Dipper-mono

Package Leaflet: Information for the Patient

Dipper-Mono, 320 mg, Film-Coated Tablets

Valsartan

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Contents of the Package Leaflet:

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

1. What is Dipper-Mono and what is it used for

Dipper-Mono belongs to a group of medicines called angiotensin II receptor antagonists, which help to control high blood pressure. Angiotensin II is a substance that narrows blood vessels in the body, increasing blood pressure. Dipper-Mono blocks the action of angiotensin II, resulting in the relaxation of blood vessels and a decrease in blood pressure.
Dipper-Mono can be used:
to treat high blood pressure in adults and in children and adolescents from 6 to 18 years of age.High blood pressure increases the workload of the heart and arteries. If left uncontrolled, it can damage blood vessels in the brain, heart, and kidneys, leading to stroke, heart failure, or kidney failure. High blood pressure also increases the risk of heart attack. Lowering blood pressure to normal levels reduces the risk of developing these complications.

2. Important information before taking Dipper-Mono

When not to take Dipper-Mono

if you are allergicto valsartan or any of the other ingredients of this medicine (listed in section 6);
if you have severe liver disease;
if you are pregnant more than 3 months(it is also better not to take Dipper-Mono in early pregnancy - see section on pregnancy);
if you have diabetes or kidney problems and are taking a blood pressure-lowering medicine containing aliskiren.

If any of the above applies to you, do not take Dipper-Mono.

Warnings and precautions

Before taking Dipper-Mono, discuss with your doctor if:

you have liver disease
you have severe kidney disease or are on dialysis
you have narrowing of the kidney arteries
you have recently had a kidney transplant (received a new kidney)
you have had a heart attack or have heart failure; your doctor may monitor your kidney function
you have severe heart disease (other than heart failure or heart attack)
you have ever had swelling of the face, lips, tongue, or throat (angioedema) due to an allergic reaction when taking other medicines (including ACE inhibitors). If such symptoms occur while taking Dipper-Mono, stop taking it immediately and never take it again. See also section 4 "Possible side effects".
you are taking medicines that increase potassium levels in the blood. These include potassium supplements, potassium-sparing diuretics, and heparin. Regular monitoring of potassium levels in the blood may be necessary.
you are under 18 years old and are taking Dipper-Mono in combination with other medicines that affect the renin-angiotensin-aldosterone system (blood pressure-lowering medicines), your doctor may monitor your kidney function and potassium levels in the blood
you have been diagnosed with hyperaldosteronism - a condition where the adrenal glands produce too much aldosterone hormone. In this case, taking Dipper-Mono is not recommended.
you have lost a lot of fluid (dehydration) due to diarrhea, vomiting, or taking high doses of diuretics
you are pregnant (or may become pregnant), you must inform your doctor.
Dipper-Mono is not recommended in early pregnancy and is contraindicated after the 3rd month of pregnancy, as its use during this period can be very harmful to the fetus (see section on pregnancy)
you are taking any of the following medicines for high blood pressure:

• an ACE inhibitor (such as enalapril, lisinopril, ramipril), especially if you have kidney disease caused by diabetes
• aliskiren if you are taking an ACE inhibitor together with certain other medicines used to treat heart failure - so-called mineralocorticoid receptor antagonists (MRA) (such as spironolactone, eplerenone) or beta-blockers (such as metoprolol).

If any of the above warnings apply to you, inform your doctor before taking Dipper-Mono.

Your doctor may regularly monitor your kidney function, blood pressure, and electrolyte levels (such as potassium) in the blood.
See also the information in the section "When not to take Dipper-Mono".
If you experience stomach pain, nausea, vomiting, or diarrhea after taking Dipper-Mono, discuss it with your doctor. Your doctor will decide on further treatment. Do not stop taking Dipper-Mono on your own.

Dipper-Mono and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.
The effectiveness of treatment may be affected by taking Dipper-Mono with certain other medicines. A dose change, other precautions, or discontinuation of one of the medicines may be necessary. This applies to both prescription and over-the-counter medicines, especially:
other blood pressure-lowering medicines, particularly diuretics,
ACE inhibitors(such as enalapril, lisinopril, etc.) or aliskiren(see also the information in the section "When not to take Dipper-Mono" and "Warnings and precautions")
medicines that increase potassium levelsin the blood. These include potassium supplements or potassium-sparing diuretics and heparin
certain painkillers, so-called non-steroidal anti-inflammatory drugs (NSAIDs)
certain antibiotics (such as rifamycin), a medicine to prevent transplant rejection (cyclosporine), or an antiretroviral medicine used to treat HIV infection and AIDS (ritonavir). These medicines may enhance the effect of Dipper-Mono
lithium, a medicine used to treat certain mental illnesses

In addition:

if you are being treated after a heart attack, as it is not recommended to take an ACE inhibitor (a medicine used to treat heart attack) at the same time
if you are taking an ACE inhibitor together with certain other medicines used to treat heart failure, such as mineralocorticoid receptor antagonists (such as spironolactone, eplerenone) or beta-blockers (such as metoprolol).

Dipper-Mono with food and drink

Dipper-Mono can be taken with or without food.

Pregnancy and breastfeeding

If you are pregnant, breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before taking this medicine.
It is essential to inform your doctor if you are pregnant (or may become pregnant).
Usually, your doctor will advise you to stop taking Dipper-Mono before you become pregnant or as soon as possible after finding out you are pregnant, and will offer an alternative medicine. The use of Dipper-Mono is not recommended in early pregnancy, and it is contraindicated after the 3rd month of pregnancy, as it may seriously harm the fetus.

You must inform your doctor about breastfeeding or intending to breastfeed.

The use of Dipper-Mono is not recommended during breastfeeding. For mothers who plan to breastfeed, especially newborns or premature babies, the doctor may choose a different suitable medicine.

Driving and using machines

Before driving, using tools, operating machinery, or performing tasks that require concentration, make sure you know how Dipper-Mono affects you. Like other blood pressure medicines, Dipper-Mono may cause dizziness in rare cases, which can affect your ability to concentrate.

3. How to take Dipper-Mono

To get the best results from treatment and reduce the risk of side effects, this medicine should always be taken as directed by your doctor. If you are unsure, consult your doctor or pharmacist.
People with high blood pressure often do not feel any symptoms of their illness. Many of them feel perfectly well. Therefore, it is crucial to attend all scheduled appointments with your doctor, even if you feel well.

Adult patients with high blood pressure

The recommended dose is 80 mg once daily. In some cases, your doctor may prescribe higher doses (e.g., 160 mg or 320 mg) and may also add another medicine to Dipper-Mono (e.g., a diuretic).

Children and adolescents (6 to 18 years old) with high blood pressure

For patients with a body weight below 35 kg, the recommended dose of valsartan is 40 mg once daily.
For patients with a body weight of 35 kg or more, the usual starting dose of valsartan is 80 mg once daily.
In some cases, your doctor may prescribe higher doses (up to 160 mg and a maximum of 320 mg).
Dipper-Mono can be taken with or without food. The tablets should be swallowed with water.
The medicine should be taken every day, approximately at the same time.

Taking a higher dose of Dipper-Mono than recommended

If you experience severe dizziness and/or fainting, contact your doctor immediately and lie down. If you accidentally take too many tablets, contact your doctor or hospital.

Missing a dose of Dipper-Mono

If you miss a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose.
Do not take a double dose to make up for a forgotten dose.

Stopping treatment with Dipper-Mono

Stopping treatment with Dipper-Mono may worsen your condition. Do not stop taking the medicine without consulting your doctor.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Dipper-Mono can cause side effects, although not everybody gets them.

Some symptoms require immediate medical attention:

It is possible to experience symptoms of angioedema (a specific allergic reaction), such as
swelling of the face, lips, tongue, or throat
difficulty breathing or swallowing
hives, itching

If you experience any of these symptoms, stop taking Dipper-Mono and contact your doctor immediately (see also section 2 "Warnings and precautions").

Side effects include:

Common(may affect up to 1 in 10 people):
dizziness
low blood pressure without symptoms or with symptoms such as dizziness and fainting when standing up
kidney problems (symptoms of kidney failure)
Uncommon(may affect up to 1 in 100 people):
angioedema (see above "Some symptoms require immediate medical attention")
sudden loss of consciousness (fainting)
feeling of spinning (vertigo)
severe kidney problems (symptoms of acute kidney failure)
muscle cramps, irregular heartbeat (symptoms of hyperkalemia)
shortness of breath, difficulty breathing when lying down, swelling of the feet or ankles (symptoms of heart failure)
headache
cough
stomach pain
nausea
diarrhea
feeling tired
weakness
Rare(may affect up to 1 in 1,000 people):
angioedema of the intestine: swelling in the intestine with symptoms such as stomach pain, nausea, vomiting, and diarrhea
Frequency not known(frequency cannot be estimated from the available data):
blistering of the skin (symptom of bullous dermatitis)
allergic reactions with rash, itching, and hives; may occur with symptoms of fever, swelling, and pain in the joints, muscle pain, swelling of lymph nodes, and/or flu-like symptoms (symptoms of serum sickness)
purple-red spots, fever, itching (symptoms of vasculitis)
unusual bleeding or bruising (symptoms of thrombocytopenia)
muscle pain (myalgia)
fever, sore throat, or mouth ulcers due to infection (symptoms of neutropenia)
decreased hemoglobin and red blood cell count (which can lead to anemia in severe cases)
increased potassium levels in the blood (which can cause muscle cramps and irregular heartbeat in severe cases)
increased liver enzyme values (which may indicate liver damage), including increased bilirubin levels in the blood (which can cause yellowing of the skin and eyes in severe cases)
increased urea and creatinine levels in the blood (which may indicate kidney problems)
low sodium levels in the blood (which can cause fatigue, confusion, muscle cramps, and/or seizures in severe cases).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist.

Side effects can be reported directly to the Department of Drug Safety, 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 Dipper-Mono

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after EXP.
The expiry date refers to the last day of that month.
Do not store above 30°C. Store in the original package to protect from moisture.
Do not use Dipper-Mono if you notice damage to the packaging or signs of tampering.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Dipper-Mono contains

The active substance is valsartan.
Each film-coated tablet contains 320 mg of valsartan.
The other ingredients are:
Core:microcrystalline cellulose, crospovidone, colloidal anhydrous silica, magnesium stearate
Coating:hypromellose, titanium dioxide (E171), macrogol 8000, iron oxide red (E172), iron oxide yellow (E172), iron oxide black (E172).

What Dipper-Mono looks like and contents of the pack

Dark gray-violet, oval, slightly convex film-coated tablet with a score line on one side and a symbol "DC" on one side of the score line and a symbol "DC" on the other side of the score line, and a symbol "NVR" on the other side of the tablet.
The score line on the tablet is only to facilitate breaking and not to divide it into equal doses.
Pack sizes:
One pack contains 14, 28, 30, 56, 60, 98 film-coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl, Austria
Manufacturer/Importer
Lek Pharmaceuticals d.d.
Verovškova 57
1526 Ljubljana, Slovenia
Lek Pharmaceuticals d.d.
Trimlini 2D
9220 Lendava, Slovenia
Lek S.A.
ul. Domaniewska 50 C
02-672 Warsaw
Lek S.A.
ul. Podlipie 16
95-010 Stryków
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben, Germany
Novartis Farmacéutica, S.A.
Gran Vía de les Corts Catalanes, 764, 08013
Barcelona, Spain
S.C. Sandoz, S.R.L.
Livezeni Street no 7A
540472 Targu Mures, Romania
Novartis Farma S.p.A.
Via Provinciale Schito 131
80058 Torre Annunziata (NA)
Italy

For more detailed information on this 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
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