How does it work?

Grazax sublingual tablets contain a standardised extract ofgrass pollen allergen from Timothy grass (Phleum pratenase). The tablets are atype of medicine called immunotherapy. They are used to treat hayfever causedspecifically by an allergy to grass pollen.

It is not fully understood how the medicine works. However, thegrass pollen extract is thought to stimulate the body’s immune system toproduce antibodies against grass pollen. These antibodies can then bind to anygrass pollen that you encounter during the grass pollen season and prevent itfrom causing allergic symptoms.

The medicine is used to prevent hayfever symptoms such as ablocked or runny nose (allergic rhinitis) and itchy, red watery eyes (allergicconjunctivitis) that are caused by a grass pollen allergy. Theallergy must be diagnosed with a positive skin prick test and/or specific IgEtest to grass pollen. The therapy will only work in people with this specificallergy.

To have the greatest effect, the tablets should ideally bestarted four months before the grass pollen season starts. However, some effectwill still be seen if they are started two to three months before theseason begins. The tablets are taken once a day and should be continuedall year round.

If your allergic symptoms do not improve during the first years pollen season yourdoctor will not continue to prescribe the tablets,because they are unlikely to be effective for the following years pollen season.

In adults, if your symptoms do improve in the first year of treatment they are likely to continue to improve, and it is recommended that you continue the treatment for three years. The medicine has not been studied for longer than one year in children.

Grazax tablets are known as oral lyophilisates. They aredesigned to dissolve in the saliva underneath the tongue, so the medicine canbe absorbed from the rich supply of blood vessels in this area.

What is it used for?

• Hay fever symptoms such as a runny or blocked nose (allergic rhinitis) and itchy, red, watery eyes (allergic conjunctivitis) caused by grass pollen allergy in adults and children aged five years and over. (The allergy must be diagnosed with a positive skin prick test and/or specific IgE test).

Warning!

• Grazax tablets are fragile and should not be forced through the foil on the blister pack as they will break easily. Instead, fold back the marked corner of the foil and pull it off. Remove the tablet using dry fingers and immediately place it under the tongue. Leave it there for a few seconds until it dissolves and is absorbed from under the tongue. Try not to swallow for a minute. You should not eat or drink for at least five minutes after taking the tablet.
• The first dose of this medicine should be taken under medical supervision, so if you get any side effects they can be treated if necessary, or discussed with your doctor.
• This medicine contains the allergen that you are allergic to. As a result, it may initially cause mild local side effects that are allergic responses. These usually settle down within a week of starting the treatment. The most common allergic responses are itching in the mouth and ears, throat irritation, sneezing and swelling in the mouth. These may last for a few minutes to a few hours after taking a tablet. If side effects are troublesome you could talk to your doctor about taking an antihistamine. If you experience symptoms of a more severe allergic reaction, such as swelling of the face, mouth or throat, difficulty swallowing or breathing, voice changes, worsening of asthma, or a rash, you should stop taking this medicine and consult your doctor or hospital immediately.
• Do not exceed the prescribed dose. If you take more tablets than you should they may cause severe allergic symptoms, including symptoms in the mouth and throat.
• If you have a tooth removed, or any other dental surgery or surgery on your mouth, or if a child's milk tooth falls out, this medicine should be stopped for seven days afterwards to allow the mouth to heal.
• You should not give this medicine to anyone else, even if they have the same symptoms as you, because it may not be suitable or effective for their allergy.
• This medicine has not been studied fully in people aged over 65 years or in children aged under five years, and it is not recommended for these age groups.

Use with caution in

• People who have recently had surgery on the mouth, a tooth removed, or a tooth fall out (this medicine should be stopped for seven days - see warning above).
• Asthma. (If it seems like your asthma is getting worse you should stop taking this medicne and consult your doctor straight away. If a child with asthma gets an infection in their airways they should stop taking this medicine until the infection has cleared up.)
• Severe allergy to fish (Grazax tablets contain gelatine derived from fish).

Not to be used in

• Diseases affecting the immune system, for example autoimmune diseases, immune complex diseases or immune deficiency diseases.
• Cancer.
• Uncontrolled or severe asthma.
• Severe inflammation of the mouth, for example due to lichen planus or severe fungal infections.

This medicine should not be used if you are allergic to one orany of its ingredients. Please inform your doctor or pharmacist if you havepreviously experienced such anallergy.If you feel you haveexperienced an allergic reaction, stop using this medicine and inform yourdoctor or pharmacist immediately.

Pregnancy and breastfeeding

Certain medicines should not be used during pregnancy orbreastfeeding. However, other medicines may be safely used in pregnancy orbreastfeeding providing the benefits to the mother outweigh the risks to theunborn baby. Always inform your doctor if you are pregnant or planning apregnancy, before using any medicine.

• Treatment with Grazax should not be started in pregnant women, as the effects of Grazax during pregnancy are not yet known.
• If you get pregnant while taking this medicine you should tell your doctor. They will let you know if you can continue this treatment after assessing your general condition and how you have reacted to the medicine in the past.
• If you have asthma your doctor will want to monitor you more closely if you continue this treatment during pregnancy.
• This medicine has not been studied in women who are breastfeeding. The manufacturer states that no effects on breastfed infants are expected. Seek medical advice from your doctor.

Side effects

Medicines and their possible side effects can affect individualpeople in different ways. The following are some of the side effects that areknown to be associated with this medicine. Just because a side effect is statedhere does not mean that all people using this medicine will experience thator any side effect. The following are some of the side effects that are knownto be associated with this medicine.

Very common (affect more than 1 in 10 people)

• Swelling and itching in the mouth.
• Sneezing.
• Itching in the ears.
• Throat irritation.

Common (affect between 1 in 10 and 1 in 100 people)

• Itchy eyes.
• Conjunctivitis.
• Runny or blocked nose.
• Swelling in the mouth or throat.
• Throat tightness.
• Cough.
• Asthma.
• Tingling or numb sensations in the mouth.
• Blistering in the mouth.
• Swollen or painful tongue.
• Headache.
• Indigestion.
• Feeling sick (nausea).
• Itching.
• Feeling tired (fatigue).

Uncommon (affect between 1 in 100 and 1 in 1000 people)

• Dizziness.
• Eye swelling.
• Upper airway infection.
• Mouth ulcers or sores.
• Dry mouth and throat.
• Vomiting.
• Diarrhoea.
• Abdominal pain.
• Swollen glands.
• Shortness of breath, wheezing or asthma attack.
• Voice changes/hoarseness.
• Difficulty or pain when swallowing.
• Nettle-type rash (hives or urticaria).
• Chest pain or tightness.
• Severe swelling of the face, mouth, tongue and throat (angioneurotic oedema).
• Fever or feeling hot.

If you experience any swelling of the face, mouth or throat, feeling of fullness in the throat, difficulty swallowing or breathing, voice changes, worsening of asthma, or a rash after taking this medicine, you should consult your doctor or hospital immediately.

The side effects listed above may not include all of the sideeffects reported by the medicine'smanufacturer.For moreinformation about any other possible risks associated with this medicine,please read the information provided with the medicine or consult your doctoror pharmacist.

How can this medicine affect other medicines?

It is important to tell your doctor or pharmacist what medicinesyou are already taking, including those bought without a prescription andherbal medicines, before you start treatment with this medicine. Similarly,check with your doctor or pharmacist before taking any new medicines whiletaking this one, to ensure that thecombination issafe.

Other medicines containing the same active ingredient

There are currently no other medicines available in the UK thatcontain stardardised allergen extracts of grass pollen from Timothy (Phleumpratense).