Candetens

Package leaflet: information for the patient

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
Please read this leaflet carefully before taking this medicine because 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact 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 taking 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 CANDETENS is and what it is used for

CANDETENS contains two active substances: candesartan and amlodipine. Both help to control high blood pressure (hypertension).
Candesartan belongs to a group of substances known as “angiotensin II receptor antagonists”.
Angiotensin II is produced by the body and causes 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 walls of blood vessels, thereby reducing vessel tension and lowering blood pressure.
The action of both substances helps counteract the narrowing of blood vessels. This results in relaxation of the blood vessels and reduction of blood pressure.
CANDETENS is used to treat high blood pressure in patients whose blood pressure is already controlled by taking candesartan and amlodipine separately at the same doses as those contained in CANDETENS.

2. What you need to know before taking CANDETENS

Do not take CANDETENS

• if you are allergic to amlodipine besylate or any other calcium channel blocker, candesartan cilexetil, or to any of the other ingredients of this medicine (listed in section 6)
• if you suffer from severe low blood pressure (severe hypotension)
• if you suffer from narrowing of the main blood vessels leaving the heart (severe aortic stenosis) or if you have a condition in which the heart is unable to supply sufficient blood to the body (cardiogenic shock)
• if you suffer from heart failure (the heart cannot pump blood adequately, causing shortness of breath or peripheral swelling such as swelling of the legs, hips, or feet) following an acute heart attack
• if you are more than 3 months pregnant (see section “Pregnancy and breastfeeding”)
• if you have severe liver disease or biliary obstruction (a condition affecting bile drainage from the gallbladder)
• if you have diabetes mellitus or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren
• if the patient is a child or adolescent under 18 years of age.

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 experienced a severe increase in blood pressure (hypertensive crisis)
• you have low blood pressure (hypotension)
• you are elderly and your dose needs to be increased
• you have kidney problems or are on dialysis
• you have liver problems
• you have recently undergone a kidney transplant
• you are vomiting, have recently had severe vomiting, or have diarrhea
• 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), particularly if you have kidney problems related to diabetes
• aliskiren.

Your doctor may monitor your kidney function, blood pressure, and blood electrolyte levels (e.g., potassium) at regular intervals.
See also the information provided under the section “Do not take CANDETENS”.
Your doctor may need to see you more frequently and perform tests if you have any of these conditions.
If you are about to undergo surgery, tell your doctor or dentist that you are taking CANDETENS. This is because CANDETENS, when used together with certain anesthetics, may cause a drop in blood pressure.
You must inform your doctor if you think you might be (or might become) pregnant. CANDETENS is not recommended during early pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to the unborn baby if used during this period (see “Pregnancy and breastfeeding”).
Children and adolescents
There is no experience with the use of CANDETENS in children (under 18 years of age). Therefore, CANDETENS must not be administered to children or adolescents.
Other medicines and CANDETENS
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
CANDETENS may affect how other medicines work, and some medicines may affect CANDETENS, such as:

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

CANDETENS with food and drink
People taking CANDETENS should not consume grapefruit or drink grapefruit juice, as grapefruit and its juice may increase blood levels of the active ingredient amlodipine, which could lead to an enhanced hypotensive effect of CANDETENS.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
You must inform your doctor if you think you might be (or might become) pregnant.
Your doctor will usually advise you to stop taking CANDETENS before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine.
CANDETENS is not recommended during early pregnancy and must not be taken after the first 3 months of pregnancy, as it may cause serious harm to your unborn baby if used beyond the third month of pregnancy.
Breastfeeding
It has been shown that amlodipine passes into breast milk in small amounts. Inform your doctor if you are breastfeeding or planning to breastfeed. CANDETENS is not recommended for breastfeeding mothers. If you wish to breastfeed, your doctor may choose an alternative treatment, especially if your baby is a newborn or premature.
Driving and using machines
CANDETENS may have a moderate effect on your ability to drive or operate machinery. If you feel tired, dizzy, unwell, or experience dizziness, fatigue, or headache, do not drive or use tools or machines and contact your doctor immediately.
CANDETENS contains lactose monohydrate. If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

3. How to take CANDETENS

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
Swallow the capsule with some water, preferably always at the same time of day.
The recommended dose is one capsule per 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 take too many capsules, your blood pressure may drop too much, which could be dangerous. You may experience dizziness, mental confusion, weakness, or fainting. The drop in blood pressure could be so severe as to cause shock. Your skin may become cold and clammy, and you may lose consciousness. If you have taken too many capsules, contact your doctor immediately.
Excess fluid may accumulate in the lungs (pulmonary edema), causing breathlessness, which may develop up to 24–48 hours after ingestion.

If you forget to take CANDETENS
If you forget to take a dose of CANDETENS, take the next dose at your usual time.
Do not take a double dose to make up for the forgotten 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 advises you to do so. Therefore, do not stop treatment with CANDETENS without first talking to your doctor.

If you have any doubts about how to use 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 experience any of the following side effects, stop taking this medicine and inform your doctor immediately:

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

Candesartan may cause a reduction 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 occurs, contact your doctor.
Your doctor may occasionally perform blood tests to check whether CANDETENS has had any effects on your blood (agranulocytosis).
Other possible side effects
Since CANDETENS is a combination of two active substances, 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)

• Dizziness/lightheadedness
• Headache
• Respiratory infection

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

• Reduction in red 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:
• Reduced sodium levels in the blood. If this is severe, you may also notice weakness, lack of energy or muscle cramps.
• Increased potassium levels in the blood, especially if you already have kidney problems or heart failure, are elderly, have diabetes or are taking other medicines that increase potassium levels. If this is severe, you may also notice fatigue, weakness, irregular heartbeat or tingling sensations.

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)

• Oedema

Common (may affect up to 1 in 10 people)

• Headache, dizziness, drowsiness (especially at the beginning of treatment)
• Palpitations (awareness of 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 limbs, loss of sensitivity to pain
• Ringing in the ears
• Low blood pressure
• Sneezing, runny nose due to inflammation of the nasal mucosa (rhinitis)
• Cough
• Dry mouth, vomiting
• Hair loss, increased sweating, skin itching, red patches on the skin, skin discoloration
• Urinary disorders, need to urinate at night, frequent need to urinate
• Inability to achieve an erection, discomfort or breast enlargement 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 people)

• Confusion

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

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

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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 requires no special storage conditions.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of that month.
Do not dispose of any medicine via 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 substances are candesartan cilexetil and amlodipine.
  CANDETENS 8 mg/5 mg hard capsules: Each capsule contains 8 mg of candesartan cilexetil and 5 mg of amlodipine, equivalent to 6.935 mg of amlodipine besylate.
  CANDETENS 8 mg/10 mg hard capsules: Each capsule contains 8 mg of candesartan cilexetil and 10 mg of amlodipine, equivalent to 13.87 mg of amlodipine besylate.
  CANDETENS 16 mg/5 mg hard capsules: Each capsule contains 16 mg of candesartan cilexetil and 5 mg of amlodipine, equivalent to 6.935 mg of amlodipine besylate.
  CANDETENS 16 mg/10 mg hard capsules: Each capsule contains 16 mg of candesartan cilexetil and 10 mg of amlodipine, equivalent to 13.87 mg of amlodipine besylate.
• Other ingredients are: Monohydrate lactose, maize starch, calcium carmellose, macrogol 8000, hydroxypropylcellulose EXF type, hydroxypropylcellulose LF type, magnesium stearate, quinoline yellow (E 104), titanium dioxide (E 171), iron oxide yellow (E 172), gelatin.

Description of the appearance of CANDETENS and contents of the pack
CANDETENS 8 mg/5 mg hard capsules: Hard gelatin capsules, size 3, with an opaque white body and a dark yellow cap, filled with white to dark white microgranules.
CANDETENS 8 mg/10 mg hard capsules: Hard gelatin capsules, size 1, with an opaque white body and a yellow cap. Printed in black ink on the capsule body is "CAN 8" and on the cap "AML 10". The capsules are filled with white to dark white microgranules.
CANDETENS 16 mg/5 mg hard capsules: Hard gelatin capsules, size 1, with an opaque white body and a pale yellow cap. Printed in black ink on the capsule body is "CAN 16" and on the cap "AML 5". The capsules are filled with white to dark white microgranules.
CANDETENS 16 mg/10 mg hard capsules: Hard gelatin capsules, size 1, with an opaque white body and cap, filled with white to dark white microgranules.
Blister packs of 28 hard capsules.

Marketing Authorization Holder
Scharper S.p.A.
Viale Ortles, 12 – 20139 Milano, Italy

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