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Active substance(s): THEOPHYLLINE

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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:
By reporting side effects you can help provide more information on the safety of
this medicine.
5. How to store Nuelin SA
Keep out of the reach and sight of children.
Do not use Nuelin SA after the expiry date which is stated on the label or carton.
The expiry date refers to the last day of that month.
Do not store above 30°C.
Medicines should not be disposed of via wastewater or household waste. Return
any medicine you no longer need to the pharmacist.
6. Further information
What Nuelin SA contains
• The active substance in Nuelin SA is theophylline. Each 175 mg tablet contains
175 mg theophylline. Each 250 mg tablet contains 250 mg theophylline.
• The other ingredients are lactose, cellulose acetate phthalate and magnesium
What Nuelin SA looks like
Nuelin SA prolonged release tablets come in two strengths: 175 mg and 250 mg.
The tablets are white, round, biconvex, uncoated tablets with “T” on one face and
“175” “or “250” on the other with a score line (only for the 250 mg tablet).
They come in a bottle or blister pack of 60 tablets.
Marketing Authorisation Holder: Meda Pharmaceuticals Ltd, Skyway House,
Parsonage Road, Takeley, Bishop's Stor tford,
CM22 6PU, United Kingdom.
3M Health Care Ltd, Loughborough,
Leicestershire, LE11 1EP, United Kingdom.
This leaflet was last updated in 11/2013

If this leaflet is difficult to see or read and you would like it
in a different format, please contact Meda Pharmaceuticals,
Skyway House, Parsonage Road, Takeley, Bishop's Stortford,
CM22 6PU, United Kingdom.

6204 2198 8

Nuelin is a trademark of MEDA AB.
The Triangle Logo on the packaging is a
trademark of 3M and is used under license.

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Patient Information Leaflet

Nuelin SA 175 mg & 250 mg
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 prolonged release tablets will be called Nuelin SA.
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:
• 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.
Check with your doctor or pharmacist before taking Nuelin SA if:
• 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

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• 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
• 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 beta-blockers, furosemide, diltiazem or
• 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 have recently taken any
other medicines, including medicines obtained without a prescription.
Taking with food and drink
Nuelin SA should always be taken after you have eaten.
Pregnancy and breast-feeding
If you are pregnant or trying to become pregnant, ask your doctor or pharmacist for
advice before taking Nuelin SA.
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.
Warnings about the ingredients in Nuelin SA
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.

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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.
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.
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.
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
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 or
4. Possible side effects
Like all medicines, Nuelin SA can cause side effects, although not everybody gets
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).

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Studio Oberländer • Rubensstrasse 33 • 60596 Frankfurt am Main • Germany
Tel. +49 69 631520-85 • Fax +49 69 631520-87 • E-Mail:

MEDA Pharma GmbH & Co. KG

Benutzte Farben:


Nuelin SA Tablets


175 & 250 mg

30% Tint of Black




6204 2198 8

Laetuscode: 625


United Kingdom


254 x 191 mm

Draw. Ref.: PE00180

Laetuscode: 625

8,5 pt / 8,5 pt

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Korrektur: 2.

14. 11. 2013

14.11.13 09:12

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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.