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NUELIN SA 250MG PROLONGED RELEASE TABLETS

Active substance(s): THEOPHYLLINE / THEOPHYLLINE

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PACKAGE LEAFLET:
INFORMATION FOR THE USER

NuelinTM SA 250mg
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.
 In this leaflet, Nuelin SA 250mg Prolonged Release
Tablets will be called Nuelin SA.
 Other strengths are also available.

Warnings and precautions
Check with your doctor or pharmacist before taking
Nuelin SA:
 if you have an irregular, or abnormally fast or slow
heart beat
 if you have a stomach or intestinal ulcer
 if you suffer from epileptic seizures
 if you have lung disease
 if you have liver disease
 if you have very high blood pressure
 if you have been told you have an overactive thyroid
gland
 if you have a disease called acute porphyria which
may cause stomach pain, sickness, diarrhoea,
seizures or mental disorders
 if you are an alcoholic
 if you have a high fever, headache and chills that
came on suddenly (acute febrile illness)
 if you smoke.
If you have been told by your doctor that you have an
intolerance to some sugars, check with your doctor or
pharmacist before taking this medicine.

Other medicines and Nuelin SA

Tell your doctor or pharmacist if you are taking,
What is in this leaflet:
have recently taken or might take any of the
1. What Nuelin SA is and what it is used for
following medicines. It is very important that you do
2. What you need to know before you take Nuelin
this, as your doctor or pharmacist may have to alter
SA
the dose of Nuelin SA that you take:
3. How to take Nuelin SA
 isoprenaline and another xanthine called
4. Possible side effects
aminophylline which are used to treat asthma or lung
5. How to store Nuelin SA
disease
6. Contents of the pack and other information
 drugs to treat stomach or intestinal ulcers such as
cimetidine or nizatidine
1. What Nuelin SA is and what it is used for
 drugs to treat high blood pressure such as betaNuelin SA belongs to a family of medicines called
blockers, furosemide, diltiazem or verapamil
bronchodilators. Bronchodilators are used to treat, and
 drugs to treat an overactive thyroid gland such as
relieve the symptoms of diseases where the passages
carbimazole
in your lungs are blocked.
 drugs to treat infections such as erythromycin or
Nuelin SA works by widening the air passages in your
other macrolide antibiotics, ciprofloxacin or
lungs which allows you to breathe more easily and feel
norfloxacin
less tight chested. You may take Nuelin SA if you have  drugs to treat fungal infections such as fluconazole
asthma or a chest disease such as chronic obstructive
 drugs to treat a joint disease called gout such as
pulmonary disease (COPD) that makes you wheeze,
allopurinol or sulfinpyrazone
cough or become short of breath.
 drugs to treat skin diseases (corticosteroids)
You must talk to a doctor if you do not feel better or if
 oral contraceptives (i.e. `the pill’)
you feel worse.
 drugs to treat irregular heart beat such as mexiletine
or propafenone
2. What you need to know before you take
 drugs to treat depression such as fluvoxamine
Nuelin SA
 a vaccine for preventing flu
Do not take Nuelin SA:
 drugs used to treat alcoholism such as disulfiram
 if you are allergic to theophylline or other
 interferon alfa, a drug used to treat several cancers
bronchodilators (such as xanthines), or any of the
 drugs to treat tuberculosis such as isoniazid or
other ingredients of this medicine (listed in section 6).
rifampicin
 if you are under 6 years of age
 drugs to treat diseases of the small blood vessels
 if you are a child and are taking medicines containing
such as pentoxifylline
ephedrine (e.g. children’s cold and cough medicines)  drugs to prevent and treat epileptic seizures such as
 if you have a disease called porphyria which may
phenytoin, carbamazepine, barbiturates or primidone
cause skin problems, chest and stomach pains,
 aminoglutethimide, a drug used to treat a disease
sickness and diarrhoea.
called Cushings Syndrome
If any of the above applies to you talk to your doctor or
pharmacist.





St John’s Wort (Hypericum perforatum), a herbal
remedy used to treat depression
ketamine, a drug used as an anaesthetic
doxapram, a drug used to stimulate breathing in
patients who struggle to breathe for themselves.

Please tell your doctor or pharmacist if you are taking,
have recently taken or might take any other medicines.

Nuelin SA with food and drink
Nuelin SA should always be taken after you have eaten.

Pregnancy, breast-feeding and fertility
Pregnancy
If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your
doctor or pharmacist for advice before taking this
medicine.
Breast-feeding
You must not breast-feed while taking this medicine.

Driving and using machines
Nuelin SA does not affect your ability to drive or use
machines.

Nuelin SA contains lactose

3.

How to take Nuelin SA

Always take this medicine 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.
The recommended dose is:
Adults:
Nuelin SA 175 mg tablets: The usual dose is one tablet
taken twice a day. If necessary, this may be increased
to two tablets twice a day.
Nuelin SA 250 mg tablets: The usual dose is one tablet
taken twice a day. If necessary, this may be increased
to two tablets twice a day.
Elderly:
Your doctor or pharmacist will tell you exactly how
much to take. The dose you take may be lower than the
usual adult dose.
While you are taking this medicine, your doctor may ask
you to have check-ups. These are to make sure that
your medicine is working properly and that the dose you
are taking is right for you.

If you take more Nuelin SA than you should
Do not take more Nuelin SA than you should. If you
accidentally take too much, immediately contact your
doctor or nearest hospital casualty department.
Taking too much Nuelin SA can have very serious
effects. You may feel or be sick, have stomach pains,
and vomit blood. Your heart may beat faster or you may
shake uncontrollably. Severe cases of overdose may
cause you to have a fit, go into a coma, or die.

If you forget to take Nuelin SA
Do not take a double dose to make up for a forgotten
dose. Take your next dose as planned.

If you stop taking Nuelin SA
Do not stop taking Nuelin SA without first talking to your
doctor or pharmacist.
If you have any further questions about the use of this
medicine, ask your doctor, pharmacist or nurse.

4.

Possible side effects

Like all medicines, this medicine can cause side effects,
although not everybody gets them.
Tell your doctor or pharmacist if:
 you notice your heart beating irregularly, or
abnormally fast or slow
 you have a fit (convulsions)
 you feel sick
 you have cramps, or a burning sensation in your
stomach
 you have a headache
 you feel restless and have difficulty sleeping
(insomnia).
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.
By reporting side effects, you can help provide more
information on the safety of this medicine.

Use in children and adolescents
Children (aged 6-12 years):
Nuelin SA 175 mg tablets: The usual dose is one tablet 5. How to store Nuelin SA
taken twice a day.
 Keep out of the sight and reach of children.
Nuelin SA 250 mg tablets: The usual dose is half to one  Do not use Nuelin SA after the expiry date which is
tablet taken twice a day.
stated on the label or carton.
Remember: Nuelin SA should always be taken after
 The expiry date refers to the last day of that month.
you have eaten. Nuelin SA tablets should be swallowed  Do not store above 25°C.
whole. Do not crush or chew the tablets. To get the
 Medicines should not be disposed of via wastewater
correct dose, the 250 mg tablets may have to be broken
or household waste. Return any medicine you no
in half along the line down the middle. Your doctor or
longer need to the pharmacist.
S0613-60-NL-PIL-09.05.2017
pharmacist will tell you how to do this.



6.

If the tablets become discoloured or show any signs
of deterioration, you should seek the advice of your
pharmacist.

Contents of the pack and other
information

What Nuelin SA contains




The active substance in Nuelin SA is theophylline.
Each prolonged release tablet contains 250 mg
theophylline.
The other ingredients are lactose, cellulose acetate
phthalate and magnesium stearate (E470b).

What Nuelin SA looks like and contents of the
pack
White, round, biconvex prolonged release tablets
marked “T” on one face and “250” on the other with a
score line.
Each pack contains blister strips of 60 tablets.
Manufacturer:
3M Health Care Ltd,
Derby Road, Loughborough,
Leicestershire LE11 5SF, United Kingdom
Procured from within the EU and repackaged by:
Amimed Direct Ltd, Hendon, London, NW9 6AQ.
Product Licence Holder: Sam Pharma Ltd, Unit 20
Garrick Industrial Estate, Irving Way, Hendon, London,
NW9 6AQ.
P

PL 33902/0613

Leaflet revision date: 09/05/2017
NeulinTM is a registered trademark of MEDA AB.

Blind or partially sighted? Is
this leaflet hard to see or
read? Call 02082033203 to
obtain the leaflet in a format
suitable for you.
S0613-60-NL-PIL-09.05.2017

PACKAGE LEAFLET:
INFORMATION FOR THE USER

NuelinTM SA 250mg
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.
 In this leaflet, Nuelin SA 250mg Prolonged Release
Tablets will be called Nuelin SA.
 Other strengths are also available.

Warnings and precautions
Check with your doctor or pharmacist before taking
Nuelin SA:
 if you have an irregular, or abnormally fast or slow
heart beat
 if you have a stomach or intestinal ulcer
 if you suffer from epileptic seizures
 if you have lung disease
 if you have liver disease
 if you have very high blood pressure
 if you have been told you have an overactive thyroid
gland
 if you have a disease called acute porphyria which
may cause stomach pain, sickness, diarrhoea,
seizures or mental disorders
 if you are an alcoholic
 if you have a high fever, headache and chills that
came on suddenly (acute febrile illness)
 if you smoke.
If you have been told by your doctor that you have an
intolerance to some sugars, check with your doctor or
pharmacist before taking this medicine.

Other medicines and Nuelin SA

Tell your doctor or pharmacist if you are taking,
What is in this leaflet:
have recently taken or might take any of the
1. What Nuelin SA is and what it is used for
following medicines. It is very important that you do
2. What you need to know before you take Nuelin
this, as your doctor or pharmacist may have to alter
SA
the dose of Nuelin SA that you take:
3. How to take Nuelin SA
 isoprenaline and another xanthine called
4. Possible side effects
aminophylline which are used to treat asthma or lung
5. How to store Nuelin SA
disease
6. Contents of the pack and other information
 drugs to treat stomach or intestinal ulcers such as
cimetidine or nizatidine
1. What Nuelin SA is and what it is used for
 drugs to treat high blood pressure such as betaNuelin SA belongs to a family of medicines called
blockers, furosemide, diltiazem or verapamil
bronchodilators. Bronchodilators are used to treat, and
 drugs to treat an overactive thyroid gland such as
relieve the symptoms of diseases where the passages
carbimazole
in your lungs are blocked.
 drugs to treat infections such as erythromycin or
Nuelin SA works by widening the air passages in your
other macrolide antibiotics, ciprofloxacin or
lungs which allows you to breathe more easily and feel
norfloxacin
less tight chested. You may take Nuelin SA if you have  drugs to treat fungal infections such as fluconazole
asthma or a chest disease such as chronic obstructive
 drugs to treat a joint disease called gout such as
pulmonary disease (COPD) that makes you wheeze,
allopurinol or sulfinpyrazone
cough or become short of breath.
 drugs to treat skin diseases (corticosteroids)
You must talk to a doctor if you do not feel better or if
 oral contraceptives (i.e. `the pill’)
you feel worse.
 drugs to treat irregular heart beat such as mexiletine
or propafenone
2. What you need to know before you take
 drugs to treat depression such as fluvoxamine
Nuelin SA
 a vaccine for preventing flu
Do not take Nuelin SA:
 drugs used to treat alcoholism such as disulfiram
 if you are allergic to theophylline or other
 interferon alfa, a drug used to treat several cancers
bronchodilators (such as xanthines), or any of the
 drugs to treat tuberculosis such as isoniazid or
other ingredients of this medicine (listed in section 6).
rifampicin
 if you are under 6 years of age
 drugs to treat diseases of the small blood vessels
 if you are a child and are taking medicines containing
such as pentoxifylline
ephedrine (e.g. children’s cold and cough medicines)  drugs to prevent and treat epileptic seizures such as
 if you have a disease called porphyria which may
phenytoin, carbamazepine, barbiturates or primidone
cause skin problems, chest and stomach pains,
 aminoglutethimide, a drug used to treat a disease
sickness and diarrhoea.
called Cushings Syndrome
If any of the above applies to you talk to your doctor or
pharmacist.





St John’s Wort (Hypericum perforatum), a herbal
remedy used to treat depression
ketamine, a drug used as an anaesthetic
doxapram, a drug used to stimulate breathing in
patients who struggle to breathe for themselves.

Please tell your doctor or pharmacist if you are taking,
have recently taken or might take any other medicines.

Nuelin SA with food and drink
Nuelin SA should always be taken after you have eaten.

Pregnancy, breast-feeding and fertility
Pregnancy
If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your
doctor or pharmacist for advice before taking this
medicine.
Breast-feeding
You must not breast-feed while taking this medicine.

Driving and using machines
Nuelin SA does not affect your ability to drive or use
machines.

Nuelin SA contains lactose

3.

How to take Nuelin SA

Always take this medicine 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.
The recommended dose is:
Adults:
Nuelin SA 175 mg tablets: The usual dose is one tablet
taken twice a day. If necessary, this may be increased
to two tablets twice a day.
Nuelin SA 250 mg tablets: The usual dose is one tablet
taken twice a day. If necessary, this may be increased
to two tablets twice a day.
Elderly:
Your doctor or pharmacist will tell you exactly how
much to take. The dose you take may be lower than the
usual adult dose.
While you are taking this medicine, your doctor may ask
you to have check-ups. These are to make sure that
your medicine is working properly and that the dose you
are taking is right for you.

If you take more Nuelin SA than you should
Do not take more Nuelin SA than you should. If you
accidentally take too much, immediately contact your
doctor or nearest hospital casualty department.
Taking too much Nuelin SA can have very serious
effects. You may feel or be sick, have stomach pains,
and vomit blood. Your heart may beat faster or you may
shake uncontrollably. Severe cases of overdose may
cause you to have a fit, go into a coma, or die.

If you forget to take Nuelin SA
Do not take a double dose to make up for a forgotten
dose. Take your next dose as planned.

If you stop taking Nuelin SA
Do not stop taking Nuelin SA without first talking to your
doctor or pharmacist.
If you have any further questions about the use of this
medicine, ask your doctor, pharmacist or nurse.

4.

Possible side effects

Like all medicines, this medicine can cause side effects,
although not everybody gets them.
Tell your doctor or pharmacist if:
 you notice your heart beating irregularly, or
abnormally fast or slow
 you have a fit (convulsions)
 you feel sick
 you have cramps, or a burning sensation in your
stomach
 you have a headache
 you feel restless and have difficulty sleeping
(insomnia).
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.
By reporting side effects, you can help provide more
information on the safety of this medicine.

Use in children and adolescents
Children (aged 6-12 years):
Nuelin SA 175 mg tablets: The usual dose is one tablet 5. How to store Nuelin SA
taken twice a day.
 Keep out of the sight and reach of children.
Nuelin SA 250 mg tablets: The usual dose is half to one  Do not use Nuelin SA after the expiry date which is
tablet taken twice a day.
stated on the label or carton.
Remember: Nuelin SA should always be taken after
 The expiry date refers to the last day of that month.
you have eaten. Nuelin SA tablets should be swallowed  Do not store above 25°C.
whole. Do not crush or chew the tablets. To get the
 Medicines should not be disposed of via wastewater
correct dose, the 250 mg tablets may have to be broken
or household waste. Return any medicine you no
in half along the line down the middle. Your doctor or
longer need to the pharmacist.
S0613-60-NL-PIL-09.05.2017v
pharmacist will tell you how to do this.



6.

If the tablets become discoloured or show any signs
of deterioration, you should seek the advice of your
pharmacist.

Contents of the pack and other
information

What Nuelin SA contains




The active substance in Nuelin SA is theophylline.
Each prolonged release tablet contains 250 mg
theophylline.
The other ingredients are lactose, cellulose acetate
phthalate and magnesium stearate (E470b).

What Nuelin SA looks like and contents of the
pack
White, round, biconvex prolonged release tablets
marked “T” on one face and “250” on the other with a
score line.
Each pack contains blister strips of 60 tablets.
Manufacturer:
3M Health Care Ltd,
Derby Road, Loughborough,
Leicestershire LE11 5SF, United Kingdom
Procured from within the EU and repackaged by:
Amimed Direct Ltd, Hendon, London, NW9 6AQ.
Product Licence Holder: Sam Pharma Ltd, Unit 20
Garrick Industrial Estate, Irving Way, Hendon, London,
NW9 6AQ.
P

PL 33902/0613

Leaflet revision date: 09/05/2017
NeulinTM is a registered trademark of MEDA AB.
The Triangle Logo on the packaging is a registered
trademark of 3M and is used under licence.

Blind or partially sighted? Is
this leaflet hard to see or
read? Call 02082033203 to
obtain the leaflet in a format
suitable for you.
S0613-60-NL-PIL-09.05.2017v

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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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