Jak stosować ONAKA
Treść ulotki
ONAKA 800 mg granules for oral solution, 400 mg oral solution
pidotimod
Read this leaflet carefully before taking this medicine as it contains important
information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
- If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of this leaflet:
- 1. What ONAKA is and what it is used for
- 2. What you need to know before you take ONAKA
- 3. How to take ONAKA
- 4. Possible side effects
- 5. How to store ONAKA
- 6. Contents of the pack and other information
1. What is ONAKA and what is it used for
ONAKA contains a substance called pidotimod, formed by chains of amino acids, capable of
activating and stimulating the body's immune defenses. This medicine helps to prevent and
treat infections, especially of the respiratory and urinary tracts in adults and children over 3 years
of age who have a weakened immune system.
2. What you need to know before you take ONAKA
Do not take ONAKA
- if you are allergic to the active ingredient or any of the other ingredients of this medicine (listed in section 6).
- if you are in the first trimester of pregnancy
Do not give ONAKA to your child
- if they are under three years of age
Warnings and precautions
Talk to your doctor or pharmacist before taking ONAKA.
In atopic subjects or with a history of allergic reactions, the medicine should be administered
with caution.
In patients with congenital immune deficiencies (hyper-IgE syndromes) the drug should be used with
caution.
Other medicines and ONAKA
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines. The product may interfere with drugs that block or stimulate the activity
of blood cells that play a very important role in the immune system (lymphocytes).
ONAKA with food, drinks and alcohol
Because there is an interference of food on the absorption of the product, the administration of Onaka
should occur away from meals.
Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, or are planning a pregnancy, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before taking this medicine.
Although studies conducted in animals have not shown any effects, as with other drugs,
use in the first three months of pregnancy is contraindicated.
Driving and operating machinery
ONAKA does not impair the ability to drive vehicles or operate machinery.
ONAKA 800 mg granules for oral solution contains:
- sodium, this medicine contains 3.3 mmol (75.9 mg) of sodium (the main component of table salt) per sachet. This is equivalent to 3.8% of the maximum recommended daily intake with the diet of an adult. To be taken into consideration in people with reduced kidney function or who are following a low-sodium diet;
- sunset yellow (E110), cochineal red A (E124), which may cause allergic reactions;
- sucrose, so if you are intolerant to any sugars, contact your doctor before taking this medicine.
ONAKA 400 mg oral solution contains:
- sodium, this medicine contains 0.2 mmol (4.6 mg) of sodium per vial, i.e. it is essentially sodium-free;
- sorbitol, so if you are intolerant to any sugars, contact your doctor before taking this medicine, it may also cause gastrointestinal problems and have a mild laxative effect;
- cochineal red A (E124), which may cause allergic reactions;
- sodium methyl parahydroxybenzoateand sodium propyl parahydroxybenzoate, which may cause allergic reactions (even delayed).
3. How to take ONAKA
Take this medicine following the instructions of your doctor or pharmacist exactly. If you
have any doubts, consult your doctor or pharmacist.
The recommended dose is:
Adults:
1 sachet of 800 mg twice a day or as prescribed by your doctor, for a period of less than 60
days
Children over 3 years:
1 vial of 400 mg twice a day or as prescribed by your doctor, for a period of less than
60 days.
If you forget to take ONAKA
Do not take a double dose to make up for a missed dose.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The frequency of possible side effects is defined according to the following convention:
- very common: may affect more than 1 in 10 people
- common: may affect up to 1 in 10 people
- uncommon: may affect up to 1 in 100 people
- rare: may affect up to 1 in 1,000 people
- very rare: may affect up to 1 in 10,000 people
- not known: frequency cannot be estimated from the available data.
Uncommon side effects
- Abdominal pain
- Diarrhoea
- Skin rash
Rare side effects
- Itching
- Urticaria (a skin condition caused by an allergy)
- Allergic Dermatitis
- Severe allergic reaction (Angioedema)
- Swelling of lips and face due to fluid retention (edema)
- Reddish spots on the skin caused by an allergy (Allergic Purpura)
- sudden allergic reaction that could be life-threatening (Anaphylactic Shock)
- Mouth ulcers
- Skin ulcers (in some severe cases)
- Increased Transaminases (enzymes that indicate liver function)
Side effects of unknown frequency
- Nausea
- Vomiting
- Dry mouth
- Abdominal discomfort
- Abdominal distension
- Heartburn
- Dizziness
- Headache
- Vertigo
- Drowsiness
- Feeling of pressure in the chest
- Increased appetite
- Palpitations
- Fever
Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your doctor or pharmacist. You can also report side effects directly through the
national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-
avverse .
By reporting side effects you can help provide more information on the safety of
this medicine.
5. How to store ONAKA
This medicine does not require any special storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack. The expiry date
refers to the last day of that month.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.
