Tevacard Co Film-Coated Tablets

TEVACARD CO contains the active substances bisoprolol and hydrochlorothiazide:

• Bisoprolol belongs to a group of medicines called beta-blockers and is used to lower blood pressure.
• Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics (“water tablets”) and also helps to lower blood pressure by increasing urine output.

TEVACARD CO is used to treat high blood pressure.

Do not take TEVACARD CO:

• if you are hypersensitive to bisoprolol, hydrochlorothiazide, other thiazides, sulphonamides or to any of the other ingredients of TEVACARD CO (listed in section 6)
• if your heart failure is not controlled by therapy, or cardiogenic shock (an acute serious heart condition causing low blood pressure and circulatory failure)
• if you have certain cardiac rhythm disorders, in particular slow heart rate causing problems, conduction disturbances or a disorder called sick sinus syndrome
• if you have severe asthma or certain severe forms of chronic bronchial diseases
• if you have severe blood circulation problems in your limbs (such as Raynaud’s syndrome which may cause your fingers or toes to tingle or turn pale or blue)
• if you have untreated pheochromocytoma (tumour of the adrenal gland secreting substances which induce severe high blood pressure)
• if you have previously had or currently have cancer of the skin and/or lip
• if you have severe liver or kidney problems
• if you have increased blood acidity (metabolic acidosis) as a result of severe illness
• if you have low blood levels of potassium, not responding to treatment
• if you are pregnant or breastfeeding your baby
• if you are under the age of 18 years as safety and efficacy has not been established in children.

Warnings and precautions:

Take special care with TEVACARD CO:

• Never suddenly stop taking treatment, in particular if you suffer from certain heart disorders (ischaemic heart disease, for example angina pectoris).
• Talk to your doctor before taking TEVACARD CO if you have:
• liver problems
• chronic bronchial disease (asthma or chronic obstructive airway disease)
• if you are breastfeeding or intend to do so
• any heart disease such as heart failure, disturbances in heart rhythm, or Prinzmetal’s angina
• blood circulation problems in your limbs (in particular Raynaud's syndrome)
• pheochromocytoma (tumour of the adrenal gland)
• diabetes
• psoriasis
• if you plan to have desensitisation therapy, because TEVACARD CO may make it more likely that you experience an allergic reaction, or that such a reaction may be more severe
• if you are going to have an anaesthetic (e.g. for surgery) because TEVACARD CO may influence how your body reacts to this situation
• thyroid disorders
• strict fasting
• if you have ever suffered from gout, as TEVACARD CO may enhance the risk for gout attacks
• if you have kidney problems

Do not share medicines prescribed for you with any other person. Always take TEVACARD CO exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The usual starting dose is one 2,5 mg/6,25 mg tablet daily. If the blood pressure-lowering effect of this dose is inadequate, the dose will be increased to one 5 mg/6,25 mg tablet daily and, if the response is still inadequate, to the maximum recommended dose of one 10 mg/6,25 mg tablet daily.

Take TEVACARD CO in the morning, with or without food. Swallow the tablet with some liquid. Do not chew.

Never suddenly stop taking treatment (see If you stop taking TEVACARD CO).

Children: There is no experience with TEVACARD CO in children, therefore its use is not recommended for children.

Your doctor will tell you how long your treatment with TEVACARD CO will last. If you have the impression that the effect of TEVACARD CO is too strong or too weak, tell your doctor or pharmacist.

If you take more TEVACARD CO than you should: In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre. Symptoms of an overdose may include low blood pressure, slow heartbeat, sudden heart problems, dizziness, nausea, sleepiness, sudden breathing problems, low blood sugar.

If you forget to take TEVACARD CO: Do not take a double dose to make up for forgotten individual doses.

TEVACARD CO can have side effects. Not all side-effects reported for TEVACARD CO are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking TEVACARD CO, please consult your healthcare provider for advice.

If any of the following happens, stop taking/using TEVACARD CO and tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing,
• rash or itching,
• fainting.

These are all very serious side effects. If you have them, you may have had a serious reaction to TEVACARD CO. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• Less frequent:
• slow heartbeat, impaired heart rate, worsening of heart failure
• breathing problems in patients with asthma or chronic bronchial disease
• increase in certain liver enzymes, inflammation of the liver, yellow colouring of skin and eyes (jaundice)

Tell your doctor if you notice any of the following:

• Frequent side effects:
• headache
• feeling of coldness or numbness in hands and feet
• stomach or intestine problems such as nausea, vomiting, diarrhoea, or constipation
• tiredness

Side effects with unknown frequency:

• skin and lip cancer (Non-melanoma skin cancer)
• acute respiratory distress (signs include severe shortness of breath, fever, weakness, and confusion)
• decrease in vision or pain in your eyes due to high pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma).

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Store all medicine out of reach of children. Store at or below 25 °C. Keep the tablets in the blisters until required for use. Do not use the tablets after the expiry date shown on the container. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).