Isoprenaline hydrochloride S.A.L.F.
Italy
Table of Contents
Package leaflet: Information for the user
ISOPRENALINE HYDROCHLORIDE S.A.L.F. 0.2 mg/ml injection solution
Isoprenaline hydrochloride
Equivalent medicine
Please read this leaflet carefully before using this medicine 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 or pharmacist.
- 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 adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contents of this leaflet:
- What ISOPRENALINE HYDROCHLORIDE S.A.L.F. is and what it is used for
- What you need to know before using ISOPRENALINE HYDROCHLORIDE S.A.L.F
- How to use ISOPRENALINE HYDROCHLORIDE S.A.L.F
- Possible side effects
- How to store ISOPRENALINE HYDROCHLORIDE S.A.L.F
- Contents of the pack and other information
1. What ISOPRENALINE HYDROCHLORIDE S.A.L.F. is and what it is used for
ISOPRENALINE HYDROCHLORIDE S.A.L.F. contains the active substance isoprenaline hydrochloride, which belongs to
a group of medicines called adrenergic and dopaminergic agents.
ISOPRENALINE HYDROCHLORIDE S.A.L.F. is indicated for the treatment of:
- severe heart problems such as complete atrioventricular block (including Adams-Stokes syndrome) and cardiac arrest;
- bronchoconstriction (bronchospasm) during anaesthesia;
- adjunctive treatment of cardiogenic shock.
2. What you need to know before using ISOPRENALINE HYDROCHLORIDE S.A.L.F.
Do not use ISOPRENALINE HYDROCHLORIDE S.A.L.F.:
if you are allergic to isoprenaline hydrochloride or to any of the other ingredients of this medicine
(listed in section 6);
if you have any of the following heart conditions:
chest pain caused by heart problems (angina pectoris);
problems caused by taking heart medications called digitalis (heart block and
tachycardia);
abnormal heart rhythms (tachyarrhythmias);
if the person to be treated is a child under 12 years of age;
if you are pregnant or breastfeeding (see section “Pregnancy and breastfeeding”).
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before ISOPRENALINE HYDROCHLORIDE S.A.L.F.
is administered to you.
This medicine must be administered to you with great caution if you have:
seizures;
problems affecting the blood vessels supplying the heart (coronary insufficiency);
diabetes mellitus;
excessive sensitivity to substances called sympathomimetic amines;
high blood pressure (hypertension);
thyroid problems (hyperthyroidism).
For athletes: the use of this medicine without therapeutic need constitutes doping and may lead to a positive anti-doping test.
Other medicines and ISOPRENALINE HYDROCHLORIDE S.A.L.F.
Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicine. Isoprenaline must not be administered together with the following medicines:
cardiac medications called cardioactive glycosides and anaesthetics (halothane, cyclopropane), because abnormal heart rhythms (arrhythmias) may occur;
medicines called ergot alkaloids, because isoprenaline increases their effect;
medicines for depression such as phenelzine, selegiline, and tranylcypromine, because they may increase blood pressure (hypertensive effect). If you experience symptoms of high blood pressure such as headache, irregular heartbeat, fever, or vomiting, stop treatment and inform your doctor;
entacapone, a medicine used for Parkinson’s disease, because it may cause heart problems (tachycardia, arrhythmias) and increased blood pressure;
nebivolol, a medicine used to lower blood pressure, because it may cause a severe drop in blood pressure;
theophylline, a medicine used for respiratory problems, because isoprenaline may reduce theophylline levels in the blood. In this case, your doctor may need to adjust the theophylline dose;
tolcapone, a medicine used for Parkinson’s disease, because it may increase isoprenaline levels in the blood. In this case, your doctor may need to reduce the isoprenaline dose.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning a pregnancy, or breastfeeding,
please consult your doctor, pharmacist, or nurse before this medicine is administered to you.
This medicine must not be used during pregnancy unless absolutely necessary, for example as a life-saving treatment in cardiac emergencies. Isoprenaline may cause complications during childbirth.
Use this medicine with caution if you are breastfeeding, as it is unknown whether isoprenaline passes into breast milk and there are no available data on its effects in newborns.
Driving and using machines
There are no data available to determine the effect of this medicine on the ability to drive vehicles or operate machinery.
ISOPRENALINE HYDROCHLORIDE S.A.L.F. contains
Sodium.
3. How to use ISOPRENALINE HYDROCHLORIDE S.A.L.F.
Use this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor,
pharmacist, or nurse.
Your doctor will determine the required dose according to your condition.
Treatment of serious heart problems (complete atrioventricular block, Adams-Stokes syndrome, and cardiac arrest)
- Intramuscular injection: initially 0.2 mg, then 0.02 mg up to 1 mg, depending on your condition.
- Intravenous infusion: 2–10 micrograms per minute, depending on your condition.
- Subcutaneous injection: initially 0.2 mg, then 0.15 mg up to 0.2 mg, depending on your condition.
Treatment of bronchial constriction (bronchospasm) during anesthesia
- Intravenous injection: initially 0.01–0.02 mg. May be repeated if necessary.
In addition to the treatment of cardiogenic shock
- Intravenous infusion: 0.5–5 micrograms per minute, depending on your condition. Higher doses (up to 20 micrograms per minute) may be used in more severe cases.
Use in children
This medicine is not recommended for use in children.
If you use more ISOPRENALINE HYDROCHLORIDE S.A.L.F. than you should
Symptoms of overdose may include tremors, palpitations, heart problems such as angina, arrhythmias and tachycardia, decreased or increased blood pressure, seizures, nervousness, headache, dry mouth, nausea, dizziness, fatigue, malaise, and insomnia.
In case of accidental ingestion/overdose of this medicine, seek immediate medical advice from your doctor or go to the nearest hospital.
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 may cause side effects, although not everybody gets them.
The following side effects may occur:
Not known (frequency cannot be estimated from the available data)
palpitations, changes in blood pressure, heart problems (changes in heartbeat, tachycardia, Adam-Stokes syndrome, cardiac arrest);
nausea, stomach and intestinal problems;
blood disorders (thrombocytopenia, eosinopenia);
tremors, dizziness, nervousness, drowsiness, headache, insomnia;
blurred vision;
difficulty in urination;
cough, throat irritation, bronchitis, increased mucus production, fluid accumulation in the lungs (pulmonary edema);
parotid swelling (in case of prolonged use), discoloration of saliva;
sweating, skin flushing.
Following the instructions provided in this leaflet reduces the risk of side effects.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist.
You can also report side effects directly via 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 ISOPRENALINE HYDROCHLORIDE 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 carton after "Expiry".
The expiry date refers to the last day of that month.
Store below 25°C in the original container, tightly closed, protected from light.
If exposed to air, light, or increased temperature, the solution may develop a pink to brownish-pink colour.
The solution must not be used if discoloured or if a precipitate is present.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.
6. Package contents and other information
What ISOPRENALINE HYDROCHLORIDE S.A.L.F. contains
The active substance is isoprenaline hydrochloride.
1 ml of solution contains 0.2 mg of isoprenaline hydrochloride.
The other components are:
sodium chloride
sodium edetate
sodium citrate
citric acid monohydrate
hydrochloric acid (pH adjuster)
water for injections
Description of the appearance of ISOPRENALINE HYDROCHLORIDE S.A.L.F. and contents of the pack
Pack containing 5 vials of 1 ml of injectable solution.
Marketing Authorisation Holder and Manufacturer
S.A.L.F. S.p.A. Laboratorio Farmacologico
Via Marconi, 2
24069 Cenate Sotto (BG)
Italy