100 micrograms / dose, 200 micrograms / dose, 400 micrograms / dose. inhalation powder
budesonide

QR Code to URL: www.oeh.fi/busc

User instructions picture

1. What Giona Easyhaler is and what it is used for

The active substance in Giona Easyhaler is budesonide. Budesonide powder is packaged in an inhaler. You inhale the powder into your lungs through the inhaler mouthpiece. Budesonide works by reducing and preventing swelling and inflammation in your lungs.

Giona Easyhaler is a medicine called ‘preventive’ medicine. It is used to prevent asthma symptoms. It belongs to a group of medicines called corticosteroids.

Budesonide does NOT stop an asthma attack that has already started. Therefore, you must always have a fast-acting bronchodilator, a “palliative” drug (a beta2- agonist ) with you.

The effect of budesonide may be noticeable after a few days of treatment, but the maximum effect is only achieved after a couple of weeks. You should use Giona Easyhaler regularly to prevent asthmatic inflammation. Continue to take this medicine regularly as instructed, even if you have no symptoms.

2. What you need to know before you use Giona Easyhaler

Do not use Giona Easyhaler if you are allergic:

  • against budesonide
  • against the other ingredient of this medicine (listed in section 6) which is lactose (which contains small amounts of milk protein)

Contact your doctor to switch to another medicine.

Warnings and cautions

Tell your doctor before using Giona Easyhaler if you have:

  • pulmonary tuberculosis
  • untreated bacterial , viral or fungal infections of the mouth, respiratory tract or lungs
  • severe liver disease.

Contact a doctor if you experience blurred vision or other visual disturbances.

Rinse your mouth after inhaling your dose to avoid fungal infections in your mouth.

Giona Easyhaler is not recommended for children under 6 years.

Other medicines and Giona Easyhaler

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

Some medicines may increase the effects of Giona Easyhaler and your doctor may want to monitor you closely if you are taking these medicines (eg some medicines for HIV: ritonavir, cobicistat).

Tell your doctor if you are using:

  • medicines taken via the nose containing corticosteroid s
  • corticosteroid tablets (eg cortisone tablets)
  • antifungal medicines containing itraconazole or ketoconazole .

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

It is important for both the fetus and the mother to maintain adequate asthma treatment during pregnancy. As with other medicines given during pregnancy, the benefits of budesonide treatment to the mother should be weighed against the risks to the fetus. The lowest effective dose of budesonide needed to maintain adequate asthma control should be used.

Driving and using machines

Giona Easyhaler has no known effect on the ability to drive or use machines.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened 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.

Giona Easyhaler contains lactose

Giona Easyhaler inhalation powder contains a small amount of lactose, which is unlikely to cause any problems even if you have lactose intolerance (do not tolerate lactose ). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Lactose contains small amounts of milk proteins that can cause an allergic reaction.

3. How to use Giona Easyhaler

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

Your doctor has prescribed an appropriate strength and dose for you. Follow your doctor’s instructions carefully.

Replacing corticosteroid tablets with Giona Easyhaler:

Tell your doctor if you are taking corticosteroid tablets (eg cortisone tablets) to treat your asthma.

Your doctor may ask you to gradually reduce the number of tablets and finally stop treatment within a few weeks. If you feel unwell during the transition period, consult your doctor but do not stop using Giona Easyhaler.

The usual dose is one for adults (including the elderly) and adolescents (12 to 17 years):

• 1-2 doses are inhaled morning and evening or once daily in the evening.

The usual dose is one for children 6 to 11 years :

• 1-2 doses are inhaled morning and evening or once daily in the evening.

During treatment, your doctor may from time to time adjust dose one to find the lowest dose required to control your asthma (maintenance dose ).

If Giona Easyhaler is to be used by your child, make sure he/she can use it properly.

In addition to the preventative Giona Easyhaler, you also need a tracheal dilator that relieves:

Budesonide does NOT stop an asthma attack that has already started. Therefore, you must always have a fast-acting reliever, relieving drugs (beta 2 – agonist ) with you if you get acute asthma symptoms.

If you regularly use a soothing inhaled medication (beta 2 – agonist ) to inhale it before Giona Easyhaler (prevention).

Exacerbation of asthma symptoms during treatment:

Contact your doctor as soon as possible if:

  • you experience wheezing and wheezing or if the tightness in your chest worsens during treatment
  • you need to use the palliative inhalation medicine more often than before
  • the palliative inhalation drug does not help as well as before
  • Your asthma may have worsened and you may need extra treatment.

If you use more Giona Easyhaler than you should

It is important that you take a dose as stated on the label of the package or as your doctor has informed you. Do not increase or decrease the dose without consulting a doctor.

If you have taken a larger dose or multi-dose more than was prescribed, tell your doctor as soon as possible. You should continue to use Giona Easyhaler unless your doctor tells you otherwise.

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 forget to use Giona Easyhaler

If you miss a dose, take one as soon as possible or take the next dose when it is time for it. It is best to take the medicine at the same time each day. Do not take a double dose to make up for a forgotten dose.

If you stop using Giona Easyhaler

Do not stop using Giona Easyhaler without consulting your doctor. If you suddenly stop taking the medicine, your asthma may worsen.

If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.

Instructions on how to use the inhaler can be found at the end of the leaflet.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Common (may affect up to 1 in 10 people)

Irritation of the throat, difficulty swallowing, cough, and fungal infection (cod) in the mouth or throat. If you get any of these side effects, do not stop taking Giona Easyhaler. Talk to your doctor.

You can help prevent the above-mentioned side effects by rinsing your mouth and throat with water or brushing your teeth after each dose. Do not swallow the rinse water but spit it out.

Uncommon (may affect up to 1 in 100 people)

Anxiety, depression, cataracts, blurred vision, muscle spasms, and tremors.

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

Too much or too little cortisol in the blood. Underactive adrenal gland ( gland next to the kidneys). Skin rash, itching, bruising, hoarse voice, restlessness, and nervousness. Growth inhibition in children. Behavioral changes, especially in children.

Rare severe allergic reaction :

In case of itching, rash, reddening of the skin, swollen eyelids, lips, face or throat, wheezing and wheezing, low blood pressure, or collapse shortly after taking a dose, do the following:

  • stop taking Giona Easyhaler
  • seek medical attention immediately

Shortness of breath immediately after dosing:

In rare cases, inhaled drugs may lead to increased wheezing and wheezing and shortness of breath ( bronchospasm ) immediately after dosing. If this happens:

  • stop taking Giona Easyhaler
  • take a fast-acting tracheal dilator
  • seek medical attention immediately.

Very rare (may affect up to 1 in 10,000 people)

Cataract ( glaucoma ). Decreased bone mineral density (osteoporosis).

Has been reported ( occurs in an unknown number of users ):

Sleep problems, aggression, increased motor activity (difficult to be still), and irritability. These side effects are more likely to occur in children.

Contact your doctor if you think you may have any of these rare side effects, or if you are worried about getting them.

Reporting of side effects ar

If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. You can also report side effects directly via:

The Medical Products Agency

Box 26

751 03 Uppsala

By reporting side effects, you can help increase the safety of medicines.

5. How to store Giona Easyhaler

Keep this medicine out of the sight and reach of children.

Before first use: Store in an unopened foil pouch.

After opening the foil bag: store at a maximum of 30 ° C in protection against moisture. Easyhaler should be stored in its case.

Replace Giona Easyhaler no later than 6 months after opening the foil bag. Write down the date you opened the bag to help you remember.

If your Giona Easyhaler gets damp, you will need to replace it with a new one.

Do not use this medicine after the expiry date which is stated on the label and carton.

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 budesonide

-The other ingredient is lactose monohydrate (which contains milk proteins).

What the medicine looks like and contents of the pack

White or almost white powder.

Giona Easyhaler 100 micrograms/dose inhalation powder

  • 200 dose is + case
  • 200 dos er
  • 2 x 200 dos er
  • 600 doses (3 x 200 doses )

Giona Easyhaler 200 micrograms/dose inhalation powder

  • 120 dos er
  • 200 dose is + case
  • 200 dos er
  • 2 x 200 dos er
  • 600 doses (3 x 200 doses )

Giona Easyhaler 400 micrograms/dose inhalation powder

  • 100 dose is + case
  • 100 dos er
  • 2 x 100 doses are

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Orion Corporation

Orionintie 1

FI-02200 Espoo

Finland

For further information on this medicine, please contact your local representative:

Orion Pharma AB, Danderyd

medinfo@orionpharma.com

Manufacturer

Orion Corporation, Orion Pharma

Orionintie 1

FI-02200 Espoo

Finland

This medicinal product is authorized by the Member States of the EEA under the following names
Spain Budesonida Easyhaler
Belgium, Poland Budesonide Easyhaler
Slovenia Budesonide Orion Easyhaler
Netherlands Budesonide Orion Easyhaler
UK Easyhaler Budesonide
Finland, Germany, Hungary Budesonide Easyhaler
Norway, Sweden, Denmark, Czech Republic, Slovakia, Estonia, Lithuania, Latvia, Malta Giona Easyhaler

Muhammad Nadeem

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