Aminophylline S.A.L.F.

Package leaflet: Information for the user

AMINOFILLINA S.A.L.F. 240 mg/10 ml solution for injection for intravenous use

Aminophylline
Equivalent medicine
Please read this leaflet carefully before this medicine is administered to you, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

1. What AMINOFILLINA S.A.L.F. is and what it is used for
2. What you need to know before using AMINOFILLINA S.A.L.F.
3. How to use AMINOFILLINA S.A.L.F.
4. Possible side effects
5. How to store AMINOFILLINA S.A.L.F.
6. Contents of the pack and other information

1. What AMINOFILLINA S.A.L.F. is and what it is used for

AMINOFILLINA S.A.L.F. contains the active substance aminophylline, which belongs to a group of medicines used in lung diseases characterized by reduced airflow (bronchial obstruction).
AMINOFILLINA S.A.L.F. is indicated for bronchial asthma and lung diseases that cause bronchial constriction (bronchospasm).

2. What you need to know before using AMINOFILLINA S.A.L.F.

Do not use AMINOFILLINA S.A.L.F.

• if you are allergic to aminophylline or to any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to other substances with a structure similar to aminophylline (xanthine derivatives);
• if you have severe heart problems (acute myocardial infarction);
• if you suffer from low blood pressure (hypotensive states);
• if you are breastfeeding (see section “Pregnancy and breastfeeding”)

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before being administered AMINOFILLINA S.A.L.F.
Aminophylline must not be administered concurrently with other xanthine preparations (substances with a structure similar to aminophylline). AMINOFILLINA S.A.L.F. must be administered with caution when used together with ephedrine or other substances used to dilate the bronchi (sympathomimetic bronchodilators).
Use particular caution and inform your doctor if you are taking antiepileptic medicines such as phenytoin, or if you smoke cigarettes, as this may require an increase in the dose of aminophylline (see section “Other medicines and AMINOFILLINA S.A.L.F.”), since in these cases the blood levels of the medicine may decrease.
AMINOFILLINA S.A.L.F. must be used with caution:

• if you are elderly;
• if you have heart problems;
• if you suffer from high blood pressure (hypertension);
• if you suffer from reduced oxygen levels in the blood (hypoxemia);
• if you have overactive thyroid (hyperthyroidism);
• if you have long-standing disease causing enlargement of the right ventricle of the heart (chronic cor pulmonale);
• if you have long-standing reduced heart function (congestive heart failure);
• if you suffer from stomach ulcer (peptic ulcer);
• if you have severe kidney or liver disease.

Blood levels of aminophylline may be increased if any of the following conditions apply to you:

• if you are over 60 years of age or if the person to be administered the medicine is a child under 1 year of age (see section “Children”);
• if you have reduced ability of the heart to pump blood (congestive heart failure);
• if you suffer from chronic diseases causing pulmonary obstruction;
• if you currently have an infection;
• if you have fever equal to or above 39°C for 24 hours or more, or lower temperatures for longer periods;
• if you have reduced thyroid function (hypothyroidism);
• if you suffer from liver diseases such as cirrhosis or acute hepatitis (liver inflammation);
• if you have fluid accumulation in the lungs (edema);
• if you suffer from widespread infection throughout the body (sepsis);
• shock;
• if you are concurrently taking certain medicines.

In these cases, your doctor will monitor your blood levels of aminophylline, bearing in mind that the therapeutic range is 10–15 µg/ml and the minimum toxic level is 20 µg/ml.
Children
AMINOFILLINA S.A.L.F. must be administered with extreme caution in children, according to the dosage reported in this leaflet (see section “Warnings and precautions”).
Other medicines and AMINOFILLINA S.A.L.F.
Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicine.
Use particular caution and inform your doctor if you are taking the following medicines, as they may either decrease the blood levels of aminophylline and thus reduce its effectiveness, or increase aminophylline blood levels and make it toxic:

• medicines used for heart conditions such as adenosine, sulfinpyrazone, propafenone, propranolol, diltiazem, amiodarone, isoproterenol, and mexiletine;
• medicines used as sedatives belonging to the barbiturate group such as butalbital and phenobarbital;
• medicines used to treat high blood pressure such as felodipine, nifedipine, and verapamil;
• medicines used to increase urine production (diuretics) such as furosemide;
• medicines used for epilepsy such as carbamazepine, phenytoin, and primidone;
• medicines used against bacterial, fungal, viral, or other parasitic infections such as isoniazid, rifapentine, rifampicin, ritonavir, pipemidic acid, albendazole, clarithromycin, clindamycin, josamycin, lincomycin, macrolides, enoxacin, erythromycin, fluoroquinolones, troleandomycin, telithromycin, imipenem, peginterferon alfa-2b, and interferons (alfa-2a, alfa-2b);
• medicines used as muscle relaxants such as pancuronium;
• medicines used for respiratory problems such as terbutaline;
• medicines used to regulate blood clotting such as ticlopidine and pentoxifylline;
• medicines used to reduce inflammation and pain such as rofecoxib;
• medicines used for depression such as paroxetine, bupropion, and fluvoxamine;
• medicines used for stomach acidity such as cimetidine and ranitidine;
• medicines used for uric acid accumulation (gout) such as allopurinol;
• medicines used in substance dependence disorders such as disulfiram;
• medicines used for bone weakness (osteoporosis) such as ipriflavone;
• oral medicines used to prevent pregnancy (oral contraceptives);
• medicines used in a nervous system disease called amyotrophic lateral sclerosis such as riluzole;
• medicines used in certain tumors such as anagrelide and methotrexate;
• preparations containing substances derived from a plant called St. John's wort (Hypericum perforatum); in such cases, aminophylline blood levels should be monitored and intake of St. John's wort discontinued, as it reduces the effect of aminophylline. Upon discontinuation of Hypericum perforatum, aminophylline blood levels may increase; dose adjustment of aminophylline may be necessary;
• influenza vaccine. Cigarette smoking and cannabis use may also interfere with the effectiveness of aminophylline. Use particular caution and inform your doctor if you are taking the following medicines, as aminophylline may reduce their effectiveness or make them toxic:
• medicines used as mood modulators such as lithium carbonate;
• medicines used for heart conditions such as digitalis derivatives and sympathomimetic amines (e.g. increased central nervous system, stomach, and intestinal toxicity of epinephrine);
• medicines used as local anesthetics such as ropivacaine;
• medicines used as general anesthetics such as ketamine (lowered seizure threshold) and halothane (increased cardiac toxicity);
• medicines used to regulate the immune system such as tacrolimus;
• medicines used as tranquilizers such as benzodiazepines.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor, pharmacist, or nurse before using this medicine.
Your doctor will prescribe AMINOFILLINA S.A.L.F. during pregnancy only if asthma poses a serious risk to the mother, although no negative effects of aminophylline on fetal development have been observed.
AMINOFILLINA S.A.L.F. must not be administered during breastfeeding.
Driving and using machines
AMINOFILLINA S.A.L.F. does not affect the ability to drive or operate machinery.

3. How to use AMINOFILLINA S.A.L.F.

This medicine must be administered strictly according to the instructions given by your doctor, pharmacist, or nurse. If you have any doubts, consult your doctor, pharmacist, or nurse.

Use in adults
Treatment is reserved for cases of severe bronchial asthma.
In any case, intravenous administration of the product must be carried out slowly (15–20 minutes), with the patient kept in a lying position.
The infusion solution is prepared by diluting 480 mg of aminophylline (equivalent to 2 vials of 240 mg/10 ml) in 50 ml of a compatible infusion solution (e.g. physiological saline, glucose solution).
The infusion rate must not exceed 3.6 ml/min (equivalent to 25 mg of aminophylline/min).
The total administered dose must not exceed 0.8 ml/kg (equivalent to 5.6 mg of aminophylline/kg).
This infusion may be followed by a maintenance infusion, prepared by diluting 240 mg of aminophylline (equivalent to 1 vial of 240 mg/10 ml) in 500 ml of an infusion solution (see above).
The maintenance infusion rate will be:

• 1.9 ml/kg/hour (equivalent to 0.9 mg of aminophylline/kg/hour) in adults under 50 years of age who are smokers;
• 0.9 ml/kg/hour (equivalent to 0.45 mg of aminophylline/kg/hour) in adults under 50 years of age who are non-smokers;
• 0.5 ml/kg/hour (equivalent to 0.25 mg of aminophylline/kg/hour) in adults with cardiac failure or hepatic impairment.

Use in children
The recommended dose in children under 9 years of age is 1 mg/kg/hour.
The solution must not be administered if a deposit of material (crystals) is observed at the bottom of the container.

If you use more AMINOFILLINA S.A.L.F. than you should
Doses exceeding the recommended amount may initially cause: agitation, tremor, confusion, vomiting, and increased heart rate (tachycardia). Later symptoms may include: vomiting with blood (haematemesis), seizures, irregular heart rhythm (cardiac arrhythmia), and fever.
The first signs of poisoning may be: generalized tonic-clonic seizures affecting various parts of the body, and irregular heart rhythm (ventricular arrhythmias).
In case of overdose, to counteract central nervous system toxic effects, the doctor may administer sedatives such as diazepam, ensure adequate ventilation, monitor blood pressure, and rehydrate the patient.
In case of accidental ingestion or administration of an excessive dose of AMINOFILLINA S.A.L.F., contact your doctor immediately or go to the nearest hospital.

If you forget to use AMINOFILLINA S.A.L.F.
Do not administer a double dose to make up for the missed dose.
If you have any doubts about how to use this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
The following side effects may occur:
Not known (frequency cannot be estimated from the available data)

• disturbances in heart contraction (atrial fibrillation), irregular slowing of the heart rate (bradyarrhythmia) in case of rapid administration, ineffectiveness or absence of heart activity (cardiac arrest), heightened perception of one's own heartbeat (palpitations), temporary loss of consciousness due to reduced blood flow to the brain (syncope), irregular rapid heartbeat (tachyarrhythmia);
• severe skin and mucous membrane damage (Stevens-Johnson syndrome);
• increased urinary excretion of free cortisol, decreased levels of triiodothyronine (thyroid hormones), decreased levels of proteins in the blood (hypoproteinemia), increased blood glucose, increased uric acid levels, changes in cholesterol and triglyceride levels (lipid abnormalities);
• headache (cephalalgia), tremors, insomnia, bleeding and accumulation of blood within the skull (intracranial hemorrhage), dizziness, seizures, stuttering, irritability, depression, anxiety, agitation;
• increased need to urinate (increased diuresis).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your
doctor or nurse. You may also report side effects directly through the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store AMINOFILLINA S.A.L.F.

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after "EXP.". The expiry date refers to the
last day of that month. The expiry date applies to the medicine in its original, unopened packaging,
correctly stored.
Keep in the original packaging to protect the medicine from light.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose
of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What AMINOFILLINA S.A.L.F. contains
AMINOFILLINA S.A.L.F. 240 mg/10 ml injectable solution for intravenous use

• The active substance is aminophylline. Each 10 ml vial contains Theophylline - ethylenediamine equivalent to 240 mg of Aminophylline dihydrate.
• The other component is: water for injections.

Description of the appearance of AMINOFILLINA S.A.L.F. and contents of the pack
AMINOFILLINA S.A.L.F. is presented as an injectable solution for intravenous use.
AMINOFILLINA S.A.L.F. 240 mg/10 ml injectable solution
Pack containing 5 vials of 10 ml.
Pack containing 100 vials of 10 ml.
Marketing Authorization Holder and Manufacturer
S.A.L.F. S.p.A. Laboratorio Farmacologico – Via Marconi, 2 - Cenate Sotto (BG) - Tel. 035 - 940097