Teva

Inhalation spray, solution 100 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 you will find information about: 
1. What AeroBec is and what it is used for 
2. What you need to know before using AeroBec 
3. How to use AeroBec 
4. Possible side effects 
5. How to store AeroBec 
6. Contents of the packaging and other information 

1. What AeroBec is and what it is used for

AeroBec 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 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 is an inhalation spray that is inhaled through the mouth.

Beclomethasone dipropionate contained in AeroBec 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

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 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. 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

AeroBec 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 is and what it is used for).

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

  • the experience that the effect of AeroBec 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

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 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 passes into breast milk.

Driving and using machines

AeroBec 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 contains ethanol

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

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

AeroBec 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 inhalation of AeroBec.

If you forget to use AeroBec

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 and contact a doctor immediately

  • 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 may in rare cases occur in connection with the use of AeroBec.

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

Keep this medicine out of the sight and reach of children

Store below 30 ° C.

Avoid direct sunlight and high heat.

AeroBec 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 can be used.

To use AeroBec:

  1. Remove the protective cap. The package does not need to be shaken before use.
  2. Exhale as much as you can, place the mouthpiece in your mouth and close your lips tightly around the mouthpiece.
  3. Inhale slowly and deeply through your mouth while pressing down on the container as shown in the figure, which triggers a dose. The drug now follows the inhaled air into the lungs. Keep breathing.
  4. Hold your breath for 10 seconds and then exhale slowly. If your doctor has prescribed more than one dose, repeat steps 2-4. After use, replace the protective cover.

Rinse mouth with water and spit out after inhalation.

The picture describes how to use the inhalation spray

Cleaning The 
the nozzle is dried on the outside with a clean and dry cloth or napkin. Neither the container nor the plastic nozzle must come into contact with water.

Muhammad Nadeem

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