Accarizax
ItalyTable of Contents
Package leaflet: Information for the user
ACCARIZAX 12 SQ-HDM sublingual lyophilisate
For use in adults and children (5-65 years)
Standardized allergen extract of house dust mites
( Dermatophagoides pteronyssinus and Dermatophagoides farinae )
Please read all of this leaflet carefully before 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 give it to other people, even if they have the same symptoms as you, because it may be harmful.
- If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contents of this leaflet:
- What ACCARIZAX is and what it is used for
- What you need to know before taking ACCARIZAX
- How to take ACCARIZAX
- Possible side effects
- How to store ACCARIZAX
- Contents of the pack and other information
1. What ACCARIZAX is and what it is used for
ACCARIZAX contains a house dust mite allergen extract. It is available as sublingual lyophilisates, which are similar to tablets but have a softer consistency and are absorbed 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 of age) and for coexisting allergic asthma in adults (18–65 years of age) who are sensitized to house dust mites. ACCARIZAX works by increasing immunological tolerance to house dust mites (i.e., your body's ability to cope with these allergens). Improvement may not be observed until after 8–14 weeks of treatment.
Your doctor will assess your allergic symptoms and perform a skin prick test and/or take a blood sample to determine whether ACCARIZAX is an appropriate treatment for you.
The first dose of ACCARIZAX must be taken under medical supervision. You must remain under medical supervision for at least 30 minutes after taking the first dose. This precaution is intended to evaluate each patient's sensitivity to the treatment and allows you to discuss possible adverse effects with your doctor.
ACCARIZAX must be prescribed by physicians with specific experience in the treatment of allergies.
2. What you need to know before taking 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 (as assessed by your doctor).
- You have had worsening severe asthma in the past three months (as assessed by your doctor).
- You have asthma and an active respiratory tract infection, such as the common cold, sore throat, or pneumonia, on the day you are due to take your first dose of ACCARIZAX. Your doctor will advise you to postpone starting treatment until you feel better.
- You have a disease affecting 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 delaying the start of treatment or interrupting it 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 previously experienced a severe allergic reaction to an injection of a dust mite allergen extract.
- You are allergic to fish. ACCARIZAX may contain traces of fish protein. Available data have not indicated an increased risk of allergic reactions in patients with fish allergy.
- You experience severe allergic symptoms such as difficulty swallowing or breathing, voice changes, hypotension (low blood pressure), or a sensation of throat tightness. 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 must continue using your usual asthma medications when starting treatment with ACCARIZAX. Your doctor will advise you on how to gradually reduce your asthma therapy over time.
If you develop severe or persistent heartburn or difficulty swallowing, stop taking ACCARIZAX and contact your doctor, as these symptoms may indicate allergic inflammation of the esophagus.
Mild to moderate local allergic reactions may occur during treatment. However, if they are severe, consult your doctor to determine whether anti-allergic medications such as antihistamines are needed.
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 mucosa):
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 patients under 18 years of age.
Other medicines and ACCARIZAX
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription. If you are taking other medications for allergy symptoms, such as antihistamines, asthma medications, or steroids, inform your doctor so they are aware of their use during treatment with ACCARIZAX. If you stop taking medications for allergy symptoms, you may experience more side effects when taking ACCARIZAX.
ACCARIZAX with food, drinks, and alcohol
Do not consume food or drinks 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 initiated during pregnancy. If you become pregnant during treatment, speak with your doctor to evaluate whether it is appropriate for you to continue therapy.
Currently, there is no experience with the use of ACCARIZAX during breastfeeding. However, effects on breastfed infants are not expected. Talk to your doctor to determine whether you can continue taking ACCARIZAX while breastfeeding.
Driving and using machines
Treatment with ACCARIZAX has no effect or negligible effect on the ability to drive vehicles or operate machinery. However, only you can judge whether you are experiencing side effects; therefore, it is essential to read all the information in this leaflet, particularly section 4 "Possible side effects," and speak with your doctor or pharmacist if you are unsure.
3. How to take ACCARIZAX
Take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is one lyophilisate tablet per day. Your doctor will inform you for how long you should take ACCARIZAX.
Before handling the medicine, make sure your hands are dry.
Take the medicine as described below:
- Tear the strip marked with triangles at the end of the packaging.
- Tear off one square from the packaging along the perforated lines.
- Do not force the medicine out through the film. This may damage it and cause breakage. Instead, fold back the corner of the film marked with the triangle and then tear it off.
- Carefully remove the medicine and take it immediately.
- Place the medicine under the tongue and keep it there until it dissolves completely. Do not swallow during the first minute. Do not eat or drink for at least 5 minutes.
If you take more ACCARIZAX than you should
If you have taken too many doses of the lyophilisate, you may experience allergic symptoms, including local symptoms in the mouth and throat. If symptoms are severe, contact your doctor or go to hospital immediately.
If you forget to take ACCARIZAX
If you have forgotten to take your scheduled dose, take it later during the day. Do not take a double dose to make up for the missed dose.
If you have not taken ACCARIZAX for more than 7 days, you must contact your doctor before taking it again.
If you stop treatment with ACCARIZAX
If you do not follow exactly the instructions prescribed for you, the treatment may not be effective. If you have any doubts about using this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Side effects may be an allergic response to the allergen you are being treated with. Most side effects last from a few minutes to several hours after taking the medicine.
Generally, most side effects tend to disappear within 1–3 months from the start of 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
- Sensation of tightness or fullness in the throat (as if swelling)
- Skin hives and itching.
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
- Airway infection.
Common (may affect up to 1 in 10 people):
- Tingling or numbness sensation 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 ache or stomach 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
- Tiredness
- Skin hives and itching.
Uncommon (may affect up to 1 in 100 people):
- Eye inflammation
- Sensation of rapid or irregular heartbeat
- Ear discomfort
- Throat tightness
- Nasal discomfort, stuffy or runny nose, sneezing
- Blisters in the mouth
- Irritation of the esophagus
- Sensation of an immovable foreign body in the throat
- Dizziness
- General malaise
- Dry mouth
- Skin tingling
- Redness of the throat
- Enlarged tonsils
- Lip pain
- Lip ulcers
- Enlargement of the salivary glands
- Increased saliva production
- Skin redness.
Rare (may affect up to 1 in 1,000 people):
- Rapid swelling of the face or skin
- Allergic inflammation of the esophagus (eosinophilic esophagitis)
If side effects are concerning or cause difficulties, you should contact your doctor, who will assess whether you should take medications 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 observed 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 children): swelling of the tongue or throat, mouth ulcer, mouth pain, altered taste, stomach ache, diarrhea, feeling unwell (nausea).
Common (may affect up to 1 in 10 children): eye inflammation.
Uncommon (may affect up to 1 in 100 children): rapid swelling of the face and skin, and allergic inflammation of the esophagus (eosinophilic esophagitis).
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you 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 stated on the blister and carton after the word
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 via wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.
6. Package contents and other information
What ACCARIZAX contains
The active substance is a standardized allergen extract from house dust mites, Dermatophagoides pteronyssinus and Dermatophagoides farinae. The activity per sublingual lyophilisate dose is expressed in SQ-HDM units. The activity per sublingual lyophilisate dose is 12 SQ-HDM.
The other excipients are: gelatin (derived from fish), mannitol, and sodium hydroxide (for pH adjustment).
Description of the appearance of ACCARIZAX and package contents
Sublingual lyophilisate in white or almost white, round tablets with an imprint on one side.
Aluminum blister with a removable aluminum foil, packed in a cardboard box. Each blister contains 10 sublingual lyophilisates.
Available pack sizes contain 10, 30 or 90 sublingual lyophilisates.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
ALK-Abelló A/S
Bøge Allé 6-8
DK-2970 Hørsholm
Denmark
Manufacturer
ALK-Abelló S.A.
Miguel Fleta 19
28037 Madrid
Spain
Sales Licensee
ALK-Abelló S.p.A.
Via Nino Bixio 31
20129 Milan
Italy
This medicinal product is authorized in the European Economic Area Member States under the following names:
Austria, Czech Republic, Denmark, Finland, France, Germany, Norway, Poland, Sweden and Slovakia: ACARIZAX
Italy: ACCARIZAX