Pigitil

Package leaflet: Information for the patient

PIGITIL 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 adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Pigitil is and what it is used for
2. What you need to know before taking Pigitil
3. How to take Pigitil
4. Possible side effects
5. How to store Pigitil
6. Contents of the pack and other information

1. What Pigitil is and what it is used for

Pigitil is a medicine containing a substance called pidotimod, which acts to activate and stimulate the body's immune defences. This medicine is indicated in adults and children over 3 years of age and is used as an adjunct to immunostimulant therapy in individuals with reduced immune defences during respiratory and urinary tract infections.

2. What you need to know before taking Pigitil

Do not take Pigitil

• 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.

Warnings and precautions
Talk to your doctor or pharmacist before taking Pigitil:

• if you suffer from a condition called “hyper-IgE syndrome”, which is characterized by very high levels of Ig-E type antibodies in the blood;
• if you are “atopic” (predisposed to develop allergic reactions) or have previously experienced allergic-type reactions.

Children
Pigitil is contraindicated in children under three years of age.
Other medicines and Pigitil
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, especially those that block or stimulate the activity of certain blood cells called lymphocytes, as Pigitil may interfere with the proper functioning of these medicines.
Pigitil and food
Food may interfere with the effectiveness of the medicine; therefore, Pigitil should be taken away from meals.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
The use of Pigitil is contraindicated during the first three months of pregnancy.
Driving and using machines
Pigitil does not impair the ability to drive vehicles or operate machinery.
Pigitil contains:
Pigitil 800 mg oral granules for solution contain:
Sodium: this medicine contains 73 mg of sodium (the main component of table salt) per dose.
This corresponds to 3.68% of the maximum recommended daily dietary intake for an adult.
Sunset Yellow (E 110) and Carmoisine A (E 124): may cause allergic reactions.
Sucrose: if your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.
Pigitil 400 mg oral solution contains:
Sodium: this medicine contains less than 1 mmol (23 mg) of sodium per vial, i.e. essentially ‘sodium-free’.
Sodium methyl parahydroxybenzoate and sodium propyl parahydroxybenzoate: may cause allergic reactions (including delayed reactions).
Sorbitol: this medicine contains 1750 mg of sorbitol per dose. Sorbitol is a source of fructose. If your doctor has told you that you (or the child) have an intolerance to certain sugars, or if you have been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which patients are unable to metabolize fructose, speak with your doctor before you (or the child) take this medicine.
Carmoisine A (E 124): may cause allergic reactions.

3. How to take Pigitil

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Adults
The recommended dose is 1 sachet of 800 mg twice daily, or as prescribed by your doctor, for a period of less than 60 days.
Children over 3 years of age
The recommended dose is 1 bottle of 400 mg twice daily, or as prescribed by your doctor, for a period of less than 60 days.
If you forget to take Pigitil
Do not take a double dose to make up for the missed dose.
If you take more Pigitil than you should
No cases of overdose have been reported following treatment with Pigitil.
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 everyone gets them.

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

• Abdominal pain
• Diarrhoea
• Skin reactions (rash)

Rare side effects (may affect up to 1 in 1000 people):

• Severe allergic reaction causing swelling of the face, tongue and throat (angioedema)
• Skin irritation, often with itching (urticaria)
• Allergic skin reaction (allergic dermatitis)
• Inflammation of blood vessels with a red-purple skin rash (allergic purpura)
• Severe allergic reaction (anaphylactic shock)
• Swelling (edema) of lips and face
• Itching (pruritus)
• Mouth or skin ulcers, sometimes severe
• Increased liver function enzymes (elevated transaminases)

Side effects not known (frequency cannot be estimated from available data):

• Nausea
• Vomiting
• Abdominal discomfort
• Dry mouth (xerostomia)
• Abdominal distension
• Heartburn
• Dizziness
• Headache (cephalalgia)
• Vertigo
• Drowsiness
• Chest tightness
• Increased appetite
• Awareness of heartbeat (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 . Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Pigitil

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 packaging after "Exp".
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 Pigitil contains
Pigitil 800 mg granules for oral solution

• The active substance is pidotimod. Each sachet contains 800 mg of pidotimod.
• The other components are: mannitol, poloxamers, polacrylate dispersion 30 percent, ethylcellulose, sodium saccharin, orange flavour, anhydrous sodium carbonate, hydrated colloidal silica, sunset yellow (E 110), carmine red A (E 124), sucrose.

Pigitil 400 mg oral solution

• The active substance is pidotimod. Each single-dose bottle contains 400 mg of pidotimod in 7 ml of solution.
• The other components are: sodium chloride, sodium saccharin, disodium edetate, tromethamine, sodium methyl para-hydroxybenzoate, sodium propyl para-hydroxybenzoate, sorbitol 70% solution, fruit-flavoured aromatic solution, anthocyanin 55, carmine red A (E 124), purified water.

Description of the appearance of Pigitil and contents of the pack
Pigitil 800 mg granules for oral solution:
10 sachets of 800 mg in a printed cardboard box.
Pigitil 400 mg oral solution:
10 single-dose bottles of 400 mg in a printed cardboard box.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Fidia Farmaceutici S.p.A. – Via Ponte della Fabbrica 3/A – 35031 Abano Terme (PD)
Manufacturer
Pigitil 800 mg granules for oral solution
Doppel Farmaceutici S.r.l. - Via Volturno 48 - Quinto de’ Stampi - Rozzano (MI)
Pigitil 400 mg oral solution
Doppel Farmaceutici S.r.l. - Via Martiri delle Foibe, 1 - 29016 Cortemaggiore (PC)