Cardex Plus is a combination of the beta-receptor blocking agent bisoprolol and
the diuretic substance hydrochlorothiazide.
Cardex Plus 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.

Do not take Cardex Plus 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
Cardex Plus.
- 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.
- 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 breast-feeding.
- You are taking floctafenine (an anti-inflammatory, painkilling medication) or
sultopride (a medicine to treat psychiatric disorders).
- You have gout.
Take special care with Cardex Plus
Talk to your doctor or, pharmacist before taking Cardex Plus.
You may have or have had in the past certain disorders that necessitate specific
measures before starting the Cardex Plus 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
atrio-ventricular 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 diarrhea.
- 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 Cardex Plus 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 Cardex Plus 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.
During long term-therapy with Cardex Plus, 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 Cardex Plus, 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.
Taking other medicines
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 Cardex
Plus.
- It is not recommended to use Cardex Plus with the following medicines:
- Verapamil or diltiazem (for heart problems or high blood pressure).
- Clonidine (used to treat high blood pressure).
- Methyldopa, guanfancine, or reserpine (medications to treat high blood pressure).
- Monoamino-oxidase inhibitors (MAO-inhibitors; e.g. to treat depression).
- Lithium (for manic-depressive disorder).
- 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 Cardex Plus only with caution with the following
medicines:
- So called dihydropyridine calcium channel blockers (such as nifedipine to
treat high blood pressure).
- Angiotensin II antagonists (e.g. losartan), ACE-inhibitors (e.g. captopril or
enalapril) to treat high blood pressure.
- Medicines to treat cardiac arrhythmias (to treat irregular heart beat; such as
amiodarone, disopyramide, quinidine, or sotalol).
- Medicines which stimulate special nerves (parasympathetic nervous system)
used to treat myasthenia gravis (a disease causing muscular weakness) or
dementia (including tacrine).
- Other beta-blocking medicines (taken by mouth or given as eye drops).
- Insulins and tablets to treat diabetes.
- Digoxin or other digitalis-preparations to treat weak heart.
- Anti-inflammatory (so called NSAIDs) and other painkilling medicines.
- Ergotamine-preparations to treat low blood pressure or migraine.
- Cardiovascular stimulating medicines (sympathomimetics; they all raise
blood pressure).
- Tricyclic antidepressants (to treat depression), phenothiazines (to treat
psychoses), or barbiturates (to treat epilepsy) and other medications to treat
high blood pressure.
- Rifampicin (to treat tuberculosis).
- Medicines to treat gout (e.g. probenecid).
- Anaesthetics, therefore be sure to inform the surgeon that you are taking
Cardex Plus before any surgical intervention.
- Cortisone-preparations by mouth or as injections or adrenocorticotropic
hormone (ACTH) which stimulates the production of cortison-like substances
in your body.
- Carbenoxolone (for gastric ulcers), amphotericin B (an anti-fungal agent), or
furosemide (water pill).
- Taken to treat constipation (laxatives).
- Muscle relaxants (of curare-type; please ask your doctor).
- Medicines to suppress immune system and to treat cancer (such as cyclophosphamide,
fluorouracil, or methotrexate).
- Colestyramine and colestipol (to bind bile acids).
- Oral anticoagulants (to prevent blood clots).
- 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.
Cardex Plus must NOT be used during breast-feeding.
Hydrochlorothiazide contained in Cardex Plus can suppress the milk production.
Driving and using machines
Cardex Plus 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.This should
be considered particularly at the start of therapy, upon change of dosage, and
ifalcohol is consumed at the same time. If affected, you should not drive or
engage with other activities requiring alertness and coordination.

Always take this medicine exactly as your doctor has told you. Check with your
doctor or pharmacist if you are not sure.
Cardex Plus tablets are for oral use.
Cardex Plus 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. Cardex Plus 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 Cardex Plus 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 Cardex Plus 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 Cardex Plus.
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 Cardex Plus
Do not interrupt or discontinue treatment with Cardex Plus before talking to your
doctor. Treatment with Cardex Plus must not be stopped abruptly but the dose
must be reduced stepwise (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.

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.
- 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 especially occur
at the beginning of the therapy and are generally mild and often disappear
within 1-2 weeks.
- Coldness or numbness of the limbs.
- Nausea, vomiting, diarrhea or constipation.
Uncommon: may affect up to 1 in 100 people
- Sleep disturbances, depression.
- 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.
- General weakness (asthenia).
- Elevated blood creatinine or urea levels.
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
- Loss of white blood cells (agranulocytosis, may cause unexplained fever or
flu-like symptoms, such as sore throat).
- Inflammation of the conjunctiva in the eye (conjunctivitis).
- Chest pain.
- Onset or worsening of psoriasis (a disease which causes red scaly patches to
appear on the skin).
- Hair loss (alopecia).
- Cutaneous lupus erythematosus (a rare auto-immune disease affecting the
skin).
If any of the side effects gets serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.

Keep out of reach of children. Store below 30°C.
Do not use beyond the expiry date or if the product shows any sign of deterioration.
Do not throw away any medicines via wastewater or household waste. Ask
your pharmacist how to throw away the medicines you no longer use. These
measures will help to protect the environment.