Package leaflet: Information for the patient

Dipper-Mono, 320 mg, film-coated tablets
Valsartanum
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are the same.
If the patient experiences any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents:

What Dipper-Mono is and what it is used for
Important information before taking Dipper-Mono
How to take Dipper-Mono
Possible side effects
How to store Dipper-Mono
Contents of the package and other information

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

Dipper-Mono contains the active substance: valsartan and belongs to a group of medicines called angiotensin II receptor antagonists, which help control high blood pressure. Angiotensin II is a substance that constricts blood vessels in the body, thereby increasing blood pressure. Dipper-Mono blocks the action of angiotensin II, resulting in relaxation of blood vessels and lowering of blood pressure.
Dipper-Mono can be used:
for the treatment of high blood pressure in adults and in children and adolescents aged 6 to below 18 years. High blood pressure increases the workload on the heart and blood vessels. If left untreated, it may damage blood vessels in the brain, heart, and kidneys, leading to stroke, heart failure, or kidney failure. High blood pressure increases the risk of myocardial infarction. Lowering blood pressure to normal levels reduces the risk of developing these conditions.

2. Important information before using Dipper-Mono

When not to use Dipper-Mono
if the patient is allergic to valsartan or to 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 (it is also better not to take Dipper-Mono
during early pregnancy – see section on pregnancy);
if the patient has diabetes or kidney function disorders and is taking a medicine lowering
arterial blood pressure containing aliskiren.
If any of the above situations apply to the patient, contact a doctor and do not take Dipper-Mono.

Warnings and precautions
Before starting to take Dipper-Mono, consult a doctor if:
the patient has liver disease
the patient has severe kidney disease or is undergoing dialysis
the patient has renal artery stenosis
the patient has recently undergone kidney transplantation (received a new kidney)
the patient has had a myocardial infarction or has heart failure; the doctor may monitor
kidney function
the patient has severe heart disease (other than heart failure or myocardial infarction)
the patient has previously experienced angioedema (swelling of the tongue and face) due to
an allergic reaction while taking other medicines (including ACE inhibitors). If such symptoms
occur during treatment with Dipper-Mono, the medicine must be discontinued immediately and
never taken again. See also section 4 "Possible side effects".
the patient is taking medicines that increase blood potassium levels. These include potassium
supplements or potassium-containing salt substitutes, potassium-sparing medicines, and
heparin. Regular monitoring of blood potassium levels may be necessary.
the patient is under 18 years of age and takes Dipper-Mono in combination with other
medicines that inhibit the renin-angiotensin-aldosterone system (medicines lowering arterial
blood pressure), the doctor may recommend regular monitoring of kidney function and blood
potassium levels
the patient has been diagnosed with hyperaldosteronism – a condition in which the adrenal
glands produce too much aldosterone hormone. In such cases, use of Dipper-Mono is not
recommended.
the patient has lost a large amount of fluid (dehydration) due to diarrhea, vomiting, or taking
high doses of diuretic medicines
the patient is pregnant (or may become pregnant), it is necessary to inform the doctor.
Dipper-Mono is not recommended during early pregnancy and is contraindicated after the 3rd
month of pregnancy, as its use during this time may be very harmful to the unborn child (see
section on pregnancy).
the patient is taking any of the following medicines used to treat high blood pressure:

ACE inhibitors (e.g. enalapril, lisinopril, ramipril), especially if the patient has kidney disease due to diabetes
aliskiren
the patient is taking an ACE inhibitor together with certain other medicines used to treat heart failure – so-called mineralocorticoid receptor antagonists (MRAs) (i.e. spironolactone, eplerenone) or beta-blockers (e.g. metoprolol).

If any of the above warnings apply to the patient, inform the doctor before taking Dipper-Mono.
The doctor may regularly monitor the patient's kidney function, blood pressure, and electrolyte levels (e.g. potassium) in the blood.
See also information in the section "When not to use Dipper-Mono".
If the patient develops abdominal pain, nausea, vomiting, or diarrhea after taking Dipper-Mono, discuss this with the doctor. The doctor will decide on further treatment. Do not make independent decisions about stopping Dipper-Mono.

Dipper-Mono and other medicines
Inform the doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take.
The effectiveness of treatment may be affected by taking Dipper-Mono together with certain other medicines. A dose adjustment, additional precautions, or in some cases discontinuation of one of the medicines may be necessary. This applies to both prescription and over-the-counter medicines, especially:
other medicines that lower arterial blood pressure, particularly diuretics,
ACE inhibitors (such as enalapril, lisinopril, etc.) or aliskiren (see also information in the section "When not to use Dipper-Mono" and "Warnings and precautions")
medicines that increase blood potassium levels. These include potassium supplements or potassium-containing salt substitutes, potassium-sparing medicines, and heparin
certain types of painkillers, so-called non-steroidal anti-inflammatory drugs (NSAIDs)
some antibiotics (from the rifamycin group), a medicine used 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 psychiatric disorders

In addition:
if the patient is being treated after a myocardial infarction, since concomitant use of an ACE inhibitor (a medicine used to treat heart attack) is not recommended
in the treatment of heart failure, concomitant use of Dipper-Mono in triple combination with ACE inhibitors and other medicines used to treat heart failure, known as mineralocorticoid receptor antagonists (MRA) (e.g. spironolactone, eplerenone) or beta-blockers (e.g. metoprolol), is not recommended.

Dipper-Mono with food and drink
Dipper-Mono can be taken independently of meals.

Pregnancy and breastfeeding
If a woman is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before using this medicine.
It is necessary to inform the doctor if the patient is pregnant (or may become pregnant).
Usually, the doctor will recommend discontinuing Dipper-Mono before pregnancy or as soon as pregnancy is confirmed, and will suggest an alternative medicine. Use of Dipper-Mono is not recommended during early pregnancy, and it must not be taken after the 3rd month of pregnancy, as the medicine may seriously harm the unborn child.
Inform the doctor about breastfeeding or plans to start breastfeeding.
Use of Dipper-Mono is not recommended during breastfeeding. For patients planning to breastfeed, especially a newborn or premature infant, the doctor may choose another suitable medicine.

Driving and using machines
Before driving, using tools, operating machinery, or performing activities requiring concentration, ensure how Dipper-Mono affects the patient. Like other medicines used to treat high blood pressure, Dipper-Mono may cause dizziness, which may impair the ability to concentrate.

3. How to use Dipper-Mono

To achieve the best treatment results and reduce the risk of adverse effects, this medicine
should always be used according to the doctor's instructions. If in doubt, consult your
doctor or pharmacist.
People with high blood pressure often do not experience any symptoms of their condition.
Many such individuals feel perfectly well. Therefore, it is all the more important to attend
all scheduled doctor visits, even if feeling 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 (e.g.
a diuretic) to Dipper-Mono.
Children and adolescents aged 6 to below 18 years with high blood pressure
Dipper-Mono is not available in an oral solution form. If an oral solution is required,
please refer to other products available on the market.
In patients with body weight below 35 kg, the recommended dose of valsartan is 40 mg once daily.
In patients with body weight of 35 kg or more, the usual initial dose of valsartan is 80 mg once daily.
In some cases, the doctor may prescribe higher doses (the dose may be increased up to 160 mg
and a maximum of 320 mg).
For children and adolescents who cannot swallow tablets, an oral solution containing valsartan
is recommended.
Dipper-Mono may be taken with or without food. Tablets should be swallowed with water.
The medicine should be taken every day, approximately at the same time.
Taking more Dipper-Mono than recommended
If severe dizziness and (or) fainting occur, contact a doctor immediately and lie down.
If a patient accidentally takes too many tablets, contact a doctor, pharmacist or hospital immediately.
If you forget to take Dipper-Mono
If a dose is missed, take it as soon as remembered.
However, if it is almost time for the next dose, skip the missed dose.
Do not take a double dose to make up for a missed dose.
Stopping Dipper-Mono treatment
Stopping treatment with Dipper-Mono may worsen the condition. Do not stop taking this medicine
without consulting your doctor.
If you have any further questions about 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 will experience them.
Some adverse reactions may be serious and require urgent medical attention:
Symptoms of angioedema (a specific allergic reaction) may occur, such as:
swelling of the face, lips, tongue or throat
difficulty breathing or swallowing
hives, itching
If any of these symptoms occur, discontinue use of the medicine Dipper-Mono immediately
and seek medical advice without delay (see also section 2 "Warnings and precautions").
Other adverse reactions include:
Common (may affect fewer than 1 in 10 people):
dizziness
low blood pressure with or without symptoms such as dizziness and fainting upon standing
renal function disorders (symptoms of kidney failure)
Uncommon (may affect fewer than 1 in 100 people):
angioedema (see above "Some adverse reactions may be serious and require urgent medical attention")
sudden loss of consciousness (fainting)
sensation of spinning (vestibular dizziness)
severe renal function disorders (symptoms of acute kidney failure)
muscle cramps, heart rhythm disturbances (symptoms of hyperkalaemia)
shortness of breath, difficulty breathing when lying down, swelling of feet or legs (symptoms of heart failure)
headache
cough
abdominal pain
nausea
diarrhoea
feeling of fatigue
weakness
Very rare (may affect fewer than 1 in 10,000 people):
intestinal angioedema: swelling in the intestine with symptoms such as abdominal pain, nausea, vomiting and diarrhoea
Adverse reactions with unknown frequency (frequency cannot be estimated from available data):
formation of blisters on the skin (symptoms of bullous dermatitis)
allergic reactions with rash, itching and urticaria; fever, swelling and joint pain, muscle pain, swollen lymph nodes and/or flu-like symptoms (symptoms of serum sickness) may occur
purplish-red spots, fever, itching (symptoms of vasculitis)
unusual bleeding or appearance of petechiae (symptoms of thrombocytopenia)
muscle pain (myalgia)
fever, sore throat or oral ulcers due to infection (symptoms of reduced white blood cell count, i.e. neutropenia)
decreased haemoglobin concentration and reduced number of red blood cells (in severe cases may lead to anaemia)
increased potassium levels in blood (in severe cases may cause muscle cramps and heart rhythm disturbances)
increased liver function test values (may indicate liver damage), including increased blood bilirubin concentration (in severe cases may cause yellowing of the skin and eyes)
increased blood urea nitrogen and serum creatinine concentration (may indicate kidney function disorders)
low sodium concentration in blood (may cause fatigue, confusion, muscle cramps and/or seizures in severe cases).
The frequency of some adverse reactions may vary depending on the underlying condition. For example, adverse reactions such as dizziness and renal function disorders have been observed less frequently in adult patients treated for high blood pressure than in adult patients treated for heart failure or after myocardial infarction.
Adverse reactions in children and adolescents are similar to those observed in adult patients.
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 authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Dipper-Mono

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister indicated by 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 Dipper-Mono 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 no longer in use. 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:
Tablet 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 grey-violet, oval, slightly convex film-coated tablet with bevelled edges, marked with a breakline on one side and imprinted with the symbol "DC" on one side of the line and the symbol "DC" on the other side of the line, and the symbol "NVR" on the opposite side of the tablet.
The breakline on the tablet is intended only to facilitate breaking the tablet for easier swallowing and does not ensure division into equal doses.

Pack sizes:
Each pack contains 14, 28, 30, 56, 60 or 98 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl, Austria
Tel. +48 22 209 70 00

Manufacturers/Importers
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 Warszawa, Poland
Lek S.A.
ul. Podlipie 16
95-010 Stryków, Poland
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

Austria Valsartan Sandoz 320 mg – Filmtabletten
Belgium Valsartan Sandoz 320 mg filmomhulde tabletten
Spain Valsartán Sandoz 320 mg comprimidos recubiertos con película EFG
Netherlands Valsartan Sandoz 320 mg, filmomhulde tabletten
Lithuania Suvartar 320 mg plėvele dengtos tabletės
Norway Valsartan Sandoz 320 mg tabletter, filmdrasjerte
Poland Dipper-Mono
Sweden Valsartan Sandoz 320 mg filmdragerade tabletter
Hungary Valsartan Sandoz 320 mg filmtabletta