EPHEDRINE HYDROCHLORIDE ALTAN 3 MG/ML SOLUTION FOR INJECTION

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Ephedrine Hydrochloride Altan 3 mg/ml Injection Solution

Contents of the leaflet:

1. What Ephedrine Hydrochloride Altan 3 mg/ml is and what it is used for.
2. What you need to know before using Ephedrine Hydrochloride Altan 3 mg/ml
3. How to use Ephedrine Hydrochloride Altan 3 mg/ml
4. Possible side effects.
5. How to store Ephedrine Hydrochloride Altan 3 mg/ml
6. Contents of the pack and other information.

1. What Hidrocloruro de Efedrina Altan 3mg/ml is and what it is used for

Ephedrine hydrochloride belongs to a group of medicines called alpha and beta adrenergic receptor agonists.

It is indicated for the treatment of low blood pressure occurring during anaesthesia.

2. What you need to know before using Hidrocloruro de Efedrina Altan 3 mg/ml

Do not use Hidrocloruro de Efedrina Altan 3 mg/ml:

• if you are allergic (hypersensitive) to the active substance or to any of the other components of this medicine (listed in section 6).
• in combination with drugs known as sympathomimetics.
• if you are being treated with monoamine oxidase inhibitors (MAOIs) within the last two weeks.
• if you have thyroid gland disorders.
• if you have severe cardiovascular diseases.
• if you have closed-angle glaucoma.
• in combination with halogenated anesthetic agents.

Warnings and precautions

Exercise special caution with Hidrocloruro de Efedrina Altan 3 mg/ml:

• if you have severe cardiovascular disorders such as ischemia, arrhythmia, or tachycardia.
• if you suffer from blood vessel-related conditions, such as arteriosclerosis, hypertension, or aortic aneurysm.
• if you have diabetes.
• if you have prostate problems.
• if you have disorders related to muscle weakness.
• if you have untreated hyperkalemia.
• You should be aware that there is a risk of physical dependence on this medicine.
• Athletes should be informed that this medicine contains a component that may lead to a positive result in doping control tests.

Consult your doctor or pharmacist before starting to use Hidrocloruro de Efedrina Altan 3 mg/ml.

Use of Hidrocloruro de Efedrina Altan 3 mg/ml with other medicines:

Inform your doctor or pharmacist about any other medicines you are taking, have recently taken, or might need to take.

Tell your doctor if you are taking any of the following medicines:

• Sympathomimetics.
• Antidepressants: monoamine oxidase inhibitors (MAOIs).
• Antihypertensives: methyldopa, reserpine, diuretics, and alpha- and beta-blockers.
• Inhalational anesthetics.
• Cardiac glycosides.
• Parasympatholytics: atropine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you might be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Hidrocloruro de Efedrina Altan must not be administered during pregnancy except in cases of absolute necessity.

Hidrocloruro de Efedrina Altan must not be administered to women who are breastfeeding. If deemed appropriate, breastfeeding may be discontinued.

Driving and use of machines

There are no data available regarding the ability to drive or operate machinery.

Hidrocloruro de Efedrina Altan 3 mg/ml contains sodium chloride. Patients on a low-sodium diet should take into account that this medicine contains 33.2 mg (1.4 mmol) of sodium per ampoule.

3. How to use Ephedrine Hydrochloride Altan 3mg/ml

Follow exactly the administration instructions for this medicine provided in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

This medicine should be used only by or under the responsibility of an anaesthesiologist.

This medicine is administered intravenously.

Your doctor will administer the appropriate dose and determine the duration of treatment.

Use in children under 12 years

The paediatric dose is 0.5 to 0.75 mg/kg or 17–25 mg/m² every 3–4 minutes, depending on response.

Use in Adults

The dose is 3 to 6 mg (maximum 9 mg) intravenously, repeated every 3 to 4 minutes as needed. The total daily dose must not exceed 150 mg in 24 hours.

Lack of efficacy should prompt reconsideration of the choice of treatment.

Renal impairment

The usual dose may be administered in patients with mild renal impairment; however, due to the characteristics of the substance, ephedrine hydrochloride should be avoided in patients with moderate to severe renal impairment or those undergoing dialysis.

If you receive more Ephedrine Hydrochloride Altan 3mg/ml than you should

If you receive more Ephedrine Hydrochloride Altan 3mg/ml Injection Solution than you should: This medicine will be administered by a healthcare professional, so it is unlikely that you will receive more than the intended dose.

In case of accidental overdose, contact the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount administered.

In the event of overdose, symptomatic treatment may be necessary.

4. Possible adverse effects

Like all medicines, Efedrina Hydrochloride Altan may cause adverse effects, although not everyone will experience them.

Psychiatric disorders:

Frequent (may affect more than 1 in 10 patients): confusion, anxiety, depression, delirium, hallucinations, and mood disturbances.

Nervous system disorders:

Frequent (may affect up to 1 in 10 patients): nervousness, feeling of tension, agitation, excited state, restlessness, increased irritability, increased speech, fatigue, and insomnia, headache.

At high doses: dizziness, mental dullness, confusional state, somnolence, tremor, increased reflexes.

Cardiac disorders:

Frequent (may affect up to 1 in 1,000 patients): palpitations and tachycardia, chest pain.

Rare (may affect up to 1 in 1,000 patients): heart rhythm problems and angina pectoris.

Respiratory and mediastinal disorders:

Frequent (may affect more than at least 1 in 10 patients): breathing difficulty.

Gastrointestinal disorders:

Frequent (may affect up to 1 in 1,000 patients): nausea, vomiting, and stomach discomfort.

Renal and urinary disorders:

Rare (may affect up to 1 in 1,000 patients): urinary retention in patients with prostate problems.

General disorders and administration site reactions:

Frequent (may affect up to 1 in 10 patients): fever or sensation of heat, sweating, nasal and pharyngeal dryness, pallor.

Other adverse effects:

Very rare (may affect up to 1 in 10,000 patients): fluid accumulation, inflammation of the heart muscle, heart hemorrhages, destruction of intestinal, liver, and kidney tissue.

If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.

5. Storage of Ephedrine Hydrochloride Altan 3 mg/ml

Keep this medicine out of the sight and reach of children.

This medicine requires no special storage conditions.

Do not use this medicine after the expiry date stated on the container after EXP. The expiry date refers to the last day of the month indicated.

Do not use this medicine if you observe particles in the solution.

Medicines must not be disposed of via wastewater or household waste. If you are unsure how to dispose of unused medicines or their packaging, please consult your pharmacist. This will help protect the environment.

6. Contents of the pack and other information

Composition of Hidrocloruro de Efedrina Altan:

The active substance is ephedrine hydrochloride. Each millilitre contains 3 mg of ephedrine hydrochloride (30 mg/10 ml ampoule).

The other components (excipients) are: Sodium chloride, Sodium citrate, Citric acid monohydrate, and water for injections.

Nature of the product and contents of the container:

Hidrocloruro de Efedrina Altan is presented in glass ampoules as a sterile, clear, colourless solution free from particles, for intravenous administration.

Each pack contains 10 ampoules of 10 ml.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Altan Pharmaceuticals, S.A.

C/ Cólquide, Nº 6, Portal 2, 1st Floor, Office F. Edificio Prisma
Las Rozas, 28230 Madrid
Spain

Manufacturer:

LABORATOIRE RENAUDIN
Z A. Errobi
ITXASSOU, 64250 CAMBO LES BAINS
France

Date of the most recent revision of this leaflet: January 2013

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.es/