25 mg, 50 mg, 100 mg and 200 mg prolonged-release tablets are
metoprolol succinate
What Metoprolol Sandoz is and what it is used for
Metoprolol succinate, which is the active ingredient in Metoprolol Sandoz, blocks certain beta receptors in your body, especially the beta receptors in your heart ( selective beta-blockers ).
Metoprolol Sandoz is used for the following conditions:
- high blood pressure
- angina ( angina pectoris )
- disturbances of heart rhythm with rapid pulse
- preventive treatment after the acute phase of a heart attack
- unpleasant sensations that the heart is beating irregularly and / or too hard
- migraine prevention
- treatment of heart failure .
Children and adolescents aged 6-18 years
For the treatment of high blood pressure ( hypertension ).
Metoprolol contained in Metoprolol Sandoz may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before taking Metoprolol Sandoz
Do not take Metoprolol Sandoz
- if you are allergic to metoprolol succinate or any of the other ingredients of this medicine (listed in section 6)
- if you are allergic to any other beta -blocker
- if you have severe asthma or severe wheezing attacks
- if you suffer from shock due to severe heart disease
- if you have a conduction disorder in the heart (grade II or III atrioventricular block, high-grade sinoatrial block) or heart rhythm disorder (sick sinus syndrome) except in patients with permanent pacemaker
- if you have severe blood circulation disorders (severe peripheral arterial disease)
- if you have untreated heart failure that is out of control (this usually causes shortness of breath and swelling of the ankles)
- if your heart beats slowly ( heart rate below 50 beats / minute at rest before treatment)
- if you have very low blood pressure (systolic blood pressure below 90 mmHg)
- if you have been told that your blood has a higher acidity than normal (a condition called metabolic acidosis )
- if you are taking any of the following medicines:
- monoamine oxidase inhibitors ( MAOIs ) (for depression)
- verapamil and diltiazem (to lower blood pressure )
- antiarrhythmic drugs such as disopyramide to treat abnormal heart rhythms.
Patients with chronic heart failure should not take metoprolol if:
- they suffer from unstable uncompensated heart failure (which can manifest itself in the form of fluid accumulation in the lungs, poor blood circulation or low blood pressure )
- they receive continuous or temporary treatment with drugs that increase the heart’s pumping ability
- they have a slow heart rate (less than 68 beats / minute at rest, before treatment)
- their systolic (upper) blood pressure is constantly below 100 mmHg.
Warnings and cautions
Talk to your doctor or pharmacist before taking Metoprolol Sandoz
- if you have asthma , bronchitis or similar lung problems
- if you have problems with your heart (such as a slow heartbeat) or with your blood circulation ( Metoprolol Sandoz may make your condition worse)
- if you are prescribed the drug fingolimod (used to treat relapsing-remitting multiple sclerosis ); concomitant use of these two drugs may potentiate the heart-lowering effect during the first days of treatment with fingolimod
- if you have diabetes
- if you have thyroid problems
- if you have severe liver disease
- if you have ever had a severe allergic reaction to anything
- if you have a rare form of angina called Prinzmetal’s angina
- if you are going to have an operation that requires anesthesia. Tell your anesthetist that you are taking Metoprolol Sandoz.
- if you have a hormone-producing tumor in the adrenal medulla ( pheochromocytoma ): in this case, prior and concomitant use of an alpha-receptor blocker is required
- if you have psoriasis .
Children and young people
There is limited experience in treating children under 6 years of age. The use of Metoprolol Sandoz is not recommended for children under 6 years of age.
Other medicines and Metoprolol Sandoz
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Metoprolol Sandoz interacts with many other medicines:
- Medicines for high blood pressure (including prazosin, clonidine , hydralazine , guanetidine, betanidine, reserpine, alpha-methyldopa, clonidine and medicines called calcium channel blockers, such as verapamil, diltiazem or nifedipine).
- Other beta-blockers (also in the form of eye drops ).
- Drugs that affect the peripheral blood circulation (fingers and toes), e.g. ergot alkaloids that can be used to treat migraines .
- Antidepressants.
- Medicines for other mental illnesses.
- Antiretroviral drugs, used to treat AIDS and certain other diseases.
- Antihistamines (including over-the-counter medicines for hay fever and other allergies , colds and other conditions).
- Drugs that prevent malaria .
- Medicines for fungal infections.
- Drugs that affect liver enzymes, e.g. rifampicin used to treat tuberculosis .
- Medicines for heart problems, including angina, e.g. amiodarone , digoxin , nitrates and antiarrhythmic drugs.
- fingolimod (a drug used to treat relapsing multiple sclerosis in adults, children and adolescents); concomitant use with beta-blockers may potentiate the heart rate-lowering effect during the first days of treatment with fingolimod
- aldesleukin (a synthetic protein drug used to treat kidney cancer that has spread to other organs); concomitant use with beta-blockers may potentiate the antihypertensive effect
- Insulin or other diabetes medicines.
- Drugs called NSAIDs that are used to treat pain and inflammation .
- A local anesthetic called lidocaine .
- A drug called dipyridamole that prevents blood clots.
Metoprolol Sandoz with food, drink and alcohol
Metoprolol Sandoz and alcohol may increase each other ‘s sedative (sedative) effects. Blood alcohol levels can reach higher levels and decrease more slowly. Avoid alcohol while taking Metoprolol Sandoz.
Pregnancy, breastfeeding and fertility
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 Sandoz should only be used during pregnancy if necessary and if the treating physician has carefully weighed the expected benefit against any possible risks. There is evidence that metoprolol reduces blood flow in the placenta and can cause disruption of fetal growth.
Treatment with Metoprolol Sandoz should be stopped 48-72 hours before the expected delivery. If this is not possible, the newborn baby should be closely monitored by a doctor for 48‑72 hours after birth.
Breast-feeding
Metoprolol Sandoz is excreted in human milk.
Metoprolol succinate should not be taken during breastfeeding unless necessary. Although no side effects are expected after using Metoprolol Sandoz at the recommended dose, breast-fed infants should be closely monitored (eg, physician monitoring of cardiac function) for symptoms that may occur with the drug.
Driving and using machines
Dizziness or tiredness may occur during treatment with Metoprolol Sandoz. This can affect the ability to react to such an extent that the ability to drive, the ability to use machines, and the ability to work in potentially dangerous situations can be weakened. This is especially the case after concomitant use of alcohol and after switching from or to the drug.
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.
Metoprolol Sandoz contains glucose, lactose 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.
How to take Metoprolol Sandoz
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Your doctor will tell you how many tablets to take and when to take them. The dose you are prescribed depends on your illness and its severity.
Unless your doctor prescribes otherwise, the usual dose is as follows:
High blood pressure ( hypertension )
- Patients with mild or moderate hypertension should take 47.5 mg metoprolol succinate once daily .
- If necessary, your doctor may increase the dose to 95-190 mg metoprolol succinate once daily . Other antihypertensive agents may also be used as supplements.
Angina pectoris _
- The usual dose is 95-190 mg metoprolol succinate once daily .
- If necessary, other drugs for the treatment of coronary heart disease can also be used as a supplement.
Disorders of the heart rhythm with a rapid pulse ( cardiac arrhythmias )
- The usual dose is 95-190 mg metoprolol succinate once daily .
Treatment after a heart attack
- The usual dose is 190 mg metoprolol succinate once daily .
Unpleasant feelings of irregular and/or strong heartbeat (palpitations)
- The usual dose is 95 mg metoprolol succinate once daily .
- If necessary, your doctor may increase the dose to 190 mg metoprolol succinate once daily .
Prevention of migraines
- The usual dose is 95-190 mg metoprolol succinate once daily .
Muscle weakness in the heart ( heart failure )
In the treatment of heart failure, the disease must first be stabilized with standard treatment for heart failure, and the dose of Metoprolol Sandoz must be adjusted individually.
- In patients with NYHA grade III-IV heart failure , the recommended initial dose during the first week is 11.88 mg metoprolol succinate once daily .Dose one may be increased during the second week of treatment to 23.75 mg metoprolol succinate once daily .In patients with NYHA grade II heart failure , the recommended initial dose for the first two weeks is 23.75 mg metoprolol succinate once daily .
- Thereafter, the dose should be doubled. Dose one can be doubled every two weeks up to 190 mg metoprolol succinate once daily or to the highest dose you tolerate.
- The recommended dose for long-term maintenance treatment is 190 mg metoprolol succinate once daily or the highest dose you can tolerate.
Use for children and adolescents
High blood pressure: For children aged 6 years and older, the dose depends on the child’s weight. The doctor will calculate the correct dose for your child.
The usual starting dose is 0.48 mg/kg metoprolol succinate once daily but not more than 47.5 mg. Dose one is adjusted to the nearest tablet strength. Your doctor may increase the dose one to 1.9 mg/kg depending on how your blood pressure reacts to the treatment. Doses above 190 mg once daily have not been studied in children and adolescents.
Metoprolol Sandoz tablets are not recommended for children under 6 years of age.
Your doctor will decide how long you should take Metoprolol Sandoz.
Talk to your doctor or pharmacist if you have the impression that the effect of Metoprolol Sandoz is too strong or too weak.
Older
No studies have been performed on patients over 80 years of age. Therefore, special care is required when increasing the dosage for patients over 80 years of age.
Metoprolol Sandoz is for oral use.
Take the tablets once a day, preferably with breakfast. The tablets can be divided into two equal doses. You can swallow the tablets either whole or divided, but avoid chewing or crushing them. Take the tablets with water (at least ½ glass).
If you take more Metoprolol Sandoz than you should
Bring the medicine pack with you so that the doctor can see which medicine you have taken and can start appropriate treatment.
Symptoms of overdose
In case of overdose with Metoprolol Sandoz, the symptoms may include dangerously low blood pressure, severe heart complications, difficulty breathing, unconsciousness (including coma ), convulsions, nausea, vomiting, cyanosis (blue or purple skin), and death.
The first signs of overdose occur 20 minutes to 2 hours after taking Metoprolol Sandoz, and with severe overdose, the effects may persist for several days.
Treatment in case of overdose
The patient must be admitted to the hospital and cared for in an intensive care unit. Even seemingly unaffected patients who have taken a small overdose should be closely monitored for at least 4 hours for signs of poisoning.
If you forget to take Metoprolol Sandoz
Do not take a double dose to make up for a forgotten dose, but continue the treatment prescribed by your doctor.
If you stop taking Metoprolol Sandoz
Ask your doctor before stopping or stopping treatment with Metoprolol Sandoz prematurely.
Treatment with Metoprolol Sandoz should not be stopped abruptly but the dose should be reduced gradually. Abrupt discontinuation of beta-blocker therapy may lead to worsening heart failure and may increase the risk of myocardial infarction and sudden cardiac death.
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.
Very common (may affect more than 1 user in 10):
- fatigue.
Common (may affect up to 1 in 10 people):
- dizziness, headache
- slow heart rate ( bradycardia )
- palpitation
- sharp drop in blood pressure, especially when getting up after lying down, very rarely accompanied by unconsciousness
- cold hands and feet
- shortness of breath on exertion in sensitive patients (eg patients with asthma )
- nausea, abdominal pain, diarrhea, constipation.
Uncommon (may affect up to 1 in 100 people):
- weight gain
- depression, drowsiness, sleep disorders, nightmares, impaired concentration
- ant crawling, tingling sensation or numbness in the skin ( paresthesia )
- temporarily aggravated symptoms of heart failure (with swelling of the ankles and feet), 1st degree disturbance of the conduction of the electrical impulse from the atrium to the ventricle ( AV block of grade I), pain in the heart area (chest pain), poor pumping ability of the heart ( cardiogenic shock ) in patients with myocardial infarction ( acute myocardial infarction )
- bronchospasm ( bronchospasm )
- skin rash (psoriasis -like hives and dystrophic skin changes), increased sweating
- muscle cramps
- vomiting.
Rare (may affect up to 1 in 1,000 people):
- exacerbated diabetes without the characteristic symptoms ( latent diabetes mellitus )
- nervousness, anxiety
- impaired vision, dryness or irritation of the eyes (should be noted when wearing contact lenses), inflammation of the conjunctiva of the eye
- disorders of the heart rhythm, conduction disturbance
- nasal congestion
- dry mouth
- deviating liver function values
- hair loss
- impotence and changes in sexual desire, Peyronie’s disease (hardening of the erectile tissue in the penis, induratio penis plastica).
Very rare (may affect up to 1 in 10,000 people):
- decreased platelet count ( thrombocytopenia ), decreased white blood cell count (leukocytopenia)
- impaired memory, confusion, hallucinations, personality changes (eg mood swings)
- tinnitus, hearing disorders
- tissue death ( necrosis ) in patients with severe impaired peripheral blood circulation when starting treatment
- taste changes
- hepatitis
- photosensitivity with skin rash after exposure to light, aggravated psoriasis , onset of psoriasis
- joint pain, muscle weakness.
Has been reported (occurs in an unknown number of users):
- abnormal levels of certain types of fat, e.g. cholesterol and triglycerides in the blood
- aggravated symptoms in patients suffering from ” intermittent claudication ” or vasospasm which results in poor blood circulation and whiteness of the toes and fingers (Raynaud’s syndrome).
How to store Metoprolol Sandoz
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, jar, and carton after EXP. The expiration date is the last day of the specified month.
Do not store above 25 ° C.
Store in the original package. Moisture sensitive.
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 succinate.Metoprolol Sandoz 25 mg:One prolonged-release tablet contains 23.75 mg metoprolol succinate equivalent to 25 mg metoprolol tartrate.
Metoprolol Sandoz 50 mg:One prolonged-release tablet contains 47.5 mg metoprolol succinate equivalent to 50 mg metoprolol tartrate.
Metoprolol Sandoz 100 mg:One prolonged-release tablet contains 95 mg metoprolol succinate equivalent to 100 mg metoprolol tartrate.
Metoprolol Sandoz 200 mg:One prolonged-release tablet contains 190 mg metoprolol succinate equivalent to 200 mg metoprolol tartrate. - The other ingredients are microcrystalline cellulose (E460), crospovidone, glucose , hypromellose, lactose monohydrate , macrogol 4000, magnesium stearate, corn starch, polyacrylate, anhydrous colloidal silica, sucrose, talc, titanium dioxide (E171).
In addition to 100 mg prolonged-release tablets :Yellow iron oxide (E172)
What the medicine looks like and contents of the pack
25 mg, 50 mg, and 200 mg prolonged-release tablets:
White, oblong tablets with a scoreline on both sides of the tablet. The tablet can be divided into two equal doses.
100 mg prolonged-release tablets:
Light yellow and oblong tablets with a scoreline on both sides of the tablet. The tablet can be divided into two equal doses.
The prolonged-release tablets are packaged in blisters of PP/aluminum or PVC / foil/aluminum and placed in a carton or are packed in an HDPE jar and inserted in a carton.
Blister:
25 mg and 200 mg:
Pack sizes: 10, 20, 28, 30, 50, 50×1, 60, 100 and 112 prolonged-release tablets
50 mg and 100 mg:
Pack sizes: 10, 20, 28, 30, 50, 50×1, 60, 90, 100 and 112 prolonged-release tablets
HDPE jar
Pack sizes: 30, 60, 100, 250 and 500 prolonged-release tablets
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Sandoz A / S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark
Manufacturer
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, D-39179 Barleben, Germany (blister packs)
or
Lek Pharmaceuticals dd, Verovškova 57, 1526 Ljubljana, Slovenia (HDPE j