Caramlo

Package Leaflet: Information for the Patient

Caramlo, 8 mg+5 mg, Tablets

Caramlo, 16 mg+10 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 inform 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 control high blood pressure.

• Candesartan belongs to a group of substances called "angiotensin II receptor antagonists". Angiotensin II is produced in the human body and causes blood vessels to constrict, thereby increasing blood pressure. Candesartan works by blocking the action of angiotensin II.
• Amlodipine belongs to a group of substances called "calcium antagonists". Amlodipine prevents calcium from entering the blood vessel walls, which inhibits blood vessel constriction. This means that both substances help to inhibit blood vessel constriction. 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 by taking 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 a 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 (see "Pregnancy and breastfeeding").
• if you have severe liver disease or biliary obstruction (difficulty in bile flow from the gallbladder).
• 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:

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

Your doctor may advise you to have regular blood tests to check your kidney function, blood pressure, and electrolyte levels (e.g., potassium). See also "When not to take Caramlo". If you experience stomach pain, nausea, vomiting, or diarrhea after taking Caramlo, you should tell your doctor. Your doctor will decide whether to continue your treatment. Do not stop taking Caramlo without consulting your doctor. If you think you might be pregnant (or plan to become pregnant), inform your doctor. 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.

Children and adolescents

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

Caramlo with other medicines

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or might take, including those obtained without a prescription. Caramlo may affect the way other medicines work, and other medicines may affect the way Caramlo works. Your doctor may need to change your dose 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.
• verapamil, diltiazem (medicines used to treat heart conditions).
• dantrolene (intravenous infusion for severe body temperature disorders).
• tacrolimus, sirolimus, temsirolimus, everolimus (used to control the body's immune response, allowing the body to accept a transplanted organ).
• simvastatin (a medicine used to lower cholesterol levels).
• cyclosporin (an immunosuppressant medicine).
• other blood pressure-lowering medicines, including beta-blockers and diazoxide.
• ACE inhibitors or aliskiren (see also "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).
• aspirin (a medicine used to reduce pain and inflammation), at doses greater than 3 g per day.
• potassium supplements or potassium-sparing diuretics (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 (water tablets).
• lithium (a medicine used to treat mental disorders).

Taking Caramlo with food and drink

Do not drink grapefruit juice or eat grapefruit while taking Caramlo. Grapefruit and grapefruit juice may increase the levels of the active substance amlodipine in the blood, which may lead to an unpredictable increase 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 might be pregnant (or plan to become pregnant). Your doctor will normally advise you to stop taking Caramlo before you become pregnant or as soon as you know you are pregnant, and will advise you to take a different 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. Breastfeeding It has been shown that small amounts of amlodipine pass into human milk. If you are breastfeeding or plan to breastfeed, you should ask your doctor for advice before taking Caramlo. Caramlo is not recommended for mothers who are breastfeeding, and if you want to breastfeed, your doctor may choose a different treatment, especially if you are breastfeeding a newborn or premature baby.

Driving and using machines

Caramlo may have a moderate influence on your ability to drive or use machines. If you feel unwell, dizzy, tired, or experience headache, do not drive or use machines, and contact your doctor immediately.

Caramlo contains lactose monohydrate and sodium

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which is essentially "sodium-free".

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 8 mg+5 mg is 1 or 2 tablets per day. The recommended dose of Caramlo 16 mg+10 mg is 1 tablet per day. The tablet can be divided into equal doses. Caramlo can be taken with or without food.

Taking more than the recommended dose of Caramlo

Taking too many tablets may 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 severe, it may lead to shock. Your skin may become cool and wet, and you may lose consciousness. Even 24-48 hours after taking the medicine, you may experience shortness of breath due to excess fluid accumulating in the lungs (pulmonary edema). If you take too many tablets, contact a doctor or hospital immediately.

Missing a dose of Caramlo

If you forget to take a tablet, skip the missed dose and 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 consulting your doctor. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Caramlo can cause side effects, although not everybody gets them. You should immediately contact your doctor if you experience any of the following very rare but 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, peeling, and swelling of the skin (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions
• heart attack, irregular heartbeat
• pancreatitis, which may cause severe stomach and back pain, with a very severe general feeling of being unwell

Candesartan may cause a decrease in the number of white blood cells. Your resistance to infection may be decreased, and you may notice symptoms such as tiredness, infection, or fever. If this happens, contact your doctor. Your doctor may need to perform regular blood tests to check whether Caramlo is affecting your blood. Other possible side effects:

Side effects related to amlodipine

Very common(may affect more than 1 in 10 people):

• swelling (fluid retention).

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

• headache, dizziness, sleepiness (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,
• trembling, taste disturbances, fainting,
• numbness or tingling in the arms or legs; decreased sensitivity to pain,
• ringing in the ears,
• low blood pressure,
• coughing and (or) runny nose due to sinus inflammation,
• 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,
• erectile dysfunction; discomfort or enlargement of the breasts in men,
• pain, general feeling of being unwell,
• 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):

• decrease in the number of white blood cells, decrease in the number of platelets, which may lead to unusual bruising and bleeding (red blood cell damage),
• excess sugar in the blood (hyperglycemia),
• nerve disorders, which may cause muscle weakness, tingling, or numbness,
• gum swelling,
• abdominal bloating (gastritis),
• abnormal liver function, inflammation of the liver (hepatitis), yellowing of the skin and the whites of the eyes (jaundice), increased activity of liver enzymes, which may affect some medical test results,
• increased muscle tension,
• inflammation of blood vessels, often with skin rash,
• sensitivity to light.

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

• trembling, stiffness of the body, mask-like face, slow movements and dragging of the feet, unsteady gait.

Side effects related to candesartan

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

• dizziness and (or) spinning sensation,
• headache,
• respiratory tract infections,
• low blood pressure. This may 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 levels become too high, you may feel tired, weak, or have an irregular heartbeat,
• effects on kidney function, especially in patients with 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,
• gastrointestinal angioedema: swelling in the gut with symptoms such as stomach 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, hives,
• itching,
• back pain, joint or muscle pain,
• changes in liver function, including hepatitis. 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 levels become too low, you may feel weak, lack energy, or have 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 inform your doctor or pharmacist. You can also report side effects directly to the Department of Drug Safety, 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 You can also report side effects to the marketing authorization holder or its representative in Poland. By reporting side effects, you can help provide more information on the safety of this medicine.

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. Do not store above 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. These measures will help protect the environment.

6. Contents of the pack and other information

What Caramlo contains

• The active substances are candesartan cilexetil and amlodipine. Caramlo 8 mg+5 mg: Each tablet contains 8 mg of candesartan cilexetil and 5 mg of amlodipine (as amlodipine besylate). Caramlo 16 mg+10 mg: Each tablet contains 16 mg of candesartan cilexetil and 10 mg of amlodipine (as amlodipine besylate).
• The other ingredients are: hydroxypropylcellulose, lactose monohydrate, croscarmellose sodium, corn starch, triethyl citrate, magnesium stearate.

What Caramlo looks like and contents of the pack

Caramlo 8 mg+5 mg: White to off-white, round, biconvex tablets with "8" engraved on one side and "5" on the other. Caramlo 16 mg+10 mg: White to off-white, round, biconvex tablets with a score line on both sides, with "16 16" engraved on one side and "10 10" on the other. The tablet can be divided into equal doses. Pack sizes: 14, 28, 30, 56, 84, 90, 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 further information on this medicine, 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:January 2025