Package leaflet: Information for the patient

POLIMOD 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 other people, even if their symptoms are the same as yours, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What POLIMOD is and what it is used for
What you need to know before taking POLIMOD
How to take POLIMOD
Possible side effects
How to store POLIMOD
Contents of the pack and other information

1. What POLIMOD is and what it is used for

POLIMOD contains a substance called pidotimod, composed of amino acid chains, which is able to
activate and stimulate the body's immune defenses. This medicine helps prevent and treat infections,
particularly of the respiratory and urinary tract, in individuals with a weakened immune system.

2. What you need to know before taking POLIMOD

Do not take POLIMOD

if you are allergic to pidotimod or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before taking POLIMOD.
If you are an allergic (atopic) subject or have a history of allergic reactions, take POLIMOD with caution.
If you suffer from congenital immunodeficiency (hyper-IgE syndromes), take this medicine with care.
Children and adolescents
Polimod is not indicated for children under 3 years of age.
Other medicines and POLIMOD
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
This product may interfere with medicines that block or stimulate the activity of blood cells playing a key role in the immune system (lymphocytes).
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
As a precautionary measure, the use of POLIMOD is not recommended during the first three months of pregnancy and during breastfeeding.
No studies on fertility in humans have been conducted.
Driving and using machines
POLIMOD does not affect the ability to drive or operate machinery.
POLIMOD 800 mg granules for oral solution contains:

sodium – this medicine contains 75.9 mg of sodium (the main component of table salt) per sachet. This corresponds to 3.8% of the maximum daily recommended dietary intake for an adult.
sunset yellow (E110), carmoisine (E124), which may cause allergic reactions;
sucrose – if your doctor has informed you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.

POLIMOD 400 mg oral solution contains:

sodium – this medicine contains less than 1 mmol (23 mg) of sodium per vial, i.e. is essentially “sodium-free”;
sorbitol – this medicine contains 2500 mg of sorbitol in each vial;
carmoisine (E124), which may cause allergic reactions;
sodium methyl parahydroxybenzoate, sodium propyl parahydroxybenzoate, which may cause allergic reactions (including delayed reactions).

3. How to take POLIMOD

This medicinal product is for oral use.
Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Recommended dose:
Adults:
One 800 mg sachet twice daily, or as prescribed by the doctor.
Children over 3 years:
One 400 mg bottle twice daily, or as prescribed by the doctor.
No dose adjustment is necessary in elderly patients.
Take POLIMOD away from meals.
If you take more POLIMOD than you should
If you take more POLIMOD than you should, contact your doctor immediately. The doctor will provide appropriate treatment.
If you forget to take POLIMOD
Do not take a double dose to make up for the missed dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.

Uncommon side effects (may affect up to 1 in 100 people)

abdominal pain
diarrhoea
skin rash

Rare side effects (may affect up to 1 in 1,000 people)

swelling of the face, tongue and throat causing severe breathing difficulties and indicating a serious allergic reaction (angioedema)
small itchy spots on the skin (urticaria)
allergic skin inflammation (allergic dermatitis)
itching

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: http://www.aifa.gov.it/content/come-segnalare-una-sospetta-reazione-avversa
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store POLIMOD

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 POLIMOD contains
POLIMOD 800 mg granules for oral solution:
One sachet contains:

The active substance is pidotimod
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.

POLIMOD 400 mg oral solution:
One single-dose bottle contains:

The active substance is pidotimod
The other components are: sodium chloride, sodium saccharin, disodium edetate, tromethamine, sodium methyl parahydroxybenzoate, sodium propyl parahydroxybenzoate, sorbitol 70% solution, fruit flavouring solution, anthocyanin 55, carmine red A (E124), purified water.

Description of the appearance of POLIMOD and package contents
800 mg granules for oral solution containing pidotimod. The package contains 10 sachets of granules.
400 mg single-dose oral solution containing pidotimod. The package contains 10 single-dose bottles.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder: Polichem S.r.l. - Via G. Marcora, 11 - 20121 Milan
Manufacturer:
Sachets
Doppel Farmaceutici S.r.l. - Quinto de’ Stampi facility - Rozzano (MI)
Oral bottles
Doppel Farmaceutici S.r.l. - Cortemaggiore (PC) facility