Ismigen

B. PATIENT LEAFLET

Leaflet enclosed with the packaging: information for the patient

ISMIGEN

Sublingual tablets

It is essential to carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• This leaflet should be kept, so it can be re-read if necessary.
• In case of any doubts, the patient should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if their disease symptoms are the same.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, they should inform their doctor or pharmacist.

Table of contents of the leaflet:

• 1. What is ISMIGEN and what is it used for
• 2. Important information before taking ISMIGEN
• 3. How to take ISMIGEN
• 4. Possible side effects
• 5. How to store ISMIGEN
• 6. Package contents and other information

1. What is ISMIGEN and what is it used for

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

2. Important information before taking ISMIGEN

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, the patient should discuss it with their doctor or pharmacist.
It is not recommended to use ISMIGEN to prevent pneumonia, as there are no clinical trial data confirming such an effect.

ISMIGEN and other medicines

No interactions with other medicines have been found.
The patient should inform their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.

Driving and using machines

No studies have been conducted on the effect of the medicine on the ability to drive and use machines.

3. How to take ISMIGEN

This medicine should always be taken according to the doctor's recommendations. In case of doubts, the patient should consult their doctor or pharmacist.
The recommended dose is:

Adults

One tablet per day before meals, to be dissolved under the tongue. To be taken for ten consecutive days per month, for a period of 3 months.

Use in children and adolescents (from 3 years of age and above)

One tablet per day before meals, to be dissolved under the tongue. To be taken for ten consecutive days per month, for a period of 3 months.
Method of administration
Sublingually: to be dissolved under the tongue.
The score line on the tablet is only to facilitate breaking the tablet to make it easier to swallow.

Taking a higher dose of ISMIGEN than recommended

In case of taking a higher dose of ISMIGEN than recommended, the patient should immediately contact their doctor or pharmacist.

Missing a dose of ISMIGEN

A double dose should not be taken to make up for a missed dose.

Stopping the use of ISMIGEN

In case of any further doubts related to the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, ISMIGEN can cause side effects, although not everybody gets them.
Side effects reported after the vaccine was placed on the market (frequency not known): sore throat, allergic-type hypersensitivity reactions including urticaria, rash, itching, and swelling, fever and headache, vomiting and abdominal pain.

Reporting side effects

If any side effects occur, including any side effects not listed in this leaflet, the patient should inform their doctor or pharmacist. Side effects can be reported directly to:
Department for Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store ISMIGEN

The medicine should be stored out of sight and reach of children.
There are no special precautions for storage.
The expiry date stated on the packaging applies only to the intact product.
The medicine should not be used after the expiry date stated on the carton.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents 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 anhydrous silica, magnesium stearate, ammonium glycyrrhizinate, powdered peppermint extract.

What ISMIGEN looks like and what the package contains

Available packages: 3 blisters of 10 sublingual tablets, in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization holder:

LALLEMAND Pharma Europe
Bredstrupvej 33
8500 Grenaa
Denmark

Manufacturer:

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

Date of last update of the leaflet: