Bisoprolol tecnigen 5 mg comprimidos recubiertos con pelicula efg
Introduction
Label: information for the patient
Bisoprolol TecniGen 5 mg film-coated tablets
bisoprolol fumarate
Read this label carefully before starting to take this medicine, as it contains important information for you.
- Keep this label, as you may need to read it again.
If you have any questions, consult your doctor or pharmacist.
- This medicine has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
- If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.
1. What is Bisoprolol TecniGen and what is it used for
The active ingredient is bisoprolol.Bisoprolol belongs to a group of medications known as beta-blockers.These medications act by affecting the body's response to certain nerve impulses, particularly in the heart. As a result, bisoprolol slows down the heartbeat and makes the heart more efficient, pumping blood throughout the body.
Heart failure occurs when the heart muscle is weak and unable to pump enough blood to meet the body's needs.
Bisoprolol is used to treat chronic stable heart failure.
Bisoprolol is used in combination with other suitable medications for this condition (such as ACE inhibitors, diuretics, and cardiac glycosides).
2. What you need to know before starting Bisoprolol TecniGen
Do not take Bisoprolol TecniGen
- if you are allergic to bisoprolol fumarate or any of the other ingredients of this medication (listed in section 6),
- severe asthma,
- serious circulatory problems in your extremities (such as Raynaud's syndrome), which can cause numbness in your fingers and toes or make them pale or blue,
- untreated phaeochromocytoma, a rare tumor of the adrenal gland,
- metabolic acidosis, a condition that occurs when there is too much acid in the blood.
Do not take bisoprolol if you have one of the following heart problems:
- acute heart failure,
- heart failure that requires intravenous medication to increase the heart's contraction force,
- slow heart rate,
low blood pressure,
- certain heart conditions that cause a very slow or irregular heart rate,
- cardiogenic shock, a severe and acute heart disease that causes a drop in blood pressure and circulatory failure.
Warnings and precautions
Consult your doctor or pharmacist before starting to take this medication. If you have any of the following conditions, consult your doctor before starting to take bisoprolol; your doctor may want to take special precautions (for example, provide additional treatment or perform more frequent examinations):
- diabetes,
- strict fasting,
- certain heart conditions such as arrhythmias or severe chest pain at rest (Prinzmetal's angina),
- kidney or liver problems,
- milder circulatory problems in your extremities,
- chronic lung disease or mild asthma,
- history of scaly skin (psoriasis),
- adrenal gland tumor (phaeochromocytoma),
- thyroid disorder.
Also, inform your doctor if you are going to undergo:
- allergy desensitization (for example, for hay fever prevention), because bisoprolol may make it more likely that you will experience an allergic reaction, or that the reaction may be more severe,
- anesthesia (for example, for surgery), because bisoprolol may affect how your body reacts to this situation.
If you have chronic lung disease or mild asthma, inform your doctor immediately if you start to notice breathing difficulties, coughing, or wheezing after exercise, etc. while using this medication.
Other medications and Bisoprolol TecniGen
Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.
Do not take the following medications with bisoprolol without special advice from your doctor:
- certain medications used to treat irregular or abnormal heartbeats (Class I antiarrhythmic medications such as quinidine, disopyramide, lidocaine, phenytoin; flecainide, propafenone),
- certain medications used to treat high blood pressure, angina, or irregular heartbeats (calcium channel blockers such as verapamil and diltiazem),
- certain medications used to treat high blood pressure, such as clonidine, methyldopa, moxonidine, rilmenidine. However,do not stop taking these medicationswithout consulting your doctor first.
