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 and amlodipine

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their 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 called "calcium channel blockers". Amlodipine prevents calcium from entering the blood vessel walls, which inhibits the constriction of blood vessels.
Candesartan belongs to a group of substances called "angiotensin II receptor antagonists".
Angiotensin II is produced by the body and causes blood vessels to constrict, thereby increasing blood pressure. Candesartan works by blocking the action of angiotensin II.
Both substances help to inhibit the constriction of blood vessels. As a result, blood vessels relax, and 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

• concomitant use with aliskiren-containing products is contraindicated in patients with diabetes or renal impairment (glomerular filtration rate, GFR <60 ml min 1.73 m²).< li>

Warnings and precautions

Before starting to take Carditrat, the patient should discuss it with their doctor or pharmacist if:

• the patient has recently had a heart attack
• the patient has heart failure
• the patient has experienced a sudden increase in blood pressure (hypertensive crisis)
• the patient has low blood pressure (hypotension)
• the patient is elderly and requires a dose increase
• the patient has liver or kidney problems, or is undergoing dialysis
• the patient has recently had a kidney transplant
• the patient is vomiting, has recently had severe vomiting, or has diarrhea
• the patient has adrenal gland disease, called Conn's syndrome (also known as primary hyperaldosteronism)
• the patient has had a stroke
• the patient is taking any of the following medicines for high blood pressure:
• ACE inhibitor (e.g. enalapril, lisinopril, ramipril), especially if the patient has kidney problems related to diabetes,
• aliskiren.

The doctor may regularly check the patient's kidney function, blood pressure, and electrolyte levels (e.g. potassium) in the blood.
See also the information under the heading "When not to take Carditrat".
If the patient has any of these conditions, the doctor may recommend more frequent visits for certain tests.
If the patient is to undergo surgery, they should inform their doctor or dentist that they are taking Carditrat. This is important because Carditrat, when used with certain anesthetics, may cause excessive lowering of blood pressure.
The patient should inform their doctor if they suspect they are pregnant or may become 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 the patient experiences stomach pain, nausea, vomiting, or diarrhea after taking Carditrat, they should discuss it with their doctor. The doctor will decide on further treatment. The patient should not stop taking Carditrat on their 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

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Carditrat may affect other medicines or other medicines may affect it:

• ketokonazole, itraconazole (antifungal medicines)
• ritonavir, indinavir, nelfinavir (so-called 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 drugs (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 the patient takes a dose greater than 3 g per day.
• potassium supplements or salt substitutes containing potassium (medicines that increase potassium levels in the blood)
• heparin (a blood-thinning medicine)
• 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),
• cyclosporin (an immunosuppressive medicine used mainly after organ transplantation to prevent rejection of the transplanted organ).

Taking Carditrat with food and drink

While taking Carditrat, the patient 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 blood pressure-lowering effect of Carditrat.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine.
Pregnancy
The patient should inform their doctor if they suspect they are pregnant or may become pregnant. Usually, the doctor will advise the patient to stop taking Carditrat before planned pregnancy or as soon as pregnancy is confirmed 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").
If the patient becomes pregnant while taking Carditrat, they should inform their doctor immediately.
Breastfeeding
It has been shown that small amounts of amlodipine pass into breast milk.
The patient should tell their doctor if they are breastfeeding or plan to breastfeed. It is not recommended to take Carditrat while breastfeeding, and if the patient wants to breastfeed, the 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, the patient should not drive or operate machinery and should contact their doctor immediately.

Carditrat contains lactose monohydrate

If the patient has been diagnosed with an intolerance to some sugars, they should contact their doctor before taking the medicine.

3. How to take Carditrat

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. In case of doubt, the patient should consult their 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.

Overdose of Carditrat

Taking too many capsules may cause a decrease or even a dangerous decrease in blood pressure. The patient may experience dizziness, fainting, or weakness. If the blood pressure drop is significant, it may lead to shock.
The skin may become cold and wet, and the patient 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.
In case of an overdose, the patient should seek medical help immediately.

Missed dose of Carditrat

If the patient misses a capsule, they should skip that dose and take the next dose at the right time. The patient should not take a double dose to make up for the missed dose.

Stopping treatment with Carditrat

The doctor will inform the patient how long they should take the medicine. If the patient stops taking the medicine before receiving the doctor's advice, their condition may worsen. Therefore, the patient should not stop taking Carditrat without consulting their doctor first.
In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Carditrat can cause side effects, although not everybody gets them.
The patient should stop taking Carditrat and seek medical help immediately if they 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, and skin peeling, Stevens-Johnson syndrome, or other allergic reactions
• heart attack, irregular heartbeat
• pancreatitis, which may cause severe stomach 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 immunity to infections, and the patient may observe fatigue, infection, or fever. In such a situation, the patient should contact their doctor. The doctor may recommend periodic blood tests to check if Carditrat has affected the patient's 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 cause the patient discomfort or persist for more than a week, they should consult their 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
• stomach 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
• feeling of 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, skin rash, 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 1000 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 easier 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 the patient has kidney problems or heart failure - if the increase is significant, the patient may experience fatigue, weakness, irregular heartbeat, or tingling
• effect on kidney function, especially if the patient already has 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, urticaria (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 spasms
• gastrointestinal angioedema: swelling in the intestine with symptoms such as stomach pain, nausea, vomiting, and diarrhea.

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

• diarrhea

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration 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, more information can be collected on the safety of the medicine.

5. How to store Carditrat

The medicine should be stored out of sight and reach of children.
There are no special precautions for storing 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. The patient should ask their pharmacist how to dispose of medicines they no longer use. 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, which corresponds 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, which corresponds 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, which corresponds 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, which corresponds to 13.87 mg of amlodipine besylate.

• Other ingredients are: lactose monohydrate, corn starch, calcium carmellose, macrogol, hydroxypropylcellulose, magnesium stearate.

Capsule shell (8 mg + 5 mg, 8 mg + 10 mg): quinoline yellow (E 104), iron oxide yellow (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), iron oxide black (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 granulate.
Carditrat, 8 mg + 10 mg, hard capsules: hard gelatin capsules, size 1, white opaque body with black printing CAN 8, yellow cap with black printing AML 10, filled with white or almost white granulate.
Carditrat, 16 mg + 5 mg, hard capsules: hard gelatin capsules, size 1, white opaque body with black printing CAN 16, light yellow cap with black printing AML 5, filled with white or almost white granulate.
Carditrat, 16 mg + 10 mg, hard capsules: hard gelatin capsules, size 1, white opaque body, white opaque cap, filled with white or almost white granulate.
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: