NYHA class III | Starting dose during the first week:12.5 mg | Dose one can be increased during the second week to:½ 50 mg prolonged-release tablet dose one is doubled every two weeks to a maximum dose of: 4 prolonged-release tablets are 50 mg each1 prolonged-release tablet is 200 mg or the highest dose the patient tolerates.200 mg Metomylan is also the recommended dose for long-term treatment of heart failure. |
Use in patients with renal impairment
Dose adjustment is not necessary.
Use in patients with hepatic impairment
For patients with severe hepatic impairment, e.g. shunt -operated patients, it may be necessary to reduce dose one.
Use for children and adolescents
In children over 6 years of age and adolescents, dose one is based on body weight. Normally, your doctor should talk about how much you can give to children and adolescents. The maximum recommended dose is 200 mg daily.
Experience with metoprolol in children under 6 years of age and adolescents is limited.
The use of metoprolol is not recommended for children under 6 years of age.
Use in elderly patients over 80 years of age
There are no adequate data from the use of metoprolol in patients over 80 years of age. Therefore, special care is required when increasing the dose to these patients.
Duration of treatment
The duration of treatment is determined by your doctor.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor or emergency doctor if you get one or more of the following symptoms:
Uncommon (may affect up to 1 in 100 people):
- Transient worsening of the symptoms of heart failure , some form of heart rhythm disturbances (first-degree AV block ), pain around the heart, shortness of breath.
Rare (may affect up to 1 in 1,000 people):
- Exacerbation of diabetes that has been without any typical symptoms ( latent diabetes mellitus )
Very rare (may affect up to 1 in 10,000 people):
- Yellowing of the skin and / or eyes (this may be a sign of inflammation in the liver).
- Tissue death ( necrosis ) in patients with severe circulatory disorders in the arms and / or legs before treatment.
Other side effects:
Very common: (may affect more than 1 user in 10):
- sharp drop in blood pressure, even when rising from a supine position (very rare with fainting)
- fatigue
Common: (may affect up to 1 in 10 people):
- slow heart rate ( bradycardia ), balance difficulties (very rare with fainting), feeling of irregular or strong heartbeat ( palpitation )
- dizziness, headache
- shortness of breath on exertion
- nausea, abdominal pain, diarrhea, constipation
- cold hands and feet
Uncommon: (may affect up to 1 in 100 people):
- tingling in the skin ( paresthesia )
- bronchospasm ( bronchospasm )
- vomiting
- skin changes, psoriasis-like rash, increased sweating
- muscle cramps
- weight gain
- fluid accumulation in the body’s tissues ( edema )
- depression, impaired concentration, drowsiness or insomnia, nightmares
- circulatory collapse (it is more likely to occur after a heart attack)
Rare: (may affect up to 1 in 1,000 people):
- functional heart disease such as galloping rhythm (when the heart skips a beat), or rapid heartbeat, certain heart rhythm disorders (conduction disturbances in the heart)
- visual disturbances, dry or irritated eyes, conjunctivitis ( conjunctivitis )
- snuva
- dry mouth
- hair loss
- abnormal values on liver function tests
- impotence and other sexual disorders (eg hardening of the soft tissue of the penis in the corpus cavernosum, ie the swollen body)
- nervousness, anxiety
Very rare: (may affect up to 1 in 10,000 people):
- decreased platelet count ( thrombocytopenia ), decreased white blood cell count ( leukopenia )
- tinnitus , tinnitus
- taste changes
- photosensitivity, worsening psoriasis , onset of psoriasis , psoriasis-like skin changes
- joint pain, muscle weakness
- deterioration in patients with intermittent claudication (ie peripheral circulatory insufficiency / peephole disease which manifests itself in a convulsive sensation in the legs during exertion) and cramps in the blood vessels of the fingers ( Raynaud’s disease )
- forgetfulness or impaired memory, confusion, hallucinations, personality changes (eg mood swings)
Has been reported (occurs in an unknown number of users):
Masking of symptoms of low blood sugar ( hypoglycemia ), e.g. palpitation.
How to store Metomylan
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 carton, can or blister after “EXP”. The expiration date is the last day of the specified month.
Do not store above 25 ° C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
- The active substance is metoprolol tartrate.
- Each prolonged-release tablet contains 47.5 mg, 95 mg or 190 mg of metoprolol succinate equivalent to 50 mg, 100 mg or 200 mg of metoprolol tartrate.
- Other ingredients are:Tablet core: Sucrose , corn starch, macrogol, polyacrylate, talc, povidone, microcrystalline cellulose, magnesium stearate, anhydrous colloidal silica, D- glucose .Tablet coating: Hypromellose, talc, macrogol, titanium dioxide (E 171).
What the medicine looks like and contents of the pack
Methomylan 50 mg, 100 mg, 200 mg prolonged-release tablets are white, oblong, biconvex with a scored notch on both sides.
Blister pack size (aluminum / aluminum):
10, 14, 20, 28, 30, 50, 60, 90, 98 and 100
Size HDPE cans (PP screw cap):
30, 60, 100, 250 and 500
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Manufacturer
McDermott Laboratories to Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland
Mylan Hungary Kft, H-2900 Komárom, Mylan utca 1, Hungary