50 micrograms/dose inhaled powder, divided dose, 100 micrograms/dose, inhaled powder, divided dose, 250 micrograms/dose inhaled powder, divided dose, 500 micrograms/dose inhaled powder, divided dose
fluticasone propionate

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

Flutide Diskus is a cortisone preparation that counteracts inflammation and allergies directly in the lungs. By reducing inflammation one can prevent asthma attacks.

Flutide Diskus is used as a regular treatment for asthma and COPD (chronic obstructive pulmonary disease ) together with a long-acting bronchodilator. The full effect comes only after a few days of regular treatment. Flutide Diskus 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 Diskus

Do not use Flutide Diskus

  • if you are allergic to fluticasone propionate or any of the other ingredients of this medicine (listed in section 6). Lactose monohydrate may contain milk protein.

Warnings and cautions

Talk to your doctor or pharmacist before using Flutide Diskus.

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

If you have previously been treated with cortisone tablets, you should carefully follow your doctor’s dosing instructions when switching to Flutide Diskus. 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, temporary stress situation, and surgery, 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.

Flutide Diskus 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.

Tell your doctor if you have pulmonary tuberculosis before starting treatment with Flutide Diskus.

Flutide Diskus can in very rare cases affect blood glucose levels. Discuss with your doctor if you have diabetes before using Flutide Diskus.

Using a high dose of Flutide Diskus for a long time can cause cortisone to affect the whole 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 Diskus should be monitored regularly.

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

Other medicines and Flutide Diskus

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 Diskus 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 Diskus during pregnancy.

It is unknown whether 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.

Flutide Diskus contains lactose

Flutide Diskus contains lactose up to 12.5 mg / dose. This amount normally does not cause any problems for lactose intolerant individuals.

3. How to use Flutide Diskus

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. Ask your doctor or pharmacist if you are unsure.

Flutide Diskus should usually be inhaled both morning and evening. To achieve full effect, Flutide Diskus should be used regularly. The mouth should be rinsed with water after each inhalation. See instructions for use for more information.

If you use more Flutide Diskus than 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 Diskus

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 Diskus

Flutide Diskus 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

Tell your doctor if you have any of the following symptoms while taking Flutide Diskus as they may be symptoms of pneumonia:

In COPD patients, pneumonia has been reported as a common side effect (may affect up to 1 in 10 people).

Other side effects may occur

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.

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.

5. How to store Flutide Diskus

  • Keep this medicine out of the sight and reach of children.
  • Do not store above 30 ° C.
  • Store Flutide Diskus in the foil pouch until it is used for the first time. Discard the foil bag after opening.
  • If the foil bag has been opened, Flutide Diskus should not be stored in a humid environment such as a bathroom.
  • 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.

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 in Flutide Diskus is fluticasone propionate. Each dose contains 50, 100, 250, and 500 micrograms of fluticasone propionate, respectively.

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

What the medicine looks like and the contents of the pack

Flutide Diskus is a molded plastic inhaler, in which the inhalation powder is packaged in divided blister doses in a foil strip with a peelable casing.

Flutide Diskus is packaged in a foil bag in a carton with a guarantee seal and is available in a pack size of 1 x 60 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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