Seretide 250 Evohaler

Страна: Велика Британія

мова: англійська

Джерело: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активний інгредієнт:

Fluticasone propionate; Salmeterol xinafoate

Доступна з:

Pharmaram Ltd

Код атс:

R03AK06

ІПН (Міжнародна Ім'я):

Fluticasone propionate; Salmeterol xinafoate

Дозування:

250microgram/1dose ; 25microgram/1dose

Фармацевтична форма:

Pressurised inhalation

Адміністрація маршрут:

Inhalation

Клас:

No Controlled Drug Status

Тип рецепту:

Caution - AMP level prescribing advised

Огляд продуктів:

BNF: 03020000; GTIN: 05060666560411

інформаційний буклет

RARE (AFFECTS LESS THAN 1 PERSON IN 1000)
•
BREATHING DIFFICULTIES OR WHEEZING THAT GET WORSE STRAIGHT AFTER
TAKING
SERETIDE. If this happens STOP USING YOUR SERETIDE INHALER. Use your
fast-acting ‘reliever’ inhaler to help your breathing and TELL
YOUR
DOCTOR STRAIGHT AWAY.
•
Seretide may affect the normal production of steroid hormones in the
body, particularly if you have taken high doses for long periods of
time. The effects include:
−
Slowing of growth in children and adolescents
−
Thinning of the bones
−
Glaucoma
−
Weight gain
−
Rounded (moon shaped) face (Cushing’s Syndrome)
Your doctor will check you regularly for any of these side effects and
make sure you are taking the lowest dose of Seretide to control your
asthma.
•
Behavioural changes, such as being unusually active and irritable
(these effects mainly occur in children).
•
Uneven heart beat or heart gives an extra beat (arrhythmias). Tell
your
doctor, but do not stop taking Seretide unless the doctor tells you to
stop.
•
A fungal infection in the oesophagus (gullet), which might cause
difficulties in swallowing.
FREQUENCY NOT KNOWN, BUT MAY ALSO OCCUR:
•
Depression or aggression. These effects are more likely to occur in
children.
•
Blurred vision.
REPORTING OF SIDE EFFECTS
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet. You can
also
report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the
GOOGLE PLAY or APPLE APP STORE. By reporting side effects you can help
provide more information on the safety of this medicine.
5 HOW TO STORE SERETIDE
•
KEEP THIS MEDICINE OUT OF THE SIGHT AND REACH OF CHILDREN.
•
Straight after use, replace the mouthpiece cover firmly and click it
into
position. Do not use excessive force.
•
Do not use this medicine after the expiry date which is stated on the
label and carton after EXP. The expiry date refers to the last day of
that month.
•

Характеристики продукта

OBJECT 1
SERETIDE 250 EVOHALER
Summary of Product Characteristics Updated 29-Nov-2019 |
GlaxoSmithKline UK
•
1. Name of the medicinal product
•
2. Qualitative and quantitative composition
•
3. Pharmaceutical form
•
4. Clinical particulars
•
4.1 Therapeutic indications
•
4.2 Posology and method of administration
•
4.3 Contraindications
•
4.4 Special warnings and precautions for use
•
4.5 Interaction with other medicinal products and other forms of
interaction
•
4.6 Fertility, pregnancy and lactation
•
4.7 Effects on ability to drive and use machines
•
4.8 Undesirable effects
•
4.9 Overdose
•
5. Pharmacological properties
•
5.1 Pharmacodynamic properties
•
5.2 Pharmacokinetic properties
•
5.3 Preclinical safety data
•
6. Pharmaceutical particulars
•
6.1 List of excipients
•
6.2 Incompatibilities
•
6.3 Shelf life
•
6.4 Special precautions for storage
•
6.5 Nature and contents of container
•
6.6 Special precautions for disposal and other handling
•
7. Marketing authorisation holder
•
8. Marketing authorisation number(s)
•
9. Date of first authorisation/renewal of the authorisation
•
10. Date of revision of the text
1. Name of the medicinal product
Seretide Evohaler 25 microgram/50 microgram per metered dose
pressurised inhalation, suspension.
Seretide Evohaler 25 microgram/125 microgram per metered dose
pressurised inhalation, suspension.
Seretide Evohaler 25 microgram/250 microgram per metered dose
pressurised inhalation, suspension.
2. Qualitative and quantitative composition
Each metered dose (ex valve) contains:
25 micrograms of salmeterol (as salmeterol xinafoate) and 50, 125 or
250 micrograms of fluticasone
propionate. This is equivalent to a delivered dose (ex actuator) of 21
micrograms of salmeterol and 44, 110 or
220 micrograms of fluticasone propionate.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Pressurised inhalation, suspension.
The canister contains a white to off white suspension.
The canisters are fitted into purple p