5 and 10 mg film-coated tablets
bisoprolol
1. What Bisoprolol STADA is and what it is used for
Bisoprolol Stada belongs to a group of medicines called beta-blockers. It contains the active substance bisoprolol.
Bisoprolol Stada is used for:
- treatment of high blood pressure
- treatment of chronic stable angina (chest pain caused by poor blood circulation in the arteries leading to the heart).
Bisoprolol contained in Bisoprolol Stada may also be approved for the treatment of other conditions not mentioned in this leaflet. 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 you use Bisoprolol STADA
Do not take Bisoprolol Stada if:
- you are allergic to bisoprolol or any of the other ingredients of this medicine (listed in section 6).
- you have acute heart failure or temporary heart failure (impaired ability of the heart to fill or pump sufficient blood through the body) which is treated intravenously
- you have insufficient blood circulation due to the heart not functioning effectively (so-called cardiogenic shock, with very low blood pressure )
- you have severe disorders of the cardiac conduction system (so-called sick-sinus syndrome, sinoatrial block, or second or third-degree AV block, without a functioning pacemaker)
- you have a low heart rate (less than 50 heartbeats per minute) before taking Bisoprolol Stada
- you have low blood pressure (systolic blood pressure below 100 mm Hg)
- you have severe asthma or severe chronic obstructive pulmonary disease(COPD)
- you have severely reduced blood circulation in your hands or feet (cold hands and feet, pain when walking)
- you suffer from Raynaud’s phenomenon (pain in fingers and toes that first becomes whitish, then bluish, and finally reddish)
- you have increased acid formation in the blood (metabolic acidosis; as in diabetic patients when blood sugar is too high)
- you suffer from untreated pheochromocytoma (a tumor in the adrenal glands that causes an excessive increase in blood pressure )
- you use floktafenin (an anti-inflammatory, painkiller) or subtopic (a medicine used to treat psychiatric disorders).
Warnings and cautions
Talk to your doctor or pharmacist before taking Bisoprolol Stada
- Bisoprolol Stada should not be used in the treatment of chronic heart failure.
If you have or have had any of the following problems, talk to your doctor before starting treatment with Bisoprolol Stada:
- difficulty breathing due to a sudden contraction of the lung muscles ( bronchospasm ) due to moderate asthma or other obstructive airway diseases. Your doctor will perform a respiratory function test before starting treatment.
- diabetes with large variations in blood sugar levels (symptoms of low blood sugar can be hidden). Your doctor will measure your blood sugar levels during treatment.
- of functioning thyroid ( hyperthyroidism )
- liver disease
- the high tendency for allergies (such as anaphylactic reactions)
- you have moderate disorders of the cardiac conduction system (first-degree AV block )
- Printzmetals angina (chest pain due to cramping of the coronary arteries)
- blood circulation disorders in the arms or legs such as Raynaud’s phenomenon (pain in fingers and toes that first becomes whitish, then bluish and finally reddish) and window peephole disease (pain in the calf muscle that makes you lame)
- you have a low heart rate (between 50 and 60 heartbeats per minute) before taking Bisoprolol Stada
- a disease that causes red scaly patches to form on the skin ( psoriasis ).
Bisoprolol Stada may reduce tear flow and increase the risk of eye irritation. This should be taken into account if you wear contact lenses.
You should tell your doctor before using this medicine if you are undergoing:
- strictly fixed, or
- desensitization therapy (special treatment program to reduce allergy sufferers’ sensitivity to what they are allergic to).
Children
The use of Bisoprolol Stada is not recommended for use in children and adolescents below 18 years of age due to a lack of data on safety and efficacy in this age group.
Other medicines and Bisoprolol STADA
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
- You should NOT take floktafenine (an anti-inflammatory and painkiller) or sultaprid (a medicine used to treat psychiatric disorders) with Bisoprolol Stada.
- It is not recommended that Bisoprolol Stada be taken with the following medicines:
- verapamil, diltiazem, bepridil (used for heart problems or for high blood pressure )
- clonidine (for the treatment of high blood pressure )
- monoamine oxidase inhibitors (MAOIs; eg for the treatment of depression)
- amiodarone (medicine to treat arrhythmias in the heart).
