Beclometasone Dipropionate Aqueous Nasal Spray
TEVA UK Ref: 231 -30-83651 -F LEA BECLOM (NASOBEC) 50MCG SPR TUK <OPA
Version: 1 13 March 2015
Read all of this leaflet carefully before you start using this medicine.
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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse.This includes any possible side effects not listed in this leaflet. See section 4.
1. What Nasobec Aqueous is and what it is used for
2. Before you use Nasobec Aqueous
3. Howto use Nasobec Aqueous
4. Possible side effects
5. Howto store Nasobec Aqueous
6. Further information
OWHAT NASOBEC AQUEOUS IS AND WHAT IT IS USED FOR Nasobec Aqueous contains beclometasone dipropionate, which is one of a group of medicines called corticosteroids.Your medicine has anti-inflammatory properties.
Nasobec Aqueous is used to treat and prevent the symptoms of allergic reactions to pollens I hayfever), house dust, and animal fur, such as itchy or runny nose and sneezing.
BEFOREYOU USE NASOBEC AQUEOUS
DO NOT use Nasobec Aqueous if you:
• are allergic (hypersensitive) to beclometasone dipropionate or any of the other ingredients of this medicine.
Take special care with Nasobec Aqueous
Talkto your doctor or pharmacist before using Nasobec Aqueous if you have an infection or ulcers in your nose, or you have recently had surgery or an injury to your nose.
Taking other medicines
Please tell your doctoror pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, mportant information about some of the ingredients of Nasobec Aqueous
Nasobec Aqueous also includes the ingredient benzalkonium chloride, which is an irritant and may cause skin reactions.
Pregnancy and breast-feeding • If you are pregnant, planning to become
pregnant or are breast-feeding, ask your doctor for advice before using this medicine.
Driving and using machines
Nasobec Aqueous is not expected to affect your ability to drive or operate machinery.
^ HOWTO USE NASOBEC AQUEOUS
Always use Nasobec Aqueous exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Tell your doctor if you have watery or itchy eyes. He or she may give you another medicine to treat your eyes.
Always shake well before use. Only use in the nose. Do not swallow.
Adults (including the elderly) and Children over six years old
The usual dose is either:
• 2 sprays into each nostril twice a day, or if you
prefer,
• 1 spray into each nostril 3 or 4 times a day.
Do not use more than eight sprays
(400 micrograms) in 24 hours.
You will only start to feel better after you have been using your medicine for a few days.
Once your symptoms are under control your doctor will change your dosage to 1 spray into each nostril twice a day.
It is very important to reduce your dose as soon as your symptoms are under control.
If your symptoms then get worse, your dosage may then be increased back to the starting dose. Do not use more than the recommended dose. If you use high doses of Nasobec Aqueous There are times when your doctor may need to adjust the dose of the steroid you are given or the way in which you take it.These times are:
• times of extreme stress
• during admission to hospital after a serious accident, injury or illness
• before or after a surgical operation.
If you think that any of these apply to you whilst using Nasobec Aqueous, speak to your doctor or pharmacist.
Children less than six years old
• Nasobec Aqueous is not recommended for use in children less than six years old.
Before you use your nasal spray 1. If you are using your nasal spray for the first time, remove the clip (diagram A).
2. Shake the bottle gently and then remove the dust cap.
3. Hold the bottle upright with yourthumb under the bottle and your index finger and middle fingeron either side of the nozzle (diagram B).
4. To make sure your pump is working, test spray it into the air before you use it for the first time, and whenever you have not used it for a week or more. Hold the bottle away from you and press down until you can see a fine mist.
Using your nasal spray
5. Gently blow your nose.
"O
CD
Close one nostril by pressing yourfinger against it and place the nozzle of the spray in your other nostril.Tilt your head slightly so that the bottle is kept upright (diagram C).
Breathe in through your open nostril and, at the same time, press the nozzle once with your fingers to release the spray.
8. Breathe out through your mouth.
If you need to use a second spray, repeat steps 7 and 8.
10. Repeat steps 6, 7, 8 and 9, with your other nostril. After using your nasal spray
Wipe the nozzle with a clean tissue and put the dust cap back on.
Cleaning your nasal spray
You should clean the pump at least once a week to stop it from getting blocked up. Gently press upwards on the white co I la r to pull the nozzle off (diagram D)
Wash the nozzle and dust cap in warm water. Put them in a warm place to dry, but do not use too much heat. Put the nozzle and dust cap back on.
If you use more Nasobec Aqueous than you should
It is important that you take your dose as stated in the "How to use" section of this leaflet or as advised by your doctor.You should not exceed the recommended dose; using more or less may make your symptoms worse.
If you use more than 8 sprays in 24 hours, tell your doctor immediately.
If you forget to use Nasobec Aqueous If you forget to use your medicine at the right time, use it as soon as you remember, and then carry on as before. Never take two doses together to make up for a forgotten dose.
If you stop using Nasobec Aqueous
Do not stop using your medicine without talking to
your doctor first even if you feel better.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
POSSIBLE SIDE EFFECTS
Like all medicines, Nasobec Aqueous can cause side effects, although not everybody gets them, an allergic reaction (swelling of the lips, face or neck leading to severe difficulty in breathing; shortness of breath or wheezing, skin rash or hives).
This is a very serious but rare side effect.You may need urgent medical attention or hospitalisation. Immediately after you use your spray
You may sneeze a little, but this soon stops Very occasionally you may find you get an unpleasant taste or smell.
Tell your doctor as soon as possible if you notice any of the following side effects:
Common (affects less than 1 in 10 people)
• A dry or painful nose or throat
• Bad nose bleeds
• Mild allergic reactions including skin rashes or redness, itching or weals like nettle rash or hives.
Very rare (affects less than 1 in 10,000 people)
• High pressure in your eye that may cause pain or blurred vision
• Clouding of the lens (cataract)
• Damage to your nose
• The nose septum (the dividing partition in the nose) may become perforated.
The following side effects may occur:
• Blood stained crusts in the nose.
It is important to follow the dose instructions shown in Section 3. Using Nasobec Aqueous at higher doses fora long time can cause a number of changes in your body, such as catching infections more easily. Children or adolescents who are using Nasobec Aqueous for prolonged periods may grow more slowly and your doctor will want to monitor their growth. Reporting of side effects If you get any side effects, talkto 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 at: www.mhra.gov.uk/yellowca rd By reporting side effects you can help provide more information on the safety of this medicine.
HOWTO STORE NASOBEC AQUEOUS
Keep out of the reach and sight of children.
Keep your medicine below 30°C in the original carton away from light. Do not put your medicine in the fridge. Do not use Nasobec Aqueous after it has been open for 3 months or after the expiry date that is stated on the outer packaging, whichever is sooner.The expiry date refers to the last day of that month. Medicines should not be disposed of via wastewater or household waste. Askyour pharmacist howto dispose of medicines no longer required.These measures will help to protect the environment.
FURTHER INFORMATION
What Nasobec Aqueous contains:
• The active ingredient is beclometasone dipropionate anhydrous.
• The other ingredients are phenylethyl alcohol, benzalkonium chloride, polysorbate 80, microcrystalline cellulose and carmellose sodium, glucose anhydrous and purified water. Your medicine may also contain hydrochloric acid to adjust the pH.
What Nasobec Aqueous looks like and contents of the pack:
• Nasobec Aqueous is a nasal spray.
• Each bottle of Nasobec Aqueous contains 200 sprays.
Marketing Authorisation Holder and Manufacturer
Marketing authorisation holder:
TEVA UK Limited, Eastbourne, BN22 9AG.
Company responsible for manufacture:
TEVA Czech Industries s.r.o., Opava, Czech Republic. This leaflet was last revised: March 2015 PL 00289/1626
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