PALFORZIA 1 mg ORAL POWDER IN CAPSULES FOR OPENING

Introduction

Package Leaflet: Information for the Patient

PALFORZIA 0.5 mg oral powder in capsules to be opened

PALFORZIA 1 mg oral powder in capsules to be opened

PALFORZIA 10 mg oral powder in capsules to be opened

PALFORZIA 20 mg oral powder in capsules to be opened

PALFORZIA 100 mg oral powder in capsules to be opened

PALFORZIA 300 mg oral powder in sachet

defatted powder of Arachis hypogaea L., seed (peanuts)

This medicinal product is subject to additional monitoring, which will allow for the quick identification of new safety information. You can help by reporting any side effects you may get. The last section of the package leaflet contains information on how to report side effects.

Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the package leaflet

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. Storage of PALFORZIA
6. Contents of the pack and other information

1. What is PALFORZIA and what is it used for

PALFORZIA contains peanut protein from defatted peanut seed powder. It belongs to a class 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 while being treated.

PALFORZIA works in people with peanut allergy by gradually increasing the body's ability to tolerate small amounts of peanut (desensitization). PALFORZIA may help reduce the severity of allergic reactions after exposure to peanut.

PALFORZIA is not effective against allergies to other nuts or foods.

You should continue to strictly avoid eating peanuts while taking PALFORZIA.

2. What you need to know before you take PALFORZIA

Do not take PALFORZIA

• if you are allergic to any of the excipients (the other components) of this medicine (listed in section 6).
• if you have severe asthma or if your asthma is not well-controlled (as assessed by a doctor).
• if you have had a condition called “food protein-induced enterocolitis syndrome (FPIES)” in the last 12 months (in case of young children from 1 to 3 years).
• if you have ever had growth or development problems, i.e. “growth delay” (in case of young children from 1 to 3 years).
• if you have or have ever had problems swallowing or long-term problems with your digestive system.
• if you have or have ever had a severe mastocytosis disorder (as assessed by a doctor).
• if you have had a severe or life-threatening anaphylaxis within the last 60 days prior to starting treatment.

Warnings and precautions

Consult your doctor before starting to take PALFORZIA, and inform your doctor of any illness you have.

You should not include peanuts or any food containing peanuts in your diet while taking PALFORZIA.

It is important to keep a record of the batch number of your PALFORZIA. To do this, each time you receive a new pack of PALFORZIA, write down the date and the batch number (which appears on the pack after «Lot»), and keep this information in a safe place.

PALFORZIA does not treat the symptoms of peanut allergy, and you should not take PALFORZIA during an allergic reaction.

Your doctor will tell you the best time to start treatment based on any other condition you may have.

PALFORZIA contains the substance to which patients with peanut allergy react. Allergic reactions to PALFORZIA may occur during treatment. These reactions mostly occur within the first two hours after taking the dose of PALFORZIA, and are usually mild or moderate, but may occasionally be severe. Patients aged 12 years or older and/or with high sensitivity to peanuts may be at higher 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
• Feeling of tightness in the throat or feeling of fullness in the throat
• Difficulty swallowing
• Changes in voice
• Dizziness or fainting, or feeling of impending doom
• Severe abdominal cramps or pain, vomiting, or diarrhea
• Severe redness or itching of the skin
• Worsening of asthma or any other respiratory condition
• Heartburn, difficulty swallowing, pain when swallowing, or abdominal or chest pain that does not go away or worsens.

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

• Worsening of asthma
• Having an open wound or other injury to the lining of the mouth or the passage that goes from the mouth to the stomach (esophagus)
• Engaging in physical exercise
• Taking a hot bath or shower
• Being very tired or lacking sleep
• For women, during the menstrual period
• Taking certain pain medications, such as aspirin or ibuprofen
• Drinking alcohol
• Being stressed
• Taking PALFORZIA on an empty stomach
• Having an illness such as a cold or flu or other viral infections.

There are measures you can take to avoid some of these factors. These factors include: physical exercise, taking a hot bath or shower, drinking alcohol, or taking this medicine on an empty stomach. See the sections «Use of PALFORZIA with food, drinks, and alcohol» and «Instructions for administration» for information on what to do regarding these.

For all other conditions or factors listed previously, consult your doctor for instructions if you experience allergic reactions during any of them.

Your doctor will prescribe adrenaline for you to self-inject, and you should have it with you at all times, in case you have a severe allergic reaction. Your doctor will inform you how to recognize an allergic reaction, and will teach you when and how to use the adrenaline. Talk to your doctor and read the package leaflet of the adrenaline if you have any questions about its use.

If you use adrenaline, do not take any further doses of PALFORZIA and immediately seek emergency medical attention.

Peanut desensitization with PALFORZIA takes time. The ability to tolerate gradually increasing amounts of peanut has been shown after completing all dose escalation levels of PALFORZIA, and after at least 3 months of maintenance therapy, and this continues to improve over time.

You will need to take PALFORZIA every day to maintain the desensitization provided by the medicine. Missing doses may increase the risk of allergic reactions.

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 while being treated.

Do not give this medicine to children under 1 year of age, as 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.

Use of PALFORZIA with food, drinks, and alcohol

PALFORZIA should not be mixed with liquids (e.g. water, milk, juice, soup, smoothie).

Do not drink alcohol, or take medicines that contain alcohol, within 2 hours before and 2 hours after taking PALFORZIA, as this may increase the likelihood of an allergic reaction.

Pregnancy, breast-feeding, and fertility

Do not start treatment with PALFORZIA if you are pregnant or planning to become pregnant.

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.

Driving and using machines

PALFORZIA may have a minor effect on your ability to drive, ride a bicycle, or use machines. Be cautious during the 2 hours after taking a dose of PALFORZIA in case you experience an allergic reaction that affects your ability to drive, ride a bicycle, or use machines. Wait until all symptoms of such allergic reactions have disappeared before driving, riding a bicycle, going to the park, or using machines.

3. How to Take PALFORZIA

Follow your doctor's instructions for taking this medication exactly. If you are unsure, consult your doctor again.

PALFORZIA is prescribed by doctors with experience in diagnosing and treating allergies and allergic reactions, including anaphylaxis.

How should I take PALFORZIA?

Administration

Treatment with PALFORZIA has 3 phases: initial dose escalation, dose increase, and maintenance. You must complete these administration phases in the order your doctor has prescribed. During the initial dose escalation and dose increase phases, the PALFORZIA dose is increased in a precise manner. During the maintenance phase, you take the same dose of PALFORZIA every day.

You must take PALFORZIA every day to maintain your level of desensitization to peanuts.

On the day of each clinic visit, tell your doctor if you are not feeling well or if you feel that your asthma is less controlled.

Initial Dose Escalation

You will be treated with the first doses (initial dose escalation) of PALFORZIA over a period of approximately 4 to 5 hours in your doctor's clinic.

Patients 1 to 3 years old:

On the first day, you will be treated with 0.5 mg, 1 mg, 1.5 mg, and 3 mg of PALFORZIA.

Patients 4 to 17 years old:

On the first day, you will be treated with 0.5 mg, 1 mg, 1.5 mg, 3 mg, and 6 mg of PALFORZIA.

Dose Increase

If you tolerate the initial dose escalation phase, you will be asked to return to your doctor's clinic another day (usually the next day) to start the dose increase phase.

The first dose of each dose increase level will be administered by your doctor in a clinic. If you tolerate the first dose of a new dose level, your doctor will ask you to continue taking that dose at home every day for about 2 weeks. You will be under observation for at least 60 minutes after administration of the first dose of a new dose increase level until you are fit for discharge.

Patients 1 to 3 years old:

There are 12 distinct dose levels for dose increase, starting with 1 mg of PALFORZIA (level 0) and increasing up to 300 mg of PALFORZIA (level 11).

The dose increase levels are shown in the following table:

You must have completed the 12 dose increase levels before you can start maintenance treatment. Completing all dose increase levels will take at least 24 weeks.

Patients 4 to 17 years old:

There are 11 distinct dose levels for dose increase, starting with 3 mg of PALFORZIA (level 1) and increasing up to 300 mg of PALFORZIA (level 11).

The dose increase levels are shown in the following table:

You must have completed the 11 dose increase levels before you can start maintenance treatment. Completing all dose increase levels will take at least 22 weeks.

During the dose increase phase, your doctor will see you approximately every 2 weeks to assess whether you can move to a new dose increase level.

Maintenance Administration

If you can tolerate the 300 mg level of the dose increase phase, your doctor will ask you to continue taking PALFORZIA at a dose of 300 mg every day as maintenance treatment.

Preparation for Use

PALFORZIA is available in capsules or sachets. The powder from the PALFORZIA capsules or sachets must be poured out.

Do not swallow the PALFORZIA capsules

Open the daily dose of PALFORZIA.

• To open a capsule, separate the two parts of the capsule by carefully pulling both ends over a bowl with a soft food, and pour the powder into the bowl by rotating each half of the capsule between your index finger and thumb. Gently tap the base of each half of the capsule to ensure that all the powder is emptied.
• To open the sachet, carefully cut or tear along the top edge at the indicated line. Invert the sachet over a bowl with a soft food, and gently tap to ensure that the powder is completely emptied.

Pour the complete dose of PALFORZIA oral powder over a small amount of a soft food that does not cause you an allergy, such as fruit puree, yogurt, or rice with milk. Make sure you are not allergic to the food used for mixing.

The food used for mixing must be cold and not exceed room temperature.

Mix well.

To mix with PALFORZIA, use only the amount of food sufficient to allow you to ingest the complete dose of PALFORZIA in a few spoonfuls.

Take PALFORZIA immediately after mixing. However, if necessary, you can mix PALFORZIA with food and store it in the refrigerator for up to 8 hours before taking it. If it is not used within 8 hours, discard it and prepare a new dose.

Handling Instructions

Do not inhale the PALFORZIA powder, as it may cause respiratory problems (worsening of asthma) or cause an allergic reaction.

Wash your hands immediately after handling the PALFORZIA capsules or sachets.

Once your doctor has told you that you have completed a dose increase level, you must discard all remaining capsules or sachets from that package (see section 5) before starting a new level. This includes all additional doses included in each package, if they have not been used.

Administration Instructions

Take PALFORZIA every day, approximately at the same time, with food, preferably as part of dinner. Do not take this medication on an empty stomach.

Do not take PALFORZIA at home on the days you visit your doctor for an evaluation, as your doctor will administer PALFORZIA on those days.

In children, each dose of PALFORZIA must be administered by an adult, and they must be monitored for approximately 1 hour to detect any symptoms of an allergic reaction.

Do not take within 2 hours before bedtime.

Do not take a hot bath or shower immediately before or during the 3 hours after taking PALFORZIA.

Do not engage in physical exercise immediately before or during the 3 hours after taking PALFORZIA.

If you have been engaging in physical exercise, or have taken a hot bath or shower and feel hot, or if you are sweating and your heart is beating rapidly, do not take PALFORZIA until you have cooled down and your heart rate (pulse) has returned to normal.

Do not take more than your individual total daily dose corresponding to your current dose level of PALFORZIA on the same day.

If you take more PALFORZIA than you should

Taking PALFORZIA in doses higher than recommended increases the risk of allergic reactions.

In case of severe adverse reactions, such as difficulty swallowing, difficulty breathing, changes in voice, or sensation of tightness in the throat, treat the reaction with the adrenaline auto-injector according to your doctor's instructions, and contact a doctor immediately.

If you forget to take PALFORZIA

Do not take a double dose to make up for missed doses.

Missed doses of PALFORZIA may cause a loss of tolerance to peanuts that you have developed and increase your risk of allergic reactions.

If you forget to take your dose of PALFORZIA for 1 to 2 consecutive days, take the corresponding dose the next day at the usual scheduled time.

If you miss your dose of PALFORZIA for 3 consecutive days or more, stop taking PALFORZIA and contact your doctor to find out how to restart your treatment.

If you interrupt treatment with PALFORZIA

Stopping the administration of PALFORZIA may cause a loss of tolerance to peanuts that you have developed and increase your risk of allergic reactions.

If you have any further questions about the use of this medication, 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 may cause serious allergic reactions, which can be life-threatening. If you have any of the following symptoms, stop taking PALFORZIA, treat the reaction according to the instructions your doctor has given you previously, and contact a doctor immediately.

• Difficulty breathing
• Tightness of the throat or sensation of fullness in the throat
• Difficulty swallowing or speaking
• Changes in voice
• Dizziness or fainting or feeling of impending doom
• Severe stomach cramps, vomiting, or diarrhea
• Severe redness or itching of the skin

PALFORZIA may cause stomach and digestive system problems, including eosinophilic esophagitis. This is a condition that affects the passage between the mouth and the stomach, and affects up to 1 in 1000 people. The symptoms of eosinophilic esophagitis may include:

• Difficulty swallowing
• Choking on food
• Heartburn in the chest, mouth, or throat
• Regurgitation
• Feeding difficulties
• Poor weight gain
• Loss of appetite

If you have these symptoms persistently, contact a doctor.

Other Side Effects

Very Common(may affect up to 1 in 10 people)

• Severe allergic reaction
• Cough
• Irritation in the throat
• Tightness in the throat
• Throat and mouth pain
• Allergic rhinitis (runny nose, sneezing, itchy nose, nasal discomfort)
• Sneezing
• Nasal congestion
• Vomiting
• Stomach pain
• Feeling sick (nausea)
• Itching in the mouth
• Numbness or tingling in the mouth
• Itching
• Rash
• Hives

Common(may affect up to 1 in 100 people)

• Difficulty breathing
• Wheezing (whistling while breathing)
• Hoarseness
• Coughing
• Itching or numbness in the throat
• Indigestion
• Difficulty swallowing
• Increased saliva in the mouth
• Lip swelling
• Diarrhea
• Mouth swelling
• Mouth ulcers
• Chest discomfort
• Redness
• Fatigue
• Facial swelling
• Sensation of having something stuck in the throat
• Headache
• Anxiety
• Swelling under the skin
• Eczema
• Itchy eyes
• Puffy eyes
• Increased tearing
• Allergic conjunctivitis (itchy eyes, tearing)
• Redness of the eyes
• Itching in the ears

Uncommon(may affect up to 1 in 1000 people)

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

Reporting Side Effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of PALFORZIA

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the carton and blister or sachet (EXP). The expiry date is the last day of the month indicated.

Store below 25°C.

Do not use this medicine if you notice powder lumps that do not break up easily, or if the powder is discolored.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package Contents and Additional Information

PALFORZIA Composition

The active ingredient is peanut protein 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 for opening

Partially pregelatinized cornstarch, microcrystalline cellulose, anhydrous colloidal silica, magnesium stearate

PALFORZIA 100 mg oral powder in capsules for opening

Microcrystalline cellulose, anhydrous colloidal silica, magnesium stearate

PALFORZIA 300 mg oral powder in sachet

Microcrystalline cellulose, anhydrous colloidal silica, magnesium stearate

Product Appearance and Package Contents

White to light brown oral powder in a capsule for opening or in a sachet.

Initial dose escalation (see section 3)

Each box contains 13 capsules in 5 single-dose blisters:

• 0.5 mg (1 x 0.5 mg capsule)
• 1 mg (1 x 1 mg capsule)
• 1.5 mg (1 x 0.5 mg capsule + 1 x 1 mg capsule)
• 3 mg (3 x 1 mg capsules)
• 6 mg (6 x 1 mg capsules)

Dose increase phase (see section 3)

Maintenance dose (see section 3)

Each box contains 30 sachets of 300 mg.

Marketing Authorization Holder

STALLERGENES

6 rue Alexis de Tocqueville

92160 Antony

France

Manufacturer

Millmount Healthcare Limited

Block 7, City North Business Campus

Stamullen

Co Meath

Ireland

STALLERGENES

6 rue Alexis de Tocqueville

92160 Antony

France

You can request more information about this medicinal product by contacting the local representative of the marketing authorization holder:

Date of Last Revision of this Leaflet:

Other Sources of Information

Detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu.