Karbis tablets 8 mg are pink, round, biconvex tablets, scored on one side. One side of the breaker score is marked with mark 8.
Karbis tablets 16 mg are round, slightly pink, biconvex tablets, scored on one side. One side of the breaker score is marked with 1 and the other side of the breaker score with 6.
The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.
The active substance is candesartan cilexetil. Each tablet contains 8 mg or 16 mg candesartan cilexetil.
Excipients/Inactive Ingredients: The other ingredients are dibutyl sebacate, sodium laurilsulfate, hydroxypropylcellulose, lactose monohydrate, maize starch, carmellose calcium, magnesium stearate and iron oxide red (E172).
The name of the medicine is Karbis. The active ingredient is candesartan cilexetil. This belongs to a group of medicines called angiotensin II receptor antagonists. It works by making the blood vessels relax and widen. This helps to lower the blood pressure. It also makes it easier for the heart to pump blood to all parts of the body.
This medicine is used for: treating high blood pressure (hypertension) in adult patients and in children and adolescents aged 6 to <18 years.
Karbis can be used to treat adult heart failure patients with reduced heart muscle function when Angiotensin Converting Enzyme (ACE) inhibitors cannot be used or in addition to ACE-inhibitors when symptoms persist despite treatment and mineralocorticoid receptor antagonists (MRA) cannot be used (ACE-inhibitors and MRAs are medicines used to treat heart failure).
Always take this medicine exactly as prescribed. Advise patient to check with the doctor or pharmacist if not sure. It is important to keep taking Karbis every day.
Karbis can be taken with or without food. The tablet should be swallowed with a drink of water. Advise patient to try to take the tablet at the same time each day. This will help the patient to remember to take it.
High blood pressure: The recommended dose of candesartan cilexetil is 8 mg once a day. This dose may be increased to 16 mg once a day and further up to 32 mg once a day depending on blood pressure response.
In some patients, such as those with liver problems, kidney problems or those who recently have lost body fluids, e.g., through vomiting or diarrhoea or by using water tablets, a lower starting dose may be prescribed.
Some black patients may have a reduced response to this type of medicine, when given as the only treatment, and these patients may need a higher dose.
Use in children and adolescents with high blood pressure: Children 6 to under 18 years of age: The recommended starting dose is 4 mg once daily.
For patients weighing <50 kg: In some patients whose blood pressure is not adequately controlled, the dose may be needed to be increased to a maximum of 8 mg once daily.
For patients weighing ≥50 kg: In some patients whose blood pressure is not adequately controlled, the dose may be needed to be increased to 8 mg once daily and to 16 mg once daily.
Heart failure in adults: The recommended starting dose of candesartan cilexetil is 4 mg once a day. The dose may be increased by doubling the dose at intervals of at least 2 weeks up to 32 mg once a day. Karbis can be taken together with other medicines for heart failure, and the doctor will decide which treatment is suitable for the patient.
Karbis 8 mg and 16 mg tablets cannot be divided, therefore Karbis 8 mg tablets are not suitable for patients who require a dose of 4 mg candesartan cilexetil. For these patients, other candesartan cilexetil preparations should be considered.
Forgotten intake of Karbis: A double dose should not be taken to make up for a forgotten dose. The next dose should be taken as normal.
Stopping intake of Karbis: If taking Karbis is stopped, the blood pressure may increase again. Therefore, advise the patient not to stop taking Karbis without first talking to the doctor.
Patients must be advised of any further questions on the use of this medicine.
If Karbis is taken more than prescribed, advise the patient to contact a doctor or a pharmacist immediately.
Karbis should not be taken: if the patient is allergic to candesartan cilexetil or any of the other ingredients of this medicine (listed in Description); if the patient is more than 3 months pregnant (it is also better to avoid Karbis in early pregnancy - see Use in Pregnancy & Lactation); if the patient has severe liver disease or biliary obstruction (a problem with the drainage of the bile from the gall bladder); if the patient is a child under 1 year of age; the concomitant use of Karbis with aliskiren-containing products is contraindicated in patients with diabetes mellitus or renal impairment (GFR <60 ml/min/1.73 m2).
If any of these apply to the patient, advise the patient to talk to the doctor or pharmacist before taking Karbis.
Advise the patient to talk to the doctor or pharmacist before taking Karbis: if the patient has heart, liver or kidney problems, or is on dialysis; if the patient has recently had a kidney transplant; if the patient is vomiting, has recently had severe vomiting, or has diarrhoea; if the patient has a disease of the adrenal gland called Conn's syndrome (also called primary hyperaldosteronism); if the patient has low blood pressure; if the patient has ever had a stroke.
Dual blockade of the renin-angiotensin-aldosterone system (RAAS): there is evidence that the concomitant use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren increases the risk of hypotension, hyperkalaemia and decreased renal function (including acute renal failure). Dual blockade of RAAS through the combined use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren is therefore not recommended.
If dual blockade therapy is considered absolutely necessary, this should only occur under specialist supervision and subject to frequent close monitoring of renal function, electrolytes and blood pressure. ACE-inhibitors and angiotensin II receptor blockers should not be used concomitantly in patients with diabetic nephropathy.
If the patient is taking any of the following medicines used to treat high blood pressure: an ACE-inhibitor (for example enalapril, lisinopril, ramipril), in particular if patient has diabetes related kidney problems; Aliskiren.
If the patient is taking an ACE-inhibitor together with a medicine which belongs to the class of medicines known as mineralocorticoid receptors antagonists (MRA). These medicines are for the treatment of heart failure (see Interactions).
Kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in the blood may be checked at regular intervals.
See also information under Contraindications.
The doctor may want to see the patient more often and do some tests if the patient has any of these conditions.
If the patient is going to have an operation, advise the patient to inform the doctor or dentist about taking Karbis. This is because Karbis, when combined with some anaesthetics, may cause a drop in blood pressure.
Karbis contains lactose and sodium: Karbis contains lactose. If the patient has been told by the doctor that he/she has an intolerance to some sugars, advise the patient to contact the doctor before taking this product.
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially 'sodium free'.
Driving and using machines: Some people may feel tired or dizzy when taking Karbis. If this happens, advise the patient not to drive or use any tools or machines.
Use in Children: Karbis has been studied in children. Advise patient for more information. Karbis must not be given to children under 1 year of age due to the potential risk to the developing kidneys.
Use in Pregnancy & Lactation: See USE IN PREGNANCY & LACTATION section for further information.
If the patient is pregnant or breast-feeding, thinks that she may be pregnant or is planning to have a baby, advise the patient to ask the doctor or pharmacist for advice before taking this medicine.
Pregnancy: Advise the patient to inform the doctor if she thinks she is (or might become) pregnant. The doctor will normally advise to stop taking Karbis before she becomes pregnant or as soon as she knows she is pregnant and will advise to take another medicine instead of Karbis. Karbis is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to the baby if used after the third month of pregnancy.
Breast-feeding: Advise the patient to inform the doctor if she is breast-feeding or about to start breast-feeding. Karbis is not recommended for mothers who are breast-feeding, and the doctor may choose another treatment if the patient wishes to breast-feed, especially if the baby is newborn, or was born prematurely.
Like all medicines, this medicine can cause side effects, although not everybody gets them. It is important that the patient is aware of what these side effects may be.
Patients must be advised to stop taking Karbis and to seek medical help immediately if they have any of the following allergic reactions: difficulties in breathing, with or without swelling of the face, lips, tongue and/or throat; swelling of the face, lips, tongue and/or throat, which may cause difficulties in swallowing; severe itching of the skin (with raised lumps).
Karbis may cause a reduction in number of white blood cells. The resistance to infection may be decreased and tiredness, an infection or a fever may be noticed. If this happens, advise the patient to contact a doctor. Blood tests may occasionally be done to check whether Karbis has had any effect on the blood (agranulocytosis).
Other possible side effects include: Common (affects 1 to 10 users in 100): Feeling dizzy/spinning sensation; Headache; Respiratory infection; Low blood pressure. This may make the patient feel faint or dizzy; Changes in blood test results: an increased amount of potassium in the blood, especially if the patient already has kidney problems or heart failure. If this is severe, the patient may notice tiredness, weakness, irregular heart beat or pins and needles; Effects on how the kidneys work, especially if the patient already has kidney problems or heart failure. In very rare cases, kidney failure may occur.
Very rare (affects less than 1 user in 10,000): Swelling of the face, lips, tongue and/or throat; A reduction in the red or white blood cells. Tiredness, an infection or a fever may be noticed; Skin rash, lumpy rash (hives); Itching; Back pain, pain in joints and muscles; Changes in how the liver is working, including inflammation of the liver (hepatitis). Tiredness, yellowing of the skin and the whites of the eyes and flu-like symptoms may be noticed; Cough; Nausea; Changes in blood test results: a reduced amount of sodium in the blood. If this is severe then the patient may notice weakness, lack of energy, or muscle cramps.
Not known (frequency cannot be estimated from the available data): Diarrhoea.
In children treated for high blood pressure, side effects appear to be similar to those seen in adults, but they happen more often. Sore throat is a very common side effect in children. Runny nose, fever and increased heart rate are common in children.
In case of any side effects, advise the patient to talk to a doctor or pharmacist. This includes any possible side effects not listed in this monograph.
Patients must be advised to inform the doctor or pharmacist if they are taking, have recently taken or might take any other medicines.
Karbis can affect the way some other medicines work and some medicines can have an effect on Karbis. If the patient is using certain medicines, blood tests may be needed to be done from time to time.
In particular, advise patients to inform the doctor if they are using any of the following medicines. The dose may be needed to change and/or other precautions to be taken: Other medicines to help lower the blood pressure, including beta-blockers, diazoxide and ACE-inhibitors such as enalapril, captopril, lisinopril or ramipril; Non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, naproxen or diclofenac, celecoxib or etoricoxib (medicines to relieve pain and inflammation); Acetylsalicylic acid (if it is taken more than 3 g each day) (medicine to relieve pain and inflammation); Potassium supplements or salt substitutes containing potassium (medicines that increase the amount of potassium in the blood); Heparin (a medicine for thinning the blood); Co-trimoxazole (an antibiotic medicine) also known as trimethoprim/sulfamethoxazole; Water tablets (diuretics); Lithium (a medicine for mental health problems); If the patient is taking an ACE-inhibitor or aliskiren (see also information under Contraindications and Precautions); Clinical trial data has shown that dual blockade of the RAAS through the combined use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren is associated with a higher frequency of adverse events such as hypotension, hyperkalaemia and decreased renal function (including acute renal failure) compared to the use of a single RAAS-acting agent; If the patient is being treated with an ACE-inhibitor together with certain other medicines to treat heart failure, which are known as mineralocorticoid receptors antagonists (MRA) (for example spironolactone, eplerenone).
Karbis with food, drink and alcohol: Karbis can be taken with or without food.
When Karbis is prescribed, advise the patient to discuss with the doctor before drinking alcohol. Alcohol may make the patient feel faint or dizzy.
Do not throw away any medicines via wastewater or household waste. Ask the pharmacist how to throw away medicines no longer used. These measures will help protect the environment.
Store below 25 °C.
Store in the original package.
C09CA06 - candesartan ; Belongs to the class of angiotensin II receptor blockers (ARBs). Used in the treatment of cardiovascular disease.
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