Nuelin SA 250 tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Theophylline

Available from:

Mawdsley-Brooks & Company Ltd

ATC code:

R03DA04

INN (International Name):

Theophylline

Dosage:

250mg

Pharmaceutical form:

Modified-release tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 03010300

Patient Information leaflet

NUELIN
® SA 250 MG TABLETS
(theophylline)
PATIENT INFORMATION LEAFLET
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.
Your medicine is available as Nuelin SA 250mg Tablets but will be
referred
to as Nuelin SA throughout this leaflet. Also available in 175 mg
strength.
WHAT IS IN THIS LEAFLET:
1. What Nuelin SA is and what it is used for
2. What you need to know before you take Nuelin SA
3. How to take Nuelin SA
4. Possible side effects
5. How to store Nuelin SA
6. Contents of the pack and other information
1. WHAT NUELIN SA IS AND WHAT IT IS USED FOR
Nuelin SA belongs to a family of medicines called bronchodilators.
Bronchodilators are used to treat, and relieve the symptoms of
diseases
where the passages in your lungs are blocked.
Nuelin SA works by widening the air passages in your lungs which
allows
you to breathe more easily and feel less tight chested. You may take
Nuelin
SA if you have asthma or a chest disease such as chronic obstructive
pulmonary disease (COPD) that makes you wheeze, cough or become short
of breath.
You must talk to a doctor if you do not feel better or if you feel
worse.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE NUELIN SA
DO NOT TAKE NUELIN SA:
- if you are allergic to theophylline or other bronchodilators (such
as
xanthines), or any of the other ingredients of this medicine (listed
in
Section 6).
- if you are under 6 years of age
- if you are a child and are taking medicines containing ephedrine
(e.g.
children's cold and cough medicines)
- if you have recentl

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Nuelin SA 250 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Theophylline 250mg
Excipients with known effect:
Each tablet contains Lactose Ph Eur.
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Prolonged release tablet
The tablets are white, round, biconvex, uncoated tablets with “T”
on one face
and “250” on the other with a score line
The score line is only to facilitate breaking for ease of swallowing
and not to
divide into equal doses.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Nuelin SA are indicated for the prophylaxis and treatment of
reversible
bronchospasm associated with asthma and chronic obstructive pulmonary
disease.
Because effective plasma levels are maintained for up to twelve hours
from a
single dose, less frequent dosing is required than with conventional
theophylline preparations.
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
One tablet twice daily, preferably after food, increasing to two
tablets twice daily,
if necessary.
_Paediatric population _
Below 6 months: Nuelin should not be used in children below 6 months
of age.
Below 6 years: Nuelin should not be used in children below 6 years of
age. Other
dosage forms are available that are more suitable for children aged
less than 6 years.
6 to 12 years: One tablet twice daily, preferably after food.
_Elderly _
Elderly patients may require lower doses due to reduced theophylline
clearance.
Method of administration
Nuelin SA-250 tablets are scored and may be halved but should not be
crushed or
chewed.
The dosage should be titrated for each individual and adjusted with
caution. Serum
theophylline levels should be monitored to ensure that they remain
within the
therapeutic range.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance, xanthines or any of the
excipients
listed in section 6.1
Recent myocardial infarction
Acute tachy