Consult your doctor before taking the following medications with bisoprolol; your doctor may need to monitor your condition more frequently:
- certain medications used to treat high blood pressure or angina (calcium channel blockers of the dihydropyridine type such as felodipine and amlodipine),
- certain medications used to treat irregular or abnormal heartbeats (Class III antiarrhythmic medications such as amiodarone),
- beta-blockers applied locally (such as eye drops of timolol for glaucoma treatment),
- certain medications used to treat, for example, Alzheimer's diseaseor for glaucoma treatment (parasympathomimetics such as tacrine or carbachol) or medications used to treat acute heart problems (sympathomimetics such as isoprenaline and dobutamine),
- antidiabetic medications including insulin,
- anesthetic agents (for example, during surgery),
- digitalis, used to treat heart failure,
- nonsteroidal anti-inflammatory drugs (NSAIDs) used to treat arthritis, pain, or inflammation (for example, ibuprofen or diclofenac),
- any medication that can lower blood pressure as a desired or undesired effect, such as antihypertensives, certain antidepressants (tricyclic antidepressants such as imipramine or amitriptyline), certain medications used to treat epilepsy or during anesthesia (barbiturates such as phenobarbital), or certain medications used to treat mental disorders characterized by a loss of contact with reality (phenothiazines such as levomepromazine),
- mefloquine, used to prevent or treat malaria,
- medications used to treat depression called monoamine oxidase inhibitors (except MAO-B inhibitors) such as moclobemide.
Bisoprolol TecniGen and alcohol
The dizziness and headache that bisoprolol may cause can worsen if you consume alcohol. If this happens, avoid consuming alcohol.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.
Pregnancy
There is a risk that using bisoprolol during pregnancy may harm the baby. If you are pregnant or planning to become pregnant, inform your doctor. Your doctor will decide if you can take bisoprolol during pregnancy.
Breastfeeding
It is unknown whether bisoprolol passes into human breast milk. Therefore, do not breastfeed during treatment with bisoprolol.
Driving and operating machinery
No studies have been conducted on the effects of bisoprolol on the ability to drive and operate machinery.
Your ability to drive or operate machinery may be affecteddepending on how well you tolerate the medication. Be especially cautious at the start of treatment, when the dose is increased or the medication is changed, and also in combination with alcohol.
3. How to Take Bisoprolol TecniGen
Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.
This medication treatment requires regular monitoring by your doctor. This is particularly necessary at the beginning of treatment, during dose increase, and at the end of treatment.
Take the tablet with a little water in the morning, with or without food. Do not crush or chew the tablet. The scored tablets can be divided into two equal doses.
This bisoprolol treatment is usually long-term.
The recommended dose is:
Adults, including the elderly
Heart failure (reduced heart pumping force)
Bisoprolol treatment should be initiated at a low dose and gradually increased.
Your doctor will decide how to increase the dose, and this will usually be done as follows:
1.25 mg once a day for one week. If well tolerated, the dose can be increased to 2.5 mg once a day for another week. If well tolerated, the dose can be increased to
3.75 mg once a day for another week. If well tolerated, the dose can be increased to
5 mg once a day for the next 4 weeks. If well tolerated, the dose can be increased to 7.5 mg once a day for the next 4 weeks. If well tolerated, the dose can be increased to 10 mg once a day as maintenance dose.
The maximum recommended daily dose is 10 mg of bisoprolol.
Depending on how well you tolerate the medication, your doctor may also decide to prolong the time between dose increases. If your condition worsens or you no longer tolerate the medication, it may be necessary to reduce the dose again or discontinue treatment. In some patients, a maintenance dose less than 10mg of bisoprolol may be sufficient.
Your doctor will tell you what to do.
Normally, if you have to discontinue treatment completely, your doctor will advise you to reduce the dose gradually, as otherwise your condition may worsen.
Use in children and adolescents
There is no experience with bisoprolol in children and adolescents, so its use is not recommended in children or adolescents.
If you take more Bisoprolol TecniGen than you should
If you have accidentally taken more doses than your doctor prescribed, consult your doctor or pharmacist immediately.
Carry the remaining tablets or this leaflet with you so that the medical team knows exactly what you have ingested. Symptoms of overdose may include dizziness, vertigo, fatigue, and/or difficulty breathing.
Additionally, a reduction in heart rate, decrease in blood pressure, heart failure, and lowering of blood glucose levels (which may cause hunger, sweating, and palpitations) may occur.
In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.
If you forgot to take Bisoprolol TecniGen
Do not take a double dose to compensate for the missed doses.Take your dose as soon as you remember and then continue with the normal dose the next day.
If you discontinue treatment withBisoprolol TecniGen
Never stop taking bisoprololexcept on the advice of your doctor. Otherwise, your condition may worsen significantly.
If you have any other doubts about the use of this medication, ask your doctor or pharmacist.
4. Possible Adverse Effects
Like all medicines, this medicine may cause side effects, although not everyone will experience them.
To prevent serious adverse reactions, talk to a doctor immediately if a side effect is severe, occurs suddenly, or worsens quickly.
The most serious side effects are related to heart function:
- Slowing of heart rate (may affect more than 1 in 10 people)
- Worsening of heart failure (may affect up to 1 in 10 people)
- Slow or irregular heartbeats (may affect up to 1 in 100 people)
If you feel dizzy or weak, or have difficulty breathing, contact your doctor as soon as possible.
Other side effects are listed below according to their frequency of possible occurrence:
Frequent(may affect up to 1 in 10 patients)
- Fatigue, weakness, dizziness, headache.
- Sensation of coldness or numbness in the extremities.
- Very low blood pressure (hypotension).
- Sensation of dizziness (nausea), vomiting, diarrhea, constipation.
Infrequent(may affect up to 1 in 100 patients)
- Drop in blood pressure when standing that may cause dizziness, drowsiness, or fainting.
- Sleep disorders.
- Depression.
- Patients with asthma or a history of respiratory problems may have difficulty breathing.
- Muscle weakness and cramps.
Rare(may affect up to 1 in 1,000 patients)
- Problems with hearing.
- Nasal discharge.
- Reduced tear flow.
- Inflammation of the liver (hepatitis), which causes jaundice with yellow discoloration of the white of the eyes and skin.
- Increased levels of lipids in the blood (triglycerides) and liver enzymes.
- Allergic-like reactions such as itching, redness, skin rash. Consult your doctor immediately if you experience more severe allergic reactions, which may include swelling of the face, neck, tongue, mouth, or throat, or difficulty breathing
- Reduced sexual performance (alterations in potency).
- Nightmares, hallucinations (imagining things).
- Fainting.
Very rare(may affect up to 1 in 10,000 patients)
- Itching or redness of the eyes (conjunctivitis).
- Worsening of psoriasis or appearance of a psoriasis-like rash with dry skin, scaly formation.
- Loss of hair.
Reporting of side effects
If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus.You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.
5. Conservation of Bisoprolol TecniGen
Keep this medication out of the sight and reach of children.
Do not use this medication after the expiration date that appears on the blister and on the packaging after CAD. The expiration date is the last day of the month indicated.
This medication does not require special conditions for conservation.
Medications should not be thrown down the drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.
6. Content of the container and additional information
Composition of Bisoprolol TecniGen
The active ingredient is bisoprolol fumarate. Each tablet contains 5 mg of bisoprolol fumarate.
The other components are:
Tablet core: microcrystalline cellulose, anhydrous calcium hydrogen phosphate, pregelatinized maize starch, crospovidone, anhydrous colloidal silica, and magnesium stearate.
Tablet coating:Opadry yellow 03B82846:hypromellose 2910, macrogol 400, titanium dioxide (E-171), and yellow iron oxide (E-172).
Appearance of the product and content of the container
Yellowish pale film-coated tablets, round, with an approximate diameter of 8.00 mm, biconvex, scored, and marked with the inscription “C” on one face, and “39” on the other face.
The tablet can be divided into equal doses.
The tablets are packaged in Aluminio-Aluminio blisters.
Container sizes:
Blisters: 28, 30, and 60 film-coated tablets.
Holder of the marketing authorization and responsible for manufacturing
Holder of the marketing authorization
Tecnimede España Industria Farmacéutica, S.A.
Avda. de Bruselas, 13, 3rd floor.
28108 Alcobendas (Madrid)
Spain
Responsible for manufacturing
Tecnimede - Sociedade Tecnico-medicinal, S.a.
Quinta da Cerca, Caixaria
2565-187 Dois Portos
Portugal
Last review date of this leaflet: April 2022
The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/
Общайтесь с врачом онлайн
Есть вопросы по этому лекарству или вашим симптомам? Свяжитесь с лицензированным врачом для получения помощи и персонализированного ухода.
