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GRAZAX 75 000 SQ-T ORAL LYOPHILISATE

Active substance: PHLEUM PRATENSE

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GRAZAX®
75 000 SQ-T
Phleum pratense

1054604

1054604_PIL_UKIE_GR_draft131127_Grazax UK_IE 27-11-2013 13:39 Side 1

PACKAGE LEAFLET:
INFORMATION FOR THE USER
GRAZAX® 75 000 SQ-T oral
lyophilisate
Standardised allergen extract of grass
pollen from Timothy (Phleum pratense)
Read all of this leaflet carefully
before you start taking this
medicine.
- 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
In this leaflet:
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

1. What GRAZAX® is and what
it is used for
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.

Draft 0 (27.12.2013)

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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.

2. Before you take GRAZAX®

Taking other medicines
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.
Taking GRAZAX® with food and
drink

Do not take GRAZAX® if:
- 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
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

Food and drink should not be taken for
5 minutes after taking this oral
lyophilisate.
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 breast-feeding.
No effects on the breastfed infants
are anticipated.
Driving and using machines
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.

- In children with asthma experiencing
an acute upper respiratory tract infection, GRAZAX® treatment should be
temporarily discontinued until the
infrection 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).

®

the oral lyophilisates 4 months prior to
the expected start of the grass pollen
season. It is recommended to continue
treatment for 3 years.

Instruction

Use in children and adults
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.
If you take more GRAZAX® than
you should

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

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.
If you forget to take GRAZAX®

Treatment with GRAZAX has no or
negligible influence on the ability to drive
or use machines.

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.

3. How to take GRAZAX

If you stop taking GRAZAX

Always take GRAZAX exactly as your
doctor has told you. You should check
with your doctor or pharmacist if you
are not sure.

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.

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

®

®

®

The usual dose is one oral lyophilisate
daily. To get the best effect start taking

1 min

5 min

®

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

1054604_PIL_UKIE_GR_draft131127_Grazax UK_IE 27-11-2013 13:39 Side 2

GRAZAX®
75 000 SQ-T

4. Possible side effects

Phleum pratense

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.

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

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
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

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

Lower airways constriction

5. How to store GRAZAX®
Keep out of the reach and sight of
children.
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 75,000 SQ-T.
* Standardised Quality units Tablet
(SQ-T)
The other ingredients are gelatine (fish
source), mannitol and sodium hydroxide.

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.

What GRAZAX® looks like and
contents of the pack

If you have troublesome side effects, you
should contact your physician who will
determine the anti-allergy medicines you
may require, such as antihistamines.

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.

If you get any side effects talk to your
doctor or pharmacist. This includes any
possible side effects not listed in this
leaflet.
You can also report side effects directly
via the MHRA Yellow Card Scheme at
www.mhra.gov.uk/yellowcard (UK) or
the IMB Pharmacovigilance Section at
www.imb.ie.
E-mail:imbpharmacovigilance@imb.ie
(Ireland) By reporting side effects you
can help provide more information on
safety of this medicine.

White to off-white circular oral
lyophilisate marked with a debossed
image on one side.

Not all pack sizes may be marketed.
Marketing Authorisation Holder
and Manufacturer
ALK-Abelló A/S
Bøge Allé 6-8
DK-2970 Hørsholm
Denmark

Distributor
ALK-Abelló Ltd.
1 Manor Park,
Manor Farm Road,
Reading, Berkshire,
RG2 0NA
UK
For information in Large Print, tape,
CD or Braille, please phone
+44 (0) 118 903 7940
This leaflet was last revised in
December 2013

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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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