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

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your 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 you experience any side effects, including those not listed in this leaflet, tell 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 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 into the cells of 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 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 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 (biliary cirrhosis) 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 has low potassium and sodium levels in the blood despite treatment to increase them; if the patient has high calcium levels in the blood despite treatment to reduce them; if the patient has been diagnosed with gout (uric acid crystals in the joints); if the patient has significantly low blood pressure (hypotension); if the patient has aortic stenosis (narrowing of the aortic valve) 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 following 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 narrowing of the renal arteries; the patient has liver problems; the patient has or has had heart failure or coronary heart disease, especially if the doctor has prescribed the maximum dose of Dipperam HCT (10 mg + 320 mg + 25 mg); the patient has had a heart attack. The doctor will closely monitor the patient's condition and may adjust the dose; the patient has narrowing of the heart valves (aortic or mitral stenosis) or abnormal thickening of the heart muscle (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; 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 taken other medicines (including ACE inhibitors) that have caused swelling, especially 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 while taking Dipperam HCT.

• the patient has visual impairment 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 pressure inside the eye - 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, or aliskiren;
• the patient has a history of skin cancer or has experienced unexpected skin changes during treatment - long-term use of hydrochlorothiazide, especially in high doses, may increase the risk of developing certain types of skin cancer and lip cancer (non-melanoma skin cancer); during treatment with Dipperam HCT, protect the skin from sunlight and UV radiation;
• if the patient has previously experienced breathing or lung problems (including pneumonia or fluid accumulation in the lungs) after taking hydrochlorothiazide. If the patient experiences severe shortness of breath or difficulty breathing 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, tell 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 is not recommended for children and adolescents under 18 years of age.

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 the maximum dose of Dipperam HCT (10 mg + 320 mg + 25 mg), regular blood pressure monitoring is recommended.

Dipperam HCT and other medicines

Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you 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 you are 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 medicines, 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 spasms, asthma, motion sickness, muscle spasms, Parkinson's disease, and as adjuncts in 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 organ rejection or in other clinical situations, such as rheumatoid arthritis or atopic dermatitis); cytotoxic medicines (used to treat cancer), such as methotrexate or cyclophosphamide; digoxin or other digitalis glycosides (medicines used to treat heart conditions); verapamil, diltiazem (medicines used to treat heart conditions); iodine-containing contrast agents (used in imaging studies); medicines used to treat diabetes (oral 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 "torsades de pointes"), such as antiarrhythmic medicines (medicines used to treat heart conditions) and certain antipsychotic medicines; medicines that can cause low sodium levels in the blood, such as antidepressant, antipsychotic, antiepileptic medicines; medicines that can cause low potassium levels in the blood, such as diuretics, corticosteroids, laxatives, amphotericin, or penicillin benzathine; medicines that 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 and gastritis (carbenoxolone); medicines used to relieve pain or inflammation, especially nonsteroidal anti-inflammatory medicines (NSAIDs), including selective cyclooxygenase-2 (COX-2) inhibitors; muscle relaxants (medicines used to reduce muscle tension used during surgery); glyceryl trinitrate ("nitroglycerin") and other nitrates or 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, do not eat grapefruits or drink grapefruit juice, as this may increase the level of one of the active substances - amlodipine - in the blood. This can lead to 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, tell the doctor. The doctor will usually 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, tell the doctor. It is not recommended to take Dipperam HCT 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 operating machinery

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

Take this medicine always as directed by your doctor. In case of doubt, consult your doctor. This will help you get the best results from the treatment and reduce the risk of side effects. The usual dose of Dipperam HCT is one tablet per day.

• Take the medicine 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 take a higher dose than recommended.

Taking a higher dose of Dipperam HCT than recommended

If you accidentally take too many Dipperam HCT tablets, contact your 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 you miss a dose, take it as soon as you remember, 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 treatment with Dipperam HCT

Stopping treatment with Dipperam HCT may worsen the condition. Do not stop taking the medicine without consulting your doctor.

Take the medicine continuously, even if you feel well

Patients with high blood pressure often do not notice any symptoms of the disease. Many people feel normal. To get the best results from the treatment and reduce the risk of side effects, it is essential to follow the doctor's instructions carefully. Attend follow-up appointments even if you feel well. If you have any further doubts about taking this medicine, consult your 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 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 you experience any of the following serious side effects after taking this medicine, consult your doctor immediately:

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 production (kidney problems)

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

• spontaneous bleeding
• irregular heartbeat
• liver problems

Very rare (may occur in less than 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, 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 low blood cell count, which can cause weakness, bruising, and frequent infections muscle stiffness

Other possible side effects

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):drowsiness palpitations (feeling of heartbeat) sudden reddening 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 or fainting when standing up reduced appetite nausea and vomiting itching and other types of rash impotence Uncommon (may occur in less than 1 in 100 people):rapid heartbeat feeling of spinning vision disturbances abdominal 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 unpleasant breath diarrhea dry mouth weight gain loss of appetite taste disturbances back pain swelling of the joints muscle cramps or weakness pain in the limbs inability to stand or walk properly 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 sore throat excessive sweating itching swelling, redness, and pain along a vein redness of the skin trembling mood changes anxiety depression insomnia abnormal taste fainting loss of vision vision disturbances ringing in the ears sneezing/runny nose (rhinitis) changes in bowel movements 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 occur in less than 1 in 1000 people):low platelet count (sometimes with bleeding or bruising) sugar in the urine high blood sugar levels worsening of metabolic status in diabetes discomfort in the abdominal cavity constipation liver problems, which can occur with 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 occur in less than 1 in 10,000 people):low white blood cell count low platelet count, which can cause unusual bruising or bleeding (blood cell damage) gum swelling stomach inflammation (gastritis) liver inflammation yellowing of the skin (jaundice) increased liver enzyme activity muscle stiffness inflammation of the blood vessels, often with a skin rash sensitivity to light movement disorders, including stiffness, trembling, and/or movement problems fever, sore throat, or mouth sores, frequent infections (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, trembling, and/or muscle cramps, rapid breathing (hypochloremic alkalosis) severe abdominal 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) inflammation of the blood vessels with symptoms such as rash, purple-red spots, fever (vasculitis) severe skin disease, which causes a rash, redness of the skin, blistering on the lips, eyes, or mouth, peeling of the skin, fever (toxic epidermal necrolysis) Frequency not known (cannot be estimated from the available data):changes in red blood cell test results low white blood cell and platelet count increased creatinine levels in the blood abnormal liver function test results severely reduced urine production kidney problems skin cancer and lip cancer (non-melanoma skin cancer) muscle cramps fever blistering skin disease (bullous pemphigoid)

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 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, you can help provide more information on the safety of this 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 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. Ask your 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), anhydrous colloidal 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), anhydrous colloidal 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), anhydrous colloidal 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), anhydrous colloidal 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), anhydrous colloidal 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 "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 "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 "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 "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 "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. 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 Ronda de Santa Maria, 158 08013 Barcelona Spain Novartis Farma S.P.A. Via Provinciale Schito 131 80058 Torre Annunziata Italy