Acarizax 12 SQ-HDM sublingual lyophilisate

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

ACARIZAX 12 SQ-HDM lyophilisate for sublingual use

For use in adults and children (aged 5–65 years)

Standardised house dust mite allergen extract

(Dermatophagoides pteronyssinus and 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 questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only. Do not pass it on to other people, even if they have the same symptoms as you, because it may harm them.

• If you experience any adverse reactions, consult your doctor or pharmacist, including any adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

1. What ACARIZAX is and what it is used for
2. What you need to know 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. It is presented in a form known as a sublingual lyophilisate, which resembles a tablet but is much softer and is absorbed into the body when placed under the tongue.

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

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

The first dose of ACARIZAX must be taken under medical supervision. You must remain under observation for at least half an hour after taking the first dose. This is a precautionary measure to monitor your sensitivity to this medicine. It also gives you the opportunity to report any possible adverse effects to your doctor.

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

2. What you need to know before starting ACARIZAX

Do not take ACARIZAX:

• if you are allergic to any of the excipients (other components) of this medicine (listed in section 6).

• if you have poor lung function (diagnosed by your doctor).

• if you have experienced a severe worsening of your asthma during the last three months (diagnosed by your doctor).

• if on the day you are due to take your first dose of ACARIZAX you have asthma and an ongoing respiratory tract infection, such as the common cold, sore throat, or pneumonia. Your doctor will delay the start of your treatment until you have recovered.

• if you have a disease affecting your immune system; are taking medicines that suppress the immune system; or have cancer.

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

Warnings and precautions

Talk to your doctor before starting ACARIZAX:

• if you are being treated for depression with tricyclic antidepressants, monoamine oxidase inhibitors (MAOIs), or COMT inhibitors for Parkinson’s disease.
• if you have previously experienced 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 an increased risk of allergic reaction in patients allergic to fish.
• if you experience severe allergic symptoms such as difficulty swallowing or breathing, changes in voice, hypotension (low blood pressure), or a sensation of throat tightness. 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 must continue using your usual asthma medication while starting treatment with ACARIZAX. Your doctor will advise you on how to gradually reduce your asthma medication over time.

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

You may expect to experience mild to moderate local allergic reactions during your treatment. However, if the reaction is severe, speak with your doctor, as you may need to take antiallergic medication such as an antihistamine.

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

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those available without a prescription. If you are taking other medications for your allergic symptoms, such as antihistamines, asthma relief medications, or steroids, tell your doctor so they can advise you on their use during ACARIZAX treatment. If you stop taking these medications for your allergic symptoms, you may experience more adverse 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 regarding 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 whether it is appropriate for you to continue.

There is currently no experience regarding the use of ACARIZAX during breastfeeding. However, effects on the breastfed infant are not expected. Consult your doctor to determine whether you may continue taking ACARIZAX during breastfeeding.

Driving and using machines

The influence of ACARIZAX treatment on the ability to drive or operate machinery is negligible or none.

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 instructions for use of this medicine provided by your doctor. If you are unsure, consult your doctor or pharmacist again.

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

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

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

1. Separate one unit from the pack along the perforated lines.

1. Do not push the medicine through the aluminum foil. This could damage it, as it breaks easily. Instead, fold back the marked corner of the aluminum foil and pull it open.

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 on the same day. Do not take a double dose to make up for forgotten doses.

If you have forgotten to take ACARIZAX for more than 7 days, you must contact your doctor before resuming treatment with ACARIZAX.

If you stop taking ACARIZAX

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

The adverse effects may represent an allergic reaction to the allergen being treated. Most adverse effects last from minutes to hours after taking the medicine, and most will resolve after 1 to 3 months of treatment.

The most serious adverse 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
• Sensation of throat fullness (as if swollen)
• Hives and skin itching

Other possible adverse effects:

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

• Sensation of irritation 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):

• Tingling or numbness sensation in the mouth or tongue
• Itching of the eyes
• Itching of the tongue or lips
• Swelling of the tongue or throat
• Inflammation, discomfort, or burning sensation in the mouth
• Redness in the mouth or mouth ulcers
• Mouth pain
• Taste disturbance
• Stomach pain or discomfort
• Diarrhea
• Malaise (nausea) and vomiting
• Pain or difficulty 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, strong, or irregular heartbeats
• Ear discomfort
• Throat tightness
• Nasal discomfort, congestion, runny nose, sneezing
• Blisters in the mouth
• Irritation in the esophagus
• Sensation of a foreign body in the throat
• Dizziness
• General malaise
• Dry mouth
• Tingling sensation in the skin
• Redness of the throat
• Enlargement of the tonsils
• Lip pain
• Ulcer on the lip
• Enlargement of the salivary gland
• Increased saliva production
• Skin redness
• Rash

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 adverse effects concern you or are causing difficulties, you should contact your doctor, who will decide whether you need to take any medication, such as antihistamines, to help relieve the adverse effects you are experiencing.

Adverse effects in children

Adverse effects in children are expected to be similar to those in adults and adolescents.

The adverse effects that may occur more frequently in children are:

Very common (may affect more than 1 in 10 people): swelling of the tongue or throat, mouth ulcers, mouth pain, taste disturbance, stomach pain, diarrhea, malaise (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 adverse effects

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse 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 stated on the blister and outer packaging following EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of ACARIZAX

• The active substance is a standardized allergen extract from house dust mites, Dermatophagoides pteronyssinus and 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 (derived from fish), mannitol, and sodium hydroxide (for pH adjustment).

Appearance of the product and contents of the pack

Round sublingual lyophilisate, white or almost white in colour, with an imprint on one side.

Aluminium blisters, with one peelable laminate, packaged in a cardboard box. Each blister contains 10 sublingual lyophilisates.

Available 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

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder: