Caramlo

Patient Information Leaflet

Caramlo, 8 mg+5 mg, tablets
Caramlo, 16 mg+10 mg, tablets
Candesartan cilexetil + Amlodipine
Please read all of this leaflet carefully before taking this medicine, as 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 a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• 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 Caramlo is and what it is used for
2. What you need to know 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 Caramlo is and what it is 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 channel blockers". Amlodipine prevents calcium from entering the walls of blood vessels, which helps prevent blood vessel constriction. As a result, both substances help prevent blood vessel constriction. This leads to relaxation of blood vessels and a reduction in blood pressure.

Caramlo is used for the treatment of high blood pressure in patients whose blood pressure is already adequately controlled by taking candesartan and amlodipine as separate tablets at the same doses as those contained in Caramlo.

2. Important information before using Caramlo

When not to use Caramlo

• if the patient is allergic to amlodipine or other medicines in the calcium channel blocker group, candesartan cilexetil, or any of the other ingredients of this medicine (listed in section 6).
• if the patient has significantly low blood pressure (hypotension).
• if the patient has aortic valve stenosis (narrowing of the heart's aortic valve) or cardiogenic shock (a condition in which the heart is unable to supply sufficient blood to the body).
• if the patient has heart failure following a heart attack.
• if the patient is pregnant beyond the 3rd month (see section "Pregnancy and breastfeeding").
• if the patient has severe liver disease or biliary obstruction (impaired bile flow from the gallbladder).
• if the patient has diabetes or kidney problems and is being treated with a blood pressure-lowering medicine containing aliskiren.

Warnings and precautions
Before starting treatment with Caramlo, consult your doctor or pharmacist if any of the following apply:

• recent heart attack.
• heart failure.
• a sudden, severe increase in blood pressure (hypertensive crisis).
• low blood pressure (hypotension).
• if dose adjustment is required and the patient is elderly.
• impaired liver or kidney function, or if the patient is on dialysis.
• if the patient has recently received a kidney transplant.
• if the patient is vomiting, has recently experienced severe vomiting, or has had diarrhoea.
• if the patient has an adrenal gland disorder called Conn's syndrome (also known as primary hyperaldosteronism).
• if the patient has ever had a stroke.
• if the patient is to receive an anaesthetic agent. Such agents may be used during surgery or dental procedures.
• if the patient is taking any of the following medicines for high blood pressure:
  • an ACE inhibitor (e.g. enalapril, lisinopril, ramipril), especially if the patient has kidney problems related to diabetes,
  • aliskiren.

Your doctor may recommend regular monitoring of kidney function, blood pressure, and blood electrolyte levels (e.g. potassium).
See also the section "When not to use Caramlo".
If the patient experiences abdominal pain, nausea, vomiting, or diarrhoea after taking Caramlo, consult a doctor. The doctor will decide whether treatment should continue. Do not stop taking Caramlo without medical advice.
If the patient suspects she may be pregnant (or plans to become pregnant), she must inform her doctor. Caramlo is not recommended during early pregnancy and must not be used after the 3rd month of pregnancy, as it may cause serious harm to the unborn baby (see section "Pregnancy and breastfeeding").

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

Caramlo with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
Caramlo may affect the action of other medicines, and other medicines may affect the action of Caramlo. Your doctor may recommend adjusting the dose and/or taking other precautions if the patient is taking any of the following medicines:

• ketoconazole, itraconazole (antifungal medicines).
• ritonavir, indinavir, nelfinavir (protease inhibitors used in the treatment of HIV infection).
• rifampicin, erythromycin, clarithromycin (antibiotics used to treat bacterial infections).
• St John's wort (Hypericum perforatum).
• verapamil, diltiazem (medicines used for heart conditions).
• dantrolene (intravenous infusion used in severe disturbances of body temperature).
• tacrolimus, sirolimus, temsirolimus, everolimus (used to suppress the immune system response to help the body accept a transplanted organ).
• simvastatin (a medicine used to lower cholesterol levels).
• cyclosporine (an immunosuppressant medicine).
• other medicines used to lower blood pressure, including beta-blockers and diazoxide.
• an ACE inhibitor or aliskiren (see also sections "When not to use Caramlo" and "Warnings and precautions").
• non-steroidal anti-inflammatory drugs (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), at doses higher than 3 g per day.
• potassium supplements or salt substitutes containing potassium (medicines that increase blood potassium levels).
• heparin (a blood-thinning medicine).
• co-trimoxazole (an antibiotic combination of trimethoprim and sulfamethoxazole).
• diuretics (water tablets).
• lithium (a medicine used to treat psychiatric disorders).

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

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

Pregnancy
The patient must inform her doctor if she suspects she may be pregnant (or plans to become pregnant). The doctor will usually advise stopping Caramlo before planning pregnancy or immediately after pregnancy is confirmed, and will recommend an alternative medicine. Caramlo is not recommended during early pregnancy and must not be used after the 3rd month of pregnancy, as it may cause serious harm to the unborn baby if used beyond the third month of pregnancy.

Breastfeeding
It has been shown that small amounts of amlodipine pass into human milk. If the patient is breastfeeding or plans to breastfeed, she should inform her doctor before starting Caramlo. Caramlo is not recommended for breastfeeding women. If a woman wishes to breastfeed, her doctor may choose an alternative treatment, especially if breastfeeding a newborn or a premature infant.

Driving and using machines
Caramlo may have a moderate effect on the ability to drive or use machinery. If the tablets cause discomfort, dizziness, tiredness, or headache, the patient should not drive or operate machinery and should contact their doctor immediately.

Caramlo contains lactose monohydrate and sodium
If the patient has been previously diagnosed with an intolerance to certain sugars, they should consult their doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet; therefore, this medicine is considered "sodium-free".

3. How to take Caramlo

This medicine should always be taken as directed by a doctor or pharmacist. If in doubt,
consult a 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 may be divided into
equal doses.
Caramlo may be taken with or without food.
Taking more Caramlo than recommended
Taking too many tablets may cause blood pressure to become low or even dangerously low.
The patient may experience dizziness, lightheadedness, fainting, or weakness. If blood pressure drops severely, shock may occur.
The skin may become cold and clammy, and the patient may lose consciousness.
Within 24 to 48 hours after taking the medicine, shortness of breath due to fluid accumulation in the lungs (pulmonary edema) may occur.
If too many tablets have been taken, seek medical help immediately.
Missing a dose of Caramlo
If a patient forgets to take a tablet, that dose should be completely omitted. The next dose should be taken at the usual time. Do not take a double dose to make up for a missed dose.
Stopping Caramlo treatment
The doctor will inform the patient how long Caramlo should be taken. Stopping treatment may cause symptoms of the disease to return. Therefore, do not stop taking Caramlo without first consulting a doctor.
If there are any further doubts regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Immediately consult a doctor if, after taking this medicine, the patient experiences any of the following very rare, serious adverse reactions (may occur in less than 1 in 10,000 people):

• sudden, wheezing breathing, 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 severe skin rash, hives, redness of the skin over the entire body, intense itching, blistering, peeling and swelling of the skin, mucosal inflammation (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions
• heart attack, heart rhythm disorders
• 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. The patient's resistance to infections may be reduced, and symptoms such as fatigue, infection or fever may occur. In such a case, contact a doctor. The doctor may order periodic blood tests to check whether Caramlo affects blood composition (agranulocytosis).
Other possible adverse reactions:
Since Caramlo contains two active substances, the reported adverse reactions are associated with the use of amlodipine or candesartan.

Adverse reactions associated with amlodipine use
Very common (may affect at least 1 in 10 people):

• swelling (fluid retention)

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

• headache, dizziness, drowsiness (especially at the beginning of treatment)
• palpitations (awareness of heartbeat), facial flushing
• abdominal pain, nausea
• changes in bowel habits, diarrhoea, constipation, indigestion
• fatigue, weakness
• visual disturbances, double vision
• painful muscle cramps
• swelling around the ankles

Uncommon (may affect less than 1 in 100 people):

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

Rare (may affect less than 1 in 1,000 people):

• disorientation

Very rare (may affect less than 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 easier bleeding (damage to red blood cells)
• excess glucose (sugar) in the blood (hyperglycaemia)
• nerve disorders, which may cause muscle weakness, tingling or numbness
• gum swelling
• abdominal bloating (gastritis)
• 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 tone
• vasculitis, often with skin rash
• photosensitivity

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

• tremor, rigidity, facial masking, slowed movements and dragging gait, unsteady gait

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

• dizziness and/or vertigo
• headache
• respiratory tract infection
• low blood pressure. This may cause fainting or dizziness
• changes in blood test results: increased potassium levels in the blood, especially in patients with impaired kidney function or heart failure. If the increase is significant, the patient may experience fatigue, weakness, irregular heartbeat or tingling sensations
• effect on kidney function, particularly in patients with pre-existing kidney disorders or heart failure. In very rare cases, kidney failure may occur

Very rare (may affect less than 1 in 10,000 people):

• swelling of the face, lips, tongue and/or throat
• intestinal angioedema: intestinal swelling with symptoms such as abdominal pain, nausea, vomiting and diarrhoea
• decrease in the number of red or white blood cells. Fatigue, infection or fever may occur
• skin rash, urticarial 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 the decrease is significant, weakness, lack of energy or painful muscle cramps may occur

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

• diarrhoea

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your 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, 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 or its representative in Poland.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Caramlo

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and/or blister after EXP. The expiry date refers to the last day of the stated month.
Do not store above 30°C. Store in the original packaging to protect from light.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Caramlo contains

• The active substances in this medicine 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 besilate).
  Caramlo 16 mg+10 mg: Each tablet contains 16 mg of candesartan cilexetil and 10 mg of amlodipine (as amlodipine besilate).
• Other ingredients are: hydroxypropylcellulose, monohydrate lactose, sodium croscarmellose, maize 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, embossed with "8" on one side and "5" on the other.
Caramlo 16 mg+10 mg: White to off-white, round, biconvex tablets with a breakline on both sides, embossed with "16 16" 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 Authorisation 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 about this medicine and its names in the Member States of the European Economic Area, please contact the representative of the Marketing Authorisation Holder in Poland:
Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
tel.: +48 22 375 92 00