Acarizax

Package leaflet: Information for the user

ACARIZAX, 12 SQ-HDM, sublingual lyophilisate
For use in adults and children (aged 5 to 65 years)
Standardized house dust mite allergen extract
(Dermatophagoides pteronyssinus and Dermatophagoides farinae)
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same as yours.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents

1. What ACARIZAX is and what it is used for
2. Important information before taking ACARIZAX
3. How to take ACARIZAX
4. Possible side effects
5. How to store ACARIZAX
6. Contents of the pack and other information

1. What ACARIZAX is and what it is used for

ACARIZAX contains a house dust mite allergen extract. The medicine is in the form of a sublingual lyophilisate, resembling a tablet but softer, which dissolves and is absorbed into the body after placement under the tongue.
ACARIZAX is used to treat allergic rhinitis (inflammation of the nasal mucosa) in adults and children (aged 5 to 65 years) and associated allergic asthma in adults (aged 18 to 65 years) caused by house dust mites.
ACARIZAX increases immunological tolerance (the body's ability to cope) to house dust mites. It may take between 8 and 14 weeks before any improvement is noticed.
Your doctor will assess your allergic symptoms and perform skin tests and/or order blood tests to determine whether ACARIZAX should be used.
The first dose of the sublingual lyophilisate must be taken under medical supervision. After taking the first dose, the patient should remain under medical observation for at least 30 minutes. This precaution allows assessment of the individual's sensitivity to treatment and discussion with the doctor regarding possible adverse effects.
ACARIZAX is prescribed by doctors experienced in allergy treatment.

2. Important information before taking ACARIZAX

When not to take ACARIZAX

• if the patient is allergic to any of the other ingredients of this medicine (listed in section 6);
• if lung function is poor (as assessed by the physician);
• if the patient has experienced worsening of severe asthma within the last three months (as assessed by the physician);
• if the patient has asthma and an ongoing respiratory tract infection such as a cold, sore throat, or pneumonia on the day the first dose of ACARIZAX is due. The physician will delay the start of treatment until the patient feels better;
• if the patient has a disease affecting the immune system, is taking medicines that suppress immune system function, or has cancer;
• if the patient has recently had a tooth extraction, other oral surgery, or has mouth ulcers or infections in the mouth. The physician may recommend postponing the start of treatment or interrupting treatment until the mouth wounds have healed.

Warnings and precautions
Before starting treatment with ACARIZAX, discuss with the physician 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 previously experienced a severe allergic reaction after receiving an injection containing house dust mite allergen extract;
• the patient has a fish allergy. ACARIZAX may contain trace amounts of fish protein. Available data do not indicate an increased risk of allergic reactions in patients allergic to fish;
• symptoms of a severe allergic reaction occur, such as difficulty swallowing or breathing, voice changes, hypotension (low blood pressure), or a sensation of throat tightness. Treatment must be stopped immediately and the physician contacted;
• asthma symptoms worsen noticeably. Treatment must be stopped immediately and the physician contacted.

If the patient has asthma, anti-asthma medications should be continued after starting treatment with ACARIZAX. The physician will advise the patient on how to gradually reduce the dose of anti-asthma medications.
ACARIZAX must be stopped immediately and the physician contacted if severe or persistent heartburn or difficulty swallowing occurs, as these may be symptoms of eosinophilic esophagitis.
Mild to moderate local allergic reactions may be expected during treatment. However, if symptoms are severe, the patient should inform the physician, who will decide whether anti-allergic medications, such as antihistamines, are needed.
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. the medicine 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 the treatment of allergic asthma in children under 18 years of age.

ACARIZAX with other medicines
Tell the physician or pharmacist about all medicines the patient is currently taking or has recently taken, including medicines obtained without a prescription. If the patient is taking other anti-allergic medicines such as antihistamines, asthma symptom relievers, or steroids, inform the physician, who will advise on how to use them during ACARIZAX treatment. If the patient stops taking anti-allergic medicines, more adverse reactions to ACARIZAX may occur.

ACARIZAX with food and drink
For 5 minutes after taking this medicine, avoid eating or drinking.

Pregnancy and breastfeeding
There is currently no experience with the use of ACARIZAX during pregnancy. Treatment with ACARIZAX should not be started during pregnancy. If a patient becomes pregnant during treatment, she should consult the physician on whether she may continue treatment with this medicine.
There is currently no experience with the use of ACARIZAX during breastfeeding.
A significant effect of the medicine on the breastfed child is not expected. Discuss with the physician whether ACARIZAX treatment can be continued during breastfeeding.

Driving and operating machinery
Treatment with ACARIZAX has no effect or a negligible effect on the ability to drive motor vehicles and operate machinery. Nevertheless, the patient should assess individually whether the medicine affects their well-being. Therefore, read all information contained in this leaflet, especially section 4 "Possible side effects", and in case of doubt, consult the physician or pharmacist.

3. How to take ACARIZAX

ACARIZAX must always be taken according to the doctor's instructions. If in doubt,
consult your doctor or pharmacist.
The usual dose is one lyophilisate per day. Your doctor will decide how long you should take
ACARIZAX.
Before handling the medicine, ensure that your hands are dry. The medicine should be taken as follows:

1. Peel off the strip marked with triangles at the top of the packaging.

2. Detach one square sublingual lyophilisate from the packaging along the perforated line.

3. Do not push the medicine through the foil. This may damage the medicine, as it is fragile and may break easily. Fold back the marked corner of the foil, then pull it gently.

4. Carefully remove the medicine from the foil and take it immediately.

5. Place the medicine under the tongue. It should remain there until completely dissolved. Do not swallow saliva during the first minute. Do not eat or drink for at least 5 minutes.

Taking more ACARIZAX than recommended
If too many lyophilisates are taken, the patient may experience allergic symptoms, including
local symptoms in the mouth and throat. If symptoms are severe, seek immediate medical advice or go to a hospital.
Missed dose of ACARIZAX
If a dose is missed, take the medicine later the same day. Do not take a double dose to make up for a missed dose.
If the patient has forgotten to take ACARIZAX for more than 7 days, contact the doctor before resuming treatment.
Stopping ACARIZAX
For treatment to be effective, the medicine must be taken as directed by the doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
An adverse reaction may be an allergic response to the allergen the patient is being treated for.
Most allergic reactions last from a few minutes to several hours after taking the medicine,
and most resolve during treatment within 1 to 3 months.

Most serious adverse reactions:
Not common (may occur in up to 1 in 100 patients):

• Severe allergic reaction

Stop taking ACARIZAX and contact your doctor or hospital immediately if any of the following symptoms occur:

• Worsening of existing asthma
• Sudden swelling of the face, mouth, throat, or skin
• Difficulty swallowing
• Breathing difficulties
• Voice changes
• Low blood pressure
• Sensation of throat fullness (similar to swelling)
• Skin hives and itching

Other possible adverse reactions:
Very common (may occur in more than 1 in 10 patients):

• Sensation of throat irritation
• Swelling in the mouth and swelling of the lips
• Itching in the mouth and itching in the ears
• Respiratory tract infection

Common (may occur in up to 1 in 10 patients):

• Pricking or numbness sensation in the mouth and tongue
• Itchy eyes
• Itching of the tongue and lips
• Swelling of the tongue or throat
• Inflammation, discomfort, or burning in the mouth
• Redness or ulceration in the mouth
• Mouth pain
• Taste disturbances
• Stomach pain or abdominal discomfort
• Diarrhea
• Nausea and vomiting
• Pain when swallowing or difficulty swallowing
• Asthma symptoms
• Cough
• Shortness of breath
• Chest discomfort
• Indigestion and heartburn
• Hoarseness
• Feeling of fatigue
• Skin hives and itching

Not common (may occur in up to 1 in 100 patients):

• Eye inflammation
• Sensation of rapid, strong, or irregular heartbeat
• Ear discomfort
• Sensation of throat pressure
• Nasal discomfort, nasal congestion, runny nose, sneezing
• Formation of blisters in the mouth
• Esophageal irritation
• Sensation of a foreign body in the throat
• Dizziness
• General feeling of malaise
• Dry mouth
• Skin tingling sensation
• Redness of the throat
• Enlarged tonsils
• Lip pain
• Lip ulceration
• Enlarged salivary glands
• Increased saliva production
• Skin redness

Rare (may occur in up to 1 in 1000 patients):

• Sudden swelling of the face or skin
• Allergic esophagitis (eosinophilic esophagitis)

If bothersome adverse reactions occur, contact your doctor, who will determine whether antihistamines should be administered to alleviate the patient's symptoms.

Adverse reactions in children
Adverse reactions in children are expected to be similar to those observed in adults and adolescents.
Some possible adverse reactions that may occur more frequently in children include:
Very common (may occur in more than 1 in 10 patients): swelling of the tongue or throat, oral ulceration, mouth pain, taste disturbances, abdominal pain, diarrhea, nausea.
Common (may occur in up to 1 in 10 patients): eye inflammation.
Not common (may occur in more than 1 in 100 patients): sudden swelling of the face and skin, and allergic esophagitis (eosinophilic esophagitis).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: 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 helps provide more information on the safety of this medicine.

5. How to store ACARIZAX

Keep this medicine out of sight and reach of children.
Do not use ACARIZAX after the expiry date stated on the blister and carton after EXP. The expiry date refers to the last day of the stated month.
No special precautions for storage of the medicinal product.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What ACARIZAX contains
The active substance in ACARIZAX is a standardized house dust mite allergen extract from
Dermatophagoides pteronyssinus and Dermatophagoides farinae. The activity of one sublingual lyophilisate
is expressed in SQ-HDM units. The activity of one lyophilisate is 12 SQ-HDM.
Other ingredients: gelatine (from fish), mannitol, and sodium hydroxide (for pH adjustment).

What ACARIZAX looks like and contents of the pack
White or almost white, embossed sublingual lyophilisate, marked with an embossing on one side.
Supplied in aluminium/aluminium blisters in a cardboard carton. Each blister contains 10 sublingual lyophilisates.
Available pack sizes: 30 and 90 sublingual lyophilisates.
Not all pack sizes may be marketed.

Marketing Authorisation 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 medicinal product is authorised in the European Economic Area under the following names:
Austria, Czech Republic, Denmark, Finland, France, Germany, Norway, Poland, Sweden, and Slovakia:
ACARIZAX
Italy: ACCARIZAX