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GRAZAX 75000 SQ-T SUBLINGUAL LYOPHILIZED

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About the medicine

How to use GRAZAX 75000 SQ-T SUBLINGUAL LYOPHILIZED

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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.

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Introduction

Package Leaflet: Information for the User

Grazax 75,000 SQ-T Sublingual Lyophilisate

Standardized allergen extract of grass pollen

Phleum pratense(Timothy grass)

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

-Keep this leaflet, 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 pass it on to others. It may harm them, even if their symptoms are the same as yours.

-If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

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

1. What is Grazax and what is it used for

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

The selection of children to receive treatment should be made by doctors specializing in the treatment of allergic diseases in children.

Your doctor will assess 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 to assess each patient's sensitivity to the treatment. This gives you the opportunity to discuss any possible side effects with your doctor.

Grazax is prescribed by doctors specializing in the treatment of allergies.

Doctor consultation

Not sure if this medicine is right for you?

Discuss your symptoms and treatment with a doctor online.

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 that affects 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 mouth 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 fish allergy.
  • 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 upper respiratory tract infection. You should temporarily discontinue treatment with Grazax until the infection is resolved.

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

Children

  • Loss of the first teeth (milk teeth). Treatment with Grazax should 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 medicines and Grazax

Tell your doctor or pharmacist if you are taking or have recently taken 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 assess the use of these medicines.

Taking Grazax with food and drinks

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

Pregnancy, breastfeeding, and fertility

There is currently no experience with the use of Grazax during pregnancy. Treatment with Grazax should not be started during pregnancy. If you become pregnant during treatment, consult your doctor about the risks of continuing treatment.

There is currently no experience with the use of Grazax during breastfeeding. No effects on breastfed infants are expected.

Driving and using machines

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

Talk to your doctor or pharmacist if you have any doubts.

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

3. How to take Grazax

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

How much Grazax to take

  • The recommended dose is one sublingual lyophilisate per day.

How to take Grazax

  • To achieve greater efficacy, start taking the medicine 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 office.

  • This is because you should remain under observation for approximately half an hour after taking the first dose.
  • This is a precaution to check your sensitivity to the medicine.
  • This will give you the opportunity to discuss any side effects you may experience with your doctor.

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 continuing treatment.

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

Take the sublingual lyophilisates as follows:

Hands holding and separating two sterile square patches with serrated edges

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

Hands holding and breaking a glass ampoule with dotted marks indicating break points

  1. Separate a unit from the package following the dotted lines.

Hands holding and separating the plastic protectors of a pre-loaded transparent syringe

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

Do not press to push this medicine through the aluminum sheet - it breaks easily.

Hand holding a circular medicinal patch with a central adhesive area and a transparent protective backing

  1. Carefully remove this medicine from the unit and place it immediately under your tongue.

Tablet placed under the tongue with hand holding it, prohibited from drinking and eating for 1 and 5 minutes respectively

  1. Keep this 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 Grazax sublingual lyophilisates, 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 make up for forgotten doses.

If you stop taking Grazax

If you do not take this medicine as prescribed by your doctor, it may not work effectively. If you have any other questions about the use of this product, ask your doctor or pharmacist.

Medicine questions

Started taking the medicine and have questions?

Discuss your symptoms and treatment with a doctor online.

4. Possible side effects

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

Side effects can be an allergic-type reaction to the allergen being treated. In most cases, side effects last from minutes to hours after taking the sublingual lyophilisate and resolve within a week of starting treatment.

Serious side effects:

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

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

If you suffer from persistent heartburn, you should contact your doctor.

Other possible side effects:

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

  • Mouth swelling
  • 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 in the eyes or mouth
  • Difficulty breathing, coughing, or sneezing
  • Throat dryness
  • Nasal discharge
  • Swelling of the eyes or lips
  • Mouth ulcers
  • Pain from blisters or discomfort in the mouth or throat
  • Stomach pain, diarrhea, nausea, vomiting
  • Heartburn
  • Itching, rash, or hives
  • Fatigue
  • Chest discomfort
  • Sensation of pressure in the throat
  • Redness in the mouth
  • Difficulty swallowing

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

  • Sensation of rapid, strong, or irregular heartbeats
  • Taste alteration
  • Redness or irritation of the eyes
  • Pain or discomfort in the ear
  • Sensation of numbness in the throat, pain when swallowing
  • Tonsil inflammation
  • Severe allergic reaction
  • Mouth dryness
  • Blisters on the lips, lip inflammation, lip ulcers
  • Inflammation of the salivary glands or hypersalivation
  • Stomach inflammation, regurgitation
  • Sensation of a foreign body in the throat
  • Redness of the skin
  • Facial swelling
  • Tongue inflammation
  • Allergic reaction
  • Tingling sensation on the skin
  • Stomach discomfort
  • Throat swelling
  • Watery eyes
  • Hoarseness
  • Redness in the throat
  • Blisters in the mouth

Rare (may affect up to 1 in 1000 people):

  • Constriction of the lower airways
  • Ear swelling

Irritation of the eyes, redness of the throat, blisters in the mouth, ear pain, and ear swelling have been reported more frequently in children than in adults.

If you experience bothersome side effects, you should contact your doctor, who will decide if you need to take anti-allergic medicines, such as antihistamines.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System of Medicines for Human Use www.notificaRAM.es.

By reporting side 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 expiration date stated on the blister and on the carton after EXP. The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Place the packages and medicines you no longer need in the SIGRE Green medical cross symbol inside a curved green circle representing health and care collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packages and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and further information

Composition of Grazax

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

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

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

Appearance of Grazax and contents of the pack

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

The sublingual lyophilisates are packaged in an aluminum-aluminum blister with a foldable sheet for opening and packed in a cardboard box. Each blister contains 10 sublingual lyophilisates.

Available packages: 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

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

ALK-Abelló, S.A.

C/ Miguel Fleta, 19.

28037 - Madrid

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

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

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Tarek Agami

General medicine 11 years exp.

Dr. Tarek Agami is a general practitioner registered in both Portugal and Israel, with broad experience in family and preventive medicine. He offers online consultations for adults and children, providing personalised support for primary care needs, chronic disease management, and everyday health concerns.

Dr. Agami received clinical training and worked in leading medical institutions in Israel (Kaplan Medical Center, Barzilai Medical Center, Wolfson Medical Center) and Portugal (European Healthcare City, Viscura Internacional, Hospital Dr. José Maria Grande, Hospital Vila Franca de Xira). His approach combines international medical standards with individualised attention to each patient.

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Dr. Agami provides medical support for patients using GLP-1 medications (such as Ozempic or Mounjaro) as part of a weight loss strategy. He offers individualised treatment planning, regular follow-up, dose adjustment, and advice on combining medication with sustainable lifestyle changes. Consultations follow the medical standards accepted in Portugal and Israel.

Dr. Agami is committed to evidence-based, patient-centred care, ensuring that each person receives trusted medical support tailored to their health goals.

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Nuno Tavares Lopes

Family medicine 18 years exp.

Dr. Nuno Tavares Lopes is a licensed physician in Portugal with 17 years of experience in emergency medicine, family and general practice, and public health. He is the Director of Medical and Public Health Services at an international healthcare network and serves as an external consultant for the WHO and ECDC.

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Dr. Nuno Tavares Lopes provides medical support for patients using GLP-1 medications (Mounjaro, Wegovy, Ozempic, Rybelsus) as part of a weight loss strategy. He offers individualised treatment planning, regular follow-up, dose adjustment, and advice on combining medication with sustainable lifestyle changes. Consultations follow the medical standards accepted in Europe.

Dr. Lopes also provides interpretation of medical tests, follow-up care for complex patients, and multilingual support. Whether for urgent concerns or long-term care, he helps patients act with clarity and confidence.

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Anastasiia Shalko

Family medicine 13 years exp.

Dr. Anastasiia Shalko is a general practitioner with a background in both paediatrics and general medicine. She graduated from Bogomolets National Medical University in Kyiv and completed her paediatric internship at the P.L. Shupyk National Medical Academy of Postgraduate Education. After working as a paediatrician in Kyiv, she relocated to Spain, where she has been practising general medicine since 2015, providing care for both adults and children.

Her work focuses on urgent, short-term medical concerns – situations where patients need quick guidance, symptom assessment and clear next steps. She helps people understand whether their symptoms require in-person evaluation, home management or a change in treatment. Common reasons for booking an online consultation include:

  • acute respiratory symptoms (cough, sore throat, runny nose, fever)
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Dr. Shalko works specifically with urgent and short-term problems, providing practical recommendations and helping patients determine the safest next step. She explains symptoms clearly, guides patients through decision-making and offers straightforward medical advice for everyday acute issues.

She does not provide long-term management of chronic conditions, ongoing follow-up or comprehensive care plans for complex long-term illnesses. Her consultations are designed for acute symptoms, sudden concerns and situations where timely medical input is important.

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Tomasz Grzelewski

Dermatology 21 years exp.

Dr Tomasz Grzelewski is an MD, PhD specialist in allergy, paediatrics, general practice and sports medicine, with a clinical focus on dermatology, endocrinology, allergology and sports-related health. He has more than 20 years of clinical experience and completed his medical training at the Medical University of Łódź, where he defended his PhD thesis with distinction. His doctoral research was recognised by the Polish Society of Allergology for its innovative contribution to the field. Throughout his career, he has gained extensive expertise in diagnosing and managing a wide range of allergic and paediatric conditions, including modern allergen desensitisation techniques.

For five years, Dr Grzelewski served as the Head of two paediatric departments in Poland, managing complex clinical cases and leading multidisciplinary teams. He also worked in medical centres in the United Kingdom, gaining experience across both primary care and specialist environments. With over a decade of telemedicine experience, he has provided online consultations across Europe and is valued for his clear, structured and evidence-based medical guidance.

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In addition to his background in allergology and paediatrics, he completed dermatology studies through the Cambridge Education Group (Royal College of Physicians of Ireland) and a Clinical Endocrinology course at Harvard Medical School. This advanced training enhances his ability to manage skin manifestations of allergies, atopic conditions, urticaria, endocrine-related symptoms and complex immunological reactions.

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Frequently Asked Questions

Is a prescription required for GRAZAX 75000 SQ-T SUBLINGUAL LYOPHILIZED?
GRAZAX 75000 SQ-T SUBLINGUAL LYOPHILIZED requires a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.
What is the active substance in GRAZAX 75000 SQ-T SUBLINGUAL LYOPHILIZED?
The active ingredient in GRAZAX 75000 SQ-T SUBLINGUAL LYOPHILIZED is grass pollen. This information helps identify medicines with the same composition but different brand names.
How much does GRAZAX 75000 SQ-T SUBLINGUAL LYOPHILIZED cost in pharmacies?
The average pharmacy price for GRAZAX 75000 SQ-T SUBLINGUAL LYOPHILIZED is around 106.84 EUR. Prices may vary depending on the manufacturer and dosage form.
Who manufactures GRAZAX 75000 SQ-T SUBLINGUAL LYOPHILIZED?
GRAZAX 75000 SQ-T SUBLINGUAL LYOPHILIZED is manufactured by Alk-Abello A/S. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of GRAZAX 75000 SQ-T SUBLINGUAL LYOPHILIZED online?
Doctors such as Family doctors, Psychiatrists, Dermatologists, Cardiologists, Endocrinologists, Gastroenterologists, Pulmonologists, Nephrologists, Rheumatologists, Hematologists, Infectious disease physicians, Allergists, Geriatricians, Paediatricians, Oncologists may assess whether GRAZAX 75000 SQ-T SUBLINGUAL LYOPHILIZED is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.
What are the alternatives to GRAZAX 75000 SQ-T SUBLINGUAL LYOPHILIZED?
Other medicines with the same active substance (grass pollen) include ORALAIR 300 IR Sublingual Tablets, ORALAIR INICIO 100 IR/300 IR SUBLINGUAL TABLETS, ACARIZAX 12 SQ-HDM SUBLINGUAL LYOPHILIZED. These may have different brand names or formulations but contain the same therapeutic ingredient. Always consult a doctor before switching or starting a new medicine.
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