Metoprolol Orion
25 mg / 50 mg / 100 mg / 200 mg prolonged-release tablet is
metoprolol tartrate
What Metoprolol Orion is and what it is used for
The active substance in Metoprolol Orion, metoprolol, belongs to a group of medicines called selective beta-blockers, which have a special effect on the heart. The drug affects how the body responds to certain nerve signals, especially in the heart. Thereby, the drug lowers blood pressure and increases the pumping power of the heart.
Metoprolol Orion is used to
- treat high blood pressure
- treat decreased blood flow to the coronary arteries (coronary heart disease, angina)
- treat arrhythmias where the heart beats too fast (tachycardic arrhythmias ), especially if they occur in the atrium of the heart ( supraventricular tachycardia )
- prevent further myocardial infarction after a previous infarction (maintenance treatment)
- treat dysfunction of the cardiovascular system
- prevent migraines
- treat mild to moderate, stable, chronic heart failure (with impaired left ventricular function) in addition to standard treatment.
Children and adolescents aged 6-18 years:
For the treatment of high blood pressure ( hypertension )
What you need to know before you use Metoprolol Orion
Do not use Metoprolol Orion
Do not take Metoprolol Orion
- if you are allergic to metoprolol , other beta- blockers or any of the other ingredients of this medicine (listed in section 6)
- if you have certain forms of arrhythmia ( AV block II or III, highly sinoatrial block)
- if your heart beats slowly ( heart rate below 50 beats / minute)
- if you have a sick sinus node in your heart
- if you have had circulatory collapse mainly due to heart failure
- if you have severe circulatory disorders in your arms and / or legs
- if you have very low blood pressure , ie. when the systolic blood pressure et (the upper value in the blood pressure et) is lower than 90 mmHg
- if you have an untreated hormone-producing tumor in the adrenal medulla ( pheochromocytoma )
- if you have high acidity in your blood caused by a metabolic disorder
- if you have severe bronchial asthma or chronic obstructive pulmonary disease
- if you are also being treated with MAO inhibitors (antidepressants) in addition to MAO-B inhibitors
- if a heart attack is suspected and your heart rate is below 45 beats / minute, your systolic blood pressure is <100 mmHg and you have some disturbances in your heart rhythm.
Patients with chronic heart failure should not take metoprolol:
- if they suffer from unstable uncompensated heart failure (which may manifest as fluid in the lungs, poor blood circulation or low blood pressure ), unless this condition has been stabilized by medical treatment
- if they are being treated continuously or temporarily with medicines that increase the heart’s pumping capacity (eg dobutamine )
- if their systolic (upper) blood pressure is constantly below 100 mmHg.
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before taking Metoprolol Orion if any of the following apply to you, or if you develop any of the following conditions during treatment.
- if you have asthma . Metoprolol may worsen the symptoms of asthma and the effect of some medicines for asthma may be weakened. Metoprolol Orion should not be used in severe asthma
- if you have diabetes . Metoprolol may mask the symptoms of low blood sugar. Regular blood sugar checks are therefore required
- if you have a mild form of a certain heart rhythm disorder ( AV block I)
- if you have a type of angina called Prinzmetal’s angina
- if you have mild or moderate circulatory disorders in your arms or legs
- if you have a hormone-producing tumor in the adrenal medulla ( pheochromocytoma ), an alpha-blocker should be used before and at the same time as metoprolol
- if your thyroid gland is overactive
- if you are going to have surgery. Before the operation , tell your anesthetist that you are taking Metoprolol Orion
- 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 .
Other medicines and Metoprolol Orion
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Careful medical supervision is required when taking the following medicines with Metoprolol Orion:
- drugs for the treatment of disorders of the heart rhythm such as calcium antagonists of the verapamil and diltiazem type or class I antiarrhythmics (eg disopyramide ). Verapamil-type calcium antagonists must not be given intravenously to you (except if you are in the intensive care unit).
- other beta- blockers (eg eye drops containing the active substance timolol ).
Other interactions:
Inhaled anesthetic enhances the heart rate lowering effect of metoprolol.
Metoprolol may potentiate the effects of antihypertensive drugs (eg reserpine, alpha methyldopa, clonidine, guanfacine, and cardiac glycosides). This can, for example, lead to a greatly reduced heart rate.
The following substances may increase the concentration of metoprolol in the blood and thereby enhance the effect of Metoprolol Orion:
- alcohol
- drugs for the treatment of high stomach acid levels such as cimetidine
- antihypertensive drugs such as hydralazine
- certain drugs for the treatment of depression such as paroxetine , fluoxetine and sertraline
- insomnia drugs such as diphenhydramine
- certain substances for the treatment of joint problems such as hydroxychloroquine and celecoxib
- certain drugs used to treat fungal infections , e.g. terbinafine
- neuroleptics (eg chlorpromazine, triflupromazine and chlorprotixen)
- certain medicines for the treatment of arrhythmias such as amiodarone , quinidine and possibly propafenone .
If you also use an anti-inflammatory drug (eg indomethacin or another inhibitor of prostaglandin synthetase), the antihypertensive effect of metoprolol may be reduced.
Rifampicin (an antibiotic used to treat, for example, tuberculosis ) and barbituric acid derivatives (used as sedatives or sedatives, for example) reduce the antihypertensive effect of metoprolol.
Beta-blockers may inhibit the release of insulin in patients with type 2 diabetes. You should therefore check your blood sugar regularly. If necessary, your doctor will change your diabetes treatment ( dose of insulin or oral antidiabetic drugs).
Your blood pressure can be significantly increased if you take Metoprolol Orion at the same time as norepinephrine or adrenaline (neurotransmitters that occur naturally in the body and which raise blood pressure through its stimulating effect on the heart and vessels ) or other drugs with a similar effect.
The effect of adrenaline on the treatment of hypersensitivity reactions may be impaired.
Metoprolol may reduce the secretion of other medicines (eg lidocaine, a local anesthetic).
If concomitant treatment with clonidine (a medicine used to treat high blood pressure ) has to be stopped, treatment with Metoprolol Orion should be stopped several days before clonidine treatment.
Metoprolol Orion with food, drink and alcohol
Metoprolol and alcohol may increase each other’s hypnotic effects. Therefore, you should not drink alcohol while taking metoprolol.
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 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 blood flow to the placenta and can therefore cause growth disorders in the fetus. Treatment with metoprolol should be discontinued 48-72 hours before the estimated date of delivery. If this is not possible, the newborn baby should be closely monitored 48-72 hours after birth.
Breast-feeding
Metoprolol accumulates in breast milk.
Although no side effects are expected when metoprolol is used in standard treatment doses, breastfed infants should be monitored for the effects of the drug.
Driving and using machines
During treatment with Metoprolol Orion, dizziness and fatigue may occur. Your ability to react may change to such an extent that your ability to drive, use machines, or work without protective equipment is impaired. This is especially true in combination with alcohol or when the metoprolol dose 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.
Metoprolol Orion 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.
How to use Metoprolol Orion
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure. If your doctor has not prescribed another dose for you, the usual dose is:
| Therapeutic indication | The usual dose, once daily | If necessary, the daily dose can be increased as follows: |
|---|---|---|
| High blood pressure | 1 prolonged-release tablet of 50 mg½ 100 mg prolonged-release tablets Other dosage strengths are available for initial treatment of this condition | Maximum dose4 prolonged-release tablets of 50 mg 2 prolonged-release tablets of 100 mg 1 prolonged-release tablet of 200 mg or concomitant treatment with another antihypertensive drug |
| Insufficient blood supply to the coronary arteries (coronary heart disease, angina) | 1 to 4 prolonged-release tablets of 50 mg ½ to 2 prolonged-release tablets of 100 mg Other dosage strengths are available for initial treatment of this condition | Maximum dose4 prolonged-release tablets of 50 mg 2 prolonged-release tablets of 100 mg 1 prolonged-release tablet of 200 mg or concomitant treatment with another antihypertensive drug |
| Fast heartbeat | 1 to 4 prolonged-release tablets of 50 mg ½ to 2 prolonged-release tablets of 100 mg Other dosage strengths are available for initial treatment of this condition | Maximum dose 4 prolonged-release tablets are 50 mg 2 prolonged-release tablets are 100 mg 1 prolonged-release tablet 200 mg |
| Functionalcardiovascular disorders | 1 to 4 prolonged-release tablets of 50 mg ½ to 2 prolonged-release tablets of 100 mg Other dosage strengths are available for initial treatment of this condition | Maximum dose 4 prolonged-release tablets are 50 mg 2 prolonged-release tablets are 100 mg 1 prolonged-release tablet 200 mg |
| Maintenance treatment after a heart attack | 1 to 4 prolonged-release tablets of 50 mg ½ to 2 prolonged-release tablets of 100 mg Other dosage strengths are available for initial treatment of this condition | Maximum dose 4 prolonged-release tablets are 50 mg 2 prolonged-release tablets are 100 mg 1 prolonged-release tablet 200 mg |
| Migraine prevention treatment | 2 prolonged-release tablets are 50 mg 1 prolonged-release tablet 100 mg ½ 200 mg prolonged-release tablet | Maximum dose 4 prolonged-release tablets are 50 mg 2 prolonged-release tablets are 100 mg 1 prolonged-release tablet 200 mg |
| Treatment of heart failure, NYHA II The treating physician should have experience in the treatment of stable symptomatic heart failure. | Starting dose during the first two weeks 1 prolonged-release tablet of 25 mg ½ prolonged-release tablet of 50 mg * The patient’s condition should be closely monitored after each dose increase. | From week 3:2 prolonged-release tablets are 25 mg 1 prolonged-release tablet 50 mg ½ prolonged-release tablet 100 mg dose one is then doubled every two weeks to a maximum dose of 8 prolonged-release tablets of 25 mg 4 prolonged-release tablets of 50 mg2 prolonged-release tablets of 100 mg 1 prolonged-release tablet of 200 mg (equivalent to 200 mg * metoprolol tartrate) or at the highest dose tolerated by the patient.200 mg * metoprolol tartrate is also the recommended dose for long-term treatment of heart failure. |
| Treatment of heart failure, NYHA III | Starting dose During the first week 12.5 mg * metoprolol tartrate (equivalent to ½ 25 mg prolonged-release tablet *) | Dose one can be increased to1 prolonged-release tablet of 25 mg½ 50 mg * prolonged-release tablet during the second week. |
Prolonged-release prolonged-release tablets are available for these doses.
Patients with renal impairment
Dose adjustment is not required.
Patients with hepatic impairment
It may be necessary to reduce the dose to patients with severe hepatic impairment, e.g. shunt -operated patients (portocaval shunt ).
Use for children and adolescents
High blood pressure: For children 6 years or older, the dose is one based on the child’s body weight. The doctor will calculate the correct dose for the child.
The usual starting dose is 0.5 mg/kg once daily but does not exceed 50 mg. Dose one will be adjusted to the nearest tablet strength. Your doctor may increase the dose one to 2.0 mg/kg depending on the blood pressure response. Doses over 200 mg once daily have not been studied in children and adolescents. Metoprolol Orion is not recommended for children under 6 years of age.
Elderly patients over 80 years
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.
How to take the medicine
The prolonged-release tablets should be taken once daily, preferably with breakfast. The prolonged-release tablets should be swallowed whole or divided but must not be chewed or crushed. They should be taken with water (at least ½ glass).
The tablet can be divided into two equal doses.
Duration of treatment
The doctor decides how long the treatment should last.
If you use more Metoprolol Orion than you should
Depending on the amount of medication you have taken, the following symptoms may occur: severe drop in blood pressure, low heart rate, heart rhythm disturbance, heart failure, circulatory collapse, cardiac arrest, narrowing/spasms in the airways, unconsciousness (including coma ), nausea, vomiting and cyan discoloration).
Concomitant intake of alcohol, antihypertensive drugs, quinidine (antiarrhythmic drugs), or barbiturates (sedatives) may worsen the symptoms.
The first signs of overdose occur 20 minutes to 2 hours after taking the medicine.
If you forget to use Metoprolol Orion
Do not take a double dose to make up for a forgotten tablet. Continue to take the tablets according to your doctor’s instructions.
If you stop using Metoprolol Orion
Discuss with your doctor if you want to stop treatment temporarily or if you want to end treatment with Metoprolol Orion prematurely.
Beta-blocker therapy must not be stopped abruptly. If treatment is to be discontinued, this should always be done slowly for at least 2 weeks and, if possible, by gradually reducing dose one by half until the lowest dose of one 25 mg prolonged-release tablet (equivalent to 12.5 mg metoprolol tartrate) is reached. The lowest dose should be used for at least 4 days before stopping treatment completely. If any symptoms occur, the dose should be reduced more slowly.
Sudden discontinuation of beta-blocker therapy may lead to a worsening of 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.
Contact a doctor immediately if you get one or more of the following symptoms:
• chest pain
• shortness of breath
Yellowing of the skin and/or eyes (this may be a sign of hepatitis)
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Other side effects are
Very common (may affect more than 1 in 10 people):
- severe drop in blood pressure, even when rising from a supine position, in very rare cases with unconsciousness
- fatigue.
Common (may affect up to 1 in 10 people):
- slow pulse ( bradycardia ), feeling of imbalance (in very rare cases with unconsciousness), 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): - transient worsening of heart failure symptoms , certain cardiac arrhythmias ( AV block I), pain around the heart
- tingling in the skin ( paresthesia )
- bronchospasm ( bronchospasm )
- vomiting
- skin changes, psoriasis-like rash, increased sweating
- muscle spasms
- weight gain
- fluid accumulation in the body’s tissues ( edema )
- depression, impaired concentration, drowsiness and insomnia, nightmares.
Rare (may affect up to 1 in 1,000 people): - disorders of heart function such as galloping rhythm (when the heart skips a beat) or rapid heartbeat, certain heart rhythm disorders (conduction disorders)
- visual disturbances, dry or irritated eyes, conjunctivitis ( conjunctivitis )
- snuva
- dry mouth
- hair loss
- exacerbated diabetes , which has previously existed without typical symptoms ( latent diabetes mellitus )
- abnormal values on liver function tests
- impotence and other sexual disorders, hardening of soft tissue in the penis (induratio penis plastica)
- nervousness, anxiety.
Very rare (may affect up to 1 in 10,000 people): - decrease in platelet count ( thrombocytopenia ), decrease in white blood cell count ( leukopenia )
- tinnitus , tinnitus
- taste disorders
- photosensitivity, worsening psoriasis , new onset of psoriasis , psoriasis-like skin changes
- joint pain, muscle weakness
- tissue death ( necrosis ) in patients with severe circulatory disorders in the arms and / or legs before starting treatment, worsening of intermittent claudication (feeling of cramping in the legs during exercise or walking, so-called window disease ) or spasms in the blood vessels that lead blood to fingers or toes (Raynaud’s syndrome)
- hepatitis
- forgetfulness, impaired memory, confusion, hallucinations, personality changes (eg mood swings).
How to store Metoprolol Orion
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 and 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
Content declaration
– The active substance is metoprolol succinate.
Each prolonged-release 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: sucrose, corn starch, macrogol, ethyl acrylate-methyl methacrylate copolymer, 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
Metoprolol Orion prolonged-release tablets are white, oblong, and biconvex with a scoreline on both sides.
Metoprolol Orion prolonged-release tablets are supplied in aluminum/aluminum blisters of 10, 14, 20, 28, 30, 50, 60, 98, or 100 prolonged-release tablets and in HDPE cans that have PP snap caps and contain 30, 60, 100, 250 or 500 prolonged-release tablets are.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Orion Corporation
Orionintie 1
FI-02200 Espoo
Finland
For further information on this medicine, please contact your local representative:
Orion Pharma AB, Danderyd, medinfo@orionpharma.com