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PHYLLOCONTIN CONTINUS 225MG PROLONGED RELEASE TABLETS

Active substance(s): AMINOPHYLLINE HYDRATE / AMINOPHYLLINE HYDRATE / AMINOPHYLLINE HYDRATE

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Package leaflet: Information for the patient
Phyllocontin® Continus® 225 mg
prolonged-release tablets and
Phyllocontin® Forte Continus® 350 mg
prolonged-release tablets
Aminophylline hydrate
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.

What is in this leaflet:
1. What Phyllocontin Continus and
Phyllocontin Forte Continus tablets
are and what they are used for
2. What you need to know before
you take Phyllocontin Continus or
Phyllocontin Forte Continus tablets
3. How to take Phyllocontin Continus
and Phyllocontin Forte Continus
tablets
4. Possible side effects
5. How to store Phyllocontin Continus
and Phyllocontin Forte Continus
tablets
6. Contents of the pack and other
information

1. What Phyllocontin Continus
and Phyllocontin Forte 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 in
adults.
They contain the active ingredient
aminophylline which belongs to a group
of medicines called bronchodilators.
Bronchodilators help stop you wheezing
and being breathless. Aminophylline
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 Phyllocontin Continus
or Phyllocontin Forte Continus
tablets
Do not take Phyllocontin Continus or
Phyllocontin Forte 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 under 6
months of age or if they are also taking
a cough medicine or 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 other heart problems;
• experience worsening of chest
symptoms e.g. breathlessness or cough
• have an over-active 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 Phyllocontin
Continus or Phyllocontin Forte
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 or
verapamil 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, 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;

• viloxazine, fluvoxamine or lithium to
treat depression;
• disulfiram to treat alcoholism;
• cough medicines or decongestants
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;
• you have recently had, or are going to
have a flu injection.
Phyllocontin Continus or Phyllocontin
Forte 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.
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.
3. How to take Phyllocontin
Continus and Phyllocontin Forte
Continus tablets
Two different strengths of tablets are
available. Your doctor will decide which
strength of tablet will suit you best.
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.

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Swallow your tablets whole with a glass
of water. Do not crush or chew them.
Phyllocontin Continus and
Phyllocontin Forte 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.
Adults
The recommended starting dose for adults
is one 225 mg tablet every 12 hours. After
a week your doctor may increase your
dose, 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
The required dose for children 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.

If you take more Phyllocontin Continus
or Phyllocontin Forte 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 Phyllocontin
Continus or Phyllocontin Forte
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 Phyllocontin Continus
or Phyllocontin Forte 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.
• Dizziness.
• Vomiting, abdominal pain, diarrhoea,
heartburn or gastrintestinal disorders
(e.g. upset stomach).
• Difficulty in sleeping, feeling
restless, irritable and shaky.
• A fast, slow or irregular heart beat.
• 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 Phyllocontin Continus
and Phyllocontin Forte 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 label
or blister pack after ‘EXP’. The expiry date
refers to the last day of that month.
Do not store your tablets above 25°C.
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 Phyllocontin Continus and
Phyllocontin Forte Continus tablets contain
The active ingredient is aminophylline
hydrate. Each tablet contains 225 mg or
350 mg of aminophylline hydrate.
The other ingredients are:
• Hydroxyethylcellulose

• Povidone
• Magnesium stearate
• Cetostearyl alcohol
• Macrogol
• Talc
• Hypromellose (E464)
• Titanium dioxide (E171)
• Iron oxide (E172)
What Phyllocontin Continus and
Phyllocontin Forte Continus tablets look
like and the contents of the pack
Phyllocontin Continus tablets are pale yellow,
film-coated tablets marked NAPP on one side
and SA on the other.

Phyllocontin Forte Continus
tablets are pale yellow, film-coated
tablets marked NAPP on one side
and SA 350 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: Phyllocontin Continus tablets
Reference number: 16950/0057
This leaflet was last revised in February 2017.
® Phyllocontin, Continus, NAPP and the NAPP logo are
registered trade marks.
© 2008 - 2017 Napp Pharmaceuticals Limited

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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