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«Package leaflet: Information for the user Bisoprolol HCT STADA 2.5 mg/6.25 mg, 5 mg/12.5 mg and 10 mg/25 mg film-coated tablets Bisoprolol/ ...»

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Package leaflet: Information for the user

Bisoprolol HCT STADA 2.5 mg/6.25 mg, 5 mg/12.5 mg and 10 mg/25 mg film-coated

tablets

Bisoprolol/ Hydrochlorothiazide

Read all of this leaflet carefully before you start taking this medicine becaus it

contains important information for you.

 Keep this leaflet. You may need to read it again.

 If you have any further questions, ask your doctor or pharmacist.

 This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

 If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Bisoprolol HCT STADA is and what it is used for

2. What you need to know before you take Bisoprolol HCT STADA

3. How to take Bisoprolol HCT STADA

4. Possible side effects

5. How to store Bisoprolol HCT STADA

6. Contents of the pack and other information

1. What Bisoprolol HCT STADA is and what it is used for Bisoprolol HCT STADA is a combination of the beta-receptor blocking agent bisoprolol and the diuretic substance hydrochlorothiazide.

Bisoprolol HCT STADA is used for the treatment of high blood pressure.

Treatment with this combination medicine is indicated in patients whose blood pressure is not adequately controlled with bisoprolol alone or hydrochlorothiazide alone.

2. What you need to know before you take Bisoprolol HCT STADA

DO NOT take Bisoprolol HCT STADA if:

 you are allergic to bisoprolol, hydrochlorothiazide or other thiazides, other sulphonamides (mainly antibiotics), or to any of the other ingredients of this medicine (listed in section 6),  you have acute heart failure or episodes of heart failure (impaired ability of the heart to fill or pump a sufficient amount of blood through the body) which are treated intravenously,  you have inadequate circulation of blood due to failure of the heart to function effectively (so called cardiogenic shock, with very low blood pressure),  you have severe conduction disturbances in your heart (so called 2nd or 3rd degree atrioventricular block, sick sinus syndrome, or sinoatrial block) and you do not have a functioning cardiac pacemaker,  you have low pulse (less than 60 heartbeats per minute) before taking Bisoprolol HCT STADA,  you have severely impaired blood circulation in your hands or feet (cold hands and feet, pain occurring during walking),  you have Raynaud´s syndrome (ache in fingers and toes which turn first whitish, then bluish, and finally reddish),  you have severe bronchial asthma or severe chronic obstructive pulmonary disease (COPD), 1  you have too much acid in your blood (metabolic acidosis; such as in diabetic patients when the blood sugar is too high),  the potassium level or sodium level in your blood is too low, or the calcium level in your blood is too high,  you have severely deteriorated kidney function or production of urine in your kidneys has diminished or stopped,  you have a kidney disease called glomerulonephritis,  you have severely impaired liver function,  you have an untreated phaeochromocytoma (a tumour of adrenal glands, causing an excessive elevation of blood pressure),  you are breastfeeding (applies only to Bisoprolol HCT STADA 5 mg/12.5 mg and Bisoprolol HCT STADA 10 mg/25 mg),  you are taking floctafenine (an anti-inflammatory, painkilling medication) or sultopride (a medicine to treat psychiatric disorders),  you have gout (applies only to Bisoprolol HCT STADA 5 mg/12.5 mg and Bisoprolol HCT STADA 10 mg/25 mg).

Warnings and precautions Talk to your doctor or, pharmacist before taking Bisoprolol HCT STADA.

You may have or have had in the past certain disorders that necessitate specific measures before starting the Bisoprolol HCT STADA therapy or during it. You should, therefore, inform your doctor before you start taking this medicine, if any of the following conditions concern or

have concerned you:

 heart failure (impaired ability of the heart to fill or pump a sufficient amount of blood through the body),  difficulty in breathing caused by a sudden constriction of the muscles in the lungs (bronchospasms) caused by moderate asthma or other obstructive pulmonary diseases,  diabetes with large fluctuations in the blood sugar values (symptoms of low blood sugar can be masked),  you have moderate conduction disturbances in your heart (1st degree atrioventricular block),  Prinzmetal´s angina (chest pain due to cramping of coronary arteries),  weakened circulation in your extremities (cold hands or feet, pain occurring during walking),  reduced blood volume due to e.g., use of water pills, or severe and prolonged vomiting or diarrhoea,  impaired liver function,  gout,  gallstones,  strong allergic tendencies (such as anaphylactic reactions),  over functioning thyroid gland (hyperthyreosis), or  a disease which causes red scaly patches to appear on the skin (psoriasis).

If you use contact lenses, be aware that Bisoprolol HCT STADA may reduce the tear flow and increases the risk for eye irritation.

You should inform your doctor before you start taking this medicine if you are undergoing:





 anaesthetic treatment (for example for surgery), because Bisoprolol HCT STADA may influence how your body reacts to this situation,  strict fasting, or  desensitisation therapy.

This medicine may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.

2 During long term-therapy with Bisoprolol HCT STADA, your doctor may wish to check the serum electrolytes (especially potassium, sodium, calcium), creatinine and urea, the serum lipids (cholesterol and triglycerides), uric acid as well as blood glucose regularly.

During treatment with Bisoprolol HCT STADA, make sure that you drink adequate amounts of fluids and eat food rich in potassium (e.g., bananas, vegetables, nuts) to compensate for the increased loss of potassium.

If you have high blood uric acid levels, this medicine may increase the risk for attacks of gout.

Other medicines and Bisoprolol HCT STADA Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines.

 You must NOT take floctafenine (an anti-inflammatory and painkilling medicine) or sultopride (a medicine to treat psychiatric disorders) together with Bisoprolol HCT STADA.

 It is not recommended to use Bisoprolol HCT STADA with the following medicines:

o verapamil or diltiazem (for heart problems or high blood pressure), o clonidine (used to treat high blood pressure), o methyldopa, guanfacine, or reserpine (medications to treat high blood pressure), o monoamine oxidase inhibitors (MAO-inhibitors; e.g. to treat depression), o lithium (for manic-depressive disorder), o astemizole or terfenadine (to treat allergic reactions), erythromycin administered to a vein or sparfloxacin (antibiotics), halofantrine (to treat malaria), pentamidine (for certain lung infections), or vincamine (to improve blood circulation in the brain).

 It is recommended to use Bisoprolol HCT STADA only with caution with the following

medicines:

o so called dihydropyridine calcium channel blockers (such as nifedipine to treat high blood pressure), o angiotensin II antagonists (e.g. losartan), ACE-inhibitors (e.g. captopril or enalapril) to treat high blood pressure, o medicines to treat cardiac arrhythmias (to treat irregular heart beat; such as amiodarone, disopyramide, quinidine, or sotalol), o medicines which stimulate special nerves (parasympathetic nervous system) used to treat myasthenia gravis (a disease causing muscular weakness) or dementia (including tacrine), o other beta-blocking medicines (taken by mouth or given as eye drops), o insulins and tablets to treat diabetes, o digoxin or other digitalis-preparations to treat weak heart, o anti-inflammatory (so called NSAIDs) and other painkilling medicines, o ergotamine-preparations to treat low blood pressure or migraine, o cardiovascular stimulating medicines (sympathomimetics; they all raise blood pressure), o tricyclic antidepressants (to treat depression), phenothiazines (to treat psychoses), or barbiturates (to treat epilepsy) and other medications to treat high blood pressure, o rifampicin (to treat tuberculosis), o medicines to treat gout, o anaesthetics, therefore be sure to inform the surgeon that you are taking Bisoprolol HCT STADA before any surgical intervention, o cortisone-preparations by mouth or as injections or adrenocorticotropic hormone (ACTH) which stimulates the production of cortisone-like substances in your body, o carbenoxolone (for gastric ulcers), amphotericin B (an anti-fungal agent), or furosemide (water pill), 3 o taken to treat constipation (laxatives), o muscle relaxants (of curare-type; please ask your doctor), o medicines to suppress immune system and to treat cancer (such as cyclophosphamide, fluorouracil, or methotrexate), o colestyramine and colestipol (to bind bile acids), o oral anticoagulants (to prevent blood clots) or probenecid (to treat gout), o mefloquine (to treat malaria).

