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
Please read carefully the entire leaflet before taking this medicine, as it contains important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

1. What Sartesta is and what it is 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 Sartesta is and what it is 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 channel blockers. It prevents calcium from entering the walls of blood vessels, thereby inhibiting blood vessel constriction.
• 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, leading to increased blood pressure. Valsartan blocks the action of angiotensin II. As a result, both substances prevent blood vessel constriction. Consequently, blood vessels relax and blood pressure decreases.

Sartesta is used for the treatment of high blood pressure in adult patients whose blood pressure is not sufficiently controlled with amlodipine or valsartan alone.

2. Important information before taking Sartesta

When not to use Sartesta

• if you are allergic to amlodipine or other medicines in the calcium channel blocker group – symptoms may include itching, skin redness, or breathing difficulties;
• if you are allergic to valsartan or any of the other ingredients of this medicine (listed in section 6) – if you suspect you may be allergic, consult your doctor before taking Sartesta;
• if you have severe liver dysfunction or biliary disorders such as biliary cirrhosis or cholestasis;
• after the third month of pregnancy (Sartesta should also be avoided during early pregnancy; see section "Pregnancy and breastfeeding");
• if you have significantly low blood pressure (hypotension);
• if you have aortic valve stenosis or cardiogenic shock (a condition in which the heart is unable to deliver sufficient blood to the body's cells);
• if you have heart failure following a myocardial infarction;
• if you have diabetes or kidney dysfunction and are being treated with 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 starting Sartesta, discuss with your doctor if:

• you are experiencing vomiting or diarrhoea;
• you have liver or kidney dysfunction;
• you have had a kidney transplant or have renal artery stenosis;
• you have adrenal gland disorders known as primary hyperaldosteronism;
• you have heart failure or have had a myocardial infarction – strictly follow your doctor's advice regarding initiation of treatment; your doctor may also recommend monitoring kidney function;
• you have heart valve stenosis (aortic or mitral stenosis) or significant thickening of the heart muscle (hypertrophic cardiomyopathy with outflow tract obstruction);
• you have previously experienced swelling, particularly of the face and throat, while taking other medicines (including angiotensin-converting enzyme inhibitors) – if such symptoms occur, stop taking Sartesta immediately, contact your doctor, and never take Sartesta again;
• 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 recommend regular monitoring of kidney function, blood pressure, and blood electrolyte levels (e.g. potassium).
See also the section "When not to use Sartesta".
If any of the above conditions apply to you, inform your doctor before taking Sartesta.

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

Sartesta with other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
Your doctor may recommend adjusting the dose and/or taking additional precautions. In some cases, discontinuation of one of the medicines may be necessary. This particularly applies to the following medicines:

• ACE inhibitors or aliskiren (see also sections "When not to use Sartesta" and "Warnings and precautions");
• diuretics (medicines that increase urine production);
• lithium (a medicine used to treat certain forms of depression);
• potassium-sparing diuretics, potassium supplements, potassium-containing salt substitutes, and other substances that may increase potassium levels;
• painkillers known as non-steroidal anti-inflammatory drugs (NSAIDs) or selective cyclooxygenase-2 (COX-2) inhibitors – your doctor may recommend monitoring kidney function;
• anticonvulsants (e.g. carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone);
• St. John's wort (Hypericum perforatum);
• glyceryl trinitrate and other nitrates or other vasodilating substances;
• medicines used to treat HIV/AIDS infection (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 (medicines used for heart conditions);
• simvastatin (a medicine used to reduce high cholesterol levels in the blood);
• dantrolene (used intravenously in severe disturbances of body temperature);
• medicines used to prevent rejection of transplanted organs (cyclosporine).

Sartesta with food and drink
While taking Sartesta, do not eat grapefruit or drink grapefruit juice, as both grapefruit and grapefruit juice may increase blood levels of the active substance amlodipine, potentially leading to unpredictable intensification of Sartesta's effect, particularly lowering of blood pressure.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, suspect you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before taking this medicine.

Pregnancy
Inform your doctor if you are pregnant, suspect you may be pregnant, or are planning pregnancy. Your doctor will usually advise stopping Sartesta before planned pregnancy or immediately after pregnancy is confirmed, and will recommend an alternative medicine instead of Sartesta.
Sartesta is not recommended during early pregnancy (first 3 months) and must not be used after the third month of pregnancy, as it may seriously harm the unborn child if used beyond 3 months of gestation.

Breastfeeding
Inform your doctor if you are breastfeeding or intend to breastfeed. Sartesta is not recommended during breastfeeding. Your doctor may recommend alternative treatment if you wish to breastfeed, particularly if the infant is a newborn or premature.
It has been shown that small amounts of amlodipine pass into human milk.

Driving and operating machinery
This medicine may cause dizziness, which may impair your ability to concentrate. Therefore, do not drive, operate machinery, or perform other tasks requiring mental alertness if you are uncertain about how this medicine affects you.

3. How to take Sartesta

This medicine should always be taken as prescribed by your doctor. If you have any doubts, consult your doctor. This will help achieve the best treatment results and reduce the risk of adverse effects.
The usual dose of Sartesta is 1 tablet per day. Your doctor will determine the appropriate dose for you, 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 daily.

• It is recommended to take the medicine at the same time every day.
• Tablets should be swallowed with a glass of water.
• Sartesta may be taken during or regardless of meals. Do not take Sartesta together with grapefruit or grapefruit juice.

