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GRAZAX 75000 SQ-T ORAL LYOPHILISATE

Active substance(s): PHLEUM PRATENSE POLLEN STANDARDIZED EXTRACT

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PACKAGE LEAFLET: INFORMATION FOR THE USER

GRAZAX® 75000 SQ-T oral lyophilisate

Revision date: 01.07.2016
Leaflet Reference: GRAZSQ-T

Standardised allergen extract of grass pollen from Timothy (Phleum pratense)
Read all of this leaflet carefully before you start taking this medicine.
Taking other medicines
 Keep this leaflet. You may need to read it again
 If you have further questions, ask your doctor or pharmacist
 This medicine has been prescribed for you. Do not pass it on to others.
It may harm them, even if their symptoms are the same as yours
 If any of the side effects gets serious, or if you notice any side effects
not listed in this leaflet, please tell your doctor or pharmacist

Please tell your doctor or pharmacist if you are taking or have recently
taken any other medicines, including medicines obtained without a
prescription. If you are taking other medicines for your allergy symptoms
such as antihistamines or corticosteroids your doctor should evaluate the
use of such medicines.

In this leaflet:

Food and drink should not be taken for 5 minutes after taking this oral
lyophilisate.

Taking GRAZAX® with food and drink

1. What grazax® is and what it is used for
2. Before you take grazax®
3. How to take grazax®
4. Possible side effects
5. How to store grazax®
6. Further information

Pregnancy and breast-feeding
At present there is no experience for the use of GRAZAX® during
pregnancy. Treatment with GRAZAX® should not be initiated during
pregnancy. If you become pregnant during treatment, speak to your
doctor about whether it is appropriate for you to continue the treatment.
At present there is no experience for the use of GRAZAX® during breastfeeding. No effects on the breastfed infants are anticipated.

1. WHAT GRAZAX® IS AND WHAT IT IS USED FOR

Driving and using machines

GRAZAX® contains an allergen extract of grass pollen.
GRAZAX® is used to treat rhinitis and conjunctivitis caused by grass
pollen in adults and children (5 years or older).
GRAZAX® modifies the allergic disease by increasing immunological
tolerance towards grass pollen.
Children are carefully selected for treatment by doctors experienced in the
treatment of allergic diseases in children.
The doctor will evaluate your allergic symptoms and make a skin prick
test or take a blood sample in order to decide if GRAZAX® should be used
for treatment.
You are advised to take the first oral lyophilisate under medical
supervision. This is a precaution in order to evaluate
each patient's sensitivity to the treatment. This gives you the possibility of
discussing possible side effects with the
doctor.
GRAZAX® is prescribed by doctors with experience in treatment of
allergy.

You alone are responsible for the judgement of your ability to drive or
perform precision work. Effects or side effects from medicine may
influence this ability. A description of these effects is available in other
sections of this leaflet.
Thus, for guidance read all the information in this leaflet.
You should check with your doctor or pharmacist if you are not sure.
Treatment with GRAZAX® has no or negligible influence on the ability to
drive or use machines.
3. HOW TO TAKE GRAZAX®
Always take GRAZAX® exactly as your doctor has told you. You should
check with your doctor or pharmacist if you
are not sure.
The usual dose is one oral lyophilisate daily. To get the best effect start
taking the oral lyophilisates 4 months prior to
the expected start of the grass pollen season. It is recommended to
continue treatment for 3 years.

2. BEFORE YOU TAKE GRAZAX®

Use in children and adults

Do not take GRAZAX® if:

GRAZAX® is an oral lyophilisate. Make sure your hands are dry before
handling the oral lyophilisates. Take the oral lyophilisates like this:
1. Tear off the strip marked with triangles at the top of the oral lyophilisate
pack
2. Tear a square off the oral lyophilisate pack along the perforated lines
3. Do not force the oral lyophilisate through the foil. It may damage the
oral lyophilisate as it easily breaks. Instead, fold back the marked
corner of the foil and then pull it off
4. Remove the oral lyophilisate carefully from the foil and take the oral
lyophilisate immediately
5. Place the oral lyophilisate under the tongue. Allow it to remain there for
a few seconds until it has dissolved. Do not swallow during the first
minute. Do not eat or drink for at least 5 minutes.

 You are allergic (hypersensitive) to any of the excipients in the oral
lyophilisate
 You have an illness which affects the immune system
 You have severe asthma (as assessed by your doctor)
 You have cancer
 You have a mouth inflammation which is severe
Take special care with GRAZAX® if:
 You have recently had a tooth taken out or other forms of oral surgery.
Treatment with GRAZAX® should in this case be stopped for 7 days to
allow your oral cavity to heal
 You have severe allergy to fish
 You previously have had an allergic reaction in connection with
injection of allergen extract of grass pollen

If you take more GRAZAX® than you should
If you have taken too many GRAZAX® oral lyophilisates you may
experience allergic symptoms including local
symptoms from mouth and throat. If you experience severe symptoms,
immediately contact a doctor or a hospital.

