Carditrat

Leaflet accompanying the packaging: patient information

Carditrat, 8 mg + 5 mg, hard capsules

Carditrat, 8 mg + 10 mg, hard capsules

Carditrat, 16 mg + 5 mg, hard capsules

Carditrat, 16 mg + 10 mg, hard capsules

candesartan cilexetil + amlodipine

You should carefully read the contents of this leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so you can read it again if you need to.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Carditrat and what is it used for
• 2. Important information before taking Carditrat
• 3. How to take Carditrat
• 4. Possible side effects
• 5. How to store Carditrat
• 6. Contents of the packaging and other information

1. What is Carditrat and what is it used for

Carditrat contains two active substances called amlodipine and candesartan. Both of these substances help control high blood pressure.
Amlodipine belongs to a group of substances known as "calcium channel blockers". Amlodipine prevents calcium from entering the walls of blood vessels, which inhibits the constriction of blood vessels.
Candesartan belongs to a group of substances known as "angiotensin II receptor antagonists".
Angiotensin II is produced by the body and causes blood vessels to constrict, thereby increasing arterial blood pressure. The action of candesartan involves blocking the action of angiotensin II.
Both of these substances help to inhibit the constriction of blood vessels. As a result, blood vessels relax, and arterial blood pressure decreases.
Carditrat is used to treat high blood pressure in patients whose blood pressure is already adequately controlled by taking candesartan and amlodipine separately, in the same doses as in Carditrat.

2. Important information before taking Carditrat

When not to take Carditrat

• if you are allergic to amlodipine or to any other calcium channel blockers, to candesartan cilexetil or to any of the other ingredients of this medicine (listed in section 6)
• if you have very low blood pressure (hypotension)
• if you have a narrowing of the aortic valve in the heart (aortic stenosis) or cardiogenic shock (a condition where the heart is unable to supply the body with enough blood)
• if you have heart failure after a heart attack
• if you are more than 3 months pregnant (see "Pregnancy and breastfeeding")
• if you have severe liver disease or biliary obstruction (disorders of bile flow from the gallbladder)
• if you are taking aliskiren-containing products and have diabetes or kidney problems (glomerular filtration rate, GFR <60 ml min 1.73 m2).< li>

Warnings and precautions

Before taking Carditrat, you should discuss it with your doctor or pharmacist if:

• you have recently had a heart attack
• you have heart failure
• you have a significant increase in blood pressure (hypertensive crisis)
• you have low blood pressure (hypotension)
• you are elderly and require a dose increase
• you have liver or kidney problems, or are undergoing dialysis
• you have recently had a kidney transplant
• you are vomiting, have recently had severe vomiting, or have diarrhea
• you have adrenal gland disease, known as Conn's syndrome (also known as primary hyperaldosteronism)
• you have had a stroke
• you are taking any of the following medicines for high blood pressure:
• ACE inhibitors (such as enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes,
• aliskiren.

Your doctor may regularly check your kidney function, blood pressure, and electrolyte levels (e.g., potassium) in your blood.
See also the information under the heading "When not to take Carditrat".
If you have any of these conditions, your doctor may recommend more frequent visits for certain tests.
If you are going to have surgery, you should inform your doctor or dentist that you are taking Carditrat. This is important because Carditrat, when used with certain anesthetics, may cause excessive lowering of blood pressure.
You should inform your doctor if you are pregnant or think you may be pregnant. It is not recommended to take Carditrat during early pregnancy and it should not be taken after the 3rd month of pregnancy, as it may seriously harm the baby (see "Pregnancy and breastfeeding").
If you experience abdominal pain, nausea, vomiting, or diarrhea after taking Carditrat, you should discuss it with your doctor. The doctor will decide on further treatment. Do not stop taking Carditrat on your own.

Children and adolescents

There is no experience with the use of Carditrat in children (under 18 years of age).
Therefore, the medicine should not be used in children and adolescents.

Carditrat and other medicines

You should tell your doctor or pharmacist about all the medicines you are taking, or have recently taken, and about any medicines you plan to take.
Carditrat may affect other medicines or other medicines may affect it:

• ketokonazole, itraconazole (antifungal medicines)
• ritonavir, indinavir, nelfinavir (protease inhibitors used to treat HIV infection)
• rifampicin, erythromycin, clarithromycin (antibiotics)
• St. John's wort (Hypericum perforatum)
• verapamil, diltiazem (heart medicines)
• dantrolene (intravenous infusion used in severe body temperature disorders)
• simvastatin (a medicine that lowers cholesterol levels)
• other medicines that help lower blood pressure, including beta-blockers, diazoxide, and ACE inhibitors (such as enalapril, captopril, lisinopril, or ramipril) or aliskiren (see also the information under the heading "When not to take Carditrat" and "Warnings and precautions").
• non-steroidal anti-inflammatory medicines (NSAIDs), such as ibuprofen, naproxen, diclofenac, celecoxib, or etoricoxib (medicines that relieve pain and inflammation)
• acetylsalicylic acid (a pain-relieving and anti-inflammatory medicine), if you are taking a dose greater than 3 g per day.
• potassium supplements or potassium-containing salt substitutes (medicines that increase potassium levels in the blood)
• heparin (a blood thinner)
• diuretic capsules (diuretics)
• lithium (a medicine used to treat mental disorders)
• tacrolimus, sirolimus, temsirolimus, and everolimus (used to control the body's immune response, allowing the body to accept a transplanted organ),
• cyclosporine (an immunosuppressive medicine used mainly after organ transplantation to prevent rejection of the transplanted organ).

Taking Carditrat with food and drink

While taking Carditrat, you should not consume grapefruit juice or grapefruit.
Grapefruit and grapefruit juice may lead to increased levels of the active substance amlodipine in the blood, which may cause unpredictable intensification of the hypotensive effect of Carditrat.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
You should inform your doctor if you are pregnant or think you may be pregnant. Usually, your doctor will advise you to stop taking Carditrat before planned pregnancy or as soon as possible after finding out that you are pregnant and will prescribe another medicine instead of Carditrat.
Carditrat should not be taken during early pregnancy and should not be taken after the 3rd month of pregnancy, as it may seriously harm the baby (see "Pregnancy and breastfeeding").
Breastfeeding
It has been shown that small amounts of amlodipine pass into breast milk.
You should inform your doctor if you are breastfeeding or plan to breastfeed. It is not recommended to take Carditrat while breastfeeding, and if you want to breastfeed, your doctor may choose another treatment method, especially if the baby is a newborn or premature.

Driving and using machines

Carditrat may have a moderate influence on the ability to drive and use machines. If the capsules cause nausea, dizziness, or fatigue, or headache, do not drive or operate machinery and contact your doctor immediately.

Carditrat contains lactose monohydrate

If you have been told that you have an intolerance to some sugars, you should contact your doctor before taking this medicine.

3. How to take Carditrat

This medicine should always be taken exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Usually, the recommended dose is one capsule per day.
Patients taking candesartan and amlodipine as separate medicines may instead receive Carditrat capsules containing the same doses of the active substances.

Take more Carditrat than prescribed

Taking too many capsules may cause a decrease or even a dangerous decrease in blood pressure. You may experience dizziness, fainting, or weakness. If the blood pressure drop is significant, it may lead to shock.
Your skin may become cool and moist, and you may lose consciousness. Excess fluid may accumulate in the lungs (pulmonary edema), causing shortness of breath, which may occur within 24-48 hours after taking the medicine. If you have taken too many capsules, seek medical help immediately.

Miss a dose of Carditrat

If you miss a capsule, skip it completely. Take the next dose at the right time. Do not take a double dose to make up for the missed dose.

Stop taking Carditrat

Your doctor will tell you how long to take the medicine. If you stop taking the medicine before getting the doctor's advice, your condition may worsen. Therefore, do not stop taking Carditrat without consulting your doctor first.
If you have any further questions about taking 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.
You should stop taking Carditrat and seek medical help immediately if you experience any of the following symptoms:

• sudden wheezing, chest pain, shortness of breath, or difficulty breathing
• swelling of the eyelids, face, or lips
• swelling of the tongue and throat, causing severe breathing difficulties
• severe skin reactions, including intense skin rash, hives, redness of the skin all over the body, severe itching, blistering, peeling, and swelling of the skin, inflammation of the mucous membranes (Stevens-Johnson syndrome) or other allergic reactions
• heart attack, irregular heartbeat
• pancreatitis, which can cause severe abdominal and back pain, accompanied by a very poor general condition.

Candesartan may cause a decrease in white blood cell count. This may lead to decreased resistance to infections, and you may experience fatigue, infection, or fever. In such cases, you should contact your doctor. Your doctor may recommend periodic blood tests to check if Carditrat has affected your blood (agranulocytosis).

Other possible side effects:

Since Carditrat is a combination of two active substances, the reported side effects are related to the use of amlodipine or candesartan.

Side effects related to the use of amlodipine

The following side effects have been reported: If any of these persist or worsen, you should inform your doctor.
Very common: may affect more than 1 in 10 people

• swelling around the ankles (edema)

Common: may affect up to 1 in 10 people

• headache, dizziness, drowsiness (especially at the beginning of treatment)
• palpitations (feeling of heartbeat), hot flashes
• abdominal pain, nausea (nausea)
• change in bowel movements, diarrhea, constipation, indigestion,
• feeling of fatigue, weakness
• vision disturbances, double vision
• muscle cramps

Uncommon: may affect up to 1 in 100 people

• mood changes, anxiety, depression, insomnia
• tremors, taste disturbances, fainting
• numbness or tingling in the limbs, loss of pain sensation
• ringing in the ears
• low blood pressure
• rhinitis (hay fever)
• cough
• dry mouth, vomiting
• hair loss, excessive sweating, itching, red spots on the skin, skin discoloration
• urination disorders, increased need to urinate at night, increased frequency of urination
• impotence, discomfort, or enlargement of the breasts in men
• pain, poor general condition
• joint or muscle pain, back pain
• weight gain or loss

Rare: may affect up to 1 in 1,000 people

• disorientation

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

• decrease in white blood cell count, decrease in platelet count, which may lead to unusual bruising or bleeding
• high blood sugar levels (hyperglycemia)
• nerve damage, which may cause weakness, numbness, or tingling
• gum swelling
• abdominal bloating (gastritis)
• abnormal liver function, liver inflammation (hepatitis), yellowing of the skin (jaundice), increased liver enzyme activity, which may affect some medical test results
• increased muscle tension
• blood vessel inflammation, often with accompanying skin rash
• sensitivity to light
• disorders, including muscle stiffness, tremors, and (or) movement disorders

Frequency not known: cannot be estimated from the available data

• tremors, stiff posture, mask-like face, slow movements, and dragging of the feet when walking, unsteady gait, toxic epidermal necrolysis.

Side effects related to the use of candesartan

Common (may affect up to 1 in 10 people):

• dizziness/vertigo
• headache
• respiratory tract infection
• low blood pressure - may cause fainting or dizziness
• changes in blood test results:
• increased potassium levels in the blood, especially if you have kidney problems or heart failure - if the increase is significant, you may experience fatigue, weakness, irregular heartbeat, or tingling
• effect on kidney function, especially if you have pre-existing kidney disease or heart failure. In very rare cases, kidney failure may occur.

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

• swelling of the face, lips, tongue, and (or) throat
• decrease in red or white blood cell count - may cause fatigue, infection, or fever
• skin rash, papular rash (hives)
• itching
• back pain, joint or muscle pain
• changes in liver function, including liver inflammation (hepatitis) - may cause fatigue, yellowing of the skin and whites of the eyes, and flu-like symptoms
• cough
• nausea
• changes in blood test results:
• decrease in sodium levels in the blood - if significant, may cause weakness, lack of energy, or painful muscle cramps
• gastrointestinal angioedema: swelling in the intestine with symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Frequency not known (frequency cannot be estimated from the available data):

• diarrhea

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
PL-02 222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Carditrat

The medicine should be stored out of sight and reach of children.
There are no special storage instructions for the medicine.
Do not use this medicine after the expiry date stated on the carton/blisters after EXP.
The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Carditrat contains

• The active substances of the medicine are amlodipine and candesartan cilexetil.

Carditrat, 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.
Carditrat, 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.
Carditrat, 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.
Carditrat, 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: lactose monohydrate, cornstarch, calcium carmellose, macrogol, hydroxypropylcellulose, magnesium stearate.

Capsule shell (8 mg + 5 mg, 8 mg + 10 mg): quinoline yellow (E 104), yellow iron oxide (E 172), titanium dioxide (E 171), gelatin
Capsule shell (16 mg + 5 mg): quinoline yellow (E 104), titanium dioxide (E 171), gelatin
Capsule shell (16 mg + 10 mg): titanium dioxide (E 171), gelatin
Ink (8 mg + 10 mg, 16 mg + 5 mg): shellac (E 904), black iron oxide (E 172), propylene glycol, concentrated ammonia, potassium hydroxide

What Carditrat looks like and contents of the pack

Carditrat, 8 mg + 5 mg, hard capsules: hard gelatin capsules, size 3, white opaque body, dark yellow cap, filled with white or almost white granules.
Carditrat, 8 mg + 10 mg, hard capsules: hard gelatin capsules, size 1, white opaque body with black print CAN 8, yellow cap with black print AML 10, filled with white or almost white granules.
Carditrat, 16 mg + 5 mg, hard capsules: hard gelatin capsules, size 1, white opaque body with black print CAN 16, light yellow cap with black print AML 5, filled with white or almost white granules.
Carditrat, 16 mg + 10 mg, hard capsules: hard gelatin capsules, size 1, white opaque body, white opaque cap, filled with white or almost white granules.
Pack sizes: 14, 28, 30, 56, 60, 90, 98, 100 hard capsules.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder
Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A.
14 km National Road 1
GR-145 64 Kifisia
Phone: +30 2108072512
Greece
Manufacturer

• 1) Adamed Pharma S.A. ul. Marszałka Józefa Piłsudskiego 5 95-200 Pabianice, Poland
• 2) Adamed Pharma S.A. ul. Szkolna 33 95-054 Ksawerów Poland

This medicine is authorized in the Member States of the European Economic Area under the following names:

Poland: Carditrat
Greece: Carditrat
Cyprus: Carditrat 8 mg + 5 mg capsules, hard
Carditrat 8 mg + 10 mg capsules, hard
Carditrat 16 mg + 5 mg capsules, hard
Carditrat 16 mg + 10 mg capsules, hard

Date of last revision of the leaflet: