Dipper-mono

Leaflet accompanying the packaging: patient information

Dipper-Mono, 160 mg, film-coated tablets

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. It may harm them, even if their symptoms are the same as yours.
• 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 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 control high blood pressure. Angiotensin II is a substance that narrows blood vessels in the body and increases blood pressure. Dipper-Mono blocks the action of angiotensin II, resulting in reduced blood vessel tension and blood pressure. Dipper-Mono can be used in three different conditions:
to treat high blood pressure in adults and in children and adolescents from 6 to 18 years of age.High blood pressure increases the burden on the heart and arteries. If left untreated, it can damage blood vessels in the brain, heart, and kidneys, leading to stroke, heart failure, or kidney failure. High blood pressure increases the risk of heart attack. Lowering blood pressure to normal values reduces the risk of developing these disorders.
to treat adult patients after a recent heart attack("recent" means from 12 hours to 10 days).
to treat symptomatic heart failure in adults. Dipper-Mono is used when ACE inhibitors (a type of medicine used to treat heart failure) cannot be used or are used in combination with ACE inhibitors when other medicines used to treat heart failure cannot be given.
The symptoms of heart failure include shortness of breath and swelling of the feet and legs due to fluid retention. Heart failure occurs when the heart muscle is not strong enough to pump blood to the entire body.

2. Important information before taking Dipper-Mono

When not to take Dipper-Mono

if the patient is allergicto valsartan or any of the other ingredients of this medicine (listed in section 6);
if the patient has severe liver disease;
if the patient is pregnant for more than 3 months(in early pregnancy, it is also better not to take Dipper-Mono – see the section on pregnancy);
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 Dipper-Mono.

Warnings and precautions

Before taking Dipper-Mono, the patient should discuss it with their doctor if:

the patient has liver disease
the patient has severe kidney disease or is undergoing dialysis
the patient has narrowing of the renal artery
the patient has recently undergone a kidney transplant (received a new kidney)
the patient has had a heart attack or has heart failure; the doctor may monitor their kidney function
the patient has severe heart disease (other than heart failure or heart attack)
if the patient has ever experienced swelling of the tongue and face (angioedema) due to an allergic reaction when taking other medicines (including ACE inhibitors). If such symptoms occur when taking Dipper-Mono, the patient should stop taking it immediately and never take it again. See also section 4 "Possible side effects".
the patient is taking medicines that increase the amount of potassium in the blood. These include potassium supplements or potassium-containing salt substitutes, potassium-sparing medicines, and heparin. Regular monitoring of potassium levels in the blood may be necessary.
the patient is under 18 years old and is taking Dipper-Mono in combination with other medicines that inhibit the renin-angiotensin-aldosterone system (blood pressure-lowering medicines), the doctor may recommend regular monitoring of the patient's kidney function and potassium levels in the blood
the patient has hyperaldosteronism – a disease in which the adrenal glands produce too much aldosterone hormone. In this case, taking Dipper-Mono is not recommended.
the patient has lost a lot of fluid (dehydration) due to diarrhea, vomiting, or taking high doses of diuretics
the patient is pregnant (or may become pregnant), it is necessary to inform the doctor. Dipper-Mono is not recommended in early pregnancy and is contraindicated after the 3rd month of pregnancy, as its use at this time may be very harmful to the fetus (see the section on pregnancy).
the patient is taking any of the following medicines used to treat high blood pressure:

• an ACE inhibitor (such as enalapril, lisinopril, etc.) or aliskiren (see also the information in the section "When not to take Dipper-Mono" and "Warnings and precautions")

If any of the above warnings apply to the patient, they should inform their doctor before taking Dipper-Mono.

The doctor may regularly monitor the patient's 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 the patient experiences stomach pain, nausea, vomiting, or diarrhea after taking Dipper-Mono, they should discuss it with their doctor. The doctor will decide on further treatment. The patient should not stop taking Dipper-Mono on their own.

Dipper-Mono 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.
Taking Dipper-Mono with some other medicines may affect the treatment outcome. It may be necessary to change the dose, take other precautions, or in some cases, stop taking one of the medicines. 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 the amount of potassiumin the blood. These include potassium supplements or potassium-containing salt substitutes, potassium-sparing medicines, and heparin
certain painkillers, known as nonsteroidal anti-inflammatory drugs (NSAIDs)
some antibiotics (from the rifamycin group), 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 the patient is 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 the patient is taking an ACE inhibitorwith other medicines used to treat heart failure, such as mineralocorticoid receptor antagonists(e.g., spironolactone, eplerenone) or beta-adrenergic blockers(e.g., metoprolol).

Dipper-Mono with food and drink

Dipper-Mono can be taken with or without food.

