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NUELIN SA 250MG PROLONGED RELEASE TABLETS

Active substance(s): THEOPHYLLINE

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S0613-60-NL-PIL-20.01.2016

PACKAGE LEAFLET:
INFORMATION FOR THE USER



(theophylline)



In this leaflet:
1. What Nuelin SA is for
2. Before you take Nuelin SA
3. How to take Nuelin SA
4. Possible side effects
5. How to store Nuelin SA
6. Further information

1. What Nuelin SA is for
Nuelin SA belongs to a family of medicines called
bronchodilators. Bronchodilators are used to treat, and
relieve the symptoms of diseases where the passages
in your lungs are blocked.
Nuelin SA works by widening the air passages in your
lungs which allows you to breathe more easily and feel
less tight chested. You may take Nuelin SA if you have
asthma or a chest disease such as chronic obstructive
pulmonary disease (COPD) that makes you wheeze,
cough or become short of breath.

2. Before you take Nuelin SA
Do not take Nuelin SA if:







NuelinTM SA 250mg
Prolonged Release Tablets
Read all of this leaflet carefully before you start
taking this medicine.
 This medicine is available without prescription.
However, you still need to take this medicine
carefully to get the best results from it.
 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.
 In this leaflet, Nuelin SA 250mg Prolonged Release
Tablets will be called Nuelin SA.
 Other strengths are also available.



Check with your doctor or pharmacist before
taking Nuelin SA if:

you are allergic to theophylline or other
bronchodilators (such as xanthines), or any of the
other ingredients in Nuelin SA (see Section 6)
you are under 6 years of age
you are a child and are taking medicines containing
ephedrine (e.g. children's cold and cough medicines)
you have a disease called porphyria which may
cause skin problems, chest and stomach pains,
sickness and diarrhoea.

If any of the above applies to you talk to your doctor or
pharmacist.











you have an irregular, or abnormally fast or slow
heart beat
you have a stomach or intestinal ulcer
you suffer from epileptic seizures
you have lung disease
you have liver disease
you have very high blood pressure
you have been told you have an overactive thyroid
gland
you have a disease called acute porphyria which may
cause stomach pain, sickness, diarrhoea, seizures or
mental disorders
you are an alcoholic
you have a high fever, headache and chills that came
on suddenly (acute febrile illness)
you smoke.

Tell your doctor or pharmacist if you are taking any
of the following medicines. It is very important that
you do this, as your doctor or pharmacist may have
to alter the dose of Nuelin SA that you take:
 isoprenaline and another xanthine called
aminophylline which are used to treat asthma or lung
disease
 drugs to treat stomach or intestinal ulcers such as
cimetidine or nizatidine
 drugs to treat high blood pressure such as betablockers, furosemide, diltiazem or verapamil
 drugs to treat an overactive thyroid gland such as
carbimazole
 drugs to treat infections such as erythromycin or
other macrolide antibiotics, ciprofloxacin or
norfloxacin
 drugs to treat fungal infections such as fluconazole
 drugs to treat a joint disease called gout such as
allopurinol or sulfinpyrazone
 drugs to treat skin diseases (corticosteroids)
 oral contraceptives (i.e. `the pill’)
 drugs to treat irregular heart beat such as mexiletine
or propafenone
 drugs to treat depression such as fluvoxamine
 a vaccine for preventing flu
 drugs used to treat alcoholism such as disulfiram
 interferon alfa, a drug used to treat several cancers
 drugs to treat tuberculosis such as isoniazid or
rifampicin
 drugs to treat diseases of the small blood vessels
such as pentoxifylline
 drugs to prevent and treat epileptic seizures such as
phenytoin, carbamazepine, barbiturates or primidone
 aminoglutethimide, a drug used to treat a disease
called Cushings Syndrome
 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 or If you take more Nuelin SA than you should
have recently taken any other medicines, including
Do not take more Nuelin SA than you should. If you
medicines obtained without a prescription.
accidentally take too much, immediately contact your
doctor or nearest hospital casualty department.

Taking with food and drink

Nuelin SA should always be taken after you have eaten. Taking too much Nuelin SA can have very serious
effects. You may feel or be sick, have stomach pains,
Pregnancy and breast-feeding
and vomit blood. Your heart may beat faster or you may
If you are pregnant or trying to become pregnant, ask
shake uncontrollably. Severe cases of overdose may
your doctor or pharmacist for advice before taking
cause you to have a fit, go into a coma, or die.
Nuelin SA.
If you forget to take Nuelin SA
You must not breast-feed while taking this medicine.
Do not take a double dose to make up for a forgotten
Driving and using machines
dose. Take your next dose as planned.
Nuelin SA does not affect your ability to drive or use
If you stop taking Nuelin SA
machines.
Do not stop taking Nuelin SA without first talking to your
Warnings about the ingredients in Nuelin SA
doctor or pharmacist.
If you have been told by your doctor that you have an
If you have any further questions about the use of this
intolerance to some sugars, check with your doctor or
medicine, ask your doctor or pharmacist.
pharmacist before taking this medicine.

3.

How to take Nuelin SA

Remember: Neulin SA should always be taken after
you have eaten. Nuelin SA tablets should be swallowed
whole. Do not crush or chew the tablets. To get the
correct dose, the 250 mg tablets may have to be
broken in half along the line down the middle. Your
doctor or pharmacist will tell you how to do this.
If you are unsure about how much of this medicine
you should take, ask your doctor or pharmacist for
advice.
Adults:
Nuelin SA 175 mg tablets:

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.
The usual dose is one
tablet taken twice a day.
If necessary this may be
increased to two tablets
twice a day.

Children (aged 6-12 years):
Nuelin SA 175 mg tablets:
The usual dose is one
tablet taken twice a day.
Nuelin SA 250 mg tablets:
The usual dose is half to
one tablet taken twice a
day.

4.

Possible side effects

Like all medicines, Nuelin SA 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.

Elderly:
Your doctor or pharmacist will tell you exactly how
much to take. The dose you take may be lower than the 5. How to store Nuelin SA
 Keep out of the sight and reach of children.
usual adult dose.
 Do not use Nuelin SA after the expiry date which is
While you are taking this medicine, your doctor may ask
stated on the label or carton.
you to have check-ups. These are to make sure that
 The expiry date refers to the last day of that month.
your medicine is working properly and that the dose
 Do not store above 30°C.
you are taking is right for you.
 Medicines should not be disposed of via wastewater
or household waste. Return any medicine you no
longer need to the pharmacist.



6.

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

Further 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: 20/01/2016
NeulinTM is a registered trademark of MEDA AB.
S0613-60-NL-PIL-20.01.2016

S0613-60-NL-PIL-20.01.2016v

PACKAGE LEAFLET:
INFORMATION FOR THE USER



(theophylline)



In this leaflet:
1. What Nuelin SA is for
2. Before you take Nuelin SA
3. How to take Nuelin SA
4. Possible side effects
5. How to store Nuelin SA
6. Further information

1. What Nuelin SA is for
Nuelin SA belongs to a family of medicines called
bronchodilators. Bronchodilators are used to treat, and
relieve the symptoms of diseases where the passages
in your lungs are blocked.
Nuelin SA works by widening the air passages in your
lungs which allows you to breathe more easily and feel
less tight chested. You may take Nuelin SA if you have
asthma or a chest disease such as chronic obstructive
pulmonary disease (COPD) that makes you wheeze,
cough or become short of breath.

2. Before you take Nuelin SA
Do not take Nuelin SA if:







NuelinTM SA 250mg
Prolonged Release Tablets
Read all of this leaflet carefully before you start
taking this medicine.
 This medicine is available without prescription.
However, you still need to take this medicine
carefully to get the best results from it.
 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.
 In this leaflet, Nuelin SA 250mg Prolonged Release
Tablets will be called Nuelin SA.
 Other strengths are also available.



Check with your doctor or pharmacist before
taking Nuelin SA if:

you are allergic to theophylline or other
bronchodilators (such as xanthines), or any of the
other ingredients in Nuelin SA (see Section 6)
you are under 6 years of age
you are a child and are taking medicines containing
ephedrine (e.g. children's cold and cough medicines)
you have a disease called porphyria which may
cause skin problems, chest and stomach pains,
sickness and diarrhoea.

If any of the above applies to you talk to your doctor or
pharmacist.











you have an irregular, or abnormally fast or slow
heart beat
you have a stomach or intestinal ulcer
you suffer from epileptic seizures
you have lung disease
you have liver disease
you have very high blood pressure
you have been told you have an overactive thyroid
gland
you have a disease called acute porphyria which may
cause stomach pain, sickness, diarrhoea, seizures or
mental disorders
you are an alcoholic
you have a high fever, headache and chills that came
on suddenly (acute febrile illness)
you smoke.

