Carditrat

Package leaflet: Information for the patient

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
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 further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. 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 any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents

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

1. What Carditrat is and what it is 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 medicines known as "calcium channel blockers". Amlodipine prevents calcium from entering the walls of blood vessels, which helps prevent blood vessel constriction.
Candesartan belongs to a group of medicines known as "angiotensin II receptor antagonists". Angiotensin II is a substance produced by the body that causes blood vessels to constrict, thereby increasing blood pressure. Candesartan works by blocking the effects of angiotensin II.
Both substances help relax blood vessels. As a result, blood vessels dilate and blood pressure is lowered.
Carditrat is used to treat high blood pressure in patients whose blood pressure is already adequately controlled by taking candesartan and amlodipine separately at the same doses as those contained in Carditrat.

2. Important information before using Carditrat

When not to take Carditrat

• if the patient is allergic to amlodipine or to any other medicines in the group of calcium channel blockers, to candesartan cilexetil, or to any of the other components of this medicine (listed in section 6)
• if the patient has very low blood pressure (hypotension)
• if the patient has narrowing of the aortic valve in the heart (aortic stenosis) or cardiogenic shock (a condition in which the patient's heart is unable to supply sufficient blood to the body)
• if the patient has heart failure following a previous heart attack
• if the patient is in the third month or later of pregnancy (see section "Pregnancy and breastfeeding")
• if the patient has severe liver disease or biliary obstruction (impaired bile flow from the gallbladder)
• concomitant use with products containing aliskiren is contraindicated in patients with diabetes or renal impairment (glomerular filtration rate, GFR <60 ml/min/1.73 m²).

Warnings and precautions
Before starting treatment with Carditrat, consult your doctor or pharmacist if:

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

The doctor may regularly monitor kidney function, blood pressure, and blood levels of electrolytes (e.g. potassium).
See also information under the heading "When not to take Carditrat".
If any of the conditions listed above apply, the doctor may recommend more frequent visits for monitoring and tests.
If the patient is to undergo surgery, inform the doctor or dentist about taking Carditrat. This is important because Carditrat, when used together with certain anaesthetics, may cause excessive lowering of blood pressure.
Inform the doctor if the patient suspects she is pregnant or may become pregnant. Use of Carditrat is not recommended during early pregnancy and must not be used after the third month of pregnancy, as it may seriously harm the unborn child (see section "Pregnancy and breastfeeding").
If the patient experiences abdominal pain, nausea, vomiting, or diarrhoea after taking Carditrat, discuss this with the 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, Carditrat should not be used in children and adolescents.

Carditrat with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
Carditrat may affect or be affected by the following medicines:

• ketoconazole, itraconazole (antifungal medicines)
• ritonavir, indinavir, nelfinavir (protease inhibitors used in the treatment of HIV infection)
• rifampicin, erythromycin, clarithromycin (antibiotics)
• St John's wort (Hypericum perforatum)
• verapamil, diltiazem (heart medicines)
• dantrolene (intravenous infusion used in serious disturbances of body temperature)
• simvastatin (a medicine that lowers cholesterol levels)
• other medicines used to lower blood pressure, including beta-blockers, diazoxide, and ACE inhibitors (such as enalapril, captopril, lisinopril or ramipril) or aliskiren (see also information under the headings "When not to use 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 (pain-relieving and anti-inflammatory medicine) if the patient is taking doses greater than 3 g per day
• potassium supplements or potassium-containing salt substitutes (medicines that increase blood potassium levels)
• heparin (a blood-thinning medicine)
• diuretic capsules (water tablets)
• lithium (a medicine used to treat psychiatric disorders)
• tacrolimus, sirolimus, temsirolimus and everolimus (used to control the immune system response, allowing acceptance of a transplanted organ)
• cyclosporine (an immunosuppressive medicine mainly used after organ transplantation to prevent organ rejection)

Taking Carditrat with food and drink
Do not consume grapefruit juice or grapefruit while taking Carditrat.
Grapefruit and grapefruit juice may increase blood levels of the active substance amlodipine, which could lead to an unpredictable intensification of the blood pressure-lowering effect of Carditrat.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.

Pregnancy
Inform the doctor if the patient suspects she is pregnant or may become pregnant. Usually, the doctor will recommend stopping Carditrat before planning a pregnancy or immediately after pregnancy is confirmed, and will prescribe an alternative medicine.
Use of Carditrat is not recommended during early pregnancy and must not be used after the third month of pregnancy, as it may seriously harm the unborn child if taken after the third month of pregnancy.

Breastfeeding
Small amounts of amlodipine have been shown to pass into breast milk.
Inform the doctor if the patient is breastfeeding or intends to breastfeed. Use of Carditrat is not recommended in breastfeeding mothers. If the patient wishes to breastfeed, the doctor may choose an alternative treatment, especially if the baby is a newborn or premature.

Driving and using machines
Carditrat may have a moderate effect on the ability to drive and use machines. If the capsules cause nausea, dizziness, fatigue, or headache, the patient should not drive or operate machinery and should contact the doctor immediately.

Carditrat contains lactose monohydrate
If the patient has been previously diagnosed with intolerance to certain sugars, consult the doctor before taking this medicine.

3. How to take Carditrat
Always take this medicine exactly as prescribed by the doctor or pharmacist. In case of doubt, consult the doctor or pharmacist.
The usual dose is one capsule daily.
Patients currently taking candesartan and amlodipine as separate medicines may instead receive Carditrat capsules containing the same doses of the components.

Taking more Carditrat than recommended
Taking too many capsules may cause lowering or even dangerously low blood pressure. The patient may experience dizziness, lightheadedness, fainting, or weakness. If blood pressure drops significantly, shock may occur.
The skin may become cold and clammy, and the patient may lose consciousness. Excess fluid may accumulate in the lungs (pulmonary oedema), causing breathlessness, which may occur within 24–48 hours after taking the medicine. If too many capsules have been taken, seek immediate medical help.

Missing a dose of Carditrat
If a dose is missed, skip that dose completely. Take the next dose at the usual time. Do not take a double dose to make up for the missed dose.

Stopping Carditrat
The doctor will advise the patient on how long to continue taking the medicine. If the patient stops taking Carditrat before receiving appropriate advice, the condition may return. Therefore, do not stop taking Carditrat without first consulting the doctor.
If you have any further questions about using this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Treatment with Carditrat should be discontinued and immediate medical help sought if the patient experiences 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 significant breathing difficulties
• severe skin reactions, including intense skin rash, urticaria, redness of the skin all over the body, severe itching, blistering, peeling and swelling of the skin, mucosal inflammation (Stevens-Johnson syndrome) or other allergic reactions
• heart attack, irregular heartbeat
• pancreatitis, which may cause severe abdominal and back pain accompanied by a very poor general condition.

Candesartan may cause a decrease in the number of white blood cells. This may reduce resistance to infections, and the patient may experience fatigue, infections or fever. In such a case, contact a doctor. The doctor may recommend periodic blood tests to check whether Carditrat has affected the patient's blood (agranulocytosis).
Other possible adverse reactions:
Since Carditrat is a combination of two active substances, reported adverse reactions are associated with the use of amlodipine or candesartan.
Adverse reactions associated with amlodipine use
The following adverse reactions have been reported: If any of them cause discomfort to the patient or persist for longer than one week, contact a 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 (awareness of heartbeat), hot flushes
• abdominal pain, nausea
• changes in bowel rhythm, diarrhea, constipation, dyspepsia
• feeling of fatigue, weakness
• visual disturbances, double vision
• muscle cramps

Uncommon: may affect up to 1 in 100 people

• mood changes, anxiety, depression, insomnia
• tremor, taste disturbances, fainting
• sensation of numbness or tingling in the limbs, loss of pain sensation
• ringing in the ears
• low blood pressure
• sneezing/runny nose due to inflammation of the nasal mucosa (rhinitis)
• cough
• dry mouth, vomiting
• hair loss, excessive sweating, itching, red spots on the skin, skin discoloration
• urinary disorders, increased need to urinate at night, increased frequency of urination
• inability to achieve erection, discomfort or enlargement of the breasts in men
• pain, malaise
• joint or muscle pain, back pain
• increase or decrease in body weight

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

• disorientation

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

• decrease in the number of white blood cells, decrease in the number of platelets, which may lead to unusual bruising or easier bleeding
• excessively high blood sugar levels (hyperglycaemia)
• nerve disorder, which may cause weakness, tingling or numbness
• gum swelling
• abdominal bloating (dyspepsia)
• abnormal liver function, inflammatory liver disease (hepatitis), yellowing of the skin (jaundice), increased liver enzyme activity, which may affect certain medical test results
• increased muscle tension
• vasculitis, often accompanied by skin rash
• photosensitivity
• movement disorders, including muscle stiffness, tremor and/or motor disturbances

Frequency unknown: frequency cannot be estimated from available data

• tremor, rigid posture, mask-like facial expression, slowed movements and shuffling gait, unbalanced gait, toxic epidermal necrolysis.

Adverse reactions associated with candesartan use
Common (may affect up to 1 in 10 people):

• dizziness/spinning sensation
• 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 dysfunction or heart failure – in case of significant increase, 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 the number of red or white blood cells – fatigue, infection or fever may occur
• skin rash, nodular rash (urticaria)
• itching
• back pain, joint and muscle pain
• changes in liver function, including inflammatory liver disease (hepatitis) – fatigue, yellowing of the skin and whites of the eyes, and flu-like symptoms may occur
• cough
• nausea
• changes in blood test results:
  • decreased sodium levels in the blood – if this is significant, weakness, lack of energy or painful muscle cramps may occur
• angioedema of the intestine: swelling in the intestine with symptoms such as abdominal pain, nausea, vomiting and diarrhea.

Frequency unknown (frequency cannot be determined from available data):

• diarrhea

Reporting of adverse reactions
If the patient experiences any adverse symptoms, including any adverse symptoms not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
PL-02 222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions allows more information on the safety of the medicine to be collected.

5. How to store Carditrat

Keep this medicine out of sight and reach of children.
No special storage instructions apply to this medicine.
Do not use this medicine after the expiry date stated on the carton/blister indicated by the abbreviation EXP.
The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the package and other information

What Carditrat contains

• The active substances in this 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, maize 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
Printing ink (8 mg + 10 mg, 16 mg + 5 mg): shellac (E 904), iron oxide black (E 172), propylene glycol, concentrated ammonium hydroxide, potassium hydroxide

What Carditrat looks like and contents of the pack
Carditrat 8 mg + 5 mg, hard capsules: hard gelatin capsules, size 3, with white opaque body and dark yellow cap, filled with white or almost white granules.
Carditrat 8 mg + 10 mg, hard capsules: hard gelatin capsules, size 1, with white opaque body printed in black with "CAN 8", yellow cap printed in black with "AML 10", filled with white or almost white granules.
Carditrat 16 mg + 5 mg, hard capsules: hard gelatin capsules, size 1, with white opaque body printed in black with "CAN 16", light yellow cap printed in black with "AML 5", filled with white or almost white granules.
Carditrat 16 mg + 10 mg, hard capsules: hard gelatin capsules, size 1, with white opaque body and 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 Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A.
14 km National Road 1
GR-145 64 Kifisia
Tel: +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 authorised for sale in 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