Use in children:
 Shedding of a deciduous (milk) tooth Treatment with GRAZAX® should
in this case be stopped for 7 days to
 allow the oral cavity to heal
 In children with asthma experiencing an acute upper respiratory tract
infection, GRAZAX® treatment should be
 temporarily discontinued until the infection has resolved.
 If any of the above applies to you, talk to your doctor before taking
GRAZAX®.
There is no experience with GRAZAX® in the elderly (65 years and older).

If you forget to take GRAZAX ®
If you have forgotten to take an oral lyophilisate, take it later in the day.
Do not take a double dose on any one day
to make up for a forgotten oral lyophilisate.
If you stop taking GRAZAX®
If you do not take this medicine as prescribed, you may not have an effect
of the treatment. If you have any further
questions on the use of this product, ask your doctor or pharmacist.

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INSTRUCTIONS

4.POSSIBLE SIDE EFFECTS

5. HOW TO STORE GRAZAX®

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

Like all medicines, this medicine can cause side effects, although not
everybody gets them.
The side effects may be an allergic response to the allergen you are
being treated with. In most cases the side effects last from minutes to
hours after taking the oral lyophilisate and settles down within one week
of starting the treatment.

Keep out of the reach and sight of children.

Stop the intake of GRAZAX® and contact your doctor or hospital
immediately if you experience any of the following symptoms:
Rapid swelling of face, mouth or throat
Difficulties in swallowing
Difficulties in breathing
Hives
Voice changes
Worsening of existing asthma
Severe discomfort

2.Tear a square off the oral lyophilisate pack along the perforated lines

Possible other side effects:
Very common (may affect more than 1 in 10 people):
Common cold
Mouth itching
Irritating sensation in the throat
Common (may affect up to 1 in 10 people):
Headache
Prickling sensation or numbess of the skin, mouth or tongue
Eye or ear itching
Eye, nose or mouth inflammation
Asthma symptoms, shortness of breath, cough or sneezing
Dry throat
Nasal discomfort, stuffy or runny nose
Swelling for example of lips or tongue
Blistering or other discomfort of mouth, tongue or throat
Stomach pain or discomfort, diarrhoea, feeling sick, vomiting
Heartburn
Itching in relation with for example rash, nettle rash or eczema
Tiredness
Chest discomfort or pain
Fever

3. Do not force the oral lyophilisate through the foil. It may damage the
oral lyophilisate as it easily breaks. Instead, fold back the marked corner
of the foil and then pull it off

Uncommon (may affect up to 1 in 100 people):
Sensation of rapid, forceful or irregular beating of the heart
Lymph node swelling
Dizziness
Altered taste, decreased appetite
Eye redness, irritation or swelling, tear flow
Ear pain or discomfort
Hoarseness
Tightness, redness or numbness in the throat, painful swallowing
Tonsil enlargement
Allergic reaction
Mouth redness or pain, dry mouth, swelling of roof of the mouth
Lip blister, lip inflammation
Salivary gland enlargement or hypersecretion
Gum swelling or pain
Gastritis, regurgitation
Feeling hot, feeling of discomfort
Sensation of foreign body in the throat
Skin redness, flushing
Swelling of face or throat

4. Remove the oral lyophilisate carefully from the foil and take the oral
lyophilisate immediately

Do not use GRAZAX® after the expiry date stated on the blister and the
carton after EXP. The expiry date refers to the last day of that month. This
medicinal product does not require any special storage conditions.
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 to protect the environment.
6. FURTHER INFORMATION
What GRAZAX® contains
The active substance is SQ standardised allergen extract of grass pollen
from Timothy (Phleum pratense). The activity per oral lyophilisate is
expressed using the unit SQ-T*. The activity of one oral lyophilisate is
75000 SQ-T.
* Standardised Quality units Tablet (SQ-T)
The other ingredients are gelatine (fish source), mannitol and sodium
hydroxide.
What GRAZAX® looks like and contents of the pack
White to off-white circular oral lyophilisate marked with a debossed image
on one side.
Aluminium blister cards with removable aluminium foil in an outer box of
carton. Each blister card contains 10 oral lyophilisates.
Following packages are available:
30 (3x10), 90 (9x10) or 100 (10x10) oral lyophilisates.
Not all pack sizes may be marketed.
Who manufactured your medicine
Manufactured by ALK-Abelló A/S, Bøge Allé 6-8, DK-2970 Hørsholm,
Denmark. Procured from within the EU and repackaged by Product
Licence holder: Beachcourse Limited, 20 Alliance Court, Alliance Road,
London W3 0RB.
PL 16378/0572

POM

Revision date: 01.07.2016
Leaflet Reference: GRAZSQ-T

GRAZAX® is a trademark of ALK-Abello A/S

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

5. Place the oral lyophilisate under the tongue. Allow it to remain there for
a few seconds until it has dissolved. Do not swallow during the first
minute. Do not eat or drink for at least 5 minutes

Eye irritation, ear pain, lip blister, salivary gland enlargement, throat
redness, skin redness, allergic reaction and chest pain are reported more
frequently in children than in adults.
If you have troublesome side effects, you should contact your physician
who will determine the anti-allergy medicines you may require, such as
antihistamines.
If you get any side effects talk to your doctor or pharmacist. This includes
any possible side effects not listed in this leaflet.
Reporting of side effects:
If you get any side effects, talk to your doctor, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the
safety of this medicine.
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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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