Efedrine Hydrochloride Altan 3mg/ml Injectable Solution

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Ephedrine Hydrochloride Altan 3 mg/ml Solution for injection

Contents of the package leaflet:

1. What is Ephedrine Hydrochloride Altan 3mg/ml and what is it used for.
2. What you need to know before you start using Ephedrine Hydrochloride Altan 3mg/ml
3. How to use Ephedrine Hydrochloride Altan 3mg/ml
4. Possible side effects.
5. Storage of Ephedrine Hydrochloride Altan 3mg/ml
6. Package contents and additional information.

1. What is Ephedrine Hydrochloride Altan 3mg/ml and what is it used for

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

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

2. What you need to know before you start using Ephedrine Hydrochloride Altan 3mg/ml

Do not use Ephedrine Hydrochloride Altan 3 mg/ml:

• if you are allergic (hypersensitive) to the active substance or to any of the other components of this medicine (included in section 6).
• In combination with medicines called sympathomimetics.
• if you are being treated with monoamine oxidase inhibitor (MAOI) medicines during the last two weeks
• if you have thyroid gland disorders.
• if you have severe cardiovascular diseases.
• if you have narrow-angle glaucoma.
• In combination with halogenated anesthetic medicines

Warnings and precautions

Be particularly careful with Ephedrine Hydrochloride Altan 3mg/ml:

• if you have severe cardiovascular disorders such as ischemia, arrhythmia, or tachycardia
• if you have blood vessel problems, such as arteriosclerosis, hypertension, and aortic aneurysm
• if you have diabetes
• if you have prostate problems.
• if you have muscle weakness disorders.
• if you have untreated hyperkalemia
• You should know that there is a risk of physical dependence on this medicine.
• Athletes are informed that this medicine contains a component that may result in a positive doping test.

Consult your doctor or pharmacist before starting to use Ephedrine Hydrochloride Altan 3mg/ml

Using Ephedrine Hydrochloride Altan 3mg/ml with other medicines:

Tell your doctor or pharmacist what you are using, have recently used, or may need to use any other medicine.

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
• Inhalation anesthetics.
• Cardiac glycosides
• Parasympatholytics: atropine

Pregnancy and breastfeeding

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

Ephedrine Hydrochloride Altan should not be administered during pregnancy except in cases of absolute necessity.

Ephedrine Hydrochloride Altan should not be administered to breastfeeding women. If considered appropriate, breastfeeding may be suppressed.

Driving and using machines

No data are available on the ability to drive and use machinery

Ephedrine Hydrochloride Altan 3 mg/mlcontains sodium chloride.Patients on low-sodium diets should note 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 of this medicine contained in this package leaflet or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

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

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 pediatric dose is 0.5 to 0.75 mg/kg or 17-25 mg/m2 every 3-4 minutes depending on the response.

Use in Adults

The dose is 3 to 6 mg (maximum 9 mg) intravenously, repeated every 3 to 4 minutes, depending on needs. The total dose should not exceed 150 mg every 24 hours.

Lack of efficacy should lead to reconsideration of the treatment choice.

Renal impairment

The usual dose can be administered in patients with mild renal impairment, although 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 moreEphedrine Hydrochloride Altan 3mg/mlthan you should

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

In case of accidental overdose, consult the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount administered.

In case of overdose, it may be necessary to receive symptomatic treatment

4. Possible side effects

Like all medicines, Ephedrine Hydrochloride Altan can cause side effects, although not everybody gets them

Psychiatric disorders:

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

Nervous system disorders:

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

At high doses: dizziness, mental impairment, confusion, somnolence, tremor, increased reflexes.

Cardiac disorders:

Frequent (may affect up to 1 in 1000 patients): palpitations and tachycardia, chest pain.

Rare (may affect up to 1 in 1000 patients): cardiac rhythm problems and angina pectoris.

Respiratory, thoracic, and mediastinal disorders

Frequent (may affect more than 1 in 10 patients): breathing difficulties.

Gastrointestinal disorders:

Frequent (may affect up to 1 in 1000 patients): nausea, vomiting, and stomach mouth problems.

Renal and urinary disorders:

Rare (may affect up to 1 in 1000 patients): urinary retention in patients with prostate problems.

General disorders and administration site conditions

Frequent (may affect up to 1 in 10 patients): fever or feeling of heat, sweating, dryness of the nose and pharynx, paleness.

Other side effects:

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

If you experience side effects, consult your doctor or pharmacist, even if it is a side effect not listed in this package leaflet.

5. Storage of Ephedrine Hydrochloride Altan 3mg/ml

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

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Do not use this medicine if you notice particles inside the solution.

Medicines should not be disposed of via wastewater or household waste. In case of doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package contents and additional information

Composition of Ephedrine Hydrochloride Altan:

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

The other components (excipients) are: sodium chloride, sodium citrate, citric acid monohydrate, and water for injectable preparations.

Appearance and package contents of the product:

Ephedrine Hydrochloride Altan is presented in glass ampoules in the form of a clear, colorless, and particle-free sterile solution for intravenous administration

Each package contains 10 ampoules of 10 ml.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Altan Pharmaceuticals, S.A.

C/ Cólquide, Nº 6, Portal 2, 1ª Planta, Oficina F. Edificio Prisma

Las Rozas, 28230 Madrid

Spain

Manufacturer:

LABORATOIRE RENAUDIN

Z A. Errobi

ITXASSOU, 64250 CAMBO LES BAINS France

Date of the last revision of this package leaflet: January 2013

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/