Camlocor

Patient Information Leaflet

Camlocor, 8 mg+5 mg, tablets
Camlocor, 16 mg+5 mg, tablets
Camlocor, 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 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, please inform your doctor or pharmacist. See section 4.

Contents of the leaflet

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

1. What Camlocor is and what it is used for

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

• Candesartan cilexetil belongs to a group of medicines known as angiotensin II receptor antagonists.
• Amlodipine belongs to a group of medicines known as calcium channel blockers.

Both substances help prevent blood vessels from narrowing by causing them to relax and widen, thereby lowering blood pressure.
Camlocor is used to treat high blood pressure (hypertension) in adult patients who have previously been treated with separate tablets containing candesartan cilexetil and amlodipine at the same doses as in Camlocor, instead of taking the two medicines separately.

2. Important information before using Camlocor

When not to use Camlocor

• if the patient is allergic to candesartan cilexetil, amlodipine, other calcium antagonists, or any of the other ingredients of this medicine (listed in section 6);
• after the 3rd month of pregnancy (use of Camlocor should also be avoided in early pregnancy – see section "Pregnancy and breastfeeding");
• in case of severe liver disease or biliary obstruction (impaired bile flow from the gallbladder);
• in children under 1 year of age;
• if the patient has diabetes or kidney impairment and is being treated with a blood pressure-lowering medicine containing aliskiren;
• if the patient has very low blood pressure (hypotension);
• if the patient has aortic valve stenosis or cardiogenic shock (a condition in which the heart cannot supply sufficient blood to the body);
• if the patient has heart failure following a heart attack.

If in doubt whether any of the above conditions apply, consult a doctor or pharmacist before using Camlocor.

Warnings and precautions

Before starting treatment with Camlocor, discuss it with your doctor or pharmacist.

Inform your doctor if the patient has or has had any of the following conditions or disorders:

• heart, liver or kidney disease, or is undergoing dialysis;
• recent kidney transplantation;
• severe vomiting or diarrhoea;
• an adrenal gland disorder called Conn's syndrome (primary hyperaldosteronism);
• low blood pressure;
• history of stroke;
• must inform the doctor about pregnancy, suspected pregnancy, or plans to become pregnant – use of Camlocor is not recommended during early pregnancy and must not be taken after the 3rd month of pregnancy, as it may seriously harm the unborn child (see section "Pregnancy and breastfeeding");
• recent myocardial infarction (heart attack);
• heart failure;
• severe increase in blood pressure (hypertensive crisis);
• need for dose adjustment in elderly patients.

Before taking Camlocor, talk to your doctor if the patient is taking:

• digoxin;
• any of the following medicines used to treat high blood pressure:
• angiotensin-converting enzyme (ACE) inhibitors, such as 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 Camlocor".

If the patient develops abdominal pain, nausea, vomiting, or diarrhoea after taking Camlocor, discuss this with the doctor. The doctor will decide on continuing treatment. Do not stop taking Camlocor on your own.

If the patient is scheduled for surgery, inform the doctor or dentist about taking Camlocor. This is because Camlocor, in combination with certain anaesthetics, may cause low blood pressure.

Children and adolescents

Camlocor is not recommended for use in children and adolescents under 18 years of age.

Camlocor with other medicines

Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.

Camlocor may affect the action of other medicines, and other medicines may affect Camlocor. If the patient is taking certain medicines, the doctor may recommend periodic blood tests.

In particular, inform the doctor if any of the following medicines are being used. The doctor may recommend a dose adjustment and/or additional precautions:

• other blood pressure-lowering medicines, including beta-blockers, diazoxide, and ACE inhibitors such as enalapril, captopril, lisinopril, or ramipril;
• non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, naproxen, diclofenac, celecoxib, or etoricoxib (medicines that relieve pain and inflammation);
• acetylsalicylic acid (in doses exceeding 3 g per day) used to relieve pain and inflammation;
• potassium supplements or potassium-containing salt substitutes (medicines that increase blood potassium levels);
• heparin (an anticoagulant);
• diuretics;
• lithium (a medicine used to treat psychiatric disorders);
• an ACE inhibitor or aliskiren (see also sections "When not to use Camlocor" and "Warnings and precautions");
• ketoconazole, itraconazole (antifungal medicines);
• ritonavir, indinavir, nelfinavir (protease inhibitors used in HIV treatment);
• rifampicin, erythromycin, clarithromycin (used to treat bacterial infections);
• St John's wort (Hypericum perforatum);
• verapamil, diltiazem (used in heart conditions);
• dantrolene (used intravenously in severe disturbances of body temperature);
• tacrolimus, sirolimus, temsirolimus, and everolimus (medicines affecting the immune system);
• simvastatin (a medicine that lowers cholesterol levels);
• cyclosporine (an immunosuppressive medicine).

Camlocor may lower blood pressure more strongly if the patient is taking other antihypertensive medicines.

Camlocor with food and drink

Do not drink grapefruit juice or eat grapefruit while taking Camlocor, as they may increase blood levels of the active substance amlodipine, which could unpredictably intensify the blood pressure-lowering effect of Camlocor.

While taking Camlocor, the patient should talk to the doctor before drinking alcohol. Alcohol may cause fainting or dizziness.

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 a doctor or pharmacist before using this medicine.

Pregnancy

Inform the doctor about pregnancy, suspected pregnancy, or plans for pregnancy. The doctor will usually advise stopping Camlocor before planning pregnancy or immediately after pregnancy is confirmed, and will recommend an alternative medicine.

Use of Camlocor is not recommended during early pregnancy and must not be used after the 3rd month of pregnancy, as it may seriously harm the unborn child.

Breastfeeding

Inform the doctor about breastfeeding or plans to breastfeed. Camlocor is not recommended during breastfeeding, especially when nursing a newborn or premature infant. The doctor may recommend an alternative medicine.

It has been shown that small amounts of amlodipine pass into breast milk.

Driving and operating machinery

Camlocor may affect the ability to drive and operate machinery. If the medicine causes nausea, dizziness, fatigue, or headache, do not drive or operate machinery – contact your doctor immediately.

Camlocor contains lactose and sodium

If the patient has previously been diagnosed with an intolerance to certain sugars, consult a doctor before taking this medicine.

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. the medicine is considered "sodium-free".

3. How to use Camlocor

This medicine should always be used exactly as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
The recommended dose of Camlocor is one tablet per day.
The tablet should be swallowed with a glass of water, during a meal or independently of meals.
It is recommended to take the medicine at the same time each day. Do not take Camlocor with
grapefruit juice.
It is important to continue taking Camlocor unless otherwise instructed by a doctor.
Taking more Camlocor than recommended
Taking too many tablets may cause a drop in blood pressure, possibly severe.
Dizziness, a feeling of "emptiness" in the head, fainting, or weakness may occur. In cases of
severely low blood pressure, shock may develop. The skin then becomes cold and
clammy, and the patient may lose consciousness.
Breathlessness due to fluid accumulation in the lungs (pulmonary edema) may occur
even 24 to 48 hours after taking the medicine.
If too many tablets of Camlocor have been taken, seek immediate medical advice or go to
the nearest hospital emergency department.
Missing a dose of Camlocor
Do not be alarmed. If a patient forgets to take a tablet, simply skip the missed dose.
Take the next dose at the usual time. Do not take a double dose to make up for a
missed dose.
Stopping Camlocor treatment
The doctor will inform the patient how long treatment should continue. If the patient stops taking
the medicine before advised to do so by the doctor, the condition may recur.
If there are any further questions about 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 will experience them.
If any of the following adverse reactions occur after using the medicine, you should contact your doctor immediately:

• 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 difficulty in breathing;
• Severe skin reactions, including severe rash, urticaria, redness of the entire skin surface, intense itching, blistering, skin peeling and swelling of the skin, mucosal inflammation (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions;
• Myocardial infarction, heart rhythm disturbances;
• Pancreatitis, which may cause severe upper abdominal pain radiating to the back, accompanied by a very poor general condition.

Kandesartan, an ingredient of Camlocor, may reduce the number of white blood cells. This may lead to reduced resistance to infections; therefore, the patient may experience fatigue, infections and fever. If such symptoms occur, contact your doctor. Your doctor may periodically recommend blood tests to check whether Camlocor is causing blood disorders (agranulocytosis).

Possible adverse reactions associated with the use of KANDESARTAN
Common (may occur in less than 1 in 10 patients):

• Dizziness/vertigo
• Headache
• Respiratory tract infection
• Low blood pressure, which may cause fainting or dizziness
• Changes in blood test results:
• increased potassium levels in blood, particularly in patients with impaired kidney function or heart failure; if the increase is significant, symptoms such as fatigue, weakness, irregular heartbeat or tingling sensation may occur
• Effect on kidney function, particularly in patients with impaired kidney function or heart failure; in very rare cases, kidney failure may occur

Very rare (may occur in less than 1 in 10,000 patients):

• Swelling of the face, lips, tongue and (or) throat
• Decreased number of red or white blood cells – fatigue, infection or fever may occur
• Skin rash, urticaria
• Itching
• Back pain, joint and muscle pain
• Intestinal angioedema: intestinal swelling with symptoms such as abdominal pain, nausea, vomiting and diarrhoea
• Liver function disorders, including hepatitis – symptoms such as fatigue, yellowing of the skin and eyes, and flu-like symptoms may occur
• Cough
• Nausea
• Changes in blood test results:
• decreased sodium levels in blood; if the decrease is significant, symptoms such as weakness, lack of energy or muscle cramps may occur

Unknown (frequency cannot be determined from available data):

• Diarrhoea

Possible adverse reactions associated with the use of AMLODIPINE
The following very common adverse reactions have been reported. If any of these adverse reactions are troublesome for the patient or persist for more than one week, contact your doctor.
Very common (may occur in at least 1 in 10 people):

• Swelling (fluid retention in the body)

The following common adverse reactions have been reported. If any of these adverse reactions are troublesome for the patient or persist for more than one week, contact your doctor.
Common (may occur in less than 1 in 10 patients):

• Headache, dizziness, drowsiness (especially at the beginning of treatment)
• Palpitations (awareness of heartbeat), sudden flushing, particularly of the face and neck
• Abdominal pain, nausea
• Changes in bowel habits, diarrhoea, constipation, indigestion
• Fatigue, weakness
• Visual disturbances, double vision
• Muscle cramps
• Swelling around the ankles

Other adverse reactions reported are listed below. If any of these adverse reactions worsen or if any adverse reactions not listed in this leaflet occur, inform your doctor or pharmacist.
Uncommon (may occur in less than 1 in 100 patients):

• Mood changes, anxiety, depression, insomnia
• Tremor, taste disturbances, fainting
• Numbness or tingling of limbs, loss of pain sensation
• Tinnitus
• Low blood pressure
• Sneezing/nasal discharge due to inflammation of the nasal mucosa (rhinitis)
• Cough
• Dryness of the oral mucosa, vomiting
• Hair loss, increased sweating, skin itching, red spots on the skin, skin discoloration
• Urinary disorders, increased need to urinate at night, increased frequency of urination
• Erectile dysfunction, discomfort or enlargement of the breasts in men
• Pain, malaise
• Joint or muscle pain, back pain
• Increase or decrease in body weight

Rare (may occur in less than 1 in 1,000 patients):

• Disorientation

Very rare (may occur in less than 1 in 10,000 patients):

• Decreased number of white blood cells, decreased number of platelets, which may lead to occurrence of unusual bruising and easier bleeding
• Increased blood glucose levels (hyperglycaemia)
• Nerve disorders, which may cause weakness, tingling or numbness
• Gingival swelling
• Abdominal distension (gastritis)
• Liver function disorders, hepatitis, jaundice, increased liver enzyme activity detected in blood tests
• Increased muscle tone
• Vasculitis, often with skin rash
• Photosensitivity

Unknown (frequency cannot be determined from available data):

• Tremor, muscle rigidity, facial masking, slowed movements, shuffling gait, unsteady gait

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 Reactions of Medicinal Products at 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.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Camlocor

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and 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 and moisture.
Medicines must 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 Camlocor contains

• The active substances are candesartan cilexetil and amlodipine (as besylate). Each tablet contains 8 mg of candesartan cilexetil and 5 mg of amlodipine (as besylate). Each tablet contains 16 mg of candesartan cilexetil and 5 mg of amlodipine (as besylate). Each tablet contains 16 mg of candesartan cilexetil and 10 mg of amlodipine (as besylate).
• The other ingredients are: microcrystalline cellulose (type 102), pregelatinized corn starch, sodium carboxymethyl starch (type A), magnesium stearate, colloidal anhydrous silica, lactose monohydrate, corn starch, hydroxypropylcellulose (type EF), polyethylene glycol 8000, calcium carmellose, iron oxide yellow (E 172) – only in Camlocor tablets 8 mg + 5 mg and 16 mg + 10 mg, and iron oxide red (E 172) – only in Camlocor tablets 16 mg + 5 mg and 16 mg + 10 mg. See section 2 "Camlocor contains lactose and sodium".

What Camlocor looks like and contents of the pack
Camlocor 8 mg + 5 mg tablets: round, biconvex, two-layer tablets. One side of the tablet is pale yellow with possible lighter spots and marked with the symbol 8-5 on one side, the other side is white to almost white. Tablet dimensions: diameter 8 mm, thickness 3.7 – 4.7 mm.
Camlocor 16 mg + 5 mg tablets: round, slightly biconvex, two-layer tablets. One side of the tablet is light pink with possible lighter and darker spots and marked with the symbol 16-5 on one side, the other side is white to almost white. Tablet dimensions: diameter 9 mm, thickness 4.0 – 5.0 mm.
Camlocor 16 mg + 10 mg: round, biconvex, two-layer tablets. One side of the tablet is pale pink with possible lighter and darker spots and marked with the symbol 16-10, the other side is white to almost white. Tablet dimensions: diameter 8 mm, thickness 3.7 – 4.7 mm.
Camlocor tablets are available in packs containing 7, 10, 14, 28, 30, 50, 56, 60, 90, 98, 100, 7 x 1, 10 x 1, 14 x 1, 28 x 1, 30 x 1, 50 x 1, 56 x 1, 60 x 1, 90 x 1, 98 x 1 or 100 x 1 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
KRKA, d.d., Novo mesto
Šmarješka cesta 6
8501 Novo mesto
Slovenia
For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
KRKA - POLSKA Sp. z o.o.
ul. Równoległa 5
02-235 Warszawa
Poland
tel.: 22 57 37 500