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
Amlodipinum + Valsartanum + Hydrochlorothiazidum
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents:

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

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

• Amlodipine belongs to a group of substances called calcium channel blockers. It inhibits the influx of calcium ions into vascular smooth muscle cells, thereby preventing blood vessel constriction.
• 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, thereby increasing blood pressure. Valsartan blocks the action of angiotensin II.
• Hydrochlorothiazide belongs to a group of so-called thiazide diuretics. Hydrochlorothiazide increases urine output, which also contributes to lowering blood pressure.

As a result of these three mechanisms, blood vessels relax and blood pressure decreases.
Dipperam HCT is used for the treatment of high blood pressure in adult patients in whom blood pressure has been controlled using amlodipine, valsartan, and hydrochlorothiazide, and in whom it may be beneficial to take a single tablet containing these three active substances.

2. Important information before using Dipperam HCT

When not to use Dipperam HCT
if the patient is more than 3 months pregnant (Dipperam HCT should also not be used during early pregnancy – see section “Pregnancy and breastfeeding”).
if the patient is allergic to amlodipine or to other drugs in the calcium channel blocker group, to walsartan, hydrochlorothiazide, sulfonamides (medicines used to treat respiratory or urinary tract infections), or to any of the other ingredients of this medicine (listed in section 6).
If in doubt, do not take Dipperam HCT and consult a doctor.
if the patient has liver disease, or damage to the small bile ducts within the liver (primary biliary cirrhosis), leading to bile stasis in the bile ducts and liver.
if the patient has severe kidney function impairment or is undergoing dialysis.
if the patient's body produces no urine (anuria).
if blood potassium or sodium levels are too low despite treatment aimed at increasing their concentration.
if blood calcium levels are too high despite treatment aimed at reducing their concentration.
if the patient has been diagnosed with gout (deposition of uric acid crystals 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 deliver adequate blood flow to the body).
if the patient has heart failure due to myocardial infarction.
if the patient has diabetes or kidney function impairment and is taking a blood pressure-lowering medicine containing aliskiren.

If any of the above situations apply, do not take Dipperam HCT and contact your doctor.

Warnings and precautions
Before starting Dipperam HCT, discuss this with your doctor or pharmacist if:

• the patient has low blood potassium or magnesium levels (with or without symptoms such as muscle weakness, muscle cramps, or irregular heartbeat).

• the patient has low blood sodium levels (with or without symptoms such as fatigue, confusion, muscle twitching, or seizures).

• the patient has high blood calcium levels (with or without symptoms such as nausea, vomiting, constipation, stomach pain, frequent urination, thirst, weakness, or muscle twitching).

• the patient has kidney function impairment, has undergone a kidney transplant, or has renal artery stenosis.

• the patient has liver function impairment.

• the patient has or has previously had heart failure or ischemic heart disease, especially if prescribed the maximum dose of Dipperam HCT (10 mg + 320 mg + 25 mg).

• the patient has had a myocardial infarction. Strictly follow the doctor’s recommendations regarding the initial dose. The doctor may also monitor kidney function.

• the patient has heart valve stenosis (aortic or mitral stenosis) or abnormal thickening of the heart muscle (hypertrophic obstructive cardiomyopathy).

• the patient has been diagnosed with hyperaldosteronism, a condition in which the adrenal glands produce too much of the hormone aldosterone. In such cases, Dipperam HCT is not recommended.

• the patient has systemic lupus erythematosus (“lupus” or SLE).

• the patient has diabetes (high blood sugar levels).

• the patient has high blood cholesterol or triglyceride levels.

• sunlight causes skin reactions such as rash in the patient.

• taking other antihypertensive or diuretic medicines previously caused an allergic reaction in the patient, especially if the patient has asthma or allergies.

• the patient has had vomiting or diarrhea.

• taking other medicines (including angiotensin-converting enzyme inhibitors) previously caused angioedema, especially of the face and throat. If such symptoms occur, discontinue Dipperam HCT immediately and contact a doctor. Dipperam HCT should never be used again.

• the patient experiences dizziness and/or fainting while taking Dipperam HCT. In such cases, contact a doctor immediately.

• the patient has blurred vision or eye pain. These may be symptoms of fluid accumulation in the vascular layer surrounding the eye (excessive fluid buildup between the choroid and sclera) or increased intraocular pressure, which may occur from a few hours to weeks after taking Dipperam HCT. If left untreated, there is a risk of permanent vision loss. The risk of such disorders may be higher in patients who previously had an allergy 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 kidney disease due to diabetes,

• aliskiren.

• the patient has previously had skin cancer or develops unexpected skin changes during treatment – long-term and high-dose use of hydrochlorothiazide may increase the risk of certain types of skin and lip cancer (non-melanoma skin cancer); during treatment with Dipperam HCT, protect the skin from sunlight and UV radiation.

• if the patient previously experienced breathing or lung problems (including pneumonia or fluid accumulation in the lungs) after taking hydrochlorothiazide. If severe shortness of breath or breathing difficulties occur after taking Dipperam HCT, seek immediate medical help.

Your doctor may recommend regular monitoring of kidney function, blood pressure, and blood electrolyte levels (e.g., potassium).
See also information in the section “When not to use Dipperam HCT”.
If any of the above warnings apply, inform your doctor.
If the patient experiences abdominal pain, nausea, vomiting, or diarrhea after taking Dipperam HCT, discuss this with the doctor. The doctor will decide on further treatment. Do not make independent decisions to stop taking Dipperam HCT.

Children and adolescents
Dipperam HCT is not recommended for use in children and adolescents under 18 years of age.

Elderly patients (aged 65 years and older)
Dipperam HCT can be used in patients aged 65 years and older at the same dose and in the same manner as in other adults, as previously used for the three active substances contained in the medicine (amlodipine, walsartan, and hydrochlorothiazide). In elderly patients, especially those taking Dipperam HCT at the maximum dose (10 mg + 320 mg + 25 mg), blood pressure should be monitored regularly.

Dipperam HCT and other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned for use. The doctor may adjust the dose and/or take additional precautions. In some cases, discontinuation of one of the medicines may be necessary. This is particularly important if the patient is taking any of the following medicines.

Concomitant use contraindicated:
lithium (a medicine used to treat certain forms of depression);
medicines or substances that increase blood potassium levels, including potassium supplements or potassium-containing salt substitutes, potassium-sparing agents, and heparin;
ACE inhibitors or aliskiren (see also sections “When not to use Dipperam HCT” and “Warnings and precautions”).

Concomitant use requiring caution:
alcohol, sedatives, and anesthetics (medicines used during surgery and other procedures);
amantadine (a medicine used in Parkinson’s disease and for treatment or prevention of certain viral infections);
anticholinergic medicines (used to treat various disorders such as stomach and intestinal spasms, bladder spasms, asthma, motion sickness, muscle spasms, Parkinson’s disease, and as adjuncts in anesthesia);
antiepileptic and mood-stabilizing medicines used in epilepsy and bipolar disorder (e.g., carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone);
cholestyramine, colestipol, or other ion-exchange resins (substances mainly used to treat high blood lipid levels);
simvastatin (a medicine used to reduce high blood cholesterol levels);
cyclosporine (a medicine used to prevent organ transplant rejection or in other clinical conditions such as rheumatoid arthritis or atopic dermatitis);
cytotoxic medicines (used in cancer treatment), such as methotrexate or cyclophosphamide;
digoxin or other cardiac glycosides (medicines used in heart disease);
verapamil, diltiazem (medicines used in heart disease);
iodine-containing contrast agents (used during imaging procedures);
medicines used to treat diabetes (oral agents [e.g., metformin] or insulin);
medicines used to treat gout, such as allopurinol;
medicines that may increase blood sugar levels (beta-blockers, diazoxide);
medicines that may cause cardiac arrhythmias of the torsade de pointes type, such as antiarrhythmics (medicines used in heart disease) and certain antipsychotics;
medicines that may reduce blood sodium levels, such as antidepressants, antipsychotics, antiepileptics;
medicines that may reduce blood potassium levels, such as diuretics, corticosteroids, laxatives, amphotericin, or benzylpenicillin;
medicines that may 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 for esophageal ulceration and inflammation (carbenoxolone);
medicines used to relieve pain or inflammation, especially non-steroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 (COX-2) inhibitors;
muscle relaxants (medicines used to reduce muscle tone during surgery);
glyceryl trinitrate (“nitroglycerin”) and other nitrates or other vasodilating substances;
other medicines used to treat high blood pressure, including methyldopa;
rifampicin (a medicine used, for example, in tuberculosis treatment), erythromycin, clarithromycin (antibiotics);
St. John’s wort;
dantrolene (a medicine administered intravenously in cases of significant body temperature disturbances);
tacrolimus (used to control immune system response, enabling acceptance of a transplanted organ);
vitamin D and calcium salts.

Dipperam HCT with food, drink, and alcohol
While taking Dipperam HCT, do not eat grapefruit or drink grapefruit juice, as this may increase blood levels of one of the active substances – amlodipine. This may 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, inform the doctor. Usually, the doctor will recommend discontinuing Dipperam HCT before conception or immediately after pregnancy is confirmed and will prescribe an alternative medicine. Dipperam HCT is not recommended during early pregnancy and must not be taken after the 3rd month of pregnancy, as it may seriously harm the unborn child.

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 is not recommended during breastfeeding. For patients planning to breastfeed, especially of a newborn or premature infant, the doctor may choose an alternative 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 or operate tools or machinery.

3. How to use Dipperam HCT

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your doctor.
This will help achieve the best treatment results and reduce the risk of adverse 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 may be taken during or independently of meals. Do not take Dipperam HCT together with grapefruit or grapefruit juice.

Depending on the patient's response to treatment, the doctor may recommend a higher or lower dose.
Do not take a higher dose than recommended.
Taking a higher than recommended dose of Dipperam HCT
If too many tablets of Dipperam HCT are accidentally taken, contact your doctor immediately.
Medical assistance may be necessary.
Breathlessness caused by excess fluid accumulating in the lungs (pulmonary edema) may occur up to 24–48 hours after taking the medicine.
Missing a dose of Dipperam HCT
If a dose is missed, take it as soon as you remember, then take the next tablet at the usual time.
However, if it is almost time for the next dose, take the next tablet at the usual time. Do not take a double dose (two tablets at the same time) to make up for a missed dose.
Stopping treatment with Dipperam HCT
Stopping treatment with Dipperam HCT may lead to worsening of the condition. Do not discontinue taking the medicine without consulting your doctor.
The medicine should be taken continuously, even if the patient feels well.
Patients with high blood pressure often do not notice any symptoms. Many people feel normal.
To achieve the best treatment outcomes and reduce the risk of adverse effects, it is important to strictly follow the doctor's instructions.
Regular follow-up visits should be attended even if the patient feels well.
If you have any further questions regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
As with any combination medicine containing three active substances, adverse reactions associated with any of the components cannot be ruled out.
The adverse reactions listed below have been reported during treatment with combination medicines containing amlodipine, valsartan, and hydrochlorothiazide, or with one of these active substances alone. These reactions may occur during treatment with Dipperam HCT.
Some adverse reactions may be serious and may require urgent medical attention.
If any of the following serious adverse reactions occur after taking this medicine, consult a doctor immediately:

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

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

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

• significantly reduced urine output (kidney function disorders)

Rare (may occur in less than 1 in 1,000 people):

• spontaneous bleeding
• irregular heart rhythm
• liver function disorders

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 breathlessness, fever, weakness, and confusion)
swelling of eyelids, face, or lips
swelling of the tongue and throat, causing significant breathing difficulty
severe skin reactions, including intense rash, urticaria, redness of the skin over the entire body, severe itching, blistering, peeling and swelling of the skin, mucosal inflammation (Stevens-Johnson syndrome, toxic epidermal necrolysis), or other allergic reactions
myocardial infarction
pancreatitis, which may cause severe abdominal and back pain with nausea and vomiting
weakness, bruising, fever, and frequent infections
stiffness
angioedema of the intestine: intestinal swelling with symptoms such as abdominal pain, nausea, vomiting, and diarrhea

Other possible adverse reactions
Very common (may occur in at least 1 in 10 people):

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

Common (may occur in less than 1 in 10 people):
drowsiness
palpitations (awareness of heartbeat)
sudden flushing of the skin
ankle swelling
abdominal pain
discomfort in the stomach after meals
fatigue
headache
frequent urination
high uric acid levels in blood
low magnesium levels in blood
low sodium levels in blood
dizziness, fainting upon standing
decreased appetite
nausea and vomiting
itchy rash and other types of skin rash
inability to achieve or maintain erection

Uncommon (may occur in less than 1 in 100 people):
rapid heartbeat
sensation of spinning
vision disturbances
discomfort in the stomach
chest pain
increased blood levels of urea, creatinine, and uric acid
high levels of calcium, fats, or sodium in blood
low potassium levels in blood
bad breath
diarrhea
dry mouth
weight gain
loss of appetite
taste disturbances
back pain
joint swelling
muscle cramps/weakness/muscle pain
limb pain
inability to stand or walk properly
weakness
coordination disturbances
dizziness upon standing or physical exertion
lack of energy
sleep disturbances
tingling or numbness
neuropathy
sudden transient loss of consciousness
low blood pressure upon standing
cough
shortness of breath
throat irritation
excessive sweating
itching
swelling, redness, and pain along the vein
skin redness
tremor
mood changes
anxiety
depression
insomnia
abnormal taste sensation
fainting
loss of pain sensation
vision disturbances
visual impairment
tinnitus (ringing in the ears)
sneezing/runny nose due to inflammation of the nasal mucosa (rhinitis)
changes in bowel habits
dyspepsia
hair loss
skin itching
skin discoloration
urination disorders
increased need to urinate at night
more frequent urination
discomfort or enlargement of the breasts in men
pain
malaise
weight loss

Rare (may occur in less than 1 in 1,000 people):
low platelet count (sometimes with bleeding or development of skin purpura)
presence of glucose in urine
high blood sugar levels
worsening of metabolic status in diabetes
abdominal discomfort
constipation
liver function disorders, which may include yellowing of the skin and eyes or dark-colored urine (hemolytic anemia)
increased sensitivity of the skin to sunlight
presence of purple spots on the skin
kidney function disorders
confusion

Very rare (may occur in less than 1 in 10,000 people):
decreased white blood cell count
decreased platelet count, which may cause unusual bruising or easy bleeding (damage to red blood cells)
gum swelling
abdominal swelling (inflammation of the gastric mucosa)
hepatitis
yellowing of the skin (jaundice)
increased liver enzyme activity detected in laboratory tests
increased muscle tension
vasculitis, often with skin rash
photosensitivity
movement disorders involving stiffness, tremor, and/or movement disturbances
fever, sore throat, or oral ulcers, frequent infections (absence or low number of white blood cells)
pale skin, fatigue, shortness of breath, dark urine (hemolytic anemia, abnormal breakdown of red blood cells in blood vessels or elsewhere in the body)
confusion, fatigue, tremor, and muscle cramps, rapid breathing (hypochloremic alkalosis)
severe upper abdominal pain (pancreatitis)
difficulty breathing with fever, cough, wheezing, breathlessness (respiratory disorders, pulmonary edema, pneumonia)
facial rash, joint pain, muscle disorders, fever (lupus erythematosus)
vasculitis with symptoms such as rash, purple-red spots, fever (vasculitis)
serious skin disease causing rash, redness of the skin, blistering around lips, eyes, or mouth, skin peeling, fever (toxic epidermal necrolysis)

Frequency not known (cannot be estimated from available data):
changes in kidney function test results, increased potassium levels in blood, low red blood cell count
abnormal red blood cell test results
low count of certain types of white blood cells and platelets
increased creatinine levels in blood
abnormal liver function test results
markedly reduced urine output
vasculitis
weakness, bruising, and frequent infections (aplastic anemia)
visual impairment or eye pain due to elevated pressure (possible symptoms of fluid accumulation in the vascular membrane surrounding the eye — excessive fluid buildup between choroid and sclera — or acute angle-closure glaucoma)
dyspnea (shortness of breath)
markedly reduced urine output (possible symptoms of kidney function disorders and kidney failure)
serious skin disease causing rash, redness of the skin, blistering around lips, eyes, or mouth, skin peeling, fever (erythema multiforme)
muscle cramps
fever
blister formation on the skin (symptoms of bullous dermatitis)
skin and lip cancer (non-melanoma skin cancer)

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions 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.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Dipperam 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 pack following EXP.
The expiry date refers to the last day of the stated month.
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 must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the package 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 amlodipine, 160 mg valsartan and 12.5 mg
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 amlodipine, 160 mg valsartan and 12.5 mg
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 amlodipine, 160 mg valsartan and 25 mg
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-shaped tablets, marked with "NVR" on one side and "VCL" on the other, approximately
15 mm in length and 5.9 mm in width.
Dipperam HCT, 10 mg + 160 mg + 12.5 mg
Light yellow, oval-shaped tablets, marked with "NVR" on one side and "VDL" on the other, approximately
15 mm in length and 5.9 mm in width.
Dipperam HCT, 10 mg + 160 mg + 25 mg
Brownish-yellow, oval-shaped tablets, marked with "NVR" on one side and "VHL" on the other, approximately
15 mm in length and 5.9 mm in width.
The medicine is available in blister packs or unit dose blisters made of PVC/PVDC/Aluminium.
Pack sizes: 28 film-coated tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl, Austria

Manufacturers/Importers
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 further information about this medicine and its trade names in the European Economic Area countries, please contact:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
tel. 22 209 70 00