Sarpin

Patient Information Leaflet

Sarpin, 10 mg + 160 mg, film-coated tablets
Amlodipine + Valsartan
Please read 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, 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, tell your doctor or pharmacist. See section 4.

Leaflet Contents

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

1. What Sarpin is and what it is used for

Sarpin tablets contain two active substances: amlodipine and valsartan. Both of these substances help control high blood pressure.

• Amlodipine belongs to a group of medicines called "calcium channel blockers". Amlodipine prevents calcium from entering the walls of blood vessels, which helps prevent blood vessel constriction.
• Valsartan belongs to a group of medicines called "angiotensin II receptor antagonists". Angiotensin II is a substance produced in the human body that causes blood vessels to constrict, thereby increasing blood pressure. Valsartan works by blocking the effects of angiotensin II. This means that both of these substances help prevent constriction of blood vessels. As a result, blood vessels relax and blood pressure is lowered.

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

2. Important information before using Sarpin

When not to use Sarpin:

• if the patient is allergic to amlodipine or other medicines in the group of calcium channel blockers. Symptoms may include itching, skin redness, or difficulty breathing;
• if the patient is allergic to valsartan or any of the other ingredients of this medicine (listed in section 6). If the patient suspects an allergy, they should inform the doctor before using Sarpin;
• if the patient has severe liver function disorders or biliary disorders such as primary biliary cirrhosis or biliary obstruction;
• if the patient is in the third trimester of pregnancy (Sarpin should also be avoided in early pregnancy; see section "Pregnancy");
• if the patient has significantly low blood pressure (hypotension);
• if the patient has aortic valve stenosis or cardiogenic shock (a condition in which the heart cannot deliver sufficient blood to the body's cells);
• if the patient has heart failure caused by a previous heart attack;
• if the patient has diabetes or kidney problems and is taking blood pressure-lowering medicines containing aliskiren.

If any of the above conditions apply, Sarpin must not be used and the patient should speak to their doctor.
Warnings and precautions
Before starting treatment with Sarpin, consult a doctor:

• if the patient has gastrointestinal disorders (vomiting, diarrhoea);
• if the patient has liver or kidney function disorders;
• if the patient has received a kidney transplant or has been informed of renal artery stenosis;
• if the patient has adrenal gland disorders known as "primary hyperaldosteronism";
• if the patient has had heart failure or a previous heart attack. Strict adherence to the doctor's recommendations regarding the initial dose is essential. The doctor may also monitor kidney function;
• if the patient has been diagnosed with heart valve stenosis ("aortic or mitral stenosis") or significantly increased thickness of the heart muscle ("hypertrophic cardiomyopathy with outflow tract obstruction");
• if the patient has previously experienced swelling, particularly of the face and throat, while taking other medicines (including angiotensin-converting enzyme inhibitors). If such symptoms occur, Sarpin must be discontinued immediately and the doctor contacted without delay. The patient must never use Sarpin again;
• if the patient is taking any of the following medicines for high blood pressure:
• ACE inhibitors (e.g. enalapril, lisinopril, ramipril), especially if the patient has kidney problems due to diabetes;
• aliskiren.

The treating physician may monitor kidney function, blood pressure, and blood electrolyte levels (e.g. potassium) at regular intervals.
See also information under the heading "When not to use Sarpin".
If any of the above conditions apply, the patient must inform their doctor before using Sarpin.
If abdominal pain, nausea, vomiting, or diarrhoea occur after taking Sarpin, the patient should discuss this with their doctor. The doctor will decide on further treatment. The patient must not stop taking Sarpin on their own.

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

Sarpin with other medicines
Inform the doctor or pharmacist about all medicines currently used, recently used, or planned for use. The doctor may need to adjust the dose and/or take 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 information under "When not to use Sarpin" and "Warnings and precautions");
• diuretics ("water tablets" that increase urine production);
• lithium (a medicine used to treat certain types of depression);
• potassium-sparing diuretics, potassium supplements, potassium-containing salt substitutes, and other substances that may increase potassium levels;
• certain painkillers known as non-steroidal anti-inflammatory drugs (NSAIDs) or selective cyclooxygenase-2 (COX-2) inhibitors. The doctor may also monitor kidney function;
• anticonvulsants (e.g. carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone);
• St. John's wort (Hypericum perforatum);
• nitroglycerin and other nitrates or other "vasodilating" substances;
• medicines used in HIV/AIDS treatment (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, telithromycin);
• clarithromycin (used to treat bacterial infections);
• verapamil, diltiazem (medicines used in heart conditions);
• simvastatin (a medicine used to reduce high cholesterol levels in the blood);
• dantrolene (intravenous infusion used in severe disturbances of body temperature);
• tacrolimus (used to control the immune system's response to allow acceptance of a transplanted organ);
• medicines used to prevent transplant rejection (cyclosporine).

Sarpin with food and drink
Patients taking Sarpin should not eat grapefruit or drink grapefruit juice. Both grapefruit and grapefruit juice may increase blood levels of the active substance amlodipine, which could lead to unpredictable intensification of Sarpin's blood pressure-lowering effect.

Pregnancy and breastfeeding
Pregnancy
Inform the doctor if the patient suspects she is pregnant or plans to become pregnant. The doctor will usually advise stopping Sarpin before planned pregnancy or immediately after pregnancy is confirmed, and will recommend an alternative medicine. Sarpin is not recommended during early pregnancy (first three months) and must not be used after the third month of pregnancy, as it may cause serious harm to the unborn child if used during this period.

Breastfeeding
Amlodipine:
It has been shown that small amounts of amlodipine pass into human milk. If the patient is breastfeeding or plans to breastfeed, she should inform the doctor before starting Sarpin.

Amlodipine/Valsartan:
Inform the doctor about breastfeeding or plans to breastfeed. Sarpin is not recommended for use in breastfeeding women. The doctor may choose an alternative treatment during breastfeeding, especially when nursing newborns or premature infants.

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before using this medicine.

Driving and operating machinery
This medicine may cause dizziness, which may impair concentration. Therefore, patients should not drive, operate machinery, or perform any other tasks requiring mental alertness if they are uncertain about how the medicine affects them.

Sarpin contains sodium
The medicinal product contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Sarpin

This medicine should always be taken exactly as directed by the physician. In case of doubt, consult
your doctor. This will help achieve the best treatment outcomes and reduce the risk of adverse
effects.
The usual recommended dose of Sarpin is 1 tablet per day.

• It is recommended to take the medicine at the same time each day.
• Tablets should be swallowed with a glass of water.
• Sarpin can be taken with or without food. Do not take Sarpin together with grapefruit or grapefruit juice.

Depending on the response to treatment, the physician may recommend a higher or lower dose.
Do not exceed the prescribed dose.
Use of Sarpin in elderly patients (aged 65 years and older)
The physician should exercise caution when increasing the dose.
If you have any further questions regarding the use of this medicine, consult your
doctor or pharmacist.
Taking more Sarpin than recommended
If too many Sarpin tablets have been taken or if the tablets have been accidentally ingested by
someone else, consult a doctor immediately.
Breathing difficulties due to excess fluid accumulating in the lungs (pulmonary edema) may occur
within 24–48 hours after taking the medicine.
Missed dose of Sarpin
If a patient forgets to take the medicine, it should be taken as soon as possible. The next dose
should be taken at the usual time. However, if the next dose is due soon, the missed dose should
be skipped. Do not take a double dose to make up for a missed dose.
Stopping Sarpin treatment
Stopping treatment with Sarpin may worsen the condition. Do not discontinue use unless instructed
by a doctor.
If you have any further questions about the use of this medicine, consult your
doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Some adverse reactions may be serious and may require immediate medical attention:
Severe adverse reactions have occurred in a few patients (may affect up to 1 in 1,000 patients).
If you experience any of the symptoms listed below, 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 of weakness, dizziness).

Other possible adverse reactions of Sarpin:
Common (may affect up to 1 in 10 patients): Influenza-like illness; nasal congestion, sore throat and discomfort during 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 (may affect up to 1 in 100 patients): Dizziness; nausea and abdominal pain; dry mouth; drowsiness, tingling or numbness of hands and feet; dizziness, rapid heartbeat including palpitations; dizziness upon standing; cough; diarrhoea; constipation; skin rash, skin redness; joint swelling, back pain; joint pain.
Rare (may affect up to 1 in 1,000 patients): Feeling of restlessness; tinnitus (ringing in the ears); fainting; passing more urine than usual or feeling a stronger urge to urinate; inability to achieve or maintain an erection; feeling of heaviness; low blood pressure with symptoms such as: dizziness, feeling of dizziness; excessive sweating; rash over the entire body; itching; muscle cramps.
If any of these symptoms occur severely, inform your doctor.

