Co-valsacor

Package Leaflet: Information for the User

Co-Valsacor, 80 mg + 12.5 mg, Film-Coated Tablets

Co-Valsacor, 160 mg + 12.5 mg, Film-Coated Tablets

Co-Valsacor, 160 mg + 25 mg, Film-Coated Tablets

Co-Valsacor, 320 mg + 12.5 mg, Film-Coated Tablets

Co-Valsacor, 320 mg + 25 mg, Film-Coated Tablets

valsartan + hydrochlorothiazide

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

• Keep this leaflet, as you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Co-Valsacor and what is it used for

Co-Valsacor contains two active substances, valsartan and hydrochlorothiazide. Both substances help control high blood pressure (hypertension).

• Valsartanbelongs to a group of medicines called angiotensin II receptor antagonists, used to treat high blood pressure. Angiotensin II is a substance produced in the human body, causing blood vessels to constrict, which increases blood pressure. Valsartan works by blocking angiotensin II. As a result, blood vessels dilate, and blood pressure decreases.
• Hydrochlorothiazidebelongs to a group of medicines called thiazide diuretics (also known as water pills). Hydrochlorothiazide increases the amount of urine excreted, which also lowers blood pressure.

Co-Valsacor is used to treat high blood pressure that cannot be adequately controlled with a single active substance. High blood pressure increases the strain on the heart and blood vessels. If left untreated, it can lead to damage to blood vessels in the brain, heart, and kidneys, which can cause stroke, heart failure, or kidney failure. High blood pressure increases the risk of heart attack. Lowering blood pressure to normal values reduces the risk of these diseases.

2. Important information before taking Co-Valsacor

When not to take Co-Valsacor

• if the patient is allergic to valsartan, hydrochlorothiazide, sulfonamide derivatives (substances with a similar chemical structure to hydrochlorothiazide), or any of the other ingredients of this medicine (listed in section 6);
• after the third month of pregnancy(it is also recommended to avoid taking Co-Valsacor in early pregnancy - see subsection "Pregnancy and breastfeeding");
• if the patient has severe liver disease, damage to the small bile ducts in the liver (biliary cirrhosis), resulting in bile stagnation in the liver (cholestasis);
• if the patient has severe kidney disease;
• if the patient is unable to urinate (anuria);
• if the patient is undergoing dialysis therapy;
• if the patient has low potassium or sodium levels in the blood or increased calcium levels in the blood, despite treatment;
• if the patient has symptomatic gout;
• if the patient has diabetes or kidney function disorders and is being treated with a blood pressure-lowering medicine containing aliskiren.

If any of the above situations apply to the patient, they should not take Co-Valsacor. They should consult a doctor.

Warnings and precautions

Before starting to take Co-Valsacor, the patient should discuss it with their doctor or pharmacist:

• if the patient is taking potassium-sparing medicines, potassium supplements, or salt substitutes containing potassium, or other medicines that increase potassium levels in the blood, such as heparin - the doctor may recommend regular monitoring of potassium levels in the blood;
• if the patient has low potassium levels in the blood;
• if the patient has diarrhea or severe vomiting;
• if the patient is taking high doses of diuretics (water pills);
• if the patient has severe heart disease;
• if the patient has heart failure or has had a heart attack - the doctor should be careful when prescribing the initial dose of Co-Valsacor, and may also check the patient's kidney function;
• if the patient has narrowing of the renal artery;
• if the patient has had a kidney transplant;
• if the patient has hyperaldosteronism, a condition in which the adrenal glands produce too much of a hormone called aldosterone; in such cases, Co-Valsacor is not recommended;
• if the patient has liver or kidney disease;
• if the patient has ever had swelling of the tongue and face, caused by an allergic reaction called angioedema, after taking another medicine (including an ACE inhibitor) - if such symptoms occur while taking Co-Valsacor, the patient should stop taking it immediately and never take it again, see also section 4;
• if the patient has had a fever, rash, and joint pain, which may be symptoms of systemic lupus erythematosus (SLE, an autoimmune disease);
• if the patient has diabetes, gout, high cholesterol, or high triglyceride levels in the blood;
• if the patient has a history of allergic reactions after taking other blood pressure-lowering medicines from this group (angiotensin II receptor antagonists) or if the patient has an allergy or asthma;
• if the patient has impaired vision or eye pain - these may be symptoms of fluid accumulation in the vascular layer surrounding the eye (excessive fluid accumulation between the choroid and sclera) or increased eye pressure, which can occur within a few hours to weeks after starting treatment with Co-Valsacor; without treatment, these symptoms can lead to complete loss of vision, and if the patient has previously been allergic to penicillin or sulfonamides, they may be at increased risk of developing these symptoms;
• Co-Valsacor may cause increased sensitivity of the skin to sunlight;
• if the patient has a history of malignant skin tumors or if an unexpected skin change occurs during treatment. Treatment with hydrochlorothiazide, especially in high doses and for a long time, may increase the risk of certain types of malignant skin tumors and lip cancer (non-melanoma skin cancer). During treatment with Co-Valsacor, the patient should protect their skin from sunlight and UV radiation;

if the patient has a history of breathing or lung problems (including pneumonia or fluid accumulation in the lungs). If the patient experiences severe shortness of breath or difficulty breathing after taking Co-Valsacor, they should seek medical attention immediately;

• if the patient is taking any of the following medicines used to treat high blood pressure:
• an ACE inhibitor (e.g., enalapril, lisinopril, ramipril), especially if the patient has diabetes-related kidney function disorders,
• aliskiren.

The doctor may recommend regular monitoring of kidney function, blood pressure, and electrolyte levels (e.g., potassium) in the blood. See also subsection "When not to take Co-Valsacor".

If any of the above conditions apply to the patient, they should contact their doctor.

The patient must inform their doctor about pregnancy, suspected pregnancy, or planned pregnancy. Co-Valsacor is not recommended during the first trimester of pregnancy and should not be taken after the third month of pregnancy, as it may seriously harm the fetus (see subsection "Pregnancy and breastfeeding").

Children and adolescents

Co-Valsacor is not recommended for children and adolescents (under 18 years of age).

Co-Valsacor 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 effect of Co-Valsacor may change if it is taken with certain other medicines. This may require a dose change, the use of other precautions, or in some cases, the discontinuation of one of the medicines. This is especially true for medicines such as:

• lithium, used to treat certain mental illnesses;
• medicines or substances that may increase potassium levels in the blood, such as potassium supplements or salt substitutes containing potassium, potassium-sparing medicines, and heparin;
• medicines that may decrease potassium levels in the blood, such as diuretics (water pills), corticosteroids, laxatives, carbenoxolone, amphotericin, or penicillin G;
• certain antibiotics (from the rifamycin group), medicines used to prevent the rejection of transplanted organs (cyclosporine), or antiretroviral medicines used to treat HIV/AIDS (ritonavir) - these medicines may enhance the effect of Co-Valsacor;
• medicines that may cause "torsade de pointes" (irregular heart rhythm), such as anti-arrhythmic medicines (used to treat heart diseases) and certain antipsychotic medicines;
• medicines that may decrease sodium levels in the blood, such as antidepressants, antipsychotic medicines, antiepileptic medicines;
• medicines used to treat gout, such as allopurinol, probenecid, sulfinpyrazone;
• therapeutic doses of vitamin D and calcium supplements;
• medicines used to treat diabetes (oral antidiabetic medicines, such as metformin, or insulins);
• other blood pressure-lowering medicines, including methyldopa;
• medicines that increase blood pressure, such as noradrenaline or adrenaline;
• digoxin or other digitalis glycosides (medicines used to treat heart diseases);
• medicines that may increase blood sugar levels, such as diazoxide and beta-adrenergic blockers;
• cytotoxic medicines (used to treat cancer), such as methotrexate or cyclophosphamide;
• pain relievers, such as non-steroidal anti-inflammatory medicines (NSAIDs), including selective cyclooxygenase-2 (COX-2) inhibitors and acetylsalicylic acid >3 g;
• muscle relaxants, such as tubocurarine;
• anticholinergic medicines (used to treat various disorders, such as gastrointestinal spasms, urinary spasms, asthma, motion sickness, muscle spasms, Parkinson's disease, and as an adjunct during anesthesia);
• amantadine (a medicine used to treat Parkinson's disease and to treat and prevent certain viral infections);
• cholestyramine and colestipol (medicines used primarily to reduce high lipid levels in the blood);
• alcohol, sedatives, and anesthetics (medicines that act as sedatives or pain relievers, used, for example, during surgical procedures);
• iodine-containing contrast agents (used in imaging studies);
• ACE inhibitors or aliskiren (see also subsections "When not to take Co-Valsacor" and "Warnings and precautions").

Co-Valsacor with food, drink, and alcohol

Co-Valsacor can be taken with or without food. The patient should avoid consuming alcohol without consulting their doctor. Alcohol may enhance the blood pressure-lowering effect and (or) increase the risk of dizziness or fainting.

Pregnancy and breastfeeding

Before taking this medicine, the patient should consult their doctor or pharmacist. PregnancyThe patient must inform their doctor about pregnancy, suspected pregnancy, or planned pregnancy.The doctor will usually recommend stopping Co-Valsacor before pregnancy or as soon as pregnancy is confirmed and prescribe another medicine. Co-Valsacor is not recommended during the first trimester of pregnancy and should not be taken after the third month of pregnancy, as it may seriously harm the fetus. BreastfeedingThe patient should inform their doctor about breastfeeding or planned breastfeeding.Co-Valsacor is not recommended during breastfeeding. The doctor may choose another medicine if the patient plans to breastfeed, especially if breastfeeding a newborn or premature baby.

Driving and using machines

Before driving, using tools, operating machines, or performing other activities that require concentration, the patient should make sure how Co-Valsacor affects them. Like many other medicines used to treat high blood pressure, Co-Valsacor may rarely cause dizziness and affect concentration.

Co-Valsacor contains lactose and sodium

If the patient has been informed by their doctor that they have an intolerance to some sugars, they should consult their doctor before taking this medicine. This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which means it is essentially "sodium-free".

3. How to take Co-Valsacor

This medicine should always be taken as directed by the doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist. This will help achieve the best treatment results and reduce the risk of side effects. Patients with high blood pressure often do not notice any symptoms of the disease. Many of them feel quite well. Therefore, it is very important to attend doctor's appointments, even if the patient feels well. The doctor will determine the dose of Co-Valsacor to be taken. Depending on the patient's response to treatment, the doctor may recommend increasing or decreasing the dose.

• The usual dose of Co-Valsacor is one tablet per day.
• The patient should not change the dose or stop taking the tablets without consulting their doctor.
• The medicine should be taken daily at the same time, usually in the morning.
• Co-Valsacor can be taken with or without food.
• The tablet should be swallowed with a glass of water.

Taking a higher dose of Co-Valsacor than recommended

In case of severe dizziness and (or) fainting, the patient should lie down and contact their doctor immediately. In case of accidental ingestion of too many tablets, the patient should contact their doctor or pharmacist or go to the nearest hospital.

Missing a dose of Co-Valsacor

If a dose is missed, the patient should take it as soon as they remember. However, if it is almost time for the next dose, the patient should not take the missed dose. The patient should not take a double dose to make up for the missed dose.

Stopping treatment with Co-Valsacor

Stopping treatment may worsen hypertension. The patient should not stop taking Co-Valsacor unless their doctor recommends it. In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Co-Valsacor can cause side effects, although not everybody gets them.

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

• the patient should contact their doctor immediately if they experience symptoms of angioedema, such as:
• swelling of the face, tongue, or throat,
• difficulty swallowing,
• hives and difficulty breathing;
• severe skin disease, causing a rash, redness of the skin, blisters on the lips, eyes, or mouth, peeling of the skin, fever (toxic epidermal necrolysis);
• impaired vision or eye pain due to increased pressure (possible symptoms of fluid accumulation in the vascular layer surrounding the eye - excessive fluid accumulation between the choroid and sclera - or acute angle-closure glaucoma);
• fever, sore throat, frequent infections (agranulocytosis);
• severe respiratory failure (symptoms include severe shortness of breath, fever, weakness, and confusion).

These side effects are very rare or have an unknown frequency.

If the patient experiences any of these symptoms, they should stop taking Co-Valsacor and contact their doctor immediately (see also subsection 2 "Warnings and precautions").

Other side effects include:

Uncommon (may affect up to 1 in 100 people):

• -cough
• low blood pressure
• feeling of "emptiness" in the head
• dehydration (with a feeling of thirst, dryness of the mucous membranes of the mouth and tongue, infrequent urination, dark urine, dry skin)
• muscle pain
• fatigue
• tingling or numbness
• blurred vision
• ringing in the ears (e.g., hissing, buzzing)

Rare (may affect up to 1 in 1,000 people):

• dizziness
• diarrhea
• joint pain

Frequency not known(frequency cannot be estimated from the available data):

• breathing difficulties
• very low urine output
• low sodium levels in the blood (which may cause fatigue, disorientation, muscle tremors, and (or) seizures in severe cases)
• low potassium levels in the blood (sometimes with muscle weakness, muscle cramps, heart rhythm disturbances)
• low white blood cell count (with symptoms such as fever, skin infections, sore throat, or mouth ulcers caused by infections, weakness)
• increased bilirubin levels in the blood (which may cause yellowing of the skin and eyes in severe cases)
• increased urea and creatinine levels in the blood (which may indicate impaired kidney function)
• increased uric acid levels in the blood (which may cause gout in severe cases)
• fainting (syncope)

The following side effects have been reported with the use of medicines containing only valsartan or only hydrochlorothiazide:

Valsartan

Uncommon (may affect up to 1 in 100 people):

• vertigo
• abdominal pain

Frequency not known(frequency cannot be estimated from the available data):

• rash with itching of the skin or without, and some of the following symptoms: fever, joint pain, muscle pain, swollen lymph nodes, and (or) flu-like symptoms
• rash, purple-red spots, fever, itching (symptoms of vasculitis)
• low platelet count (sometimes with unusual bleeding or bruising on the skin)
• high potassium levels in the blood (sometimes with muscle cramps, heart rhythm disturbances)
• allergic reactions (with symptoms such as rash, itching, hives, difficulty breathing or swallowing, dizziness)
• swelling, mainly of the face and throat; rash; itching
• increased liver enzyme activity
• decreased hemoglobin and red blood cell count in the blood (both of which may cause anemia in severe cases)
• kidney failure
• low sodium levels in the blood (which may cause fatigue, disorientation, muscle tremors, and (or) seizures in severe cases)

Hydrochlorothiazide

Very common (may affect more than 1 in 10 people):

• low potassium levels in the blood
• increased lipid levels in the blood

Common (may affect up to 1 in 10 people):

• low sodium levels in the blood
• low magnesium levels in the blood
• high uric acid levels in the blood
• itching rash and other types of rash
• decreased appetite
• mild nausea and vomiting
• dizziness, fainting when standing up
• erectile dysfunction

Rare (may affect up to 1 in 1,000 people):

• swelling and blisters on the skin (due to increased sensitivity to sunlight)
• high calcium levels in the blood
• high blood sugar levels
• presence of sugar in the urine
• worsening of metabolic disorders in diabetes
• constipation, diarrhea, abdominal discomfort or intestinal disorders, liver disorders, which may occur with yellowing of the skin and eyes
• irregular heart rhythm
• headache
• sleep disorders
• depression

Very rare (may affect up to 1 in 10,000 people):

• vasculitis with symptoms such as rash, purple-red spots, fever
• rash, itching, hives, difficulty breathing or swallowing, dizziness (allergic reactions)
• rash, redness of the skin, blisters on the lips, eyes, or mouth, peeling of the skin, fever (symptoms of erythema multiforme)
• muscle cramps
• fever
• weakness (asthenia)

Frequency not known(frequency cannot be estimated from the available data):

• malignant skin tumors and lip cancer (non-melanoma skin cancer)
• weakness, bruising, frequent infections (aplastic anemia)
• significant decrease in urine output (possible symptoms of impaired kidney function or kidney failure)
• rash, redness of the skin, blisters on the lips, eyes, or mouth, peeling of the skin, fever (possible symptoms of toxic epidermal necrolysis)
• muscle cramps

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. 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 this medicine.

5. How to store Co-Valsacor

The medicine should be stored out of sight and reach of children. Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated. Do not store above 30°C. Store in the original packaging to protect from light and moisture. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Co-Valsacor contains

• The active substances of Co-Valsacor are valsartan and hydrochlorothiazide. Each film-coated tablet of Co-Valsacor contains 80 mg of valsartan and 12.5 mg of hydrochlorothiazide. Each film-coated tablet of Co-Valsacor contains 160 mg of valsartan and 12.5 mg of hydrochlorothiazide. Each film-coated tablet of Co-Valsacor contains 160 mg of valsartan and 25 mg of hydrochlorothiazide. Each film-coated tablet of Co-Valsacor contains 320 mg of valsartan and 12.5 mg of hydrochlorothiazide.

Each film-coated tablet of Co-Valsacor contains 320 mg of valsartan and 25 mg of hydrochlorothiazide.

• Other ingredients are: microcrystalline cellulose, lactose monohydrate, magnesium stearate, sodium croscarmellose, povidone K-25, and anhydrous colloidal silica in the tablet core, and hypromellose, titanium dioxide (E 171), macrogol 4000, red iron oxide (E 172) - only in 80 mg + 12.5 mg, 160 mg + 12.5 mg, 160 mg + 25 mg, and 320 mg + 12.5 mg tablets, yellow iron oxide (E 172) - only in 80 mg + 12.5 mg, 160 mg + 25 mg, and 320 mg + 25 mg tablets in the tablet coating. See section 2 "Co-Valsacor contains lactose and sodium".

What Co-Valsacor looks like and contents of the pack

The 80 mg + 12.5 mg film-coated tablets are pink, oval, and biconvex. The 160 mg + 12.5 mg film-coated tablets are reddish-brown, oval, and biconvex. The 160 mg + 25 mg film-coated tablets are light brown, oval, and biconvex. The 320 mg + 12.5 mg film-coated tablets are pink, oval, and biconvex. The 320 mg + 25 mg film-coated tablets are light yellow, oval, and biconvex with a score line on one side. The tablet can be divided into equal doses. Co-Valsacor is available in packs of 28, 56, or 98 film-coated tablets in blisters, in a cardboard box for 80 mg + 12.5 mg, 160 mg + 12.5 mg, and 160 mg + 25 mg. Co-Valsacor is available in packs of 28, 30, 56, or 60 film-coated tablets in blisters, in a cardboard box for 320 mg + 12.5 mg and 320 mg + 25 mg.

Marketing authorization holder:

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer:

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany KRKA-POLSKA Sp. z o.o., ul. Równoległa 5, 02-235 Warsaw, Poland For more information on the names of medicinal products in other EU member states, please contact the local representative of the marketing authorization holder: KRKA-POLSKA Sp. z o.o. ul. Równoległa 5 02-235 Warsaw Tel. 22 57 37 500

Date of last revision of the leaflet:04.06.2022