Pregnancy and breastfeeding

If a woman is pregnant or breastfeeding, or thinks she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before taking this medicine.
The patient must inform their doctor if they are pregnant (or may become pregnant).
Usually, the doctor recommends stopping Dipper-Mono before the patient becomes pregnant or as soon as possible after pregnancy is confirmed, and instead, offers another medicine. Taking 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.

The patient should inform their doctor about breastfeeding or intending to breastfeed.

Taking Dipper-Mono is not recommended during breastfeeding. For patients planning to breastfeed, especially newborns or premature babies, the doctor may choose another suitable medicine.

Driving and using machines

Before driving a vehicle, using tools, operating machinery, or performing tasks that require concentration, the patient should make sure how Dipper-Mono affects their body. Like other blood pressure-lowering medicines, Dipper-Mono may rarely cause dizziness, which can affect concentration.

3. How to take Dipper-Mono

To get the best results from treatment and minimize the risk of side effects, this medicine should always be taken as directed by the doctor. If in doubt, the patient should consult their doctor or pharmacist.
People with high blood pressure often do not experience any symptoms of their illness. Many of them feel perfectly fine. Therefore, it is especially important to follow all appointments with the doctor, even if the patient feels well.

Adult patients with high blood pressure

The recommended dose is 80 mg once daily. In some cases, the 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, the doctor may prescribe higher doses (the dose can be increased to 160 mg and up to 320 mg).

Adult patients after a heart attack

Treatment after a heart attack usually starts within 12 hours, typically with a low dose of 20 mg twice daily. The 20 mg dose is obtained by dividing a 40 mg tablet in half. The doctor will gradually increase this dose over several weeks to a maximum dose of 160 mg twice daily. The final dose depends on the patient's individual tolerance.
Dipper-Mono can be given with other medicines used to treat heart attack, and the doctor will choose the most suitable treatment for the patient.

Adult patients with heart failure

Treatment usually starts with a dose of 40 mg twice daily. The doctor will increase this dose gradually over several weeks to a maximum dose of 160 mg twice daily. The final dose depends on the patient's individual tolerance.
Dipper-Mono can be given with other medicines used to treat heart failure, and the doctor will choose the most suitable treatment for the patient.
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

In case of severe dizziness and/or fainting, the patient should contact their doctor immediately and lie down. If the patient accidentally takes too many tablets, they should contact their doctor or hospital.

Missing a dose of Dipper-Mono

If a dose is missed, the patient should take it as soon as possible after remembering. However, if it is almost time for the next dose, they should skip the missed dose.
The patient should not take a double dose to make up for the missed dose.

Stopping treatment with Dipper-Mono

Stopping treatment with Dipper-Mono may worsen the disease. The patient should not stop taking the medicine without their doctor's advice.
If the patient has any further doubts about taking this medicine, they should consult their 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 special allergic reaction), such as
swelling of the face, lips, tongue, or throat
difficulty breathing or swallowing
hives, itching

If any of these symptoms occur, the patient should stop taking Dipper-Mono and immediately consult their doctor (see also section 2 "Warnings and precautions").

The following are side effects:

Common(may occur in less than 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 occur in less than 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, heart rhythm disturbances (symptoms of hyperkalemia)
shortness of breath, difficulty breathing when lying down, swelling of the feet or legs (symptoms of heart failure)
headache
cough
stomach pain
nausea
diarrhea
feeling of tiredness
weakness
Rare(may occur in less than 1 in 10,000 people):
angioedema of the intestine: swelling in the intestine with symptoms such as stomach pain, nausea, vomiting, and diarrhea
Unknown frequency(frequency cannot be estimated from the available data):
blistering of the skin (symptom of bullous dermatitis)
allergic reactions with rash, itching, and hives; symptoms of fever, swelling, and pain in the joints, muscle pain, swelling of the lymph nodes, and/or flu-like symptoms (symptoms of serum sickness)
red-purple 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 heart rhythm disturbances 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).
The frequency of some side effects may vary depending on the disease. For example, side effects such as dizziness and kidney problems are observed less frequently in adult patients treated for high blood pressure than in adult patients treated for heart failure or after a heart attack.
Side effects in children and adolescents are similar to those observed in adult patients.

Reporting side effects

If the patient experiences any side effects, including any 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.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Dipper-Mono

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 Dipper-Mono 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 pack and other information

What Dipper-Mono contains

The active substance is valsartan.
Each film-coated tablet contains 160 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

Gray-orange, oval, slightly convex film-coated tablet with a dividing line on one side and an embossed "DX" symbol on one side of the line and an "NVR" symbol on the other side of the line, and an "NVR" symbol on the other side of the tablet.
The dividing line on the tablet is only to facilitate breaking the tablet to make it easier to swallow, 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

To obtain more detailed information on the medicine and its names in the Member States of the European Economic Area, the patient should 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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