Perosall D

Leaflet included in the packaging: patient information

Perosall D,solution for sublingual use.
A mixture of tree pollen allergens.
Basic treatment set:10 JS*/1 ml, 100 JS/1 ml, 1,000 JS/1 ml, 5,000 JS/1 ml
Maintenance treatment set:5,000 JS/1 ml
Set for individual orders:1 JS/1 ml
*JS standard unit
You should read the contents of the leaflet before using the medicine, as it contains
important information for the patient

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to you for a specific reason. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any undesirable effects, including any undesirable effects not mentioned in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Perosall D and what is it used for
• 2. Important information before using Perosall D
• 3. How to use Perosall D
• 4. Possible undesirable effects
• 5. How to store Perosall D
• 6. Contents of the packaging and other information

1. What is Perosall D and what is it used for

Perosall D is intended for desensitization of individuals with an allergy to tree pollen. The medicine is in the form of a solution for sublingual use in four increasing concentrations. Each solution contains a mixture of allergens derived from tree pollen. The treatment involves the systematic administration of increasing doses of allergens to produce a state of tolerance (lack of reaction to the allergen). This leads to the alleviation or disappearance of allergy symptoms during the tree pollen season.
The decision to undergo sublingual desensitization is made exclusively by a specialist allergist, based on the patient's history, allergic symptoms, skin diagnostic tests, and/or the level of specific IgE antibodies.

2. Important information before using Perosall D

When not to use Perosall D:

• if the patient is allergic to any of the excipients listed in section 6
• if the patient has been diagnosed with an autoimmune disease
• if the patient has been diagnosed with a malignant disease
• if the patient has been diagnosed with an active tuberculosis
• if the patient is constantly being treated with beta-adrenolytics (e.g., during coronary artery disease, with high blood pressure)
• in patients with clinically significant immunological deficiencies
• in case of lack of cooperation from the patient
• in patients with acute infectious diseases with fever (desensitization may be resumed after 5-7 days after the infection has subsided, after consultation with an allergist)
• during exacerbation of chronic infections (desensitization may be resumed after 5-7 days after the exacerbation has subsided, after consultation with an allergist)
• in patients with unstable cardiovascular diseases, e.g., unstable coronary artery disease (requiring periodic use of beta-adrenolytics or ACE inhibitors)
• in patients with severe, unstable asthma - with spirometry measurements - FEV1 below 70% of the normal value
• in patients with severe atopic dermatitis during exacerbation

Warnings and precautions

• if undesirable effects occur, the patient should immediately inform their doctor
• on the day of taking the medicine, the patient should avoid excessive effort, drinking alcohol, and overheating (e.g., sauna, hot shower, sunbathing)

Children

• Perosall D should not be used in children under 5 years of age

Perosall D and other medicines

• concomitant use of anti-allergic medicines, e.g., antihistamines, cromones, corticosteroids, may modify (shift in time) the actual reaction to the medicine
• if desensitization (basic treatment) and vaccination are planned at the same time, according to the Vaccination Program, desensitization should be started after vaccination
• if maintenance doses and vaccination are planned at the same time, according to the Vaccination Program, vaccination should be performed between maintenance doses and desensitization should be continued according to the scheme (do not use desensitization and vaccination on the same day)

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

Perosall D with food and drink

The medicine should be taken on an empty stomach, at least 15 minutes before a meal

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, or thinks they may be pregnant, or plans to have a child, they should consult their doctor before using this medicine.
During pregnancy and breastfeeding, therapy with Perosall D should not be started. If such treatment has been started before pregnancy, it may be continued in agreement with the attending physician. Currently, there is a lack of sufficiently documented data on the use of allergen desensitization in pregnant women. The potential risk to the mother and fetus is therefore unknown.

Driving and operating machines

The medicine does not affect the ability to drive vehicles or operate machines

3. How to use Perosall D

Perosall D should be used before the tree pollen season, before the symptoms of allergy appear.
It should be taken on an empty stomach, at least 15 minutes before a meal. The head should be tilted slightly backwards and the recommended number of drops should be administered under the tongue. The bottle, after being tilted, automatically doses the drops thanks to the appropriate design of the dropper. The medicine can be administered to a child by a caregiver.
The treatment is divided into two stages:

• basic treatment - gradual increase in dose
• maintenance treatment - constant dose

Basic treatment

Unless the doctor recommends otherwise, the medicine should be taken daily, with the dose increased by one drop every day until the maximum maintenance dose is reached, i.e., 10 drops of concentration 4, according to the following scheme:

Basic treatment scheme

Concentration 1- 10 JS/ml
Concentration 2- 100 JS/ml
Day
Number of drops
Day
Number of drops
1
2
3
4
5
6
7
8
9
10
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
1
2
3
4
5
6
7
8
9
10
Concentration 3- 1,000 JS/ml
Concentration 4- 5,000 JS/ml
Day
Number of drops
Day
Number of drops
21
22
23
24
25
26
27
28
29
30
1
2
3
4
5
6
7
8
9
10
31
32
33
34
35
2
4
6
8
10
The above dosing scheme should be considered as a guideline and example of treatment. The doctor may modify the scheme depending on the patient's condition and their reaction to the treatment.
In case of allergic symptoms such as:

• swelling of the eye and face area, runny nose, conjunctivitis
• difficulty breathing, swallowing, the dose should be reduced, using fewer drops or a lower concentration, for at least 3 days. Then, the dose should be increased by one drop daily, according to the basic treatment scheme

Maintenance treatment

The maximum, individual, well-tolerated dose of concentration 4should be used 2 times a week. The treatment should be finished 2-3 weeks before the tree pollen season.
Note:
In the case of patients who are particularly sensitive to pollen allergens, treatment may be started with concentration 0-1 JS/ml, which is prepared on individual order

Before using Perosall D, the patient should check the expiration date on the packaging

Taking a higher dose of Perosall D than recommended

Local and general undesirable effects may occur, including anaphylactic shock, the symptoms of which are: sudden drop in blood pressure and loss of consciousness.
In case of taking a higher dose than recommended, the patient should immediately consult a doctor or pharmacist

Missing a dose of Perosall D

The patient should take the last used dose and then continue the treatment according to the scheme

Discontinuing the use of Perosall D

If the basic treatment is discontinued for more than 2 weeks, it should be resumed using half of the last used and well-tolerated dose (the dose that did not cause allergic symptoms). In case of a longer break than 4 weeks, the treatment should be started from concentration 1.
Discontinuation of desensitization may occur in case of infection or exacerbation of chronic infections (in accordance with section 2 of the leaflet). Desensitization may be resumed after 5-7 days after the infection/exacerbation has subsided, after consultation with an allergist.
In case of any further doubts related to the use of this medicine and discontinuation of treatment, the patient should consult an allergist

4. Possible undesirable effects

Like all medicines, Perosall D can cause undesirable effects, although not everybody gets them.
To date, in the course of spontaneous monitoring, no undesirable effects have been reported after the use of Perosall D. However, it should be remembered that sublingual immunotherapy, like the administration of other biological preparations, carries the risk of undesirable effects, both local and general

Frequency not known (frequency cannot be estimated from the available data):

• worsening of conjunctivitis
• worsening of rhinitis, asthma exacerbation
• gastrointestinal disorders, abdominal pain, diarrhea
• generalized urticaria, generalized skin itching
• itching in the throat, burning in the mouth, lip swelling

These symptoms are usually short-term and resolve on their own.
If any undesirable effects occur, including any undesirable effects not mentioned in the leaflet, the patient should consult their doctor or pharmacist

Reporting undesirable effects

If any undesirable effects occur, including any undesirable effects not mentioned in the leaflet, the patient should inform their doctor, pharmacist, or nurse.
Undesirable effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products {current address, phone number, and fax of the above Department} e-mail: ndl@urpl.gov.pl.
Thanks to the reporting of undesirable effects, more information can be collected on the safety of the use of the medicine

5. How to store Perosall D

The medicine should be stored out of sight and reach of children.
The medicine should not be used after the expiration date stated on the bottle.
It should be stored in a refrigerator (2°C - 8°C).
It should not be frozen. If frozen, the medicine should be destroyed.
After the first opening, the bottle with concentration 4of Perosall D can be stored for a maximum of 5 days in a refrigerator (2°C - 8°C) within the validity period of the medicine.
After the first opening, bottles with concentrations 0-3of Perosall D can be stored for a maximum of 10 days in a refrigerator (2°C - 8°C) within the validity period of the medicine.
Opened, unused medicine should not be used in subsequent desensitization seasons

6. Contents of the packaging and other information

What Perosall D contains

The active substance of the medicine is a mixture of tree pollen allergens of the following species:

Latin name Common name

Alnussp.
alder
Betulasp.
birch
Corylus avellana
common hazel
The other ingredients (excipients) are: glycerol, sodium chloride, disodium phosphate dodecahydrate, potassium dihydrogen phosphate, water for injections

What Perosall D looks like and what the packaging contains

Basic treatment set:

4 bottles of 10 ml (concentrations 1-4)
Concentration 1- 10 JS/ml
Concentration 2- 100 JS/ml
Concentration 3- 1,000 JS/ml
Concentration 4- 5,000 JS/ml

Maintenance treatment set:

1 bottle of 10 ml (concentration 4)
Concentration 4- 5,000 JS/ml

Set for individual orders:

1 bottle of 10 ml (concentration 0)
Concentration 0- 1 JS/ml
10 ml solution in a bottle, closed with a polypropylene and polyethylene dropper, in a cardboard box.
To obtain more detailed information, the patient should contact the representative of the marketing authorization holder

Marketing authorization holder and manufacturer

Biomed S.A.
Al. Sosnowa 8
30-224 Kraków
Phone: +48 12 37 69 200
Fax: +48 12 37 69 205
e-mail: marketing@biomed.pl

Date of the last update of the leaflet: