Package leaflet: Information for the patient

ISMIGEN
Sublingual tablets
Please read all of this leaflet carefully before taking this medicine, as it contains
important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any further questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist.

Contents of the leaflet:

What ISMIGEN is and what it is used for
Important information before taking ISMIGEN
How to take ISMIGEN
Possible side effects
How to store ISMIGEN
Contents of the pack and other information

1. What ISMIGEN is and what it is used for

ISMIGEN is indicated for use in the following age groups:
ADULTS
Prophylaxis of recurrent respiratory tract infections (RTI) in adults.
CHILDREN
Prophylaxis of recurrent respiratory tract infections (RTI) in children aged 3 years and older.

2. Important information before taking ISMIGEN medicine

When not to take ISMIGEN:
If the patient is allergic to the active substances or any of the other ingredients of this medicine
listed in section 6.
Warnings and precautions
Before starting to take ISMIGEN, discuss it with a doctor or pharmacist.
The use of ISMIGEN for the prevention of pneumonia is not recommended, as there are no
clinical study data confirming such an effect.
ISMIGEN and other medicines
No interactions with other medicines have been reported.
You should tell your doctor about all medicines currently taken or recently taken, as well as any medicines the patient intends to take.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have
a child, she should consult a doctor or pharmacist before using this medicine.
Driving and operating machinery
Studies on the influence of the medicine on the ability to drive vehicles and operate machinery
have not been conducted.

3. How to take the medicine ISMIGEN

This medicine should always be taken as directed by the physician. In case of doubts, consult
your doctor or pharmacist.
Recommended dose:
Adults
One tablet daily before meals, dissolve under the tongue. Use for ten consecutive
days per month, for a period of 3 months.
Use in children and adolescents (aged 3 years and above)
One tablet daily before meals, dissolve under the tongue. Use for ten consecutive
days per month, for a period of 3 months.
Method of administration
Sublingually: dissolve under the tongue.
The score line on the tablet is intended only to facilitate breaking the tablet for easier swallowing.
Taking more than the recommended dose of ISMIGEN
In case of taking more than the recommended dose of ISMIGEN, contact your doctor or pharmacist immediately.
Missed dose of ISMIGEN
Do not take a double dose to make up for a missed dose.
Stopping treatment with ISMIGEN
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicinal product, this vaccine may cause adverse reactions, although not everybody will experience them.
Adverse reactions reported after vaccine placement on the market (frequency unknown): sore throat, allergic-type hypersensitivity reactions including urticaria, rash, itching and swelling, fever and headache, vomiting and abdominal pain.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to:
Department of Monitoring Adverse Drug Reactions
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 marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the vaccine.

5. How to store the medicine ISMIGEN

Keep the medicine out of the sight and reach of children.
There are no special storage requirements for this medicine.
The stated expiry date refers only to the product in its original, undamaged packaging.
Do not use this medicine after the expiry date stated on the carton.
Medicines should not be disposed of via wastewater. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the packaging and other information

What ISMIGEN contains
Each tablet contains 7 mg of bacterial lysate:
Staphylococcus aureus 6 billion
Streptococcus pyogenes 6 billion
Streptococcus (viridans) oralis 6 billion
Klebsiella pneumoniae 6 billion
Klebsiella ozaenae 6 billion
Haemophilus influenzae 6 billion
Neisseria catarrhalis 6 billion
Streptococcus pneumoniae 6 billion
(including type TY1 - 1 billion, type TY2 - 1 billion, type TY3 - 1 billion, type TY5 - 1 billion, type TY8 - 1 billion, type TY47 - 1 billion)
and 43 mg of glycine.
Excipients:
microcrystalline cellulose, calcium hydrogen phosphate dihydrate, colloidal hydrated silica, magnesium stearate, ammonium glycyrrhizinate, extract of powdered mint.

What ISMIGEN looks like and contents of the pack
Available pack sizes: 3 blisters of 10 sublingual tablets in a cardboard box.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
LALLEMAND Pharma Europe
Bredstrupvej 33
8500 Grenaa
Denmark

Manufacturer:
Bruschettini S.r.l.
Via Isonzo 6
16147 Genoa
Italy