6. Contents of the pack and other information
What ONAKA contains
Onaka 800 mg granules for oral solution:
One sachet contains:
The active ingredient is pidotimod 800 mg.
The other ingredients are: mannitol, poloxamers, polyacrylate dispersion 30 percent, ethylcellulose,
sodium saccharin, orange aroma, anhydrous sodium carbonate, hydrated colloidal silica, sunset yellow
(E110), cochineal red A (E124), sucrose.
Onaka 400 mg oral solution:
One single-dose vial contains:
The active ingredient is pidotimod 400 mg.
The other ingredients are: sodium chloride, sodium saccharin, disodium edetate, tromethamine, methyl
parahydroxybenzoate sodium, propyl parahydroxybenzoate sodium, sorbitol solution 70%, flavoring solution
with forest fruits, anthocyanin 55, cochineal red A (E124), purified water.
Description of the appearance of ONAKA and contents of the pack
Granules for oral solution of 800 mg of pidotimod. The pack contains 10 sachets of
granules.
Single-dose oral solution of 400 mg of pidotimod. The pack contains 10 single-dose vials.
Marketing authorisation holder and manufacturer
Marketing authorisation holder: I. B. N. Savio S.r.l. - Via del Mare, 36 - Pomezia (RM)
Manufacturer:
Sachets
Doppel Farmaceutici S.r.l. - Via Volturno, 48 –Quinto de’ Stampi – 20089 Rozzano (MI)
Oral vials
Doppel Farmaceutici S.r.l. - Via Martiri delle Foibe, 1 - Cortemaggiore (PC)

- Kraj rejestracji
- Postać farmaceutycznaGranules, 800 MG
- Kod ATCL03AX05
- Substancja czynna
- Wymaga receptyTak
- Producent
- Te treści mają charakter wyłącznie informacyjny i nie zastępują konsultacji lekarskiej.
- Zamienniki ONAKAPostać farmaceutyczna: Granules, 800 MGSubstancja czynna: pidotimodProducent: POLICHEM S.R.L.Wymaga receptyPostać farmaceutyczna: Powder, 800 MGSubstancja czynna: pidotimodProducent: FIDIA FARMACEUTICI S.P.A.Wymaga receptyPostać farmaceutyczna: Tablet, 400 MGSubstancja czynna: pidotimodProducent: POLICHEM S.R.L.Wymaga recepty
Odpowiedniki ONAKA w innych krajach
Leki z tą samą substancją czynną dostępne w innych krajach.
Odpowiednik ONAKA w Hiszpania
Odpowiednik ONAKA w Polska
Odpowiednik ONAKA w Ukraina
Lekarze online w sprawie ONAKA
Omów stosowanie ONAKA, bezpieczeństwo i ocenę zasadności recepty zgodnie z obowiązującymi przepisami.
Uzyskaj receptę na ONAKA online
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Często zadawane pytania
ONAKA wymaga recepty w Włochy. Możesz skonsultować się z lekarzem online, aby sprawdzić, czy ten lek może być odpowiedni w Twojej sytuacji.
Substancją czynną w ONAKA jest pidotimod. Informacja ta pomaga rozpoznać leki o tym samym składzie, ale pod różnymi nazwami handlowymi.
ONAKA jest produkowany przez I.B.N. SAVIO S.R.L. Nazwy handlowe i opakowania mogą się różnić w zależności od dystrybutora.
Lekarze, tacy jak Lekarze rodzinni, Psychiatrzy, Dermatolodzy, Kardiolodzy, Endokrynolodzy, Gastroenterolodzy, Pulmonolodzy, Nefrolodzy, Reumatolodzy, Hematolodzy, Zakaźnicy, Alergolodzy, Geriatrzy, Pediatrzy, Onkolodzy, mogą ocenić, czy stosowanie ONAKA jest odpowiednie w Twoim przypadku, w zależności od sytuacji klinicznej i lokalnych przepisów. Możesz umówić konsultację online, aby omówić objawy i możliwe dalsze kroki.
Polska posiada dobrze rozwiniętą infrastrukturę ochrony zdrowia w dużych miastach, takich jak Warszawa, Kraków, Wrocław i Gdańsk. Apteki są łatwo dostępne i działają zgodnie z obowiązującymi przepisami, zapewniając dostęp do leków na receptę.
Możesz kupić ONAKA w Warszawie, Krakowie, Wrocławiu lub Gdańsku w każdej aptece, posiadając ważną receptę.
Aby uzyskać receptę, możesz skorzystać z Oladoctor:
Inne leki zawierające tę samą substancję czynną (pidotimod) to m.in. AXIL, PIJITIL, POLIMOD. Mogą one różnić się nazwą handlową lub postacią, ale zawierają ten sam składnik terapeutyczny. Przed zmianą lub rozpoczęciem nowego leku skonsultuj się z lekarzem.
















