Acarizax

Package Leaflet: Information for the User

ACARIZAX, 12 SQ-HDM, Sublingual Lyophilisate

For Use in Adults and Children (from 5 to 65 Years of Age)

Standardized House Dust Mite Allergen Extract
(Dermatophagoides pteronyssinusand Dermatophagoides farinae)

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this Package Leaflet, You May Need to Read it Again.
• In Case of Any Doubts, Consult a Doctor or Pharmacist.
• This Medication has been Prescribed Specifically for You. Do Not Pass it on to Others. The Medication may Harm them, even if their Symptoms are the Same.
• If the Patient Experiences any Adverse Reactions, Including any Adverse Reactions not Listed in this Package Leaflet, Inform a Doctor or Pharmacist. See Section 4.

Package Leaflet Contents

• 1. What is ACARIZAX and What is it Used for
• 2. Important Information Before Taking ACARIZAX
• 3. How to Take ACARIZAX
• 4. Possible Adverse Reactions
• 5. How to Store ACARIZAX
• 6. Package Contents and Other Information

1. What is ACARIZAX and What is it Used for

ACARIZAX Contains a Standardized House Dust Mite Allergen Extract. The Medication is in the Form of a Sublingual Lyophilisate, Similar to a Tablet, but Softer and Absorbed into the Body after Placement under the Tongue.
ACARIZAX is Used to Treat Allergic Rhinitis (Nasal Mucosa Inflammation) in Adults and Children (from 5 to 65 Years of Age) and Associated Allergic Asthma in Adults (from 18 to 65 Years of Age), Caused by House Dust Mites.
ACARIZAX Increases Immunological Tolerance (the Body's Ability to Cope) to House Dust Mites. It may Take 8 to 14 Weeks for the Patient to Notice any Improvement.
The Doctor will Assess the Allergic Symptoms and Perform Skin Tests and (or) Order a Blood Test to Decide if ACARIZAX Should be Used.
The First Dose of the Sublingual Lyophilisate Should be Taken in the Presence of a Doctor. After Taking the First Dose, the Patient Should Remain under Medical Supervision for at Least Half an Hour. This Precaution Allows for the Assessment of the Patient's Individual Sensitivity to the Treatment and Discussion with the Doctor of Possible Adverse Reactions.
ACARIZAX is Prescribed by Doctors with Experience in Treating Allergies.

2. Important Information Before Taking ACARIZAX

When Not to Take ACARIZAX

• If the Patient is Allergic to any of the Other Ingredients of this Medication (Listed in Section 6);
• If Lung Function is Poor (as Assessed by a Doctor);
• If the Patient has had a Worsening of Severe Asthma in the Last Three Months (as Assessed by a Doctor);
• If the Patient has Asthma and a Current Respiratory Tract Infection, such as a Cold, Sore Throat, Pneumonia, on the Day of the First Dose of ACARIZAX. The Doctor will Postpone the Start of Treatment until the Patient Feels Better;
• If the Patient has a Disease Affecting the Immune System, is Taking Medications that Suppress the Immune System, or has Cancer;
• If the Patient has Recently had a Tooth Extraction, Other Oral Surgery, or has Ulcers or Infections in the Mouth. The Doctor may Recommend Postponing the Start of Treatment or Interrupting Treatment until the Mouth Sores have Healed.

Warnings and Precautions

Before Starting to Take ACARIZAX, Discuss with a Doctor if:

• The Patient is Being Treated for Depression with Tricyclic Antidepressants, Monoamine Oxidase Inhibitors (MAOIs), or is Being Treated for Parkinson's Disease with Catechol-O-Methyltransferase (COMT) Inhibitors;
• The Patient has had a Severe Allergic Reaction to an Injection Containing a House Dust Mite Allergen Extract in the Past;
• The Patient has a Fish Allergy. ACARIZAX may Contain Trace Amounts of Fish Protein. Available Data do not Indicate an Increased Risk of an Allergic Reaction in Patients with a Fish Allergy;
• Severe Allergic Reaction Symptoms Occur, such as Difficulty Swallowing or Breathing, Voice Changes, Low Blood Pressure, or a Feeling of a Constricted Throat. Treatment Should be Stopped Immediately and a Doctor Consulted;
• Asthma Symptoms Worsen Noticeably. Treatment Should be Stopped Immediately and a Doctor Consulted.

If the Patient has Asthma, After Starting Treatment with ACARIZAX, Anti-Asthmatic Medications Should be Continued. The Doctor will Advise on How to Gradually Reduce the Dose of Anti-Asthmatic Medications.
ACARIZAX Should be Stopped Immediately and a Doctor Consulted if Severe or Persistent Heartburn or Difficulty Swallowing Occurs, as these may be Symptoms of Allergic Esophagitis.
During Treatment, Mild to Moderate Local Allergic Reactions can be Expected. However, if Symptoms are Severe, the Doctor Should be Informed, who will Decide if the Patient Requires Administration of Anti-Allergic Medications, such as Antihistamines.
This Medication Contains Less than 1 mmol (23 mg) of Sodium per Dose, i.e., the Medication is Considered "Sodium-Free".

Children

Allergic Rhinitis (Nasal Mucosa Inflammation):
ACARIZAX is not Indicated for Use in Children Under 5 Years of Age.
Allergic Asthma:
ACARIZAX is not Indicated for Use in the Treatment of Allergic Asthma in Children Under 18 Years of Age.

ACARIZAX and Other Medications

Inform a Doctor or Pharmacist about all Medications Currently Being Taken or Recently Taken, as well as Planned Medications. This Includes Medications Available Without a Prescription. If the Patient is Taking Other Anti-Allergic Medications, such as Antihistamines, Asthma Symptom Relief Medications, or Steroids, Inform a Doctor, who will Advise on How to Use them During Treatment with ACARIZAX. If the Patient Stops Taking Anti-Allergic Medications, More Adverse Reactions to ACARIZAX may Occur.

ACARIZAX with Food and Drink

For 5 Minutes After Taking this Medication, Avoid Eating and Drinking.

Pregnancy and Breastfeeding

There is Currently no Experience with the Use of ACARIZAX During Pregnancy. Do not Start Treatment with ACARIZAX During Pregnancy. If the Patient Becomes Pregnant During Treatment, Consult a Doctor About Continuing Treatment with this Medication.
There is Currently no Experience with the Use of ACARIZAX During Breastfeeding.
No Effect of the Medication on the Breastfed Child is Expected. Consult a Doctor About Continuing to Take ACARIZAX During Breastfeeding.

Driving and Operating Machines

Treatment with ACARIZAX has no Significant Effect on the Ability to Drive and Use Machines. However, the Patient Should Assess Whether the Medication Affects their Well-Being. Therefore, Read all the Information in this Package Leaflet, Especially Section 4 "Possible Adverse Reactions", and in Case of Doubts, Consult a Doctor or Pharmacist.

3. How to Take ACARIZAX

ACARIZAX Should Always be Taken as Directed by a Doctor. In Case of Doubts, Consult a Doctor or Pharmacist.
The Dose is Usually one Sublingual Lyophilisate per Day. The Doctor will Decide How Long to Take ACARIZAX.
Before Touching the Medication, Ensure Hands are Dry. Take the Medication as Follows:

• 1. Tear off the Strip Marked with Triangles at the Top of the Packaging.

• 2. Tear off one Sublingual Lyophilisate Square from the Packaging along the Perforation Line.

• 3. Do not Push the Medication Through the Foil. This may Damage it, as the Medication is Fragile. Bend the Marked Corner of the Foil and then Pull it.

• 4. Carefully Remove the Medication from the Foil and Take it Immediately.

• 5. Place the Medication under the Tongue. It Should Remain there Until it Dissolves. Do not Swallow Saliva for the First Minute. Do not Eat or Drink for at Least 5 Minutes.

Taking More than the Recommended Dose of ACARIZAX

In Case of Taking too Many Sublingual Lyophilisates, the Patient may Experience Allergic Symptoms, Including Local Symptoms in the Mouth and Throat. If Symptoms are Severe, Consult a Doctor or Go to the Hospital Immediately.

Missing a Dose of ACARIZAX

In Case of Missing a Dose, Take the Medication Later the Same Day. Do not Take a Double Dose to Make up for the Missed Dose.
If the Patient has Forgotten to Take ACARIZAX for More than 7 Days, Consult a Doctor Before Taking the Medication Again.

Stopping Treatment with ACARIZAX

The Effectiveness of the Treatment Depends on Taking the Medication as Directed by the Doctor.
In Case of any Further Doubts About the Use of this Medication, Consult a Doctor or Pharmacist.

4. Possible Adverse Reactions

Like all Medications, ACARIZAX can Cause Adverse Reactions, although not Everybody Gets them.
An Adverse Reaction may be an Allergic Reaction to the Allergen Being Treated.
Most Allergic Reactions Last from a Few Minutes to a Few Hours After Taking the Medication and Most of them Disappear During Treatment Within 1 to 3 Months.
The Most Severe Adverse Reactions:
Uncommon (may Occur in Less than 1 in 100 Patients):

• Severe Allergic Reaction

Stop Taking ACARIZAX and Inform a Doctor or Hospital Immediately if the Following Symptoms Occur:

• Worsening of Existing Asthma
• Sudden Swelling of the Face, Mouth, Throat, or Skin
• Swallowing Problems
• Breathing Problems
• Voice Changes
• Low Blood Pressure
• Feeling of Fullness in the Throat (Similar to Swelling)
• Hives and Itching of the Skin

Other Possible Adverse Reactions:
Very Common (may Occur in More than 1 in 10 Patients):

• Irritation of the Throat
• Swelling in the Mouth and Swelling of the Lips
• Itching in the Mouth and Itching of the Ears
• Respiratory Tract Infections

Common (may Occur in Less than 1 in 10 Patients):

