25 mg, 50 mg, 100 mg, 200 mg prolonged-release tablet is
metoprolol
1. What Bloxazoc is and what it is used for
Metoprolol succinate 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) in these situations.
Bloxazoc is used to treat :
- high blood pressure ( hypertension ),
- chest cramps caused by an insufficient flow of oxygen to the heart (angina),
- irregular heartbeat ( arrhythmia ),
- palpitations (feeling pulse one) due to inorganic (functional) heart disease,
- stable heart failure with symptoms (such as shortness of breath or swollen ankles) when taken with other heart failure medicines.
Bloxazoc is used to prevent :
- more heart attacks or damage to the heart after a heart attack,
- migraine.
Bloxazoc is used to treat high blood pressure in children and adolescents from 6‑18 years of age.
Metoprolol succinate contained in Bloxazoc may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist or other healthcare professional if you have any further questions and always follow their instructions.
2. What you need to know before you use Bloxazoc
Do not use Bloxazoc
- if you are allergic to metoprolol succinate or any of the other ingredients of this medicine (listed in section 6),
- if you have unstable heart failure , receive treatment to increase heart contractions,
- if you have heart failure and your blood pressure is below 100 mmHg,
- if you have a low heart rate (below 45 beats / min) or low blood pressure ( hypotension ),
- if you suffer from shock due to heart disease,
- if you have a conduction disorder of the heart (grade II or III atrioventricular block) or a disorder of the heart rhythm (diseased sinus node),
- if you have a severe circulatory disorder (severe peripheral arterial disease).
Warnings and cautions
Talk to your doctor or pharmacist before taking Bloxazoc.
- if you are receiving verapamil intravenously
- if you have poor blood circulation which can lead to tingling in the fingers and toes or that they whiten or get a bluish tone
- if you have a cramping chest pain that usually occurs at night (Prinzmetal’s angina)
- if you have asthma or other chronic obstructive pulmonary disease
- low blood sugar levels can be hidden by this medicine ( diabetes mellitus )
- if you have a conduction disorder in the heart (heart block)
- if you are receiving treatment for an allergic reaction . Bloxazoc may increase your hypersensitivity to the substances you are allergic to and aggravate allergic reactions
- if you have high blood pressure due to a rare tumor in one of the adrenal glands ( pheochromocytoma )
- if you have heart failure
- if you are going to be anesthetized, tell your doctor or dentist that you are taking metoprolol tablets
- if you have too high levels of acidic substances in your blood (metabolic acidosis )
- if you have severe kidney failure
- if you are being treated with digitalis .
Other medicines and Bloxazoc
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines:
- propafenone , amiodarone , quinidine , verapamil, diltiazem , clonidine , disopyramide and hydralazine , digitalis / digoxin (cardiovascular drugs),
- barbituric acid derivatives (medicines for epilepsy ),
- anti- inflammatory drugs (eg indomethacin and celecoxib),
- adrenaline (medicine for acute shock and severe allergic reaction ),
- phenylpropanolamine (medicine for nasal mucosal swelling),
- diphenhydramine (medicine for allergic conditions),
- terbinafine (medicine for fungal infections),
- rifampicin ( antibiotic ),
- other beta-blockers (eg eye drops ),
- MAO inhibitors (antidepressants and Parkinson’s disease ),
- inhalation anesthetics (medicines for anesthesia),
- drugs against diabetes , symptoms of low blood sugar levels can be hidden,
- cimetidine (medicines for heartburn and acid reflux),
- paroxetine , fluoxetine and sertraline (antidepressants).
Bloxazoc with food, drink and alcohol
Bloxazoc can be taken with or without food.
Pregnancy, breastfeeding, and fertility
Beta-receptor blockers (including metoprolol ) may reduce the heart rate of the fetus and newborn baby. Bloxazoc is not recommended during pregnancy and lactation. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Bloxazoc may make you feel tired and dizzy. Make sure that you are not affected by the treatment before driving or using machines, especially in case of changes in medication and in connection with alcohol.
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.
Bloxazoc contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie essentially ‘sodium-free’.
3. How to use Bloxazoc
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Bloxazoc prolonged-release tablet is a form of medicine that gives an even effect throughout the day and should be taken once daily with a glass of water in the morning.
Bloxazoc 25 mg prolonged-release tablets can be divided into two equal doses .
Bloxazoc 50 mg, 100 mg, 200 mg prolonged-release tablets can be halved to facilitate swallowing, not to divide the tablet into two equal doses .
Bloxazoc tablets (or divided halves) should not be chewed or crushed. Swallow with liquid.
Recommended dose:
High blood pressure ( hypertension ):
47.5-95 mg metoprolol succinate (50-100 mg metoprolol tartrate) once daily.
Spasmodic chest pain ( angina pectoris ):
95-190 mg metoprolol succinate (100-200 mg metoprolol tartrate) once daily.
Irregular heartbeats ( arrhythmias ):
95-190 mg metoprolol succinate (100-200 mg metoprolol tartrate) once daily.
Preventive treatment after a heart attack:
190 mg metoprolol succinate (200 mg metoprolol tartrate) once daily.
Palpitations due to heart disease:
95 mg metoprolol succinate (100 mg metoprolol tartrate) once daily.
Preventive treatment for migraines:
95-190 mg metoprolol succinate (100-200 mg metoprolol tartrate) once daily.
Patients with stable heart failure in combination with other drugs:
The starting dose is 11.88-23.75 mg metoprolol succinate (12.5-25 mg metoprolol tartrate) once daily. The dose can be increased gradually as needed to a maximum of 190 mg metoprolol succinate (200 mg metoprolol tartrate) once daily.
Patients with hepatic impairment:
If you have severe hepatic impairment, your doctor may adjust your dose . Always follow your doctor’s instructions.
Use for children and adolescents
Bloxazoc is not recommended for use in children below 6 years of age. Always use Bloxazoc for children and adolescents according to your doctor’s instructions.
The doctor will calculate the dose that is right for your child. Dose one depends on the weight of the child.
The recommended starting dose for high blood pressure is 0.48 mg / kg metoprolol succinate (0.5 mg / kg metoprolol tartrate) once daily (half a tablet of Bloxazoc 25 mg for a child weighing 25 kg). Dose one will be adjusted to the nearest tablet strength. In patients not responding to 0.5 mg / kg metoprolol tartrate, the dose may be increased to 0.95 mg / kg metoprolol succinate (1.0 mg / kg metoprolol tartrate), not exceeding 50 mg metoprolol tartrate. In patients who do not respond to 1.0 mg / kg metoprolol tartrate, the dose may be increased to 1.9 mg / kg metoprolol succinate (2 mg / kg metoprolol tartrate) once daily (1 tablet Bloxazoc 50 mg for a child weighing 25 kg) . Dosemore than 190 mg metoprolol succinate (200 mg metoprolol tartrate) once daily has not been studied in children and adolescents.
If you forget to use Bloxazoc
If you forget to take a dose , take it as soon as you remember, then continue as before.
Do not take a double dose to make up for a forgotten tablet.
If you stop using Bloxazoc
Cancel your treatment with Bloxazoc suddenly as it may worsen your heart failure increase the risk of heart attack. Only change dose one or stop treatment in consultation with your doctor.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very common (affects more than 1 user in 10):
- fatigue.
Common (affects up to 1 in 10 people):
- headache, dizziness,
- cold hands and feet, low heart rate , palpitations,
- shortness of breath on exertion,
- nausea, abdominal pain, vomiting, diarrhea, constipation.
Uncommon (affects up to 1 in 100 people):
- depression, nightmares, sleep disorders,
- tingling in the skin,
- transient worsening of heart failure ,
- during a heart attack, blood pressure may drop sharply, cardiogenic shock in patients with acute myocardial infarction,
- shortness of breath, aggravated tracheal problems,
- hypersensitivity reaction from the skin,
- chest pain, fluid retention (swelling), weight gain.
Rare (affects up to 1 in 1,000 people):
- a decrease in the number of platelets in the blood ( thrombocytopenia ),
- memory disorders, confusion, hallucinations, nervousness, anxiety,
- taste changes,
- visual disturbances, dry or irritated eyes,
- conduction disturbance in the heart, disorders of the heart rhythm,
- changes in liver function tests,
- psoriasis (a type of skin disease) may worsen, photosensitivity, increased sweating, hair loss,
- impotence (inability to get an erection ),
- tinnitus.
No known frequency (cannot be calculated from the available data):
- impaired concentration,
- muscle cramps,
- eye inflammation,
- tissue death in patients with severe circulatory disorders,
- rinnsnuva,
- dry mouth,
- hepatitis ( hepatitis ),
- joint pain.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.
5. How to store Bloxazoc
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. The expiration date is the last day of the specified month.
Do not store above 30 ° 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.
6. Contents of the packaging and other information
Content declaration
- The active substance is metoprolol succinate.
- Each prolonged-release tablet contains 23.75 mg metoprolol succinate equivalent to 25 mg metoprolol tartrate.
- Each prolonged-release tablet contains 47.5 mg metoprolol succinate equivalent to 50 mg metoprolol tartrate.
- Each prolonged-release tablet contains 95 mg metoprolol succinate equivalent to 100 mg metoprolol tartrate.
- Each prolonged-release tablet contains 190 mg metoprolol succinate equivalent to 200 mg metoprolol tartrate.
- The other ingredients are silica, colloidal, anhydrous; microcrystalline cellulose; hypromellose; sodium lauryl sulfate; polysorbate 80; glycerol; hydroxypropyl cellulose; ethylcellulose and sodium stearyl fumarate in the tablet core and hypromellose; titanium dioxide (E171); talc and propylene glycol in the film coating. See section 2 “Bloxazoc contains sodium”.
What the medicine looks like and the contents of the pack
25 mg: white to off-white, oval, biconvex, film-coated tablet with a notch on one side of the tablet (dimension 8.5 mm x 4.5 mm). One side of the notch is marked with “C” and the other side of the notch is marked with “1”.
50 mg: white to off-white, oval, slightly biconvex, film-coated tablet with a notch on one side of the tablet (dimension 10.5 mm x 5.5 mm). One side of the notch is marked with “C” and the other side of the notch is marked with “2”.
100 mg: white to off-white, oval, biconvex, film-coated tablet with a notch on one side of the tablet (dimension 13 mm x 8 mm). One side of the notch is marked with “C” and the other side of the notch is marked with “3”.
200 mg: white to off-white, oval, biconvex, capsule-shaped film-coated tablet, scored on both sides of the tablet (dimension 19 mm x 8 mm). One side of the notch on one side of the tablet is marked with “C” and the other side of the notch is marked with “4”.
Bloxazoc is supplied in cartons containing 10, 14, 28, 30, 50, 56, 60, 84, 90, 98 and 100 tablets in blisters.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
KRKA, dd, Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Local representative
KRKA Sverige AB, Göta Ark 175, 118 72 Stockholm,
Manufacturer
KRKA, dd, Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany