12 SQ-HDM lyophilised tablet 
Standardized allergenic extract from house dust mites (Dermatophagoides pteronyssinus and Dermatophagoides farinae)

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

– Save this information, 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 give it to others. It can harm them, even if they show signs of illness similar to yours.

– If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this 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 ingredients information 

1. What Acarizax is and what it is used for

Acarizax contains allergenic extracts from house dust mites. The drug is in the form of lyophilized tablets, which are like regular tablets but much softer. The tablets are absorbed into the body by placing them under the tongue.

Acarizax is used to treat allergic rhinitis ( inflammation of the nasal mucosa ) in adults and adolescents (12-65 years) and allergic asthma caused by house dust mites in adults (18-65 years). Acarizax increases the immune system’s tolerance to (your body’s ability to handle) house dust mites. It may take 8 to 14 weeks before you notice any improvement in treatment.

Your doctor will investigate your allergic symptoms and perform a skin prick test and/or a blood test to determine if you should be treated with Acarizax.

The first dose of Acarizax should be taken at the doctor’s office. You should stay at the reception for at least half an hour after the first tablet. It is a precautionary measure to assess your sensitivity to treatment. It also gives you the opportunity to discuss any side effects with your doctor.

Acarizax is prescribed by a doctor who has experience in the treatment of allergic diseases.

2. What you need to know before you take Acarizax

Do not take Acarizax:

  • if you are allergic to any of the other ingredients of this medicine (listed in section 6).
  • if you have poor lung function (according to a doctor’s assessment).
  • if you have had severe asthma worsening within the last three months (according to a doctor’s assessment).
  • If you have asthma and an ongoing respiratory infection, such as a common cold, sore throat, or pneumonia, the day you should take the first dose of one of Acarizax. Your doctor will postpone the start of treatment until you are better.
  • if you have a disease that affects the immune system, take drugs that suppress the immune system or have cancer.
  • if you have recently extracted a tooth, undergone other surgical procedures in the oral cavity, or have sores or infection in your mouth. Your doctor may recommend that the start of treatment is postponed or that the treatment be stopped until the mouth has healed.

Warnings and cautions

Talk to your doctor before taking Acarizax:

  • if you are being treated for depression with tricyclic antidepressants, monoamine oxidase inhibitors ( MAOIs ), or for Parkinson’s disease with COMT inhibitors.
  • if you have previously had a severe allergic reaction in connection with the injection of allergenic extracts from house dust mites.
  • if you are allergic to fish. Acarizax may contain traces of fish protein. Available data do not indicate an increased risk of allergic reactions in patients with fish allergies.
  • if you experience severe allergic symptoms, such as difficulty swallowing or breathing, voice changes, low blood pressure, or the feeling of a lump in your throat. Discontinue treatment and contact a physician immediately.
  • if your asthma symptoms become noticeably worse than normal. Discontinue treatment and contact a physician immediately.

If you have asthma, you should continue to use your usual asthma medication when starting treatment with Acarizax. Your doctor will tell you how you can gradually reduce your asthma treatment over time.  

If you experience persistent heartburn or difficulty swallowing, consult your doctor.

You can expect mild to moderate local allergic reactions during treatment. If these are severe, you should talk to your doctor to see if you need any anti-allergic medicine such as an antihistamine.

Children and young people

Allergic rhinitis ( inflammation of the nasal mucosa ):

Acarizax is used to treat allergic rhinitis in adolescents (12-17 years). Acarizax is not intended for use in children under 12 years of age.

Allergic asthma:

Acarizax is not indicated for the treatment of allergic asthma in children under 18 years of age.

Other medicines and Acarizax

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription. If you are taking other medicines for your allergic symptoms such as antihistamines, bronchodilators, or steroids, tell your doctor so that you can get advice on how to use them when taking Acarizax. If you stop taking these medicines for your allergic symptoms, you may experience more side effects from Acarizax.

Acarizax with food and drink

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

Pregnancy and breastfeeding

There is currently no experience with treatment with Acarizax during pregnancy. Acarizax treatment should not be initiated during pregnancy. If you become pregnant during treatment, consult your doctor if further treatment is appropriate.

There is currently no experience with treatment with Acarizax during breast-feeding. However, no effects are expected on breast-fed infants. Talk to your doctor about continuing treatment with Acarizax while breast-feeding your baby. 

Driving and using machines

Treatment with Acarizax has no or negligible effect on the ability to drive and use machines. However, you can only determine if you feel that you are being affected, so read all the information in this leaflet, especially section 4 “Possible side effects” and talk to your doctor or pharmacist if you are not sure.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

3. How to take Acarizax

Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

The recommended dose is one freeze-dried tablet daily. Your doctor will tell you how long to take Acarizax.

Use for adults and adolescents

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

Picture 1

1. Tear off the tab marked with triangles on top of the package.

Picture 2

2. Tear off a box from the package along the perforated lines.

Picture 3

3. Do not push the tablet through the foil. It may damage the tablet as it is brittle. Instead, fold the foil back from the marked corner and then pull off the foil.

Picture 4

4. Carefully remove the tablet from the foil and use it immediately.  

Picture 5

5. Place the tablet under the tongue. Leave it there until it dissolves. Avoid swallowing for the first minute. Do not eat or drink for at least 5 minutes.

If you take more Acarizax than you should

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

If you forget to take Acarizax

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

If you have not taken Acarizax for more than 7 days, you should consult your doctor before taking Acarizax again.

If you stop taking Acarizax

If you do not take the medicine as prescribed, you may not get the desired effect of the treatment.

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

4. Possible side effects

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

The side effects can be an allergic reaction to the allergen you are being treated with. Most allergic side effects last from minutes to hours after taking the drug and usually subside after 1-3 months of treatment.  

Most serious side effects:

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

  • severe allergic reaction

Stop taking Acarizax and contact a doctor or hospital immediately if you get any of the following symptoms:

  • worsening of existing asthma
  • swelling of the face, mouth, throat, or skin
  • difficulty swallowing
  • difficulty breathing
  • voice changes
  • low blood pressure
  • the feeling of fullness in the throat (like a swelling)
  • hives and skin itching

Other possible side effects

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

  • irritating sensation in the throat
  • swelling of the mouth and lips
  • itching in the mouth and ears
  • respiratory infections

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

  • stinging sensation or numbness in the mouth or tongue
  • itchy eyes
  • itchy tongue and lips
  • swelling of the tongue or throat
  • inflammation, discomfort, or burning sensation in the mouth
  • redness or sores in the mouth
  • pain in the mouth
  • taste change
  • stomach pain or discomfort from the stomach
  • diarrhea
  • nausea and vomiting
  • pain when swallowing or difficulty swallowing
  • asthma symptoms
  • respiratory distress
  • chest discomfort
  • indigestion and heartburn
  • huskiness
  • fatigue
  • hives and skin itching

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

  • eye inflammation
  • the feeling of fast powerful or irregular heartbeat
  • discomfort in the ears
  • tightness in the throat
  • nasal discomfort, stuffy or runny nose, sneezing
  • blisters in the mouth
  • irritation of the esophagus
  • the feeling of foreign objects in the throat
  • dizziness
  • general discomfort
  • dry mouth
  • stinging sensation in the skin
  • redness in the throat
  • enlarged tonsils
  • pain in the lip
  • sores on the lip
  • enlarged salivary glands
  • increased saliva production
  • reddening of the skin

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

  • rapid swelling of the face or skin

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor. antihistamines to relieve your discomfort.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.

5. How to store Acarizax

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 carton after EXP. The expiration date is the last day of the specified month.

This medicine does not require any special storage instructions.

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 to protect the environment.

6. Contents of the packaging and other information

Content declaration

The active substance is standardized allergen extract from house dust mites Dermatophagoides pteronyssinus and Dermatophagoides farinae. The activity per lyophilized tablet is expressed in the unit SQ-HDM. The activity of a lyophilized tablet is 12 SQ-HDM.

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

What the medicine looks like and the contents of the pack

White to off-white round lyophilized tablet marked with an embossed image on one side.

Blister packaging of aluminum with peelable aluminum foil in an outer carton. Each blister pack contains 10 lyophilized tablets.

The following pack sizes are available: 10, 30, or 90 freeze-dried tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

ALK-Abelló A / S

Bøge Allé 6-8

2970 Hørsholm

Denmark

Manufacturer

ALK-Abelló SA

Miguel Fleta 19

28037 Madrid

Spain

Information is provided by

ALK Nordic A / S, Denmark Branch

tel: 0300 – 185 45

email: infose@alk.net

This medicinal product is authorized under the European Economic Area under the names:

Austria, Czech Republic, Denmark, Finland, France, Germany, Norway, Poland, Sweden, and Slovakia: ACARIZAX 
Italy: ACCARIZAX

Muhammad Nadeem

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