Grazax PACKAGE LEAFLET: INFORMATION
FOR THE USER
Patient information leaflet
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® is used to treat rhinitis and conjunctivitis caused
by grass pollen in adult patients.
GRAZAX® is prescribed by doctors with experience in treatment
of allergy.
2. Before you take GRAZAX®
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 an inflamed mouth 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
If any of the above applies to you, talk to your doctor before
taking GRAZAX®.
There is no experience with GRAZAX® in children or the
elderly.
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
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.
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.
You are advised to take the first oral lyophilisate under
medical supervision. This gives you the possibility of discussing
possible side effects with the
doctor.
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 and continue throughout the pollen season.
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
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 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.
4. Possible side effects
Like all medicines, GRAZAX® 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.
Very common (affecting more than 1 in 10 people):
Itching in the mouth and ears, irritation of the throat, sneezing
and swelling in the mouth.
Common (affecting more than 1 in 100 but
less than 1 in 10 people): Itchy eyes, inflammation in the
eyes, stuffy or runny nose. Swelling, prickling,
numbness, blistering, or other discomforts of mouth and tongue.
Fatigue, headache. Itching. A feeling of swelling or tightness
in the throat, coughing,
asthma. Gastrointestinal problems such as stomach pain, feeling
sick and heartburn. Inflammation in the throat.
Uncommon (affecting more than 1 in 1000 but
less than 1 in 100 people): Lip blister, mouth ulceration,
pain in mouth and gullet, inflammation in the
mouth, dryness of mouth and throat, affection of the tongue,
salivary gland disorders, difficulty in swallowing, vomiting,
diarrhoea. Feeling of swollenness
in the throat, discomfort at breathing, short of breath, wheezing
breath, hoarseness. Inflammation of the nose and throat. Infection
of the upper respiratory
tract. Dizziness. Lymph node disease. Chest discomfort, chest
pain, chest tightness. Feeling hot, feeling of discomfort,
fever. Sensation of foreign
body in the throat. Eye swelling.
Stop the intake of GRAZAX® and contact your doctor
or hospital immediately if you experience any of the following
symptoms:
- Swelling of the face, mouth or throat
- Difficulties in swallowing
- Rash
- Difficulties in breathing
- Voice changes
- Worsening of existing asthma
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 notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
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.
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. Following packages are available: 30
or 100 oral lyophilisates.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
ALK-Abelló A/S
Bøge Allé 6-8
DK-2970 Hørsholm
Denmark
This leaflet was last approved in 2006-09-25
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