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
Please read all of 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.

Contents of the leaflet

1. What Co-Valsacor is and what it is used for
2. What you need to know 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 Co-Valsacor is and what it is used for

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

• Valsartan belongs 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 that causes blood vessels to narrow, leading to increased blood pressure. Valsartan works by blocking the action of angiotensin II. As a result, blood vessels widen and blood pressure decreases.
• Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics (also known as water tablets). Hydrochlorothiazide increases the amount of urine produced, which also helps lower 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 workload on the heart and blood vessels. If left untreated, it may lead to damage of blood vessels in the brain, heart, and kidneys, potentially causing stroke, heart failure, or kidney failure. High blood pressure also increases the risk of heart attack. Lowering blood pressure to normal levels reduces the risk of developing these conditions.

2. Important information before using Co-Valsacor

When not to use Co-Valsacor

• if the patient is allergic to valsartan, hydrochlorothiazide, sulfonamide derivatives (substances chemically similar to hydrochlorothiazide), or to any of the other ingredients of this medicine (listed in section 6);
• during pregnancy after 3 months (use of Co-Valsacor should also be avoided in early pregnancy – see section "Pregnancy and breastfeeding");
• if the patient has severe liver disease, damage to the small bile ducts in the liver (biliary cirrhosis), resulting in bile accumulation in the liver (cholestasis);
• if the patient has severe kidney disease;
• if the patient is unable to pass urine (anuria);
• if the patient is undergoing dialysis;
• if the patient has low blood potassium or sodium levels, or high blood calcium levels, despite treatment;
• if the patient has symptomatic gout;
• if the patient has diabetes or kidney function impairment and is being treated with a blood pressure-lowering medicine containing aliskiren.

If any of the above situations apply, do not take Co-Valsacor.
Consult your doctor.
Warnings and precautions
Before starting treatment with Co-Valsacor, discuss the following with your doctor or pharmacist:

• if the patient is taking potassium-sparing medicines, potassium supplements, potassium-containing salt substitutes, or other medicines that increase blood potassium levels, such as heparin – your doctor may recommend regular monitoring of blood potassium levels;
• if the patient has low blood potassium levels;
• if the patient has diarrhoea or severe vomiting;
• if the patient is taking high doses of diuretics (water tablets);
• if the patient has severe heart disease;
• if the patient has heart failure or has had a heart attack – follow your doctor's advice carefully regarding the initial dose; your doctor may also check kidney function;
• if the patient has renal artery stenosis;
• if the patient has recently received 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 previously experienced swelling of the tongue and face due to an allergic reaction known as angioedema after taking another medicine (including an ACE inhibitor) – if such symptoms occur while taking Co-Valsacor, stop immediately and never take it again; see also section 4;
• if the patient develops 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 triglyceride levels in the blood;
• if the patient has previously had allergic reactions after taking other blood pressure-lowering medicines from this group (angiotensin II receptor antagonists), or if the patient has allergies or asthma;
• if the patient experiences vision disturbances 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 intraocular pressure, which may occur within hours to weeks after starting treatment with Co-Valsacor; without treatment, these symptoms may lead to complete vision loss; patients who previously had an allergy to penicillin or sulfonamides may be at increased risk of developing these symptoms;
• Co-Valsacor may increase skin sensitivity to sunlight;
• if the patient has previously had skin cancer or develops unexpected skin changes during treatment.

Treatment with hydrochlorothiazide, especially in high doses over a prolonged period, may increase the risk of certain types of non-melanoma skin cancer and lip cancer (non-melanoma skin cancer). While taking Co-Valsacor, protect the skin from sunlight and UV radiation.

• if the patient previously experienced breathing problems or lung issues (including pneumonia or fluid accumulation in the lungs) after taking hydrochlorothiazide. If the patient develops severe shortness of breath or breathing difficulties after taking Co-Valsacor, seek immediate medical help;
• if the patient is taking any of the following medicines for high blood pressure:
• an ACE inhibitor (e.g. enalapril, lisinopril, ramipril), especially if the patient has 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 section "When not to use Co-Valsacor".
If any of the above conditions apply, contact your doctor.
Always inform your doctor if you are pregnant, suspect you may be pregnant, or are planning a pregnancy. Co-Valsacor is not recommended during the first trimester of pregnancy and must not be taken after 3 months of pregnancy, as it may seriously harm the unborn child (see section "Pregnancy and breastfeeding").

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

Co-Valsacor and other medicines
Inform your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.

The effect of Co-Valsacor may change when taken together with certain other medicines. This may require dose adjustments, additional precautions, or in some cases, discontinuation of one of the medicines. This particularly applies to:

• lithium, used to treat certain psychiatric disorders;
• medicines or substances that may increase blood potassium levels, such as potassium supplements, potassium-containing salt substitutes, potassium-sparing medicines, and heparin;
• medicines that may decrease blood potassium levels, such as diuretics (water tablets), corticosteroids, laxatives, carbenoxolone, amphotericin, or penicillin G;
• certain antibiotics (rifamycins), medicines used to prevent rejection of transplanted organs (cyclosporine), or antiretroviral medicines used to treat HIV/AIDS (ritonavir) – these may enhance the effect of Co-Valsacor;
• medicines that may cause torsade de pointes (an irregular heart rhythm), such as antiarrhythmics (used to treat heart conditions) and certain antipsychotics;
• medicines that may decrease blood sodium levels, such as antidepressants, antipsychotics, antiepileptics;
• medicines used to treat gout, such as allopurinol, probenecid, sulfinpyrazone;
• therapeutic doses of vitamin D and calcium supplements;
• medicines used to treat diabetes (oral antidiabetics such as metformin or insulin);
• other blood pressure-lowering medicines, including methyldopa;
• medicines that may increase blood pressure, such as noradrenaline or adrenaline;
• digoxin or other cardiac glycosides (used to treat heart conditions);
• medicines that may increase blood glucose levels, such as diazoxide and beta-blockers;
• cytotoxic medicines (used in cancer treatment), such as methotrexate or cyclophosphamide;
• painkillers such as non-steroidal anti-inflammatory drugs (NSAIDs), including selective COX-2 inhibitors and acetylsalicylic acid >3 g;
• muscle relaxants such as tubocurarine;
• anticholinergic medicines (used to treat various disorders such as gastrointestinal spasms, bladder spasms, asthma, motion sickness, muscle spasms, Parkinson's disease, and as an adjunct during anaesthesia);
• amantadine (used to treat Parkinson's disease and to treat and prevent certain viral infections);
• cholestyramine and colestipol (mainly used to reduce high blood lipid levels);
• alcohol, sedatives, and anaesthetics (medicines with sedative or pain-relieving effects, used e.g. during surgical procedures);
• iodine-containing contrast agents (used in imaging procedures);
• ACE inhibitors or aliskiren (see also sections "When not to use Co-Valsacor" and "Warnings and precautions").

Co-Valsacor with food, drink, and alcohol
Co-Valsacor may be taken with or without food.
Avoid alcohol without consulting your doctor. Alcohol may worsen the blood pressure-lowering effect and/or increase the risk of dizziness or fainting.

Pregnancy and breastfeeding
Consult your doctor or pharmacist before taking this medicine.
Pregnancy
Always inform your doctor if you are pregnant, suspect you may be pregnant, or are planning a pregnancy. Your doctor will usually recommend stopping Co-Valsacor before becoming pregnant or immediately after pregnancy is confirmed, and will prescribe an alternative medicine. Co-Valsacor is not recommended during the first trimester of pregnancy and must not be taken after 3 months of pregnancy, as it may seriously harm the unborn child.
Breastfeeding
Inform your doctor if you are breastfeeding or intend to breastfeed. Co-Valsacor is not recommended during breastfeeding. Your doctor may choose an alternative medicine, especially if you are breastfeeding a newborn or a premature infant.

Driving and operating machinery
Before driving, using tools, operating machinery, or performing any tasks requiring concentration, patients should ensure 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 you have been told by your doctor that you have an intolerance to certain sugars, consult your doctor before taking this medicine.
This medicine contains less than 1 mmol sodium (23 mg) per tablet, so it is essentially "sodium-free".

3. How to use Co-Valsacor

This medicine should always be taken exactly as directed by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist. This will help achieve the best treatment results and
reduce the risk of adverse effects.
Patients with high blood pressure often do not notice any symptoms of the condition. Many of them
feel quite well. Therefore, it is very important to attend regular doctor's appointments, even if you
feel well.
Your doctor will determine how many Co-Valsacor tablets you should take. Depending on your
response to treatment, your doctor may decide to increase or decrease the dose.

• The usual dose of Co-Valsacor is one tablet per day.
• Do not change the dose or stop taking the tablets without consulting your doctor.
• The medicine should be taken every day at the same time, usually in the morning.
• Co-Valsacor may be taken with food or independently of meals.
• Swallow the tablet with a glass of water.

Taking more Co-Valsacor than prescribed
If you experience severe dizziness and/or fainting, lie down immediately and contact your doctor without delay.
If you accidentally take too many tablets, contact your doctor or pharmacist, or go to the nearest hospital.

Missed dose of Co-Valsacor
If you miss a dose, take it as soon as you remember. However, if it is almost time for your next dose,
do not take the missed dose.
Do not take a double dose to make up for a missed one.

Stopping Co-Valsacor treatment
Stopping treatment may cause worsening of hypertension. Do not discontinue taking this medicine unless
your doctor tells you to do so.
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 they do not occur in everyone.
Some adverse reactions may be serious and require immediate medical attention:

• seek medical advice immediately if symptoms of angioedema occur, such as:
• swelling of the face, tongue or throat,
• difficulty swallowing,
• urticaria and breathing difficulties;
• severe skin disease causing rash, redness of the skin, formation of blisters on the lips, eyes or in the mouth, peeling of the skin, fever (toxic epidermal necrolysis);
• worsening of vision or eye pain due to increased pressure (possible symptoms of fluid accumulation in the vascular membrane surrounding the eye – excessive fluid accumulation between choroid and sclera – or acute angle-closure glaucoma);
• fever, sore throat, frequent infections (agranulocytosis);
• acute respiratory failure (symptoms include severe shortness of breath, fever, weakness and confusion).

These adverse reactions occur very rarely or with unknown frequency.
If any of these symptoms occur, treatment with Co-Valsacor must be discontinued and
immediate medical advice must be sought (see also section 2 "Warnings and precautions").
Other adverse reactions include:
Not common (may occur in less than 1 in 100 patients):

• cough
• low blood pressure
• feeling of "emptiness" in the head
• dehydration (with sensation of thirst, dryness of the oral and tongue mucosa, infrequent urination, dark urine colour, dry skin)
• muscle pain
• fatigue
• tingling or numbness
• blurred vision
• tinnitus (e.g. ringing, buzzing)

Very rare (may occur in less than 1 in 10,000 patients):

• dizziness
• diarrhoea
• joint pain

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

• difficulty breathing
• very low volume of urine
• low sodium levels in blood (which may cause fatigue, disorientation, muscle twitching and/or seizures in severe cases)
• low potassium levels in blood (sometimes with muscle weakness, muscle cramps, heart rhythm disorders)
• low white blood cell count (with symptoms such as fever, skin infections, sore throat or oral ulcers due to infections, weakness)
• increased bilirubin levels in blood (which in severe cases may cause yellowing of the skin and eyes)
• increased blood urea and creatinine levels in blood (which may indicate impaired kidney function)
• increased uric acid levels in blood (which in severe cases may trigger an attack of gout)
• fainting (syncope)

The following adverse reactions have been reported after use of medicines containing only
valsartan or only hydrochlorothiazide:
Valsartan
Not common (may occur in less than 1 in 100 patients):

• sensation of spinning (vertigo)
• abdominal pain

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

• skin rash with or without itching and with one or more 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 skin purpura)
• high potassium levels in blood (sometimes with muscle cramps, heart rhythm disorders)
• allergic reactions (with symptoms such as rash, itching, urticaria, breathing or swallowing difficulties, dizziness)
• swelling, mainly of the face and throat; rash; itching
• increased liver enzyme activity
• decreased haemoglobin concentration and percentage of red blood cells in blood (both symptoms may lead to anaemia in severe cases)
• kidney failure
• low sodium levels in blood (which may cause fatigue, disorientation, muscle twitching and/or seizures in severe cases)

Hydrochlorothiazide
Very common (may occur in at least 1 in 10 patients):

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

Common (may occur in less than 1 in 10 patients):

• low sodium levels in blood
• low magnesium levels in blood
• high uric acid levels in blood
• itchy rash and other types of skin rash
• decreased appetite
• mild nausea and vomiting
• dizziness, fainting upon standing
• inability to achieve or maintain erection

Rare (may occur in less than 1 in 1,000 patients):

• swelling and blisters on the skin (due to increased sensitivity to sunlight)
• high calcium levels in blood
• high blood glucose levels
• presence of glucose in urine
• worsening of metabolic disturbances in diabetes
• constipation, diarrhoea, gastric or intestinal discomfort, liver disorders which may occur together with yellowing of the skin and eyes
• irregular heart rhythm
• headache
• sleep disturbances
• depression
• low platelet count (sometimes with subcutaneous bleeding or bruising)
• dizziness
• tingling or numbness sensation
• visual disturbances

Very rare (may occur in less than 1 in 10,000 patients):

• vasculitis with symptoms such as rash, purple-red spots, fever
• rash, itching, urticaria, breathing or swallowing difficulties, dizziness (hypersensitivity reactions)
• facial rash, joint pain, muscle disorders, fever (lupus erythematosus)
• severe upper abdominal pain (pancreatitis)
• breathing difficulties with fever, cough, wheezing, shortness of breath (respiratory failure, including pneumonia and pulmonary oedema)
• pale skin, fatigue, shortness of breath, dark urine (haemolytic anaemia)
• fever, sore throat or oral mucosal ulceration due to infection (leukopenia)
• confusion, fatigue, muscle tremor and cramps, rapid breathing (hypochloraemic alkalosis)

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

• malignant skin and lip tumours (non-melanoma skin cancers)
• weakness, bruising and frequent infections (aplastic anaemia)
• marked decrease in urine volume (possible symptoms of impaired kidney function or kidney failure)
• rash, redness of the skin, formation of blisters on the lips, eyes or in the mouth, peeling of the skin, fever (possible symptoms of erythema multiforme)
• muscle cramps
• fever
• weakness (asthenia)

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of 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 authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Co-Valsacor

Keep this medicine 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 stated month.
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. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the package and other information

What Co-Valsacor contains

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

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

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

What Co-Valsacor looks like and contents of the pack
Coated tablets 80 mg + 12.5 mg are pink, oval, biconvex.
Coated tablets 160 mg + 12.5 mg are reddish-brown, oval, biconvex.
Coated tablets 160 mg + 25 mg are light brown, oval, biconvex.
Coated tablets 320 mg + 12.5 mg are pink, oval, biconvex.
Coated tablets 320 mg + 25 mg are light yellow, oval, biconvex with a division line on one
side. The tablet can be divided into equal doses.
Pack sizes of Co-Valsacor, 80 mg + 12.5 mg, 160 mg + 12.5 mg and 160 mg + 25 mg: 28, 56 or 98
coated tablets in blisters, in a cardboard box
Pack sizes of Co-Valsacor, 320 mg + 12.5 mg and 320 mg + 25 mg: 28, 30, 56 or 60 coated
tablets in blisters, in a cardboard box

Marketing Authorisation 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 Warszawa, Poland

For more detailed information on the product names in other European Economic Area countries, please contact the local representative of the Marketing Authorisation Holder:
KRKA-POLSKA Sp. z o.o.
ul. Równoległa 5
02-235 Warszawa
Tel. 22 57 37 500