50 micrograms / dose inhalation spray, suspension, 125 micrograms / dose inhalation spray, suspension
fluticasone propionate

1. What Flutide Evohaler is and what it is used for

Flutide Evohaler is a cortisone preparation that counteracts inflammation and allergies directly in the lungs. By reducing inflammation one can prevent asthma attacks. Flutide Evohaler is used as a regular treatment for asthma. The full effect comes only after a few days of regular treatment. Flutide Evohaler does not provide rapid relief in acute asthma symptoms. You should then take a fast and short-acting bronchodilator medication. If the treatment does not give the desired effect, consult a doctor.

2. What you need to know before using Flutide Evohaler

Do not use Flutide Evohaler

  • if you are allergic to fluticasone propionate or any of the other ingredients of this medicine (listed in section 6).

Warnings and cautions

Talk to your doctor or pharmacist before using Flutide Evohaler.

Flutide Evohaler is not intended to treat acute asthma symptoms. You should have an anti-seizure medication, such as a short-acting bronchodilator, for acute asthma attacks.

Immediately after dosing Flutide Evohaler, paradoxical bronchospasm (increased respiratory tract) may occur with increased wheezing. If this happens, inhale a fast-acting bronchodilator immediately. Stop taking Flutide Evohaler and contact your doctor.

Those who have previously been treated with cortisone tablets should carefully follow the doctor’s dosing instructions when switching to Flutide Evohaler. With this transition, you can get back your previous allergic problems, e.g. runny nose and eczema. You can also feel tired in the beginning, get headaches, muscle and joint pain, and sometimes nausea and vomiting. This is because the total amount of cortisone in the body is reduced by treating the disease locally in the lungs. The symptoms disappear after a certain period of treatment. If the symptoms increase, do not change the dosage without consulting a doctor.

In case of acute deterioration and temporary stress situation, the treatment may need to be supplemented with cortisone in tablet form. Talk to your doctor about getting any written information about and how to handle your cortisone treatment in the above situation.

In case of acute deterioration, temporary stress situation, and surgery, the treatment may need to be supplemented with cortisone in tablet form.

Flutide Evohaler treatment should not be stopped abruptly, as there is a risk of worsening symptoms. Your doctor will decide how fast your dose can be reduced.

If you have or have had pulmonary tuberculosis talk to your doctor.

If you have diabetes, talk to your doctor as you have rarely seen elevated blood sugar levels.

Use of high-dose Flutide Evohaler for a long time can cause cortisone to affect the entire body. Symptoms such as weight gain with altered fat distribution (abdomen, neck, face), thin and brittle skin, increased body hair, decreased bone density, high blood pressure can then occur (Cushing’s syndrome). In children and young people, growth retardation can be seen. If any of these are observed, consult a treating physician.

Length growth in children receiving long-term treatment with Flutide Evohaler should be monitored regularly.

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

Other medicines and Flutide Evohaler

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

Some other medicines may increase the effect of Flutide Evohaler and your doctor may want to monitor you closely if you are taking these medicines (eg some medicines for HIV: ritonavir, cobicistat, or some medicines for fungal infectionsketoconazole, itraconazole).

Pregnancy and breastfeeding

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

Limited experience of use during pregnancy. Therefore, consult a physician before using Flutide Evohaler during pregnancy.

It is not known if fluticasone propionate passes into breast milk. Therefore consult a doctor before use during breast-feeding.

Driving and using machines

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

3. How to use Flutide Evohaler

Always use this medicine exactly as your doctor or pharmacist has told you. Dose one is determined by the doctor, who adjusts it individually for you. Do not exceed dosage one. To achieve full effect, Flutide Evohaler should be used regularly.

Ask your doctor or pharmacist if you are unsure.

The usual dosage for adults and adolescents over 16 years:

1-2 inhalations morning and evening.

The usual dosage for children 4 years and older:

1-4 inhalations of Flutide Evohaler 50 micrograms/dose (minimum strength) morning and evening.

The usual dosage for children 1-4 years:

2 inhalations of Flutide Evohaler 50 micrograms/dose (lowest strength) morning and evening with a respirator.

The mouth should be rinsed with water after each inhalation.

Shake inhalation spray one before use. See instructions for use for more information.

A respirator can be used to improve treatment with Flutide Evohaler, especially for young children, or for those who have difficulty squeezing a spray dose and inhaling through the mouth at the same time.

If you use more Flutide Evohaler then you should

You must take a dose as stated on the label on the package or as your doctor has informed you. Do not increase or decrease the dose without consulting a doctor.

If you have ingested too much medicine or if e.g. If a child has inadvertently ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

If you forget to use Flutide Evohaler

Continue treatment in the usual way if you have forgotten to take a dose.

Do not take a double dose to make up for a forgotten dose.

If you stop using Flutide Evohaler

Flutide Evohaler treatment should not be stopped abruptly, as there is a risk of worsening symptoms. Your doctor will decide how fast your dose can be reduced.

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.

Contact a doctor immediately if you experience any of the following symptoms (signs of an allergic/anaphylactic reaction):

swelling of the face, oral cavity, and pharynx, convulsions of the trachea, shortness of breath.

This is a very rare side effect.

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

  • fungal infection (“cod”, Candida ) in the oral cavity, larynx, and pharynx. The risk of infection is reduced by rinsing the mouth with water after each inhalation

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

  • bruises.
  • throat irritation and hoarseness
  • Pneumonia has been reported in patients with COPD (chronic obstructive pulmonary disease ).

Less common side effects are (may affect up to 1 in 100):

Rare side effects are (may affect up to 1 in 1000):

  • fungal infection of the esophagus.

Very rare side effects are (may affect up to 1 in 10 000 users):

  • Inhalation treatment can, through unclear mechanisms, give rise to cramps in the trachea.
  • sleep problems, anxiety, restlessness, anxiety (these side effects are more likely to occur in children)
  • Cushing-like symptoms (moon face, abdominal obesity)
  • decreased cortisone formation in the adrenal glands
  • reduced bone density
  • glaucoma ( cataract ), cataract (cataract)
  • Delayed height growth in children has been seen in very rare cases when cortisone has been given in high doses for a long time.
  • Elevated blood glucose levels have been reported in very rare cases.

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

  • depression, feeling of being very hurried and/or irritable. These side effects are more likely to occur in children.
  • nosebleed
  • dimsyn.

Because Flutide is inhaled directly into the lungs in small amounts, the risk of side effects is small.

5. How to store Flutide Evohaler

  • Keep this medicine out of the sight and reach of children.
  • Do not store above 30 ° C. Protected from frost and direct sunlight.
  • Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month.
  • Always replace the protective cap immediately after use. You do not need to use much force when the protective hood is pressed into place until a snap is heard.
  • Risk of impaired function and effect when inhalation spray is cold.
  • The contents of the metal container are under pressure. Do not puncture, burn or otherwise injure even if the container is empty.

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.

As drug residues can remain in the empty packages, they should not be thrown in the rubbish but the empty packages should also be returned to pharmacies.

6. Contents of the packaging and other information

Content declaration

The active substance is fluticasone propionate. Each dose contains 50 or 125 micrograms of fluticasone propionate. The other ingredient is norflurane.

What the medicine looks like and the contents of the pack

Suspension one is stored under pressure in an 8 ml large metal container. The metal container is placed in a plastic inhaler with a spray nozzle fitted with a protective cap. The medicine is available in pack sizes of 120 doses.

Marketing Authorization Holder and Manufacturer

GlaxoSmithKline AB, Box 516, 169 29 Solna

Tel: 08-638 93 00

Email: info.produkt@gsk.com

Muhammad Nadeem

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