Phyllocontin Continus 225 mg Prolonged Release Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

AMINOPHYLLINE HYDRATE

Available from:

Mundipharma Pharmaceuticals Limited

ATC code:

R03DA; R03DA05

INN (International Name):

AMINOPHYLLINE HYDRATE

Dosage:

225 milligram(s)

Pharmaceutical form:

Prolonged-release tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Xanthines; aminophylline

Authorization status:

Not marketed

Authorization date:

1984-04-01

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
_PHYLLOCONTIN_
_®_
_ CONTINUS_
_®_
_ _225 MG PROLONGED-RELEASE TABLETS
Aminophylline hydrate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
Always take this medicine exactly as described in this leaflet or as
your doctor, pharmacist or nurse has told
you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if their
signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not
listed in this leaflet. See section 4.

You must talk to a doctor if you do not feel better or if you feel
worse after 3 days.
WHAT IS IN THIS LEAFLET:
1.
What _PHYLLOCONTIN CONTINUS_ tablets are and what they are used for
2.
What you need to know before you take _PHYLLOCONTIN CONTINUS_ tablets
3.
How to take _PHYLLOCONTIN CONTINUS_ tablets
4.
Possible side effects
5.
How to store _PHYLLOCONTIN CONTINUS_ tablets
6.
Contents of the pack and other information
1.
WHAT _PHYLLOCONTIN CONTINUS_ TABLETS ARE AND WHAT THEY ARE USED FOR
These tablets are used to treat asthma, long-term breathing
difficulties such as emphysema and chronic
bronchitis, and are sometimes used to treat heart failure in adults.
They contain the active ingredient aminophylline which belongs to a
group of medicines called
bronchodilators. Bronchodilators help stop you wheezing and being
breathless. Aminophylline also reduces
swelling in the lungs of asthma patients and relieves the feeling of
‘tightness’ in their chest.
These tablets may be taken by adults and children aged 6 years and
above.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE_ PHYLLOCONTIN CONTINUS_ TABLETS
DO NOT TAKE _PHYLLOCONTIN CONTINUS_ TABLETS IF YOU:

are allergic (hypersensitive) to theophylline, aminophylline or any of
th

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
PHYLLOCONTIN CONTINUS 225 mg Prolonged Release Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains aminophylline hydrate 225 mg
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Prolonged release tablets.
Pale yellow, round, film-coated tablet with the Napp logo marked on
one side and SA on the other.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the treatment and prophylaxis of bronchospasm and inflammation
associated with asthma, emphysema and chronic
bronchitis. Also indicated in adults for the treatment of cardiac
asthma and left ventricular or congestive cardiac failure.
PHYLLOCONTIN CONTINUS tablets are indicated for use in adults and
children aged 6 years and above.
Aminophylline should not be used as the first drug of choice in the
treatment of asthma in children.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults and the elderly
The usual maintenance dose is one PHYLLOCONTIN CONTINUS tablet 225 mg
twice daily. This may be titrated to
higher dosage as required.
Paediatric population aged 6 years and above
The usual paediatric maintenance dose is 10 mg/kg twice daily.
Some children with chronic asthma require and tolerate much higher
doses (11-18 mg/kg twice daily).
Clearance is increased in children compared to values observed in
adult subjects. The rapid clearance observed in children
decreases towards adult values in late teens. Therefore lower doses
may be required for adolescents.
Aminophylline should not be administered to children less than 6 years
of age (approximately 22 kg). Other dosage forms
are available that are more suitable for children less than 6 years of
age.
Theophylline distributes poorly into body fat, therefore mg/kg doses
should be calculated on the basis of lean (ideal) body
weight.
Plasma theophylline concentrations should ideally be maintained
between 5 and 12 mcg/mL. A plasma level of 5 mcg/mL
probably represents the lower level of clinical effectiveness.
S