25 mg, 50 mg, 100 mg and 200 mg prolonged-release tablets
metoprolol succinate, respectively
What Metoprolol Teva is and what it is used for
The active substance metoprolol in Metoprolol Teva belongs to the group of beta-blockers. Metoprolol reduces the effects of stress hormones on the heart during physical and mental exertion. This causes the heart to beat more slowly ( heart rate decreases).
Metoprolol Teva is used:
Adults:
- for the treatment of high blood pressure
- to prevent angina
- for the treatment of heart failure
- for the treatment of palpitations (too fast or uneven heart rate ) in some cases
- for the treatment of certain types of disorders of the heart rhythm
- as a preventive treatment after a heart attack
- as a preventive treatment for migraines .
Children and adolescents from 6 to 18 years:
- for the treatment of high blood pressure
Metoprolol contained in Metoprolol Teva may also be approved for the treatment of other conditions not mentioned in this leaflet. 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 taking Metoprolol Teva
Do not take Metoprolol Teva:
- if you are allergic to metoprolol or any of the other ingredients of this medicine (listed in section 6)
- if you suffer from shock due to severe heart disease
- if you have a diseased sinus node in your heart (so-called diseased sinus syndrome)
- if you have severe heart block (conduction disturbance in the heart)
- if you have untreated heart failure
- if you have very low blood pressure and / or very low heart rate
- if you have recently had a heart attack and your heart rate is below 45 beats per minute, you have a deviating ECG curve or your systolic blood pressure (upper pressure) is below 100 mmHg
- if you have heart failure and your upper pressure is below 100 mmHg measured in the supine position
- if you have a advanced circulatory disorder in your hands and / or feet.
Warnings and cautions
Talk to your doctor or pharmacist before taking Metoprolol Teva if you have any of the following conditions:
- asthma
- narrow airways that produce noticeable symptoms
- a severe acute condition due to accumulation of acidic substances in the body ( acidosis )
- a form of angina due to spasm of the coronary arteries (Prinzmetal’s angina)
- severe renal failure
- window viewing disease; the condition may worsen as a result of the decrease in blood pressure caused by Metoprolol Teva.
If you are going to have an operation, tell your doctor that you are taking metoprolol.
Other medicines and Metoprolol Teva
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
The effect of Metoprolol Teva may be altered by the concomitant use of certain other medicines. Likewise, Metoprolol Teva may alter the effect of other medicines. Therefore, you must tell your doctor if you are taking any of the following medicines:
- propafenone , amiodarone , quinidine , verapamil, diltiazem , clonidine , disopyramide , hydralazine , digitalis / digoxin (medicines used to treat cardiovascular disease)
- barbituric acid derivatives (epilepsy drugs)
- medicines for inflammation and pain (eg indomethacin and celecoxib)
- adrenaline (drug for the treatment of acute shock and severe allergic reactions)
- phenylpropanolamine (medicine for nasal congestion)
- diphenhydramine (allergy medicine)
- terbinafine (medicine used to treat fungal infections of the skin)
- rifampicin (medicine used to treat tuberculosis )
- other beta- blockers (eg certain eye drops )
- MAO inhibitors (medicines to treat depression and Parkinson’s disease )
- inhalation anesthetics (inhaled anesthetics)
- diabetes drugs taken by mouth
- cimetidine (antacids or antacids)
- antidepressants ( paroxetine , fluoxetine and sertraline ).
Metoprolol Teva with food and drink
Metoprolol Teva can be taken either with a meal or on an empty stomach.
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 can only be used during pregnancy (especially during the last three months) if the treating physician has made a specific assessment of the benefits and risks of the treatment. Metoprolol crosses the placenta and impairs its blood circulation, which can harm the fetus. Treatment with metoprolol should be discontinued 48-72 hours before the expected delivery. If this is not possible, the newborn should be closely observed for 48-72 hours after birth.
Breastfeeding
Metoprolol is excreted in human milk. Side effects are not expected to occur during treatment with therapeutic doses. However, breastfed infants should be observed for possible side effects.
Driving and using machines
Metoprolol Teva may in rare cases cause dizziness and fatigue and reduce the ability to concentrate. Thus, do not drive, use machines or start with other concentration-intensive tasks before you know what effect Metoprolol Teva has on you.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened vigilance. 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.
Metoprolol Teva contains sucrose
Metoprolol Teva contains sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
How to take Metoprolol Teva
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
The recommended dose is:
Adults:
- High blood pressure:
50-100 mg once daily - Vasospasm:
100–200 mg once daily - Heart failure , functional class II:
The starting dose for the first two weeks is 25 mg once daily. After two weeks, dose one can be increased to 50 mg once daily and thereafter dose one can be doubled every two weeks. For long-term treatment, the target dose is 200 mg once daily. - Heart failure , functional classes III and IV:
The starting dose for the first two weeks is half a 25 mg tablet (ie 12.5 mg) once daily. After 1-2 weeks, the dose can be increased to 25 mg once daily. During the following two weeks, dose one can be increased to 50 mg once daily and thereafter dose one can be doubled every two weeks to a maximum of 200 mg once daily, if the patient tolerates large doses . - Irregular heartbeat without organic cause:
100 mg once daily - Cardiac arrhythmias:
100–200 mg once daily - Preventive treatment after an acute myocardial infarction:
200 mg once daily - Preventive treatment of migraine:
100 – 200 mg once daily
Children and young people
Hypertension:
For children aged 6 years or older, the dose depends on the weight of the child. Your doctor will determine the correct dose for your child.
The usual starting dose is 0.5 mg/kg once daily. Dose one will be adjusted to the nearest tablet strength. Your doctor may increase the dose to 2.0 mg/kg once a day depending on the effect on your blood pressure. Doses over 200 mg once daily have not been studied in children and adolescents.
Metoprolol Teva is not recommended for children under 6 years of age.
Method of use
Metoprolol Teva prolonged-release tablets can be divided, but must not be crushed or chewed. The tablets are swallowed with a sufficient amount of liquid (at least half a glass).
Metoprolol Teva prolonged-release tablets have a smooth effect throughout the day. Therefore, the drug should be taken only once daily.
The tablet can be divided into two equal doses.
If you take more Metoprolol Teva than you should
Depending on the size/degree of overdose, it can lead to excessive blood pressure lowering and slower heart rate. As a result, heart function deteriorates, which can even lead to cardiac arrest, weakened heart muscle, and shock. Other symptoms include difficulty breathing, contraction of the muscles of the airways, vomiting, disturbances of consciousness, and sometimes even generalized seizures.
If you forget to take Metoprolol Teva
If you forget to take Metoprolol Teva, take the missed dose as soon as you remember. However, if it is almost time for your next dose , skip the missed dose and continue taking your medicine normally. Ask your doctor or pharmacist if you are unsure.
Do not take a double dose to make up for a forgotten tablet.
If you stop taking Metoprolol Teva
Do not stop taking Metoprolol Teva without discussing it with your doctor as some symptoms (eg palpitations and angina) may worsen if you suddenly stop taking the medicine.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects , although not everybody gets them.
Common (affects less than 1 in 10 but more than 1 in 100 patients):
Fatigue, headache, dizziness, cold hands and feet, slow heart rate , palpitations, abdominal pain, nausea, vomiting, diarrhea, constipation.
Uncommon (affects less than 1 in 100 but more than 1 in 1,000 patients):
Chest pain, weight gain, sleep disturbances, skin tingling, shortness of breath, worsening of breathing symptoms, transient worsening of heart failure . Blood pressure can drop sharply during a heart attack.
Rare (affects less than 1 in 1,000 but in more than 1 in 10,000 patients):
Increased sweating; hair loss; taste changes; transient impairment of sexual function; nightmares; Depression; memory disorders; confusion; nervousness; anxiety; hallucinations; hypersensitivity reaction in the skin, such as redness or rash; aggravated psoriasis; photosensitivity; decreased platelet count ( thrombocytopenia ); slower heart activity; arrhythmias; swelling; fainting; liver impact; visual disturbances; ringing in the ears ( tinnitus ).
Very rare (affects less than 1 in 10,000 patients):
The following reactions have been reported: joint pain, hepatitis, muscle cramps, dry mouth , dry and irritated eyes, allergic rhinitis, impaired concentration and local tissue death ( necrosis ) in patients with severe circulatory disorders.
If you get any side effects , talk to your doctor or pharmacist. This also applies to side effects that are not mentioned in this information
How to store Metoprolol Teva
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 after EXP. or 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. 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 succinate.
One tablet contains 23.75 mg, 47.5 mg, 95 mg or 190 mg metoprolol succinate, equivalent to 25 mg, 50 mg, 100 mg or 200 mg metoprolol tartrate. - The other ingredients are
Tablet core:
sugar spheres (containing sucrose and maize starch), macrogol, ethyl acrylate methyl methacrylate copolymer, povidone, microcrystalline cellulose, magnesium stearate, silica ( colloidal , anhydrous).
Tablet coating:
hypromellose, talc, macrogol, titanium dioxide (E 171).
What the medicine looks like and contents of the pack
Metoprolol Teva 25 mg prolonged-release tablet
White, oblong, biconvex tablet with a score line on both sides (size: approximately 9.2 x 4.2 mm)
Metoprolol Teva 50 mg prolonged-release tablet
White, oblong, biconvex tablet with a score line on both sides (size: approximately 12.2 x 5.7 mm)
Metoprolol Teva 100 mg prolonged-release tablet
White, oblong, biconvex tablet with a score line on both sides (size: approximately 15.2 x 7.2 mm)
Metoprolol Teva 200 mg prolonged-release tablet
White, oblong, biconvex tablet with a score line on both sides (size: approximately 19.2 x 9.2 mm)
Blister packs: Pack sizes
for Metoprolol Teva 25 mg prolonged-release tablets are 14, 28, 30, 50 x 1, 50, 56, 60, 90, 98 and 100 prolonged-release tablets.
Pack sizes for Metoprolol Teva 50 mg prolonged-release tablets are 28, 30, 50 x 1, 50, 56, 60, 90, 98 and 100 prolonged-release tablets.
Pack sizes for Metoprolol Teva 100 mg prolonged-release tablets are 28, 30, 50 x 1, 50, 56, 60, 90, 98 and 100 prolonged-release tablets.
Pack sizes for Metoprolol Teva 200 mg prolonged-release tablets are 28, 30, 50, 56, 60, 90, 98 and 100 prolonged-release tablets.
Tablet cans: Pack sizes
for Metoprolol Teva prolonged-release tablets in tablet cans are 30, 60, 100, 250 and 500 prolonged-release tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Manufacturer
Merckle GmbH
Ludwig-Merckle-Strasse 3
D-89143 Blaubeuren, Germany