Caramlo

Package Leaflet: Information for the Patient

Caramlo, 16 mg + 5 mg, Tablets

Candesartan cilexetil + Amlodipine

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, 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 tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Caramlo and what is it used for

Caramlo contains two active substances: candesartan and amlodipine. Both of these substances help to lower high blood pressure.

• Amlodipine belongs to a group of substances known as calcium antagonists. Amlodipine inhibits the entry of calcium into 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 in the body and causes blood vessels to constrict, thereby increasing blood pressure. Candesartan works by blocking the action of angiotensin II. This means that both substances help to prevent blood vessels from constricting. As a result, blood vessels relax and blood pressure is lowered.

Caramlo is used to treat high blood pressure in patients whose blood pressure is already adequately controlled with candesartan and amlodipine in separate tablets, in the same doses as in Caramlo.

2. Important information before taking Caramlo

When not to take Caramlo

• if you are allergic to amlodipine or other calcium antagonists, candesartan cilexetil or any of the other ingredients of this medicine (listed in section 6);
• if you have severely low blood pressure (hypotension);
• if you have narrowing of the aortic valve in the heart (aortic stenosis) or cardiogenic shock (a condition where the heart is unable to supply enough blood to the body);
• if you have heart failure after a heart attack;
• if you are more than 3 months pregnant (it is also recommended to avoid taking Caramlo in early pregnancy - see section "Pregnancy and breastfeeding");
• if you have severe liver disease or biliary obstruction (obstruction of the bile ducts);
• if you have diabetes or kidney problems and are being treated with a blood pressure-lowering medicine containing aliskiren.

Warnings and precautions

Before taking Caramlo, tell your doctor or pharmacist if you have or have had any of the following conditions:

• recent heart attack;
• heart failure;
• a sudden increase in blood pressure (hypertensive crisis);
• low blood pressure (hypotension);
• if an increase in dose is necessary and you are elderly;
• liver or kidney problems, or if you are on dialysis;
• if you have recently had a kidney transplant;
• if you are vomiting, have recently had severe vomiting or have diarrhea;
• if you have a disease of the adrenal glands called Conn's syndrome (also known as primary hyperaldosteronism);
• if you have ever had a stroke;
• if you are to receive an anesthetic. Such an anesthetic may be used for an operation or dental treatment;
• if you are taking any of the following medicines for high blood pressure:
• ACE inhibitor (e.g. enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes;
• aliskiren.

Your doctor may recommend regular monitoring of kidney function, blood pressure, and electrolyte levels (e.g. potassium) in the blood. See also section "When not to take Caramlo". If you experience stomach pain, nausea, vomiting, or diarrhea after taking Caramlo, you should discuss this with your doctor. Your doctor will decide on further treatment. Do not stop taking Caramlo on your own. If you are pregnant or think you may be pregnant (or are planning to have a baby), you should tell your doctor. Your doctor will usually recommend stopping Caramlo before planned pregnancy or as soon as possible after becoming pregnant and will recommend another medicine instead of Caramlo. Caramlo is not recommended in early pregnancy and must not be taken after the 3rd month of pregnancy, as it may cause serious harm to the baby if taken after the 3rd month of pregnancy.

Children and adolescents

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

Caramlo and other medicines

Tell your doctor or pharmacist about all the medicines you are taking now or have recently taken, as well as any medicines you plan to take. Caramlo may affect the action of other medicines, and other medicines may affect the action of Caramlo. Your doctor may recommend a change in dose and/or take other precautions if you are taking any of the following medicines:

