1.25 mg, 2.5 mg and 3.75 mg tablets of
bisoprolol fumarate, respectively
1. What Bisoprolol Teva is and what it is used for
Bisoprolol Teva contains the active substance bisoprolol fumarate. Bisoprolol belongs to a group of medicines called beta-blockers. Bisoprolol prevents irregular heartbeat (arrhythmia) during stress and reduces the workload of the cardiovascular system. Bisoprolol also facilitates blood flow by dilating blood vessels.
Bisoprolol Teva is used for:
- treatment of high blood pressure ( hypertension ).
- treatment of coronary heart disease and chest pain ( angina pectoris ) caused by a lack of oxygen in the heart muscle.
- treatment of heart failure in combination with other drugs. Heart failure occurs when the heart muscle is weak and can not pump enough blood to meet the body’s needs and causes swelling ( edema ) of the arms and legs and shortness of breath.
Bisoprolol contained in Bisoprolol Teva 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 Bisoprolol Teva
Do not take Bisoprolol Teva
- if you are allergic to bisoprolol or any of the other ingredients of this medicine (listed in section 6).
- if you have acute heart failure that suddenly worsens and/or may require hospitalization
- if you have very low blood pressure or slow heart rate due to circulatory failure(so-called cardiogenic shock ).
- if you have conduction disturbances in the heart such as diseased sinus node, sinoatrial block, or second or third-degree AV block.
- if you have a very slow heart rate
- if you have very low blood pressure
- if you have an untreated tumor that may cause increased blood pressure (so-called pheochromocytoma ).
- if you have severe asthma or severe chronic obstructive pulmonary disease.
- if you have severe circulatory problems in your arms and legs that manifest as recurrent lameness (easily triggered pain in the legs when walking) or Raynaud’s syndrome (with whitish, bluish, and finally reddish fingers or toes associated with pain).
- if you have so-called metabolic acidosis which is a condition where the blood is too acidic as well as what diabetic patients have at too high blood sugar.
Warnings and cautions
Talk to your doctor before taking this medicine. He or she may want to take special precautions (eg give additional treatment or carry out more frequent checks):
- if you have asymptomatic and well-treated heart failure.
- if you have kidney or liver problems.
- if you have heart valve problems or a congenital heart defect.
- if you have had a heart attack in the last three months.
- if you have asthma or chronic obstructive pulmonary disease (if you are using bronchodilators, that dose may need to be adjusted and lung function may need to be monitored).
- if you are going to have surgery or receive other treatment that requires anesthesia or spinal anesthesia (you must inform your anesthetist that you are using Bisoprolol Teva).
- if you have diabetes and your blood sugar varies greatly (Bisoprolol Teva can mask low blood sugar symptoms and slow down the improvement in blood sugar).
- if you are under strict fasting.
- if you have an overactive thyroid gland (Bisoprolol Teva may mask the symptoms of hyperthyroidism ).
- if you are receiving desensitization treatment (Bisoprolol Teva may make an allergic reaction more serious and additional medicines may be needed to treat the allergic reaction).
- if you have a mild conduction disturbance in the heart (first-degree atrioventricular block).
- if you have chest pain caused by cramps in the coronary arteries of the heart (so-called Prinzmetals angina pectoris ).
- if you wear contact lenses (Bisoprolol Teva may reduce tear flow and cause dry eyes).
- if you have or have had a scaly rash ( psoriasis ).
Other medicines and Bisoprolol Teva
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not take the following medicines with Bisoprolol Teva unless specifically advised by your doctor:
- quinidine, disopyramide, lidocaine, phenytoin, flecainide, propafenone (used to treat irregular or abnormal heart rhythms)
- verapamil and diltiazem (used to treat irregular heartbeat and high blood pressure )
- clonidine, methyldopa, guanfacine, moxonidine, and cimetidine (to treat high blood pressure and certain neurological diseases).
However, do not stop taking these medicines without first asking your doctor.
Ask your doctor before taking the following medicines with Bisoprolol Teva; you may need to go for more frequent medical check-ups for your condition:
- nifedipine, felodipine, and amlodipine (used to treat high blood pressure, angina, or abnormal heart rhythm).
- amiodarone (used to treat irregular or abnormal heart rhythms).
- beta-blockers, including eye drops containing beta-blockers, such as timolol for the treatment of glaucoma ).
- digitalis such as digoxin for the treatment of heart failure.
- donepezil or tacrine (for the treatment of dementia).
- neostigmine or pyridostigmine (for the treatment of myasthenia gravis, a disease that causes muscle weakness).
- physostigmine (for the treatment of increased pressure in the eye, glaucoma ).
- so-called ergot alkaloids (for the treatment of migraines or low blood pressure ).
- other antihypertensive drugs.
- other drugs that can lower blood pressure such as tricyclic antidepressants (such as imipramine and amitriptyline), phenothiazines such as levomepromazine (for the treatment of psychosis ), or barbiturates such as phenobarbital (for the treatment of epilepsy ).
- adrenaline for the treatment of allergic reactions.
- baclofen and tizanidine (muscle relaxant).
- amifostine (a protective substance in certain cancer treatments).
- mefloquine (against malaria ).
- rifampicin ( antibiotic ).
- insulin and other medicines to treat diabetes mellitus.
- oral or intravenous cortisone substances.
- so-called monoamine oxidase inhibitors, MAO inhibitors (but not MAO-B inhibitors) such as moclobemide or phenelzine (for depression).
Non-steroidal anti-inflammatory drugs ( NSAIDs ) such as acetylsalicylic acid, diclofenac, ibuprofen, ketoprofen, naproxen, celecoxib, or etoricoxib (especially with long-term and regular use) may reduce the effect of Bisoprolol Teva in the treatment of hypertension. Small daily doses of acetylsalicylic acid, e.g. However, 100 mg, to prevent blood clots, is safe to use with Bisoprolol Teva.
Bisoprolol Teva with food and drink
Bisoprolol Teva tablets should be taken in the morning and can be taken with or without food. They should be swallowed with liquid and must not be chewed.
Pregnancy and breastfeeding
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.
Bisoprolol Teva should be used during pregnancy only when clearly needed. If you are planning to become pregnant or become pregnant while being treated with Bisoprolol Teva, you should contact your doctor for advice on alternative treatment.
It is not known if Bisoprolol Teva passes into breast milk. Therefore, breast-feeding is not recommended during treatment with Bisoprolol Teva.
Driving and using machines
Bisoprolol Teva has only minimal or no effect on the ability to drive. Side effects related to a drop in blood pressure such as dizziness, headache, fatigue, or other side effects (see section 4) may impair the ability to drive a motor vehicle. If you get any of these side effects, it is advisable to refrain from driving or using machines as well as other activities that require increased vigilance. Particular attention should be paid during the first weeks of treatment and after dose escalation. Bisoprolol Teva does not usually affect your ability to drive if the treatment is well-balanced.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased 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.
How to take Bisoprolol Teva
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
The tablet (s) should be swallowed with a glass of water, usually once a day in the morning. The tablets must not be chewed. Ingestion with food does not affect the absorption of the drug.
Dosage
Adults
In the treatment of hypertension and angina pectoris
- The starting dose is usually 5 mg once a day.
- Your doctor may increase the dose one step at a time (usually every few weeks) to 10 mg or a maximum of 20 mg if necessary.
In the treatment of stable chronic heart failure
Treatment with bisoprolol is started with a low dose which is then gradually increased. Your doctor will decide how to increase your dose, but a common schedule is as follows:
- 1.25 mg bisoprolol once daily for one week,
- 2.5 mg bisoprolol once daily for an additional week,
- 3.75 mg bisoprolol once daily for an additional week,
- 5 mg bisoprolol once daily for the following 4 weeks,
- 7.5 mg bisoprolol once daily for the following 4 weeks,
- 10 mg bisoprolol once daily as maintenance treatment (ongoing treatment).
The maximum recommended dose is 10 mg bisoprolol once daily.
Your doctor may extend the intervals between dose increases depending on how well you tolerate the medicine. If your condition worsens or you can no longer tolerate the medication, it may be necessary to return to a lower dose or stop treatment altogether. For some patients, a maintenance dose of less than 10 mg may be sufficient. Your doctor will tell you how to proceed. If your treatment needs to be stopped completely, your doctor will usually instruct you to reduce your dose gradually, otherwise, your condition may worsen.
Use for children and adolescents (under 18 years)
There is insufficient experience with Bisoprolol Teva in children. Use in children and adolescents under 18 years of age can therefore not be recommended.
Elderly
If the patient does not have hepatic or renal impairment, no dose adjustment is required, see below.
Patients with renal or hepatic impairment
In patients with severe renal or hepatic impairment, the dose should be increased gradually and very carefully. For these patients, the dosage should not exceed 10 mg once daily.
If you experience nausea or dizziness, lie down or get help to lie down and seek medical attention. An unconscious patient should be placed in a stable lateral position.
If you forget to take Bisoprolol Teva
Take your usual dose when it’s time for it. Do not take a double dose to make up for a forgotten dose.
If you stop taking Bisoprolol Teva
Treatment with Bisoprolol Teva should not be stopped abruptly, especially not in patients with heart disease. Dose one should be reduced gradually over, for example, 1-2 weeks to avoid worsening the symptoms of heart disease.
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.
To avoid serious reactions, tell your doctor immediately if any side effects are severe, occur suddenly, or get worse quickly. The most serious side effects have to do with the function of the heart, where the most common side effects have been too slow heart rate, a sharp drop in blood pressure, dizziness, and fatigue.
Other possible side effects are listed below. The side effects are grouped according to how common they are:
Very common (in more than 1 user in 10)
- slow heart rate (in patients with heart failure )
Common (for less than 1 user in 10)
- dizziness, headache
- aggravated heart failure symptoms (in patients with heart failure )
- cold or numb arms or legs
- low blood pressure (in patients with heart failure )
- gastrointestinal upset such as nausea, vomiting, diarrhea, or constipation
- weakness (in patients with heart failure ), fatigue
Uncommon (with less than 1 user in 100)
- depression, sleep disorders
- heart block (conduction disorders in the heart)
- slow heart rate (in patients with high blood pressure or coronary heart disease)
- bronchospasm (wheezing, wheezing in patients with asthma or other chronic obstructive pulmonary disease )
- muscle weakness, muscle cramps
- weakness (in patients with high blood pressure or angina)
- low blood pressure in a standing position ( orthostatic hypotension )
Rare (in less than 1 user in 1,000)
- nightmares, hallucinations
- fainting ( syncope )
- reduced tear flow (keep this in mind if you wear contact lenses)
- hearing problems
- liver disease that causes abdominal pain in the upper abdomen ( hepatitis )
- allergy-like reactions such as itching, redness, rash
- potency problem
- increased levels of liver enzymes (laboratory test ALT or AST )
- allergic rhinitis (stuffy, stuffy, itchy nose)
Very rare (in less than 1 user in 10,000)
- conjunctivitis (eye inflammation)
- hair loss ( alopecia ), worsening psoriasis or psoriasis-like rash
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 Bisoprolol Teva
Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage instructions.
Do not use this medicine after the expiry date which is stated on the blister after EXP and on the carton after EXP. The expiry date refers to the last day of that month.
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 bisoprolol fumarate.
Each 1.25 mg tablet contains 1.25 mg of bisoprolol fumarate.
Each 2.5 mg tablet contains 2.5 mg of bisoprolol fumarate.
Each 3.75 mg tablet contains 3.75 mg of bisoprolol fumarate.
The other ingredients are microcrystalline cellulose, colloidal anhydrous silica, croscarmellose sodium, sodium starch glycolate (type A) and magnesium stearate.
What the medicine looks like and the contents of the pack
Bisoprolol Teva 1.25 mg tablets are white to off-white, round, biconvex tablets.
Bisoprolol Teva 2.5 mg tablets are white to off-white, round, biconvex tablets with a score line on one side.
Bisoprolol Teva 3.75 mg tablets are white to off-white, round, biconvex tablets.
Packs of 20, 21, 28, 30, 50, 56, 60, 90 and 100 tablets (not all pack sizes may be marketed).
Marketing Authorization Holder and Manufacturer
Manufacturer
Chanelle Medical
Loughrea, Ireland
Merckle GmbH
Blaubeuren, Germany