200 micrograms/dose inhaled powder
Beclomethasone dipropionate
1. What Beclomet Easyhaler is and what it is used for
Beclomet Easyhaler is a cortisone preparation ( corticosteroid ) that counteracts inflammation in the lungs. By treating inflammation, asthma symptoms are prevented. Therefore, Beclomet Easyhaler should be used regularly. The full effect comes only after about 10 days of treatment. Beclomet Easyhaler does not provide quick relief in acute asthma symptoms. If you have an asthma attack, you will need to use another type of medicine: a fast-acting bronchodilator (a beta2- agonist ).
Beclomethasone dipropionate is the active substance in Beclomet Easyhaler. Beclomethasone dipropionate is a powder that is inhaled (inhaled) into the lungs with an inhaler called Easyhaler. You inhale the powder into your lungs through the mouthpiece of the inhaler.
2. What you need to know before using Beclomet Easyhaler
Do not use Beclomet Easyhaler
if you are allergic (hypersensitive) to beclomethasone dipropionate or the ingredient lactose in Beclomet Easyhaler.
Warnings and cautions
- Contact a doctor if you experience that the effect of Beclomet Easyhaler is impaired, e.g. if you have asthma attacks more often. You may need to change your medication.
- If you switch from cortisone tablets to Beclomet Easyhaler, you may find that your condition worsens. You can get cold symptoms, eczema, fatigue, headaches, muscle, and joint pain, and sometimes even nausea and vomiting. These symptoms are due to the fact that the total amount of cortisone in the body decreases, as you receive local cortisone treatment. The symptoms disappear after a period of treatment.
- If you have an infection of the respiratory tract.
- If you have tuberculosis
- If you need to increase the use of other asthma medications
If you experience any of these, consult a doctor.
If you experience contractions/spasms in the airways after using Beclomet Easyhaler, consult a doctor.
Also pay attention to:
- Beclomet Easyhaler has no effect on acute asthma attacks, as a short-acting bronchodilator should be used. Beclomet Easyhaler has a preventive effect and should be taken regularly even if you do not experience any discomfort. The effect is achieved only after a few days of treatment. The full effect depends on regular use over a long period of time. If no effect is achieved, consult a doctor.
- Possible systemic side effects such as inhibited height growth in children and adolescents.
Contact a doctor if you experience blurred vision or other visual disturbances.
Other medicines and Beclomet Easyhaler
Tell your doctor if you are taking other medicines that contain cortisone ( corticosteroids ), e.g. tablets or nasal spray.
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Some medicines may increase the effects of Beclomet Easyhaler 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
Talk to your doctor if you are pregnant, planning to become pregnant, or breast-feeding. Your doctor will decide if you should continue with your treatment.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
There are 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 increased 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.
Beclomet Easyhaler contains excipients
Beclomet Easyhaler contains a small amount of lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before using Beclomet Easyhaler.
3. How to use Beclomet Easyhaler
Always use Beclomet Easyhaler exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
The usual dose for adults and children over 12 years: 1-4 inhalations twice daily.
The usual dose for children:
5-7 years: 1 inhalation 1-2 times daily.
7-12 years: 1-2 inhalations are 1-2 times daily.
The medicine accompanies the inhalation into the trachea as you inhale through the Easyhaler according to the instructions for use (see instructions at the end of the package leaflet). It is important that the entire dose is inhaled properly. The mouth should be rinsed with water after each inhalation. Read and follow the instructions carefully!
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.
If you forget to use Beclomet Easyhaler
If you forget to take a dose, take one as soon as possible or take the next dose when it is time for it. It is best to take the medicine at the same time each day, to avoid forgetting it.
If you stop using Beclomet Easyhaler
Do not stop using Beclomet Easyhaler without talking to your doctor. If you suddenly stop taking the medicine, your asthma may worsen.
Instructions on how to use the inhaler can be found at the end of the leaflet.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact a doctor as soon as possible if you experience convulsions in the trachea immediately after using Beclomet Easyhaler. This is a rare reaction.
Stop taking Beclomet Easyhaler and contact your doctor immediately if you get any of the following symptoms ( angioedema ):
- swelling of face, tongue, and throat
- difficulty swallowing
- hives and difficulty breathing
This is a rare allergic reaction.
Common (may affect up to 1 in 10 people):
- Fungal infection (“cod”) in the oral cavity, larynx, and throat, throat irritation and hoarseness, sore throat, and cough.
These side effects can be reduced by rinsing the mouth with water after each inhalation.
Rare (may affect up to 1 in 1,000 people):
- Hypersensitivity reactions, e.g. hives, rash, itching, allergic shock.
- Thinning of skin and easy to get bruises.
- Spasm of the trachea and respiratory tract infection.
Has been reported (occurs in an unknown number of users):
- Sleep problems, depression, anxiety, restlessness, anxiety, feeling of being very hurried and/or irritable. These side effects are more likely to occur in children.
- Underactive adrenal gland ( gland next to the kidneys).
- Cataracts ( cataract ), glaucoma ( glaucoma ).
- Decreased bone density (osteoporosis).
- Inhibited height growth in children and adolescents.
- Cushing-like symptoms (moon face, abdominal obesity, stretch marks, and bleeding in the skin, high blood pressure, and sometimes diabetes ).
- Dimsyn
Reporting of side effects ar
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. You can also report side effects directly via:
The Medical Products Agency
Box 26
751 03 Uppsala
www.lakemedelsverket.se
By reporting side effects, you can help increase drug safety information.
5. How to store Beclomet Easyhaler
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton. The expiration date is the last day of the specified month. After the foil bag is opened, the shelf life is 6 months.
Do not store above 25 ° C. After opening the foil pouch, store the inhaler dry. Moisture sensitive.
The medicine 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.
6. Contents of the packaging and other information
Content declaration
– The active substance is beclomethasone dipropionate
– The other ingredient is lactose monohydrate
What the medicine looks like and the contents of the pack
The inhalation powder is packaged in an inhaler (Easyhaler).
Inhaler with 200 doses and case.
Inhaler with 200 doses is.
Marketing Authorization Holder and Manufacturer
Orion Corporation
Orionintie 1
FI-02200 Espoo
Finland
Manufacturer
Orion Corporation, Orion Pharma
Orionintie 1
FI-02200 Espoo
Finland