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PHYLLOCONTIN CONTINUS 225MG PROLONGED RELEASE TABLETS

Active substance: AMINOPHYLLINE HYDRATE

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4757-10

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

In this leaflet:
1. What Phyllocontin Continus and
Phyllocontin Forte Continus tablets
are and what they are used for
2. 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. Further 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.
2. Before you take Phyllocontin
Continus or Phyllocontin Forte
Continus tablets
Do not take Phyllocontin Continus or
Phyllocontin Forte 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 Phyllocontin
Continus and Phyllocontin Forte
Continus tablets
Before treatment with these tablets tell
your doctor or pharmacist if you:
• have an irregular heartbeat, high
blood pressure or 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;
• smoke, as smoking may alter the way
your tablets work.
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;
• 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 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,
norfloxacin, ofloxacin;
• fluconazole to treat fungal infections;
• rifampicin or isoniazid to treat
tuberculosis;
• 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.
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;
• 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 Phyllocontin Continus or
Phyllocontin Forte 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.

4757-10

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
your doctor or pharmacist has told you.
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 usual starting dose for adults is one
tablet every 12 hours. After a week your
doctor may increase your dose to two
tablets every 12 hours, depending upon
how you respond to treatment. If you
are elderly your doctor may suggest a
lower dose.

Children
The required dose for children 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 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.
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.
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 or pharmacist.
4. Possible side effects
Like all medicines, these tablets
can cause side effects, although not
everybody gets them.
The following side effects have been
reported in patients treated with
these tablets:
• Feeling sick.
• Gastrointestinal disorders
(e.g. upset stomach).
• Headache.
• Difficulty in sleeping, feeling
restless, irritable and shaky.
• A fast, slow or irregular heart beat.
• Seizures, fits or convulsions.
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 Phyllocontin Continus
and Phyllocontin Forte 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 label or
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 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
• Industrial methylated spirit
• 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 approved in 09/2010
® Phyllocontin, Continus and the NAPP device (logo) are
Registered Trade Marks.
© 2008 Napp Pharmaceuticals Limited

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

In this leaflet:
1. What Phyllocontin Continus and
Phyllocontin Forte Continus tablets
are and what they are used for
2. 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. Further 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.
2. Before you take Phyllocontin
Continus or Phyllocontin Forte
Continus tablets
Do not take Phyllocontin Continus or
Phyllocontin Forte 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 Phyllocontin
Continus and Phyllocontin Forte
Continus tablets
Before treatment with these tablets tell
your doctor or pharmacist if you:
• have an irregular heartbeat, high
blood pressure or 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;
• smoke, as smoking may alter the way
your tablets work.
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;
• 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 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, norfloxacin, ofloxacin;
• fluconazole to treat fungal infections;
• rifampicin or isoniazid to treat
tuberculosis;
• 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.
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;
• 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 Phyllocontin Continus or
Phyllocontin Forte 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.
P0599-A

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
your doctor or pharmacist has told you.
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 usual starting dose for adults is one
tablet every 12 hours. After a week your
doctor may increase your dose to two
tablets every 12 hours, depending upon
how you respond to treatment. If you
are elderly your doctor may suggest a
lower dose.

Children
The required dose for children 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 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.
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.
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 or pharmacist.
4. Possible side effects
Like all medicines, these tablets
can cause side effects, although not
everybody gets them.
The following side effects have been
reported in patients treated with
these tablets:
• Feeling sick.
• Gastrointestinal disorders
(e.g. upset stomach).
• Headache.
• Difficulty in sleeping, feeling
restless, irritable and shaky.
• A fast, slow or irregular heart beat.
• Seizures, fits or convulsions.
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 Phyllocontin Continus
and Phyllocontin Forte 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 label or
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 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
• Industrial methylated spirit
• 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.
CODE: UP/DRUG/02/05

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 approved in 09/2010
® Phyllocontin, Continus and the NAPP device (logo) are
Registered Trade Marks.
© 2008 Napp Pharmaceuticals Limited
P0599-A

Expand view ⇕

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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