Prospect: information for the user

ACARIZAX 12 SQ-HDM lyophilized sublingual

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

Standardized allergenic extract of house dust mites

(Dermatophagoides pteronyssinusandDermatophagoides farinae)

Read this prospect carefully before starting to take this medication, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.

-This medication has been prescribed only to you, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.

-If you experience any adverse effects, consult your doctor or pharmacist,even if they are not listed in this prospect. See section 4.

1. What isACARIZAXand what it is used for

2. What you need to know before starting to takeACARIZAX

3. How to takeACARIZAX.

4.Possible adverse effects

5. Storage ofACARIZAX

6. Contents of the package and additional information

ACARIZAX contains an allergenic extract of house dust mites. It is presented in a form known as sublingual lyophilisate, which is similar to a tablet, but much softer and is absorbed by the body when placed 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 acts by increasing immunological tolerance (the body's ability to act) to house dust mites. It may be necessary to take the treatment for 8 to 14 weeks to notice any improvement.

The doctor will check your allergic symptoms and perform a prick test and/or take a blood sample to determine if ACARIZAX is the appropriate 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 be taken to observe your sensitivity to this medication. It will also give you the opportunity to inform your doctor of any possible adverse effects you may be experiencing.

ACARIZAX is prescribed by specialist doctors in the treatment of allergy.

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 over the last three months (diagnosed by your doctor).
• if you have asthma and an ongoing respiratory tract infection, such as a common cold, sore throat, or pneumonia, on the day you are due to take the first dose of ACARIZAX. Your doctor will delay the start of your treatment until you improve.
• if you have a disease that affects your immune system; are taking medicines that suppress your immune system or have cancer.

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

Warnings and precautions

Consult your doctor before starting to take 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 have an allergy to fish. ACARIZAX may contain traces of fish proteins. Available data do not indicate a higher risk of allergic reaction in patients allergic to fish.
• if you have severe allergic symptoms, such as difficulty swallowing or breathing, voice changes, low blood pressure, or a sensation of having a lump in your throat. Discontinue treatment and contact your doctor immediately.
• if your asthma symptoms worsen more than usual. Discontinue 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 instruct you on how to gradually reduce your asthma medication over time.

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

You may experience some local allergic reactions, ranging from mild to moderate, during treatment. However, if it is severe, talk to your doctor about taking some antiallergic medication, such as an antihistamine.

This medicine contains less than 1 mmol of sodium (23mg) per dose, which 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.

ACARIZAX with other medicines

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

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. Do not start treatment with ACARIZAX during pregnancy. If you become pregnant during treatment, consult your doctor about whether it is appropriate for you to continue with it.

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

Driving and operating machinery

The influence of ACARIZAX treatment on the ability to drive or operate machinery is negligible or insignificant.

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

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

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

Make sure your hands are dry before touching this medication. Take the medication in the following way:

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

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

3. Do not press the medication to pull it out through the aluminum. It may be damaged, as it breaks easily. Instead, fold the corner marked on the aluminum sheet and pull it.

4. Carefully remove the medication from the unit and take it immediately.

5. Place the medication under the 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 the missed doses.

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

If you interrupt treatment with ACARIZAX

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

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Side effects can be an allergic reaction to the allergen being treated. Most side effects last between minutes and hours after taking the medicine, and most will resolve within 1-3 months of treatment.

Most serious side effects:

Rare (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
• Quick swelling of the face, mouth, or throat
• Difficulty swallowing
• Difficulty breathing
• Changes in voice
• Low blood pressure
• Sensation 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):

• Sensation of throat irritation
• 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 sensation of burning in the mouth
• Redness in the mouth or ulcers in the mouth
• Mouth pain
• Alteration of taste
• Stomach pain or discomfort
• Diarrhea
• Uncomfort (nausea) and vomiting
• Difficulty swallowing
• Asthma symptoms
• Cough
• Lack of air
• Chest pain
• Indigestion and heartburn
• Snoring
• Tiredness
• Hives and skin itching

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

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

Throat constriction

• Nasal congestion or runny nose, sneezing
• Blistering in the mouth
• Esophageal irritation
• Sensation of foreign body in the throat
• Dizziness
• General discomfort
• Dry mouth
• Sensation of tingling in the skin
• Throat redness
• Enlargement of the tonsils
• Lip pain
• Ulcer on the lip
• Salivary gland enlargement
• Increased saliva production
• Redness of the skin

Very rare (may affect up to 1 in 1000 people):

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

If any of the side effects concern you or are causing you difficulties, you should contact your doctor, who will decide if you need to take any medication, such as antihistamines, to help alleviate the side effects you are experiencing.

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, ulcers in the mouth, mouth pain, alteration of taste, stomach pain, diarrhea, discomfort (nausea).

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

Rare (may affect up to 1 in 100 people): quick swelling of the face and skin and allergic esophagitis (eosinophilic esophagitis).

Reporting side effects

If you experienceany type of side effect, consult your doctor or pharmacist, even if it is apossibleside effect that does not appear in this prospectus.You can also report them directlythrough the Spanish System for the Pharmacovigilance of Medicines for Human Usewww.notificaRAM.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use ACARIZAX after the expiration date that appears on the blister pack and on the outer packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of ACARIZAX

• The active principle is a standardized allergenic extract of domestic dust mites,Dermatophagoides pteronyssinusandDermatophagoides farinae. The sublingual lyophilized activity is expressed in SQ-HDM units. The activity of a sublingual lyophilizate is 12 SQ-HDM.

• The othercomponents are gelatin (from fish), mannitol andsodium hydroxide (for pH adjustment).

Appearance of the product and contents of the packaging

Sublingual lyophilizate, round, white or off-white in color, with an engraving on one of the faces.

Aluminum blisters, with one of the sheets foldable, packaged in a cardboard box. Each blister contains 10 sublingual lyophilizates.

Packaging sizes available: 10, 30, and 90 sublingual lyophilizates.

Not all packaging sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

ALK-Abelló A/S

Bøge Allé 6-8

DK-2970 Hørsholm

Denmark.

Responsible manufacturer

ALK-Abelló.S.A.

C/ Miguel Fleta, 19

28037 – Madrid

Spain

For further information about this medicinal product, please contact the local representative of the marketing authorization holder: