Package leaflet: Information for the patient

Dipper-Mono, 80 mg, film-coated tablets
Dipper-Mono, 160 mg, film-coated tablets
Valsartanum
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

Keep this leaflet, as you may need to read it again.
If you have any further questions, please ask your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. This 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.

Leaflet contents:

What Dipper-Mono is and what it is used for
What you need to know before taking Dipper-Mono
How to take Dipper-Mono
Possible side effects
How to store Dipper-Mono
Contents of the pack 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 reduction in blood pressure.

Dipper-Mono can be used in three different conditions:
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 disorders.
for the treatment of adult patients after a recent myocardial infarction ("recent" means from 12 hours to 10 days after the event).
for the treatment of symptomatic heart failure in adults. Dipper-Mono is used when an ACE inhibitor (a medicine used to treat heart failure) cannot be administered, or in combination with ACE inhibitors when other heart failure medicines cannot be given.
Symptoms of heart failure include breathlessness and swelling of the feet and legs due to fluid retention. Heart failure occurs when the heart muscle is unable to pump blood strongly enough to supply the entire body.

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, discuss this with a doctor if the patient:
has liver disease
has severe kidney disease or is undergoing dialysis
has renal artery stenosis
has recently undergone kidney transplantation (received a new kidney)
has had a myocardial infarction or has heart failure; the doctor may monitor kidney function
has severe heart disease (other than heart failure or myocardial infarction)
has previously experienced angioedema (swelling of the face and tongue) due to an allergic
reaction while taking other medicines (including ACE inhibitors). If such symptoms occur while
taking Dipper-Mono, discontinue immediately and never take it again. See also section 4
"Possible side effects".
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.
is under 18 years of age and is taking Dipper-Mono in combination with other medicines
inhibiting the renin-angiotensin-aldosterone system (blood pressure-lowering medicines), the
doctor may recommend regular monitoring of kidney function and blood potassium levels
has been diagnosed with hyperaldosteronism – a condition in which the adrenal glands produce
excess aldosterone hormone. In such a case, use of Dipper-Mono is not recommended.
has lost a large amount of fluid (dehydration) due to diarrhea, vomiting, or taking high doses
of diuretic medicines
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 period may be highly harmful to the fetus (see section on pregnancy)
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, or is taking an ACE inhibitor together with certain other medicines used to treat heart failure – so-called mineralocorticoid receptor antagonists (MRA) (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 blood electrolyte
levels (e.g. potassium).
See also information in the section "When not to use Dipper-Mono".
If the patient experiences abdominal pain, nausea, vomiting, or diarrhea after taking Dipper-Mono,
discuss this with the doctor. The doctor will decide on further treatment. Do not independently decide
to stop taking Dipper-Mono.
Dipper-Mono and other medicines
Tell 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, and
especially:
other medicines lowering 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 increasing 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 (rifamycin group), a medicine preventing 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
Additionally:
if the patient is being treated after a myocardial infarction, as 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 with ACE inhibitors and
other medicines used to treat heart failure known as mineralocorticoid receptor antagonists
(MRAs) (e.g. spironolactone, eplerenone) or beta-blockers (e.g. metoprolol) in triple therapy is
not recommended.
Dipper-Mono with food and drink
Dipper-Mono can be taken regardless 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 conception or as soon as
possible after pregnancy is confirmed, and will suggest an alternative medicine. Use of Dipper-Mono
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.
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 a different suitable medicine.
Driving and operating machinery
Before driving, using tools, operating machinery, or performing tasks requiring concentration, ensure
how Dipper-Mono affects the patient. Like other medicines used to treat high blood pressure, Dipper-Mono
may cause dizziness and impair concentration ability.