Adverse reactions reported after administration of amlodipine alone or walsartan alone, which have not been observed after administration of Sarpin or which have been observed more frequently with amlodipine or walsartan alone than with Sarpin:

Amlodipine
If any of the following very rare, serious adverse reactions occur after taking the medicine, contact your doctor immediately:

• Sudden onset of wheezing, chest pain, shortness of breath or difficulty breathing.
• Swelling of eyelids, face and lips.
• Swelling of the tongue and throat, causing significant breathing difficulties.
• Severe skin reactions including: intense rash, urticaria, generalized skin redness, severe itching, blisters, skin peeling and swelling, mucosal inflammation (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions.
• Myocardial infarction, heart rhythm disorders.
• Pancreatitis, which may cause acute abdominal and back pain accompanied by severe malaise.

The following adverse reactions have been reported. If any of these adverse reactions are bothersome to the patient or persist for more than one week, contact your doctor.
Common (may affect up to 1 in 10 patients): Dizziness, drowsiness; palpitations (awareness of heartbeat); hot flushes; ankle swelling (edema); abdominal pain, nausea.
Uncommon (may affect up to 1 in 100 patients): Mood changes, anxiety, depression, insomnia, tremor, taste disturbances, fainting, lack of pain sensation; visual disturbances, worsening of vision, tinnitus; low blood pressure; sneezing/cold due to inflammation of the nasal mucosa; indigestion, vomiting; hair loss, increased sweating, skin itching, skin discoloration; urinary disturbances, increased need to urinate at night, increased frequency of urination; erectile problems, discomfort or enlargement of breast tissue in men, pain, malaise, muscle pain, painful muscle cramps; weight gain or weight loss.
Rare (may affect up to 1 in 1,000 patients): Disorientation.
Very rare (may affect up to 1 in 10,000 patients): Decreased white blood cell count, decreased platelet count, which may lead to unusual bruising and easier bleeding (damage to red blood cells); excessively high blood glucose levels (hyperglycaemia); gum swelling, abdominal bloating (gastric mucosal inflammation); abnormal liver function, 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 including stiffness, tremor and (or) difficulty moving.
Frequency unknown: tremor, postural rigidity, facial mask-like expression, slowed movements and shuffling gait.

Walsartan
Very rare (may affect up to 1 in 10,000 people): Angioedema of the intestine: intestinal swelling with symptoms such as abdominal pain, nausea, vomiting and diarrhoea.
Frequency unknown (frequency cannot be estimated from available data): Decreased red blood cell count, fever, sore throat or mouth ulcers due to infection; spontaneous bleeding or bruising; high potassium levels in the blood; abnormal liver function test results; kidney function disorders and severe kidney dysfunction; swelling, mainly of the face and throat; muscle pain; rash, purple-red blisters; fever; itching; allergic reactions, skin blisters (symptoms of a disease called bullous pemphigoid).
If any of these symptoms occur, inform your doctor immediately.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. Adverse reactions 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, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
By reporting adverse reactions, more information on the safety of this medicine can be collected.

5. How to store the medicine Sarpin

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label, carton, and blister pack
after: EXP. The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicinal product.
Medicines must 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 Sarpin contains

• The active substances in this medicine are amlodipine and valsartan.

Each tablet contains 10 mg of amlodipine (as amlodipine besilate) and 160 mg of valsartan.

• Other ingredients are:
  Core: microcrystalline cellulose (Grade-101), colloidal anhydrous silica, sodium carboxymethyl starch (type A), povidone (K-30), pregelatinized corn starch, magnesium stearate.
  Coating: hypromellose 2910, talc, titanium dioxide (E171), macrogol 4000, yellow iron oxide (E172), red iron oxide (E172).

What Sarpin looks like and contents of the pack
Film-coated tablet
Light yellow, oval, biconvex film-coated tablet with bevelled edges, embossed with
"J" on one side and "38" on the other side.
Sarpin, film-coated tablets, is available in blisters made of Polymide/Aluminium/PVC-Aluminium foil and in HDPE bottles with polypropylene caps containing silica gel as a desiccant to absorb moisture.
Pack sizes:
Blisters: 14, 28, 30, 56, 90 and 98 film-coated tablets.
HDPE bottles: 100, 250 and 500 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Aurovitas Pharma Polska Sp. z o.o.
Sokratesa 13D lok. 27
01-909 Warsaw
Poland
Manufacturer/Importer
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
This medicinal product is authorised in the European Economic Area member states under the following names:
Netherlands: Amlodipine/Valsartan Aurobindo 5 mg/80 mg; 5 mg/160 mg; 10 mg/160 mg, film-coated tablets
Germany: Amlodipin/Valsartan PUREN 5 mg/80 mg; 5 mg/160 mg; 10 mg/160 mg film-coated tablets
Poland: Sarpin
Portugal: Amlodipina+Valsartan Aurovitas