Grazax

Package Leaflet: Information for the User

GRAZAX, 75,000 SQ-T, sublingual lyophilisate

Standardized allergen extract of grass pollen from timothy grass (Phleum pratense)

Read the package leaflet carefully before taking the medicine, as it contains important information for you.

• Keep this package 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, including any not listed in this package leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet:

• 1. What is Grazax and what is it used for
• 2. Important information 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 is Grazax and what is it used for

Grazax contains an allergen extract from grass pollen. Grazax is used to treat hay fever and allergic conjunctivitis caused by grass pollen in adults and children (5 years of age and older).
Grazax relieves allergy symptoms by increasing immune tolerance to grass pollen.
Children should be qualified for treatment by doctors who have experience in treating allergic diseases in children.
The doctor will assess the allergic symptoms and perform skin tests or order a blood test to decide if Grazax should be used.
It is recommended to take the first sublingual lyophilisate in the presence of a doctor. This precaution allows for the assessment of the patient's individual sensitivity to treatment and discussion with the doctor of possible side effects.
Grazax is prescribed by doctors with experience in treating allergies.

2. Important information before taking Grazax

When not to take Grazax

Warnings and precautions

Before starting treatment with Grazax, discuss with your doctor:

Some side effects can be severe and require immediate medical attention.
Symptoms, see section 4.

Children

• Loss of milk teeth. In such cases, treatment with Grazax should be interrupted for a period of 7 days to allow the tissues of the oral cavity to heal.

If any of the above situations occur, consult your doctor before taking Grazax.
There is a lack of experience with the use of Grazax in the elderly (65 years of age or older).

Grazax and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, including those obtained without a prescription. If you are taking other allergy medicines, such as antihistamines or corticosteroids, your doctor should assess the use of such medicines.

Taking Grazax with food and drink

Do not eat or drink anything for 5 minutes after taking the sublingual lyophilisate.

Pregnancy, breastfeeding, and fertility

Currently, there are no data on the use of Grazax during pregnancy. Do not start treatment with Grazax during pregnancy. If you become pregnant during treatment, consult your doctor about whether to continue treatment.
Currently, there is no experience with the use of Grazax during breastfeeding. It is not expected to affect the breastfed baby.

Driving and using machines

The patient is responsible for assessing their ability to drive or perform precision work. The effects or symptoms of the medicine may affect this ability. The description of these effects is presented in other sections of this package leaflet. Therefore, read all the information in this package leaflet before driving or operating machinery.
In case of doubts, consult your doctor or pharmacist again.
Treatment with Grazax has no significant effect on the ability to drive and use machines.

3. How to take Grazax

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

How much Grazax to take

• The recommended dose is one sublingual lyophilisate per day.

How to take Grazax

• To get the best effect, start taking the medicine at least 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 a doctor's office, because:

• After taking the first dose, the patient should remain under medical supervision for at least half an hour.
• This precaution allows for the assessment of the patient's individual sensitivity to treatment.
• It also allows for discussion with the doctor about possible side effects.

Take Grazax every day, even if it takes some time before the symptoms improve.
If the allergy symptoms do not improve during the first grass pollen season, consult your doctor to discuss continuing treatment.
Before touching the medicine, make sure your hands are dry.

How to take the sublingual lyophilisate:

• 1. Tear off the strip marked with triangles at the top of the packaging.

• 2. Tear off one square from the packaging along the dotted line.

• 3. Bend the marked corner of the foil and then pull it. Do not push the medicine through the foil, as it may break easily.

• 4. Carefully remove the medicine from the foil and immediately place it under your tongue.

• 5. Leave the medicine under your tongue until it dissolves.
• Do not swallow saliva for 1 minute.
• Do not eat or drink anything for at least 5 minutes after taking the medicine.

What to do if you take more Grazax than you should

If you take too many Grazax sublingual lyophilisates, you may experience allergy symptoms, including local symptoms in the mouth and throat. If the symptoms are severe, seek medical attention immediately.

What to do if you miss a dose of Grazax

If you miss a sublingual lyophilisate, take it later that day. Do not take a double dose in one day to make up for the missed dose.

What to do if you stop taking Grazax

The condition for the effectiveness of the treatment is to take the medicine as recommended by your doctor.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Grazax can cause side effects, although not everybody gets them.
A side effect can be an allergic reaction to the allergen being treated.
In most cases, side effects last from a few minutes to a few hours after taking the sublingual lyophilisate and disappear within one week of starting treatment.

Severe side effects

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

• Sudden swelling of the face, mouth, or throat
• Difficulty swallowing
• Breathing difficulties
• Hives
• Voice changes
• Worsening of existing asthma
• Feeling of severe discomfort

If you experience persistent heartburn, consult your doctor.

Other possible side effects:

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

• Mouth swelling
• Itching in the mouth or ears
• Irritation of the throat

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

• Feeling of tingling or numbness in the mouth
• Itching of the eyes, lips, or nose
• Eye or mouth inflammation
• Shortness of breath, cough, sneezing
• Dryness in the throat
• Runny nose
• Eye or lip swelling
• Mouth ulcers
• Blisters, pain, or discomfort in the mouth or throat
• Stomach pain, diarrhea, nausea, vomiting
• Heartburn
• Itching, rash, or hives
• Fatigue
• Unspecified unpleasant feeling in the chest
• Feeling of pressure in the throat
• Redness in the mouth
• Difficulty swallowing

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

• Feeling of rapid, strong, or irregular heartbeat
• Taste disturbances
• Redness or irritation of the eyes
• Ear pain or discomfort
• Feeling of numbness in the throat, pain when swallowing
• Tonsil hypertrophy
• Severe allergic reaction
• Dry mouth
• Blisters on the lips, lip inflammation, lip ulcers
• Salivary gland enlargement or excessive salivation
• Gastritis, gastroesophageal reflux
• Feeling of a foreign body in the throat
• Redness of the skin
• Facial swelling
• Tongue inflammation
• Allergic reaction
• Feeling of tingling on the skin
• Discomfort in the stomach
• Throat swelling
• Tearing
• Hoarseness
• Throat redness
• Blisters in the mouth

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

• Narrowing of the airways
• Ear swelling

In children, eye irritation, throat redness, mouth blisters, ear pain, and ear swelling are more common than in adults.
If you experience troublesome side effects, consult your doctor, who will determine whether it is necessary to administer anti-allergic medicines, such as antihistamines.

Reporting side effects

If you experience any side effects, including any not listed in this package leaflet, please tell your doctor or pharmacist.
Side effects can be reported directly to the Department of Post-Marketing Surveillance of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: + 48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will allow for more information to be collected on the safety of the medicine.

5. How to store Grazax

Keep out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after the term "Expiry date" or "EXP". The expiry date refers to the last day of the month.
There are no special precautions for the storage of the medicinal product.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Grazax contains

The active substance of Grazax is a standardized allergen extract from grass pollen from timothy grass (Phleum pratense).The activity of the medicine is expressed in SQ-T* units per sublingual lyophilisate.
The activity of one sublingual lyophilisate is 75,000 SQ-T units. One sublingual lyophilisate contains 6 micrograms of Phl p 5 allergen.
* (Standardised Quality units Tablet (SQ-T) – standardized quality unit of the tablet)
The other ingredients of the medicine are: gelatin (from fish), mannitol, and sodium hydroxide.

What Grazax looks like and contents of the pack

Round, white to off-white sublingual lyophilisate, marked with an embossed image on one side.
Aluminum blisters with a removable aluminum foil in an outer cardboard box. Each blister contains 10 sublingual lyophilisates. The following pack sizes are available: 30 (3 x 10), 90 (9 x 10), or 100 (10 x 10) sublingual lyophilisates.
Not all pack sizes may be marketed.

Marketing authorization holder

ALK-Abelló A/S
Bøge Allé 6-8
DK-2970 Hørsholm
Denmark

Manufacturer

ALK-Abelló S.A.
Miguel Fleta 19
28037 Madrid
Spain
Date of last revision of the package leaflet:19.12.2024