Sartesta

Leaflet attached to the packaging: patient information

Sartesta, 5 mg + 80 mg, film-coated tablets

Sartesta, 5 mg + 160 mg, film-coated tablets

Sartesta, 10 mg + 160 mg, film-coated tablets

Amlodipine + Valsartan

Read the 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 a specific person. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Sartesta and what is it used for

Sartesta contains two active substances: amlodipine and valsartan. Both substances help control high blood pressure.

• Amlodipine belongs to a group of medicines called calcium antagonists. It prevents calcium from entering the blood vessel walls, which inhibits the constriction of blood vessels.
• Valsartan belongs to a group of medicines called angiotensin II receptor antagonists. Angiotensin II is produced in the human body and causes blood vessel constriction, increasing blood pressure. Valsartan blocks the action of angiotensin II. This means that both substances prevent blood vessel constriction. As a result, blood vessels relax, and blood pressure decreases.

Sartesta is used to treat high blood pressure in adult patients whose blood pressure is not adequately controlled by taking only amlodipine or only valsartan.

2. Important information before taking Sartesta

When not to take Sartesta

• after the third month of pregnancy (it is also recommended to avoid taking Sartesta in early pregnancy, see section "Pregnancy and breastfeeding");

Do not take Sartesta if any of the above conditions apply to the patient. Consult a doctor.

Warnings and precautions

Before starting to take Sartesta, the patient should discuss it with their doctor if:

• the patient has vomiting or diarrhea;
• the patient has liver or kidney problems;
• the patient has had a kidney transplant or has narrowing of the renal arteries;
• the patient has adrenal gland problems, called primary hyperaldosteronism;
• the patient has heart failure or has had a heart attack - the doctor will closely monitor the patient's condition and may also monitor kidney function;
• the patient has narrowing of the heart valves (called aortic or mitral stenosis) or significant thickening of the heart muscle (called hypertrophic cardiomyopathy with outflow obstruction);
• the patient has experienced swelling, especially of the face and throat, while taking other medicines (including ACE inhibitors) - if such symptoms occur, the patient should stop taking Sartesta immediately, consult their doctor, and never take Sartesta again;
• 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.

The doctor may recommend regular monitoring of kidney function, blood pressure, and electrolyte levels (e.g., potassium) in the blood. See also the section "When not to take Sartesta". If any of the above conditions apply to the patient, they should inform their doctor before taking Sartesta.

Children and adolescents

Sartesta is not recommended for children and adolescents (under 18 years of age).

Sartesta and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or plan to take. The doctor may recommend a dose change and/or take other precautions. In some cases, it may be necessary to stop taking one of the medicines. This applies especially to the medicines listed below:

• ACE inhibitors or aliskiren (see also sections "When not to take Sartesta" and "Warnings and precautions");
• diuretics (which increase urine production);
• lithium (used to treat certain types of depression);
• potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium, and other substances that may increase potassium levels;
• non-steroidal anti-inflammatory drugs (NSAIDs) or selective cyclooxygenase-2 (COX-2) inhibitors - the doctor may recommend monitoring kidney function;
• antiepileptic drugs (e.g., carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone);
• St. John's Wort;
• glyceryl trinitrate and other nitrates or other vasodilators;
• medicines used to treat HIV/AIDS (e.g., ritonavir, indinavir, nelfinavir);
• medicines used to treat fungal infections (e.g., ketoconazole, itraconazole);
• medicines used to treat bacterial infections (such as rifampicin, erythromycin, clarithromycin, telithromycin);
• verapamil, diltiazem (used to treat heart conditions);
• simvastatin (used to lower high cholesterol levels in the blood);
• dantrolene (used in infusion for severe body temperature disorders);
• medicines used to prevent the rejection of a transplanted organ (cyclosporine).

Sartesta with food and drink

While taking Sartesta, the patient should not eat grapefruits or drink grapefruit juice, as both grapefruits and grapefruit juice can lead to increased levels of the active substance amlodipine in the blood, which can cause unpredictable intensification of the effect of Sartesta, resulting in decreased blood pressure.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine. Pregnancy The patient should inform their doctor about pregnancy, suspected pregnancy, or planned pregnancy. The doctor will usually recommend stopping Sartesta before planned pregnancy or immediately after pregnancy is confirmed and recommend taking another medicine instead of Sartesta. Sartesta should not be taken during early pregnancy (in the first 3 months) and should not be taken after the third month of pregnancy, as it may seriously harm the baby if taken after 3 months of pregnancy. Breastfeeding The patient should tell their doctor about breastfeeding or intending to breastfeed. Sartesta is not recommended during breastfeeding. The doctor may recommend alternative treatment if the patient wants to breastfeed, especially if the breastfed baby is a newborn or premature. It has been shown that small amounts of amlodipine pass into human milk.

Driving and using machines

This medicine may cause dizziness, which can affect the patient's ability to concentrate. Therefore, the patient should not drive vehicles, operate machinery, or perform other activities that require concentration of attention, in case of doubts about the effect of the medicine on a particular patient.

3. How to take Sartesta

This medicine should always be taken exactly as prescribed by the doctor. In case of doubts, the patient should consult their doctor. This will help achieve the best treatment results and reduce the risk of side effects. The usual dose of Sartesta is one tablet per day. The doctor will determine the dose suitable for the patient, which may be one tablet of Sartesta 5 mg + 80 mg, one tablet of Sartesta 5 mg + 160 mg, or one tablet of Sartesta 10 mg + 160 mg per day.

• It is recommended to take the medicine every day at the same time.
• The tablets should be swallowed with a glass of water.
• Sartesta can be taken with or without food. Do not take Sartesta with grapefruit or grapefruit juice.

Depending on the response to treatment, the doctor may recommend a higher or lower dose of the medicine. Do not take a dose higher than recommended. Taking Sartesta in elderly patients (65 years of age and older)When increasing the dose, the doctor will exercise caution. If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist. Taking Sartesta in children and adolescentsSartesta is not recommended for children and adolescents.

Taking a higher dose of Sartesta than recommended

In case of taking too many Sartesta tablets or accidental ingestion by another person, the patient should immediately consult their doctor.

Missing a dose of Sartesta

If the patient forgets to take the medicine, they should take it as soon as possible. The next dose should be taken at the usual time. However, if it is almost time for the next dose, the patient should skip the missed dose. Do not take a double dose to make up for the missed dose.

Stopping Sartesta treatment

Stopping Sartesta treatment may worsen the disease. The patient should not stop taking the medicine unless their doctor recommends it.

4. Possible side effects

Like all medicines, Sartesta can cause side effects, although not everybody gets them.

Some side effects may be serious and may require immediate medical attention:

Severe side effects have been reported in a few patients (occurring in less than 1 in 1,000 patients).

If the patient experiences any of the following symptoms, they should immediately inform their doctor:

Allergic reaction, with symptoms such as rash, itching, swelling of the face, lips, or tongue, difficulty breathing, low blood pressure (feeling of fainting, dizziness).

Other possible side effects of Sartesta:

Common (occurring in less than 1 in 10 patients):flu-like symptoms; nasal congestion, sore throat, and discomfort when swallowing; headache; swelling of the arms, hands, legs, ankles, or feet; fatigue; asthenia (weakness); flushing and feeling of warmth on the face and (or) neck. Uncommon (occurring in less than 1 in 100 patients):dizziness of central origin; nausea and abdominal pain; dryness of the mucous membranes; drowsiness, tingling, and numbness of the hands and feet; dizziness of labyrinthine origin, rapid heartbeat, including palpitations; dizziness when standing up; cough; diarrhea; constipation; skin rash, redness of the skin; swelling of the joints, back pain; joint pain. Rare (occurring in less than 1 in 1,000 patients):feeling of unease; ringing in the ears (tinnitus); fainting; increased urination or feeling of strong urge to urinate; inability to achieve or maintain an erection; feeling of heaviness; low blood pressure, with symptoms such as dizziness, feeling of fainting; excessive sweating; skin rash all over the body; itching; muscle cramps.

If any of these symptoms worsen, the patient should inform their doctor. Side effects reported after taking amlodipine or valsartan alone, and which have not been observed after taking Sartesta or have been observed more frequently than after taking Sartesta: Amlodipine

The patient should immediately contact their doctor if they experience any of the following very rare, serious side effects:

• 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 significant difficulty breathing;
• severe skin reactions, including severe skin 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, arrhythmias;
• pancreatitis, which can cause severe abdominal pain radiating to the back with very poor general condition.

The following side effects have been reported. If any of the side effects are troublesome for the patient or last for more than a week, they should consult their doctor. Common (occurring in less than 1 in 10 patients):dizziness, drowsiness; palpitations (feeling of heartbeats); sudden flushing, especially of the face and neck; swelling of the ankles (edema); abdominal pain, nausea. Uncommon (occurring in less than 1 in 100 patients):mood changes, anxiety, depression, insomnia, tremors, taste disturbances, fainting, loss of pain sensation; vision disturbances, impaired vision, tinnitus; low blood pressure; sneezing and (or) runny nose caused by nasal mucous membrane inflammation (rhinitis); indigestion, vomiting; hair loss, increased sweating, itching of the skin, skin color changes; urinary disturbances, increased need to urinate at night, increased frequency of urination; erectile dysfunction, discomfort or enlargement of the breasts in men, pain, malaise, muscle pain, muscle cramps; weight gain or weight loss. Rare (occurring in less than 1 in 1,000 patients):disorientation. Very rare (occurring in less than 1 in 10,000 patients):decreased white blood cell count, decreased platelet count, which can lead to unusual bruising and easier bleeding; increased blood sugar levels (hyperglycemia); gum swelling, abdominal bloating (gastritis); liver function disorders, liver inflammation, yellowing of the skin (jaundice), increased liver enzyme activity, which can affect some test results; increased muscle tone; blood vessel inflammation, often with skin rash, hypersensitivity to light; disorders including stiffness, tremors, and (or) difficulty moving. Valsartan Unknown (frequency cannot be estimated from the available data):decreased red blood cell count, fever, sore throat, or mouth ulcers caused by infection; spontaneous bleeding or bruising; high potassium levels in the blood; abnormal liver function test results; worsening of kidney function and severe kidney function disorders; swelling, mainly of the face and throat; muscle pain; skin rash, purple-red spots; fever; itching; allergic reactions, blistering of the skin (a condition called pemphigus). If the patient experiences any of these symptoms, they should immediately inform their doctor.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should tell their 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 e-mail: [email protected] Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Sartesta

Do not store above 25°C. Store in the original package to protect from moisture. The medicine should be stored out of sight and reach of children. Do not use this medicine after the expiry date stated on the carton and blister. The expiry date refers to the last day of the month. The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot/LOT means the batch number. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Sartesta contains

• The active substances of Sartesta are amlodipine and valsartan. Each film-coated tablet of 5 mg + 80 mg contains 5 mg of amlodipine (as amlodipine maleate) and 80 mg of valsartan. Each film-coated tablet of 5 mg + 160 mg contains 5 mg of amlodipine (as amlodipine maleate) and 160 mg of valsartan. Each film-coated tablet of 10 mg + 160 mg contains 10 mg of amlodipine (as amlodipine maleate) and 160 mg of valsartan.
• The other ingredients are:

core: microcrystalline cellulose, crospovidone (type A), colloidal anhydrous silica, magnesium stearate; coating: hypromellose, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172), macrogol 8000.

What Sartesta looks like and contents of the pack

Sartesta, 5 mg + 80 mg: round, biconvex, dark yellow film-coated tablets with a diameter of 8 mm. Sartesta, 5 mg + 160 mg: oval, biconvex, dark yellow film-coated tablets with the symbol "5" embossed on one side, measuring 14 mm x 8 mm. Sartesta, 10 mg + 160 mg: oval, biconvex, light yellow film-coated tablets with the symbol "10" embossed on one side, measuring 14 mm x 8 mm. Aluminum/PVC/PCTFE blisters. The pack contains 28, 30, 56, 90, or 98 film-coated tablets. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Zakłady Farmaceutyczne POLPHARMA SA ul. Pelplińska 19 83-200 Starogard Gdański To obtain more detailed information, the patient should contact the local representative of the marketing authorization holder: POLPHARMA Biuro Handlowe Sp. z o.o. ul. Bobrowiecka 6 00-728 Warszawa tel. 22 364 61 01

Date of last revision of the leaflet: