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NUELIN SA 250 MG TABLETS

Active substance(s): THEOPHYLLINE / THEOPHYLLINE / THEOPHYLLINE

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Nuelin® SA 250 mg Tablets

2662
04.04.17[3]

(theophylline)
PATIENT INFORMATION LEAFLET
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 Tablets will be called Nuelin SA.
Nuelin SA is also available in 175 mg strength.
What is in this leaflet:
1. What Nuelin SA is and what it is used for
2. What you need to know before you take Nuelin SA
3. How to take Nuelin SA
4. Possible side effects
5. How to store Nuelin SA
6. Contents of the pack and other information
1. WHAT NUELIN SA IS AND WHAT IT IS USED 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.
You must talk to a doctor if you do not feel better or if you feel worse.
2. WHAT YOU NEED TO KNOW 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 of this medicine (listed in
section 6).
- if you are under 6 years of age
- if you are a child and are taking medicines containing ephedrine (e.g.
children's cold and cough medicines)
- if 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.
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, have recently taken or
might take 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 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, 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 checkups.
These are to make sure that your medicine is working properly and that the
dose you are taking is right for you.
Use in children and adolescents
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.
Remember: Nuelin 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 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 or pharmacist.

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.
5. HOW TO STORE NUELIN SA
- Keep this medicine out of the sight and reach 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.
- If your tablets becomes discoloured or shown any other signs of
deterioration, please contact your doctor or pharmacist before taking your
medication.
- Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required. This
will help protect the environment.
6. 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 monohydrate, cellulose acetate
phthalate and magnesium stearate.
What Nuelin SA looks like
The tablets are white, round, biconvex, uncoated tablets with “T” on one
face and “250” on the other with a score line.
They come in a blister pack of 60 and 100 tablets.
MANUFACTURER AND PRODUCT LICENCE HOLDER
Manufactured by 3M Health Care Ltd, 3M House, 1 Morley Street,
Loughborough, Leicestershire, LE11 1EP, United Kingdom.
Procured from within the EU by Product Licence holder
Star Pharmaceuticals Ltd, 5 Sandridge Close, Harrow, Middlesex, HA1 1XD.
Repackaged by Servipharm Ltd.
P

PL 20636/2662

Leaflet revision and issue date (Ref) 04.04.17[3]
Nuelin is a trademark of MEDA AB.
The Triangle Logo on the packaging is a trademark of 3M.

Blind or partially sighted?
Is this leaflet hard to see or read?
Call 020 8423 2111 to obtain the
leaflet in a format suitable for you.

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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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