CANDETENS 8 мг/5 мг Капсулы твердые

Содержание инструкции

1. CANDETENS 8 mg/5 mg hard capsules, 8 mg/10 mg hard capsules, 16 mg/5 mg hard capsules, 16 mg/10 mg hard capsules
   1. What is CANDETENS and what is it used for
   2. What you need to know before taking CANDETENS
   3. How to take CANDETENS
   4. Possible side effects
   5. How to store CANDETENS
   6. Package Contents and Other Information

CANDETENS 8 mg/5 mg hard capsules, 8 mg/10 mg hard capsules, 16 mg/5 mg hard capsules, 16 mg/10 mg hard capsules

Candesartan cilexetil and Amlodipine

Read this leaflet carefully before you start taking this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What CANDETENS is and what it is used for
• 2. What you need to know before you take CANDETENS
• 3. How to take CANDETENS
• 4. Possible side effects
• 5. How to store CANDETENS
• 6. Contents of the pack and other information

1. What is CANDETENS and what is it used for

CANDETENS contains two active ingredients: candesartan and amlodipine. Both help to control high blood pressure (hypertension).
Candesartan belongs to a group of substances called “angiotensin II receptor antagonists”.
Angiotensin II is produced by the body and causes a narrowing of the blood vessels, which increases
blood pressure. Candesartan works by blocking the effect of angiotensin II.
Amlodipine belongs to a group of substances called “calcium channel blockers”. Amlodipine
prevents calcium from entering the wall of blood vessels, counteracting their tension and reducing
arterial pressure.
The action of both substances helps to counteract the narrowing of the blood vessels. This
results in relaxation of the vessels and a reduction in blood pressure.
CANDETENS is used to treat high blood pressure in patients whose blood pressure is already controlled
by the association of candesartan and amlodipine taken separately at the same doses contained in
CANDETENS.

2. What you need to know before taking CANDETENS

Do not take CANDETENS

• if you are allergic to amlodipine besilate or to any calcium antagonist, candesartan cilexetil or to any of the other components of this medicine (listed in section 6)
• if you suffer from severely low blood pressure (severe hypotension)
• if you suffer from narrowing of the main blood vessels leaving the heart (severe aortic stenosis) or a condition in which the heart is unable to supply enough blood to the body (cardiogenic shock)
• if you suffer from heart failure (the heart is unable to pump blood adequately causing shortness of breath or peripheral swelling such as swelling of the legs, ankles or feet) after an acute heart attack
• if you are pregnant for more than 3 months (see section “Pregnancy and breastfeeding”)
• if you have a severe liver disease or obstruction of the bile ducts (a problem with drainage of bile from the gallbladder)
• if you suffer from diabetes mellitus or your kidney function is impaired and you are being treated with a medicine that lowers blood pressure, containing aliskiren
• if the patient is a child or adolescent under the age of 18 years.

Warnings and precautions
Talk to your doctor or pharmacist before taking CANDETENS if:

• you have recently had a heart attack
• you suffer from heart failure
• you have had a severe increase in blood pressure (hypertensive crisis)
• you have low blood pressure (hypotension)
• you are elderly and your dosage needs to be increased
• you have problems with your kidneys or if you are on dialysis
• you have problems with your liver
• you have recently had a kidney transplant
• you are vomiting, have recently had severe vomiting or have diarrhoea
• you have a disease of the adrenal gland, known as Conn’s syndrome (also called primary hyperaldosteronism)
• you have ever had a stroke
• you are taking any of the following medicines used to treat high blood pressure:
• an ACE inhibitor (e.g. enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes
• aliskiren.

The doctor may check your kidney function, blood pressure and the amount of electrolytes (such as potassium) in your blood at regular intervals.
See also what is stated in the section “Do not take CANDETENS”.
The doctor may need to see you more often and do tests if you experience any of these conditions.
If you are about to have an operation, tell your doctor or dentist that you are taking CANDETENS. This is because CANDETENS, when combined with some anaesthetics, can cause a drop in blood pressure.
You should inform your doctor if you think you may be (or become) pregnant. CANDETENS is not recommended in early pregnancy and should not be taken if you are pregnant for more than 3 months as it can cause serious harm to the baby if used at this stage (see “Pregnancy and breastfeeding”).

Children and adolescents
There is no experience with the use of CANDETENS in children (under 18 years). Therefore CANDETENS should not be given to children and adolescents.

Other medicines and CANDETENS
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
CANDETENS can affect the mechanism of action of other medicines and some medicines can have an effect on CANDETENS such as:

• ketoconazole, itraconazole, (medicines used for the treatment of fungal infections)
• ritonavir, indinavir, nelfinavir (medicines called protease inhibitors used for the treatment of HIV)
• rifampicin, erythromycin, clarithromycin (antibiotics)
• St John’s wort (herbal remedy with antidepressant and antiviral properties)
• verapamil, diltiazem (medicines for the heart)
• dantrolene (infusion for the treatment of malignant hyperthermia)
• simvastatin (medicine used to reduce cholesterol)
• other medicines for high blood pressure, including beta-blockers, diazoxide and ACE inhibitors such as enalapril, captopril, lisinopril or ramipril) or aliskiren (see also the information given in the sections “Do not take CANDETENS” and “Warnings and precautions”)
• non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, naproxen, diclofenac, celecoxib or etoricoxib (medicines for relieving pain and inflammation)
• acetylsalicylic acid (medicine for relieving pain and inflammation) if you are taking more than 3 g per day
• potassium supplements or salt substitutes containing potassium (medicines that increase the level of potassium in the blood)
• heparin (a medicine for thinning the blood)
• water tablets (diuretics)
• lithium (a medicine for mental health problems)
• tacrolimus (immunosuppressant medicine used to modulate the body’s immune response)
• cyclosporine (immunosuppressant medicine used mainly after an organ transplant to avoid the risk of rejection)

CANDETENS with food and drink
People taking CANDETENS should not consume grapefruit or drink grapefruit juice as grapefruit and its juice can increase the levels of the active ingredient amlodipine in the blood and this can lead to an increase in the hypotensive effect of CANDETENS.

Pregnancy and breastfeeding
If you are pregnant, if you suspect you are pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
You should tell your doctor if you think you may be (or become) pregnant.
Normally your doctor will advise you to stop taking CANDETENS before becoming pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of CANDETENS.
CANDETENS is not recommended in early pregnancy, and should not be taken if you are pregnant for more than 3 months, as it can cause serious harm to your baby if used after the third month of pregnancy.
Breastfeeding
Amlodipine has been shown to pass into breast milk in small amounts. Tell your doctor if you are breastfeeding or are about to start breastfeeding. CANDETENS is not recommended in breastfeeding mothers and if you wish to breastfeed your doctor may choose another treatment for you, especially if your baby is newborn or premature.

Driving and using machines
CANDETENS can have a moderate influence on your ability to drive or operate machines. If you experience fatigue, dizziness or feeling unwell, lightheadedness, tiredness or headache, do not drive or use tools or machines and contact your doctor immediately.

CANDETENS contains lactose monohydrate. If you have been diagnosed with intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take CANDETENS

Take this medicine following exactly the instructions of your doctor. If you have doubts, consult your
doctor or pharmacist.
Swallow the capsule with a little water, preferably always at the same time of day.
The recommended dose is one capsule a day.
CANDETENS is usually prescribed for patients who are already taking candesartan and amlodipine
in separate capsules/tablets.

If you take more CANDETENS than you should
If you should take an excessive number of capsules, your blood pressure may drop too low and this may
be dangerous. You may experience dizziness, mental confusion, weakness or fainting. The drop in blood
pressure may be so severe as to cause you to go into shock. Your skin may become cold and clammy and
you may lose consciousness. If you have taken an excessive number of capsules, contact
your doctor immediately.

Excess fluid may accumulate in the lungs (pulmonary edema) causing shortness of breath which
may develop up to 24-48 hours after taking it.
If you forget to take CANDETENS
If you forget to take a dose of CANDETENS, take the next dose at the usual time.
Do not take a double dose to make up for a missed tablet.

If you stop taking CANDETENS
Your doctor will tell you how long to take the medicine. Your condition may return if you
stop treatment before your doctor tells you to. Therefore, do not stop treatment with
CANDETENS without talking to your doctor.
If you have any doubts about 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.
If you get any of the following side effects, stop taking this medicine and tell your doctor immediately:

• Sudden onset of shortness of breath, chest pain, wheezing or difficulty breathing
• Swelling of the eyelids, face or lips
• Swelling of the tongue and throat which can cause difficulty breathing
• Severe skin reactions including intense rash, hives, redness of the skin all over the body, severe itching, blisters, peeling and swelling of the skin, inflammation of the mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions
• Heart attack, abnormal heart rhythm
• Inflammation of the pancreas which can cause intense abdominal and back pain together with a feeling of severe illness

Candesartan can cause a decrease in the number of white blood cells in the blood. Your resistance to infections may decrease and you may notice fatigue, infection or fever. If this happens, contact your doctor.
The doctor may occasionally perform blood tests to check if CANDETENS has had any effects on your blood (agranulocytosis).

Other possible side effects
Since CANDETENS is a combination of two active ingredients, the reported side effects are related to both the use of candesartan and amlodipine.

Side effects related to the use of candesartan:
Common (may affect up to 1 in 10 people)

• Feeling of dizziness/lightheadedness
• Headache
• Respiratory infection

Very rare (may affect up to 1 in 10,000)

• A decrease in red blood cells or white blood cells. You may notice fatigue, infection or fever
• Skin rash, rash with swelling (urticaria)
• Itching
• Back pain, joint and muscle pain
• Changes in liver function, including inflammation of the liver (hepatitis). You may notice fatigue, yellowing of the skin and whites of the eyes and flu-like symptoms.
• Reduced kidney function, including kidney failure in susceptible patients.
• Cough
• Nausea
• Changes in blood test results:
• A reduced amount of sodium in the blood. If this is severe, you may also notice weakness, lack of energy or muscle cramps.
• An increased amount of potassium in the blood, especially if you already have kidney problems or heart failure, are an elderly person, suffer from diabetes or take other medicines that increase potassium levels. If this is severe, you may also notice fatigue, weakness, irregular heartbeat or tingling.

Not known (frequency cannot be estimated from the available data)

• Diarrhoea

Side effects related to the use of amlodipine
Very common (may affect more than 1 in 10 people)

• Edema

Common (may affect up to 1 in 10 people)

• Headache, dizziness, drowsiness (especially at the beginning of treatment)
• Palpitations (being aware of your heartbeat), flushing
• Hot flushes
• Abdominal pain, nausea
• Altered bowel habits, diarrhoea, constipation, indigestion
• Swelling of the ankles
• Fatigue, weakness
• Visual disturbances including double vision

Uncommon (may affect up to 1 in 100 people)

• Mood changes, anxiety, depression, insomnia
• Tremor, altered taste, fainting
• Numbness and tingling in the extremities, loss of pain sensation
• Ringing in the ears
• Low blood pressure
• Sneezing/runny nose caused by inflammation of the nasal mucosa (rhinitis)
• Cough
• Dry mouth, vomiting
• Hair loss, increased sweating, itchy skin, red patches on the skin, skin discoloration
• Urinary disorders, need to urinate at night, frequent urination
• Inability to achieve an erection, discomfort or enlargement of the breasts in men
• Chest pain, pain, discomfort
• Joint or muscle pain, back pain
• Weight gain or loss

Rare (may affect up to 1 in 1,000)

• Confusion

Very rare (may affect up to 1 in 10,000)

• Low levels of white blood cells and platelets in the blood which can lead to unusual bruising or a tendency to bleed (damage to red blood cells)
• High blood sugar levels (hyperglycaemia)
• A nervous disorder that can cause weakness, tingling or numbness
• Swelling of the gums
• Swollen stomach (gastritis)
• Abnormal liver function, inflammation of the liver (hepatitis), yellowing of the skin (jaundice), increased liver enzymes which can lead to changes in some clinical tests
• Increased muscle tension
• Inflammation of blood vessels, often with a skin rash
• Sensitivity to light
• Disorders related to stiffness, tremor and/or movement disorders

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store CANDETENS

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date which is stated on the packaging.
The expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What CANDETENS contains

• The active ingredients are candesartan cilexetil and amlodipine. CANDETENS 8 mg/5 mg hard capsulesEach capsule contains 8 mg of candesartan cilexetil and 5 mg of amlodipine equivalent to 6.935 mg of amlodipine besilate. CANDETENS 8 mg/10 mg hard capsulesEach capsule contains 8 mg of candesartan cilexetil and 10 mg of amlodipine equivalent to 13.87 mg of amlodipine besilate. CANDETENS 16 mg/5 mg hard capsulesEach capsule contains 16 mg of candesartan cilexetil and 5 mg of amlodipine equivalent to 6.935 mg of amlodipine besilate. CANDETENS 16 mg/10 mg hard capsulesEach capsule contains 16 mg of candesartan cilexetil and 10 mg of amlodipine equivalent to 13.87 mg of amlodipine besilate.
• The other ingredients are: Lactose monohydrate, corn starch, calcium carmellose, macrogol type 8000, hydroxypropylcellulose type EXF, hydroxypropylcellulose type LF, magnesium stearate, quinoline yellow (E 104), titanium dioxide (E 171), yellow iron oxide (E 172), gelatin.

Description of the appearance of CANDETENS and package contents
CANDETENS 8 mg/5 mg hard capsules: hard gelatin capsules, size 3, with an opaque white body and a dark yellow cap, filled with granules ranging in color from white to off-white.
CANDETENS 8 mg/10 mg hard capsules: hard gelatin capsules, size 1, with an opaque white body and a yellow cap. The capsules are imprinted with black ink CAN 8 on the body and AML 10 on the cap. The capsules are filled with granules ranging in color from white to off-white.
CANDETENS 16 mg/5 mg hard capsules: hard gelatin capsules, size 1, with an opaque white body and a pale yellow cap. The capsules are imprinted with black ink CAN 16 on the body and AML 5 on the cap. The capsules are filled with granules ranging in color from white to off-white.
CANDETENS 16 mg/10 mg hard capsules: hard gelatin capsules, size 1, with an opaque white body and cap, filled with granules ranging in color from white to off-white.
Blister packs of 28 hard capsules.

Marketing Authorisation Holder
Scharper S.p.A.
Viale Ortles, 12 – 20139 Milan

Manufacturers
Special Product’s Line S.p.A.
Via Fratta Rotonda Vado Largo 1
03012 Anagni (FR) – Italy
Adamed Pharma S.A.
Manufacturing site:
ul. Marszałka Józefa Piłsudskiego 5
95-200 Pabianice - Poland