Depending on the response to treatment, your doctor may recommend adjusting the dose to a higher or lower strength.
Do not take more than the recommended dose.
Use of Sartesta in elderly patients (aged 65 years and above)
Your doctor will exercise caution when increasing the dose.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.
Use in children and adolescents
The use of this medicine is not recommended in children and adolescents.
Taking more Sartesta than prescribed
If you or someone else has taken too many Sartesta tablets, contact a doctor immediately.
Missing a dose of Sartesta
If you forget to take your dose, take it as soon as possible. Take the next dose at your 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 the missed one.
Stopping Sartesta
Stopping treatment with Sartesta may lead to worsening of the condition. Do not discontinue the medicine unless instructed by your doctor.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Some adverse effects may be serious and may require immediate medical attention:
Severe adverse reactions have occurred in a few patients (occurring in less than 1 in 1,000 patients).
If any of the following symptoms occur, contact your doctor immediately:
Allergic reaction, with symptoms such as: rash, itching, swelling of the face, lips or tongue,
difficulty breathing, low blood pressure (feeling faint or dizzy).

Other possible adverse effects of Sartesta:
Common (occur in less than 1 in 10 patients): flu-like symptoms; nasal congestion, sore throat and
discomfort when swallowing; headache; swelling of arms, hands, legs, ankles or feet; fatigue;
asthenia (weakness); flushing and sensation of warmth in the face and (or) neck.
Uncommon (occur in less than 1 in 100 patients): central dizziness;
nausea and abdominal pain; dryness of the oral mucosa; drowsiness, tingling and numbness in hands and feet;
vestibular dizziness, rapid heartbeat including palpitations; dizziness upon standing; cough; diarrhoea;
constipation; skin rash, skin redness; joint swelling, back pain; joint pain.
Rare (occur in less than 1 in 1,000 patients): feeling of anxiety; ringing in the ears (tinnitus);
fainting; increased urine output or sensation of stronger urge to urinate;
inability to achieve or maintain erection; feeling of heaviness; low blood pressure, with symptoms
such as: dizziness, feeling of lightheadedness; excessive sweating; skin rash over the entire body;
itching; muscle cramps.
If any of these symptoms worsen, inform your doctor.

Adverse effects reported after administration of amlodipine or valsartan alone, which have not been observed after administration of Sartesta or which have been observed more frequently with amlodipine or valsartan than with Sartesta:

Amlodipine
Contact your doctor immediately if any of the following very rare, serious adverse effects occur after taking the medicine:

• sudden, wheezing breath, chest pain, shortness of breath or difficulty breathing;
• swelling of eyelids, face or lips;
• swelling of the tongue and throat causing significant breathing difficulties;
• severe skin reactions, including severe skin rash, urticaria, generalized redness of the skin, intense itching, formation of blisters, skin peeling and swelling, mucosal inflammation (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions;
• heart attack, cardiac arrhythmias;
• pancreatitis, which may cause severe upper abdominal pain radiating to the back, accompanied by a very poor general condition.

The following adverse effects have been reported. If any of these adverse effects are bothersome to the patient or persist for more than one week, contact your doctor.
Common (occur in less than 1 in 10 patients): dizziness, drowsiness; palpitations (awareness of heartbeat); sudden flushing, especially of the face and neck; ankle swelling (oedema); abdominal pain, nausea.
Uncommon (occur in less than 1 in 100 patients): mood changes, anxiety, depression, insomnia, tremor, taste disturbances, fainting, loss of pain sensation; visual disturbances, blurred vision, tinnitus; low blood pressure; sneezing and (or) nasal discharge due to inflammation of the nasal mucosa (rhinitis); indigestion, vomiting; hair loss, increased sweating, skin itching, skin discoloration; urinary disorders, increased need to urinate at night, increased frequency of urination; erectile dysfunction, discomfort or enlargement of breasts in men, pain, malaise, muscle pain, muscle cramps; weight gain or weight loss.
Rare (occur in less than 1 in 1,000 patients): disorientation.
Very rare (occur in less than 1 in 10,000 patients): decreased number of white blood cells, decreased number of platelets, which may lead to unusual bruising and easier bleeding; increased blood glucose levels (hyperglycaemia); gum swelling, abdominal distension (dyspepsia); liver function disorders, hepatitis, yellowing of the skin (jaundice), increased liver enzyme activity, which may affect certain test results; increased muscle tension; vasculitis, often with skin rash, photosensitivity; movement disorders involving stiffness, tremor and (or) difficulty moving.

Valsartan
Unknown (frequency cannot be estimated from available data): decreased number of red blood cells, fever, sore throat or ulceration of the oral mucosa due to infection; spontaneous bleeding or bruising; high potassium levels in the blood; abnormal liver function test results; worsening of kidney function and severe kidney disorders; swelling, mainly of the face and throat; muscle pain; rash, purplish-red spots; fever; itching; allergic reactions, blistering of the skin (symptom of a disease called bullous pemphigoid).
In case any of these symptoms occur, inform your doctor immediately.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects 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
e-mail: [email protected]
Adverse effects may also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Sartesta

Do not store above 25°C.
Keep in the original packaging to protect from moisture.
Keep the medicine 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 specified month.
The marking on the packaging following "EXP" indicates the expiry date, and following "Lot" or "LOT" indicates the batch number.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. 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.
• 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.
Aluminium/PVC/PCTFE blisters.
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 further information, please contact the local representative of the Marketing Authorisation Holder:
POLPHARMA Biuro Handlowe Sp. z o.o.
ul. Bobrowiecka 6
00-728 Warsaw
tel. 22 364 61 01