Fostair NEXThaler 200micrograms/dose / 6micrograms/dose dry powder inhaler

Land: Storbritannien

Språk: engelska

Källa: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiva substanser:

Formoterol fumarate dihydrate; Beclometasone dipropionate

Tillgänglig från:

Chiesi Ltd

ATC-kod:

R03AK08

INN (International namn):

Formoterol fumarate dihydrate; Beclometasone dipropionate

Dos:

6microgram/1dose ; 200microgram/1dose

Läkemedelsform:

Inhalation powder

Administreringssätt:

Inhalation

Klass:

No Controlled Drug Status

Receptbelagda typ:

Valid as a prescribable product

Produktsammanfattning:

BNF: 03020000; GTIN: 5028613002988

Bipacksedel

PAGE 1/2
00331/RE
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
_200 MICROGRAMS/6 MICROGRAMS _
_PER ACTUATION INHALATION POWDER_
_BECLOMETASONE DIPROPIONATE ANHYDROUS/_
_FORMOTEROL FUMARATE DIHYDRATE_
_ _
FOR USE IN ADULTS
SHOULD YOU NEED TO GO TO THE HOSPITAL, remember to take all of your
medicines and inhalers with you, including
Fostair NEXThaler and any medicines or tablets bought without a
prescription, in their original package, if
possible.
CHILDREN AND ADOLESCENTS
Do not give this medicine to children and adolescents aged less than
18 years.
OTHER MEDICINES AND FOSTAIR NEXTHALER
Tell your doctor or pharmacist if you are taking, have recently taken
or might take any other medicines, including
any other inhalers and including medicines obtained without a
prescription. This is because Fostair NEXThaler
may affect the way some other medicines work. Also, some medicines can
affect the way Fostair NEXThaler works.
Some medicines may increase the effects of Fostair NEXThaler and your
doctor may wish to monitor you carefully
if you are taking these medicines (including some medicines for HIV:
ritonavir, cobicistat).
DO NOT USE BETA BLOCKERS WITH THIS MEDICINE. Beta blockers are
medicines used to treat many conditions including
heart problems, high blood pressure or glaucoma (increased pressure in
the eyes). If you need to use beta
blockers (including eye-drops), the effect of formoterol may be
reduced or formoterol may not work at all.
USING FOSTAIR NEXTHALER WHEN YOU ARE TAKING THE FOLLOWING MEDICINES:
•
other medicines which work in the same way as
formoterol (i.e. beta adrenergic drugs, commonly used
to treat asthma)
Æ can increase the effects of formoterol.
•
quinidine, disopyramide, procainamide (to treat
abnormal heart rhythms)
•
some antihistamines for example terfenadine (to treat
allergic reactions)
•
monoamine oxidase inhibitors or tricyclic
antidepressants for example phenelzine, isocarboxazid,
amitriptyline and imipramine; phenothiazines (to treat
depression or mental disorders)
Æ can cause c

Produktens egenskaper

OBJECT 1
FOSTAIR NEXTHALER 200/6
Summary of Product Characteristics Updated 13-Jun-2017 | Chiesi
Limited
1. Name of the medicinal product
Fostair NEXThaler 200 micrograms/6 micrograms per actuation inhalation
powder.
2. Qualitative and quantitative composition
Each metered dose of 10 mg inhalation powder contains:
200 micrograms of beclometasone dipropionate anhydrous and 6
micrograms of formoterol fumarate
dihydrate.
This is equivalent to a delivered dose of 158.8 micrograms of
beclometasone dipropionate anhydrous and
4.9 micrograms of formoterol fumarate dihydrate.
Excipient with known effect:
Each metered dose contains 9.8 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Inhalation powder.
The multidose inhaler contains a white or almost white powder.
4. Clinical particulars
4.1 Therapeutic indications
Fostair NEXThaler is indicated in the regular treatment of asthma
where use of a combination product
(inhaled corticosteroid and long-acting beta
2
-agonist) is appropriate:
- patients not adequately controlled with inhaled corticosteroids and
'as needed' inhaled short-acting
beta
2
-agonist or
- patients already adequately controlled on both inhaled
corticosteroids and long-acting beta
2
-agonists.
Fostair NEXThaler is indicated in adults.
Note: there are no relevant clinical data on the use of Fostair
NEXThaler for the treatment of acute
asthma attacks.
4.2 Posology and method of administration
Posology
The dosage of Fostair NEXThaler is individual and should be adjusted
to the severity of the disease. This
should be considered not only when treatment with combination products
is initiated but also when the
dose is adjusted. If an individual patient should require a
combination of doses other than those available
in the combination inhaler, appropriate doses of beta
2
-agonists and/or corticosteroids by individual
inhalers should be prescribed.
Because of its extrafine particle size distribution, dose adjustment
is required when patients are
transferred to Fostai