ACCARIZAX 12 SQ-HDM Liofilizat sublingwalny

Treść ulotki

1. ACCARIZAX 12 SQ-HDM lyophilized sublingual
   1. What is ACCARIZAX and what is it used for
   2. What you need to know before you take ACCARIZAX
   3. How to take ACCARIZAX
   4. Possible side effects
   5. How to store ACCARIZAX
   6. Contents of the pack and other information

ACCARIZAX 12 SQ-HDM lyophilized sublingual

For use in adults and children (5-65 years)
Standardized dust mite allergen extract
( Dermatophagoides pteronyssinusand Dermatophagoides farinae)

Read this leaflet carefully before taking this medicine as 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 others, even if they have the same symptoms as you, as it may be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is ACCARIZAX and what is it used for

ACCARIZAX contains an allergenic extract from house dust mites. It is available in the form of sublingual lyophilates, which are similar to tablets, but have a softer consistency and are absorbed by the body by placing them under the tongue.
ACCARIZAX is used for the treatment of allergic rhinitis (inflammation of the nasal mucosa) in adults and children (5-65 years) and allergic asthma associated with it, in adults (between 18 and 65 years), sensitized to house dust mites. ACCARIZAX works by increasing immunological tolerance to house dust mites (i.e. the ability of your body to cope with these allergens). Treatment may need to be taken for 8-14 weeks before an improvement is observed.
The doctor will assess your allergic symptoms and perform a skin test (skin prick test) and/or take a blood sample to decide if ACCARIZAX is a suitable treatment for you.
The first dose of ACCARIZAX must be taken under the supervision of the doctor. You must remain under the supervision of the doctor for at least half an hour after taking the first dose. This is a precaution to assess the sensitivity of each patient to the treatment. In this way, you will have the opportunity to discuss possible undesirable effects with the doctor.
ACCARIZAX must be prescribed by doctors with specific experience in the treatment of allergies.

2. What you need to know before you take ACCARIZAX

Do not take ACCARIZAX if:

• You are allergic to any of the excipients (other ingredients) of this medicine (listed in section 6).
• You have poor lung function (assessed by your doctor).
• You have had severe worsening asthma in the last three months (assessed by your doctor).
• You have asthma and a current respiratory tract infection, such as the common cold, sore throat or pneumonia, on the day you are due to take the first dose of ACCARIZAX. Your doctor will advise you to postpone the start of treatment until you feel better.
• You have a disease that affects the immune system, are taking medicines that suppress the immune system, or have cancer.
• You have recently had a tooth extracted, undergone other forms of oral surgery, or have mouth ulcers or mouth infections. Your doctor may recommend that you delay or discontinue treatment until your mouth has healed.

Warnings and precautions
Talk to your doctor or pharmacist before taking ACCARIZAX if:

• You are being treated for depression with tricyclic antidepressants, monoamine oxidase inhibitors (MAOIs) or for Parkinson's disease with COMT inhibitors.
• You have already had a severe allergic reaction to an injection of a dust mite allergen extract.
• You have an allergy to fish. ACCARIZAX may contain traces of fish protein. Available data have not indicated an increased risk of allergic reactions in patients who have a fish allergy.
• You experience severe allergic symptoms, such as difficulty swallowing or breathing, changes in voice, hypotension (low blood pressure) or a feeling of a lump in your throat. Stop treatment and contact your doctor immediately.
• Your asthma symptoms worsen significantly compared to normal. Stop treatment and contact your doctor immediately.

If you have asthma you should continue to use your usual asthma medicines when you start the
treatment with ACCARIZAX. Your doctor will tell you how to gradually reduce your asthma therapy over
time.
If you experience severe or persistent heartburn or difficulty swallowing, you should stop taking
ACCARIZAX and contact your doctor, as these symptoms may be signs of allergic inflammation of the
esophagus.
Local allergic reactions from mild to moderate may occur during treatment.
However, if they are severe, consult your doctor to see if the use of allergy medications
such as antihistamines is necessary.
This medicine contains less than 1 mmol of sodium (23 mg) per dose, that is to say essentially "sodium-free".

Children
Allergic rhinitis (inflammation of the inner lining of the nose):
ACCARIZAX is not indicated for the treatment of children under 5 years of age.
Allergic asthma
ACCARIZAX is not indicated for the treatment of allergic asthma in children under 18 years of age.

Other medicines and ACCARIZAX
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines, including those available without a prescription. If you are taking other medicines for allergy symptoms, such as antihistamines, asthma medications or steroids, tell your
doctor so that they are aware of their use during treatment with ACCARIZAX. If you stop
taking medicines for allergy symptoms, more side effects may occur with
taking ACCARIZAX.

ACCARIZAX with food, drinks and alcohol
You should not eat or drink for 5 minutes after taking this medicine.

Pregnancy, breastfeeding and fertility
Currently, there is no experience with the use of ACCARIZAX during pregnancy. Treatment with
ACCARIZAX should not be started during pregnancy. If you become pregnant during treatment, talk
to your doctor to assess whether it is appropriate for you to continue therapy.
Currently, there is no experience with the use of ACCARIZAX during breastfeeding. However,
no effects on breastfed infants are expected. Talk to your doctor to find out if you can continue to take
ACCARIZAX while breastfeeding your baby.

Driving and using machines
Treatment with ACCARIZAX has no effect or little effect on the ability to drive vehicles and operate
machinery. However, only you can judge whether you experience side effects; therefore you should read all
and talk to your doctor or pharmacist if you are not sure.

3. How to take ACCARIZAX

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your
doctor or pharmacist.
The recommended dose is one lyophilisate tablet a day. Your doctor will tell you for how long
you will need to take ACCARIZAX.
Before handling the medicine, your hands must be dry.
Take the medicine as follows:

• 1. Tear off the strip marked with triangles at the end of the packaging.

• 2. Tear off a square from the packaging along the perforated lines.
• 3. Do not force the medicine out through the foil. This may damage it causing it to break. Instead, fold back the marked corner of the foil and then tear it off.

• 4. Carefully remove the medicine and take it immediately.

• 5. Place the medicine under the tongue and keep it until it has dissolved. Do not swallow during the first minute. Do not take food or drinks for at least 5 minutes.

If you take more ACCARIZAX than you should
If you have taken too many doses of lyophilisate, you may experience allergic symptoms, including local symptoms
in the mouth and throat. If the symptoms are severe, contact your doctor or
hospital immediately.

If you forget to take ACCARIZAX
If you have forgotten to take the scheduled dose, take it later during the day. Do not
take a double dose to make up for a forgotten dose.
If you have not taken ACCARIZAX for more than 7 days, contact your doctor before taking
ACCARIZAX again.

If you stop taking ACCARIZAX
If you do not follow the instructions you have been given exactly, the treatment may not
be effective. If you have any doubts about 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 everyone will experience them.
Side effects may be an allergic reaction to the allergen you are being treated with. Most side effects last from a few minutes to a few hours after taking the medicine.
Generally, most side effects tend to disappear within 1-3 months of starting
treatment.
Very serious side effects:
Uncommon (may affect up to 1 in 100 people):

• Severe allergic reaction

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

• Worsening of pre-existing asthma
• Rapid swelling of the face, mouth, throat or skin
• Difficulty swallowing
• Difficulty breathing
• Change in voice tone
• Low blood pressure
• Feeling of fullness in the throat (as if swollen)
• Hives and itchy skin.

Other possible side effects:
Very common (may affect more than 1 in 10 people):

• Sensation of irritation in the throat
• Swelling of the mouth and lips
• Itching of the mouth and ears
• Upper airway infection.

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

• Sensation of tingling or numbness in the mouth or tongue
• Itchy eyes
• Itching of the tongue and lips
• Swelling of the tongue or throat
• Inflammation, discomfort or burning sensation in the mouth
• Redness in the mouth or mouth ulcers
• Mouth pain
• Altered taste
• Stomach pain or discomfort
• Diarrhea
• Feeling unwell (nausea) and vomiting
• Pain when swallowing or difficulty swallowing
• Asthma symptoms
• Cough
• Shortness of breath
• Chest discomfort
• Indigestion and heartburn
• Hoarseness
• Fatigue
• Hives and itchy skin.

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

• Eye inflammation
• Sensation of a fast or irregular heartbeat
• Ear discomfort
• Constriction of the throat
• Nasal discomfort, stuffy or runny nose, sneezing
• Blisters in the mouth
• Irritation of the esophagus
• Sensation of a foreign body in the throat that cannot be removed
• Dizziness
• General feeling of discomfort
• Dry mouth
• Skin tingling
• Redness of the throat
• Swollen tonsils
• Lip pain
• Lip ulcers
• Enlargement of the salivary glands
• Increased saliva production
• Skin redness.

Rare (may affect up to 1 in 1,000):

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

If side effects are worrying or cause difficulty, you should contact your doctor who will assess whether to give you medicines such as antihistamines to help relieve the side effects you are experiencing.

Side Effects in Children
Side effects in children are expected to be similar to those seen in adults and
adolescents.
Some possible side 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 ulcer, mouth pain, altered taste, stomach pain, diarrhea, feeling unwell (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 get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national
reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse. Reporting side effects can help provide more information on the safety of this medicine.

5. How to store ACCARIZAX

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and the packaging after the words
EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What ACCARIZAX contains
The active ingredient is a standardized allergenic extract from house dust mites, Dermatophagoides

pteronyssinusand Dermatophagoides farinae. The activity for one dose of sublingual lyophilized product is expressed in
SQ-HDM units. The activity for one dose of sublingual lyophilized product is 12 SQ-HDM.
The other excipients are: gelatin (obtained from fish), mannitol and sodium hydroxide (for pH adjustment).

Description of the appearance of ACCARIZAX and contents of the pack
Sublingual lyophilized product in round white or almost white tablets with an image imprinted on one side.
Aluminum blisters with a removable aluminum foil inserted in a cardboard box. Each blister contains
10 sublingual lyophilized products.
Available pack sizes are 10, 30 or 90 sublingual lyophilized products.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
ALK-Abelló A/S
Bøge Allé 6-8
DK-2970 Hørsholm
Denmark

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

Distributor for sales
ALK-Abelló S.p.A.
Via Nino Bixio 31
20129 Milano
Italy

This medicinal product is authorised 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