Dipperam Hct

Package Leaflet: Information for the Patient

Dipperam HCT, 5 mg + 160 mg + 12.5 mg, Film-Coated Tablets

Dipperam HCT, 10 mg + 160 mg + 12.5 mg, Film-Coated Tablets

Dipperam HCT, 10 mg + 160 mg + 25 mg, Film-Coated Tablets

Amlodipine + 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, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

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

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

Dipperam HCT tablets contain three active substances: amlodipine, valsartan, and hydrochlorothiazide. All these substances help control high blood pressure.

• Amlodipine belongs to a group of substances called calcium antagonists. It prevents the transport of calcium ions into the cells of the blood vessel walls, which inhibits the contraction of blood vessels.
• Valsartan belongs to a group of substances called angiotensin II receptor antagonists. Angiotensin II is a substance produced in the body that causes blood vessels to constrict, increasing blood pressure. Valsartan blocks the action of angiotensin II.
• Hydrochlorothiazide belongs to a group of so-called thiazide diuretics. Hydrochlorothiazide increases urine production, which also reduces blood pressure.

As a result of all three actions, blood vessels relax and blood pressure decreases. Dipperam HCT is used to treat high blood pressure in adult patients who have achieved blood pressure control using amlodipine, valsartan, and hydrochlorothiazide, and for whom it is beneficial to take one tablet containing these three active substances.

2. Important information before taking Dipperam HCT

When not to take Dipperam HCT

if the patient is pregnant for more than 3 months (in early pregnancy, Dipperam HCT should not be taken either - see "Pregnancy and breastfeeding"). if the patient is allergic to amlodipine or other calcium antagonists, to valsartan, to hydrochlorothiazide, sulfonamides (drugs used to treat infections of the respiratory or urinary tract) or to any of the other ingredients of this medicine (listed in section 6). In case of doubt, do not take Dipperam HCT and consult a doctor. if the patient has liver disease, bile duct obstruction (bile duct obstruction leading to bile stagnation in the bile ducts and liver). if the patient has severe kidney problems or is on dialysis. if the patient's body does not produce urine (anuria). if the patient's blood potassium and sodium levels are too low despite treatment to increase them. if the patient's blood calcium level is too high despite treatment to decrease it. if the patient has been diagnosed with gout (uric acid crystal deposition in the joints). if the patient has significantly low blood pressure (hypotension). if the patient has aortic stenosis (aortic valve narrowing) or is in cardiogenic shock (a condition in which the heart is unable to supply the body with enough blood). if the patient has heart failure due to a heart attack. if the patient has diabetes or kidney problems and is taking a blood pressure-lowering medicine containing aliskiren.

If any of the above situations apply to the patient, do not take Dipperam HCT and consult a doctor.

Warnings and precautions

Before starting to take Dipperam HCT, discuss it with your doctor or pharmacist if: the patient has low potassium or magnesium levels in the blood (with or without symptoms such as muscle weakness, muscle cramps, irregular heartbeat). the patient has low sodium levels in the blood (with or without symptoms such as fatigue, confusion, tremors, seizures). the patient has high calcium levels in the blood (with or without symptoms such as nausea, vomiting, constipation, stomach pain, frequent urination, thirst, weakness, and tremors). the patient has kidney problems, has undergone a kidney transplant, or has been diagnosed with renal artery stenosis. the patient has liver problems. the patient has or has had heart failure or coronary heart disease, especially if the doctor has prescribed Dipperam HCT in the maximum dose (10 mg + 320 mg + 25 mg). the patient has had a heart attack. The doctor will closely follow the patient's initial dose of the medicine and may also monitor the patient's kidney function. the patient has narrowing of the heart valves (e.g., aortic or mitral stenosis) or abnormal thickening of the heart muscle (e.g., hypertrophic cardiomyopathy). the patient has been diagnosed with hyperaldosteronism - a disease in which the adrenal glands produce too much of a hormone called aldosterone. In this case, it is not recommended to take Dipperam HCT. the patient has a disease called systemic lupus erythematosus (lupus or SLE). the patient has diabetes (high blood sugar levels). the patient has high cholesterol or triglyceride levels in the blood. the patient experiences skin reactions to sunlight, such as a rash. the patient has had an allergic reaction to other blood pressure-lowering medicines or diuretics, especially if they have asthma or allergies. the patient has had vomiting or diarrhea. the patient has had an allergic reaction to other medicines (including ACE inhibitors), especially if they have experienced swelling of the face and throat. If such symptoms occur, stop taking Dipperam HCT and consult a doctor immediately. Do not take Dipperam HCT again.

• the patient experiences dizziness and/or fainting. In this case, consult a doctor immediately.
• the patient experiences vision loss 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 - they can occur within a few hours to weeks after taking Dipperam HCT. If left untreated, there is a risk of permanent vision loss. The risk of developing such disorders may be higher in patients who have previously been allergic to penicillin or sulfonamides;

the patient is taking any of the following medicines for high blood pressure: ACE inhibitors (e.g., enalapril, lisinopril, ramipril), especially if the patient has diabetic kidney disease, aliskiren. the patient has had cancer or if an unexpected skin change occurs during treatment - long-term and high-dose use of hydrochlorothiazide may increase the risk of developing certain types of skin and lip cancer (non-melanoma skin cancer); during Dipperam HCT treatment, protect the skin from sunlight and UV radiation. if the patient has had breathing or lung problems (including pneumonia or fluid accumulation in the lungs) after taking hydrochlorothiazide. If severe shortness of breath or difficulty breathing occurs after taking Dipperam HCT, seek medical help immediately.

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

If any of the above warnings apply to the patient, inform the doctor.

If the patient experiences stomach pain, nausea, vomiting, or diarrhea after taking Dipperam HCT, discuss it with the doctor. The doctor will decide on further treatment. Do not stop taking Dipperam HCT on your own.

Children and adolescents

Dipperam HCT should not be used in children and adolescents under 18 years of age.

Elderly patients (65 years of age and older)

Dipperam HCT can be used in patients 65 years of age and older at the same dose as in other adults and in the same way as the three active substances contained in the medicine (amlodipine, valsartan, and hydrochlorothiazide) were previously taken. In elderly patients, especially those taking Dipperam HCT in the maximum dose (10 mg + 320 mg + 25 mg), regular blood pressure monitoring is recommended.

Dipperam HCT and other medicines

Inform the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take. The doctor may recommend a dose change and/or take other precautions. In some cases, it may be necessary to stop taking one of the medicines. This is especially important if the patient is taking any of the following medicines: lithium (a medicine used to treat certain types of depression); medicines or substances that increase potassium levels in the blood, including potassium supplements or salt substitutes containing potassium, potassium-sparing diuretics, and heparin; ACE inhibitors or aliskiren (see also subsections "When not to take Dipperam HCT" and "Warnings and precautions").

Dipperam HCT with food, drink, and alcohol

Do not eat grapefruits or drink grapefruit juice while taking Dipperam HCT, as this may increase the level of one of the active substances - amlodipine - in the blood. As a result, the blood pressure-lowering effect of Dipperam HCT may be unpredictable. Planned alcohol consumption should be discussed with a doctor. Alcohol may cause excessive lowering of blood pressure and/or increase the risk of dizziness or fainting.

Pregnancy and breastfeeding

Pregnancy If the patient is (or may be) pregnant, inform the doctor. Usually, the doctor will recommend stopping Dipperam HCT before becoming pregnant or immediately after confirming pregnancy and prescribe a different medicine instead of Dipperam HCT. It is not recommended to take Dipperam HCT in early pregnancy and it should not be taken after the 3rd month of pregnancy, as the medicine taken at this time may seriously harm the fetus.

• after the 3rd month of pregnancy, as the medicine taken at this time may seriously harm the fetus.

Breastfeeding If the patient is breastfeeding or plans to breastfeed, inform the doctor. It has been shown that small amounts of amlodipine pass into human milk. Dipperam HCT should not be used during breastfeeding. For patients planning to breastfeed, especially newborns or premature babies, the doctor may choose a different suitable medicine. Before taking any medicine, consult a doctor or pharmacist.

Driving and using machines

Dipperam HCT may cause dizziness, drowsiness, nausea, or headache. If these symptoms occur, do not drive vehicles or operate tools or machines.

3. How to take Dipperam HCT

This medicine should always be taken exactly as prescribed by the doctor. In case of doubt, consult a doctor. This will help achieve the best treatment results and reduce the risk of side effects. The usual dose of Dipperam HCT is one tabletper day.

• The medicine should be taken every day at the same time, preferably in the morning.
• Swallow the tablets whole with a glass of water.
• Dipperam HCT can be taken with or without food. Do not take Dipperam HCT with grapefruit or grapefruit juice.

Depending on the patient's response to treatment, the doctor may recommend a higher or lower dose of the medicine. Do not exceed the recommended dose.

Taking a higher than recommended dose of Dipperam HCT

In case of accidental ingestion of too many Dipperam HCT tablets, consult a doctor immediately. Medical attention may be necessary. Even 24-48 hours after taking the medicine, shortness of breath due to excessive fluid accumulation in the lungs (pulmonary edema) may occur.

Missing a dose of Dipperam HCT

If a dose is missed, take it as soon as remembered, and then take the next tablet at the usual time. However, if it is almost time for the next dose, take it at the usual time. Do nottake a double dose (two tablets at the same time) to make up for the missed dose.

Stopping Dipperam HCT treatment

Stopping Dipperam HCT treatment may worsen the disease. Do not stop taking the medicine without consulting a doctor.

Take the medicine continuously, even if the patient feels well

Patients with high blood pressure often do not notice any symptoms of the disease. Many people feel normal. To achieve the best treatment results and reduce the risk of side effects, it is essential to follow the doctor's instructions carefully. Attend follow-up appointments even if the patient feels well. If there are any further doubts about taking this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Dipperam HCT can cause side effects, although not everybody gets them. As with any combination medicine containing three active substances, it cannot be excluded that side effects of each component may occur. The following side effects have been reported during treatment with the combination medicine containing amlodipine, valsartan, and hydrochlorothiazide or with any of these active substances. These effects may occur when taking Dipperam HCT.

Some side effects can be serious and may require immediate medical attention.

If the patient experiences any of the following serious side effects after taking this medicine, consult a doctor immediately:

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

• dizziness
• low blood pressure (feeling of fainting, dizziness, sudden loss of consciousness)

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

• significantly reduced urine production (kidney problems)

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

• spontaneous bleeding
• irregular heartbeat
• liver problems

Very rare (may affect up to 1 in 10,000 people):sudden wheezing, chest pain, shortness of breath, or difficulty breathing acute respiratory failure (symptoms include severe shortness of breath, fever, weakness, and confusion). swelling of the eyelids, face, or lips swelling of the tongue and throat, which can greatly difficulty breathing severe skin reactions, including intense rash, hives, redness of the skin all over the body, severe itching, blistering, peeling, and swelling of the skin, and allergic reactions myocardial infarction pancreatitis, which can cause severe stomach and back pain with nausea and vomiting weakness, bruising, fever, and frequent infections stiffness edema of the intestines: intestinal swelling with symptoms such as stomach pain, nausea, vomiting, and diarrhea

Other possible side effects

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):drowsiness palpitations (feeling of heartbeat) flushing of the skin edema of the ankles pain in the stomach discomfort in the stomach after eating fatigue headache frequent urination high uric acid levels in the blood low magnesium levels in the blood low sodium levels in the blood dizziness or fainting when standing up decreased appetite nausea and vomiting itching rash and other types of rash impotence Uncommon (may affect up to 1 in 100 people):rapid heartbeat feeling of spinning vision disturbances stomach discomfort chest pain increased levels of urea, creatinine, and uric acid in the blood high calcium, fat, or sodium levels in the blood low potassium levels in the blood shortness of breath diarrhea dry mouth weight gain loss of appetite taste disturbances back pain joint swelling muscle cramps or weakness pain in the limbs inability to stand or walk properly weakness coordination disturbances dizziness when standing up or exercising lack of energy sleep disturbances tingling or numbness neuropathy sudden loss of consciousness low blood pressure when standing up cough shortness of breath sore throat excessive sweating itching swelling, redness, and pain along a vein redness of the skin tremors mood changes anxiety depression insomnia abnormal taste fainting loss of pain sensation vision disturbances vision loss ringing in the ears sneezing or runny nose (rhinitis) changes in bowel habits indigestion hair loss itching of the skin skin discoloration urinary disorders increased need to urinate at night frequent urination discomfort or enlargement of the breasts in men pain general malaise weight loss Rare (may affect up to 1 in 1,000 people):low platelet count (sometimes with bleeding or bruising under the skin) sugar in the urine high blood sugar levels worsening of metabolic status in diabetes discomfort in the abdominal cavity constipation liver problems, which may be accompanied by yellowing of the skin and eyes or dark urine (hemolytic anemia) increased sensitivity of the skin to sunlight purple spots on the skin kidney problems confusion Very rare (may affect up to 1 in 10,000 people):decreased white blood cell count decreased platelet count, which can cause unusual bruising or easy bleeding (red blood cell damage) gum swelling stomach inflammation (gastritis) liver inflammation (hepatitis) yellowing of the skin (jaundice) increased liver enzyme activity muscle stiffness vasculitis, often with skin rash sensitivity to light disorders including stiffness, tremors, and/or movement disturbances fever, sore throat, or mouth sores (low white blood cell count) pale skin, fatigue, shortness of breath, dark urine (hemolytic anemia, abnormal breakdown of red blood cells in the blood vessels or in any part of the body) confusion, fatigue, tremors, and muscle cramps, rapid breathing (hypochloremic alkalosis) severe stomach pain (pancreatitis) breathing difficulties with fever, cough, wheezing, shortness of breath (respiratory disorders, pulmonary edema, pneumonia) rash on the face, joint pain, muscle disorders, fever (lupus) vasculitis with symptoms such as rash, purple-red spots, fever (vasculitis) severe skin disease causing rash, redness of the skin, blistering on the lips, eyes, or mouth, peeling, and swelling of the skin, fever (toxic epidermal necrolysis, Stevens-Johnson syndrome) Frequency not known (cannot be estimated from the available data):changes in kidney function test results, increased potassium levels in the blood, low red blood cell count abnormal red blood cell test results low levels of a certain type of white blood cell and platelets increased creatinine levels in the blood abnormal liver function test results significantly reduced urine production vasculitis weakness, bruising, and frequent infections (aplastic anemia) vision loss 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) shortness of breath significantly reduced urine production (possible symptoms of kidney problems and kidney failure) severe skin disease causing rash, redness of the skin, blistering on the lips, eyes, or mouth, peeling, and swelling of the skin, fever (erythema multiforme) muscle cramps fever blistering of the skin (symptoms of bullous pemphigoid) non-melanoma skin cancer (skin and lip cancer)

Reporting side effects

If side effects occur, including those not listed in this leaflet, inform the 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 the medicine.

5. How to store Dipperam HCT

Keep the medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month stated. Do not store above 30°C. Store in the original package to protect from moisture. Do not use this medicine if the packaging is damaged or shows signs of tampering. Medicines should not be disposed of via wastewater or household waste. Ask a 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 Dipperam HCT contains

The active substances are amlodipine (as amlodipine besylate), valsartan, and hydrochlorothiazide. Dipperam HCT, 5 mg + 160 mg + 12.5 mg Each film-coated tablet contains 5 mg of amlodipine, 160 mg of valsartan, and 12.5 mg of hydrochlorothiazide. The other ingredients are microcrystalline cellulose, crospovidone (type A), colloidal anhydrous silica, magnesium stearate, hypromellose (type 2910), titanium dioxide (E171), macrogol 4000, talc. Dipperam HCT, 10 mg + 160 mg + 12.5 mg Each film-coated tablet contains 10 mg of amlodipine, 160 mg of valsartan, and 12.5 mg of hydrochlorothiazide. The other ingredients are microcrystalline cellulose, crospovidone (type A), colloidal anhydrous silica, magnesium stearate, hypromellose (type 2910), titanium dioxide (E171), macrogol 4000, talc, yellow iron oxide (E172), red iron oxide (E172). Dipperam HCT, 10 mg + 160 mg + 25 mg Each film-coated tablet contains 10 mg of amlodipine, 160 mg of valsartan, and 25 mg of hydrochlorothiazide. The other ingredients are microcrystalline cellulose, crospovidone (type A), colloidal anhydrous silica, magnesium stearate, hypromellose (type 2910), macrogol 4000, talc, yellow iron oxide (E172).

What Dipperam HCT looks like and contents of the pack

Dipperam HCT, 5 mg + 160 mg + 12.5 mg White, oval, with "NVR" on one side and "VCL" on the other, approximately 15 mm long and 5.9 mm wide. Dipperam HCT, 10 mg + 160 mg + 12.5 mg Light yellow, oval, with "NVR" on one side and "VDL" on the other, approximately 15 mm long and 5.9 mm wide. Dipperam HCT, 10 mg + 160 mg + 25 mg Brown-yellow, oval, with "NVR" on one side and "VHL" on the other, approximately 15 mm long and 5.9 mm wide. The medicine is available in blisters or unit-dose blisters made of PVC/PVDC/Aluminum. Pack sizes: 28 film-coated tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder Sandoz GmbH Biochemiestrasse 10 6250 Kundl, Austria Manufacturer/Importer Salutas Pharma GmbH Otto-von-Guericke-Allee 1 39179 Barleben, Germany Novartis Pharma GmbH Roonstrasse 25 90429 Nürnberg, Bayern Germany Novartis Farmacéutica SA Gran Via de les Corts Catalanes 764 08013 Barcelona Spain Novartis Farma S.P.A. Via Provinciale Schito 131 80058 Torre Annunziata Italy

For more information on the medicine and its names in the Member States of the European Economic Area, please contact:

Sandoz Polska Sp. z o.o. ul. Domaniewska 50 C 02-672 Warszawa tel. 22 209 70 00 Date of last revision of the leaflet:06/2025 Sandoz logo