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 all of this leaflet carefully before taking this medicine because it contains important information for you.

• 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

• 1. What Sartesta is and what it is used for
• 2. What you need to know before you take 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 Sartesta is and what it is 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 channel blockers. It works by preventing calcium from entering the blood vessel walls, which helps to relax the blood vessels and improve blood flow.
• Valsartan belongs to a group of medicines called angiotensin II receptor antagonists. Angiotensin II is a substance in the body that causes blood vessels to narrow, which increases blood pressure. Valsartan blocks the action of angiotensin II, which helps to relax the blood vessels and lower blood pressure.

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

2. What you need to know before you take Sartesta

Do not take Sartesta

• if you are allergic to amlodipine, valsartan, or any of the other ingredients of this medicine;
• if you have severe liver problems or biliary obstruction (e.g., cholestasis);
• if you are more than 3 months pregnant (see also "Pregnancy and breast-feeding");
• if you have low blood pressure (hypotension);
• if you have narrowing of the aortic valve (aortic stenosis) or heart failure after a heart attack;
• if you have diabetes or kidney problems and are treated with aliskiren;

Do not take Sartesta if any of the above applies 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 arteries supplying the kidneys;
• you have primary hyperaldosteronism (a condition where the adrenal glands produce too much aldosterone);
• you have heart failure or have had a heart attack - your doctor may monitor your kidney function;
• you have narrowing of the heart valves (e.g., aortic or mitral stenosis) or significant thickening of the heart muscle (hypertrophic cardiomyopathy);
• you have had angioedema (swelling of the face, lips, tongue, or throat) with other medicines (including ACE inhibitors);
• you 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 monitor your kidney function, blood pressure, and potassium levels. See also "Do not take Sartesta" and "Warnings and precautions". If any of the above applies 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 the medicines you are taking or have recently taken, and about any medicines you plan to 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.

Sartesta with food and drink

Do not eat grapefruit or drink grapefruit juice while taking Sartesta, as it may increase the levels of amlodipine in your blood, leading to unpredictable and increased effects of Sartesta.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, 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 might 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. You should not take Sartesta during the first 3 months of pregnancy and you must not take it after the third month of pregnancy, as it may harm your baby.

Breast-feeding

Tell your doctor if you are breast-feeding or about to start breast-feeding. You should not take Sartesta while breast-feeding. Your doctor may prescribe a different treatment for you if you want to breast-feed, especially if your baby is a newborn or premature.

It has been shown that small amounts of amlodipine are excreted in breast milk.

Driving and using machines

This medicine may cause dizziness. If you feel dizzy, do not drive or operate machinery.

3. How to take Sartesta

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. The recommended dose is one tablet per day. Your doctor will decide the best dose 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.

• Take the tablet at the same time each day.
• Swallow the tablet with a glass of water.
• You can take Sartesta with or without food. Do not take Sartesta with grapefruit or grapefruit juice.

Depending on how you respond to the treatment, your doctor may increase or decrease the dose. Do not take more than the recommended dose.

Taking Sartesta in patients over 65 years of age

Your doctor will be cautious when increasing the dose.

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

Use in children and adolescents

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

If you take more Sartesta than you should

If you have taken too many tablets, contact your doctor immediately.

If you forget to take Sartesta

If you forget to take a dose, take it as soon as you remember. Take the next dose at the usual time. 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.

If you stop taking Sartesta

Stopping Sartesta may cause your blood pressure to rise. Do not stop taking Sartesta without talking to your doctor.

4. Possible side effects

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

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

Some patients have experienced serious side effects (occurring in less than 1 in 1,000 patients).

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

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

Other possible side effects of Sartesta:

Common (occurring in less than 1 in 10 patients):flu-like symptoms; stuffy nose, sore throat, and discomfort when swallowing; headache; swelling of the arms, hands, legs, ankles, or feet; tiredness; weakness; flushing and feeling of warmth in the face and/or neck.

Uncommon (occurring in less than 1 in 100 patients):dizziness; nausea and stomach pain; dry mouth; drowsiness, tingling, and numbness of the hands and feet; vertigo; fast heartbeat; dizziness when standing up; cough; diarrhea; constipation; skin rash, redness of the skin; joint swelling, back pain; joint pain.

Rare (occurring in less than 1 in 1,000 patients):feeling anxious; ringing in the ears (tinnitus); fainting; increased urine production or feeling the need to urinate more often; impotence; feeling heavy; low blood pressure, with symptoms such as dizziness, fainting; excessive sweating; skin rash all over the body; itching; muscle cramps.

If any of these side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

Side effects reported with amlodipine or valsartan alone, but not with Sartesta, or more frequently with Sartesta than with amlodipine or valsartan alone:

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

• sudden wheezing, chest pain, or difficulty breathing;
• swelling of the eyelids, face, or lips;
• swelling of the tongue and/or throat, causing great difficulty in breathing;
• severe skin reactions, including severe rash, itching, and blistering;
• heart attack or abnormal heart rhythm;
• pancreatitis, which may cause severe abdominal pain and very serious illness.

Other side effects reported with amlodipine:

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

Uncommon (occurring in less than 1 in 100 patients):mood changes, anxiety, depression, insomnia, tremor, taste disturbances, fainting, loss of pain; visual disturbances, blurred vision, ringing in the ears; low blood pressure; sneezing and/or runny nose (rhinitis); indigestion, vomiting; hair loss, increased sweating, itching, skin discoloration; urinary disorders, increased need to urinate at night, frequent urination; erectile dysfunction, breast tenderness in men, pain, general feeling of being unwell, muscle pain, muscle cramps; weight gain or loss.

Rare (occurring in less than 1 in 1,000 patients):disorientation.

Very rare (occurring in less than 1 in 10,000 patients):reduction in white blood cell count, reduction in platelet count, which may lead to an increased risk of bleeding or bruising; increased blood sugar levels (hyperglycemia); gum swelling, abdominal bloating (gastritis); liver disorders, liver inflammation, yellowing of the skin (jaundice), increased liver enzyme levels; increased muscle tension; inflammation of blood vessels, often with skin rash, sensitivity to sunlight; disorders that include stiffness, tremor, and/or movement difficulties.

Other side effects reported with valsartan:

Unknown frequency (cannot be estimated from the available data):reduction in red blood cell count, fever, sore throat, or mouth ulcers due to infections; spontaneous bleeding or bruising; high levels of potassium in the blood; abnormal liver function tests; worsening of kidney function and severe kidney problems; swelling, mainly of the face and throat; muscle pain; skin rash, purple spots; fever; itching; allergic reactions, blistering of the skin (pemphigus).

If you experience any of these side effects, tell your doctor immediately.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in the "Further information" section.

5. How to store Sartesta

Do not store above 25°C.

Store in the original package to protect from moisture.

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 throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures 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 tablet contains 5 mg amlodipine (as amlodipine maleate) and 80 mg valsartan. Each 5 mg + 160 mg tablet contains 5 mg amlodipine (as amlodipine maleate) and 160 mg valsartan. Each 10 mg + 160 mg 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: dark yellow, round, biconvex film-coated tablets, 8 mm in diameter.

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

Sartesta 10 mg + 160 mg: light yellow, oval, biconvex film-coated tablets with a symbol "10" engraved 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 Authorisation Holder and Manufacturer

Zakłady Farmaceutyczne POLPHARMA SA

ul. Pelplińska 19

83-200 Starogard Gdański

For more information, contact your local representative of the Marketing Authorisation 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: