Dipperam

Leaflet attached to the packaging: patient information

Dipperam, 5 mg + 80 mg, film-coated tablets

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

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

Amlodipine + Valsartan

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

• Keep this leaflet, you may need to read it again.
• In case of any doubts, 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.
• If the patient experiences any side effects, including any 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 and what is it used for
• 2. Important information before taking Dipperam
• 3. How to take Dipperam
• 4. Possible side effects
• 5. How to store Dipperam
• 6. Contents of the pack and other information

1. What is Dipperam and what is it used for

Dipperam tablets contain two active substances: amlodipine and valsartan. Both substances help control high blood pressure.  Amlodipinebelongs 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 contraction of blood vessels.  Valsartanbelongs 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. Both active substances prevent the constriction of blood vessels. As a result, the blood vessels dilate, and blood pressure decreases. Dipperam is used to treat high blood pressure in adults who are not adequately controlled by amlodipine or valsartan alone.

2. Important information before taking Dipperam

When not to take Dipperam

if the patient is allergic to amlodipine or other calcium antagonists. Symptoms of an allergy may include itching, redness of the skin, or difficulty breathing. if the patient is allergic to valsartan or any of the other ingredients of this medicine (listed in section 6). In case of doubt, consult a doctor before taking Dipperam. if the patient has severe liver dysfunction or biliary obstruction, such as biliary cirrhosis or cholestasis.

• if the patient is pregnant for more than 3 months (in early pregnancy, Dipperam should not be taken either - see section "Pregnancy and breastfeeding"). if the patient has significantly decreased blood pressure (hypotension). if the patient has aortic stenosis (aortic stenosis) or is in cardiogenic shock (a condition in which the heart is unable to supply enough blood to the body's cells). 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, they should not take Dipperam and should consult a doctor.

Warnings and precautions

Before starting to take Dipperam, the patient should discuss it with their doctor if: they have gastrointestinal disorders (vomiting or diarrhea) they have liver or kidney problems they have had a kidney transplant or have renal artery stenosis they have been diagnosed with adrenal gland disorders, so-called primary hyperaldosteronism they have heart failure or have had a heart attack. The doctor will closely monitor the patient's condition and may also monitor their kidney function. the patient has aortic stenosis (aortic stenosis) or mitral stenosis (mitral stenosis) or abnormal thickening of the heart muscle (hypertrophic cardiomyopathy) if the patient has taken other medicines (including ACE inhibitors) that have caused swelling, especially of the face and throat. If such symptoms occur, the patient should stop taking Dipperam and consult a doctor immediately. The patient should never take Dipperam again. if 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 doctor may recommend regular monitoring of kidney function, blood pressure, and electrolyte levels (e.g., potassium). See also the section "When not to take Dipperam". If any of the above warnings apply to the patient, they should inform their doctor before taking Dipperam. If the patient experiences stomach pain, nausea, vomiting, or diarrhea after taking Dipperam, they should discuss it with their doctor. The doctor will decide on further treatment. The patient should not stop taking Dipperam on their own.

Children and adolescents

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

Dipperam 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 applies especially to: ACE inhibitors or aliskiren (see also sections "When not to take Dipperam" and "Warnings and precautions"); diuretics (drugs that increase urine production); lithium (a medicine used to treat certain types of depression); potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium, and other substances that increase potassium levels in the blood; certain painkillers, so-called non-steroidal anti-inflammatory drugs (NSAIDs) or selective cyclooxygenase-2 (COX-2) inhibitors - the doctor may also monitor kidney function; antiepileptic drugs (e.g., carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone); St. John's Wort; glyceryl trinitrate ("nitroglycerin") and other nitrates or other substances that dilate blood vessels; medicines used to treat HIV/AIDS (e.g., ritonavir, indinavir, nelfinavir); medicines used to treat fungal infections (e.g., ketoconazole, itraconazole); antibiotics (e.g., rifampicin, erythromycin, clarithromycin, telithromycin); verapamil, diltiazem (medicines used to treat heart conditions); simvastatin (a medicine used to lower high cholesterol levels in the blood); dantrolene (a medicine given by infusion in case of significant body temperature disorders); medicines used to prevent organ rejection (cyclosporine).

Dipperam with food and drink

While taking Dipperam, 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. As a result, the blood pressure-lowering effect of Dipperam may be unpredictable.

Pregnancy and breastfeeding

Pregnancy The patient should inform their doctor about pregnancy, suspected pregnancy, or planned pregnancy. Usually, the doctor will recommend stopping Dipperam before becoming pregnant or as soon as pregnancy is confirmed, and will recommend taking another medicine instead of Dipperam. Dipperam should not be used in early pregnancy (first 3 months) and should not be taken after the 3rd month of pregnancy, as the medicine may seriously harm the fetus.

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

Breastfeeding The patient should inform their doctor if they are breastfeeding or plan to breastfeed. Dipperam 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 may cause dizziness, which can affect the ability to concentrate. The patient should not drive vehicles, operate machines, or perform tasks that require attention if they do not know how they react to the medicine.

3. How to take Dipperam

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

• The medicine is best taken at the same time every day.
• The tablets should be swallowed with a glass of water.
• Dipperam can be taken with or without food. The patient should not take Dipperam 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 higher dose than recommended.

Taking Dipperam in elderly patients (65 years or older)

The doctor will exercise caution when increasing the dose. In case of any further doubts about taking this medicine, the patient should consult a doctor or pharmacist.

Taking a higher dose of Dipperam than recommended

If the patient has taken too many Dipperam tablets or someone else has taken them, they should contact a doctor immediately.

Missing a dose of Dipperam

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, the patient should skip the missed dose. The patient should not take a double dose to make up for the missed dose.

Stopping treatment with Dipperam

Stopping treatment with Dipperam may worsen the condition. The patient should not stop taking the medicine without consulting a doctor.

4. Possible side effects

Like all medicines, Dipperam can cause side effects, although not everybody gets them.

Some symptoms may be severe and may require immediate medical attention.

Such side effects occur rarely (in less than 1 in 1000 people).

If the patient experiences any of the following symptoms, they should contact a doctor immediately:

• allergic reaction with symptoms such as rash, itching, swelling of the face, lips, or tongue, difficulty breathing, low blood pressure (feeling of fainting, dizziness)

Other possible side effects of Dipperam

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

• flu-like symptoms
• nasal congestion, sore throat, and discomfort when swallowing
• headache
• swelling of the arms, hands, legs, ankles, or feet
• fatigue
• weakness
• redness of the skin and feeling of heat on the face and/or neck

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

• dizziness of central origin
• nausea and stomach pain
• dry mouth
• drowsiness, tingling, or numbness of the hands or feet
• feeling of spinning
• rapid heartbeat, including palpitations
• dizziness when standing up
• cough
• diarrhea
• constipation
• rash, redness of the skin
• swelling of the joints, back pain
• joint pain

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

• feeling of anxiety
• ringing in the ears (tinnitus)
• fainting
• increased urine production or sudden urge to urinate
• inability to achieve or maintain an erection
• feeling of heaviness
• low blood pressure with symptoms such as dizziness, dizziness
• excessive sweating
• rash on the skin all over the body
• itching
• muscle cramps

If any of these symptoms are severe, the patient should consult a doctor. Side effects reported after taking only amlodipine or only valsartan, which have not been observed after taking Dipperam or which occurred more frequently after taking Dipperam:

If the patient experiences any of the following very rare, serious side effects, they should consult a doctor immediately:

• sudden onset of wheezing, chest pain, shortness of breath, or difficulty breathing
• swelling of the eyelids, face, or lips
• swelling of the tongue and throat, causing severe difficulty breathing
• severe skin reactions, including intense rash, urticaria, redness of the skin all over the body, severe itching, blistering, peeling, and swelling of the skin, or other allergic reactions
• heart attack, arrhythmias
• pancreatitis, which can cause severe, radiating abdominal pain with very poor general condition.

Such side effects have been reported. If any side effect is troublesome for the patient or persists for more than a week, they should consult a doctor.

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

dizziness, drowsiness, palpitations (feeling of heartbeat), sudden redness, especially of the face, swelling of the ankles (edema), stomach pain, nausea.

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

mood changes, anxiety, depression, insomnia, tremors, taste disorders, fainting, lack of pain sensation, vision disturbances, worsening vision, ringing in the ears, low blood pressure, sneezing/runny nose due to nasal inflammation (rhinitis), indigestion, vomiting, hair loss, excessive sweating, itching of the skin, skin discoloration, urinary disorders, increased need to urinate at night, frequent urination, inability to achieve an erection, discomfort or enlargement of the breasts in men, pain, poor general condition, muscle pain, muscle cramps.

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

confusion.

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

decreased white blood cell count, decreased platelet count, which can lead to unusual bruising or easy bleeding, increased blood sugar levels (hyperglycemia), gum swelling, abdominal bloating (gastritis), liver function disorders, liver inflammation, yellowing of the skin (jaundice), increased liver enzyme activity (found in the results of some tests), increased muscle tension, blood vessel inflammation, often with skin rash, hypersensitivity to light, disorders involving stiffness, tremors, and/or difficulty moving. Valsartan

Frequency not known (cannot be estimated from the available data):

decreased red blood cell count, fever, sore throat or mouth ulcers due to infection, spontaneous bleeding or bruising, high potassium levels in the blood, abnormal liver function test results, worsening kidney function and severe kidney function disorders, swelling, mainly of the face and throat, muscle pain, rash, purple spots, fever, itching, allergic reaction, blistering of the skin (a symptom of a disease called pemphigus). If the patient experiences any of these symptoms, they should consult a doctor immediately.

Reporting side effects

If the patient experiences any side effects, including any not listed in the 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

The medicine should be stored out of 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. Do not store above 30°C. Store in the original package to protect from moisture. Do not use this medicine if visible signs of deterioration are observed. 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 pack and other information

What Dipperam contains

• The active substances are amlodipine (as amlodipine besylate) and valsartan. Each film-coated tablet of 5 mg + 80 mg contains 5 mg of amlodipine and 80 mg of valsartan.

Each film-coated tablet of 5 mg + 160 mg contains 5 mg of amlodipine and 160 mg of valsartan. Each film-coated tablet of 10 mg + 160 mg contains 10 mg of amlodipine and 160 mg of valsartan. The other ingredients are: Film-coated tablets 5 mg+80 mg and 5 mg+160 mg:microcrystalline cellulose, crospovidone (type A), magnesium stearate, colloidal anhydrous silica, hypromellose 2910 (3 mPa.s), titanium dioxide (E171), yellow iron oxide (E172), macrogol 4000, talc. Film-coated tablets 10 mg+160 mg:microcrystalline cellulose, crospovidone (type A), magnesium stearate, colloidal anhydrous silica, hypromellose 2910 (3 mPa.s), titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), macrogol 4000, talc.

What Dipperam looks like and contents of the pack

Dipperam, 5 mg + 80 mg Dark yellow, round film-coated tablets with beveled edges, with the inscription "NVR" on one side and "NV" on the other side. Approximate size: diameter 8.2 mm. Dipperam, 5 mg + 160 mg Dark yellow, oval film-coated tablets with beveled edges, with the inscription "NVR" on one side and "ECE" on the other side. Approximate size: 14.2 mm (width) x 5.7 mm (length). Dipperam, 10 mg + 160 mg Light yellow, oval film-coated tablets with beveled edges, with the inscription "NVR" on one side and "UIC" on the other side. Approximate size: 14.2 mm (width) x 5.7 mm (length). Pack sizes: 7, 14, 28, or 56 film-coated tablets in blisters. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder Sandoz GmbH Biochemiestrasse 10 6250 Kundl, Austria Manufacturer/Importer Novartis Pharma GmbH Roonstrasse 25 90429 Nürnberg, Germany Novartis Farmacéuticá S.A. 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 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