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 exactly as directed by the doctor. If in doubt, consult the
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 keep
all medical appointments, even when 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 formulation. If an oral solution is required,
consider 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 starting dose of valsartan
is 80 mg once daily.
In some cases, the doctor may prescribe higher doses (the dose may be increased to 160 mg
and up to a maximum of 320 mg).
For children and adolescents who cannot swallow tablets, an oral solution containing valsartan
is recommended.
Adult patients after myocardial infarction
Treatment after myocardial infarction usually begins within 12 hours, typically starting with a low dose of 20 mg given twice daily. The 20 mg dose is obtained by dividing a 40 mg tablet in half. The doctor will gradually increase the dose over several weeks to a maximum dose of 160 mg twice daily. The final dose depends on the individual patient's tolerance.
Dipper-Mono may be administered together with other medicines used in the treatment of myocardial infarction, and the doctor will choose the most appropriate treatment for the patient.
Adult patients with heart failure
Treatment usually starts with a dose of 40 mg twice daily. The doctor will gradually increase the dose over several weeks to a maximum dose of 160 mg twice daily. The final dose depends on the individual patient's tolerance.
Dipper-Mono may be administered together with other medicines used in the treatment of heart failure, and the doctor will choose the most appropriate treatment for the patient.
Dipper-Mono can 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 prescribed
If severe dizziness and/or fainting occurs, contact the doctor immediately and lie down.
If a patient accidentally takes too many tablets, contact the doctor, pharmacist, or hospital.
Missed dose of 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
Stopping Dipper-Mono may lead to worsening of the condition. Do not discontinue taking the medicine without the doctor's advice.
If there are any further doubts about the use of this medicine, consult the
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 severe and require urgent medical intervention:
Symptoms of angioedema (a specific allergic reaction) may occur, such as:
swelling of the face, lips, tongue or throat
difficulty breathing or swallowing
urticaria (hives), itching
If any of the symptoms listed above occur, you must stop taking the medicine
Dipper-Mono and seek immediate medical advice (see also section 2 "Warnings and precautions").
Other adverse reactions include:
Common (may occur in fewer than 1 in 10 people):
dizziness
low blood pressure without symptoms or with symptoms such as dizziness and fainting
upon standing
renal function disorders (symptoms of kidney failure)
Uncommon (may occur in fewer than 1 in 100 people):
angioedema (see above "Some adverse reactions may be severe and require urgent medical intervention")
sudden loss of consciousness (fainting)
sensation of spinning (vestibular dizziness)
severe renal function disorders (symptoms of acute kidney failure)
muscle cramps, cardiac arrhythmias (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 occur in 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 blistering skin inflammation)
allergic reactions with rash, itching and urticaria; symptoms such as fever, swelling and joint pain, muscle pain, swollen lymph nodes and/or flu-like symptoms (symptoms of serum sickness)
purplish-red skin 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 decreased white blood cell count, so-called neutropenia)
decreased haemoglobin concentration and reduced number of red blood cells (which in severe cases may lead to anaemia)
increased blood potassium concentration (which in severe cases may cause muscle cramps and cardiac arrhythmias)
increased liver function test values (which may indicate liver damage), including increased blood bilirubin concentration (which in severe cases may cause yellowing of the skin and eyes)
increased blood urea nitrogen and serum creatinine concentration (which may indicate renal function disorders)
low blood sodium concentration (which 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, you should inform your doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring of Adverse Reactions of Medicinal Products, Medical Devices and Biocidal Products at 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 responsible entity.
Reporting adverse reactions enables further collection of safety information regarding the use of the 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 pack following EXP.
The expiry date refers to the last day of the specified 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 must 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.
Dipper-Mono 80 mg, film-coated tablets
Each film-coated tablet contains 80 mg of valsartan.
Dipper-Mono 160 mg, film-coated tablets
Each film-coated tablet contains 160 mg of valsartan.
The other ingredients are:
Tablet core: microcrystalline cellulose, crospovidone, colloidal anhydrous silica, magnesium stearate.
Dipper-Mono 80 mg, film-coated tablets
Coating: hypromellose, titanium dioxide (E171), macrogol 8000, iron oxide red (E172), iron oxide yellow (E172).
Dipper-Mono 160 mg, film-coated tablets
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
Dipper-Mono 80 mg, film-coated tablets
Light red, round film-coated tablet with bevelled edges, with a breakline on one side and embossed with the letter “D” on one side of the line and “V” on the other side, and with the symbol “NVR” on the reverse side of the tablet.
The breakline on the tablet is intended only to facilitate breaking for easier swallowing and does not ensure equal dose division.

Dipper-Mono 160 mg, film-coated tablets
Grey-orange, oval, slightly convex film-coated tablet with a breakline on one side and embossed with “DX” on both sides of the line, and with the symbol “NVR” on the reverse side of the tablet.
The breakline on the tablet is intended only to facilitate breaking for easier swallowing and does not ensure equal dose division.

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

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 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

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Austria
Belgium Valsartan Sandoz 80 mg film-coated tablets
Valsartan Sandoz 160 mg film-coated tablets
Bulgaria SUVARTAR 160 MG FILM-COATED TABLETS
Finland Valsartan Sandoz 80 mg film-coated tablets
Valsartan Sandoz 160 mg film-coated tablets
France VALSARTAN SANDOZ 80 mg, film-coated tablet
VALSARTAN SANDOZ 160 mg, film-coated tablet
Spain Valsartán Sandoz 80 mg film-coated tablets EFG
Valsartán Sandoz 160 mg film-coated tablets EFG
Netherlands Valsartan Sandoz 80 mg, film-coated tablets
Valsartan Sandoz 160 mg, film-coated tablets
Lithuania Suvartar 80 mg film-coated tablets
Suvartar 160 mg film-coated tablets
Norway Valsartan Sandoz 80 mg tablets, film-coated
Valsartan Sandoz 160 mg tablets, film-coated
Poland Dipper-Mono
Slovenia Valsartan Lek 80 mg film-coated tablets
Valsartan Lek 160 mg film-coated tablets
Sweden Valsartan Sandoz 80 mg film-coated tablets
Valsartan Sandoz 160 mg film-coated tablets
Hungary Valsartan Sandoz 80 mg film-coated tablets
Valsartan Sandoz 160 mg film-coated tablets