ONAKA

Package leaflet: Information for the patient

ONAKA 800 mg granules for oral solution, 400 mg oral solution

pidotimod
Please read this leaflet carefully before taking this medicine because 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 give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, consult 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 taking 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 ONAKA is and what it is used for

ONAKA contains a substance called pidotimod, composed of amino acid chains, capable of activating and stimulating the body's immune defenses. This medicine helps prevent and treat infections, particularly of the respiratory and urinary tracts, in adults and children over 3 years of age who have a weakened immune system.

2. What you should know before taking ONAKA

Do not take ONAKA

• if you are allergic to the active substance or to 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.
This medicine should be administered with caution in atopic individuals or those with a history of allergic reactions.
The drug should be used cautiously in patients with congenital immunodeficiency (hyper-IgE syndromes).

Other medicines and ONAKA
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This 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
Since food interferes with the absorption of the product, ONAKA should be administered away from meals.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Although animal studies have not shown any effects, as with other medicines, use during the first three months of pregnancy is contraindicated.

Driving and using machines
ONAKA does not affect the ability to drive or operate machinery.

ONAKA 800 mg oral 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 corresponds to 3.8% of the maximum recommended daily dietary intake for an adult. This should be taken into consideration in individuals with impaired renal function or those on a low-sodium diet;
• sunset yellow (E110), carmoisine (E124), which may cause allergic reactions;
• sucrose, so if you are intolerant to certain sugars, consult 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 bottle, i.e. it is essentially sodium-free;
• sorbitol, so if you are intolerant to certain sugars, consult your doctor before taking this medicine; sorbitol may also cause gastrointestinal disturbances and has a mild laxative effect;
• carmoisine (E124), which may cause allergic reactions;
• sodium methyl hydroxybenzoate and sodium propyl hydroxybenzoate, which may cause allergic reactions (including delayed reactions).

3. How to take ONAKA

Take this medicine exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
The recommended dose is:
Adults:
1 sachet of 800 mg twice daily, or as prescribed by the doctor, for a period of less than 60
days.
Children over 3 years:
1 bottle of 400 mg twice daily, or as prescribed by the 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 forgotten dose.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences 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
• Rash

Rare side effects

• Itching (Pruritus)
• Urticaria (a skin condition caused by an allergy)
• Allergic dermatitis
• Severe allergic reaction (Angioedema)
• Swelling of lips and face due to fluid accumulation (edema)
• Reddish spots on the skin caused by an allergy (Allergic Purpura)
• Sudden potentially life-threatening allergic reaction (Anaphylactic Shock)
• Mouth ulcers
• Skin ulcers (in some cases severe)
• Increased Transaminases (enzymes indicating liver function)

Side effects of unknown frequency

• Nausea
• Vomiting
• Dry mouth
• Abdominal discomfort
• Abdominal distension
• Heartburn
• Dizziness
• Headache
• Vertigo
• Drowsiness
• Sensation of pressure in the chest
• Increased appetite
• Palpitations
• Fever

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via 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 stated on the carton. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What ONAKA contains
Onaka 800 mg granules for oral solution:
Each sachet contains:
The active substance is pidotimod 800 mg.
The other components are: mannitol, poloxamers, polyacrylate dispersion 30 percent, ethylcellulose,
sodium saccharin, orange flavour, anhydrous sodium carbonate, hydrated colloidal silica, sunset yellow
(E110), carmine red A (E124), sucrose.

Onaka 400 mg oral solution:
Each single-dose vial contains:
The active substance is pidotimod 400 mg.
The other components are: sodium chloride, sodium saccharin, disodium edetate, tromethamine, sodium methyl para-hydroxybenzoate, sodium propyl para-hydroxybenzoate, sorbitol 70% solution, fruit-flavoured solution, anthocyanin 55, carmine red A (E124), purified water.

Description of the appearance of ONAKA and package contents
Oral solution granules containing 800 mg of pidotimod. The pack contains 10 granule sachets.
Single-dose oral solution containing 400 mg of pidotimod. The pack contains 10 single-dose vials.

Marketing Authorization Holder and Manufacturer
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)
ITC Production Srl - Via Pontina, 5 Km 29 – Pomezia (RM)
Oral vials
Doppel Farmaceutici S.r.l. - Via Martiri delle Foibe, 1 - Cortemaggiore (PC)