Artwork No. 020515/5 Colours Used Customer Ennogen Black Description Leaflet Keyline Market UK Language English Size 160 x 360 mm Min. Font Size 9 pt Page No. 1 of 1 Version No. 9 Date 20-05-19 e-mail : [email protected] Ph : +91-09845156610 Software Coreldraw 12

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3. Keep your thumb still, and press down with ! Mild allergic reactions including skin your fingers to pump the spray. You may need rashes or redness, itching or weals to do this 4-5 times. like nettle rash or hives. PACKAGE LEAFLET: INFORMATION FOR THE USER If the spray does not work and you think it may be Very rare (may affect up to 1 in 10,000 blocked, you will need to clean it. Please see the people) section, Cleaning your spray. ! Damage to your nose Beclometasone Dipropionate Aqueous ! Cloudy lens in the eye () Never try to unblock or enlarge the tiny spray hole ! Increased pressure in the eye with a pin or other sharp object. This will damage (glaucoma). the way the spray works. Read all of this leaflet carefully before you start Not known (frequency cannot be taking this medicine because it contains Some medicines may increase the effects of Using your spray estimated from the available data) important information for you. Beclometasone Dipropionate Aqueous Nasal 1. Shake the bottle vigorously up and down and ! Blurred vision (see Section 2). ! Keep this leaflet. You may need to read it Spray and your doctor may wish to monitor you take off the dust cap. again. carefully if you are taking these medicines 2. Holding the spray away from your nostril ! Very rarely, the normal production of in If you have any further questions, ask your (including some medicines for HIV: ritonavir, breathe out through your nose. your body may be affected. This is more likely to doctor, pharmacist or nurse. cobicistat). 3. Close one nostril with your finger and put the ! happen if you use high doses for a long time. Your This medicine has been prescribed for you nozzle in the other nostril. Tilt your head doctor will help stop this happening by making sure only. Do not pass it on to others. It may harm and breast-feeding forward slightly and keep the bottle upright. you use the lowest dose of which controls them, even if their signs of illness are the same If you are pregnant or breast-feeding, think you 4. Start to breathe in slowly through your nose. your symptoms. In children this side effect can as yours. may be pregnant or are planning to have a baby, While you are breathing in press down firmly on ! rarely cause them to grow more slowly than others. If you get any , talk to your doctor, ask your doctor or pharmacist for advice before the collar with your fingers. A spray of fine mist Children who receive this treatment for a long pharmacist or nurse. This includes any side taking this medicine. will go into your nostril. period of time will have their height checked effects not listed in this leaflet. See section 4. There is a very small risk of abnormalities in babies 5. Remove the nozzle from your nostril and slowly regularly by their doctor. whose mothers have taken Beclometasone breathe out through your mouth. What is in this leaflet Dipropionate during pregnancy. 6. Repeat step 4 to use a second spray in the Reporting of side effects same nostril. 1. What Beclometasone Dipropionate Aqueous You should discuss with your doctor whether you If you get any side effects, talk to your doctor, 7. Remove the nozzle from this nostril and Nasal Spray is and what it is used for should take this medicine during pregnancy. They pharmacist or nurse. This includes any possible breathe out through your mouth. 2. What you need to know before you use may advise you to take the lowest dose that will side effects not listed in the leaflet. You can also 8. Repeat steps 3 to 6 for your other nostril. Beclometasone Dipropionate Aqueous Nasal control your symptoms for a short period of time. report any side effects directly via the Yellow Card 9. After using your spray, wipe the nozzle carefully Spray Similarly, this medicine may be passed on to Scheme at: www.mhra.gov.uk/yellowcard or search with a clean tissue or handkerchief, and 3. How to use Beclometasone Dipropionate babies through breast milk by mothers taking for MHRA Yellow Card in the Google Play or Apple replace the dust cap. Aqueous Nasal Spray Beclometasone Dipropionate Aqueous Nasal App Store. 4. Possible side effects Spray. You should discuss with your doctor using By reporting side effects you can provide more 5. How to store Beclometasone Dipropionate this medicine while you are breast- feeding. Cleaning your spray information on the safety of this medicine. Aqueous Nasal Spray It is very important to keep the plastic cap and 6. Contents of the pack and other information Driving and using machines nozzle clean, to prevent any build up of powder. Using Beclometasone Dipropionate Aqueous Nasal Washing the applicator regularly (weekly) is 5. HOW TO STORE BECLOMETASONE 1. WHAT BECLOMETASONE DIPROPIONATE Spray should not affect your ability to drive or recommended. DIPROPIONATE AQUEOUS NASAL SPRAY AQUEOUS NASAL SPRAY IS AND WHAT IT operate machinery. If however, you do feel affected IS USED FOR when you have taken this medicine, you should not 1. Take the dust cap off. Keep this medicine out of the sight and reach of drive or operate machinery until you feel better. 2. Pull upwards on the white collar to remove the children. Beclometasone Dipropionate Aqueous Nasal nozzle. Spray contains a medicine called beclometasone Beclometasone Dipropionate Aqueous Nasal 3. Soak the nozzle and dust cap in warm water for Do not use this medicine after the expiry date dipropionate. This belongs to a group of medicines Spray contains benzalkonium chloride a few minutes. which is stated on the label and carton. The expiry called steroids (also called 'cortico-steroids'). Benzalkonium chloride may cause irritation or 4. Then rinse under a running tap. date refers to the last day of that month. swelling inside the nose, especially if used for a 5. Shake off the excess water and let them dry in Steroids work by reducing . They long time. a warm place. Do not store above 30°C. Store in the original reduce swelling and irritation in your nose which 6. Put the nozzle back on the spray. package. Do not refrigerate. helps to relieve itching, sneezing and your blocked 3. HOW TO USE BECLOMETASONE 7. You need to 'Prime' the bottle as described in or runny nose. DIPROPIONATE AQUEOUS NASAL SPRAY the section above before using again. Stop using this bottle three months after you first opened it. Beclometasone Dipropionate Aqueous Nasal Always use this medicine exactly as your doctor If you use more Beclometasone Dipropionate If you are told to stop taking this medicine return Spray is used to prevent and treat: has told you. Check with your doctor or pharmacist Aqueous Nasal Spray than you should any unused spray to your pharmacist to be ! Inflammation in the lining of your nose () if you are not sure. Tell your doctor if you use more than you were told destroyed. due to seasonal , such as Hayfever. to. ! Inflammation in the lining of your nose (rhinitis) Maximum benefit is produced after a few days of It is important that you take your dose as stated on Do not throw away any medicines via wastewater due to year round (perennial) allergies, such as regular use. This medicine should be used the pharmacist's label or as advised by your or household waste. Ask your pharmacist how to animal allergies. regularly to maintain its efficacy. Your dose may be doctor. You should use only as much as your throw away medicines you no longer use. These altered by your doctor when your symptoms have doctor recommends; using more or less may make measures will help protect the environment. 2. WHAT YOU NEED TO KNOW BEFORE YOU improved. your symptoms worse. USE BECLOMETASONE DIPROPIONATE Do not use this medicine in children under 6 years 6. CONTENTS OF THE PACK AND OTHER AQUEOUS NASAL SPRAY of age. If you forget to use Beclometasone INFORMATION Dipropionate Aqueous Nasal Spray Do not take Beclometasone Dipropionate Adults and children over 6 years of age: If you have forgotten to take a dose, this should not What Beclometasone Dipropionate Aqueous Aqueous Nasal Spray: Recommended dose: 2 sprays (equivalent to 100 be a problem. Skip the missed dose and take your Nasal Spray contains ! next dose at the normal time. Do not take a double If you are allergic to beclometasone micrograms) into each nostril twice a day. Each spray contains 50 micrograms of dose to make up for a forgotten dose. If you have dipropionate or any of the other ingredients of Do not take more than 8 sprays (4 sprays per beclometasone dipropionate. this medicine (listed in section 6). nostril) or 400 micrograms (200 micrograms per trouble remembering when to take your medicine, nostril) in any 24 hour period. tell your doctor or pharmacist. Warnings and precautions The other ingredients are: anhydrous glucose, Talk to your doctor, pharmacist or nurse before Long term use of topical should be If you stop using Beclometasone Dipropionate microcrystalline cellulose, sodium using Beclometasone Dipropionate Aqueous Nasal avoided. Aqueous Nasal Spray carboxymethylcellulose, polysorbate 80, Spray: Do not stop using Beclometasone Dipropionate phenylethyl alcohol, benzalkonium chloride ! If you are already taking another steroid If you use high doses of Beclometasone Aqueous Nasal Spray even if you feel better, solution and purified water. medicine Dipropionate Aqueous Nasal Spray unless your doctor tells you to stop. If you do stop, ! If you have a cold or an in your nose There are times when your doctor may need to the symptoms may come back. What Beclometasone Dipropionate Aqueous ! If you have had nasal surgery adjust the dose of the steroid you are given or the If you have any further questions on the use of this Nasal Spray looks like and contents of the pack ! If you have pulmonary tuberculosis. way in which you take it. These times are: medicine, ask your doctor or pharmacist. Beclometasone Dipropionate Aqueous Nasal ! times of extreme stress Spray is an aqueous suspension used for Contact your doctor if you experience blurred ! during admission to hospital after a serious 4. POSSIBLE SIDE EFFECTS intranasal inhalation via a metered dose atomising vision or other visual disturbances. accident, injury or illness pump. ! before and after a surgical operation. Like all medicines, this medicine can cause side Beclometasone Dipropionate Aqueous Nasal If this medicine has been prescribed in If you think that any of these apply to you whilst effects, although not everybody gets them. Spray is available in a glass or HDPE vial fitted replacement of an oral steroid product and your using Beclometasone Dipropionate Aqueous Nasal with a metering pump and nasal applicator. They condition gets worse, you develop a severe Spray, speak to your doctor or pharmacist. Severe allergic reactions may occur rarely. The are provided in packs of 1. infection, you are injured or if you are going to signs may include swelling of your face or throat, have an operation you should talk to your doctor How to Use Beclometasone Dipropionate shortness of breath or wheezing and skin rashes. If Marketing Authorisation Holder before using it. They may prescribe a short course Aqueous Nasal Spray this happens, tell your doctor straight away Ennogen Pharma Limited of treatment with an oral anti-inflammatory steroid Each spray has a dust cap which protects the you may need urgent medical treatment. Unit G4, Riverside Industrial Estate, in addition to the nasal spray. During this change nozzle and keeps it clean. Remember to take this Riverside Way, Dartford, DA1 5BS, UK. over from an oral steroid to this nasal spray you off before using the spray. Immediately after you use your spray may develop allergic reactions including skin A new spray (or one that has not been used for a ! You may sneeze a little, but this will quickly Manufacturer rashes or a runny nose. These reactions may have few days), may not work first time. You need to stop Lagap Pharmaceuticals Limited been disguised by your previous medication. You 'prime' the spray by pumping the spray a few times ! Very occasionally you may find you get an Woolmer Way, Bordon should consult your doctor. until a fine mist is produced. unpleasant taste or smell. Hampshire, GU35 9QE 1. Hold the bottle upright, and make sure it is United Kingdom Other medicines and Beclometasone pointed away from you Tell your doctor as soon as possible if you notice any of the following side effects: Dipropionate Aqueous Nasal Spray 2. Put your forefinger and middle finger on the This leaflet was last revised in May 2019. Tell your doctor or pharmacist if you are taking, collar either side of the nozzle and put your Common (may affect up to 1 in 10 people) have recently taken or might take any other thumb underneath the bottle ! A dry or painful nose or throat medicines. ! Bad nose bleeds