Nuelin SA 175mg 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:

175mg

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

•
you have a headache
• you feel restless or agitated
• you have difficulty sleeping (insomnia)
• you feel light headed or dizzy
• you get muscle pain or weakness
• you get high blood sugar or blood creatinine levels
• you need to urinate more frequently.
Nuelin SA are prolonged release tablets. This means they release the
medicine
slowly over a long period of time. This reduces the chance of you
getting any side
effects and makes any side effects milder.
If any of the side effects gets serious, or if you notice any side
effects not listed in
this leaflet, please tell your doctor or pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse.
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 Nuelin SA
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the
label or
carton after EXP. The expiry date refers to the last day of that
month.
Do not store above 25 °C.
Do not throw away any medicines via wastewater or household waste. Ask
your
pharmacist how to throw away medicines you no longer use. These
measures will
help protect the environment.
6. Contents of the pack and other information
What Nuelin SA contains
•
The active substance in Nuelin SA is theophylline. Each 175 mg tablet
contains
175 mg theophylline. Each 250 mg tablet contains 250 mg theophylline.
•
The other ingredients are lactose, cellulose acetate phthalate and
magnesium
stearate.
What Nuelin SA looks like and contents of the pack
Nuelin SA prolonged release tablets come in two strengths: 175 mg and
250 mg.
The tablets are white, round, biconvex, uncoated tablets with “T”
on one face and
“175” “or “250” on the other

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Nuelin SA 175 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Theophylline 175mg
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
“175” on the other face.
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 tablets should be swallowed whole and not 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 tachyarrhythmia
Concomitant use with ephedrine in children.
Children under 6 months of age.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
The