What <Tradename> contains
The active substances are fluticasone propionate and formoterol fumarate dihydrate. There are three different strengths of inhaler available. Each puff (actuation) contains either 50 micrograms fluticasone propionate and 5 micrograms formoterol fumarate dihydrate, 125 micrograms fluticasone propionate and 5 micrograms formoterol fumarate dihydrate or 250 micrograms fluticasone propionate and 10 micrograms formoterol fumarate dihydrate.
The other ingredients are:
- Sodium cromoglicate
- Ethanol
- Apaflurane HFA 227 (propellant)
What <Tradename> looks like and the contents of the pack
These inhalers are small aerosol cans containing a white to off white liquid suspension fitted with a metering valve. The aerosol cans are inserted into grey and white plastic dispensers (actuators) with a light grey mouthpiece cover. Each inhaler contains 120 puffs (actuations). There is one inhaler in a pack.
Marketing Authorisation Holder and Manufacturer
Mundipharma Pharmaceuticals B.V.
De Wel 20
3871 MV Hoevelaken
In het register ingeschreven onder:
RVG 107247
RVG 107248
RVG 107249
This medicinal product is authorised in the Member States of the EEA under the following names:
Flutiform:
Austria
Belgium
Bulgaria
Cyprus
Czech Republic
Denmark
Finland
France
Germany
Republic of Ireland
Iceland
Luxembourg
Netherlands
Norway
Poland
Portugal
Romania
Slovak Republic
Sweden
Flutiformo:
Italy
Tradename – to be confirmed :
UK
This leaflet was last approved in juli 2012.
Trademark registration details: <To be completed Nationally.>
ADDITIONAL MEMBER STATE SPECIFIC INFORMATION TO BE AGREED ON A NATIONAL BASIS
Belgium
Section 3. If you take more <Tradename> <pharmaceutical form> than you should …
If you have used too much <Tradename>, contact your doctor, pharmacist or the poison centre (tel. 070/245 245
Section 6. Further information
Supply classification of the medicianl product:.<....>
Denmark
Section 2 Before you use...
Please notice that your doctor may have prescribed the medicinal product for a different therapeutic indication and/or at a different dosage than that stated in the package leaflet. Always follow the doctor’s prescription and the instructions on the dosage label.
Section 4 Possible side effects
Side effects can thereby be reported to the Danish Medicines Agency and the knowledge about side effects can be improved. Patients or their relatives can also report side effects to the Danish Medicines Agency. You can find guidance on The Danish Medicines Agency’s website (see Pharmacovigilance) http://www.laegemiddelstyrelsen.dk/
France
Throughout ‘actuation’ will be replaced by ‘dose’.
Section 6
Each metered dose (ex-valve) contains:
50 micrograms of fluticasone propionate and 5 micrograms of formoterol fumarate dihydrate. This is equivalent to a delivered dose (ex-actuator) of approximately 46 microgram of fluticasone propionate/4.5 microgram of formoterol fumarate dihydrate.
125 micrograms of fluticasone propionate and 5 micrograms of formoterol fumarate dihydrate. This is equivalent to a delivered dose (ex-actuator) of approximately 115 microgram of fluticasone propionate/4.5 microgram of formoterol fumarate dihydrate.
250 micrograms of fluticasone propionate and 10 micrograms of formoterol fumarate dihydrate. This is equivalent to a delivered dose (ex-actuator) of approximately 230 microgram of fluticasone propionate/9.0 microgram of formoterol fumarate dihydrate.
Germany
Section 2:
The use of Flutiform may produce positive results in doping controls.
Section 4
Evaluation of side effects is based on the following frequency information:
Very common | More than 1 of 10 treated patients |
Common | Less than 1 of 10, however more than 1 of 100 treated patients |
Uncommon | Less than 1 of 100, however more than 1 of 1,000 treated patients |
Rare | Less than 1 of 1,000 but more that 1 of 10, 000 treated patients |
Very rare | Less than 1 of 10,000 treated patients |
Iceland
Section 2 Before you use...
Please notice that your doctor may have prescribed the medicinal product for a different therapeutic indication and/or at a different dosage than that stated in the package leaflet. Always follow the doctor’s prescription and the instructions on the pharmacy label.
Section 3. If you take more <Tradename> <pharmaceutical form> than you should
Contact your doctor, the hospital or “Eitrunarmiðstöð” (sìmi 543 2222) if you have taken more <Tradename>
than you should or if children have been taking medicine by accident.
Section 4 Possible side effects
Side effects can thereby be reported to the Icelandic Medicines Control Agency. You can find guidance on The Icelandic Medicines Control Agency’s website (see “Adverse reactions”) www.lyfjastofnun.is
Norway
Section 2 Before you use...
Please notice that your doctor may have prescribed the medicinal product for a different therapeutic indication and/or at a different dosage than that stated in the package leaflet. Always follow the doctor’s prescription and the instructions on the pharmacy label.
Driving and using machines
You should drive a vehicle or carry out dangerous work only when you can do it safely. Medicines may influence your capabilty to drive or carry out dangerous work. Read all the information provided in the package leaflet carefully. Ask your doctor or pharmacy for advice if you are unsure.
Section 3. If you take more <Tradename> <pharmaceutical form> than you should
Contact your doctor, the hospital or Giftinformasjonen (tel. 22 59 13 00) if you have taken more <Tradename> than you should or if children have been taking medicine by accident. For other questions about the medicine, contact your doctor or pharmacy.
Poland
Evaluation of side effects is based on the following frequency information:
Very common | More than 1 of 10 treated patients |
Common | Less than 1 of 10, however more than 1 of 100 treated patients |
Uncommon | Less than 1 of 100, however more than 1 of 1,000 treated patients |
Rare | Less than 1 of 1,000 but more that 1 of 10, 000 treated patients |
Very rare | Less than 1 of 10,000 treated patients |
Republic of Ireland
Throughout ‘per actuation’ will be replaced by ‘per metered dose’.
Slovak Republic
Legal status
Section 6:
If you need any further information about the drug, please contact local representative office: (local contact address)
UK
The term “asthma nurse” should be incorporated throughout the leaflet where there is a reference to doctors and pharmacists.
P0448-A R0V19DCP 20-12-11