Beclazone

Beclazone

beclometasone

Manufacturer:

Teva

Distributor:

KLN Pharma
Full Prescribing Info
Contents
Beclometasone dipropionate (anhydrous).
Description
Each puff (metered dose) of Beclazone 50 micrograms CFC-Free Inhaler contains 50 micrograms of beclometasone dipropionate.
Each puff (metered dose) of Beclazone 250 micrograms CFC-Free Inhaler contains 250 micrograms of beclometasone dipropionate.
The other ingredients are ethanol anhydrous (alcohol) and the propellant norflurane (HFA-134a). This medicine does not contain any CFCs.
Action
Effect: Beclazone CFC-Free Inhaler contains Beclometasone Dipropionate, which belongs to a group of medicines called corticosteroids. Beclometasone dipropionate works on the lungs to help prevent asthma attacks by reducing the swelling and irritation in the walls of the small air passages. This eases the breathing problems. Very little corticosteroid gets absorbed into the body. This medicine is not the same type of steroid used by body-builders and athletes to increase their performance.
Indications/Uses
Beclazone CFC-Free Inhalers are used to treat asthma. This type of medicine is known as a 'preventer'. The patient must keep on taking this type of medicine regularly, even when the patient do not seem to have the asthma symptoms.
The patient should not use this inhaler to relieve wheezing or breathlessness. The patient will probably need a different kind of medicine in a different coloured pack for this purpose. The patient may be using an inhaler that widens the airways during an asthma attack. This type of inhaler is known as a 'reliever'. The patient can safely use the 'reliever' with the Beclazone CFC-Free Inhaler.
Dosage/Direction for Use
Always take Beclazone CFC-Free Inhaler exactly as the doctor has told to the patient. The patient should check with the doctor or pharmacist if not sure.
All patients are different and the doctor may have prescribed a different dose for the patient.
The usual dose for Because CFC-Free Inhaler is: Adults and the elderly: Beclazone 50 micrograms CFC-Free Inhaler: Take one to two puffs twice daily.
Usually the most the patient would take in 24 hours is sixteen puffs.
Beclazone 250 micrograms CFC-Free Inhaler: Take one to two puffs twice daily.
Usually the most the patient would take in 24 hours is four puffs.
Children seven years and older: Beclazone 50 micrograms CFC-Free Inhaler: Take one or two puffs twice daily.
Usually the most the patient would take in 24 hours is four puffs.
Beclazone 250 micrograms CFC-Free Inhaler is not recommended for use in children.
Hepatic or renal impairment: Dose adjustments are not required. Follow the doctor's instructions.
If the patient forgets to take Beclazone CFC-Free Inhaler: Do not take a double dose to make up for a forgotten dose. If the patient forgets to use the inhaler, take the recommended number of puffs when remembered. Then continue the treatment as prescribed by the doctor.
Overdosage
If the patient takes more Beclazone CFC-Free Inhaler than it should: The dose has been carefully worked out for the patient. It is important that the patient do not take too much. If the patient accidentally takes more puffs than the doctor has recommended, don't worry. However, if the patient regularly uses more than the recommended dose, the patient should tell the doctor as soon as possible.
Contraindications
Do not use Beclazone CFC-Free Inhaler: If the patient is allergic to beclometasone dipropionate (active ingredient) or to any of the other ingredients of Beclazone CFC-Free Inhaler.
If the patient suffers from or has ever suffered from tuberculosis (TB).
Special Precautions
Because the inhaler is used to prevent asthma attacks, it is important to use it regularly, even when the patient feels well.
It may take a few days for the medicine to work. Do not stop using the inhaler unless told by a doctor.
If the patient has started to use Beclazone CFC-Free Inhaler with, or instead of, taking steroid tablets the patient should carry a steroid warning card (if the patient has one) until the doctor tells the patient to no longer need to carry it.
Consult a doctor immediately if the usual treatment is not working. The doctor will tell if the patient needs any extra treatment. The dosage should only be increased on medical advice.
If the patient notices more short of breath and wheeze is getting worse, tell the doctor immediately.
He or she will tell if the patient needs any extra treatment.
Driving and using machines: Beclazone CFC-Free Inhaler dose not affect the ability to drive or to use machinery.
Use In Pregnancy & Lactation
Pregnancy and breast-feeding: Ask the doctor or pharmacist for advice before taking any medicine. Beclazone CFC-Free Inhaler should only be used if recommended by a doctor.
Side Effects
Like all medicines Beclazone CFC-Free Inhaler can cause side effects, although not everybody gets them.
Contact the doctor immediately if the patient experiences hypersensitivity (allergic) reactions. These include rash, swelling of the face, eyes, lips and throat and wheezing (because of narrowed airways).
Infections and infestations: Common side effects (affecting more than 1 in 100 and less than 1 in 10 individuals): Candidiasis (thrush) in the mouth and throat, which is seen as white spots. Rinsing the mouth with water immediately after using the inhaler will help prevent this from occurring. If the patient has these symptoms, tell the doctor but do not stop using the inhaler unless the doctor told to.
Immune system disorders: Rare side effects (affecting more than 1 in 10,000 and less than 1 in 1,000 individuals): Hypersensitivity reactions as described previously.
Respiratory, thoracic and mediastinal disorders: Common side effects (affecting more than 1 in 100 and less than 1 in 10 individuals): Hoarseness and throat irritation.
Rare side effects (affecting more than 1 in 10,000 and less than 1 in 1,000 individuals): Wheezing, difficulty in breathing or tightness in the chest. If this happens, stop using the inhaler and tell the doctor immediately.
Skin and subcutaneous tissue disorders: Very rare side effects (affecting less than 1 in 10,000 individuals including isolated reports): Itching, rash and reddening of the skin.
Musculoskeletal and connective tissue disorders: Very rare side effects (affecting less than 1 in 10,000 individuals including isolated reports): Decreased bone density.
Endocrine disorders: Very rare side effects (affecting less than 1 in 10,000 individuals including isolated reports): Decrease in function of the adrenal gland, which is responsible for producing some hormones that control the body. Decrease in growth, particularly in children and adolescents.
Eye disorders: Very rare side effects (affecting less than 1 in 10,000 individuals including isolated reports): Cataracts (formation of a film over the eye lens). Glaucoma (a disease in which the eye pressure increases).
If any of the side effects get serious, or if the patient notices any side effects not listed, please tell the doctor or pharmacist.
Drug Interactions
Please tell the doctor or pharmacist if the patient is taking or has recently taken any other medicines, including medicines that are obtained without a prescription.
The following medicines may influence the effect of Beclazone CFC-Free Inhaler: Other asthma medicines, such as bronchodilators, or other corticosteroids in tablet form.
Taking Beclazone CFC-Free Inhaler with food or drink: Beclazone CFC-Free Inhaler should be used as prescribed by the doctor.
Caution For Usage
Medicines should not be disposed of via wastewater or household waste. Ask the pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Storage
Do not store above 25°C.
Do not refrigerate or freeze. If the inhaler gets very cold, remove the metal can and warm it in the hands for a few minutes before using it. Do not warm the can in any other way. Pressurized aerosol can. Do not expose to temperatures higher than 50°C. Do not puncture, break or burn the can, even if it seems empty.
Patient Counseling Information
Instructions for use of the inhaler: Important: Before using your inhaler, please read and follow the instructions carefully. If you are not sure how or when to use your inhaler, ask your doctor or a pharmacist. Do not stop using the inhaler unless your doctor tells you to. If your doctor tells you to stop using your inhaler, take any inhalers you have left back to your pharmacist.
If you find it difficult to use your inhaler with one hand, use both hands.
Children may need to help to use Beclazone CFC-Free Inhaler.
Parents can help by spraying the aerosol when the child begins to breathe in.
Using the Inhaler: Test spray the inhaler before you use it for the first time and also if you have not used it for a while.
1. Take the cap off the inhaler. Make sure the mouthpiece is clean and free of fluff and dirt.
2. Hold the inhaler upright with your thumb on the base and your first finger on the top of the can. Shake the inhaler vigorously up and down.
3. Breathe out normally as far as you comfortably can. Then hold the mouthpiece firmly between your lips. Breathe in slowly and deeply. As you first start to breathe in, press the aerosol can with your first finger to spray the aerosol and release the medicine. Continue to breathe in slowly and deeply.
4. Take the inhaler out of your mouth and hold your breath for 10 seconds, or for as long as you comfortably can. Breathe out slowly.
5. If you need more than one puff, wait for about one minute and then start again from step 2. Put the cap back on the inhaler.
Note: Do not rush step 3. It is important that you start to breathe in as slowly as possible just before using your inhaler. Practice in front of a mirror for the first few times. If you see 'mist' coming from the top of the inhaler or from the sides of your mouth you should start again from step 2.
Cleaning the inhaler: You must keep your inhaler clean, especially the mouthpiece. This will prevent deposits from the aerosol building up.
Clean your inhaler at least once a week.
Take the metal can from the plastic body and rinse the plastic body and cap in warm water. Do not use very hot water to clean your inhaler.
Dry thoroughly (leave to dry overnight if possible) but do not use direct heat. Put the metal can back in the plastic mouthpiece and replace the cap. Do not put the metal can into water.
Failure to allow the mouthpiece to dry properly will result in an increase in blockage problems.
How to clean your inhaler: Keeping the plastic mouthpiece clean is very important as it will help prevent your inhaler becoming blocked. You must clean your inhaler once a week.
A. To clean your inhaler first remove the mouthpiece cap.
B. Remove the metal can from the plastic mouthpiece. Do not put the metal can into water.
C. Rinse the inhaler mouthpiece and the mouthpiece cap with warm running water for at least 30 seconds.
D. Shake off any excess water and dry the plastic mouthpiece and mouthpiece cap thoroughly (leave to dry overnight if possible) but do not use direct heat. Put the metal can back in your inhaler. Replace the cap.
Failure to allow the mouthpiece to dry properly will result in an increase in blockage problems.
If you need to use your inhaler before it is dry, shake off any excess water from the plastic mouthpiece and put the can back in. Test spray the inhaler by firing two puffs into the air before taking your usual dose. Wash and dry the mouthpiece again as described previously.
MIMS Class
Antiasthmatic & COPD Preparations
ATC Classification
R03BA01 - beclometasone ; Belongs to the class of other inhalants used in the treatment of obstructive airway diseases, glucocorticoids.
Presentation/Packing
Form
Beclazone 250 CFC-Free inhaler 250 mcg/actuation
Packing/Price
200 actuation x 1's
Form
Beclazone 50 CFC-Free inhaler 50 mcg/actuation
Packing/Price
200 actuation x 1's
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