Grazax

Package leaflet: Information for the user

Grazax 75,000 SQ-T sublingual lyophilisate

Standardized allergen extract of grass pollen (Phleum pratense)
Read this entire leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. 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, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this 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 a grass pollen allergen extract. Grazax is used for the treatment of rhinitis and
conjunctivitis caused by grass pollen in adults and children (aged 5 years or older). Grazax modifies the
allergic disease by increasing immunological tolerance to grass pollen.
Children are selected for treatment by physicians experienced in managing allergic diseases in pediatric patients.
Your doctor will assess your allergic symptoms and perform a skin prick test or take a blood sample to determine whether Grazax is appropriate for your treatment.
It is recommended that the first sublingual lyophilisate be taken under medical supervision. This is a precautionary measure to evaluate each patient's sensitivity to the treatment. This will also allow you to discuss possible adverse effects with your doctor.
Grazax must be prescribed by physicians with specific experience in the treatment of allergies.

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 immune system disorders
• if you suffer from severe asthma (as assessed by your doctor)
• if you have a tumour
• if you have severe inflammation of the mouth

Warnings and precautions
Talk to your doctor before taking Grazax:

• if you have recently had a tooth extracted or undergone other forms of oral surgery. In this case, treatment with Grazax should be suspended for 7 days to allow your oral cavity to heal
• if you have a severe allergy to fish
• if you have previously experienced an allergic reaction following injection of grass pollen allergen extract
• if you have asthma and are experiencing an acute infection of the upper respiratory tract. Treatment with Grazax should be temporarily suspended until the infection resolves.
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Some adverse effects can be serious and require immediate medical attention. See section 4 for symptoms.
Children

• Loss of a deciduous tooth (milk tooth). In this case, treatment with Grazax should be suspended for 7 days to allow the oral cavity to heal.

If you are in any of the conditions described above, discuss this with your doctor before taking Grazax.
Clinical data with Grazax in elderly patients (65 years or older) are not available.
Other medicines and Grazax
Inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those not requiring a prescription. If you are taking other medicines for allergic symptoms, such as antihistamines or corticosteroids, your doctor will need to evaluate how these should be used.
Grazax with food and drink
Food and drink should not be taken until at least 5 minutes have passed after administration of this sublingual lyophilisate.
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, talk to your doctor about whether or not to continue therapy.
Currently, there is no experience with the use of Grazax during breastfeeding. No effects on breastfed infants are expected.
Driving and using machines
You are the only one who can judge your ability to drive or perform precision tasks. The effects of the medicine or its adverse reactions may affect this ability. A description of these effects is available in other sections of this leaflet. For this reason, it is essential that you read all the information contained in this leaflet.
If you have any doubts, consult your doctor or pharmacist.
Treatment with Grazax does not affect or affects negligibly the ability to drive vehicles or use machinery.

3. How to take Grazax

Always take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
How much Grazax to take

• The recommended dose is one sublingual lyophilisate per day.

How to take Grazax

• To achieve the best effect, start taking the medicine 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 at the doctor's office.

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

Continue taking Grazax every day, even though it may take some time before your allergy improves. If your allergy symptoms do not improve during the first grass pollen season, you should consult your doctor to discuss continuing the treatment.

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Before handling the medicine, make sure your hands are dry.
Take the sublingual lyophilisates as follows:

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

2. Tear off one square of the pack along the dotted lines.

3. Fold back the marked corner of the foil and then tear it away. Do not force the medicine out through the foil, as it breaks easily.

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

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5. Hold the medicine under the tongue until it has completely dissolved.
   • Do not swallow for one minute.
   • Do not eat or drink for at least 5 minutes after taking the 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 symptoms are severe, contact a doctor or hospital immediately.
If you forget to take Grazax
If you have forgotten to take a sublingual lyophilisate, take it at any time during the day. Do not take a double dose to make up for a missed dose on previous days.
If you stop taking Grazax
If you do not follow the prescribed instructions exactly, the treatment may not be effective. If you have any doubts about using Grazax, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them. Side effects may be an allergic response to the allergen you are being treated with.
In most cases, side effects last from a few minutes to several hours after taking the sublingual lyophilisate and tend to disappear within one week of starting treatment.

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

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

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

Other possible side effects:
Very common (may affect more than 1 in 10 people):

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

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

• Tingling or numbness sensation in the mouth
• Itching of the eye, lips or nose
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• Inflammation of eyes or mouth
• Shortness of breath, cough or 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, skin rash or hives
• Tiredness
• Chest discomfort
• Throat tightness
• Redness of the mouth
• Difficulty swallowing

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

• Sensation of rapid, strong or irregular heartbeat
• Altered taste
• Eye redness or irritation
• Pain or discomfort in the ear
• Numbness in the throat, painful swallowing
• Enlargement of the tonsils
• Severe allergic reaction
• Dry mouth
• Blisters on the lips, inflammation of the lips, lip ulcers
• Enlargement of the salivary glands or increased secretion
• Stomach inflammation, regurgitation
• Sensation of a foreign body in the throat
• Skin redness
• Facial swelling
• Inflammation of the tongue
• Allergic reaction
• Skin tingling sensation
• Stomach discomfort
• Swelling of the throat
• Tearing
• Hoarseness
• Red throat
• Mouth blisters

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

• Constriction of the lower airways
• Swelling of the ear

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

If you experience bothersome side effects, you should contact your doctor, who will evaluate whether you need anti-allergic medications such as antihistamines.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.

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Side effects can also be reported directly via the national reporting system at the website: http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. Reporting side effects helps provide more information on the safety of this 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 after EXP. The expiry date refers to the last day of the month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Grazax contains
The active substance is a standardized allergen extract in SQ units of grass pollen (Phleum pratense).
The activity of the sublingual lyophilisate is expressed using SQ-T* units. The activity of one sublingual lyophilisate is
75,000 SQ-T. The content of the allergen Phl p 5 in the sublingual lyophilisate is 6 micrograms.
* (Standardised Quality Units-Tablet)
The other ingredients are: gelatine (derived from fish), mannitol, and sodium hydroxide.

Description of the appearance of Grazax and the contents of the pack
Sublingual lyophilisate in white or almost white, round shape, with an imprint on one side.
Aluminium blister with a removable aluminium foil lid, packed in a cardboard box. Each blister contains 10
sublingual lyophilisates.
Available pack sizes are 10 (1x10), 30 (3x10), 90 (9x10), or 100 (10x10) 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

Concessionaire for sale
ALK-Abelló S.p.A.
Via Nino Bixio 31
20129 Milano
Italy

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