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UNIPHYLLIN CONTINUS 300MG PROLONGED RELEASE TABLETS

Active substance: THEOPHYLLINE

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6152-13

Package leaflet: Information for the user
Uniphyllin Continus 200 mg, 300 mg and
400 mg prolonged-release tablets
Theophylline
®

Read all of this leaflet carefully
because it contains important
information for you.
This medicine is available without
prescription. However you still need
to take Uniphyllin Continus tablets
carefully to get the best results from
them.
• Keep this leaflet. You may need to
read it again.
• Ask your pharmacist if you need
more information or advice.
• You must contact a doctor if your
symptoms worsen or do not improve.
• If any of the side effects become
serious, or if you notice any side
effects not listed in this leaflet, please
tell your doctor or pharmacist.

UNIPHYLLIN TABS PIL UK 6152-13 V1.indd 2

®

In this leaflet:
1. What Uniphyllin Continus tablets are
and what they are used for
2. 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. Further 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.

2. Before you take Uniphyllin
Continus tablets
Do not take Uniphyllin Continus
tablets if you:
• are allergic (hypersensitive) to
theophylline, aminophylline or any
of the other ingredients of the tablets
(see section 6 ‘Further Information’);
• have porphyria (a rare disease of the
blood pigments).
Take special care with Uniphyllin
Continus tablets
Before treatment with these tablets tell
your doctor or pharmacist if you:
• have high blood pressure or any other
heart problems;
• have an over-active thyroid gland
(hyperthyroidism);
• have a stomach ulcer;
• have liver problems;
• 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 instance due to an
enlarged prostate gland);

• smoke, as smoking may alter the way
your tablets work.
Children under six years of age should
not take these tablets.
Taking other medicines
Tell your doctor or pharmacist if you
are taking:
• 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, moracizine, diltiazem,
isoprenaline, mexiletine,
propafenone, propranolol, verapamil
or beta blockers to treat high blood
pressure and other heart problems;

• oxpentifylline to treat diseased blood
vessels;
• medicines known as benzodiazepines,
which are used as a sedative or to
treat anxiety;
• 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, norfloxacin, ofloxacin;
• 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;
• viloxazine, fluvoxamine or lithium to
treat depression;
• doxapram to stimulate breathing;
• disulfiram to treat alcoholism.

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;
• these tablets have been prescribed for
your child and they are also taking
a cough medicine or decongestant
containing ephedrine.
Please tell your doctor or pharmacist
if you are taking or have recently
taken any other medicines, including
medicines obtained without a
prescription. If you take these tablets
with some other medicines, the effect of
these tablets or the other medicine may
be changed.
Taking Uniphyllin Continus tablets
with alcohol
Alcohol can alter the way these tablets
work. Please consult your doctor if you
intend to drink alcohol whilst taking
these tablets.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding
do not take these tablets until you have
talked to your doctor or pharmacist.
Ask your doctor or pharmacist for
advice before taking any medicine.

3. How to take Uniphyllin Continus
tablets
Always take these tablets exactly as
your doctor or pharmacist has told you.
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 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.

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6152-13

Adults
The usual 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.
Children
Children over six years of age can take
these tablets. The required dose will
depend on their weight and the severity
of their breathing problems. This
should be discussed with your doctor or
pharmacist.
Do not exceed the dose recommended
by your doctor. You should check with
your doctor or pharmacist if you are
not sure.
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. They may also have a
fast or irregular heartbeat, feel very
restless or have a fit. 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.

UNIPHYLLIN TABS PIL UK 6152-13 V1.indd 3

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
or pharmacist.

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 are rare. 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 shaking.
• A fast heart beat or palpitations.
• Dizziness.
• Difficulty in passing urine
(especially in men) or passing
increased amounts of urine.

• Increased uric acid level in the blood,
which could cause painful, swollen
joints.
• Seizures, fits or convulsions.
• Rash or itchy skin.
If any of the side effects become
serious, or if you notice any side
effects not listed in this leaflet, please
tell your doctor or pharmacist.

5. How to store Uniphyllin
Continus tablets
Keep out of the reach and sight of
children.
Do not use any tablets after the expiry
date stated on the outer carton and
blister pack. EXP 08 2010 means that
you should not take the tablets after the
last day of that month i.e. August 2010.
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.
Medicines should not be disposed of
via wastewater or household waste.
Ask your pharmacist how to dispose
of medicines no longer required.
These measures will help to protect the
environment.

6. Further 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 with “U200” on the other.
The 300 mg tablets are plain on one side and marked with “U300” on the other.
The 400 mg tablets are marked “UNIPHYLLIN” on one side and marked with
“U400 ” on the other.
In each box there are 56 tablets.
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 October 2013.
® Uniphyllin, Continus, NAPP and the NAPP device
(logo) are Registered Trade Marks.
© 2008 - 2013 Napp Pharmaceuticals Limited
P0084-A R4V1 UK AW 12-09-13

01/10/2013 14:39

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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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