Sarpin

Leaflet included in the packaging: information for the user

Sarpin, 10 mg + 160 mg, coated tablets

Amlodipine+Valsartan
You should carefully read the contents of the leaflet before taking the medicine, as it contains
important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any further questions, you should ask your doctor or pharmacist.
• This medicine has been prescribed to you by a doctor. Do not give it to others. The medicine may harm them, even if their symptoms are the same as yours.
• If any of the following side effects occur in the patient, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Sarpin and what is it 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 substances called "calcium channel blockers". Amlodipine prevents calcium from entering the walls of blood vessels, which prevents the blood vessels from contracting.
• Valsartan belongs to a group of substances called "angiotensin II receptor antagonists". Angiotensin II is produced in the human body and causes blood vessels to contract, increasing blood pressure. Valsartan works by blocking the action of angiotensin II. This means that both of the above substances help block the contraction 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 who are not adequately controlled by amlodipine or valsartan alone.

2. Important information before taking Sarpin

When not to take Sarpin:

• if the patient is allergic to amlodipine or other calcium channel blockers. This may cause swelling, redness of the skin, 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 thinks they may be allergic, they should inform their doctor before taking Sarpin;
• if the patient has severe liver or kidney problems, such as liver cirrhosis or cholestasis;
• if the patient is pregnant after the third month of pregnancy (Sarpin should also be avoided in early pregnancy, see "Pregnancy");
• if the patient has severely low blood pressure (hypotension);
• if the patient has narrowing of the aortic valve (aortic stenosis) or cardiogenic shock (a condition where the heart is unable to supply enough blood to the body's cells);
• if the patient has heart failure following a heart attack.
• if the patient has diabetes or kidney problems and is taking blood pressure-lowering medicines that contain aliskiren.

If any of the above points apply to the patient, they should not take Sarpin and should discuss this with their doctor.

Warnings and precautions

Before starting to take Sarpin, the patient should tell their doctor:

• if they have gastrointestinal problems (vomiting, diarrhea);
• if they have liver or kidney problems;
• if they have had a kidney transplant or have been told they have narrowing of the renal arteries;
• if they have primary hyperaldosteronism (a condition where the adrenal glands produce too much aldosterone);
• if they have severe heart failure or have had a heart attack. The doctor may need to monitor the patient's kidney function and adjust the dose of Sarpin accordingly;
• if the patient has been told they have narrowing of the heart valves (called "aortic or mitral stenosis") or significant thickening of the heart muscle (called "hypertrophic cardiomyopathy with outflow obstruction");
• if the patient has had an allergic reaction, especially swelling of the face or throat, while taking other medicines (including ACE inhibitors). If the patient experiences such symptoms, they should stop taking Sarpin and contact their doctor immediately. The patient should never take Sarpin again.
• if the patient is taking any of the following medicines for high blood pressure:
• ACE inhibitors (such as enalapril, lisinopril, ramipril), especially if the patient has kidney problems related to diabetes;
• aliskiren.

The doctor may need to monitor the patient's kidney function, blood pressure, and electrolyte levels (such as potassium) at regular intervals.
See also the information under "When not to take Sarpin".

If any of the above points apply to the patient, they should tell their doctor before taking Sarpin.

Children and adolescents

Sarpin should not be used in children and adolescents (under 18 years of age).

Sarpin and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. The doctor may need to adjust the dose and/or take other precautions. In some cases, it may be necessary to stop taking one of the medicines. This is especially true for the following medicines:

• ACE inhibitors or aliskiren (see also the information under "When not to take Sarpin" and "Warnings and precautions");
• diuretics (water pills that increase the amount of urine produced);
• lithium (a medicine used to treat certain types of depression);
• potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium, and other substances that may increase potassium levels;
• certain pain relievers called non-steroidal anti-inflammatory drugs (NSAIDs) or selective cyclooxygenase-2 (COX-2) inhibitors. The doctor may also need to monitor the patient's kidney function;
• antiepileptic drugs (such as carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone);
• St. John's Wort;
• nitroglycerin and other nitrates or other substances that "widen blood vessels"
• medicines used to treat HIV/AIDS (such as ritonavir, indinavir, nelfinavir);
• medicines used to treat fungal infections (such as ketoconazole, itraconazole);
• medicines used to treat bacterial infections (such as rifampicin, erythromycin, telithromycin);
• clarithromycin (used to treat bacterial infections);
• verapamil, diltiazem (medicines used to treat heart conditions);
• simvastatin (a medicine used to lower high cholesterol levels in the blood);
• dantrolene (an injection used in severe disturbances of body temperature);
• tacrolimus (used to control the immune system's response, allowing the body to accept 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 can increase the levels of the active substance amlodipine in the blood, which can lead to unpredictable strengthening of the effect of Sarpin, which is based on lowering blood pressure.

Pregnancy and breastfeeding

Pregnancy
The patient should inform their doctor if they are pregnant or plan to become pregnant. The doctor will usually advise the patient to stop taking Sarpin before planned pregnancy or as soon as pregnancy is detected and will prescribe another medicine instead of Sarpin. Sarpin 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 unborn baby if taken 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, they should inform their doctor before taking Sarpin.
Amlodipine/Valsartan:
The patient should inform their doctor about breastfeeding or plans to breastfeed. Sarpin should not be taken by breastfeeding women. The doctor may choose another treatment during breastfeeding, especially in the case of newborns and premature babies.
If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to become pregnant, they should consult their doctor or pharmacist before taking this medicine.

Driving and using machines

This medicine may cause dizziness. This can affect the patient's ability to concentrate. Therefore, the patient should not drive vehicles, operate machines, or perform other activities that require concentration of attention if they are unsure about the effect of the medicine on them.

Sarpin contains sodium

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

3. How to take Sarpin

This medicine should always be taken exactly as prescribed by the doctor. If the patient is unsure, they should ask their doctor. This will help the patient get the best results from the treatment and reduce the risk of side effects.
The recommended dose of Sarpin is one tablet per day.

• The patient should take the medicine at the same time every day.
• The tablets should be swallowed with a glass of water.
• Sarpin can be taken with or without food. The patient should not take Sarpin with grapefruit or grapefruit juice.

Depending on the patient's response to the treatment, the doctor may prescribe a higher or lower dose of Sarpin.
The patient should not exceed the prescribed dose.

Taking Sarpin in elderly patients (65 years of age and older)

When increasing the dose, the doctor should be cautious.
If the patient has any further questions about taking this medicine, they should ask their doctor or pharmacist.

Taking a higher dose of Sarpin than recommended

If the patient has taken too many Sarpin tablets or if someone else has taken the tablets by mistake, they should contact their doctor immediately.
Even 24-48 hours after taking the medicine, shortness of breath due to excess fluid accumulation in the lungs (pulmonary edema) may occur.

Missing a dose of Sarpin

If the patient forgets to take a dose, 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. The patient should not take a double dose to make up for the missed dose.

Stopping treatment with Sarpin

Stopping treatment with Sarpin may worsen the disease. The patient should not stop taking Sarpin unless their doctor tells them to.
If the patient has any further questions about taking this medicine, they should ask their doctor or pharmacist.

4. Possible side effects

Like all medicines, Sarpin 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 occurred in a few patients (may affect up to 1 in 1000 patients). If any of the following symptoms occur, the patient should immediately inform their doctor:
allergic reaction with symptoms such as rash, swelling, face or lip swelling, or tongue swelling, difficulty breathing, low blood pressure (feeling weak, dizzy).

Other possible side effects of Sarpin:

Common (may affect up to 1 in 10 patients):flu; runny nose, 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 (may affect up to 1 in 100 patients):dizziness; nausea and stomach pain; dry mouth; drowsiness, tingling, or numbness of the hands and feet; dizziness, fast 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 (may affect up to 1 in 1000 patients):anxiety; ringing in the ears (tinnitus); fainting; increased urine production or feeling of frequent urination; impotence or difficulty maintaining an erection; feeling of heaviness; low blood pressure with symptoms such as dizziness, feeling dizzy; excessive sweating; skin rash, hives; muscle pain; muscle cramps.

If any of these symptoms occur in a severe form, the patient should inform their doctor.

Side effects reported after taking only amlodipine or only valsartan, and which have not been observed after taking Sarpin or have been observed more frequently after taking Sarpin:

Amlodipine

If any of the following very rare, serious side effects occur after taking the medicine, the patient should immediately contact their doctor:

• Sudden onset of wheezing, chest pain, shortness of breath, or difficulty breathing.
• Swelling of the eyelids, face, and lips.
• Swelling of the tongue and throat, causing severe difficulty breathing.
• Severe skin reactions including intense rash, hives, redness of the skin, severe itching, blistering, and peeling of the skin, Stevens-Johnson syndrome, toxic epidermal necrolysis, or other allergic reactions.
• Heart attack, irregular heartbeat.
• Pancreatitis, which can cause severe abdominal and back pain, as well as a very bad feeling.

The following side effects have been reported. If any of the side effects are troubling the patient or last for more than a week, they should contact their doctor.
Common (may affect up to 1 in 10 patients):dizziness, drowsiness; palpitations (feeling of heartbeat); hot flashes; swelling of the ankles (edema); stomach pain, nausea.
Uncommon (may affect up to 1 in 100 patients):mood changes, anxiety, depression, insomnia, tremors, changes in taste, fainting, lack of sensation; vision disturbances, worsening of vision, tinnitus; low blood pressure; sneezing/runny nose caused by sinusitis; indigestion, vomiting; hair loss, increased sweating, flushing of the skin, skin discoloration; urinary disturbances, increased need to urinate at night, increased frequency of urination; erection problems, discomfort or enlargement of the breasts in men, pain, malaise, muscle pain, painful muscle spasms; weight gain or loss.
Rare (may affect up to 1 in 1000 patients):disorientation.
Very rare (may affect up to 1 in 10,000 patients):decreased white blood cell count, decreased platelet count, which can lead to unusual bruising and bleeding (blood cell damage); high blood sugar levels (hyperglycemia); liver problems, liver disease, jaundice, increased liver enzyme activity, which can affect some test results; increased muscle tone; vasculitis, often with skin rash, sensitivity to light; disorders including stiffness, tremors, and (or) difficulty moving.
Frequency not known:tremors, stiffness, mask-like face, slow movements, and shuffling gait.
Valsartan
Frequency not known (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 tests; kidney problems and severe kidney problems; swelling, mainly of the face and throat; muscle pain; skin rash, purple spots; fever; itching; allergic reactions, blistering skin disease (pemphigus).
If any of these symptoms occur, the patient should immediately inform their doctor.
Reporting side effects
If the patient experiences any side effects, including those not listed in the leaflet, they should tell their doctor or pharmacist, or nurse. 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, website: https://smz.ezdrowie.gov.pl
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 Sarpin

The medicine should be stored out of sight and reach of children.
The patient should not take this medicine after the expiry date stated on the label, carton, and blister after: EXP. The expiry date refers to the last day of the month stated.
There are no special precautions for storage of the medicinal product.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer need. This will help protect the environment.

6. Contents of the packaging and other information

What Sarpin contains

• The active substances of Sarpin are amlodipine and valsartan.

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

• The other ingredients are: Core:microcrystalline cellulose (Grade-101), anhydrous colloidal silica, sodium carboxymethylcellulose (Type A), povidone (K-30), 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

Coated tablet
Light yellow, oval, biconvex, film-coated tablet with beveled edges, with "J" engraved on one side and "38" on the other side.
Sarpin, coated tablets are available in blisters of polyamide/Aluminum/PVC-Aluminum and HDPE bottles with a polypropylene cap containing a silicone desiccant as a drying agent.

Pack sizes:

Blisters:14, 28, 30, 56, 90, and 98 coated tablets.
HDPE bottles:100, 250, and 500 coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lok. 27
01-909 Warsaw

Manufacturer/importer

APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Belgium:
Amlodipine/Valsartan AB 5 mg/80 mg; 5 mg/160 mg; 10 mg/160 mg
film-coated tablets
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
Romania:
Amlodipina/Valsartan Aurobindo 5 mg/80 mg; 5 mg/160 mg; 10 mg/160 mg
film-coated tablets

Date of last revision of the leaflet: 07/2022