Nuelin Sa 250mg Prolonged Release Tablets
2. Before you take Nuelin SA
S0613-60-NL-PI L-20.01.2016
PACKAGE LEAFLET:
INFORMATION FOR THE USER
Nuelin™ SA 250mg Prolonged Release Tablets
(theophylline)
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.
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.
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
• 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 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.
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.
The usual dose is one tablet taken twice a day. The usual dose is half to one tablet taken twice a day.
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.
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:
Children (aged 6-12 years):
Nuelin SA 175 mg tablets:
Nuelin SA 250 mg tablets:
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 SAthan 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.
Possible side effects
Like all medicines, Nuelin SAcan 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.
How to store Nuelin SA
• Keep 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.
• Medicines should not be disposed of via wastewater or household waste. Return any medicine you no longer need to the pharmacist.
• 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
Neulin™ is a registered trademark of MEDA AB.
S0613-60-NL-PIL-20.01.2016
2. Before you take Nuelin SA
S0613-60-NL-PIL-20.01,2016v
PACKAGE LEAFLET:
INFORMATION FOR THE USER
Nuelin™ SA 250mg Prolonged Release Tablets
(theophylline)
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.
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.
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
• 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 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.
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.
The usual dose is one tablet taken twice a day. The usual dose is half to one tablet taken twice a day.
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.
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:
Children (aged 6-12 years):
Nuelin SA 175 mg tablets:
Nuelin SA 250 mg tablets:
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 SAthan 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.
Possible side effects
Like all medicines, Nuelin SAcan 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.
How to store Nuelin SA
• Keep 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.
• Medicines should not be disposed of via wastewater or household waste. Return any medicine you no longer need to the pharmacist.
• 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
Neulin™ 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