PATIENT INFORMATION LEAFLET

Efedrine Hydrochloride Altan 3 mg/ml Injectable Solution

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

It is indicated for the treatment of a drop in blood pressure during anesthesia.

Do not use Hydrochloride of Ephedrine Altan 3 mg/ml:

• if you are allergic (hypersensitive) to the active ingredient or to any of the other components of this medication (listed in section 6).
• in association with medications called sympathomimetics.
• if you are being treated with monoamine oxidase inhibitors (MAOIs) in the last two weeks
• if you have thyroid disorders.
• if you have severe cardiovascular diseases.
• if you have closed-angle glaucoma.
• in association with halogenated anesthetics

Warnings and precautions

Be especially careful with Hydrochloride of Ephedrine Altan 3mg/ml:

• if you have severe cardiovascular diseases such as ischemia, arrhythmia, or tachycardia
• if you have problems related to blood vessels, such as arteriosclerosis, hypertension, and aortic aneurysm
• if you have diabetes
• if you have problems with the prostate.
• if you have muscle weakness disorders.
• if you have untreated hypercalcemia
• You should know that there is a risk of physical dependence on this medication.
• It is reported to athletes that this medication contains a component that may establish a positive analytical result for doping control.

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

Use of Hydrochloride of Ephedrine Altan 3mg/ml with other medications:

Inform your doctor or pharmacist about what you are using, have used recently, or may need to use any other medication.

Inform your doctor if you are taking any of the following medications:

Pregnancy and lactation

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

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

Hydrochloride of Ephedrine Altan should not be administered to women in lactation. If considered necessary, lactation may be suppressed.

Driving and operating machinery

No data is available on the ability to drive and operate machinery

Hydrochloride of Ephedrine Altan 3 mg/mlcontains sodium chloride.The patients with low-sodium diets should note that this medication contains 33.2 mg (1.4 mmol) of sodium per ampoule.

Follow exactly the administration instructions of this medication contained in this leaflet or those indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

This medication must be used only under the responsibility of an anesthesiologist.

This medication is administered via intravenous route.

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 according to response.

Use in Adults

The dose is 3 to 6 mg (maximum 9 mg) via intravenous route, repeated every 3 to 4 minutes, according to needs. The total dose must not exceed 150 mg per 24 hours.

The absence of efficacy must reconsider the choice of treatment.

Renal Insufficiency

The usual dose can be administered in patients with mild renal insufficiency, although due to the characteristics of the substance, hydrochloride of ephedrine should be avoided in patients with moderate to severe renal insufficiency or undergoing dialysis.

If you receive more Hidrocloruro de Efedrina Altan 3mg/ml than you should

If you receive more Hidrocloruro de Efedrina Altan 3mg/ml Injectable Solution than you should: This medication will be administered by a healthcare professional, so it is unlikely that you will receive more medication than you should.

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

In case of overdose, symptomatic treatment may be necessary.

Like all medications, Altan Hydrochloride Ephedrine may produce adverse effects, although not all people may experience them

Mental Health Disorders:

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

Nervous System Disorders:

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

At high doses: dizziness, mental impairment, confused state, drowsiness, tremor, increased reflexes.

Cardiac Disorders:

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

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

Respiratory and Mediastinal Disorders

Common (may affect more thanat least 1 in 10 patients): difficulty breathing.

Gastrointestinal Disorders:

Common (may affect up to 1 in 1000 patients):nausea, vomiting, and stomach 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

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

Other Adverse Effects:

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

If you experience adverse effects, consult your doctor or pharmacist, even if they do not appear in this prospectus.

Keep this medicationout of the sight and reach of children.

This medication does not require any special conditions for conservation.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not use this medication if you observe particles within the solution.

Medications should not be disposed of through drains or in the trash. If in doubt, ask your pharmacist how to dispose of the packaging and medications that you no longer need. By doing so, you will help protect the environment.

Composition of Hydrochloride of Ephedrine Altan:

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

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

Appearance of the product and contents of the packaging:

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

Each package contains 10 ampoules of 10 ml.

Holder of the marketing authorization and responsible for manufacturing:

Holder of the marketing authorization:

Altan Pharmaceuticals, S.A.

C/ Cólquide, Nº 6, Portal 2, 1st Floor, Office F. Edificio Prisma

The Rozas, 28230 Madrid

Spain

Responsible for manufacturing:

LABORATOIRE RENAUDIN

Z A. Errobi

ITXASSOU, 64250 CAMBO LES BAINS France

Last review date of this leaflet: January 2013

Detailed and updated information on this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.es/