Ismigen
Italy
Table of Contents
PACKAGE LEAFLET: INFORMATION FOR THE USER
ISMIGEN 50 mg sublingual tablets
Lyophilized bacterial lysate
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, tell your doctor or pharmacist.
Contents of this leaflet:
- What Ismigen is and what it is used for
- What you need to know before taking Ismigen
- How to take Ismigen
- Possible side effects
- How to store Ismigen
- Contents of the pack and other information
1. WHAT IS ISMIGEN AND WHAT IS IT USED FOR
Pharmacotherapeutic category: Bacterial vaccines
ISMIGEN contains as its active substance a mixture of lyophilized bacterial lysates (bacterial antigens), belonging to the group of bacterial vaccines, which locally stimulate the activity of the body's defense system (immune system).
IN ADULTS
Prophylaxis of recurrent respiratory tract infections in adults.
2. WHAT YOU SHOULD KNOW BEFORE TAKING ISMIGEN
Do not take Ismigen
If you are allergic to the active substance or to any of the excipients of this medicinal product
(listed in section 6)
In case of autoimmune diseases
In case of acute intestinal infections
Warnings and precautions
Talk to your doctor or pharmacist before taking ISMIGEN.
Stop treatment and consult your doctor, who will assess whether to definitively discontinue
therapy with ISMIGEN, if you experience any of the following conditions:
allergic reactions (hypersensitivity reactions);
asthma attacks in predisposed patients;
fever, especially if it occurs at the beginning of treatment.
The type of high fever exceeding 39°C that may occur as a rare, isolated adverse event without known cause must be differentiated from fever arising due to the underlying disease, based on laryngeal, nasal, or otological conditions.
The medicine should only be administered when strictly necessary and under direct medical supervision.
The use of ISMIGEN for the prevention of pneumonia is not recommended, as there are no clinical study data demonstrating such an effect.
Other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.
Avoid taking ISMIGEN together with other medicines that stimulate immune system activity (immunostimulants).
ISMIGEN may be less effective if you have immune system disorders (with congenital or acquired immunodeficiency), if you are undergoing treatment with medicines that reduce immune system activity (immunosuppressive therapy), or if you are taking medicines used to treat allergies and inflammation (corticosteroids).
No interaction studies with other drugs or vaccines have been conducted.
Pregnancy and breastfeeding
Do not take ISMIGEN if you are pregnant.
Do not take ISMIGEN if you are breastfeeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and use of machines
To date, no effects on the ability to drive or operate machinery have been reported.
However, no specific studies have been conducted.
Ismigen contains: Silicon dioxide, Microcrystalline cellulose, Dibasic calcium phosphate, Magnesium stearate, Ammonium glycyrrhizinate, Powdered peppermint essence.
3. HOW TO TAKE ISMIGEN
Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Route of administration: sublingual (allow to dissolve under the tongue)
The recommended dose is one 50 mg tablet daily, to be allowed to dissolve under the tongue, for 10 consecutive days per month, for a duration of three consecutive months.
If you take more Ismigen than you should
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To date, there have been no reported cases of overdose.
If you have taken more ISMIGEN than you should, inform your doctor immediately or go to the nearest hospital.
If you forget to take Ismigen
Do not take a double dose to make up for the missed dose; continue taking the medicine as prescribed until the end of the treatment.
If you stop treatment with Ismigen
If you have any doubts about using 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.
The following side effects have been reported in very rare cases:
- Respiratory, thoracic and mediastinal disorders: oropharyngeal pain
- Skin and subcutaneous tissue disorders: allergic reactions such as urticaria, rash, pruritus and oedema
- General disorders and administration site conditions: fever and headache
- Gastrointestinal disorders: stomach ache and vomiting
- Infections and infestations: rhinitis
If any disturbance occurs, treatment must be discontinued.
If you notice a worsening of symptoms or any side effect not listed in this leaflet, consult your doctor or pharmacist.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. You may also report side effects directly through the national reporting system at the following website: 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 ISMIGEN
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 store above 25°C. Store in the original packaging.
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. CONTENTS OF THE PACKAGE AND OTHER INFORMATION
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What Ismigen contains:
- The active substance is lyophilized bacterial lysate:
Staphylococcus aureus 6 billion, Streptococcus pyogenes 6 billion, Streptococcus oralis 6
billion, Klebsiella pneumoniae 6 billion, Klebsiella ozaenae 6 billion, Haemophilus
influenzae 6 billion, Neisseria catarrhalis 6 billion, Streptococcus pneumoniae 6 billion
(of which type 1, 1 billion – type 2, 1 billion – type 3, 1 billion – type 5, 1 billion – type 8, 1
billion – type 47, 1 billion)
and glycocolle as lyophilization support.
- The other ingredients are Silicon dioxide, Microcrystalline cellulose, Dibasic calcium phosphate, Magnesium stearate, Ammonium glycyrrhizinate, Powdered mint essence.
Description of the appearance of Ismigen and the contents of the pack
Ismigen sublingual tablets are whitish, have brown specks, and are packaged in aluminum/PVC blisters containing 10 tablets. The score line on the tablet is intended to facilitate breaking when necessary and is not intended for dividing the tablet into equal doses.
3 blisters contained in a printed cardboard carton.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
LALLEMAND PHARMA EUROPE
Toftebakken 9B
3460 Birkerød
DENMARK
Manufacturer:
Bruschettini S.r.l
Via Isonzo, 6
16147 Genoa
Italy
Distributor:
Zambon Italia S.r.l.
Via Lillo del Duca 10
20091 Bresso (MI)
Italy
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