Valtap hct

Package leaflet: Information for the patient

VALTAP HCT, 160 mg + 12.5 mg, film-coated tablets
VALTAP HCT, 160 mg + 25 mg, film-coated tablets
Valsartanum + Hydrochlorothiazidum
Please read carefully all of this leaflet before taking this medicine, because it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents

1. What Valtap HCT is and what it is used for
2. What you need to know 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 Valtap HCT is and what it is used for

Valtap HCT contains two active substances, called valsartan and hydrochlorothiazide.
Both substances help control high blood pressure (hypertension).

• Valsartan belongs to a group of medicines known as angiotensin II receptor antagonists, which 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 activity of angiotensin II. As a result, blood vessels widen and blood pressure decreases.
• Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics. Hydrochlorothiazide increases the amount of urine produced, which also helps lower blood pressure.

Valtap HCT is used in the treatment of high blood pressure that is not sufficiently controlled
by using only one of the components (either valsartan or hydrochlorothiazide) alone.
High blood pressure increases the workload on the heart and arteries. If left untreated, it may lead
to damage of blood vessels in the brain, heart, and kidneys, possibly resulting in stroke,
heart failure, or kidney failure. High blood pressure increases the risk of heart attack.
Lowering blood pressure to normal levels reduces the risk of developing these complications.

2. Important information before using Valtap HCT

When not to use Valtap HCT

• If the patient is allergic (hypersensitive) to valsartan, hydrochlorothiazide, sulphonamide derivatives (chemically related substances to hydrochlorothiazide), or any of the other ingredients of this medicine (listed in section 6). If the patient is more than 3 months pregnant (it is also better to avoid using Valtap HCT in early pregnancy - see section Pregnancy).
• If the patient has severe liver disease, damage to the small bile ducts in the liver (primary 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 with an artificial kidney.
• If the patient has low levels of potassium or sodium in the blood, or high levels of calcium in the blood, despite treatment.
• In patients with gout.
• If the patient has diabetes or kidney problems and is being treated with a blood pressure-lowering medicine containing aliskiren.

If any of the above points apply to the patient, consult a doctor
and do not take Valtap HCT.
Warnings and precautions
Before starting Valtap HCT, discuss this with your doctor or pharmacist:

• If the patient is taking potassium-sparing medicines, potassium supplements, or salt substitutes containing potassium, or other medicines that increase blood potassium levels, such as heparin. Regular monitoring of blood potassium levels may be necessary.
• If the patient has low potassium levels in the blood.
• 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 the doctor's advice carefully regarding the initial dose. The doctor may also check the patient's kidney function.
• If the patient has renal artery stenosis (narrowing of the artery to the kidney).
• 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. If this condition is present, Valtap HCT is not recommended.
• If the patient has kidney or liver disease.
• If the patient has ever had swelling of the tongue and face due to an allergic reaction, called angioedema, after taking another medicine (including ACE inhibitors), inform the doctor. If such symptoms occur while taking Valtap HCT, stop taking the medicine immediately and never take it again. See also section 4, "Possible side effects".
• If the patient has 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 skin cancer or if unexpected skin changes occur during treatment. Treatment with hydrochlorothiazide, especially at high doses over a long period, may increase the risk of certain types of non-melanoma skin cancer and lip cancer (non-melanoma skin cancer). While taking Valtap HCT, protect the skin from sunlight and UV radiation.
• If the patient has previously had allergic reactions after taking other blood pressure-lowering medicines of this class (angiotensin II receptor antagonists), or if the patient has allergies or asthma.
• If the patient experiences blurred vision or eye pain. These may be symptoms of fluid accumulation in the vascular layer surrounding the eye (excessive fluid accumulation between choroid and sclera) or increased eye pressure and may occur within hours to weeks after starting treatment with Valtap HCT. Without treatment, these symptoms may lead to complete loss of vision. If the patient previously had

an allergy to penicillin or sulphonamides, they may be at increased risk of developing
such symptoms.

• If the patient is taking any of the following medicines used to treat high blood pressure:
• ACE inhibitors (e.g. enalapril, lisinopril, ramipril), especially if the patient has kidney problems related to diabetes,
• aliskiren.
• If the patient has previously had breathing or lung problems (including pneumonia or fluid accumulation in the lungs) after taking hydrochlorothiazide. If the patient develops severe shortness of breath or difficulty breathing after taking Valtap HCT, seek immediate medical help.

The doctor may recommend regular monitoring of kidney function, blood pressure, and blood levels of electrolytes (e.g. potassium).
See also the section "When not to use Valtap HCT".
If the patient experiences abdominal pain, nausea, vomiting, or diarrhoea after taking Valtap HCT,
discuss this with the doctor.
The doctor will decide on further treatment. Do not make independent decisions to
stop taking Valtap HCT.
Valtap HCT may increase skin sensitivity to sunlight.
Inform the doctor if the patient is pregnant, suspects pregnancy, or plans to become pregnant. Use of
Valtap HCT is not recommended in early pregnancy and must not be used after the 3rd month of
pregnancy, as it may seriously harm the unborn child if used during this period
(see section Pregnancy).
Children and adolescents
Valtap HCT is not recommended for use in children and adolescents (under 18 years of age).
Valtap HCT with other medicines
Tell the doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Taking Valtap HCT together with certain medicines may affect treatment.
The doctor may recommend adjusting the dose and/or taking other precautions, or in some cases may advise stopping one of the medicines. This particularly applies to the following medicines:

• lithium, a medicine used to treat certain psychiatric disorders,
• medicines or substances that may increase blood potassium levels. These include potassium supplements or potassium-containing salt substitutes, potassium-sparing medicines, and heparin,
• medicines that may decrease blood potassium levels, such as diuretics, corticosteroids, laxatives, carbenoxolone, amphotericin or penicillin G,
• certain antibiotics (rifamycin group), medicines used to prevent rejection of transplanted organs (cyclosporine), or antiretroviral medicines used to treat HIV/AIDS (ritonavir). These medicines may enhance the effect of Valtap HCT,
• medicines that may cause torsade de pointes (irregular heartbeat), such as antiarrhythmics (used to treat heart conditions) and certain antipsychotics,
• medicines that may reduce blood sodium levels, such as antidepressants, antipsychotics, anticonvulsants,
• medicines used to treat gout, such as allopurinol, probenecid, sulfinpyrazone,
• vitamin D in therapeutic doses and calcium supplements,
• medicines used to treat diabetes (oral medications 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 (medicines 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 at doses > 3 g per day,
• 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 (a medicine used to treat Parkinson's disease and to treat and prevent certain viral infections),
• cholestyramine and colestipol (medicines mainly used to treat high blood lipid levels),
• cyclosporine, a medicine used in patients with transplanted organs to prevent rejection,
• alcohol, sedatives, and anaesthetics (medicines with sleep-inducing 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 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 the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Pregnancy
Inform the doctor if the patient is pregnant, suspects pregnancy, or is planning pregnancy.
The doctor will usually advise stopping Valtap HCT before becoming pregnant or as soon as pregnancy is confirmed, and will recommend an alternative medicine instead of Valtap HCT. Use of Valtap HCT is not recommended in early pregnancy and must not be used after the 3rd month of pregnancy, as it may seriously harm the unborn child if used during this period.
Breastfeeding
Inform the doctor if the patient is breastfeeding or plans to breastfeed.
Use of Valtap HCT is not recommended in breastfeeding mothers; the doctor may in such cases choose another treatment for the patient who intends to breastfeed, especially if the infant is a newborn or premature.
Driving and operating machinery
Before driving, using tools, operating machinery, or performing other tasks requiring concentration, each patient should determine how Valtap HCT affects them. Like many other medicines used to treat high blood pressure, Valtap HCT may rarely cause dizziness and affect the ability to concentrate.
Valtap HCT contains lactose monohydrate, sorbitol and sodium
Valtap HCT contains lactose and sorbitol, which are sugars. If the doctor has diagnosed the patient with an intolerance to certain sugars, consult the doctor before starting this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per dose, meaning the medicine is considered "sodium-free".

3. How to use Valtap HCT

This medicine should always be taken exactly as directed by your doctor or pharmacist. Following these instructions will help ensure the best results and reduce the risk of unwanted side effects. If you have any doubts, consult your doctor or pharmacist.

People with high blood pressure often do not experience any symptoms. Many people feel quite well. For this reason, it is especially important to attend regular check-ups with your doctor, even if you feel well.

Your doctor will inform you how many tablets of Valtap HCT you should take. Depending on your response to treatment, your doctor may decide to increase or decrease the dose.

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

Taking more Valtap HCT than recommended
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, pharmacist, or go to the nearest hospital immediately.

Missed 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, skip the missed dose.
Do not take a double dose to make up for a forgotten dose.

Stopping treatment with Valtap HCT
Discontinuing treatment with Valtap HCT may cause high blood pressure to return. Do not stop taking this medicine unless your doctor advises you to do so.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Some adverse effects may be serious and may require immediate medical attention:

• Immediately consult a doctor if symptoms of angioedema (an allergic reaction) occur, such as:
  • swelling of the face, tongue or throat,
  • difficulty swallowing,
  • hives and difficulty breathing.
• Severe skin disease causing rash, redness of the skin, formation of blisters on the lips, conjunctiva or oral mucosa, skin peeling and fever (toxic epidermal necrolysis).
• Impaired vision or eye pain due to increased intraocular pressure (possible symptoms of fluid accumulation in the vascular membrane surrounding the eye (excessive fluid accumulation between choroid and sclera), acute myopia or acute angle-closure glaucoma).
• Fever, sore throat, more frequent infections (agranulocytosis).

These adverse effects are very rare or occur with unknown frequency.
If any of these symptoms occur, stop taking Valtap HCT immediately and contact your doctor (see also section 2 "Warnings and precautions").
Other adverse effects include:
Not common (may occur in less than 1 in 100 people):

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

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

• dizziness,
• diarrhoea,
• joint pain.

Frequency unknown (frequency cannot be estimated from available data):

• difficulty breathing,
• significantly reduced urine output,
• low sodium levels in the blood (which may cause fatigue, confusion, muscle tremors and/or seizures in severe cases),
• low potassium levels in the blood (which may sometimes be accompanied by muscle weakness, cramps, heart rhythm disturbances),
• 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 the blood (which may, in rare cases, cause yellowing of the skin and eyes),
• increased blood urea nitrogen and creatinine levels (which may indicate impaired kidney function),
• increased blood uric acid levels (which may, in rare cases, trigger gout),
• fainting.

The following adverse effects have been reported after administration of medicines containing
either walsartan or hydrochlorothiazide alone.
Walsartan
Not common (may occur in less than 1 in 100 people):

• sensation of spinning,
• abdominal pain.

Not common (may occur in less than 1 in 100 people):

• intestinal angioedema: swelling in the intestine with symptoms such as abdominal pain, nausea, vomiting and diarrhoea.

Frequency unknown (frequency cannot be estimated from available data):

• skin blisters (symptoms of bullous dermatitis),
• skin rash with or without itching, occurring with some of the following objective and subjective symptoms: fever, joint pain, muscle pain, lymph node swelling and/or flu-like symptoms,
• rash, purple-red spots, fever, itching (symptoms of vasculitis),
• low platelet count (sometimes with unexplained bleeding 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 haemoglobin concentration and proportion of red blood cells in the blood (both factors may cause anaemia in severe cases),
• kidney failure,
• low sodium levels in the blood (which may cause fatigue, confusion, muscle tremors and/or seizures in severe cases).

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

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

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

• low sodium levels in the blood,
• low magnesium levels in the blood,
• high uric acid levels in the 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 people):

• swelling and blistering of the skin (due to photosensitivity),
• high calcium levels in the blood,
• high blood glucose levels,
• presence of glucose in the urine,
• worsening of metabolic disorders in diabetes,
• constipation, diarrhoea, discomfort in the stomach or intestines, liver disorders which may occur with yellowing of the skin and eyes,
• irregular heart function,
• headache,
• sleep disturbances,
• low mood (depression),
• low platelet count (sometimes with bleeding or subcutaneous bruising),
• dizziness,
• tingling or numbness,
• visual disturbances.

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

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

Frequency unknown (frequency cannot be estimated from available data):

• skin and lip cancers (non-melanoma skin cancers),
• weakness, bruising and frequent infections (aplastic anaemia),
• significantly reduced urine output (possible symptoms of impaired kidney function or kidney failure),
• rash, redness of the skin, formation of blisters on the lips, eyes or oral mucosa, skin peeling, fever (possible symptoms of erythema multiforme),
• muscle cramps,
• fever,
• weakness (asthenia).

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects 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.: 22 49 21 301, fax: 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorisation holder or its representative in Poland.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Valtap HCT

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after: Expiry. The expiry date refers to the last day of the stated month.
Store below 25°C. Keep in the original packaging to protect from moisture.
Do not use this medicine if the packaging is damaged or shows any signs of tampering.
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 package and other information

What Valtap HCT contains

• The active substances are valsartan and hydrochlorothiazide.
  Valtap HCT, 160 mg + 12.5 mg: each film-coated tablet contains 160 mg of valsartan and 12.5 mg of hydrochlorothiazide.
  Valtap HCT, 160 mg + 25 mg: each film-coated tablet contains 160 mg of valsartan and 25 mg of hydrochlorothiazide.
• Other ingredients:
  Tablet core: microcrystalline cellulose silicified, sorbitol (E 420), heavy magnesium carbonate 90, povidone K-25, pregelatinized corn starch, sodium stearyl fumarate, sodium lauryl sulfate, crospovidone (type A), colloidal anhydrous silica;
  Tablet coating: lactose monohydrate, hypromellose, talc, macrogol 6000, indigo carmine (E 132).
  Valtap HCT, 160 mg + 12.5 mg: iron oxide red (E 172).
  Valtap HCT, 160 mg + 25 mg: iron oxide yellow and brown (E 172).

What Valtap HCT looks like and contents of the pack
Valtap HCT, 160 mg + 12.5 mg: red, round, biconvex film-coated tablets.
Valtap HCT, 160 mg + 25 mg: brown, round, biconvex film-coated tablets.
The medicine is available in packs of 14 (only Valtap HCT, 160 mg + 25 mg), 28, 30, 56, 84, and 90 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:
Zentiva k.s., U kabelovny 130, Dolní Měcholupy, 102 37 Prague 10, Czech Republic.

For further information and the names of the medicine in the European Economic Area countries, contact the local representative of the Marketing Authorisation Holder in Poland:
Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
tel.: +48 22 375 92 00