1. What is GRAZAX and what is it used for?
GRAZAX contains a grass pollen allergen extract and is available in the form of white or nearly white round oral lyophilisates (fast dissolving tablets) printed on one side. It is available in packages containing 30 or 100 oral lyophilisates.
GRAZAX is used for the treatment of rhinitis (cold-like symptoms in the nose) and conjunctivitis (inflammation of the eyes) caused by grass pollen in adults and children (5 years and older). GRAZAX changes the course of your allergy disease by increasing your immune tolerance to grass pollen. The effect is permanent after you complete your treatment.
Children to be treated should be treated by doctors experienced in the treatment of allergic diseases in children.
Your doctor will evaluate your allergy symptoms and
will perform a skin prick test or take your blood sample to determine its usability.
It is recommended that you take the first oral lyophilisate under medical supervision. This is a measure to assess the sensitivity of each patient to treatment and allows you to report any side effects you may experience to your doctor.
GRAZAX can be prescribed by doctors experienced in the treatment of allergies.
2.How to use GRAZAX?
Instructions for proper use and dose/frequency of administration
Always use GRAZAX as recommended by your doctor. If you are unsure of any situation, please consult your doctor or pharmacist.
The usual dose is one oral lyophilisate per day. For best effect, start taking GRAZAX 4 months before the expected start of the grass pollen season and continue throughout the year. Continue treatment for 3 years.
Application route and method
GRAZAX is an oral lyophilisate. Before handling oral lyophilisates, make sure your hands are dry.
3. What are the possible side effects?
Like all medicines, there may be side effects in people who are sensitive to the substances in the content of GRAZAX.
Side effects may be an allergic response to the allergen you are being treated for. In most patients, side effects persist within minutes to hours of ingestion of each oral lyophilisate and subside within a week.
If any of the following occur, stop using GRAZAX and IMMEDIATELY inform your doctor or go to the nearest hospital emergency department:
• Swelling of the face, mouth or throat
• Itchy rash
worsening of your existing asthma
These are all very serious side effects.
If you have one of these, you have a serious allergy to GRAZAX. You may need emergency medical attention or hospitalization.
Upper respiratory tract infection, abdominal pain and vomiting were reported more frequently in children than in adults.
Undesirable effects are grouped according to system organ classification and frequency: very common (affecting more than 1 user in 10 in 10), common (>1/100 to <1/10 affecting more than 1 in 100 but less than 1 in 10 people) uncommon (>1/1000 to <1/100 affecting more than 1 user in 1000 but less than 1 user in 100), rare (>1/10000 to <1/1000 affecting more than 1 user in 10000 but less than 1 user in 1000 ) and very rare (affecting less than 1 person in 10000 people in <1/10000)
Rare: Feeling of the heart beating violently, fast, or irregularly.
Infections and infestations
Uncommon: upper respiratory tract inflammation
Diseases of the blood and lymphatic system:
Uncommon: lymph node swelling
Nervous system diseases:
Common: eye itching, eye inflammation Uncommon: eye swelling
Ear and inner ear diseases
Very common: itchy ears
Uncommon: fall in blood pressure
Respiratory, thoracic and mediastinal diseases:
Very common: Throat irritation, sneezing
Common: Asthma, cough, runny or stuffy nose, feeling of tightness or swelling in the throat, inflammation of the throat and nose
Uncommon: Dry throat, shortness of breath, hoarseness, wheezing, respiratory distress
immune system diseases
Uncommon: Allergic reaction
Very common: Mouth itching, swelling in the mouth
Common: stomach pain, digestive problems such as nausea or burning, swelling of the lips, swelling of the mouth and tongue, tingling, blistering or other discomfort.
Uncommon: Diarrhoea, vomiting, sore mouth, oral inflammation, dry mouth, dysphagia, lip blister, mouth and esophagus pain, salivary gland disorders, tongue tenderness
Skin and subcutaneous tissue diseases
Common: Itching, hives
General disorders and administration site conditions
Uncommon: Chest discomfort, chest pain, chest tightness, feeling hot, feeling uncomfortable, fever, foreign body sensation in throat