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Terms Of Use

FLUTICASONE PROPIONATE

Brand Name(s) : Flixotide Evohaler, Flixotide Accuhaler, Flixonase, fluticasone propionate, Nasofan, Flixonase Nasule, Cutivate, with azelastine hydrochloride Dymista
Warnings
Uses
Side Effects
Precautions
Interactions
Overdose

FLUTICASONE PROPIONATE WARNINGS

Inhaler, nebules, nasal drops and nasal spray
Fluticasone propionate should be used with caution in:

  • People who have or have had tuberculosis (TB)
  • Women who are pregnant or breastfeeding
  • People who have had a nose operation (nasal spray)
  • People with certain untreated infections
  • People who have a nose infection (nasal spray)
  • People taking steroid tablets or who have just finished taking steroid tablets (inhaler)

It should not be used in:

  • People who are allergic or sensitive to or have had a reaction to fluticasone or to any of the ingredients in the medicine
  • Children under 4 years (nasal spray)
  • Children under 12 years (nasal spray with azelastine hydrochloride).
  • Children 16 years and under (nebules 2mg/2mL and certain fluticasone inhalers)
  • Children under 16 years (nasal drops)
  • People taking ritonavir for HIV infection

Skin cream and ointment
Fluticasone propionate should be used with caution in:

  • Women who are pregnant or breastfeeding
  • People with the cream / ointment applied under an airtight dressing or nappy
  • People with psoriasis

It should not be used in:

Also see list of precautions and interactions

STORAGE

Do not store above 30°C.

Nasal spray with azelastine. Once opened, do not use the nasal spray for longer than 6 months, even if there is some medicine still left in the bottle after this time.
Do not put the nasal spray in the fridge.

FLUTICASONE PROPIONATE USES

What is it used for?

  • Fluticasone propionate is used to treat inflammation in the lung and nasal passages in people with conditions such as asthma, seasonal allergic rhinitis (inflammation of the nose), perennial rhinitis (all year round allergy, e.g. animal allergies) and nasal polyps (lumps). It can also be used to treat inflammation of various skin conditions.
  • It is a corticosteroid, sometimes known as a glucocorticoid or steroid.
  • It is used to treat asthma by reducing inflammation in the lung which helps to keep the airways open and make it easier to breathe properly. Fluticasone propionate is taken using an inhaler device to treat asthma so that the medicine is delivered directly to the lungs where it is needed. It is known as a 'preventer' medicine as it is taken regularly every day to reduce the inflammation and prevent asthma attacks. A ‘reliever’ medicine (fast-acting bronchodilator) is needed to give you immediate relief of any sudden asthma attacks. In seasonal allergic or perennial rhinitis, fluticasone propionate reduces the inflammation in the nasal passages when taken using a nasal spray. Seasonal allergic rhinitis is a condition with inflammation of the nose arising from seasonal allergy, such as pollen in hayfever, leading to cold-like symptoms, such as sneezing, itchiness and a blocked or runny nose. Perennial rhinitis is a condition with inflammation of the lining of the nose due to all year round allergies, such as house dust mites or animal fur. Fluticasone propionate nasal spray helps to prevent symptoms of seasonal allergic rhinitis and perennial rhinitis. Nasal drops are used to treat nasal polyps (lumps) or other symptoms of nasal obstruction. It is also used as a cream and ointment to reduce the swelling and irritation of some skin conditions.
  • In general this drug is used to treat asthma and allergic rhinitis.
  • Benefits of being on inhaled fluticasone propionate can include a reduction in asthma symptoms and exacerbations of asthma in patients previously treated with bronchodilators alone or with other prophylactic therapy. Fluticasone propionate is effective in controlling asthma and the need for people to use oral steroids is reduced limiting the likelihood of serious side effects.

Listed below are the typical uses of fluticasone propionate.

  • Asthma
  • Seasonal allergic rhinitis
  • Perennial rhinitis
  • Nasal polyps
  • Symptoms associated with nasal obstruction
  • Skin conditions such as dermatitis, eczema, psoriasis, insect bites or ‘prickly heat’
  • Dermatitis in infants and children which had not responded to other milder treatment

On occasion your doctor may prescribe this medicine to treat a condition not on the above list. Such conditions are listed below.

  • Chronic obstructive pulmonary disease (COPD)

HOW TO USE/TAKE

Fluticasone propionate is available as several different types of inhaler device including a metered dose inhaler (Evohaler) and a breath-actuated device (Accuhaler). It is also available as nebules, which are used with a machine called a nebuliser. This converts the medicine inside the nebules into particles which can then be inhaled. Fluticasone propionate is also available as a nasal spray, nasal drops and as a cream and ointment. It can be taken with or without food.

How often do I take it?

  • Inhaler and nebules
  • Take this medication by inhalation, usually twice daily.
  • Advice on how to take fluticasone propionate can be found in the Patient Information Leaflet . It is important to rinse your mouth out with water after inhaling each dose as this reduces your chance of getting side effects such as hoarseness and infections of the throat and mouth. It is best to administer the nebules using a mouthpiece to prevent any possible changes to the skin, which may occur with long-term use of a face mask.
  • Use this medication regularly, every day in order to get the most benefit from it as this is a 'preventer' medicine.
  • Remember to use it at the same time each day - unless specifically told otherwise by your doctor. You must be reviewed regularly to ensure that the dose of inhaled corticosteroid is reduced to the lowest dose at which effective control of asthma is maintained.
  • It may take up to 4 to 7 days before the full benefit of this drug takes effect in the treatment of asthma and the symptoms start to resolve.

Nasal spray

  • The usual starting dose is 1 or 2 sprays into each nostril, once a day, preferably in the morning.
  • It may take 3 to 4 days before the full benefit of this medicine takes effect.

Nasal drops

  • Use the nasal drops once daily in your nose only using the instructions in the Patient Information Leaflet.
  • It may take a few weeks before the full benefit of this medicine takes effect.

Skin cream and ointment

  • Apply a thin layer of the cream or ointment to the affected area once a day for dermatitis and eczema and 1-2 times a day for other skin conditions. Only apply it to your face if your doctor tells you to and do not let the medicine get into your eyes. Follow the instructions in the Patient Information Leaflet carefully.

If the skin condition of a child has not improved within 7 to 14 days, see your child's doctor.

Certain medical conditions may require different dosage instructions as directed by your doctor.

What dose?

  • Dosage is based on your age, gender, medical condition, response to therapy, and use of certain interacting medicines.

Do I need to avoid anything?

  • This medicine is unlikely to affect driving ability or the ability to operate machinery. Consult your doctor or pharmacist for more details.

When can I stop?

  • Inhaler, nebules, nasal drops and nasal spray
  • It is important to continue taking this medication even if you feel well, unless your doctor tells you to stop.

Skin cream /ointment

  • The skin cream /ointment should not used daily in children for more than 4 weeks.

FLUTICASONE PROPIONATE SIDE EFFECTS

Inhaler and nebules:

  • Fungal Infections of the mouth or throat
  • Pneumonia or worsening of pneumonia (in people with a lung condition known as chronic obstructive pulmonary disease, COPD)
  • Difficulty speaking
  • Hoarseness
  • Bruising
  • Allergic skin reactions
  • Behavioural changes including hyperactivity or feeling irritable (mainly in children)
  • Inhalation induced bronchospasm
  • Breathlessness
  • Difficulty breathing (bronchospasm)
  • Adrenal problems
  • Lowering of bone mineral density
  • Cushing's syndrome or Cushingoid features (including changes in the look and shape of the face)
  • Eye problems including cataracts and increased pressure in the eye (glaucoma)
  • Eyesight problems
  • Reduced growth in children and adolescents
  • Increased blood sugar levels
  • Severe allergic reactions (see below)
  • Swelling (angioedema)
  • Difficulty sleeping
  • Anxiety
  • Indigestion
  • Joint pain

Nasal drops and nasal spray:

  • Nose bleed
  • Headaches
  • Nasal irritation/dryness
  • Throat irritation/dryness
  • Unpleasant smell or taste
  • Headache
  • Swelling (angiooedema)
  • Eye problems including cataracts and increased pressure in the eye (glaucoma)
  • Eyesight problems
  • Nasal separation (hole in the wall of the nose between the nostrils)
  • Severe allergic reactions (see below)
  • Breathlessness
  • Difficulty breathing (bronchospasm)
  • Allergic skin reactions
  • Adrenal problems
  • Lowering of bone mineral density
  • Cushing's syndrome or Cushingoid features (including changes in the look and shape of the face)
  • Reduced growth in children and adolescents

Skin cream and ointment:

  • Redness and swelling
  • Irritation and itchiness (due to an ingredient in the ointment known as imidurea)
  • Burning feeling
  • Raised pus with bumps in people with psoriasis
  • Infections
  • Stretch marks
  • Prominent veins under the skin (due to widening of the blood vessels)
  • Increased hair growth
  • Loss of skin colour
  • Thinning of the skin
  • Weight gain
  • High blood pressure
  • Adrenal problems
  • Lowering of bone mineral density
  • Cushing's syndrome or Cushingoid features (including changes in the look and shape of the face)
  • Reduced growth in children and adolescents

If your skin problem gets worse or your skin becomes swollen, stop using the ointment and see your doctor as soon as possible.

Prolonged treatment with fluticasone, particularly at high doses may result in effects such as Cushing's syndrome, Cushingoid features (changes in the look and shape of the face), adrenal suppression, poor growth, weak bones, cataract and glaucoma (increased pressure in the eye).

If any of these persist or you consider them severe then inform your doctor.

Tell your doctor immediately if you develop any of the following symptoms:

  • An increase in wheezing immediately after using your inhaler. You must treat this immediately with a fast-acting inhaled bronchodilator ('reliever' medicine) and then seek immediate medical advice.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

The Yellow Card Scheme allows you to report suspected side effects from any type of medicine (which includes vaccines, herbals and over the counter medicines) that you are taking. It is run by the medicines safety watchdog called the Medicines and Healthcare products Regulatory agency (MHRA). Please report any suspected side effect on the Yellow Card Scheme website.

FLUTICASONE PROPIONATE PRECAUTIONS

Before taking fluticasone propionate, tell your doctor or pharmacist if you are allergic to it; or to other corticosteroids; or if you have any other allergies.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have:

  • An allergy to fluticasone propionate or to any of the other ingredients in the medicine

Before using this medication, tell your doctor or pharmacist your medical history, especially any of the following

  • Diabetes
  • Have or have had tuberculosis
  • Any other nasal problems (if taking nasal preparations)
  • Skin conditions (if taking skin cream or ointment)

Before having surgery, tell your doctor or dentist that you are taking this medication.

Does alcohol intake affect this drug?

  • Alcohol intake is not known to affect fluticasone propionate.

The elderly: fluticasone propionate can be used in the elderly.

Pregnancy and breastfeeding - please ensure you read the detailed information below

PREGNANCY

The safety of fluticasone propionate has not been established during pregnancy. Administration of fluticasone propionate during pregnancy should only be considered if the expected benefit to the mother is greater than any possible risk to the unborn baby.

Ask your doctor or pharmacist if you have any doubts or questions about this.

It is sensible to limit use of medication during pregnancy whenever possible. However, your doctor may decide that the benefits outweigh the risks in individual circumstances and after a careful assessment of your specific health situation.

If you have any doubts or concerns you are advised to discuss the medicine with your doctor or pharmacist.

BREAST FEEDING

It is not known whether fluticasone passes into breast milk.

When fluticasone propionate is used in breastfeeding mothers the therapeutic benefits must be weighed against the potential hazards to mother and baby.

It is sensible to limit use of medication during breastfeeding whenever possible. However, your doctor may decide that the benefits outweigh the risks in individual circumstances and after a careful assessment of your specific health situation.

If you have any doubts or concerns you are advised to discuss the medicine with your doctor or pharmacist.

FLUTICASONE PROPIONATE INTERACTIONS

Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with them first.

This drug should not be used with the following medications because very serious, possibly fatal interactions may occur:

  • Ritonavir (used to treat HIV) is a potent inhibitor of the cytochrome P450 (CYP3A) enzyme system and leads to very high concentrations of fluticasone propionate in the blood.
  • If you are currently using any of these medications, tell your doctor or pharmacist before starting fluticasone propionate.

Before using this medication, tell your doctor or pharmacist of all prescription and non-prescription/herbal products you may use, especially of:

  • Itraconazole and ketoconazole (used to treat fungal infections), as they are cytochrome P450 (CYP3A) inhibitors.
  • Nelfinavir (used to treat HIV)
  • Treatment with any other steroids.

This information does not contain all possible interactions. Therefore, before using fluticasone propionate, tell your doctor or pharmacist of all the products you use.

FLUTICASONE PROPIONATE OVERDOSE

If you think you, or someone you care for, might have accidentally taken more than the recommended dose of fluticasone propionate or intentional overdose is suspected, contact your local hospital, GP or if in England call 111. In Scotland call NHS 24. In Wales, call NHS Direct Wales. In the case of medical emergencies, always dial 999.

MISSED DOSE

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

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Source: Selected from data included with permission and copyrighted by Boots UK Limited or TicTac Communications Ltd. This copyrighted material is sourced from a licensed data provider and is not for distribution, except as may be authorised by the applicable terms of use.
CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgement of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse events, nor should it be construed to indicate that use of a particular medicine is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any medicine, changing any diet, or discontinuing any course of treatment.

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