• ketokonazole, itraconazole (antifungal medicines);
• ritonavir, indinavir, nelfinavir (protease inhibitors used to treat HIV infection);
• rifampicin, erythromycin, clarithromycin (antibiotics used to treat bacterial infections);
• St. John's Wort (Hypericum perforatum);
• verapamil, diltiazem (medicines used to treat heart conditions);
• dantrolene (intravenous infusion in severe disturbances of body temperature);
• tacrolimus, sirolimus, temsirolimus, and everolimus (used to limit the body's immune response, allowing the body to accept a transplanted organ);
• simvastatin (a medicine that lowers cholesterol levels);
• cyclosporin (an immunosuppressive medicine);
• other medicines that help lower blood pressure, including beta-blockers and diazoxide;
• ACE inhibitor or aliskiren (see also sections "When not to take Caramlo" and "Warnings and precautions");
• non-steroidal anti-inflammatory medicines (NSAIDs), such as ibuprofen, naproxen, diclofenac, celecoxib, or etoricoxib (medicines used to reduce pain and inflammation);
• acetylsalicylic acid (a medicine used to reduce pain and inflammation), in doses greater than 3 g per day;
• potassium supplements or salt substitutes containing potassium (medicines that increase potassium levels in the blood);
• heparin (a medicine that "thins" the blood);
• co-trimoxazole (an antibiotic), which is a combination of trimethoprim and sulfamethoxazole;
• diuretics (medicines that increase urine production);
• lithium (a medicine used to treat mental disorders).

Taking Caramlo with food and drink

Do not drink grapefruit juice or eat grapefruits while taking Caramlo. Grapefruits and grapefruit juice can lead to increased levels of the active ingredient amlodipine in the blood, which can cause unpredictable increases in the blood pressure-lowering effect of Caramlo.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Pregnancy You must tell your doctor if you think you may be pregnant (or are planning to have a baby). Your doctor will usually recommend stopping Caramlo before planned pregnancy or as soon as possible after becoming pregnant and will recommend another medicine instead of Caramlo. Caramlo is not recommended in early pregnancy and must not be taken after the 3rd month of pregnancy, as it may cause serious harm to the baby if taken after the 3rd month of pregnancy. Breastfeeding It has been shown that small amounts of amlodipine pass into human milk. If you are breastfeeding or plan to breastfeed, you should tell your doctor before taking Caramlo. Caramlo is not recommended for breastfeeding women, and if a woman wishes to breastfeed, the doctor may choose another treatment, especially in the case of breastfeeding a newborn or premature baby.

Driving and using machines

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

Caramlo contains lactose monohydrate

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

3. How to take Caramlo

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist. The recommended dose of Caramlo is 1 tablet per day. Caramlo can be taken with or without food.

Taking a higher dose of Caramlo than recommended

Taking too many tablets can cause your blood pressure to become too low or even dangerously low. You may feel dizzy, faint, or weak. If the drop in blood pressure is very large, it can lead to shock. Your skin may become cool and moist, and you may lose consciousness. Even up to 24-48 hours after taking the medicine, shortness of breath due to excess fluid accumulation in the lungs (pulmonary edema) may occur. If you have taken too many tablets, contact a doctor or hospital immediately.

Missing a dose of Caramlo

If you forget to take a tablet, skip that dose completely. Take the next dose at the right time. Do not take a double dose to make up for a forgotten dose.

Stopping treatment with Caramlo

Your doctor will tell you how long to take Caramlo. Stopping treatment may cause your symptoms to return. Therefore, do not stop taking Caramlo without first talking to your doctor. If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Caramlo can cause side effects, although not everybody gets them. You should immediatelysee a doctor if you experience any of the following very rare, serious side effects (may affect up to 1 in 10,000 people):

• sudden, wheezing cough, chest pain, shortness of breath, or difficulty breathing;
• swelling of the eyelids, face, or lips;
• swelling of the tongue and throat, causing great difficulty in breathing;
• severe skin reactions, including severe rash, hives, redness of the skin all over the body, severe itching, blistering, and peeling of the skin, inflammation of the mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions;
• heart attack, irregular heartbeat;
• pancreatitis, which can cause severe stomach and back pain, with very poor general health.

Candesartan may cause a decrease in the number of white blood cells. Your resistance to infections may be reduced, and you may notice symptoms such as fatigue, infection, or fever. You should then contact your doctor. Your doctor may order periodic blood tests to check if Caramlo is affecting your blood (agranulocytosis). Other possible side effects: Since Caramlo consists of two active substances, the side effects reported are related to the use of amlodipine or candesartan.

Side effects related to the use of amlodipine

Very common(may affect up to 1 in 10 people):

• edema (fluid retention).

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

• headache, dizziness, drowsiness (especially at the start of treatment),
• palpitations (awareness of heartbeat), flushing of the face,
• stomach pain, nausea,
• changes in bowel movements, diarrhea, constipation, indigestion,
• fatigue, weakness,
• visual disturbances, double vision,
• muscle cramps,
• swelling around the ankles.

Uncommon(may affect up to 1 in 100 people):

• mood changes, anxiety, depression, insomnia,
• tremors, taste disturbances, fainting,
• numbness or tingling in the limbs; lack of sensation,
• ringing in the ears,
• low blood pressure,
• coughing and (or) runny nose due to inflammation of the nasal mucosa,
• cough,
• dry mouth, vomiting (nausea),
• hair loss, excessive sweating, itching of the skin, 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, malaise,
• joint or muscle pain, back pain,
• weight gain or weight 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 the number of white blood cells, decrease in the number of platelets, which can lead to unusual bruising and easier bleeding,
• excess glucose (sugar) in the blood (hyperglycemia),
• nerve disorders, which can cause muscle weakness, numbness, or tingling,
• gum swelling,
• abdominal bloating (gastritis),
• abnormal liver function, liver inflammation (hepatitis), yellowing of the skin (jaundice), increased activity of liver enzymes, which can affect some medical test results,
• increased muscle tension,
• vasculitis, often with skin rash,
• sensitivity to light.

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

• tremors, stiffness, mask-like face, slow movements and dragging of the feet, uneven gait.

Side effects related to the use of candesartan

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

• dizziness and (or) vertigo,
• headache,
• respiratory tract infections,
• low blood pressure. This can cause dizziness or fainting,
• 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 feel tired, weak, or have irregular heartbeat or tingling sensation,
• effect on kidney function, especially in patients with pre-existing kidney problems 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,
• angioedema of the intestine: swelling in the intestine with symptoms such as abdominal pain, nausea, vomiting, and diarrhea,
• decrease in the number of red or white blood cells. You may feel tired, get infections, or have a fever,
• skin rash, urticaria (hives),
• itching,
• back pain, joint or muscle pain,
• changes in liver function, including hepatitis (liver inflammation). You may feel tired, yellowing of the skin and the whites of the eyes, and flu-like symptoms,
• cough,
• nausea,
• changes in blood test results: decreased sodium levels in the blood. If the decrease is significant, you may feel weak, lack energy, or have painful muscle cramps.

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 tell your 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, 02-222 Warsaw, tel.: +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 or its representative in Poland.

5. How to store Caramlo

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month. Store in a temperature not exceeding 30°C. Store in the original package to protect from light. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Caramlo contains

• The active substances are candesartan cilexetil and amlodipine. Each tablet contains 16 mg of candesartan cilexetil and 5 mg of amlodipine (as amlodipine besylate).
• The other ingredients are: lactose monohydrate, mannitol, maize starch, calcium carmellose, hydroxypropylcellulose, macrogol 8000, stearic acid, magnesium stearate, silica colloidal anhydrous.

What Caramlo looks like and contents of the pack

White to light beige, round, two-layer tablets with a diameter of 8 ± 0.3 mm, with the inscription "16" on one side and "5" on the other. Pack sizes: 14, 28, 30, 56, 84, 90, 91, or 98 tablets. Not all pack sizes may be marketed.

Marketing authorization holder

Zentiva k.s. U Kabelovny 130 Dolní Měcholupy 102 37 Prague 10 Czech Republic

Manufacturer

Zentiva k.s. U Kabelovny 130 Dolní Měcholupy 102 37 Prague 10 Czech Republic

For more information about this medicine, including its names in the Member States of the European Economic Area, please contact the representative of the marketing authorization holder in Poland:

Zentiva Polska Sp. z o.o. ul. Bonifraterska 17 00-203 Warsaw tel.: +48 22 375 92 00 Date of last revision of the leaflet:May 2025