ACARIZAX 12 SQ-HDM SUBLINGUAL LYOPHILIZED

Introduction

Package Leaflet: Information for the User

ACARIZAX 12 SQ-HDM Sublingual Lyophilisate

For use in adults and children (5-65 years of age)

Standardized allergen extract of house dust mites

(Dermatophagoides pteronyssinusand Dermatophagoides farinae)

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 or pharmacist.

• 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is ACARIZAX and what is it used for

ACARIZAX contains an allergen extract of house dust mites. It comes in a form known as sublingual lyophilisate, which is similar to a tablet, but much softer and is absorbed into the body by placing it under the tongue.

ACARIZAX is used to treat allergic rhinitis (inflammation of the nasal membranes) in adults and children (5-65 years of age) and associated allergic asthma caused by house dust mites in adults (18-65 years of age). ACARIZAX works by increasing immunological tolerance (the ability of your body to act) to house dust mites. You may need to take the treatment for 8 to 14 weeks before you notice any improvement.

Your doctor will check your allergic symptoms and perform a skin prick test and/or take a blood sample to determine if ACARIZAX is the right treatment for you.

The first dose of ACARIZAX should be taken under medical supervision. You should remain under observation for at least half an hour after taking the first dose. This is a precaution to observe your sensitivity to this medicine. It will also give you the opportunity to inform your doctor of any possible side effects you are experiencing.

ACARIZAX is prescribed by doctors specializing in the treatment of allergies.

2. What you need to know before you start taking ACARIZAX

Do not take ACARIZAX:

• if you are allergic to any of the excipients (other components) of this medicine (listed in section 6).
• if your lung function is poor (diagnosed by your doctor).
• if you have had a severe worsening of your asthma in the last three months (diagnosed by your doctor).
• if on the day you are due to take the first dose of ACARIZAX you have asthma and an ongoing respiratory tract infection, such as a common cold, throat irritation, or pneumonia. Your doctor will delay the start of your treatment until you improve.
• if you have a disease that affects your immune system; you are taking medicines that suppress the immune system or you have cancer.

• if you have recently had a tooth extraction, or any other intervention in the mouth, or have ulcers or infections in the mouth. Your doctor may recommend delaying the start of treatment or interrupting treatment until your mouth has healed.

Warnings and precautions

Tell your doctor before you start taking ACARIZAX:

• if you are being treated for depression with tricyclic antidepressants, monoamine oxidase inhibitors (MAOIs), or with COMT inhibitors for Parkinson's disease.
• if you have previously had a severe allergic reaction to an injection of a house dust mite allergen extract.
• if you are allergic to fish. ACARIZAX may contain traces of fish proteins. Available data do not indicate that there is a greater risk of an allergic reaction in patients allergic to fish.
• if you experience severe allergic symptoms, such as difficulty swallowing or breathing, changes in voice, low blood pressure, or a feeling of having a lump in the throat. Stop treatment and contact your doctor immediately.
• if your asthma symptoms worsen more than usual. Stop treatment and contact your doctor immediately.

If you have asthma, you should continue using your usual asthma medication while starting treatment with ACARIZAX. Your doctor will tell you how to gradually reduce your asthma medication over time.

You should stop taking ACARIZAX and contact your doctor if you experience severe stomach burning or persistent difficulty swallowing, as these symptoms may be signs of an allergic inflammation of the esophagus.

You may expect to experience some local allergic reaction, from mild to moderate, during your treatment. However, if it is severe, talk to your doctor in case you need to take some anti-allergic medication, such as an antihistamine.

This medicine contains less than 1 mmol of sodium (23mg) per dose, i.e., it is essentially "sodium-free".

Children

Allergic rhinitis (inflammation of the nasal membranes):

ACARIZAX is not intended for use in children under 5 years of age.

Allergic asthma:

ACARIZAX is not intended for the treatment of allergic asthma in children under 18 years of age.

Taking ACARIZAX with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those that can be obtained without a prescription. If you are taking other medicines for your allergic symptoms such as antihistamines, asthma relief medications, or steroids, tell your doctor so that they can advise you on their use while being treated with ACARIZAX. If you stop taking these medicines for your allergic symptoms, you may experience more side effects from ACARIZAX.

Taking ACARIZAX with food and drinks

Do not eat or drink for 5 minutes after taking this medicine.

Pregnancy and breastfeeding

There is currently no experience with the use of ACARIZAX during pregnancy. Treatment with ACARIZAX should not be initiated during pregnancy. If you become pregnant during treatment, consult your doctor to determine if it is appropriate for you to continue with it.

There is currently no experience with the use of ACARIZAX during breastfeeding. However, no effects on the breastfed infant are expected. Consult your doctor if you can continue taking ACARIZAX during breastfeeding.

Driving and using machines

The influence of treatment with ACARIZAX on the ability to drive or use machines is negligible.

However, only you can judge whether your abilities are affected. Therefore, read all the information contained in this leaflet, especially section 4 "Possible side effects", and if in doubt, consult your doctor or pharmacist.

3. How to take ACARIZAX

Follow exactly the administration instructions of this medicine given by your doctor. In case of doubt, consult your doctor or pharmacist again.

The usual dose is one lyophilisate per day. Your doctor will tell you how long you should take ACARIZAX.

Make sure your hands are dry before touching this medicine. Take the medicine as follows:

1. Detach the strip marked with triangles at the top of the package.

1. Separate one unit from the package following the perforated lines.

1. Do not press the medicine to push it through the aluminum. It could be damaged, as it breaks easily. Instead, fold the marked corner of the aluminum sheet and pull it.

1. Carefully remove the medicine from the unit and take it immediately.

1. Place the medicine under your tongue. Let it dissolve there for a few seconds. Do not swallow during the first minute. Wait at least 5 minutes before eating or drinking.

If you take more ACARIZAX than you should

If you have taken too many lyophilisates, you may experience allergic symptoms, including local symptoms in the mouth and throat. If you experience severe symptoms, contact your doctor or hospital immediately.

If you forget to take ACARIZAX

If you forget to take a dose, take it later in the day. Do not take a double dose to make up for forgotten doses.

If you forget to take ACARIZAX for more than 7 days, you should contact your doctor before taking ACARIZAX again.

If you stop taking ACARIZAX

If you do not take this medicine as prescribed, you may not benefit from all the effects of the treatment.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Side effects can be an allergic reaction to the allergen being treated. Most side effects last from minutes to hours after taking the medicine and will disappear when you have been taking the treatment for 1-3 months.

The most serious side effects:

Uncommon (may affect up to 1 in 100 people):

• Severe allergic reaction

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

• Worsening of existing asthma
• Rapid swelling of the face, mouth, or throat
• Difficulty swallowing
• Difficulty breathing
• Changes in voice
• Low blood pressure
• Feeling of fullness in the throat (like swelling)
• Hives and skin itching

Other possible side effects:

Very common (may affect more than 1 in 10 people):

• Irritation sensation in the throat
• Swelling in the mouth and lips
• Itching in the mouth and ears
• Respiratory tract infection

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

• Sensation of tingling or numbness in the mouth or tongue
• Itching in the eyes
• Itching in the tongue or lips
• Swelling in the tongue or throat
• Inflammation, discomfort, or burning sensation in the mouth
• Redness in the mouth or mouth ulcers
• Mouth pain
• Taste alteration
• Stomach pain or discomfort
• Diarrhea
• Nausea and vomiting
• Difficulty or pain when swallowing
• Asthma symptoms
• Cough
• Shortness of breath
• Chest pain
• Indigestion and heartburn
• Hoarseness
• Fatigue
• Hives and skin itching

Uncommon (may affect up to 1 in 100 people):

• Eye inflammation
• Sensation of rapid and strong or irregular heartbeats
• Ear discomfort

Throat tightness

• Nasal discomfort, congestion, or runny nose, sneezing
• Mouth ulcers
• Esophageal irritation
• Feeling of a foreign body in the throat
• Dizziness
• General discomfort
• Dry mouth
• Sensation of tingling on the skin
• Throat redness
• Tonsil enlargement
• Lip pain
• Lip ulcer
• Salivary gland enlargement
• Increased saliva production
• Skin redness

Rare (may affect up to 1 in 1000 people):

• Rapid swelling of the face or skin
• Allergic inflammation of the esophagus (eosinophilic esophagitis)

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Side effects in children

Side effects in children are expected to be similar to side effects in adults and adolescents.

The side effects that can be expected to occur more frequently in children are:

Very common (may affect more than 1 in 10 people): swelling in the tongue or throat, mouth ulcers, mouth pain, taste alteration, stomach pain, diarrhea, nausea.

Common (may affect up to 1 in 10 people): eye inflammation

Uncommon (may affect up to 1 in 100 people): rapid swelling of the face and skin and allergic inflammation of the esophagus (eosinophilic esophagitis).

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of ACARIZAX

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

Do not use ACARIZAX after the expiry date which is stated on the blister and on the package after EXP. The expiry date is the last day of the month shown.

This medicine does not require any special storage conditions.

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

Composition of ACARIZAX

• The active substance is a standardized allergen extract of house dust mites, Dermatophagoides pteronyssinusand Dermatophagoides farinae. The activity per sublingual lyophilisate is expressed in SQ-HDM units. The activity of one sublingual lyophilisate is 12 SQ-HDM.

• The other components are gelatin (from fish), mannitol, and sodium hydroxide (for pH adjustment).

Appearance of the product and pack contents

Sublingual lyophilisate, round, white or off-white, with an engraving on one side.

Aluminum blisters, with one foldable sheet, packaged in a cardboard box. Each blister contains 10 sublingual lyophilisates.

Pack sizes: 10, 30, and 90 sublingual lyophilisates.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

ALK-Abelló A/S

Bøge Allé 6-8

DK-2970 Hørsholm

Denmark.

Manufacturer

ALK-Abelló. S.A.

C/ Miguel Fleta, 19

28037 – Madrid

Spain

You can obtain further information on this medicine by contacting the local representative of the marketing authorization holder: