PALFORZIA 0.5 MG/1 MG Oral powder in openable capsules

Содержание инструкции

1. PALFORZIA 0.5 mg oral powder in open capsules, 1 mg oral powder in open capsules, 10 mg oral powder in open capsules, 20 mg oral powder in open capsules, 100 mg oral powder in open capsules, 300 mg oral powder in sachet
   1. What is PALFORZIA and what is it used for
   2. What you need to know before you take PALFORZIA
   3. How to take PALFORZIA
   4. Possible side effects
   5. How to store PALFORZIA
   6. Contents of the pack and other information

PALFORZIA 0.5 mg oral powder in open capsules, 1 mg oral powder in open capsules, 10 mg oral powder in open capsules, 20 mg oral powder in open capsules, 100 mg oral powder in open capsules, 300 mg oral powder in sachet

Defatted powder of Arachis hypogaea L.(peanuts) seeds

This medicinal product is subject to additional monitoring. This will allow the rapid identification of new
safety information. You can contribute by reporting any adverse effects you experience
while taking this medicine. See the end of section 4 for information on how to
report adverse effects.

Read this leaflet carefully before you start to take this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor. See section 4.

Contents of this leaflet

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

1. What is PALFORZIA and what is it used for

PALFORZIA contains peanut protein derived from the defatted powder of peanut seeds. It belongs to a category of medicines called food allergens. It is a treatment for people who are allergic to peanuts ( Arachis hypogaea L.).
PALFORZIA is intended for children and adolescents from 1 to 17 years of age and those who become adults during therapy.
PALFORZIA works in subjects with peanut allergy by gradually increasing the body's ability to tolerate small amounts of peanuts (desensitization). PALFORZIA may help to reduce the severity of allergic reactions that develop after coming into contact with peanuts.
PALFORZIA is not effective against other nut allergies or other food allergies.
During therapy with PALFORZIA you will need to continue to strictly avoid consuming peanuts.

2. What you need to know before you take PALFORZIA

Do not take PALFORZIA

• if you are allergic to any of the other ingredients of this medicine (listed in section 6)
• if you have severe asthma or if your asthma is not well controlled (according to your doctor's opinion)
• if you have had a condition called “food protein-induced enterocolitis syndrome” (food protein-induced enterocolitis syndrome,FPIES) in the last 12 months (applicable to children between 1 and 3 years of age)
• if you have ever had problems with growth or development, i.e. “failure to thrive” (applicable to children between 1 and 3 years of age)
• if you have or have ever had problems swallowing or long-standing problems with the digestive system
• if you have or have ever had a severe mast cell disorder (according to your doctor's opinion)
• if you have suffered from severe or potentially life-threatening anaphylaxis in the 60 days before starting treatment.

Warnings and precautions
Talk to your doctor before taking PALFORZIA and tell them about any medical problems you have.
While taking PALFORZIA, you must not consume any type of peanuts or foods containing peanuts through your diet.
It is important to note the lot number of PALFORZIA. Each time you receive a new pack of PALFORZIA, make a note of the date and lot number (which can be found on the pack after “Lot”) and keep them in a safe place.

PALFORZIA does not treat the symptoms of a peanut allergy and should not be taken during an allergic reaction.
Your doctor will tell you the best time to start treatment based on any medical problems you may have.
PALFORZIA contains the substance to which patients with peanut allergy react. Allergic reactions to PALFORZIA may occur during treatment. These reactions usually occur within the first two hours after taking the dose of PALFORZIA and are generally mild to moderate, but can sometimes be severe. Patients aged 12 years or older and/or with a high sensitivity to peanuts may be at greater risk of experiencing allergic symptoms during treatment.
Stop taking PALFORZIA and seek immediate medical attention if you experience any of the following symptoms:

• difficulty breathing
• a feeling of tightness in the throat or a feeling of fullness in the throat
• difficulty swallowing
• changes in your voice
• dizziness or fainting or a feeling that something bad is about to happen
• severe cramps or stomach pain, vomiting or diarrhea
• severe redness or itching of the skin
• worsening of asthma or any other breathing problem
• heartburn, difficulty swallowing, pain when swallowing, stomach pain or chest pain that does not go away or gets worse

Some conditions or factors may increase the likelihood of an allergic reaction. These include:

• a worsening of asthma
• the presence of an open sore or other damage to the lining of the mouth or the passage from the mouth to the stomach (esophagus)
• physical activity
• taking a very hot bath or shower
• severe fatigue or lack of sleep
• for women, menstruation
• taking certain pain relievers such as aspirin or ibuprofen
• drinking alcohol
• stress
• taking PALFORZIA on an empty stomach
• an illness such as a cold or flu or other viral infections

To avoid some of these factors affecting you, there are actions you should take. These factors include: physical activity, hot baths or showers, consuming alcohol or taking this medicine on an empty stomach. See the sections “PALFORZIA with food, drinks and alcohol” and “Instructions for use” for advice on how to behave.
For all other conditions or factors listed above, ask your doctor for advice if you experience allergic reactions during these activities.
Your doctor will prescribe auto-injectable epinephrine, which you should always carry with you in case of a severe allergic reaction. Your doctor will show you how to recognize an allergic reaction and will teach you when and how to use epinephrine. If you have questions about its use, ask your doctor and read the epinephrine leaflet.
If you use epinephrine, do not take any further doses of PALFORZIA and seek immediate medical attention immediately.
Desensitization to peanuts with PALFORZIA takes time. The ability to tolerate gradually increasing small amounts of peanut has been demonstrated after completion of all levels of the dose escalation of PALFORZIA and after at least 3 months of maintenance therapy, and this ability continues to improve over time.
You must take PALFORZIA every day to maintain the desensitization that the medicine provides. Missing doses may lead to an increased risk of allergic reactions.
Treatment with PALFORZIA may not work in all patients.

Children and adolescents
PALFORZIA is intended for children and adolescents from 1 to 17 years of age and those who become adults during therapy.
Do not give this medicine to children under 1 year of age because it is not known if PALFORZIA is safe and effective in this age group.

Other medicines and PALFORZIA
Tell your doctor if you are taking, have recently taken or might take any other medicines.

PALFORZIA with food, drinks and alcohol
PALFORZIA should not be mixed with liquids (such as water, milk, juice, soup, smoothie).
Do not consume alcohol or medicines containing alcohol 2 hours before and 2 hours after taking PALFORZIA because it may increase the likelihood of an allergic reaction.

Pregnancy, breastfeeding and fertility
Do not start treatment with PALFORZIA if you are pregnant or planning a pregnancy.
If you are pregnant, suspect you are pregnant, are planning to become pregnant or are breastfeeding, ask your doctor for advice before taking this medicine.

Driving and using machines
PALFORZIA may slightly impair your ability to drive vehicles, ride a bicycle or use machinery. Exercise caution for 2 hours after taking a dose of PALFORZIA if you experience an allergic reaction that affects your ability to drive vehicles, ride a bicycle or use machinery. Wait for all symptoms of an allergic reaction to disappear before driving vehicles, riding a bicycle, going to the playground or using machinery.

3. How to take PALFORZIA

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your doctor.
PALFORZIA must be prescribed by doctors experienced in the diagnosis and treatment of allergies and
allergic reactions, including anaphylaxis.

How is PALFORZIA taken?
Administration
Treatment with PALFORZIA involves three phases: gradual increase of the initial dose, administration at
increasing doses and maintenance. You must complete these phases of treatment following the order
prescribed by your doctor. During the phases of gradual increase of the initial dose and administration at
increasing doses, the dose of PALFORZIA is increased in a very specific way. During the maintenance
phase, you take the same dose of PALFORZIA every day.
To maintain the level of desensitization to peanuts, you must take PALFORZIA every day.
If you feel unwell or if you think your asthma is less controlled, inform your doctor on the day of the
clinic visit.
Gradual increase of the initial dose
You will receive the first doses (gradual increase of the initial dose) of PALFORZIA over approximately 4-
5 hours at your doctor's clinic. On the first day you will receive 0.5 mg, 1 mg, 1.5 mg, 3 mg and 6 mg of
PALFORZIA.
Patients from 1 to 3 years:
on the first day you will receive 0.5 mg, 1 mg, 1.5 mg and 3 mg of PALFORZIA.
Patients aged between 4 and 17 years:
on the first day you will receive 0.5 mg, 1 mg, 1.5 mg, 3 mg and 6 mg of PALFORZIA.
Administration at increasing doses
If you tolerate the initial dose escalation phase, you will be asked to return to the clinic another day
(usually the next day) to begin the increasing dose administration phase.
The first dose of each level of increasing dose administration is administered by the doctor in the
outpatient clinic. If the patient tolerates the first dose of a new dosage level, the doctor will ask them to
continue taking that dose every day at home for about 2 weeks. The patient will be monitored for at least
60 minutes after the administration of the first dose of a new dosage level until they can be discharged.
Patients from 1 to 3 years:
There are 12 different levels of increasing dose administration, starting from PALFORZIA 1 mg
(level 0) up to PALFORZIA 300 mg (level 11).
The levels of increasing dose administration are illustrated in the table below:
Before starting maintenance treatment, you must have completed all 12 levels of increasing dose
administration. At least 24 weeks are required to complete all levels of increasing dose administration.
Patients aged between 4 and 17 years:
in this phase there are 11 different levels of increasing dose administration, starting with
PALFORZIA 3 mg (level 1) and increasing up to PALFORZIA 300 mg (level 11).

The levels of increasing dose administration are illustrated in the table below:
You must have completed all 11 levels of increasing dose administration before you can
start maintenance treatment. At least 22 weeks are required to complete all levels of increasing dose
administration.
During the increasing dose administration phase, the doctor will visit the patient approximately every 2 weeks
to evaluate them and determine the new level of increasing dose administration.
Maintenance therapy
If you are able to tolerate level 11 (300 mg) of the increasing dose administration phase, your doctor will
ask you to continue taking PALFORZIA at a dose of 300 mg every day as maintenance therapy.

Preparation for use
PALFORZIA is available in capsules or sachets. Empty the powder contained in the capsules or sachets of
PALFORZIA.
Do not swallow the PALFORZIA capsules.
Open the daily dose of PALFORZIA.

• To open a capsule, gently separate the two ends over a bowl containing soft food and empty the powder into the bowl by rolling each half of the capsule between your index finger and thumb. Tap on the ends of each half of the capsule to make sure to empty all the powder.
• To open a sachet, carefully cut or tear along the top line indicated. Turn the sachet upside down over a bowl containing soft food and tap it to make sure to empty all the powder.

Empty the entire dose of PALFORZIA oral powder onto a small amount of soft food to which you are not
allergic, such as fruit puree, yogurt or rice pudding. Make sure you are not allergic to the food used for
mixing.
The food used for mixing must be cold and must not be warmer than room temperature.
Mix well.

The levels of increasing dose administration are illustrated in the table below:
You must have completed all 11 levels of increasing dose administration before you can
start maintenance treatment. At least 22 weeks are required to complete all levels of increasing dose
administration.
During the increasing dose administration phase, the doctor will visit the patient approximately every 2 weeks
to evaluate them and determine the new level of increasing dose administration.
Maintenance therapy
If you are able to tolerate level 11 (300 mg) of the increasing dose administration phase, your doctor will
ask you to continue taking PALFORZIA at a dose of 300 mg every day as maintenance therapy.

Instructions for handling
Do not inhale PALFORZIA powder as it may cause breathing problems (worsening of asthma) or trigger an
allergic reaction.
Wash your hands immediately after handling the PALFORZIA capsules or sachets.
When your doctor tells you that a level of increasing dose administration has been completed, you must
discard all remaining capsules or sachets in the package (see section 5) before starting a new level, including
any unused supplementary doses in each package, if not used.

Instructions for administration
Take PALFORZIA at approximately the same time each day with food, preferably during the evening meal. Do
not take this medicine on an empty stomach.
Do not take PALFORZIA at home on the days when you have to see your doctor for evaluations because on
these occasions the doctor will administer PALFORZIA to you.
Children must receive each dose of PALFORZIA from an adult and must be observed for about an hour
after taking it to detect any symptoms of an allergic reaction.
Do not take within 2 hours of bedtime.
Do not take a hot bath or shower immediately before or within 3 hours after taking PALFORZIA.
Do not engage in physical activity immediately before or within 3 hours after taking PALFORZIA.
If you have engaged in physical activity or taken a hot bath or shower and you feel hot, or if your heart rate is
accelerated, do not take PALFORZIA until you have cooled down and your heart rate (pulse) has returned to
normal.
Do not take more than your total individual daily dose established by your current PALFORZIA dose level in
a single day.

If you take more PALFORZIA than you should
Taking PALFORZIA at doses higher than those recommended increases the risk of allergic reactions.
In case of severe reactions, such as difficulty swallowing, difficulty breathing, changes in voice or a feeling
of fullness in the throat, treat the reaction with the adrenaline auto-injector according to the instructions
provided by your doctor and then contact them immediately.

If you forget to take PALFORZIA
Do not take a double dose to make up for a missed dose.
Missing doses of PALFORZIA may cause you to lose the tolerance to peanuts that you have accumulated and
increase the risk of allergic reactions.
If you miss the PALFORZIA dose for 1-2 days in a row, take the next dose the next day at the usual scheduled
time.
If you miss the PALFORZIA dose for 3 days in a row, stop taking PALFORZIA and contact your doctor for
instructions on how to restart treatment.

If you stop taking PALFORZIA
Stopping PALFORZIA may cause you to lose the tolerance to peanuts that you have accumulated and increase
the risk of allergic reactions.
If you have any further questions about the use of this medicine, ask your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Important side effects
PALFORZIA can cause serious allergic reactions, which can be life-threatening. If you should
develop any of the following symptoms, stop taking PALFORZIA, treat the reaction according to
any instructions you have previously received from your doctor and contact them immediately.

• Difficulty breathing
• A feeling of tightness or fullness in the throat
• Difficulty swallowing or speaking
• Changes in voice
• Dizziness or fainting or a feeling that a catastrophe is imminent
• Severe cramps or stomach pain, vomiting or diarrhea
• Severe redness or itching of the skin PALFORZIA can cause problems with the stomach and digestive system, including eosinophilic esophagitis. This is a condition that affects the passage connecting the mouth to the stomach and affects up to 1 in 1,000 people. Symptoms of eosinophilic esophagitis may include:
• Difficulty swallowing
• Food stuck in the throat
• Burning in the chest, mouth or throat
• Regurgitation
• Difficulty feeding
• Poor weight gain
• Loss of appetite If you experience these symptoms persistently, consult your doctor.

Other side effects
Very common(may affect up to 1 in 10 people)

• Severe allergic reaction
• Cough
• Throat irritation
• Throat tightness
• Sore throat and mouth
• Allergic rhinitis (runny nose, sneezing, itchy nose, nasal discomfort)
• Sneezing
• Blocked nose
• Vomiting
• Stomach pain
• Feeling sick (nausea)
• Itchy mouth
• Tingling or numbness of the mouth
• Itching
• Rash
• Hives

Common(may affect up to 1 in 100 people)

• Shortness of breath
• Wheezing
• Hoarse voice
• Clearing of the throat
• Tingling or numbness of the throat
• Indigestion
• Difficulty swallowing
• Increased salivation in the mouth
• Inflammation of the lips
• Diarrhea
• Swelling of the mouth
• Mouth ulcers
• Chest discomfort
• Flushing
• Fatigue
• Swelling of the face
• Feeling of something stuck in the throat
• Headache
• Anxiety
• Swelling under the skin
• Eczema
• Itchy eyes
• Swollen eyes
• Increased tearing
• Allergic conjunctivitis (itchy eyes, tearing)
• Redness of the eye
• Itchy ears

Uncommon(may affect up to 1 in 1,000 people)

• Symptoms of eosinophilic esophagitis (difficulty swallowing, food stuck in the throat, burning in the chest, mouth or throat, regurgitation, difficulty feeding, poor weight gain, loss of appetite)

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any side effects not listed in this leaflet. You can also report side effects directly
through the national reporting system listed in Annex V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store PALFORZIA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package and on the blister or sachet
after “EXP”. The expiry date refers to the last day of that month.
Store at a temperature below 25°C.
Do not use this medicine if you notice the presence of hard lumps of powder that do not crumble easily or
if the powder has changed colour.
Do not dispose of any medicine in household waste. Ask your pharmacist how to eliminate medicines that
you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What PALFORZIA contains
The active ingredient is a peanut protein derived from defatted peanut seed powder ( Arachis

hypogaea L.).
The other ingredients are:
PALFORZIA 0.5 mg, 1 mg, 10 mg, 20 mg oral powder in capsules to open
Partially pregelatinized corn starch, microcrystalline cellulose, anhydrous colloidal silicon dioxide,
magnesium stearate
PALFORZIA 100 mg oral powder in capsules to open
Microcrystalline cellulose, anhydrous colloidal silicon dioxide, magnesium stearate
PALFORZIA 300 mg oral powder in sachet
Microcrystalline cellulose, anhydrous colloidal silicon dioxide, magnesium stearate

Description of the appearance of PALFORZIA and contents of the pack
Oral powder from white to beige in color in capsule to open or sachet.
Initial dose escalation (see section 3)
Each box contains 13 capsules in 5 single-dose blisters:

• 0.5 mg (1 capsule of 0.5 mg)
• 1 mg (1 capsule of 1 mg)
• 1.5 mg (1 capsule of 0.5 mg and 1 capsule of 1 mg)
• 3 mg (3 capsules of 1 mg)
• 6 mg (6 capsules of 1 mg)

Dose escalation phase (see section 3)

Maintenance dose levels (see section 3)
Each box contains 30 sachets of 300 mg.

Marketing authorisation holder
STALLERGENES
6 rue Alexis de Tocqueville
92160 Antony
France

Manufacturer
Millmount Healthcare Limited
Block 7, City North Business Campus
Stamullen
Co Meath
Ireland
For further information on this medicine, contact the local representative of the marketing authorisation holder:

België/Belgique/Belgien
STALLERGENES
Tel: +353 (0)1 5827964

Lietuva
STALLERGENES
Tel: +353 (0)1 5827964

България
STALLERGENES
Тел.: +353 (0)1 5827964

Luxembourg/Luxemburg
STALLERGENES
Tél/Tel: +353 (0)1 5827964

Česká republika
STALLERGENES
Tel: +353 (0)1 5827964

Magyarország
STALLERGENES
Tel.: +353 (0)1 5827964

Danmark
STALLERGENES
Tlf: +353 (0)1 5827964

Malta
STALLERGENES
Tel: +353 (0)1 5827964

Deutschland
STALLERGENES
Tel: +49 (0)800 00 09 897

Nederland
STALLERGENES
Tel: +353 (0)1 5827964

Eesti
STALLERGENES
Tel: +353 (0)1 5827964

Norge
STALLERGENES
Tlf: +353 (0)1 5827964

Ελλάδα
STALLERGENES
Τηλ: +353 (0)1 5827964

Österreich
STALLERGENES
Tel: +43 (0)800 017821

España
STALLERGENES
Tel: +353 (0)1 5827964

Polska
STALLERGENES
Tel.: +353 (0)1 5827964

France
STALLERGENES
Tel: +33 (0)805 542 377

Portugal
STALLERGENES
Tel: +353 (0)1 5827964

Hrvatska
STALLERGENES
Tel: +353 (0)1 5827964

România
STALLERGENES
Tel: +353 (0)1 5827964

Ireland
STALLERGENES
Tel: (+353) 0151 34005

Slovenija
STALLERGENES
Tel: +353 (0)1 5827964

Ísland
STALLERGENES
Sími: +353 (0)1 5827964

Slovenská republika
STALLERGENES
Tel: +353 (0)1 5827964

Italia
STALLERGENES
Tel: +353 (0)1 5827964

Suomi/Finland
STALLERGENES
Puh/Tel: +353 (0)1 5827964

Κύπρος
STALLERGENES
Τηλ: +353 (0)1 5827964

Sverige
STALLERGENES
Tel: +353 (0)1 5827964

Latvija
STALLERGENES
Tel: +353 (0)1 5827964

Other sources of information
More detailed information on this medicine is available on the website of the European Medicines Agency: http://www.ema.europa.eu

ANNEX IV
CONCLUSIONS RELATING TO THE GRANT OF THE MARKETING AUTHORISATION
SUBJECT TO CONDITIONS AND WITH ANNUAL VALIDITY
PRESENTED BY THE EUROPEAN MEDICINES AGENCY
Conclusions presented by the European Medicines Agency on:

• Protection of commercial interests for a period of one year

In view of the provisions of Article 14(11) of Regulation 726/2004/EC, the
Committee for Medicinal Products for Human Use ( Committee for Human Medicinal Products,CHMP) has
examined the data submitted by the marketing authorisation holder, and considers that the
new therapeutic indication provides a clinically relevant benefit compared to the existing therapy(ies), as further described in the European Public Assessment Report ( European Public Assessment Report, EPAR)