Grazax

Package leaflet: Information for the user

GRAZAX, 75 000 SQ-T, sublingual lyophilisate
Standardised allergen extract from Timothy grass pollen (Phleum pratense)
Please 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, please 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 leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents:

1. What Grazax is and what it is used for
2. What you need to know before you take 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 to treat rhinitis and conjunctivitis caused by grass pollen in adults and children (aged 5 years and older).
Grazax relieves allergic symptoms by increasing immunological tolerance to grass pollen.
Children should be selected for treatment by doctors experienced in managing allergic diseases in children.
Your doctor will assess your allergic symptoms and perform skin tests or order blood tests to determine whether Grazax should be used.
It is recommended that the first sublingual lyophilisate be taken under medical supervision. This precaution allows evaluation of the patient's individual sensitivity to treatment and discussion with the doctor of any possible side effects.
Grazax should be prescribed by doctors experienced in the management of allergic diseases.

2. Important information before using Grazax

When not to use Grazax

• if you are allergic (hypersensitive) to any of the ingredients of this medicine (listed in section 6),
• if you have a disease affecting the immune system,
• if you have severe asthma (diagnosed by a doctor),
• if you have malignant cancer,
• if you have a severe inflammatory condition of the oral cavity.

Warnings and precautions
Before starting treatment with Grazax, discuss with your doctor:

• if you have recently had a tooth extracted or undergone other oral surgical procedures. In such a case, treatment with Grazax should be interrupted for 7 days to allow healing of the oral cavity,
• if you have severe allergy to fish,
• if you have previously experienced an allergic reaction after receiving allergen extract injections containing grass pollen,
• if you have asthma and currently suffer from an acute respiratory tract infection. Treatment with Grazax should be temporarily suspended until the infection resolves.

Some adverse reactions may be severe and require immediate medical attention.
Symptoms, see section 4.
Children

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

If any of the above situations apply, you should consult your doctor before using Grazax.
There is no experience with the use of Grazax in elderly patients (aged 65 years or older).
Grazax with other medicines
You should inform your doctor or pharmacist about all medicines you are currently taking or have recently taken, including those obtained without a prescription. If you are taking other medications for allergies, such as antihistamines or corticosteroids, your doctor should evaluate whether their use is appropriate.
Taking Grazax with food and drink
Do not eat or drink anything for 5 minutes after administering the sublingual lyophilisate.
Pregnancy, breastfeeding and fertility
Currently, there are no data on the use of Grazax during pregnancy. You should not start treatment with Grazax during pregnancy. If you become pregnant while undergoing treatment, consult your doctor whether continuing treatment is advisable.
Currently, there is no experience with the use of Grazax during breastfeeding. A significant effect of the medicine on the breastfed infant is not expected.
Driving and operating machinery
It is the patient's responsibility to assess their ability to drive or perform precision tasks. Adverse effects or symptoms of the medicine may affect this ability. A description of these effects is provided in other sections of this leaflet. Therefore, you should read all the information provided in this leaflet carefully.
If in doubt, contact your doctor or pharmacist again.
Treatment with Grazax has no effect or negligible effect on the ability to drive motor vehicles or operate mechanical equipment.
Grazax contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per sublingual lyophilisate, meaning the medicine is considered "sodium-free".

3. How to use Grazax

This medicine should always be used as directed by the physician. In case of doubt, consult
your doctor or pharmacist.
How much Grazax should be taken

• The recommended dose is one sublingual lyophilisate per day.

How to take Grazax

• For best results, treatment should be started at least 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 should be taken in a doctor's office because:

• After taking the first dose, the patient should remain under medical supervision for at least 30 minutes.
• This precaution allows assessment of the individual patient's sensitivity to treatment.
• It also enables discussion with the doctor regarding possible adverse effects.

Grazax should be taken daily, even if it takes some time before improvement occurs.
If allergy symptoms do not improve during the first grass pollen season, contact your
doctor to discuss continuing treatment.
Before handling the medicine, ensure that your hands are dry.
Sublingual lyophilisates should be taken as follows:

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

2. Tear off one square from the package along the dotted line.

3. Fold the corner of the foil marked with an arrow, then pull it gently. Do not push the medicine through the foil, as the lyophilisate may easily break.

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

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

Taking more Grazax than recommended
If too many sublingual lyophilisates of Grazax are taken, the patient may experience
allergic symptoms, including local reactions in the mouth and throat. If symptoms are
severe, contact a doctor immediately or go to a hospital.
Missing a dose of Grazax
If a sublingual lyophilisate is missed, take it later the same day. Do not take a double
dose in one day to make up for a missed dose.
Stopping Grazax treatment
Effective treatment depends on taking the medicine exactly as prescribed by the doctor.
If you have any further doubts about using this medicine, consult your
doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
An adverse reaction may be an allergic response to the allergen the patient is being treated for.
In most cases, adverse reactions last from several minutes to several hours after taking the sublingual lyophilisate and resolve within one week of starting treatment.

Serious adverse reactions
You should stop taking Grazax and contact your doctor or hospital immediately if any of the following symptoms occur:

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

If persistent heartburn occurs, you should contact your doctor.

Other possible adverse reactions:
Very common (may affect more than 1 in 10 people):

• Swelling in the mouth
• Itching in the mouth or ears
• Throat irritation

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

• Tingling or numbness in the mouth
• Itching of the eyes, lips or nose
• Inflammation of the eyes or mouth
• Shortness of breath, cough, sneezing
• Dry throat
• Runny nose
• Swelling of the eyes or lips
• Mouth ulcers
• Blisters, pain or discomfort in the mouth or throat
• Stomach pain, diarrhoea, nausea, vomiting
• Heartburn
• Itching, rash or hives
• Fatigue
• Unspecified discomfort in the chest
• Throat tightness
• Redness in the mouth

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

• Sensation of rapid, strong or irregular heartbeat
• Taste disturbances
• Redness or irritation of the eyes
• Ear pain or discomfort in the ear
• Numbness in the throat, pain when swallowing
• Tonsillar hypertrophy
• Severe allergic reaction
• Dry mouth
• Blisters on the lips, lip inflammation, lip ulceration
• Enlargement of salivary glands or excessive salivation
• Gastritis, gastroesophageal reflux
• Foreign body sensation in the throat
• Skin redness
• Facial swelling
• Glossitis
• Allergic reaction
• Skin tingling
• Gastric discomfort
• Throat swelling
• Tearing
• Hoarseness
• Sore throat
• Blisters in the mouth

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

• Constriction of the lower airways
• Swelling of the ears

In children, eye irritation, sore throat, blisters in the mouth, ear pain and swelling of the ears were observed more frequently than in adults.

If troublesome adverse reactions occur, you should contact your doctor, who will decide whether anti-allergic treatment, such as antihistamines, is necessary.

Reporting of adverse reactions
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration 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
Adverse reactions may also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store 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 carton following
"Expiry date" or "EXP". The expiry date refers to the last day of the stated month.
No special storage precautions are required for this medicinal product.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. These measures will help
protect the environment.

6. Contents of the pack and other information

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

What Grazax looks like and contents of the pack
Round, white to off-white sublingual lyophilisate, marked on one side with an embossed image.
Aluminium blisters with removable aluminium foil, packed in an outer cardboard box. Each blister
contains 10 sublingual lyophilisates. The following pack sizes are available: 10 (1 x 10), 30 (3 x
10), 90 (9 x 10), or 100 (10 x 10) sublingual lyophilisates.
Not all pack sizes may be marketed.

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

Manufacturer
ALK-Abelló S.A.
Miguel Fleta 19
28037 Madrid
Spain