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1059200_PIL_UKIE_GR_160121_Grazax UKIE 21-01-2016 14:55 Side 1

order to evaluate each patient´s sensitivity to the
treatment. This gives you the possibility of
discussing possible side effects with the doctor.

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

Grazax is prescribed by doctors with experience in
treatment of allergy.

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.

2. Before you take Grazax
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
- 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
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

21.01.2016 ALK Madrid

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
- You have severe asthma (as assessed by your
- 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
Some side effects can be severe and need immediate
medical care. Please see section 4 for symptoms.
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).
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.


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

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.

At present there is no experience for the use of
Grazax during breast-feeding. No effects on the
breastfed infants are anticipated.

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

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

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.

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.
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

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

1059200_PIL_UKIE_GR_160121_Grazax UKIE 21-01-2016 14:55 Side 2

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.
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
Voice changes
Worsening of existing asthma
Severe discomfort

If you experience persisting heartburn you should
contact your physician
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 numbness 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

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

5. How to store Grazax

- 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

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)

Rare (may affect up to 1 in 1,000 people):
- Lower airways constriction
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
Reporting of side effects
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 (UK) or the
HPRA Pharmacovigilance Section at
E-mail: (Ireland)
By reporting side effects you can help provide more
information on safety of this medicine.


The other ingredients are gelatine (fish source),
mannitol and sodium hydroxide.
What Grazax looks like and contents of the
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.
Marketing Authorisation Holder and
ALK-Abelló A/S
Bøge Allé 6-8
DK-2970 Hørsholm
This leaflet was last revised in July 2015

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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.