Grazax – Allergen, timotejpollen uses, dose and side effects

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75,000 SQ-T lyophilised tablet
Standardized allergen extract from timothy (Phleum pratense)

1. What Grazax is and what it is used for

Grazax contains allergenic extracts of grass pollen. Grazax is used to treat hay fever ( rhinitis ) and eye inflammation ( conjunctivitis ) caused by grass pollen allergy in adults and children from five years of age. Grazax affects allergic disease by increasing the immune system’s tolerance to grass pollen.

When treating children, patients are selected by doctors who have experience in treating allergic diseases in children.

Your doctor will investigate your allergic symptoms, and perform a spot test or blood test to determine if you should be treated with Grazax.

It is recommended that you take the first tablet at the doctor’s office. It is a precautionary measure to assess how sensitive you are to the treatment and allows you to discuss any side effects with your doctor.

Grazax is prescribed by a doctor who has experience in the treatment of allergic diseases.

2. What you need to know before taking Grazax

Do not take Grazax

  • if you are allergic to any of the other ingredients of this medicine (listed in section 6)
  • if you have a disease that affects the immune system
  • if you have severe asthma (according to a doctor’s assessment)
  • if you have cancer
  • if you have severe inflammation in your mouth

Warnings and cautions

Talk to your doctor before taking Grazax:

  • if you have recently extracted a tooth or undergone other procedures in the oral cavity. Then discontinue treatment with Grazax for 7 days to allow the oral cavity to heal
  • if you have a severe fish allergy
  • if you have previously had an allergic reaction in connection with the injection of grass pollen allergen
  • if you have asthma and an ongoing acute infection of the upper respiratory tract. Grazax treatment should be stopped temporarily until infection has subsided.

Some side effects can be serious and require immediate medical attention. See section 4 for symptoms.

Children

  • if you have lost a baby tooth: treatment with Grazax should be stopped for 7 days to give the oral cavity time to heal.

If any of the above apply to you, tell your doctor before starting Grazax.

There is no experience with Grazax treatment in the elderly ≥ 65 years.

Other medicines and Grazax

Tell your doctor or pharmacist if you have recently taken or might take any other medicines, including medicines obtained without a prescription.

If you are taking other medicines for your allergic problems such as antihistamines or corticosteroids, your doctor should evaluate the use of these medicines.

Grazax with food and drink

Do not eat or drink for five minutes after taking the tablet.

Pregnancy, breastfeeding and fertility

There is currently no experience with treatment with Grazax during pregnancy. Grazax treatment should not be initiated during pregnancy. If you become pregnant during treatment, consult your doctor to assess whether further treatment is appropriate.

There is currently no experience with treatment with Grazax during breastfeeding. However, Grazax is not expected to affect breastfed infants. Talk to your doctor before use during breastfeeding.

Driving and using machines

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance.

If you are not sure, talk to your doctor or pharmacist.

Grazax has no or negligible effect on the ability to drive and use machines.

3. How to take Grazax

Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

How much Grazax to take

  • The recommended dose is one freeze-dried tablet daily.

How to take Grazax

  • For best effect, treatment should start at least 4 months before the grass pollen season is expected to begin. Recommended treatment time with Grazax is 3 years.

The first dose of Grazax should be taken at the doctor’s office.

  • This is so that you can be supervised by healthcare professionals for about half an hour after taking the first tablet.
  • It is a precautionary measure to check how sensitive you are to the medicine.
  • It is also an opportunity for you to discuss any side effects with your doctor.

Continue to take Grazax every day – even if it takes a while before your allergies improve.

If your allergy symptoms do not subside during the first grass pollen season, consult a doctor to discuss further treatment.

Your hands must be completely dry before handling the tablets.

The tablets should be taken as follows:

1. Tear off the tab marked with triangles on top of the package.

2. Tear off a box from the package along the dotted lines.

3. Fold the foil back from the marked corner and then pull off the foil.
– Do not push the tablet through the foil – it will break easily.

4. Carefully remove the tablet from the foil and place it immediately under the tongue.

5. Leave the tablet under the tongue until it dissolves.
– Avoid swallowing for 1 minute.
– Do not eat or drink for at least 5 minutes after taking the tablet.

If you take more Grazax than you should

If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice. If you take more Grazax tablets than you should you may have allergic symptoms such as local symptoms in your mouth and throat.

If you forget to take Grazax

If you forget to take a tablet, you can take it later the same day. Do not take a double dose to make up for a forgotten tablet.

If you stop taking Grazax

If you do not take this medicine as prescribed, you may not get any effect from 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.

The side effects can be an allergic reaction to the allergen you are being treated with. The reactions generally last minutes to hours after taking the tablet and usually subside spontaneously within a week after starting treatment.

Serious side effects:
Stop taking Grazax and contact a doctor or hospital immediately if you get any of the following symptoms:

  • sudden swelling of the face, mouth or throat
  • difficulty swallowing
  • difficulty breathing
  • hives
  • changes of voice
  • worsening of existing asthma
  • severe malaise

If you get persistent heartburn, you should contact your doctor.

Other possible side effects:

Very common (may affect more than 1 user in 10):

  • swelling in the mouth
  • itching in the mouth or ears
  • irritating sensation in the throat

Common (may affect up to 1 in 10 people):

  • stinging sensation or numbness in the mouth
  • itching in eyes, lips or nose
  • inflammation of the eyes or mouth
  • shortness of breath, cough or sneezing
  • dryness in the throat
  • Runny nose
  • swelling of eyes or lips
  • sores in the mouth
  • blistering, pain or discomfort from mouth or throat
  • abdominal pain, diarrhea, nausea, vomiting
  • heartburn
  • itching , rash or hives
  • fatigue
  • chest discomfort
  • tightness in the throat
  • redness in the mouth
  • difficulty swallowing

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

  • feeling of fast, strong or irregular heartbeat
  • taste change
  • red or irritated eyes
  • pain or discomfort in the ears
  • loss of sensation in the throat, pain when swallowing
  • enlarged tonsils
  • severe allergic reaction
  • dry mouth
  • blisters on the lips, lip inflammation, sores on the lips
  • enlarged salivary glands or increased saliva production
  • inflammation of the stomach, regurgitation
  • feeling of foreign objects in the throat
  • reddening of the skin
  • swelling of face
  • inflammation of the tongue
  • allergic reaction
  • stinging sensation in the skin
  • stomach discomfort
  • swelling in the throat
  • tear flow
  • huskiness
  • redness in the throat
  • blisters in the mouth

Rare (may affect up to 1 in 1,000 people):

  • contraction of the lower respiratory tract
  • swollen ears

Eye irritation, redness of the throat, blisters in the mouth, pain in the ears, and swollen ears are more common in children than in adults.

If you experience troublesome side effects, contact your doctor who can determine if you need to take symptom-relieving allergy medications, e.g. antihistamine is.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.

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 carton after EXP. The expiration date is the last day of the specified month.

This medicine does not require any special storage instructions.

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. Contents of the packaging and other information

Content declaration

  • The active substance is SQ standardized allergenic extract of timothy pollen ( Phleum pratense ). The activity per tablet is expressed in the unit SQ-T *, one tablet contains 75,000 SQ-T.

* [Standardized Quality units Tablet (SQ-T)]

  • The other ingredients are gelatin (from fish), mannitol and sodium hydroxide.

What the medicine looks like and contents of the pack

White to off-white round lyophilised tablet marked with a circle on one side.

Blister packs of aluminum with peelable aluminum foil in an outer carton. Each blister pack contains 10 lyophilised tablets.
The following packs are available: 30 (3×10), 90 (9×10) or 100 (10×10) lyophilised tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

ALK-Abelló A / S

Bøge Allé 6-8

2970 Hørsholm

Denmark

Manufacturer

ALK-Abelló SA

Miguel Fleta 19

28037 Madrid

Spain

Information is provided by

ALK Nordic A / S, Denmark Branch

tel: 0300 – 185 45

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