Nuelin Sa 250 mg Tablets

Theophylline belongs to a group 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. NUELIN SA is used for the treatment of bronchospasm.

Do not take NUELIN SA :

• if you are hypersensitive (allergic) to theophylline or any of the other ingredients of NUELIN SA (listed in section 6);
• if you are receiving any other theophylline therapy;
• if you are hypersensitive to products called xanthine derivatives (e.g.: caffeine, theobromine and methylxanthines. These are components of coffee, tea and chocolate) and aminophylline;
• if you have suffered from a heart attack recently;
• if you have acute tachydysrhythmia (fast and/or irregular heartbeat);
• if you have a disease called porphyria which may cause skin problems, chest and stomach pains, nausea and diarrhoea;
• if you are a child and are taking medicines containing ephedrine (e.g. children’s cold and cough medicines);
• if you are a child under 2 years old.

Warnings and precautions

Special care should be taken with NUELIN SA:

• if your asthma symptoms become worse;
• if you are taking medicines used to treat colds or flu (sympathomimetic medicines);
• if you have any heart disease because it can cause other unwanted effects of the heart and influence the theophylline levels in your body;
• if you have high blood pressure because it can cause other side effects of the heart;
• if you have an overactive or underactive thyroid gland because it can influence the elimination of theophylline from your body;
• if you have any liver disease or kidney disease;
• if you are abusing alcohol;
• if you have a chronic obstructive pulmonary disease (COPD: kind of tight chest);
• if your lungs are inflamed, you experience shortness of breath or if you have excess fluid in your lungs (pulmonary oedema);
• if you have a stomach ulcer or suffer from reflux of gastric acid because theophylline it can increase gastric acid secretion;
• if you smoke tobacco because it can decrease the clearance of theophylline;
• if you have a high fever, headache and chills that came on suddenly (acute febrile illness) because it can delay the elimination of theophylline from your body;
• if you have a viral infection because it can delay the elimination of theophylline from your body;
• if you have a history of seizures (convulsions);
• if you are taking products called xanthine derivates or xanthine containing beverages (such as tea, coffee, cola, cocoa) because it can influence the level of theophylline in your body;
• if you are more than 55 years old;
• if you are dehydrated (you have lost too much fluids from your body).

Children

Do not give NUELIN SA to children under 2 years old because they cannot metabolise theophylline sufficiently.

For children taking NUELIN SA tablets, NUELIN LIQUID may be considered as an alternative and more appropriate dosage form.

Other medicines and NUELIN SA

Always tell your healthcare provider if you are taking any other medicine. (This includes all complementary or traditional medicines.) Tell your doctor or pharmacist if you are taking any of the following medicines because they may have to alter the dose of NUELIN SA that you take:

• medicines to treat stomach or intestinal ulcers such as cimetidine, nizatidine or ranitidine;
• medicines to treat high blood pressure such as furosemide, beta-blockers, calcium channel blockers, diltiazem, verapamil, diltiazem;
• medicines to treat an overactive thyroid gland such as carbimazole;
• antibiotics such as erythromycin, clarithromycin, ciprofloxacin, enoxacin;
• medicines to treat worm infections such as thiabendazole;
• medicines to treat bacterial infections such as imipenem;
• medicines to treat fungal infections such as fluconazole;
• medicines to treat gout such as allopurinol or sulfinpyrazone;
• medicines to treat skin diseases such as corticosteroids;
• oral contraceptives (“the pill”);
• medicines to treat irregular heart beat and heart conditions such as mexiletine, digoxin or propafenone;
• medicines to treat depression such as fluvoxamine and viloxazine;
• tacrine used for the treatment of dementia;
• medicine for the management of rheumatoid arthritis such as methotrexate;
• medicine used to improve blood flow and treat small blood vessels such as pentoxifylline;
• ticlopidine used to reduce the risk of thrombotic stroke;
• a vaccine for preventing flu;
• medicines to treat alcoholism such as disulfiram;
• interferon alpha, a medicine used to treat several cancers;
• medicines to treat tuberculosis such as isoniazid or rifampicin;
• antiretroviral medicines such as ritonavir;
• medicines to prevent and treat epileptic seizures such as phenobarbitone, phenytoin, carbamazepine, barbiturates, primidone;
• aminoglutethimide, used to treat a disease called Cushing’s Syndrome;
• St John’s Wort (Hypericum perforatum), a herbal remedy used to treat depression;
• ketamine or halothane, medicines used as an anaesthetic;
• medicines used to treat mood disorders called lithium;
• adrenaline and another xanthine called aminophylline which are used to treat asthma or lung disease.

Pregnancy, breastfeeding and fertility

NUELIN SA should not be taken if you are pregnant or breastfeeding your baby. If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, please consult your doctor, pharmacist or other health care provider for advice before taking this medicine.

Driving and using machinery

Even when taken as prescribed, NUELIN SA may affect your ability to drive a vehicle, operate machinery or work safely under hazardous conditions. This applies particularly when it is taken in conjunction with alcohol or other medicines liable to impair judgment and motor skills. It is not always possible to predict to what extent NUELIN SA may interfere with the daily activities of a patient. Patients should ensure that they do not engage in the above activities until they know how NUELIN SA affects them.

Do not share medicines prescribed for you with any other person. Always take NUELIN SA exactly as described in this leaflet or as your doctor or pharmacist have told you. Check with your doctor or pharmacist if you are not sure. The usual dose for adults is one NUELIN SA tablet taken by mouth twice daily (i.e. 12 hourly), to be increased gradually to two tablets twice daily (i.e. 12 hourly), if required and if tolerated. The doctor will calculate the specific dose for your child depending on their age and body weight. The usual dose is:

• 5 to 8 years: 24 mg/kg/24 hours
• 9 to 12 years: 20 mg/kg/24 hours
• 13 to 16 years: 18 mg/kg/24 hours

NUELIN SA tablets may be halved but should not be crushed or chewed. You can take Nuelin-SR tablets with or immediately after food so that it does not upset your stomach. Always take Nuelin-SR tablets regularly, as your doctor has told you to, even if you are not suffering any asthma symptoms. If you think your asthma is getting worse or if you suffer asthma attacks, please consult your doctor immediately. Nuelin-SR tablets will not give you relief during an asthma attack. If you have an asthma attack, please use your relieving inhaler. Nuelin-SR tablets work best when there is a certain amount of theophylline, the active ingredient, in your blood. Your doctor may sometimes need to take samples of your blood to check the level of theophylline.

Your doctor will tell you how long your treatment with NUELIN SA will last. If you have the impression that the effect of NUELIN SA is too strong or too weak, tell your doctor or pharmacist.

If you take more NUELIN SA than you should

In the event of over dosage, consult your doctor or pharmacist. If neither is available contact the nearest hospital or poison centre. Taking too much NUELIN SA can have very serious effects. You may experience the following:

• nausea, vomiting, stomach pain;
• lack or loss of appetite for food (anorexia);
• headache;
• heart palpitations (heart is beating too fast or skipping beats);
• irritability, agitation, anxiety;
• struggling to sleep (insomnia);
• shortness of breath, rapid pulse or faints;
• decreased blood pressure, dizziness or light-headedness;
• insomnia (not being able to sleep);
• sensory disturbances such as numbness or pins and needles;
• confusion, delirium (disorientation), wild or changed behaviour;
• hyperthermia (increased body temperature);
• dehydration and extreme thirst;
• seizures.

You will be given symptomatic and supportive care by the hospital following a NUELIN SA overdose. Theophylline overdose can potentially be fatal, and patients should be monitored closely.

If you forget to take NUELIN SA

If you forgot to take your medicine, take it as soon as you remember. Do not take a double dose to make up for forgotten individual doses. However, if it is more than 4 hours late, skip the dose that you missed. Take your next dose at the normal time.

NUELIN SA can have side effects. Not all side effects reported for NUELIN SA are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking NUELIN SA, please consult your health care provider for advice. Tell your doctor if you notice any of the following:

Frequent side effects:

• nausea, vomiting, stomach pain, loss of appetite
• twitching and tremors (involuntary shaking and spasms)
• convulsions (seizures)
• fast, uncomfortable or irregular heartbeat
• headache
• difficulty sleeping (insomnia)
• feeling anxious, irritated, agitated or restless
• lack or loss of appetite for food
• stomach irritation
• worsening of a stomach ulcer
• heartburn
• vomiting of blood

Side effects with unknown frequency include:

• diarrhoea
• abnormal heart beats and heart rhythm
• flushing, skin rash
• irregular breathing or feeling short of breath
• hair loss
• high blood glucose
• decreased blood pressure
• decreased levels of potassium or magnesium in your body
• excessive urination and/or blood in your urine
• dehydration and electrolyte imbalance

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor of pharmacist. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reactions Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8publications. By Reporting side effects, you can help provide more information on the safety of NUELIN SA. Alternately you can contact iNova Pharmaceuticals (Pty) Ltd. at +27 11 087 0000. Website: www.inovapharma.co.za.

Store all medicines out of reach of children.

• Store at or below 30 °C in tightly closed containers.
• Blisters should be stored in the original blister pack until required for use.
• Do not use after the expiry date stated on the label or carton. Return all unused medicine to your pharmacist.

Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).