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This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information.
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The product code(s) for this leaflet is: PL10085/0059.
ITULAZAX 12 SQ-Bet
ITULAZAX®
ITULAZAX 12 SQ-Bet sublingual lyophilisate
For use in adults
Standardised allergen extract of pollen from white birch (Betula verrucosa)
▼This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.
1. What ITULAZAX is and what it is used for
2. What you need to know before you take ITULAZAX
3. How to take ITULAZAX
4. Possible side effects
5. How to store ITULAZAX
6. Contents of the pack and other information
ITULAZAX contains an allergen extract of birch pollen. It comes in a form known as a sublingual lyophilisate, which is like a tablet but much softer and absorbed into the body by putting it under the tongue.
Treatment of:
when these are caused by tree pollen from birch, alder, hazel, hornbeam, oak and beech trees.
ITULAZAX is used in adults.
ITULAZAX is prescribed by doctors with experience in treating allergies.
Itulazax works by increasing the immunological tolerance (your body´s ability to cope) to tree pollen.
The doctor will check your allergic signs and do a skin prick test and/or take a blood sample.
Talk to your doctor before taking ITULAZAX if:
Talk to your doctor before taking ITULAZAX if any of the above apply to you.
You should stop taking ITULAZAX and contact your doctor, if you experience severe or persistent heart-burn or difficulty in swallowing, as these symptoms could be signs of allergic inflammation of the oesophagus.
ITULAZAX contains the pollen that you are allergic to – so you can expect some mild to moderate allergic reactions. These reactions may be in the mouth and throat. If they are troublesome, talk to your doctor to see if you need any anti-allergic medicines such as antihistamines. You may experience new allergic reactions on the first few days of at-home treatment, which were not observed on the first day of treatment at the doctors surgery. See section 4 for information about possible side effect.
ITULAZAX is not intended for use in children or adolescents.
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 allergy symptoms such as antihistamines or corticosteroids, your doctor should evaluate the use of such medicines. If you stop taking these medicines for your allergy symptoms you may experience more side effects of ITULAZAX.
Do not eat or drink for at least 5 minutes after taking the medicine.
There is no experience with the use of ITULAZAX during pregnancy. Treatment with ITULAZAX should not be started during pregnancy. If you become pregnant during treatment, talk to your doctor about whether it is appropriate for you to continue the treatment.
There is no experience with the use of ITULAZAX during breast-feeding. However, no effects on the breast-fed babies are anticipated. Talk to your doctor about whether you may continue to take ITULAZAX while breast-feeding your baby.
There is no experience with the use of ITULAZAX when you are planning to have a baby. Talk to your doctor for advice before taking this medicine if you are planning to have a baby.
ITULAZAX has no or very little effect on the ability to drive or use machines. However, only you can judge if you feel that your ability is affected, therefore, if you are unsure, please talk to your doctor or pharmacist.
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Start taking ITULAZAX at least 4 months before the expected start of the tree pollen season - your doctor will tell you how long you should take ITULAZAX for. It is recommended to continue ITULAZAX treatment for 3 years to obtain long-term effect.
The first dose of ITULAZAX should be taken at the doctors surgery.
Keep taking ITULAZAX every day - even if it takes some time before your allergy improves.
Make sure your hands are dry before handling the medicine.
1. Tear off the strip marked with triangles at the top of the pack.
2. Tear a square off the pack along the dotted lines.
3. Fold back the marked corner of the foil and then pull it off.
4. Remove the medicine carefully from the foil and place it under your tongue straight away.
5. Keep the medicine under your tongue until it has dissolved.
ITULAZAX is not intended for use in children or adolescents.
Experience in elderly (65 years and older) is limited.
If you take more ITULAZAX than you should, you are more likely to get allergic side effects – such as those in the mouth and throat. If you get severe side effects, contact a doctor or a hospital immediately. See section 4.
If you do not take this medicine as you have been told, you may not get the benefits.
If you have any questions on the use of this medicine, talk to your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects may be an allergic response to the allergen (pollen) you are being treated with.
If they are worrying you or causing you difficulties, talk to your doctor who will decide if you need any anti-allergic medicines such as antihistamines.
If you have side effects, they typically start within 10 minutes after taking ITULAZAX on each day of taking the medicine - and decrease within an hour.
Not known (frequency cannot be estimated from available data):
Stop taking ITULAZAX and talk to your doctor or hospital immediately if you experience any of the following:
Very common (may affect more than 1 in 10 people):
Common (may affect up to 1 in 10 people):
Uncommon (may affect up to 1 in 100 people):
Not known (frequency cannot be estimated from available data):
If any side effects are worrying you or causing you difficulties, talk to your doctor who will decide if you need any other medicines such as antihistamines to help relieve the side effects.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for “MHRA Yellow Card” in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
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 expiry date refers to the last day of that month.
Store in the original blister in order to protect from moisture. This medicinal product does not require any special temperature storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
The active substance is standardised allergen extract of pollen from white birch (Betula verrucosa).
The activity per sublingual lyophilisate is expressed using the unit SQ-Bet. The activity of one sublingual lyophilisate is 12 SQ-Bet. Content of the allergen Bet v 1 per sublingual lyophilisate is 194 micrograms.
The other ingredients are gelatine (from fish), mannitol and sodium hydroxide (for pH adjustment).
White to off-white circular sublingual lyophilisate marked with a debossed image on one side.
Aluminium blister cards with removable aluminium foil in an outer carton. Each blister card contains 10 sublingual lyophilisates.
Following pack sizes are available:
30 or 90 sublingual lyophilisates.
This leaflet was last revised in December 2024.