12 SQ-Bet freeze-dried tablet
For adults. Standardized allergenic extract of birch pollen (Betula verrucosa).

1. What Itulazax is and what it is used for

What Itulazax is

Itulazax contains allergenic extracts of birch pollen. The drug is in the form of freeze-dried tablets, which are like regular tablets but much softer and are absorbed into the body by placing them under the tongue.

What Itulazax is used for

Treatment of:

  • allergic rhinitis and / or
  • conjunctivitis

caused by tree pollen from birch, alder, hazel, hornbeam, oak, and beech.

  • Allergic rhinitis is an inflammation of the nose that causes you to sneeze and get a stuffy nose or runny nose.
  • Conjunctivitis is an eye inflammation that makes the eyes red, itchy or runny.

Itulazax is used in adults.

Itulazax is prescribed by a doctor who has experience in treating allergies.

How Itulazax works

Itulazax increases the immune system’s tolerance to (your body’s ability to handle) tree pollen.

How does your doctor decide if Itulazax is right for you?

The doctor will investigate your allergic symptoms and perform a skin prick test and/or take a blood sample.

2. What you need to know before you take Itulazax

Do not take Itulazax if:

  • you are allergic to any of the other ingredients of this medicine (listed in section 6).
  • you have poor lung function (according to the doctor’s assessment).
  • you have had a severe asthma exacerbation or episodes of uncontrolled asthma within the last 3 months (at the doctor’s discretion).
  • you have a disease that affects the immune system, take drugs that suppress the immune system or have cancer.
  • 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 be postponed or that treatment be stopped until your mouth has healed.

Warnings and cautions

Talk to your doctor before taking Itulazax if:

  • you are being treated for depression with tricyclic antidepressants , monoamine oxidase inhibitors ( MAOIs ) or for Parkinson’s disease with COMT inhibitors.
  • you have heart disease and / or are being treated with beta blockers .
  • you have previously had a severe allergic reaction in connection with the injection of allergenic extracts from tree pollen.
  • you have asthma and an ongoing respiratory infection, such as a cold, sore throat or pneumonia on the day you start treatment. Your doctor will postpone treatment until you feel better.
  • you have had a severe asthma exacerbation in the last 12 months.
  • you have severe or persistent heartburn or difficulty swallowing.
  • you have a disease that affects the immune system or are taking drugs that suppress the immune system.
  • you should be vaccinated. Your doctor will decide if you can be vaccinated without stopping treatment with Itulazax.
  • you are allergic to fish. Itulazax may contain traces of fish protein. Available data do not indicate an increased risk of allergic reactions in patients with fish allergies.

Talk to your doctor before taking Itulazax if any of the above apply to you.

Itulazax contains the pollen you are allergic to, so you can expect to get some mild to moderate allergic reactions. These reactions can occur in the mouth and throat. If it becomes difficult, you can contact your doctor to see if you need any medicine for allergies, such as antihistamines. During the first days when you take the tablets at home, you may experience new allergic reactions that did not occur during the first day of treatment, when you were at the doctors. For information on possible side effects, see section 4.

Children and young people

Itulazax is not intended for use in children and adolescents.

Other medicines and Itulazax

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 or corticosteroids, your doctor should evaluate the use of these medicines. If you stop taking these medicines for your allergic symptoms, you may experience more side effects from Itulazax.

Itulazax with food and drink

Do not eat or drink for at least 5 minutes after taking the medicine.

Pregnancy, breastfeeding and fertility

There is no experience of treatment with Itulazax during pregnancy. Itulazax treatment should not be started during pregnancy. If you become pregnant during treatment, ask your doctor if it is appropriate for you to continue treatment.

There is no experience of treatment with Itulazax during breastfeeding. However, no effect is expected on breast-fed infants. Talk to your doctor about continuing treatment with Itulazax while you are breastfeeding your baby.

There is no experience of treatment with Itulazax in people planning pregnancy. Talk to your doctor before taking this medicine if you are planning to become pregnant.

Driving and using machines

Itulazax has no or very little effect on the ability to drive and use machines. 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 Itulazax

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

How much Itulazax to take

  • The recommended dose is one lyophilised tablet (soft tablet) daily.

How to take Itulazax

Start taking Itulazax at least 4 months before the pollen season is expected to begin. Your doctor will tell you how long to take Itulazax. The recommended treatment time with Itulazax is 3 years to have a long-lasting effect.

The first dose of Itulazax is taken at the doctor’s office.

  • This is so that you can be supervised by healthcare staff for at least half an hour after taking the first tablet.
  • It is a precautionary measure to check how sensitive you are to the medicine.
  • It is also an opportunity for you to discuss any side effects with your doctor.

Continue to take Itulazax every day even if it takes a while before your allergy improves.

Make sure you have completely dry hands before handling the tablets.

Take the medicine as follows:

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

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

2. Tear off a box from the blister pack along the perforated lines.

2. Tear off a box from the blister pack along the perforated lines.

3. Fold the foil back from the marked corner and then pull off the foil.

3. Fold the foil back from the marked corner and then pull off the foil.

  • Do not push the tablet through the foil – it will break easily.
4. Carefully remove the tablet from the foil and place it under the tongue immediately.

4. Carefully remove the tablet from the foil and place it under the tongue immediately.

5. Leave the tablet under the tongue until it has completely dissolved.

5. Leave the tablet under the tongue until it has completely dissolved.

  • Avoid swallowing for 1 minute.
  • Do not eat or drink for at least 5 minutes after taking the medicine.

Use for children and adolescents

Itulazax is not intended for use in children and adolescents.

Use in the elderly
Experience in the elderly (≥ 65 years) is limited.

If you take more Itulazax than you should

If you take more Itulazax than you should, you are more likely to have allergic reactions, such as in your mouth and throat. If you experience severe side effects, contact your doctor or hospital immediately. See section 4.

If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

If you forget to take Itulazax

  • If you forget to take a tablet of Itulazax, you can take it later in the day.
  • Do not take a double dose to make up for a forgotten tablet.
  • If you have not taken Itulazax for more than 7 days, talk to your doctor before taking Itulazax again.

If you stop taking Itulazax

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

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 (pollen) you are being treated with.

  • Most allergic side effects are mild to moderate and occur within the first few days of treatment.
  • They should disappear within a few months, or in many cases already within one to a couple of weeks.

If you are worried or it is becoming difficult for you, contact your doctor who will decide if you need any medicine for allergies, such as antihistamines.

Any side effects usually occur within 10 minutes of taking Itulazax every day you take the medicine and subside within an hour.

Serious side effects are :

No known frequency (cannot be calculated from the available data):

  • Severe allergic reaction

Stop taking Itulazax and contact a doctor or hospital immediately if you experience any of the following:

  • Symptoms of a severe allergic reaction:
  • Your asthma will be significantly worse than normal
  • Severe swelling in the throat
  • Difficult to swallow
  • Hard to breathe
  • Voice changes (eg hoarseness)
  • Low blood pressure ( hypotension )
  • Feeling full in the throat
  • Severe or persistent heartburn

Other side effects:

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

  • Itching in the ears, mouth or tongue
  • Swelling in the mouth
  • Irritation in the throat
  • Stinging sensation in the mouth

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

  • Runny nose
  • Oral allergy syndrome ( itching and / or swelling in the mouth and throat after eating certain raw vegetables, fruits or nuts)
  • Changed taste
  • Cough
  • Dry throat
  • Huskiness
  • Respiratory distress
  • Pain in the mouth or throat
  • Swelling of the throat
  • Stomach pain
  • Diarrhea
  • Heartburn
  • Pain when swallowing or difficulty swallowing
  • Pain or burning sensation in the tongue
  • Numbness in the mouth
  • Swelling of the lips or tongue
  • Itching on the lips
  • Nausea
  • Discomfort in the mouth
  • Blisters in the mouth
  • Stinging sensation in the throat
  • Inflammation of the mouth
  • Hives
  • Discomfort in the chest
  • Feeling that something is stuck in the throat

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

  • Tightness in the throat
  • Inflammation of the tongue
  • Blisters on the lips
  • Sores in the mouth
  • Irritation of the esophagus
  • Rapid swelling of the face, mouth or throat

If you are worried about any of the side effects or if it becomes difficult for you, contact your doctor who will decide if you need any other medicines, such as antihistamines, to relieve your symptoms.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.

5. How to store Itulazax

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

Store in the original package. Moisture sensitive. No special temperature 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 pack and other information

Content declaration

The active substance is a standardized allergenic extract of birch pollen ( Betula verrucosa ). The activity per freeze-dried tablet is expressed in the unit SQ-Bet. The activity of a lyophilized tablet is 12 SQ-Bet.

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

What the medicine looks like and contents of the pack

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

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

The following pack sizes are available: 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, Danmark Filial
tel: 0300 – 185 45

email: infose@alk.net

Muhammad Nadeem

Leave a Reply