Package leaflet: Information for the user

AMINOFILLINA MONICO

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 because it contains important information for you.

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

Contents of this leaflet:

What AMINOFILLINA MONICO is and what it is used for
What you need to know before using AMINOFILLINA MONICO
How to use AMINOFILLINA MONICO
Possible side effects
How to store AMINOFILLINA MONICO
Contents of the pack and other information

1. What AMINOFILLINA MONICO is and what it is used for

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

2. What you need to know before using AMINOFILLINE MONICO

Do not use AMINOFILLINE MONICO

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 that of aminophylline (xanthine derivatives) or if you are being treated with them;
if you suffer from severe heart problems (acute myocardial infarction);
if you suffer from low blood pressure (hypotensive states);
if you are breastfeeding.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before receiving AMINOFILLINE MONICO.
Aminophylline must not be administered simultaneously with other xanthine preparations (substances with a structure similar to aminophylline). AMINOFILLINE MONICO must be administered with caution together with ephedrine or other substances used to dilate the bronchi (sympathomimetic bronchodilators).
Exercise particular caution and inform your doctor if you are taking medicines for epilepsy (antiepileptics) such as phenytoin, or if you smoke cigarettes, as it may be necessary to increase the dose of aminophylline (see section “Other medicines and AMINOFILLINE MONICO”), since in these cases the blood levels of the medicine may decrease.
AMINOFILLINE MONICO 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 pulmonary heart disease);
if you have long-standing reduced heart function (congestive heart failure);
if you suffer from stomach ulcer (peptic ulcer);
if you suffer from severe kidney or liver disease.

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

if you are over 60 years of age or if the person to receive the medicine is a child under 1 year of age (see section “Children and elderly”);
if you have reduced ability of the heart to pump blood (congestive heart failure);
if you suffer from chronic diseases causing pulmonary obstruction;
infections;
if you have fever with temperature equal to or above 39°C for 24 hours or more, or with temperatures below 39°C 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 lung (edema);
if you suffer from systemic infection throughout the body (sepsis);
shock;
if you are taking certain medicines at the same time. In these cases, monitoring of aminophylline blood levels is recommended, bearing in mind that the therapeutic range is 10–15 µg/ml and the minimum toxic level is 20 µg/ml.

Cigarette smoking and cannabis use may also interfere with the effectiveness of aminophylline.
Children and elderly
AMINOFILLINE MONICO must be administered with extreme caution in children and elderly patients, and according to the dosage specified in this leaflet (see section “Warnings and precautions”).
Other medicines and AMINOFILLINE MONICO
Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicine.
Exercise particular caution and inform your doctor if you are taking the following medicines, as they may either reduce 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, isoprenaline, and mexiletine;
medicines used as sedatives belonging to the barbiturate group such as butalbital and phenobarbital;
medicines for 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 addiction 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 disorder called amyotrophic lateral sclerosis such as riluzole;
medicines used in certain tumors such as anagrelide and methotrexate;
herbal preparations containing substances derived from St. John’s wort (Hypericum perforatum); in such cases, aminophylline blood levels should be monitored and 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.

Exercise 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 stabilizers 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 sedatives such as benzodiazepines.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor, pharmacist, or nurse before using this medicine.
The use of AMINOFILLINE MONICO during pregnancy should be limited to cases where asthma poses a serious risk to the mother, although no negative effects of aminophylline on fetal development have been observed.
AMINOFILLINE MONICO must not be administered during breastfeeding.
Driving and using machines
AMINOFILLINE MONICO does not impair the ability to drive or use machinery.

3. How to use AMINOFILLINA MONICO

This medicine must always be administered exactly as directed 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 performed slowly (15–20 minutes), with the patient kept in a lying position.

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 MONICO than you should
When doses higher than those recommended are administered, initial symptoms may include: restlessness, tremor, confusion, vomiting, and increased heart rate (tachycardia). Later symptoms may include: vomiting with blood traces (haematemesis), seizures, irregular heart rhythm (cardiac arrhythmia), and fever.
The first signs of intoxication may be: generalized tonic-clonic seizures involving 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, use methods to ensure adequate respiration, monitor blood pressure, and rehydrate the patient.
In case of accidental ingestion or intake of an excessive dose of AMINOFILLINA MONICO, contact your doctor immediately or go to the nearest hospital.

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

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody gets them.
The following adverse reactions 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 awareness 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 levels of uric acid, 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 adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, please consult your doctor or pharmacist. You may also report adverse reactions directly through the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. By reporting adverse reactions, you can help provide further information on the safety of this medicine.

5. How to store AMINOFILLINA MONICO

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 kept in its original, undamaged packaging and
correctly stored.
Store 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 no longer used. This will help protect the environment.

6. Package contents and other information

What AMINOFILLINA MONICO contains
AMINOFILLINA MONICO 240 mg/10 ml injectable solution for intravenous use

The active substance is aminophylline. Each 10 ml vial contains 240 mg of aminophylline.
The other component is: water for injections.

Description of the appearance of AMINOFILLINA MONICO and contents of the pack
AMINOFILLINA MONICO is available as an injectable solution for intravenous use.
AMINOFILLINA MONICO 240 mg/10 ml injectable solution
The pack contains 5 vials of 10 ml each.
Marketing Authorization Holder and Manufacturer
MONICO SPA – Via Ponte di Pietra 7, 30173 – VENEZIA/MESTRE - Italy