Grazax 75000 SQ-T sublingual lyophilisate

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Grazax 75,000 SQ-T sublingual lyophilisate

Standardised allergen extract from grass pollen

Phleum pratense (Timothy grass)

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as 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, and you should not give it to other people, even if they have the same symptoms as you, as it may harm them.

• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet:

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

1. What Grazax is and what it is used for

Grazax contains an allergen extract from grass pollen. Grazax is used for the treatment of rhinitis and conjunctivitis caused by grass pollen in adults and children (aged 5 years and older). Grazax modifies the allergic disease by increasing immunological tolerance to grass pollen.

The selection of children to receive treatment should be carried out by physicians specialized in the treatment of allergic diseases in children.

The doctor will evaluate your allergic symptoms and perform a skin diagnostic test or take a blood sample to determine whether Grazax should be used as treatment.

It is recommended that the first sublingual lyophilisate be taken under medical supervision. This precaution aims to assess each patient's sensitivity to the treatment, and provides an opportunity to discuss potential adverse effects with the doctor.

Grazax is prescribed by physicians specialized in allergy treatment.

2. What you need to know before taking Grazax

Do not take Grazax:

• if you are allergic (hypersensitive) to any of the excipients of this medicine (listed in section 6).
• if you have a disease affecting the immune system.
• if you have severe asthma (diagnosed by your doctor).
• if you have cancer.
• if you have severe inflammation in the mouth.

Warnings and precautions:

Talk to your doctor before starting to take Grazax

• if you have recently had a tooth extraction or any other type of oral surgery. In this case, you should interrupt treatment with Grazax for 7 days to allow complete healing of the mouth.
• if you have a severe allergy to fish.
• if you have previously had an allergic reaction related to injection of a grass pollen allergen extract.
• if you have asthma and are suffering from an acute upper respiratory tract infection. You should temporarily discontinue treatment with Grazax until the infection has resolved.

Some adverse effects may be serious and require immediate medical treatment. Please see section 4 for symptoms.

Children

• Loss of primary dentition (milk teeth). Treatment with Grazax should be interrupted for 7 days to allow complete healing of the mouth.

If you are in any of these situations, inform your doctor before starting to take Grazax.

There is no experience with Grazax in elderly patients (65 years of age or older).

Other medicines and Grazax

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription. If you are taking other medicines to treat allergy symptoms, such as antihistamines or corticosteroids, your doctor should evaluate the need for continued use of these medicines.

Taking Grazax with food and drink

You should wait 5 minutes after taking the sublingual lyophilisate before eating and/or drinking.

Pregnancy, breastfeeding and fertility

Currently, there is no experience with the use of Grazax during pregnancy. Treatment with Grazax should not be initiated during pregnancy. If you become pregnant while undergoing treatment, consult your doctor about the risks of continuing treatment.

Currently, there is no experience with the use of Grazax during breastfeeding. Effects on breastfed infants are not expected.

Driving and using machines

You are solely responsible for judging your ability to drive or perform precision tasks. The effects or adverse effects of the medicine may influence this ability. These effects are described elsewhere in this leaflet. Therefore, read the entire leaflet for your information.

Consult your doctor or pharmacist if you have any doubts.

The influence of treatment with Grazax on the ability to drive or use machines is none or negligible.

Grazax contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per sublingual lyophilisate; this is essentially “sodium-free”.

3. How to take Grazax

Follow exactly the instructions for administration of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

How much Grazax should you take

• The recommended dose is one sublingual lyophilisate per day.

How to take Grazax

• For optimal effectiveness, start taking the medicine approximately 4 months before the expected onset of the grass pollen season. It is recommended to continue treatment with Grazax for 3 years.

The first dose of Grazax must be taken in your doctor's office.

• This is because you must remain under observation for about half an hour after taking the first dose.

• This precaution is to assess your sensitivity to the medicine.

• It will also give you the opportunity to discuss with your doctor any adverse reactions you may experience.

Continue taking Grazax every day—even if it takes some time before your allergy improves.

If your allergy symptoms do not improve during the first grass pollen season, schedule a consultation with your doctor to discuss continuing the treatment.

Make sure your hands are completely dry before handling this medicine.

Take the sublingual lyophilisates as follows:

1. Peel off the strip marked with triangles at the top of the pack.

1. Separate one unit by tearing along the perforated lines.

3. Bend and pull the marked corner of the aluminum foil.

Do not push the medicine through the aluminum foil—it breaks easily.

1. Carefully remove the lyophilisate from its compartment and place it immediately under your tongue.

1. Keep the medicine under your tongue until it dissolves.
   • Do not swallow for one minute.
   • Wait at least 5 minutes before eating or drinking after taking this medicine.

If you take more Grazax than you should

If you have taken too many sublingual lyophilisates of Grazax, you may experience allergic symptoms, including local reactions in the mouth and throat. If you experience severe symptoms, contact your doctor or hospital immediately.

If you forget to take Grazax

If you forget to take a sublingual lyophilisate, take it as soon as you remember on the same day. Do not take a double dose on the same day to make up for a missed dose.

If you stop taking Grazax

If you do not take this medicine as prescribed by your doctor, the treatment may not be effective. If you have any further questions about the use of this product, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

Adverse effects may be an allergic-type response to the allergen against which the treatment is directed. In most cases, adverse effects last from minutes to hours after taking the sublingual lyophilisate and resolve within one week of starting treatment.

Serious adverse effects:

Stop taking Grazax and immediately contact your doctor or go to a hospital if you experience any of the following:

• Rapid swelling of the face, mouth, or throat
• Difficulty swallowing
• Difficulty breathing
• Hives
• Changes in voice
• Worsening of existing asthma
• Severe malaise

If you experience persistent heartburn, you should contact your doctor.

Other possible adverse effects:

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

• Swelling of the mouth
• Itching in the mouth or ear
• Irritation sensation in the throat

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

• Tingling or numbness sensation in the mouth
• Itching in the eyes, lips, or nose
• Inflammation of the eyes or mouth
• Difficulty breathing, cough, or sneezing
• Sore throat
• Runny nose
• Swelling of eyes or lips
• Mouth ulcers
• Pain or discomfort from blisters in the mouth or throat
• Stomach pain, diarrhea, nausea, vomiting
• Heartburn
• Itching, rash, or urticaria
• Fatigue
• Chest discomfort
• Throat tightness sensation
• Redness in the mouth
• Difficulty swallowing

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

• Sensation of rapid, strong, or irregular heartbeat
• Taste disturbance
• Redness or irritation of the eyes
• Ear pain or discomfort
• Numbness sensation in the throat, pain when swallowing
• Tonsil inflammation
• Severe allergic reaction
• Dry mouth
• Blisters on the lips, lip swelling, lip ulcers
• Inflammation of the salivary glands or hypersecretion
• Stomach inflammation, regurgitation
• Foreign body sensation in the throat
• Skin redness
• Facial swelling
• Tongue swelling
• Allergic reaction
• Skin tingling sensation
• Stomach discomfort
• Throat swelling
• Tearing
• Hoarseness
• Throat redness
• Mouth blisters

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

• Constriction of the lower airways
• Swelling of the ears

Eye irritation, throat redness, mouth blisters, ear pain, and ear swelling have been reported more frequently in children than in adults.

If you experience bothersome adverse effects, you should contact your doctor, who will decide whether you need to take antiallergic medicines such as antihistamines.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Grazax

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 on the outer packaging following EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE Point at your pharmacy. If you are unsure how to dispose of unused medicines or packaging, ask your pharmacist. This will help protect the environment.

6. Contents of the pack and other information

Composition of Grazax

The active substance is an allergen extract from the grass pollen Phleum pratense (Timothy grass), standardized in SQ units. The activity per sublingual lyophilisate is expressed using the standardized quality unit (SQ-T*). The activity of one sublingual lyophilisate is 75,000 SQ-T. The content of the allergen Phl p 5 per sublingual lyophilisate is 6 micrograms.

* (Sublingual lyophilisate in Standardized Quality units (SQ-T)).

The other components are gelatin (derived from fish), mannitol and sodium hydroxide.

Appearance of Grazax and contents of the pack

Round sublingual lyophilisate, white or almost white, with an imprint on one side.

The sublingual lyophilisates are packed in an aluminium-aluminium blister with a peelable foil for opening, and boxed in a cardboard carton. Each blister contains 10 sublingual lyophilisates.

Available pack sizes: 10 (1x10), 30 (3x10), 90 (9x10), or 100 (10x10) sublingual lyophilisates.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

ALK-Abelló A/S

Bøge Allé 6-8

DK-2970 Hørsholm

Denmark

Manufacturer

ALK-Abelló S.A.

C/ Miguel Fleta, 19.

28037 – Madrid

Spain

For further information on this medicinal product, please contact the local representative of the Marketing Authorization Holder:

ALK-Abelló S.A.

C/ Miguel Fleta, 19.

28037 - Madrid

Date of the most recent revision of this leaflet: 01/2026

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/