Sartesta

Package Leaflet: Information for the Patient

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

• Keep this package 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 package leaflet, tell your doctor or pharmacist. See section 4.

Contents of the Package 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 to control high blood pressure.

• Amlodipine belongs to a group of medicines called calcium antagonists. It prevents calcium from entering the blood vessel walls, which helps to relax the blood vessels.
• Valsartan belongs to a group of medicines called angiotensin II receptor antagonists. Angiotensin II is a substance produced in the body that causes blood vessels to constrict, which increases blood pressure. Valsartan blocks the action of angiotensin II, which means that both substances help to relax the blood vessels. As a result, the blood vessels dilate, and blood pressure is reduced.

Sartesta is used to treat high blood pressure in adult patients whose blood pressure is not adequately controlled with amlodipine or valsartan alone.

2. Important information before taking Sartesta

When not to take Sartesta

• if you are allergic to amlodipine or other calcium antagonists - you may experience itching, redness of the skin, or difficulty breathing;
• if you are allergic to valsartan or any of the other ingredients of this medicine - if you think you may be allergic, consult your doctor before taking Sartesta;
• if you have severe liver disease or biliary obstruction, such as biliary cirrhosis or cholestasis;
• after the third month of pregnancy - you should also avoid taking Sartesta during early pregnancy, see section "Pregnancy and breastfeeding";
• if you have significantly low blood pressure (hypotension);
• if you have narrowing of the aortic valve (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 have diabetes or kidney problems and are taking a blood pressure-lowering medicine containing aliskiren.

Do not take Sartesta if any of the above conditions apply to you. Consult your doctor.

Warnings and precautions

Before taking Sartesta, tell your doctor if:

• you have vomiting or diarrhea;
• you have liver or kidney problems;
• you have had a kidney transplant or have narrowing of the renal arteries;
• you have adrenal gland problems, called primary hyperaldosteronism;
• you have heart failure or have had a heart attack - your doctor will closely monitor your treatment and may also monitor your kidney function;
• you have narrowing of the heart valves (called aortic or mitral stenosis) or significant thickening of the heart muscle (called hypertrophic cardiomyopathy with outflow obstruction);
• you have experienced swelling, particularly of the face and throat, while taking other medicines (including ACE inhibitors) - if you experience such symptoms, stop taking Sartesta immediately, contact your doctor, and never take Sartesta again;
• you are taking any of the following medicines for high blood pressure:
• an ACE inhibitor (e.g., enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes;
• aliskiren.

Your doctor may monitor your kidney function, blood pressure, and blood electrolyte levels (e.g., potassium). See also the section "When not to take Sartesta". If any of the above conditions apply to you, tell your doctor before taking Sartesta.

Children and adolescents

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

Sartesta with other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take. Your doctor may need to change the dose or take other precautions. In some cases, it may be necessary to stop taking one of the medicines. This is especially important for the following medicines:

• 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 - your doctor may monitor your kidney function;
• antiepileptic drugs (e.g., carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone);
• St. John's Wort;
• glyceryl trinitrate and other nitrates or other vasodilators;
• HIV/AIDS medicines (e.g., ritonavir, indinavir, nelfinavir);
• antifungal medicines (e.g., ketoconazole, itraconazole);
• antibacterial medicines (such as rifampicin, erythromycin, clarithromycin, telithromycin);
• verapamil, diltiazem (used to treat heart conditions);
• simvastatin (used to lower high cholesterol levels);
• dantrolene (used in the treatment of severe body temperature disturbances);
• medicines used to prevent the rejection of transplanted organs (cyclosporine).

Sartesta with food and drink

Do not eat grapefruits or drink grapefruit juice while taking Sartesta, as both grapefruits and grapefruit juice may increase the levels of the active substance amlodipine in the blood, which may lead to unpredictable and increased effects of Sartesta, resulting in lowered blood pressure.

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

Tell your doctor if you are pregnant, think you may be pregnant, or are planning to become pregnant. Your doctor will normally advise you to stop taking Sartesta before you become pregnant or as soon as you know you are pregnant, and will advise you to take a different medicine instead of Sartesta.

Sartesta should not be taken during the first three months of pregnancy 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

Tell your doctor if you are breastfeeding or plan to breastfeed. Sartesta is not recommended during breastfeeding. Your doctor may prescribe a different treatment if you want to breastfeed, especially if your baby is a newborn or premature.

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

Driving and using machines

This medicine may cause dizziness, which may affect your ability to concentrate. Therefore, do not drive, operate machinery, or perform other activities that require concentration, if you are unsure about the effects of this medicine on you.

3. How to take Sartesta

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor.

The usual dose of Sartesta is one tablet per day. Your doctor will determine the dose that is right for you, which may be one Sartesta 5 mg + 80 mg tablet, one Sartesta 5 mg + 160 mg tablet, or one Sartesta 10 mg + 160 mg tablet per day.

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

Depending on your response to treatment, your doctor may increase or decrease the dose of Sartesta.

Do not take more than the recommended dose.

Taking Sartesta in patients over 65 years of age

When increasing the dose, your doctor will exercise caution.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Use in children and adolescents

Sartesta is not recommended for children and adolescents.

If you take more Sartesta than you should

If you have taken too many Sartesta tablets or if someone else has taken your tablets, contact your doctor immediately.

If you forget to take Sartesta

If you miss a dose, take it as soon as possible. Take the next dose at the usual time. However, if it is almost time for your next dose, skip the missed dose. Do not take a double dose to make up for a forgotten dose.

Stopping Sartesta treatment

Stopping Sartesta treatment may worsen your condition. Do not stop taking Sartesta unless your doctor tells you to.

4. Possible side effects

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

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

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

If you experience any of the following symptoms, tell your doctor immediately:

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 (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 (less than 1 in 100 patients):dizziness of central origin; nausea and abdominal pain; dryness of the mouth; 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 (less than 1 in 1,000 patients):feeling of unease; ringing in the ears (tinnitus); fainting; increased urine production 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, tell your doctor.

Side effects reported with amlodipine or valsartan alone, and not observed with Sartesta or observed more frequently with Sartesta:

If you experience any of the following very rare, serious side effects, contact your doctor immediately:

• 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 severe difficulty 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, inflammation of the mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions;
• heart attack, irregular heartbeat;
• pancreatitis, which can cause severe abdominal pain, radiating to the back, with very severe illness.

Other side effects have been reported. If any side effect bothers you or lasts more than a week, contact your doctor.

Common (less than 1 in 10 patients):dizziness, drowsiness; palpitations (feeling of heartbeat); sudden flushing, especially of the face and neck; swelling of the ankles (edema); abdominal pain, nausea.

Uncommon (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 due to nasal inflammation (rhinitis); indigestion, vomiting; hair loss, increased sweating, itching of the skin, skin discoloration; 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 (less than 1 in 1,000 patients):disorientation.

Very rare (less than 1 in 10,000 patients):decreased white blood cell count, decreased platelet count, which may lead to unusual bruising and bleeding; increased blood sugar levels (hyperglycemia); gum swelling, abdominal bloating (gastritis); liver function disturbances, liver inflammation, jaundice, increased liver enzyme activity, which may affect some laboratory test results; increased muscle tension; blood vessel inflammation, often with skin rash, hypersensitivity to light; movement disorders, including stiffness, tremors, and (or) difficulty moving.

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, tell your doctor or pharmacist. You can also report side effects 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: ndl@urpl.gov.pl. You can also report side effects to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Sartesta

Do not store above 25°C.

Store in the original package to protect from moisture.

Keep the medicine out of the 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 notation 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. 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 Sartesta contains

• The active substances are amlodipine and valsartan. Each 5 mg + 80 mg film-coated tablet contains 5 mg amlodipine (as amlodipine maleate) and 80 mg valsartan. Each 5 mg + 160 mg film-coated tablet contains 5 mg amlodipine (as amlodipine maleate) and 160 mg valsartan. Each 10 mg + 160 mg film-coated tablet contains 10 mg amlodipine (as amlodipine maleate) and 160 mg 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, 8 mm in diameter.

Sartesta, 5 mg + 160 mg: oval, biconvex, dark yellow film-coated tablets with a symbol "5" embossed on one side, 14 mm x 8 mm in size.

Sartesta, 10 mg + 160 mg: oval, biconvex, light yellow film-coated tablets with a symbol "10" embossed on one side, 14 mm x 8 mm in size.

Aluminium/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

Polpharma S.A.

ul. Pelplińska 19

83-200 Starogard Gdański