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UNIPHYLLIN CONTINUS 400MG PROLONGED RELEASE TABLETS

Active substance(s): THEOPHYLLINE / THEOPHYLLINE / THEOPHYLLINE

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6152-14

460x148mm (LSN-NAPP-02) (L) V1

V9-2012

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UNIPHYLLIN TABS PIL UK 6152-14
3369
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UK
6152-14
N/A
Datamatrix
6152-14
N/A
N/A
BARD
460x148mm (LSN-NAPP-02)(L) V1
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LSN-NAPP-02
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460X148mm
148x36,34mm
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28-02-17

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6152-14

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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.

UNIPHYLLIN TABS PIL UK 6152-14 V5.indd 2

What is 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 chronic obstructive pulmonary
disease and chronic bronchitis, and are
sometimes used to treat heart failure.
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.

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);
• have porphyria (a rare disease of the
blood pigments).
Do not give to your child if they are
under 6 months of age or if they are
also taking a cough medicine or if they
are less than 6 years of age (or less
than 22 kg) and taking a decongestant
containing ephedrine.
Warnings and precautions
Talk to your doctor, pharmacist or nurse
before taking these tablets if you:
• have an irregular heartbeat, high
blood pressure or any other heart
problems;
• experience worsening of chest
symptoms e.g. breathlessness or
cough;
• have an over or under-active thyroid
gland (hyper/hypothyroidism);
• have a stomach ulcer;
• have liver problems;
• have cystic fibrosis;

• suffer from seizures, fits or
convulsions;
• are unwell with a high temperature or
fever;
• have a viral infection;
• are addicted to alcohol;
• are male and have difficulty in
passing urine (for example due to an
enlarged prostate gland);
• smoke, as smoking may alter the way
your tablets work.
Other medicines and Uniphyllin
Continus tablets
Tell your doctor, pharmacist or nurse
if you are taking, have recently taken
or might take any other medicines,
including:
• certain other medicines to treat
asthma or breathing conditions that
contain theophylline, aminophylline,
salbutamol, terbutaline or salmeterol,
as you may need additional
monitoring;
• steroids;
• diuretics to increase urine production;
• oral contraceptives;
• a herbal remedy called St John’s
Wort (also known as Hypericum
perforatum);
• aminoglutethimide, methotrexate or
lomustine to treat cancer;

• carbamazepine or phenytoin to treat
seizures, fits or convulsions;
• medicines known as barbiturates to
help you sleep;
• adenosine, diltiazem, isoprenaline,
mexiletine, propafenone, propranolol,
verapamil or beta blockers to treat
high blood pressure and other heart
problems;
• regadenoson or dipyridamol used in
heart problems;
• pentoxifylline to treat diseased blood
vessels;
• medicines known as benzodiazepines,
which are used as a sedative or to
treat anxiety;
• aciclovir to treat Herpes viruses;
• sulphinpyrazone or allopurinol to
treat gout;
• carbimazole to treat problems with
your thyroid gland;
• cimetidine or nizatidine to treat
stomach ulcers, indigestion or
heartburn;
• certain antibiotics such as
ciprofloxacin, clarithromycin,
erythromycin, enoxacin;
• fluconazole to treat fungal infections;
• rifampicin or isoniazid to treat
tuberculosis;
• ritonavir to treat HIV;

• medicines known as interferons,
which you may be taking to treat
conditions such as herpes, cancer,
leukaemia or hepatitis;
• thiabendazole to treat worms such as
threadworms;
• fluvoxamine or lithium to treat
depression;
• doxapram to stimulate breathing;
• disulfiram to treat alcoholism;
• a cough medicine or decongestant
containing ephedrine.
Also tell your doctor or pharmacist if:
• you are going to have an operation, as
these tablets may interact with certain
anaesthetics such as halothane and
ketamine;
• you have recently had, or are going to
have a flu injection.
Uniphyllin Continus tablets and
alcohol
Alcohol can alter the way these tablets
work. Please consult your doctor if you
intend to drink alcohol whilst taking
these tablets.

3. How to take Uniphyllin Continus
tablets
Always take these tablets exactly as
described in this leaflet or as your
doctor, pharmacist or nurse has
told you. Check with your doctor,
pharmacist or nurse if you are not sure.
Swallow your tablets whole with a glass
of water. Do not crush or chew them.
Uniphyllin Continus tablets are
designed to work properly over 12
hours. If a tablet is broken, crushed
or chewed the entire 12-hour dose
may be absorbed rapidly into your
body. This can be dangerous, causing
serious problems such as an overdose.
You should take your tablets every 12
hours. For instance, if you take a tablet
at 8 o’clock in the morning, you should
take your next tablet at 8 o’clock in the
evening.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding,
think you may be pregnant or are
planning to have a baby, ask your doctor
or pharmacist for advice before taking
this medicine.

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Adults
The recommended starting dose for
adults is one 200 mg tablet every 12
hours. Your doctor may increase your
dose to one 300 mg or 400 mg tablet
every 12 hours, depending upon how
you respond to treatment. If you are
elderly your doctor may suggest a
lower dose.
Different doses will also be required
if you have certain other medical
conditions. Your doctor may ask you
to have regular blood tests to ensure
you are taking the correct dose.
Use in children
Children over six years of age can take
these tablets. The required dose will
depend on their weight, age and the
severity of their breathing problems.
This should be discussed with your
doctor, pharmacist or nurse.
Do not exceed the dose recommended
by your doctor. Check with your
doctor, pharmacist or nurse if you are
not sure.

UNIPHYLLIN TABS PIL UK 6152-14 V5.indd 3

If you take more Uniphyllin Continus
tablets than you should or if someone
accidentally swallows your tablets
Call your doctor or hospital straight
away. People who have taken an
overdose may have stomach pains
and feel or be sick (possibly vomiting
blood). They may also have a fast
or irregular heartbeat, low blood
pressure, feel very restless, experience
overactive reflexes or unusual muscle
stiffness, have a fit or even go into a
coma. These symptoms may appear
up to 12 hours after the overdose.
When seeking medical attention make
sure that you take this leaflet and any
remaining tablets with you to show the
doctor.
If you forget to take Uniphyllin
Continus tablets
If you remember within 4 hours of the
time your tablet was due, take your
tablet straight away. Take your next
tablet at your normal time. If you are
more than 4 hours late, please call your
doctor or pharmacist for advice. Do
not take a double dose to make up for a
forgotten tablet.

If you stop taking Uniphyllin
Continus tablets
You will probably take these tablets for
a long time. Do not stop taking them
unless your doctor tells you to, even if
you feel better.
If you have any further questions on the
use of these tablets, ask your doctor,
pharmacist or nurse.
4. Possible side effects
Like all medicines, these tablets
can cause side effects, although not
everybody gets them.
All medicines can cause allergic
reactions, although serious allergic
reactions have been reported in rare
cases. Tell your doctor immediately
if you get any sudden wheeziness,
difficulties in breathing, swelling of
the eyelids, face or lips, rash or itching
especially those covering your whole
body.
The following side effects have been
reported in patients treated with these
tablets:
• Feeling sick.
• Headache.

• Vomiting (being sick), abdominal
pain, diarrhoea, heartburn or
gastrointestinal disorders (e.g. upset
stomach).
• Difficulty in sleeping, agitation,
anxiety or tremors.
• A fast, slow or irregular heart beat.
• Dizziness.
• Difficulty in passing urine
(especially in men) or passing
increased amounts of urine.
• Increased uric acid levels in the
blood, which could cause painful,
swollen joints.
• Seizures, fits or convulsions.
• Rash or itchy skin.
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. By reporting
side effects, you can help provide
more information on the safety of this
medicine.

5. How to store Uniphyllin
Continus tablets
Keep these tablets out of the sight and
reach of children.
Do not use these tablets after the expiry
date which is stated on the outer carton
and blister pack after ‘EXP’. The
expiry date refers to the last day of that
month.
Do not store your tablets above 25ºC.
Do not take your tablets if they are
broken or crushed as this can be
dangerous and can lead to serious
problems such as overdose.
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 to protect the
environment.

6. Contents of the pack and other
information
What Uniphyllin Continus tablets
contain
The active ingredient is theophylline.
Each tablet contains 200 mg, 300 mg or
400 mg of theophylline.
The other ingredients are:
• Hydroxyethylcellulose
• Povidone
• Magnesium stearate
• Cetostearyl alcohol
• Macrogol
• Talc

What Uniphyllin Continus tablets look like and the contents of the pack
The tablets are white and capsule shaped.
The 200 mg tablets are plain on one side and marked “U200” on the other.
The 300 mg tablets are plain on one side and marked “U300” on the other.
The 400 mg tablets are marked “UNIPHYLLIN” on one side and “U400 NAPP”
on the other.
In each box there are [8 or] 56* tablets.
(* The printed leaflet will refer to marketed pack sizes only. Note: this text relates to blister
packed tablets only.)

Marketing Authorisation Holder and Manufacturer
The tablets are made by Bard Pharmaceuticals Limited for the
marketing authorisation holder Napp Pharmaceuticals Limited, both at
Cambridge Science Park, Milton Road, Cambridge CB4 0GW, UK.

This leaflet is also available in large print, Braille or as an
audio CD. To request a copy, please call the RNIB Medicine
Information line (free of charge) on:

0800 198 5000
You will need to give details of the product name and
reference number.
These are as follows:
Product name: Uniphyllin Continus tablets
Reference number: 16950/0066
This leaflet was last revised in November 2016.
® Uniphyllin, Continus, NAPP and the NAPP logo are
registered trade marks.
© 2008 - 2015 Napp Pharmaceuticals Limited.

28/02/2017 11:50

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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