- It is recommended that Bisoprolol Stada be used only with caution in combination with the following drugs:
- drugs for the treatment of cardiac arrhythmia (for the treatment of irregular heartbeats; such as disopyramide and quinidine )
- Drugs for blood pressure control
- so-called calcium channel blockers (such as nifedipine for the treatment of high blood pressure )
- drugs that stimulate special nerves (parasympathetic nervous system) for the treatment of myasthenia gravis (a disease that causes muscle weakness) or dementia (including tacrine and galantamine)
- other beta-blockers (eg taken orally or given as eye drops )
- insulin and tablets for the treatment of diabetes
- anesthetic, therefore inform your surgeon that you are taking Bisoprolol Stada before any surgery
- digital drugs for the treatment of weak heart
- ergotamine medicines used to treat low blood pressure or migraines
- cardiovascular stimulants (sympathomimetics; they all increase blood pressure)
- tricyclic antidepressants (used to treat depression), phenothiazines (used to treat psychosis ) or barbiturates (used to treat epilepsy ) and other medicines used to treat high blood pressure
- baclofen (a muscle relaxant)
- iodinated contrast agents (drugs used in X-ray examinations)
- mefloquine (for the treatment of malaria )
- corticosteroids (anti-inflammatory drugs)
- NSAIDs (anti-inflammatory drugs)
- rifampicin (for the treatment of tuberculosis )
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.
Pregnancy
If you are pregnant, you should not take Bisoprolol Stada unless your doctor tells you that it is absolutely necessary.
Breast-feeding
It is not known whether bisoprolol is excreted in human milk. Therefore, breast-feeding is not recommended during treatment with Bisoprolol Stada.
Driving and using machines
Bisoprolol Stada may affect your ability to drive and use machines.
This is especially true
- at the beginning of treatment
- in case of changes in dosage and
- in connection with alcohol intake.
You should not drive or engage in other activities that require increased attention and coordination if you feel that your attention and coordination are affected.
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.
How to use Bisoprolol STADA
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
Method of administration
Bisoprolol Stada tablets are for oral use (taken by mouth). Take the tablet with a sufficient amount of water (eg glass) in the morning. Do not chew the tablet. The tablet can be divided into two equal doses.
Your doctor will decide which dose to take and will examine you regularly at the start of treatment.
The usual starting dose is 5 mg bisoprolol per day.
Your doctor may increase the dose by one to 10 mg of bisoprolol per day. The maximum recommended dose is 20 mg bisoprolol per day.
Patients with severe renal impairment
In patients with severe renal impairment, the dose should not exceed 10 mg bisoprolol per day. Dose one can possibly be divided into two dosing occasions.
For patients receiving dialysis: As bisoprolol is not removed by dialysis, no additional dose of Bisoprolol Stada is required.
Patients with severe hepatic impairment
In patients with severe hepatic impairment, the dose should not exceed 10 mg bisoprolol Stada per day.
Elderly patients
Normally no dose adjustment is required. However, it is recommended to start treatment with the lowest possible dose.
Children and adolescents (under 18 years)
The use of Bisoprolol Stada is not recommended for use in children and adolescents, as there is insufficient information on safety and efficacy in this age group.
Treatment time
The doctor determines the treatment time. Treatment with Bisoprolol Stada is usually long-term.
Symptoms of overdose may include slow heart rate, low blood pressure which may cause dizziness or fainting, shortness of breath ( bronchospasm ), conduction or arrhythmias of the heart, or low blood sugar.
If you forget to use Bisoprolol STADA
Take the next dose as usual when it is time for it. Do not take a double dose to make up for a forgotten dose.
If you stop using Bisoprolol STADA
Do not stop or stop taking Bisoprolol Stada until you have talked to a doctor.
Treatment with Bisoprolol Stada must not be stopped abruptly and especially not in patients with ischemic heart disease (lack of oxygen in the heart). Dose one must be tapered off gradually (according to the doctor’s instructions). A sudden end can lead to acute deterioration of your medical condition.
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.
Common side effects (may affect up to 1 in 10 people):
- a feeling of cold or numbness in the hands and feet
- Raynaud’s phenomenon (pain in fingers and toes that first becomes whitish, then bluish, and finally reddish)
- aggravated window disease (pain in the calf muscle that makes you lame)
- fatigue, exhaustion, dizziness, or headache. These symptoms appear especially at the beginning of treatment, are usually mild, and often disappear after 1-2 weeks
- dizziness
- nausea, vomiting, diarrhea, abdominal pain, or constipation
- low blood pressure ( hypotension ).
Uncommon side effects (may affect up to 1 in 100 people):
- muscle weakness and cramps
- the feeling of weakness ( asthenia )
- joint disease ( arthropathy )
- slow heart rhythm, disturbances in the conduction system of the heart, or worsening of heart failure (increased swelling, shortness of breath)
- the sudden drop in blood pressure if you get up quickly (with dizziness or fainting)
- sleep disorders, depression
- bronchospasm (difficulty breathing or wheezing when breathing) in asthma patients or patients with chronic obstructive pulmonary disease.
Rare side effects (may affect up to 1 in 1,000 people):
- nightmares, hallucinations
- hypersensitivity reactions ( itching, redness, rash)
- elevated levels of certain liver values ( AST , ALT ) in the blood
- inflammation of the liver (hepatitis; with pain in the upper abdomen)
- elevated levels of certain blood fats ( triglycerides )
- low blood sugar ( glucose )
- potency disorders
- hearing loss
- allergic rhinitis (swelling and irritation inside the nose)
- reduced tear flow (and dry eyes – to keep in mind for lens wearers)
- autoimmune reactions (autoimmunity means that an organism cannot recognize its own constituents (down to submolecular levels), resulting in its own immune system attacking the body’s own cells and tissues ) such as lupus syndrome.
- fainting ( syncope )
Very rare side effects (may affect up to 1 in 10,000 people):
- inflammation of the conjunctiva of the eye ( conjunctivitis )
- causing or exacerbating psoriasis (a disease that causes red scaly patches on the skin); induction of psoriasis-like rash
- hair loss ( alopecia ).
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 STADA
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. The expiration date is the last day of the specified month.
Store in the original package.
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.
6. Contents of the packaging and other information
Content declaration
The active substance is bisoprolol hemifumarate.
Bisoprolol Stada 5 mg
One film-coated tablet contains 5 mg bisoprolol hemifumarate.
Bisoprolol Stada 10 mg
One film-coated tablet contains 10 mg bisoprolol hemifumarate.
Other ingredients are
Microcrystalline cellulose, calcium hydrogen phosphate, pregelatinized maize starch, crospovidone, silica ( colloidal, anhydrous), magnesium stearate, hypromellose, macrogol 400, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172).
What the medicine looks like and the contents of the pack
Bisoprolol Stada 5 mg
Light pink, round, biconvex film-coated tablets. The tablets are scored on both sides and embossed with the text “BSL5” on one side.
Bisoprolol Stada 10 mg
Yellow-orange, round, biconvex film-coated tablets. The tablets are scored on both sides and embossed with the text “BSL10” on one side.
PVC / PE / PVDC / Al blisters containing 14, 20, 28, 30, 50, 56, 100 or 120 tablets.
PVC / PE / PVDC / Al blisters in aluminum bag containing 14, 20, 28, 30, 50, 56, 100 or 120 tablets.
HDPE jar containing 30 or 50 tablets.
PVC / PE / PVDC / Al perforated unit dose blisters containing 50 tablets (50×1).
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
Alternative manufacturer
Centrafarm Services BV
Nieuwe Donk 9, 4879 AC Etten-Leur
Netherlands
PharmaCoDane ApS
Marielundvej 46A, 2730 Herlev
Denmark
STADA Arzneimittel GmbH
Muthgasse 36/2, 1190 Vienna
Austria
Cosmo SpA
Via C. Colombo, 1, 20020 Lainate-Milano
Italy
Dragenopharm, Apotheker Püschl GmbH & Co. KG
Göllstrasse 1, 84529 Tittmoning
Germany
Contact the representative of the marketing authorization holder to find out more about this medicine:
STADA Nordic ApS
Marielundvej 46 A
2730 Herlev
Denmark