Dipperam Hct

Leaflet accompanying the packaging: patient information

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, 5 mg + 160 mg + 25 mg, film-coated tablets

Dipperam HCT, 10 mg + 160 mg + 25 mg, film-coated tablets

Dipperam HCT, 10 mg + 320 mg + 25 mg, film-coated tablets

Amlodipine + Valsartan + Hydrochlorothiazide

You should carefully read the contents of this leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their 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 packaging 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 to the cells of the blood vessel walls, which inhibits the constriction 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 excretion, which also reduces blood pressure.

As a result of all three actions, blood vessels dilate and blood pressure decreases. Dipperam HCT is used to treat high blood pressure in adult patients who have achieved blood pressure control with amlodipine, valsartan, and hydrochlorothiazide, and for whom it may be 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, valsartan, hydrochlorothiazide, sulfonamides (drugs used to treat respiratory or urinary tract infections) or any of the other ingredients of this medicine (listed in section 6); if the patient has liver disease, bile duct obstruction (bile duct cirrhosis) leading to bile stagnation in the bile ducts and liver; if the patient has severe kidney dysfunction or is undergoing 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 valve stenosis 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 dysfunction and is taking a blood pressure-lowering medicine containing aliskiren.

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

Warnings and precautions

Before starting to take Dipperam HCT, the patient should discuss it with their doctor or pharmacist if: they have low blood potassium or magnesium levels (with or without symptoms such as muscle weakness, muscle cramps, irregular heartbeat); they have low blood sodium levels (with or without symptoms such as fatigue, confusion, tremors, seizures); they have high blood calcium levels (with or without symptoms such as nausea, vomiting, constipation, stomach pain, frequent urination, thirst, weakness, and tremors); they have kidney dysfunction, have undergone a kidney transplant, or have been diagnosed with renal artery stenosis; they have liver dysfunction; they have or have had heart failure or coronary heart disease, especially if their doctor has prescribed Dipperam HCT at the maximum dose (10 mg + 320 mg + 25 mg); they have had a heart attack. The doctor will closely monitor the patient's condition and may adjust the initial dose of Dipperam HCT; they have aortic valve stenosis or mitral stenosis or abnormal thickening of the heart muscle (hypertrophic cardiomyopathy); they have been diagnosed with hyperaldosteronism - a disease in which the adrenal glands produce too much of a hormone called aldosterone. In such cases, the use of Dipperam HCT is not recommended; they have a disease called systemic lupus erythematosus (lupus or SLE); they have diabetes; they have high cholesterol or triglyceride levels in the blood; they experience skin reactions to sunlight, such as a rash; they have taken other blood pressure-lowering medicines or diuretics and experienced an allergic reaction, especially if they have asthma or allergies; they have had vomiting or diarrhea; they have taken other medicines (including ACE inhibitors) and experienced swelling, especially of the face and throat. If such symptoms occur, the patient should stop taking Dipperam HCT and consult a doctor immediately. They should never take Dipperam HCT again; they experience dizziness and/or fainting while taking Dipperam HCT.

• The patient should immediately consult a doctor if they experience any of the above.

The doctor may recommend regular monitoring of kidney function, blood pressure, and electrolyte levels (such as 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, they should tell their doctor.

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

Children and adolescents

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

Elderly patients (65 years and older)

Dipperam HCT can be used in patients 65 years 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 at the maximum dose (10 mg + 320 mg + 25 mg), regular blood pressure monitoring is recommended.

Dipperam HCT 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 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 blood potassium levels, including potassium supplements or salt substitutes containing potassium, potassium-sparing diuretics, and heparin; ACE inhibitors or aliskiren (see also the subsections "When not to take Dipperam HCT" and "Warnings and precautions"); alcohol, sedatives, and anesthetics (medicines that allow surgery and other procedures to be performed); amantadine (a medicine used to treat Parkinson's disease and to treat or prevent certain viral diseases); anticholinergic medicines (medicines used to treat a range of disorders, such as stomach and intestinal cramps, bladder cramps, asthma, motion sickness, muscle cramps, Parkinson's disease, and as adjuncts to anesthesia); antiepileptic and mood-stabilizing medicines used to treat epilepsy and bipolar disorder (e.g., carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone); cholestyramine, colestipol, or other ion-exchange resins (substances used mainly to treat high lipid levels in the blood); simvastatin (a medicine used to lower high cholesterol levels in the blood); cyclosporine (a medicine used to prevent transplant rejection or in other clinical situations, such as rheumatoid arthritis or atopic dermatitis); cytotoxic medicines (used to treat cancer), such as methotrexate or cyclophosphamide; digitalis or other cardiac glycosides (medicines used to treat heart conditions); verapamil, diltiazem (medicines used to treat heart conditions); iodine-containing contrast agents (used during imaging tests); oral antidiabetic medicines (such as metformin) or insulin; medicines used to treat gout, such as allopurinol; medicines that can increase blood sugar levels (beta-adrenolytics, diazoxide); medicines that can cause abnormal heart rhythms (type torsade de pointes), such as antiarrhythmic medicines (medicines used to treat heart conditions) and certain antipsychotic medicines; medicines that can lower blood sodium levels, such as antidepressant, antipsychotic, antiepileptic medicines; medicines that can lower blood potassium levels, such as diuretics, corticosteroids, laxatives, amphotericin, or penicillin; medicines that can increase blood pressure, such as adrenaline or noradrenaline; medicines used to treat HIV/AIDS (e.g., ritonavir, indinavir, nelfinavir); medicines used to treat fungal infections (e.g., ketoconazole, itraconazole); medicines used to treat esophagitis or esophageal ulcers (carbenoxolone); nonsteroidal anti-inflammatory medicines (NSAIDs), including selective cyclooxygenase-2 (COX-2) inhibitors; muscle relaxants (medicines used to reduce muscle tension during surgery); glyceryl trinitrate ("nitroglycerin") and other nitrates or other vasodilators; other medicines used to treat high blood pressure, including methyldopa; rifampicin (a medicine used, for example, to treat tuberculosis), erythromycin, clarithromycin (antibiotics); St. John's wort; dantrolene (a medicine given by infusion in case of significant body temperature disorders); vitamin D and calcium salts.

Dipperam HCT with food, drink, and alcohol

While taking Dipperam HCT, the patient should not eat grapefruits or drink grapefruit juice, as this may increase the level of one of the active substances - amlodipine - in the blood. This may result in unpredictable intensification of the blood pressure-lowering effect of Dipperam HCT. 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, they should tell their doctor. The doctor will usually recommend stopping Dipperam HCT before becoming pregnant or immediately after confirming pregnancy and prescribe another medicine instead of Dipperam HCT. Dipperam HCT should not be used in early pregnancy and 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, they should tell their doctor. Dipperam HCT should not be used during breastfeeding. For patients planning to breastfeed, especially newborns or premature babies, the doctor may choose another suitable medicine. Before taking any medicine, the patient should consult a doctor or pharmacist.

Driving and using machines

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

3. How to take Dipperam HCT

This medicine should always be taken as directed by the doctor. If the patient has any doubts, they should 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 tablet per day.

• The medicine should be taken daily at the same time, preferably in the morning.
• The tablets should be swallowed whole with a glass of water.
• Dipperam HCT can be taken with or without food. The patient should 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. The patient should not take a dose higher than recommended.

Taking a higher dose of Dipperam HCT than recommended

If the patient accidentally takes too many Dipperam HCT tablets, they should immediately consult a doctor. Medical attention may be necessary. Even 24-48 hours after taking the medicine, shortness of breath due to excess fluid accumulation in the lungs (pulmonary edema) may occur.

Missing a dose of Dipperam HCT

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

Stopping treatment with Dipperam HCT

Stopping treatment with Dipperam HCT may worsen the disease. The patient should not stop taking the medicine without their doctor's advice.

The medicine should be taken 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. The patient should attend follow-up appointments even if they feel well. If the patient has any further doubts about taking this medicine, they should 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 ruled out 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 during treatment with one 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 serious side effects listed below, they should immediately consult a doctor:

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

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

Uncommon (may occur in less than 1 in 100 people):

• significantly reduced urine excretion (kidney dysfunction)

Rare (may occur in less than 1 in 1000 people):

• spontaneous bleeding
• irregular heartbeat
• liver dysfunction

Very rare (may occur in less than 1 in 10,000 people):
sudden wheezing, chest pain, shortness of breath, or difficulty breathing
swelling of the eyelids, face, or lips
swelling of the tongue and throat, which can significantly impede 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, inflammation of the mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions
heart attack
pancreatitis, which can cause severe abdominal and back pain with nausea and vomiting
weakness, bruising, fever, and frequent infections
stiffness
angioedema of the intestines: intestinal swelling with symptoms such as abdominal pain, nausea, vomiting, and diarrhea

Other possible side effects

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

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

Common (may occur in less than 1 in 10 people):
drowsiness
palpitations (feeling of heart activity)
sudden flushing of the skin
swelling of the ankles
abdominal pain
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, fainting when standing up
decreased appetite
nausea and vomiting
itchy rash and other types of rash
erectile dysfunction
Uncommon (may occur in less than 1 in 100 people):
rapid heartbeat
feeling of spinning
vision disturbances
discomfort in the stomach
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
unpleasant breathing
diarrhea
dry mouth
weight gain
loss of appetite
taste disturbances
back pain
swelling of the joints
muscle cramps/weakness/pain
limb pain
difficulty standing or walking
weakness
coordination disorders
dizziness when standing up or exercising
lack of energy
sleep disturbances
tingling or numbness
neuropathy
sudden brief loss of consciousness
low blood pressure when standing up
cough
shortness of breath
throat irritation
excessive sweating
itching
swelling, redness, and pain along a vein
redness of the skin
tremors
mood changes
anxiety
depression
insomnia
abnormal taste sensation
fainting
loss of pain sensation
vision disturbances
visual impairment
ringing in the ears
sneezing/runny nose caused by nasal mucosal inflammation (rhinitis)
change in bowel movements
constipation
hair loss
itching of the skin
skin discoloration
urination disorders
increased need to urinate at night
more frequent urination
discomfort or enlargement of the breasts in men
pain
general malaise
weight loss
Rare (may occur in less than 1 in 1000 people):
low platelet count (sometimes with bleeding or bruising under the skin)
presence of sugar in the urine
high blood sugar levels
worsening of metabolic status in diabetes
discomfort in the abdominal cavity
constipation
liver dysfunction, which may be accompanied by yellowing of the skin and eyes or dark urine (hemolytic anemia)
increased sensitivity of the skin to sunlight
presence of purple spots on the skin
kidney dysfunction
confusion
Very rare (may occur in less than 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
abdominal swelling (gastritis)
hepatitis
jaundice (yellowing of the skin)
increased liver enzyme activity detected in laboratory tests
increased muscle tone
vasculitis, often with skin rash
sensitivity to light
disorders involving stiffness, tremors, and/or movement disorders
fever, sore throat, or mouth ulcers, frequent infections (low white blood cell count)
pale skin, fatigue, shortness of breath, dark urine (hemolytic anemia, abnormal breakdown of red blood cells in blood vessels or in any part of the body)
confusion, fatigue, tremors, and/or muscle cramps, rapid breathing (hypochloremic alkalosis)
severe abdominal pain (pancreatitis)
difficulty breathing 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 in the mouth, eyes, or genital area, peeling of the skin, fever (toxic epidermal necrolysis)
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 count of a certain type of white blood cell and platelets
increased creatinine levels in the blood
abnormal liver function test results
significantly reduced urine excretion
vasculitis
weakness, bruising, and frequent infections (aplastic anemia)
visual impairment or eye pain due to fluid accumulation in the vascular layer surrounding the eye (excessive fluid accumulation between the choroid and sclera) or increased intraocular pressure - these may 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 these disorders may be higher in patients who have previously been allergic to penicillin or sulfonamides; shortness of breath; significantly reduced urine excretion (possible symptoms of kidney dysfunction and kidney failure); severe skin disease causing rash, redness of the skin, blistering in the mouth, eyes, or genital area, peeling of the skin, fever (erythema multiforme); muscle cramps; fever; blistering of the skin (bullous pemphigoid); non-melanoma skin cancer and lip cancer.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell 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 the medicine.

5. How to store Dipperam HCT

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 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 packaging 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. 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 packaging 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, 5 mg + 160 mg + 25 mg Each film-coated tablet contains 5 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, titanium dioxide (E171), yellow 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). Dipperam HCT, 10 mg + 320 mg + 25 mg Each film-coated tablet contains 10 mg of amlodipine, 320 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, biconvex tablets with beveled edges, with the inscription "NVR" on one side and "VCL" on the other side, approximately 15 mm long and 5.9 mm wide. Dipperam HCT, 10 mg + 160 mg + 12.5 mg Light yellow, oval, biconvex tablets with beveled edges, with the inscription "NVR" on one side and "VDL" on the other side, approximately 15 mm long and 5.9 mm wide. Dipperam HCT, 5 mg + 160 mg + 25 mg Yellow, oval, biconvex tablets with beveled edges, with the inscription "NVR" on one side and "VEL" on the other side, approximately 15 mm long and 5.9 mm wide. Dipperam HCT, 10 mg + 160 mg + 25 mg Brown-yellow, oval, biconvex tablets with beveled edges, with the inscription "NVR" on one side and "VHL" on the other side, approximately 15 mm long and 5.9 mm wide. Dipperam HCT, 10 mg + 320 mg + 25 mg Brown-yellow, oval, biconvex tablets with beveled edges, with the inscription "NVR" on one side and "VFL" on the other side, approximately 19 mm long and 7.5 mm wide. The medicine is available in blisters or single-dose blisters made of PVC/PVDC/Aluminum. Package 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 Ronda de Santa Maria, 158 08013 Barcelona Spain Novartis Farma S.P.A. Via Provinciale Schito 131 80058 Torre Annunziata Italy

For more information about 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 Warsaw tel. 22 209 70 00 Date of last revision of the leaflet:01/2025 Sandoz logo