Grazax 75000 sq-t liofilizado sublingual

Package Leaflet: Information for the user

Grazax 75,000 SQ-T lyophilized sublingual

Standardized allergenic extract of grass pollen

Phleum pratense(Timothy grass)

Read this leaflet carefully before you start taking this medicine, becauseit 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. Do not give it to others even if they have the same symptoms as you, as it may harm them.

-If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What is Grazax and what it is used for

2. What you need to know before starting to take Grazax

3. How to take Grazax

4. Possible side effects

5. Storage of Grazax

6. Contents of the pack and additional information

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

The selection of children who receive treatment should be made by specialist doctors 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 decide if Grazax should be used as treatment.

It is recommended to take the first sublingual lyophilisate under medical supervision. This is a precaution aimed at evaluating the sensitivity of each patient to the treatment. This gives you the opportunity to discuss possible adverse effects with the doctor.

Grazax is prescribed by specialist doctors in allergy treatment.

Do not take Grazax:

• If you are allergic (hypersensitive) to any of the excipients of this medication (listed in section 6).
• If you have a disease that affects your 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:

Consult your doctor before starting to take Grazax

• If you have recently had a tooth extraction or any other type of surgery in the mouth. In that case, you must interrupt the 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 the injection of a grass pollen allergen extract.
• If you have asthma and have an acute infection of the upper respiratory tract. You must temporarily discontinue treatment with Grazax until the infection has resolved.

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

Children

- Delayed shedding of the first teeth (baby teeth). Treatment with Grazax must be interrupted for 7 days to allow complete healing of the mouth.

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

There is no experience with Grazax in the elderly (65 years or older).

Other medications and Grazax

Inform your doctor or pharmacist if you are taking or have recently taken other medications, including those purchased without a prescription. If you are taking other medications to treat allergy symptoms, such as antihistamines or corticosteroids, your doctor must evaluate the use of these medications.

Taking Grazax with food and drinks

You must wait 5 minutes after taking the sublingual lyophilisate before consuming food and/or drinks.

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 during treatment, consult your doctor about the risks of continuing with it.

Currently, there is no experience with the use of Grazax during breastfeeding. No effects are expected in the infants.

Driving and operating machinery

You are the only one responsible for judging your ability to drive or perform precision work. The effects or side effects of the medication may affect this ability. These effects are described in other parts of this prospectus. Therefore, read the entire prospectus for your information.

Consult your doctor or pharmacist if you have doubts.

The influence of treatment with Grazax on the ability to drive or use machinery is negligible or insignificant.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

How much Grazax should be taken

• The recommended dose is one sublingual lyophilisate per day.

How to take Grazax

• To achieve greater efficacy, start taking the medication 4 months before the expected start of the grass pollen season. It is recommended to continue treatment with Grazax for 3 years.

The first dose of Grazax should be taken in the doctor's consultation.

• Esto es debido a que debe permanecer en observación durante media hora aproximadamente tras la toma de la primera dosis.

• Esto es una precaución para comprobar su sensibilidad al medicamento.
• Esto le dará la oportunidad de discutir con su médico cualquier efecto adverso que pudiera sufrir.

Continue taking Grazax every day - even if it takes time for your allergy to improve.

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

Make sure your hands are well dry before touching this medication.

Take the sublingual lyophilisates in the following way:

1. Remove the strip marked with triangles at the top of the package.

2. Separate one unit from the package following the discontinuous lines.

3. Fold the corner marked on the aluminum sheet and pull it.

Do not press to remove this medication through the aluminum sheet - it breaks easily.

4. Carefully remove this medication from the unit and place it immediately under your tongue.

5. Keep this medication under your tongue until it dissolves.

• Do not swallow for a minute.
• Wait at least 5 minutes before eating or drinking after taking this medication.

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 symptoms in the mouth and throat. If you experience severe symptoms, contact your doctor or hospital immediately.

If you forget to take Grazax

In case you forget to take a sublingual lyophilisate, take another as soon as possible on the same day. Do not take a double dose on the same day to compensate for the missed doses.

If you interrupt treatment with Grazax

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Side effects may be an allergic reaction to the allergen being treated. In most cases, side effects have a duration of minutes to hours after taking the sublingual lyophilisate and resolve within a week of starting treatment.

Severe side effects:

Stop taking Grazax and seek immediate medical attention or go to a hospital if you experience any of the following side effects:

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

If you experience persistent stomach burning, contact your doctor.

Other possible side effects:

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

• Swelling of the mouth
• Itching in the mouth or ear
• Sensation of throat irritation
  

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

• Sensation of tingling or numbness in the mouth
• Itching in the eyes, lips, or nose
• Inflammation in the eyes or mouth
• Difficulty breathing, cough, or sneezing
• Throat dryness
• Nasal discharge
• Swelling of the eyes or lips
• Ulcers in the mouth
• Pain or discomfort in the mouth or throat
• Stomach pain, diarrhea, nausea, vomiting
• Stomach burning
• Itching, rash, or urticaria
• Fatigue
• Discomfort in the chest
• Sensation of throat constriction
• Enlargement of the mouth
• Difficulty swallowing

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

• Sensation of rapid, strong, or irregular heartbeats
• Alteration of taste
• Redness or irritation of the eyes
• Pain or discomfort in the ear
• Sensation of numbness in the throat, difficulty swallowing
• Inflammation of the tonsils
• Severe allergic reaction
• Dry mouth
• Blisters on the lips, inflammation of the lips, ulcers on the lips
• Inflammation of the salivary glands or excessive secretion
• Inflammation of the stomach, regurgitation
• Sensation of foreign body in the throat
• Redness of the skin
• Swelling of the face
• Inflammation of the tongue
• Allergic reaction
• Sensation of tingling in the skin
• Discomfort in the stomach
• Swelling of the throat
• Excess tear production
• Hoarseness
• Redness in the throat
• Blisters in the mouth

Rare (may affect up to 1 in 1000 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 side effects, contact your doctor, who will decide if you need to take antiallergic medications, such as antihistamines.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this prospectus. You can also report them directly throughthe Spanish System for Pharmacovigilance of Medicines for Human Usewww.notificaRAM.es.

By reporting side effects, you can contribute to providing more information about the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the blister and on the packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE Collection Pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Grazax

The active ingredient is an allergenic extract of grass pollen from Phleum pratense (Timothy Grass), standardized in SQ units. The activity by sublingual lyophilisate is expressed using the SQ-T* unit. The activity of a 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 (from fish), mannitol, and sodium hydroxide.

Appearance of Grazax and contents of the packaging

Round sublingual lyophilisate, white or off-white in color, with an engraving on one of the faces.

The sublingual lyophilisates are packaged in an aluminum-aluminum blister with one of the sheets deployable for opening and packaged in a cardboard box. Each blister contains 10 sublingual lyophilisates.

Packaging available: 30 (3x10), 90 (9x10), or 100 (10x10) sublingual lyophilisates.

Not all packaging sizes will be marketed.

Holder of the marketing authorization and responsible for manufacturing

ALK-Abelló A/S

Bøge Allé 6-8

DK-2970 Hørsholm

Denmark

Responsible for manufacturing

ALK-Abelló. S.A.

C/ Miguel Fleta, 19.

28037 – Madrid

Spain

You can request more information about this medication by contacting the local representative of the holder of the marketing authorization:

ALK-Abelló. S.A.

C/ Miguel Fleta, 19.

28037 - Madrid

Date of the last review of this leaflet:2024-12-19

The detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/