GRAZAX 75,000 SQ-T Liofilizowany podjęzykowo
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Treść ulotki
Grazax 75.000 SQ-T lyophilized sublingual
Standardized pollen extract of Grasses (Phleum pratense)
Read this leaflet carefully before taking this medicine as 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 pass it on to others, even if they have the same symptoms as you, as it could be harmful.
- If you get any side effects, even 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 you take 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 is Grazax and what is it used for
Grazax contains an allergenic extract of Grass pollen .Grazax is used for the treatment of rhinitis and
conjunctivitis caused by grass pollen in adults and in children (5 years or older). Grazax modifies the disease
allergy by increasing immunological tolerance to grass pollen.
Children are selected for treatment by doctors experienced in the treatment of allergic diseases in
pediatrics.
The doctor will assess your allergic symptoms and perform a skin test (skin prick test) or take a blood sample in order to decide if Grazax can be used for treatment.
It is recommended to take the first sublingual lyophilate under the supervision of the doctor. This is a precaution
in order to assess the sensitivity of each patient to the treatment. In this way you will have the opportunity to discuss with
the doctor any possible undesirable effects.
Grazax must be prescribed by doctors with specific experience in the treatment of allergies.
2. What you need to know before you take 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 disorders of the immune system
- if you have severe asthma (evaluated by your doctor)
- if you have cancer
- if you have a severe inflammation of the mouth
Warnings and precautions
Talk to your doctor before taking Grazax:
- if you have recently had a tooth extracted or have 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 had a previous allergic reaction in relation to the injection of grass pollen allergen extract
- if you have asthma and have an acute infection of the upper respiratory tract. Treatment with Grazax should be temporarily suspended until the infection resolves.
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Some side effects can be serious and require immediate medical attention. See section 4 for the
symptoms.
Children
- Loss of a deciduous tooth (baby 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, talk to your doctor before taking Grazax.
No clinical data are available with Grazax in the elderly (65 years or older).
Other medicines and Grazax
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including
those available without a prescription. If you are taking other medicines for allergy symptoms, such as antihistamines
or corticosteroids, your doctor will need to evaluate how to use these medicines.
Grazax with food and drink
Food and drinks should not be taken before 5 minutes have passed after taking this sublingual lyophilate.
Pregnancy, breastfeeding and fertility
Currently, there is no experience with the use of Grazax during pregnancy. Treatment with Grazax
should not be started during pregnancy. If you become pregnant during 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 are expected
on breastfed infants.
Driving and operating machinery
You are the only one able to judge your ability to drive or perform precision work. The effects of the medicine
or its side effects can affect this ability. A description of these effects is available in
other sections of this leaflet. For this reason, you need to read all the information contained in this
leaflet.
If you have any doubts, consult your doctor or pharmacist.
Treatment with Grazax does not alter or negligibly alters the ability to drive vehicles or operate
machinery.
3. How to take Grazax
Always take this medicine exactly as your doctor has instructed. 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 start 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 observation for about half an hour after taking the first dose.
- This is a precaution to check your sensitivity to the medicine.
- This will also give you the opportunity to discuss any side effects you may experience with your doctor.
Continue to take Grazax every day, even if it takes some time before your allergy improves. If the symptoms
of your allergy do not improve during the first grass pollen season, you should consult your doctor to
discuss continuing treatment.
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Before handling the medicine, you must make sure your hands are dry.
Take the sublingual lyophilisates as follows:
- 1. Tear off the strip marked with triangles at the top of the pack.
- 2. Tear off a square of the pack along the dashed lines.
- 3. Fold back the marked corner of the film and then tear it off. Do not force the medicine out through the film as it breaks easily.
- 4. Carefully remove the medicine from the film and place it immediately under your tongue.
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- 5. Hold the medicine under your tongue until it has dissolved.
- Do not swallow for one minute.
- Do not take food or drinks 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 symptoms at
the level of the mouth and throat. If the 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 in the previous days.
If you stop taking Grazax
If you do not follow the instructions exactly as prescribed, the treatment may not be effective. If
you have any doubts about the use of Grazax, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects may be an allergic reaction to the allergen with which you are being treated.
In most cases, side effects last from a few minutes to several hours after taking the
sublingual lyophilate and tend to disappear within a week of starting treatment.
Serious side effects:
Stop taking Grazax and contact your doctor or hospital immediately if you experience any of the
following symptoms:
- Rapid swelling of the face, mouth or throat
- Difficulty swallowing
- Difficulty breathing
- Urticaria (hives)
- Change in voice
- Worsening of pre-existing asthma
- Severe discomfort
If you experience persistent heartburn, you should contact your doctor.
Possible other 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):
- Sensation of tingling or numbness 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, diarrhea, nausea, vomiting
- Heartburn
- Itching, rash or urticaria (hives)
- Fatigue
- Chest discomfort
- Constriction of the throat
- Redness of the mouth
- Difficulty swallowing
Uncommon (may affect up to 1 in 100 people):
- Sensation of a fast, strong or irregular heartbeat
- Alteration of taste
- Redness or irritation of the eyes
- Ear pain or discomfort
- Numbness in the throat, painful swallowing
- Enlargement of the tonsils
- Severe allergic reaction
- Dry mouth
- Blisters on the lips, inflammation of the lips, ulcers of the lips
- Enlargement of the salivary glands or hypersecretion
- Inflammation of the stomach, regurgitation
- Sensation of a foreign body in the throat
- Redness of the skin
- Swelling of the face
- Inflammation of the tongue
- Allergic reaction
- Skin tingling sensation
- Stomach discomfort
- Swelling of the throat
- Tearing
- Hoarseness
- Red throat
- Blisters in the mouth
Rare (may affect up to 1 in 1000)
- Constriction of the lower airways
- Swelling of the ear
Eye irritation, red throat, blisters in the mouth, ear pain and swelling of the ear have been
reported more frequently in children than in adults.
If you experience troublesome side effects, you should contact your doctor who will assess the allergy medications you
may need, such as antihistamines.
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.
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You can also report side effects directly through the national reporting system
at http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . Reporting side effects helps to 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 which is stated on the blister and the box 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 any medicine in waste water or household waste. Ask your pharmacist how to dispose of medicines
that 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 allergenic extract in SQ of grass pollen ( Phleum pratense).
The activity per sublingual lyophilisate is expressed using SQ-T* units. The activity of a sublingual lyophilisate is
- 75,000 SQ-T. The content of the Phl p 5 allergen per sublingual lyophilisate is 6 micrograms. * (Standardised Quality Units-Tablet)
The other ingredients are: gelatin (obtained from fish), mannitol and sodium hydroxide.
Description of the appearance of Grazax and contents of the pack
Sublingual lyophilisate of round shape, white or almost white, with an image imprinted on one side.
Aluminum blisters with a removable aluminum foil inserted in a cardboard box. Each blister contains 10
sublingual lyophilisates.
Available pack sizes are 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
Distributor for sales
ALK-Abelló S.p.A.
Via Nino Bixio 31
20129 Milan
Italy
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- Kraj rejestracji
- Postać farmaceutycznaSublingual lyophilized, 75,000 SQ-T
- Kod ATCV01AA02
- Substancja czynna
- Wymaga receptyTak
- Producent
- Te treści mają charakter wyłącznie informacyjny i nie zastępują konsultacji lekarskiej.
- Zamienniki GRATSAXPostać farmaceutyczna: Sublingual tablet, 100IR & 300IRSubstancja czynna: grass pollenProducent: STALLERGENESWymaga receptyPostać farmaceutyczna: Sublingual lyophilized, 12 SQ-HDMSubstancja czynna: house dust mitesProducent: ALK-ABELLO A/SWymaga receptyPostać farmaceutyczna: Injectable suspension, 100.000 SQ U/MLSubstancja czynna: insectsProducent: ALK-ABELLO A/SBez recepty
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GRATSAX wymaga recepty w Włochy. Możesz skonsultować się z lekarzem online, aby sprawdzić, czy ten lek może być odpowiedni w Twojej sytuacji.
Substancją czynną w GRATSAX jest grass pollen. Informacja ta pomaga rozpoznać leki o tym samym składzie, ale pod różnymi nazwami handlowymi.
GRATSAX jest produkowany przez ALK-ABELLO A/S. Nazwy handlowe i opakowania mogą się różnić w zależności od dystrybutora.
Lekarze, tacy jak Lekarze rodzinni, Psychiatrzy, Dermatolodzy, Kardiolodzy, Endokrynolodzy, Gastroenterolodzy, Pulmonolodzy, Nefrolodzy, Reumatolodzy, Hematolodzy, Zakaźnicy, Alergolodzy, Geriatrzy, Pediatrzy, Onkolodzy, mogą ocenić, czy stosowanie GRATSAX jest odpowiednie w Twoim przypadku, w zależności od sytuacji klinicznej i lokalnych przepisów. Możesz umówić konsultację online, aby omówić objawy i możliwe dalsze kroki.
Polska posiada dobrze rozwiniętą infrastrukturę ochrony zdrowia w dużych miastach, takich jak Warszawa, Kraków, Wrocław i Gdańsk. Apteki są łatwo dostępne i działają zgodnie z obowiązującymi przepisami, zapewniając dostęp do leków na receptę.
Możesz kupić GRATSAX w Warszawie, Krakowie, Wrocławiu lub Gdańsku w każdej aptece, posiadając ważną receptę.
Aby uzyskać receptę, możesz skorzystać z Oladoctor:
Inne leki zawierające tę samą substancję czynną (grass pollen) to m.in. ORALAIR, AKKARITSAX, ALUTARD APIS MELLIFERA. Mogą one różnić się nazwą handlową lub postacią, ale zawierają ten sam składnik terapeutyczny. Przed zmianą lub rozpoczęciem nowego leku skonsultuj się z lekarzem.
