UNIPHYLLIN Continus 400 mg Prolonged-Release Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Theophylline

Available from:

Mundipharma Pharmaceuticals Limited

ATC code:

R03DA; R03DA04

INN (International Name):

Theophylline

Dosage:

400 milligram(s)

Pharmaceutical form:

Prolonged-release tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Xanthines; theophylline

Authorization status:

Marketed

Authorization date:

1983-06-20

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
UNIPHYLLIN® CONTINUS® 200 MG, 300 MG AND 400 MG PROLONGED-RELEASE
TABLETS
Theophylline
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.
•
Ask your pharmacist if you need more information or advice.
•
If you get any side effects, talk to your doctor, pharmacist or nurse.
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.
IN THIS LEAFLET:
1.
What _UNIPHYLLIN CONTINUS_ tablets are and what they are used for
2.
What you need to know before you take _UNIPHYLLIN CONTINUS_ tablets
3.
How to take _UNIPHYLLIN CONTINUS_ tablets
4.
Possible side effects
5.
How to store _UNIPHYLLIN CONTINUS_ tablets
6.
Contents of the pack and other information
1.
WHAT _UNIPHYLLIN 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 theophylline which belongs to a
group of medicines called
bronchodilators. Bronchodilators help stop you wheezing and being
breathless. Theophylline 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 (and weighing no less
than 22 kg).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE _UNIPHYLLIN CONTINUS_ TABLETS
DO NOT TAKE _UNIPHYLLIN CONTINUS_ TABLETS IF YOU:
•
are allergic to theophylline, aminophylline or any of the other
ingredients of the tablets
(listed in section 6).
Do not give _UNIPHYLLIN CONTINUS_ to your child if they are under 6
years of age (or less than 22 kg).

Summary of Product characteristics

Health Products Regulatory Authority
13 March 2023
CRN00DFF9
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
UNIPHYLLIN Continus 400 mg Prolonged-Release Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains theophylline 400 mg as theophylline monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged release tablet.
White, capsule shaped tablet with ‘UNIPHYLLIN’ on one side and
marked ‘U400’ and the Napp logo on the other.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
In the treatment and prophylaxis of bronchospasm and inflammation
associated with asthma, chronic bronchitis and
emphysema. Also indicated in adults for the treatment of cardiac
asthma and left ventricular or congestive cardiac failure.
UNIPHYLLIN CONTINUS tablets are indicated for use in adults and
children aged 6 years and above (and weighing no less than
22 kg).
Theophylline should not be used as first drug of choice in the
treatment of asthma in children.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Asthma
_Adults and the elderly_
The usual maintenance dose is 200 mg 12-hourly.
In more severe cases, the dosage may be increased to 300 mg 12-hourly
or 400 mg 12-hourly.
For asthmatic patients whose nocturnal symptoms are particularly
troublesome, a higher dose at night may provide additional
bronchodilator benefit.
_Paediatric population aged 6 years and above (equating to body weight
of 22 kg)_
The usual paediatric maintenance dose is 200 mg 12-hourly but some
children with chronic asthma require and tolerate much
higher doses for which purpose UNIPHYLLIN CONTINUS tablets 300 mg may
be prescribed.
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 dosages
(based on usual adult dose) may be required for
adolescents.
UNIPHYLLIN CONTINUS tablets should not be used in children below 6
years of age (or less than 22 k