Fluticasone propionate 400 micrograms (1mg/ml), nasal drops suspension

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Fluticasone propionate nasal drops are and what they are used for
2. What you need to know before you use Fluticasone propionate nasal drops
3. How to use Fluticasone propionate nasal drops
4. Possible side effects
5. How to store Fluticasone propionate nasal drops
6. Contents of the pack and other information

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

Check with your doctor or pharmacist before using your medicine:

• if you have an infection in your nose.

If you are not sure if the above applies to you, talk to your doctor or pharmacist before using Fluticasone propionate nasal drops.

Fluticasone propionate may lower the normal production of steroid hormones in your body, particularly if doses higher than those recommended are used for a long time. In this situation people may need to take extra steroids in times of extreme stress, following serious injury or before a surgical operation.

It is important therefore that you are taking the lowest dose of Fluticasone propionate to control your symptoms. Your doctor will check you for signs of any problems.

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

Please tell your doctor or pharmacist if you are taking, or have recently taken any prescribed medicines, including medicines or herbal products obtained without a prescription.

Particularly if:

• you are taking a type of antiviral medicine known as a protease inhibitor (such as ritonavir)
• you are taking a medicine used to treat fungal infections (such as ketoconazole)
• you have had steroids for a long time, either as an injection or by your mouth.

Some medicines may increase the effect of Fluticasone propionate nasal drops and your doctor may wish to monitor you carefully if you are taking these medicines (including some medicines for HIV: ritonavir, cobicistat).

Do not use this medicine if you are pregnant, or planning to become pregnant, or if you are breast-feeding, unless your doctor or pharmacist tells you to.

This medicine is not likely to affect you being able to drive or use any tools or machines.

• The usual starting dose is one single-use plastic container (400 micrograms) divided equally between each nostril, once or twice a day.
• As your symptoms improve, your doctor may ask you to use a lower dose.
• If your symptoms do not improve after 4 to 6 weeks your doctor may change your medicine.

What the plastic container looks like

Top tab

Bottom tab

1. Open the foil pack by tearing off one side. Do not open the pack until the drops are needed.
2. Take out the strip of plastic containers from the foil and pull off one container.

3. Put the remaining containers back into the foil pack and put the pack back in the box.
4. Flick and shake the plastic container for 30 seconds. The contents of the container must be well mixed before use.
5. Then shake downwards to make sure the liquid is not in the neck of the container.
6. Hold the bottom tab of the container firmly. Twist and remove the top tab to open it.

Before you put the drops in, you must choose one of the positions shown in these pictures. Although they may not be easy, the positions will make sure the drops get to where they are needed.
1. Gently blow your nose to clear it.
2. While standing up, bend right over.

3. If you can’t do this, kneel down and then bend right over.

4. Put the opened container into one nostril and gently squeeze.
5. Keep squeezing until the sides of the container touch each other. This will mean that about half the dose has been given (about 6 drops).
6. Repeat this step to use the rest in your other nostril.
7. Stay with your head down for at least one minute after putting the drops in.

If these positions are difficult you can lie on a bed with your head tilted over the edge. After you have put the drops in, rest your head sideways on the bed for at least one minute.

Be careful not to get the drops in your eyes or on broken skin. If you do, rinse your eyes or skin with water immediately.

Tell your doctor if you use more than you were told to.

If you miss a dose, just use the next dose when it is due. Do not use a double dose to make up for a forgotten dose.

Do not stop treatment even if you feel better, unless your doctor tells you to stop. If you do stop, the symptoms may come back.

A small number of people get allergic reactions to Fluticasone propionate nasal drops, which can develop into a more serious, even life-threatening problem if not treated. Symptoms include;

• becoming very wheezy, coughing or having difficulty with breathing
• suddenly feeling weak or light-headed (which may lead to collapse or loss of consciousness)
• swelling around the face, mouth or tongue
• skin rashes or redness.

In many cases, these symptoms will be signs of less serious side effects. But you must be aware that they are potentially serious — so, if you notice any of these symptoms:

See a doctor as soon as possible.

Allergic reactions to Fluticasone propionate nasal drops are very rare (these affect less than 1 in 10,000 people).

Other side effects include:

Very common (may affect more than 1 in 10 people)

• Nose bleeds.

Common (may affect up to 1 in 10 people)

• A dry or irritated nose or throat.

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

• Cloudy lens (cataract), increased pressure in the eye that can cause problems with vision (glaucoma). These eye problems occurred in people who used Fluticasone propionate for a long time.
• Small holes (perforations) in the ridge inside the nose that separates the nostrils.

Not known (frequency cannot be estimated from the available data)

• Blurred vision.
• Sores in the nose.

In addition, the production of steroids in your body may be affected. This is more likely to happen if you use high doses for a long time. Your doctor will help stop this happening by making sure you use the lowest dose of steroid which controls your symptoms.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme (Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store). By reporting side effects you can help provide more information on the safety of this medicine.

• The active substance is fluticasone propionate.
• The other ingredients are polysorbate 20, sorbitan laurate, sodium dihydrogen phosphate dihydrate, disodium phosphate anhydrous, salt (sodium chloride), water for injections.

Each container contains 400 micrograms of fluticasone propionate, giving a strength of 1 milligram per millilitre. Each carton contains 6 strips of 5 single-dose containers (30 single-dose containers per carton).

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