• Feeling of Prickling or Numbness in the Mouth and Tongue
• Itching of the Eyes
• Itching of the Tongue and Lips
• Swelling of the Tongue or Throat
• Inflammation, Discomfort, or Burning in the Mouth
• Redness or Ulcers in the Mouth
• Pain in the Mouth
• Taste Disorders
• Stomach Pain or Discomfort in the Abdomen
• Diarrhea
• Nausea (Nausea) and Vomiting
• Difficulty Swallowing or Pain when Swallowing
• Asthma Symptoms
• Cough
• Shortness of Breath
• Discomfort in the Chest
• Indigestion and Heartburn
• Hoarseness
• Feeling of Fatigue
• Hives and Itching of the Skin

Uncommon (may Occur in Less than 1 in 100 Patients):

• Eye Inflammation
• Feeling of Rapid, Strong, or Irregular Heartbeat
• Discomfort in the Ears
• Feeling of Pressure in the Throat
• Discomfort in the Nose, Stuffy Nose, or Runny Nose, Sneezing
• Formation of Blisters in the Mouth
• Irritation of the Esophagus
• Feeling of a Foreign Body in the Throat
• Dizziness
• Feeling of General Malaise
• Dryness in the Mouth
• Feeling of Tingling on the Skin
• Redness of the Throat
• Enlargement of the Tonsils
• Pain in the Lips
• Ulcers on the Lips
• Enlargement of the Salivary Glands
• Increased Saliva Production
• Redness of the Skin

Rare (may Occur in Less than 1 in 1000 Patients):

• Sudden Swelling of the Face or Skin
• Allergic Esophagitis (Eosinophilic Esophagitis)

If Troublesome Adverse Reactions Occur, Inform a Doctor, who will Decide if it is Necessary to Administer Anti-Allergic Medications to Relieve the Symptoms.

Adverse Reactions in Children

It is Expected that Adverse Reactions in Children will be Similar to those in Adults and Adolescents.
Some Possible Adverse Reactions that may Occur More Frequently in Children are:
Very Common (may Occur in More than 1 in 10 Patients): Swelling of the Tongue or Throat, Ulcers in the Mouth, Pain in the Mouth, Taste Disorders, Abdominal Pain, Diarrhea, Nausea.
Common (may Occur in Less than 1 in 10 Patients): Eye Inflammation.
Uncommon (may Occur in Less than 1 in 100 Patients): Sudden Swelling of the Face and Skin, and Allergic Esophagitis (Eosinophilic Esophagitis).

Reporting Adverse Reactions

If any Adverse Reactions Occur, Including any Adverse Reactions not Listed in this Package Leaflet, Inform a Doctor or Pharmacist. Adverse Reactions can be Reported Directly to the Department of Adverse Reaction Monitoring of Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw
tel.: 22 49-21-301
fax: 22 49-21-309
Website: https://smz.ezdrowie.gov.pl
Adverse Reactions can also be Reported to the Marketing Authorization Holder.
Reporting Adverse Reactions will Help to Gather More Information on the Safety of the Medication.

5. How to Store ACARIZAX

Store the Medication out of Sight and Reach of Children.
Do not Use ACARIZAX After the Expiration Date Stated on the Blister and Carton after: EXP. The Expiration Date Refers to the Last Day of the Specified Month.
No Special Precautions are Required for the Storage of the Medicinal Product.
Medications Should not be Disposed of in Sewers or Household Waste Containers. Ask a Pharmacist how to Dispose of Unused Medications. This will Help Protect the Environment.

6. Package Contents and Other Information

What ACARIZAX Contains

The Active Substance of the Medication is a Standardized House Dust Mite Allergen Extract Dermatophagoides pteronyssinusand Dermatophagoides farinae. The Activity of one Sublingual Lyophilisate is Expressed in SQ-HDM Units. The Activity of one Lyophilisate is 12 SQ-HDM.
The Other Ingredients are: Gelatin (Derived from Fish), Mannitol, and Sodium Hydroxide (to Adjust pH).

What ACARIZAX Looks Like and What the Package Contains

A White or Almost White Embossed Sublingual Lyophilisate with an Embossing on one Side.
Aluminum/Aluminum Blisters in a Cardboard Box. Each Blister Contains 10 Sublingual Lyophilisates.
The Following Package Sizes are Available: 30, 90 Sublingual Lyophilisates.
Not all Package Sizes may be Marketed.

Marketing Authorization Holder

ALK-Abelló A/S, Bøge Allé 6-8, DK-2970 Hørsholm, Denmark

Manufacturer

ALK-Abelló S.A., Miguel Fleta 19, 28037 Madrid, Spain

This Medication is Authorized for Marketing in the Member States of the European Economic Area Under the Following Names:

Austria, Czech Republic, Denmark, Finland, France, Germany, Norway, Poland, Sweden, and Slovakia:
ACARIZAX
Italy: ACCARIZAX
Date of Last Update of the Package Leaflet:12/2024