Valtap Hct

Package Leaflet: Information for the Patient

VALTAP HCT, 320 mg + 12.5 mg, film-coated tablets

VALTAP HCT, 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, 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 only. 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 those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the package leaflet:

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

1. What is Valtap HCT and what is it used for

Valtap HCT film-coated tablets contain two active substances: valsartan and hydrochlorothiazide.
Both substances help to control high blood pressure (hypertension).
Valsartanbelongs to a group of so-called angiotensin II receptor antagonists. These drugs help
control high blood pressure. 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 action of angiotensin II. As a result, blood vessels dilate, and blood pressure decreases.
Hydrochlorothiazidebelongs to a group of drugs called thiazide diuretics.
Hydrochlorothiazide increases the amount of urine, which also lowers blood pressure.
Valtap HCT is used to treat high blood pressure that is not sufficiently controlled by taking only one of the components.
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 result in stroke, heart failure, or kidney failure. High blood pressure also increases the risk of heart attack. Lowering blood pressure to normal values helps reduce the risk of these disorders.

2. Important information before taking Valtap HCT

When not to take Valtap HCT

• in patients with gout.

If any of the above points apply to you, you should contact your doctor and not take Valtap HCT.

Warnings and precautions

Before starting Valtap HCT, discuss it with your doctor or pharmacist.

• ACE inhibitors (such as enalapril, lisinopril, ramipril), especially if you have diabetic kidney problems.
• aliskiren.

Your doctor may recommend regular monitoring of kidney function, blood pressure, and electrolyte levels (such as potassium) in your blood.
See also the subsection "When not to take Valtap HCT".
Valtap HCT may cause increased sensitivity of the skin to the sun.
Tell your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant. It is not recommended to take Valtap HCT in early pregnancy and it should not be taken by pregnant women after the third month of pregnancy, as it may seriously harm the baby if taken during this period of pregnancy (see section "Pregnancy, breastfeeding, and fertility").

Children and adolescents

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

Valtap HCT with other medicines

Tell your doctor or pharmacist about all the medicines you are taking now or recently, and about any medicines you plan to take.
Taking Valtap HCT with some medicines may affect your treatment.
Your doctor may need to change the dose and/or take other precautions or, in some cases, stop treatment with one of the medicines. This applies especially to the following medicines:

• lithium, a medicine used to treat certain mental illnesses.
• medicines or substances that may increase potassium levels in your blood. These include potassium supplements or salt substitutes containing potassium, potassium-sparing medicines, and heparin.
• medicines that may decrease potassium levels in your blood, such as diuretics, corticosteroids, laxatives, carbenoxolone, amphotericin, or penicillin G.
• certain antibiotics (such as rifampicin), medicines used to prevent organ rejection (cyclosporin), or antiviral medicines used to treat HIV/AIDS (ritonavir). These medicines may enhance the effect of Valtap HCT.
• medicines that may cause "torsades de pointes" (irregular heartbeat), such as anti-arrhythmic medicines (medicines used to treat heart problems) and some antipsychotic medicines.
• medicines that may decrease sodium levels in your blood, 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 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 conditions).
• medicines that may increase blood sugar levels, such as diazoxide or beta-adrenolytics.
• cytotoxic medicines (used to treat cancer), such as methotrexate or cyclophosphamide.
• analgesic medicines, such as non-steroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 (COX-2) inhibitors and acetylsalicylic acid >3 g.
• muscle relaxants, such as tubocurarine.
• anticholinergic medicines (medicines used to treat various disorders, such as intestinal cramps, urinary cramps, asthma, motion sickness, muscle cramps, Parkinson's disease, and as an adjunct in anesthesia).
• amantadine (a medicine used to treat Parkinson's disease or to prevent certain viral diseases).
• cholestyramine and colestipol (medicines used mainly to treat high blood lipid levels).
• cyclosporin, a medicine used after organ transplantation to prevent rejection.
• alcohol, sleeping pills, and anesthetics (medicines that act as sedatives or painkillers, used, for example, during surgery).
• iodine-containing contrast agents (used for imaging tests).
• ACE inhibitors or aliskiren (see also subsections "When not to take Valtap HCT" and "Warnings and precautions").

Valtap HCT with food, drink, and alcohol

Avoid consuming alcohol until you have consulted your doctor. Alcohol may cause additional lowering of blood pressure and/or increase the risk of dizziness or fainting.

Pregnancy, breastfeeding, and fertility

If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medicine.

• Pregnancy Tell your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant. Your doctor will normally advise you to stop taking Valtap HCT before you become pregnant or as soon as you know you are pregnant, and will advise you to take a different medicine instead of Valtap HCT. It is not recommended to take Valtap HCT in early pregnancy and it should not be taken by pregnant women after the third month of pregnancy, as it may seriously harm the baby if taken during this period of pregnancy.
• Breastfeeding Tell your doctor if you are breastfeeding or plan to start breastfeeding. Valtap HCT is not recommended for mothers who are breastfeeding. Your doctor may choose a different treatment for you if you want to breastfeed, especially if you are breastfeeding a newborn or premature baby.

Driving and using machines

Before driving, using tools, or operating machinery, or performing other activities that require concentration, each patient should make sure how Valtap HCT affects them. Like many other medicines used to treat high blood pressure, Valtap HCT can cause dizziness and affect concentration in rare cases.

Valtap HCT contains lactose, soybean oil, and sodium

If you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking this medicine.
Do not take if you are allergic to peanuts or soy.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which is considered "sodium-free".

3. How to take Valtap HCT

Take this medicine always as directed by your doctor or pharmacist. This will help you get the best results from your treatment and reduce the risk of side effects.
In case of doubt, consult your doctor or pharmacist.
People with high blood pressure often do not notice any symptoms. Many of them feel quite well. Therefore, it is especially important to attend your doctor's appointments, even if you feel well.
Your doctor will determine the exact number of Valtap HCT tablets you should take. Your doctor may recommend increasing or decreasing the dose of the medicine, depending on your response to treatment.

• The recommended dose of Valtap HCT is one tablet per day.
• Do not change the dose or stop treatment without consulting your doctor.
• Take the medicine every day at the same time, usually in the morning.
• Valtap HCT can be taken with or without food.
• Swallow the tablet with a glass of water.

Taking a higher dose of Valtap HCT than recommended

In case of severe dizziness and/or fainting, lie down and contact your doctor immediately.
In case of accidental overdose, contact your doctor, pharmacist, or go to the hospital.

Missing a dose of Valtap HCT

If you miss a dose, take it as soon as you remember. However, if it is almost time for your next dose, you should skip the missed dose and continue with your regular dosing schedule.
Do not take a double dose to make up for a missed dose.

Stopping treatment with Valtap HCT

Stopping treatment with Valtap HCT may worsen your high blood pressure. Do not stop taking the medicine unless your doctor tells you to.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Valtap HCT can cause side effects, although not everybody gets them.

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

You should contact your doctor immediately if you experience:

• Symptoms of angioedema (allergic reaction), such as: swelling of the face, tongue, or throat, difficulty swallowing, hives, and difficulty breathing.
• Severe skin disease, which causes a rash, redness of the skin, blisters on the lips, eyelids, or mucous membranes of the mouth, peeling of the skin, fever (toxic epidermal necrolysis).
• Blurred vision or eye pain due to increased pressure in the eyeball (possible symptoms of fluid accumulation in the vascular layer of the eye (excessive accumulation of fluid between the choroid and sclera), acute angle-closure glaucoma, or acute myopia).

These side effects are very rare or of unknown frequency.
If you experience any of these symptoms, stop taking Valtap HCT and contact your doctor immediately (see also section 2 "Warnings and precautions").

Other side effects:

Uncommon(occurring in less than 1 in 100 patients):

• 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,
• feeling of fatigue,
• tingling or numbness,
• blurred vision,
• ringing in the ears (such as buzzing or ringing).

Rare(occurring in less than 1 in 1,000 patients):

• dizziness,
• diarrhea,
• joint pain.

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

• breathing difficulties,
• significant decrease in urine output,
• low sodium levels in the blood (which may cause fatigue, confusion, tremors, and/or seizures in severe cases),
• low potassium levels in the blood (which may be accompanied by muscle weakness, muscle cramps, and/or heart rhythm disturbances),
• low white blood cell count (which may be accompanied by fever, skin infections, sore throat, or mouth ulcers caused by infections, weakness),
• increased bilirubin levels in the blood (which may, in rare cases, cause yellowing of the skin and eyes),
• increased urea and creatinine levels in the blood (which may indicate kidney dysfunction),
• increased uric acid levels in the blood (which may, in severe cases, cause gout),
• loss of consciousness (fainting).

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

Valsartan
Uncommon(occurring in less than 1 in 100 patients):

• vertigo,
• abdominal pain.

Unknown(frequency cannot be estimated from the available data):

• blistering of the skin (symptom of bullous dermatitis),
• skin rash with itching or without, accompanied by 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 bleeding of unknown cause or bruising),
• 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 can cause anemia in severe cases),
• kidney failure,
• low sodium levels in the blood (which may cause fatigue, confusion, tremors, and/or seizures in severe cases).

Hydrochlorothiazide
Very common(occurring in more than 1 in 10 patients):

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

Common(occurring in less than 1 in 10 patients):

• 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(occurring in less than 1 in 1,000 patients):

• swelling and blistering of the skin (due to sun sensitivity),
• high calcium levels in the blood,
• high glucose levels in the blood,
• presence of sugar in the urine,
• worsening of metabolic disorders in diabetes,
• constipation, diarrhea, discomfort in the stomach or intestines, liver disorders, which may occur with yellowing of the skin and eyes),
• irregular heartbeat,
• headache,
• sleep disorders,
• depression,
• low platelet count (sometimes with bleeding or bruising),
• dizziness,
• tingling or numbness,
• vision disturbances.

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

• vasculitis with symptoms such as rash, purple-red spots, fever,
• rash, itching, hives, difficulty breathing or swallowing, dizziness (allergic reactions),
• rash, joint pain, muscle pain, fever (lupus erythematosus),
• severe abdominal pain (pancreatitis),
• breathing difficulties with fever, cough, wheezing, shortness of breath (respiratory failure, including pneumonia and pulmonary edema); acute respiratory failure (symptoms include severe shortness of breath, fever, weakness, and confusion),
• pale skin, feeling of fatigue, shortness of breath, dark urine (hemolytic anemia),
• fever, sore throat, or mouth ulcers caused by infections (leukopenia),
• disorientation, fatigue, tremors, and muscle cramps, rapid breathing (hypochloremic alkalosis).

Unknown(frequency cannot be estimated from the available data)

• malignant skin tumors and lip tumors (non-melanoma skin tumors),
• feeling of weakness, bruising, and frequent infections (aplastic anemia),
• significant decrease in urine output (possible symptoms of kidney dysfunction or kidney failure),
• rash, redness of the skin, blisters on the lips, eyelids, or mucous membranes of the mouth, peeling of the skin, fever (possible symptoms of erythema multiforme),
• muscle cramps,
• fever (elevated body temperature),
• weakness (asthenia).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your 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 181 C

• 02 - 222 Warsaw Tel.: + 48 22 49 21 301 Fax: + 48 22 49 21 309 Website: https://smz.ezdrowie.gov.pl By reporting side effects, you can help provide more information on the safety of this medicine. Side effects can also be reported to the marketing authorization holder or its representative in Poland.

5. How to store Valtap HCT

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging or blister.
The expiry date refers to the last day of that month.
Do not store above 30°C.
Medicines should 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 Valtap HCT contains

• The active substances of Valtap HCT are valsartan and hydrochlorothiazide.

Valtap HCT 320 mg + 12.5 mg: Each film-coated tablet contains 320 mg of valsartan and 12.5 mg of hydrochlorothiazide.
Valtap HCT 320 mg + 25 mg: Each film-coated tablet contains 320 mg of valsartan and 25 mg of hydrochlorothiazide.

• Other ingredients are: tablet core:microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, povidone K29-K32, talc, magnesium stearate, silica colloidal anhydrous. tablet coating:Valtap HCT, 320 mg + 12.5 mg: Opadry II Pink 85G34643:polyvinyl alcohol, talc, titanium dioxide, macrogol 3350, yellow iron oxide (E172), lecithin (E322), red iron oxide (E172). Valtap HCT, 320 mg + 25 mg: Opadry II Yellow 85G32408:polyvinyl alcohol, talc, titanium dioxide, macrogol 3350, yellow iron oxide (E172), lecithin (E322), red iron oxide (E172).

What Valtap HCT looks like and contents of the pack

Valtap HCT, 320 mg + 12.5 mg: pink, oval, biconvex film-coated tablets, 18.9 x 7.5 mm, marked with "V" on one side and "H" on the other side.
Valtap HCT, 320 mg + 25 mg: yellow, oval, biconvex film-coated tablets, 18.9 x 7.5 mm, with a dividing line at the top and sides of the tablet, marked with the letter "V" on one side and the letter "H" on the other side.
The tablet can be divided into equal doses.
Pack size: 28 film-coated tablets.

Marketing authorization holder:

Zentiva k.s., U kabelovny 130, Dolní Měcholupy, 102 37 Prague 10, Czech Republic.

Manufacturer:

Zentiva k.s., U kabelovny 130, Dolní Měcholupy, 102 37 Prague 10, Czech Republic.
Winthrop Arzneimittel GmbH, Brüningstraße 50, 65926 Frankfurt am Main, Germany.

To obtain more detailed information on this medicine and its authorized names in the Member States of the European Economic Area, contact the representative of the marketing authorization holder in Poland:

Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
tel.: +48 22 375 92 00
Date of last revision of the leaflet:March 2022