Tell your doctor or pharmacist if you are taking any
of the following medicines. It is very important that
you do this, as your doctor or pharmacist may have
to alter the dose of Nuelin SA that you take:
 isoprenaline and another xanthine called
aminophylline which are used to treat asthma or lung
disease
 drugs to treat stomach or intestinal ulcers such as
cimetidine or nizatidine
 drugs to treat high blood pressure such as betablockers, furosemide, diltiazem or verapamil
 drugs to treat an overactive thyroid gland such as
carbimazole
 drugs to treat infections such as erythromycin or
other macrolide antibiotics, ciprofloxacin or
norfloxacin
 drugs to treat fungal infections such as fluconazole
 drugs to treat a joint disease called gout such as
allopurinol or sulfinpyrazone
 drugs to treat skin diseases (corticosteroids)
 oral contraceptives (i.e. `the pill’)
 drugs to treat irregular heart beat such as mexiletine
or propafenone
 drugs to treat depression such as fluvoxamine
 a vaccine for preventing flu
 drugs used to treat alcoholism such as disulfiram
 interferon alfa, a drug used to treat several cancers
 drugs to treat tuberculosis such as isoniazid or
rifampicin
 drugs to treat diseases of the small blood vessels
such as pentoxifylline
 drugs to prevent and treat epileptic seizures such as
phenytoin, carbamazepine, barbiturates or primidone
 aminoglutethimide, a drug used to treat a disease
called Cushings Syndrome
 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 or If you take more Nuelin SA than you should
have recently taken any other medicines, including
Do not take more Nuelin SA than you should. If you
medicines obtained without a prescription.
accidentally take too much, immediately contact your
doctor or nearest hospital casualty department.

Taking with food and drink

Nuelin SA should always be taken after you have eaten. Taking too much Nuelin SA can have very serious
effects. You may feel or be sick, have stomach pains,
Pregnancy and breast-feeding
and vomit blood. Your heart may beat faster or you may
If you are pregnant or trying to become pregnant, ask
shake uncontrollably. Severe cases of overdose may
your doctor or pharmacist for advice before taking
cause you to have a fit, go into a coma, or die.
Nuelin SA.
If you forget to take Nuelin SA
You must not breast-feed while taking this medicine.
Do not take a double dose to make up for a forgotten
Driving and using machines
dose. Take your next dose as planned.
Nuelin SA does not affect your ability to drive or use
If you stop taking Nuelin SA
machines.
Do not stop taking Nuelin SA without first talking to your
Warnings about the ingredients in Nuelin SA
doctor or pharmacist.
If you have been told by your doctor that you have an
If you have any further questions about the use of this
intolerance to some sugars, check with your doctor or
medicine, ask your doctor or pharmacist.
pharmacist before taking this medicine.

3.

How to take Nuelin SA

Remember: Neulin SA should always be taken after
you have eaten. Nuelin SA tablets should be swallowed
whole. Do not crush or chew the tablets. To get the
correct dose, the 250 mg tablets may have to be
broken in half along the line down the middle. Your
doctor or pharmacist will tell you how to do this.
If you are unsure about how much of this medicine
you should take, ask your doctor or pharmacist for
advice.
Adults:
Nuelin SA 175 mg tablets:

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.
The usual dose is one
tablet taken twice a day.
If necessary this may be
increased to two tablets
twice a day.

Children (aged 6-12 years):
Nuelin SA 175 mg tablets:
The usual dose is one
tablet taken twice a day.
Nuelin SA 250 mg tablets:
The usual dose is half to
one tablet taken twice a
day.

4.

Possible side effects

Like all medicines, Nuelin SA 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.

Elderly:
Your doctor or pharmacist will tell you exactly how
much to take. The dose you take may be lower than the 5. How to store Nuelin SA
 Keep out of the sight and reach of children.
usual adult dose.
 Do not use Nuelin SA after the expiry date which is
While you are taking this medicine, your doctor may ask
stated on the label or carton.
you to have check-ups. These are to make sure that
 The expiry date refers to the last day of that month.
your medicine is working properly and that the dose
 Do not store above 30°C.
you are taking is right for you.
 Medicines should not be disposed of via wastewater
or household waste. Return any medicine you no
longer need to the pharmacist.



6.

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

Further 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: 20/01/2016
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.
S0613-60-NL-PIL-20.01.2016v

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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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