Pregnancy and breast-feeding 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 HCT STADA 5 mg/12.5 mg and Bisoprolol HCT STADA 10 mg/25 mg STADA must NOT be used during breast-feeding.

Hydrochlorothiazide contained in Bisoprolol HCT STADA can suppress the milk production.

Driving and using machines Bisoprolol HCT STADA has no or little influence on the ability to drive and use machines.

However, due to individual differences in reaction to the medicinal product, the ability to drive a vehicle or to operate machinery may be impaired (see section 4 of this package leaflet).

This should be considered particularly at the start of therapy, upon change of dosage, and if alcohol is consumed at the same time. If affected, you should not drive or engage with other activities requiring alertness and coordination.

3. How to take Bisoprolol HCT STADA Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Bisoprolol HCT STADA tablets are for oral use.

Bisoprolol HCT STADA may be used in patients whose blood pressure is not adequately controlled with bisoprolol alone or hydrochlorothiazide alone.

The recommended starting dose is 5 mg bisoprolol/12.5 mg hydrochlorothiazide per day.

The doctor may increase the dose to 10 mg bisoprolol/25 mg hydrochlorothiazide per day, if necessary.

Older people No dosage adjustment is normally required. It is recommended to start with the lowest possible dose.

Impaired kidney or liver function In patients with mild to moderately impaired kidney or liver function dosage adjustment may be required. Therefore, the doctor may instruct the use of a lower dose. Bisoprolol HCT STADA tablets must not be taken, if the patient has severely impaired kidney or liver function.

Use in children and adolescents (under 18 years of age) Use of Bisoprolol HCT STADA is not recommended in children and adolescents since there is not enough information on the safety and efficacy in this age group.

Method of administration Take the film-coated tablets as whole, with sufficient amount of water (e.g. one glass) on an empty stomach in the morning or with breakfast.

–  –  –

Duration of treatment The duration of therapy will be determined by your doctor.

If you take more Bisoprolol HCT STADA than you should Contact a doctor or casualty department immediately if you have taken too many tablets.

Symptoms of overdose can be passing water more frequently, slow heartbeat, low blood pressure causing dizziness or fainting, shortness of breath (bronchospasm), or conduction or rhythm disorders of the heart.

The patient should be placed in the supine position with only a small pillow under the head and feet lifted up, while waiting for the medical help/ambulance.

If you forget to take Bisoprolol HCT STADA Take the next dose normally, when it is the time to take it. Do not take a double dose to make up for the forgotten dose.

If you stop taking Bisoprolol HCT STADA Do not interrupt or discontinue treatment with Bisoprolol HCT STADA before talking to your doctor.

Treatment with Bisoprolol HCT STADA must not be stopped abruptly but the dose must be reduced step-wise (according to the instructions of the doctor). An abrupt withdrawal can lead to an acute worsening of your medical condition.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking the medicine and contact your doctor soon if you get:

 disturbances of the electrolyte balance (see below at “common side effects” for the symptoms),  dizziness or fainting due to lowering of blood pressure when getting to the upright position,  any hypersensitivity reaction,  pronounced abdominal complaints,  symptoms of decreased white blood cell count (unexplained fever, flu-like symptoms such as sore throat),  symptoms of decreased platelets (easy bruising or nasal bleeding), or  worsening of existing short-sightedness (myopia).

Common: may affect up to 1 in 10 people  elevated blood lipid levels (triglycerides and cholesterol)  elevated blood sugar (glucose) level (hyperglycaemia) or glucose in urine (glucosuria)  elevated blood uric acid level (hyperuricaemia)  disturbances of the fluid and electrolyte balance: lowered potassium or sodium level in the blood, lowered magnesium or chloride level in the blood, elevated calcium level in the blood, or metabolic alkalosis (these may manifest with symptoms like fatigue, muscle weakness, arrhythmias of the heart, nausea, abdominal pain, confusion, headache, impaired consciousness, muscle cramps, tremors, or convulsions)  tiredness, fatigue, dizziness, or headache. These symptoms specially occur at the beginning of the therapy and are generally mild and often disappear within 1-2 weeks.



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