Teva

Inhalation spray, solution 50 micrograms / dose 
(inhalation spray, solution)

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor, pharmacist, or nurse.
  • This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. See section 4

In this leaflet: 
1. What AeroBec Autohaler is and what it is used for 
2. What you need to know before you use AeroBec Autohaler 
3. How to use AeroBec Autohaler 
4. Possible side effects 
5. How to store AeroBec Autohaler 
6. Contents of the package and other information 

1. What AeroBec Autohaler is and what it is used for

AeroBec Autohaler contains the active substance beclomethasone dipropionate. Beclomethasone dipropionate belongs to a group of medicines called corticosteroids( cortisone ) that counteract inflammation and allergies directly in the lungs. By reducing inflammation, asthma attacks are prevented.

AeroBec Autohaler is used for asthma. This type of medicine is used for prevention and must be taken regularly, even when there are no signs of symptoms. The full effect is expected only after about 10 days of treatment.

AeroBec Autohaler is inhalation controlled and automatically delivers the correct dose of the medicine when inhaled through the mouth.

Beclomethasone dipropionate contained in AeroBec Autohaler may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.

2. What you need to know before using AeroBec Autohaler

Do not use AeroBec:

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

Warnings and cautions

Talk to your doctor or nurse before using AeroBec Autohaler if you:

  • have tuberculosis or some other form of lung disease
  • treated with cortisone tablets. Your doctor may reduce the number of tablets you should take when you start using AeroBec Autohaler. If you have been taking cortisone tablets for a long time, your doctor may want to take regular blood tests. When the treatment with cortisone tablets is reduced, you may feel a general feeling of illness even if your respiratory symptoms improve. You may get symptoms such as a stuffy or runny nose, weakness, joint pain, muscle aches, and rash ( eczema ). If you get any of these symptoms or if symptoms such as headache, fatigue, nausea, or vomiting occur, contact your doctor immediately. You may need to take other medicines if you develop symptoms of allergies or arthritis. You should talk to your doctor if you are wondering if you should continue to use AeroBec Autohaler.

AeroBec Autohaler is not intended for the acute treatment of asthma but only for long-term preventive treatment of asthma, even when you have no symptoms (see section 1 What AeroBec Autohaler is and what it is used for).

Talk to your doctor or nurse while using AeroBec Autohaler if you:

  • the experience that the effect of AeroBec Autohaler deteriorates, e.g. if you have asthma attacks more often. You may need to change your medication.
  • have a severe infection or are undergoing surgery. Your doctor may consider adding cortisone tablets to your regular treatment during stressful periods
  • experiencing blurred vision or other visual disturbances.

Children

For children who are treated for a longer period of time, the height growth should be controlled. Some side effects are more common in children (see section 4 Possible side effects ).

Other medicines and AeroBec Autohaler

Tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Some medicines may increase the effects of AeroBec Autohaler and your doctor may want to monitor you closely if you are taking these medicines (eg some medicines for HIV: ritonavir, cobicistat).

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Limited experience of use during pregnancy.

Breast-feeding

It is unknown if AeroBec Autohaler passes into breast milk.

Driving and using machines

AeroBec Autohaler has no known effects on the ability to drive or use machines.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

AeroBec Autohaler contains excipients

This medicine contains 4.74 mg of alcohol ( ethanol ) per inhalation. The amount in inhalation of this medicine corresponds to less than 0.1 ml of beer or 0.05 ml of wine.

The low amount of alcohol in this medicine does not produce any noticeable effects.

3. How to use AeroBec Autohaler

Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

AeroBec Autohaler should be used regularly, even during symptom-free periods.

Adults and children over 12 years

A typical dosage is 50-100 micrograms morning and evening. The doctor may initially prescribe a higher dose, 200-400 micrograms morning and evening. The maximum recommended daily dose is 800 micrograms.

Children 5-12 years

Dose one may need to be individualized. The recommended dose is 50 micrograms morning and evening. If necessary, a higher dose may be given, but not more than 200 micrograms/day.

It is important that you take a dose as stated on the package label or as your doctor has informed you. Do not increase or decrease the dose without consulting a doctor.

See the instructions for use at the end of this leaflet for information on inhalingAeroBec Autohaler.

If you forget to use AeroBec Autohaler

Take the missed dose as soon as you find out you forgot to take your medicine. Then continue the treatment as usual. 
Do not take a double dose to make up for a forgotten dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking AeroBec Autohaler and contact a doctor immediately if:

  • you get swelling of the face, tongue, or throat, difficulty swallowing, hives, difficulty breathing, or a sudden feeling of fainting. This may be a sign of an allergic reaction or angioedema.
  • after inhalation of the medicine, you experience sudden, acute wheezing or shortness of breath (respiratory cramps).

This can rarely occur in connection with the use of AeroBec Autohaler.

Other possible side effects are listed below by occurrence.

Common (may affect up to 1 in 10 people):

  • fungal infection of the oral cavity, larynx, and pharynx, throat irritation, and hoarseness. The risk of fungal infection is reduced if you rinse your mouth with water after each inhalation, the water should be spat out after rinsing.

Uncommon (may affect up to 1 in 100 people):

  • hives
  • eczema
  • cough
  • increasing asthma symptoms
  • tremor
  • headache
  • dizziness

Rare (may affect up to 1 in 1,000 people):

  • nausea

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

  • Cushing-like symptoms (moon face, abdominal obesity, stretch marks and bleeding in the skin, high blood pressure, and sometimes diabetes )
  • decreased cortisone formation in the adrenal glands
  • reduced bone density
  • eye problems
  • delayed height growth in children and adolescents

Has been reported (occurs in an unknown number of users):

  • Tamsyn
  • sleep disorders, depression, anxiety, restlessness, overactivity, irritability, or behavioral disorders (effects mainly seen in children).

Reporting of side effects

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 to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.

5. How to store AeroBec Autohaler

Keep this medicine out of the sight and reach of children.

Store below 30 ° C.

Avoid direct sunlight and high heat.

AeroBec Autohaler provides the correct dose in temperatures down to -10 o C.

Do not use this medicine after the expiry date which is stated on the label and carton after “EXP”. The expiration date is the last day of the specified month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

The contents of the container are stored under pressure. The container must not be exposed to damage.

6. Contents of the packaging and other information

Content declaration

  • The active substance is beclomethasone dipropionate. One dose contains 50 micrograms resp. 100 micrograms anhydrous beclomethasone dipropionate.
  • The other ingredients are norflurane and ethanol (96%).

What the medicine looks like and the contents of the pack

The package contains an inhaler with 200 doses.

Manufacturer

Norton (Waterford) Limited

T / A Teva Pharmaceuticals Ireland

Waterford, Ireland

This leaflet was last modified on 10/08/2020

Instructions for use

The first time you use your spray or if the spray has been unused for 14 days or longer, you must first push two spray doses into the air before AeroBec Autohaler can be used. Do as follows:

  1. Remove the protective cover by pulling on the rear edge.
  2. Hold the nozzle so that the dose that comes out is directed away from you, into the air. Pull the charger so that it is upright.
  3. To trigger a dose, slide the dose trigger at the bottom of the nozzle in the direction indicated in the figure.
  4. To be able to trigger the second spray dose, the charger must be pushed down again, and then steps 2 and 3 are repeated. After the second spray dose, the charger is pressed down again and the AeroBec Autohaler is ready for use.



Do not use the automatic dose trigger when taking your medicine. AeroBec Autohaler automatically triggers a dose as you inhale through the mouthpiece.

To use AeroBec Autohaler:

  1. Remove the protective cover by pulling on the rear edge. The package does not need to be shaken before use.
  2. Hold the inhaler upright as shown in the figure. Pull the charger so that it is upright. Continue to hold the inhaler upright. Be careful that your fingers do not block the air valve (marked X in picture 2) at the bottom of the inhaler.
  3. Exhale as much as you can, place the mouthpiece in your mouth and close your lips tightly around the mouthpiece.
  4. Inhale slowly and deeply through the mouthpiece. The drug now follows the inhaled air into the lungs. Continue inhaling even when you hear a “click” and feel the taste of medicine in your mouth. It is important that you continue inhaling after dose one is released.
  5. Hold your breath for 10 seconds and then exhale slowly.
  6. The charger must be pushed back after each dose. If your doctor has prescribed more than one dose, repeat steps 2-6. After use, replace the protective cover.

Rinse mouth with water and spit out after inhalation.







Cleaning

The nozzle is dried on the outside with a clean and dry cloth or napkin.

Warning: Do not put the cloth or napkin in the inhaler. It can destroy the mechanism. Do not disassemble the inhaler. The inhaler must not come into contact with water.

Muhammad Nadeem

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