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Bisoprolol / Hydrochlorothiazide

Bisoprolol + HCT is a combination of the beta-receptor blocking agent bisoprolol and the diuretic substance hydrochlorothiazide.


Generic Name

Bisoprolol/Hydrochlorothiazide


Packing

30,500


Therapeutic Category

Antihypertensive


Storage

Do not store above 30°C.


adobe-pdf-logoProduct Insert(PIL)

adobe-pdf-logoPrescribing Information(SPC)


Product Description

Product Overview


What Bisoprolol + HCT is and what it is used for ?

Bisoprolol + HCT is a combination of the beta-receptor blocking agent bisoprolol and the diuretic substance hydrochlorothiazide.
Bisoprolol + HCT 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.

What you need to know before you take Bisoprolol + HCT

DO NOT take Bisoprolol + HCT if:
• you are allergic to bisoprolol, hydrochlorothiazide or other thiazides, other sulphonamides (mainly antibiotics), or to any of the other ingredients of this medicine,
• 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,
• 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),
• 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,

Warnings and precautions

Talk to your doctor or, pharmacist before taking Bisoprolol + HCT.
You may have or have had in the past certain disorders that necessitate specific measures before starting the Bisoprolol + HCT therapy or during it. You should, therefore, inform your
doctor before you start taking this medicine, if anyof 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 may reduce the tear flow and increases the risk for eye irritation.

How to take Bisoprolol + HCT Tablets

Always take this medicine exactly as your doctor has told you.
Check with your doctor or pharmacist if you are not sure.
Bisoprolol + HCT tablets are for oral use.
Bisoprolol + HCT 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.
Elderly
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 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 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 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 tablets
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 tablets
Do not interrupt or discontinue treatment with Bisoprolol + HCT tablets before talking to your doctor.
Treatment with Bisoprolol + HCT tablets 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.

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)
• slow heart beat (bradycardia), conduction disturbances in the heart or worsening of the heart failure (increased swellings, shortness of breath)
• too low blood pressure when getting to upright position, with dizziness or fainting (orthostatic hypotension)
• worsening of symptoms (bronchospasms) in patients with asthma or a history of obstructive airway disease
• loss of appetite, abdominal complaints
• inflammation of the pancreas (with upper abdominal pain) or elevated blood amylase level
• muscular weakness and cramps

Rare: may affect up to 1 in 1,000 people
• decreased number of white blood cells (leucopenia, may cause unexplained fever or flu-like symptoms, such as sore
throat)
• decreased number of platelets (thrombocytopenia, may cause easy bruising or nasal bleeding)
• nightmares, hallucinations
• reduced tear flow (and drying of eyes – to be noted by wearers of contact lenses), visual disturbances
• hearing disorders
• allergic rhinitis (swelling and irritation inside the nose)
• elevated liver enzyme (ASAT, ALAT) levels in the blood, jaundice (yellow discolouration of the eye whites or skin), or inflammation of the liver (hepatitis; with upper abdominal pain)
• skin hypersensitivity reactions (itching, flushing, rash, photosensitivity, purpura or urticaria)
• impotence (erectile dysfunction)

Very rare: may affect up to 1 in 10,000 people
If you get any side effects, talk to your doctor or pharmacist.
This includes any side effects not listed in this leaflet.

How to store Bisoprolol + HCT tablets

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 expiry date refers to the last day of that month.
Store in the original package.
Do not store above 30°C.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use.
These measures will help protect the environment.

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