Ephedrine hydrochloride Altan 10 mg/ml solution for injection

Package leaflet: Information for the user

Introduction

HIDROCLORURO DE EFEDRINA ALTAN

10 mg/ml, Injection solution

Package leaflet:

1. WHAT EFEDRINE HYDROCHLORIDE ALTAN 10 mg/ml, Injection solution IS AND WHAT IT IS USED FOR.
2. BEFORE USING EFEDRINE HYDROCHLORIDE ALTAN 10 mg/ml, Injection solution.
3. HOW TO USE EFEDRINE HYDROCHLORIDE ALTAN 10 mg/ml, Injection solution.
4. POSSIBLE SIDE EFFECTS.
5. HOW TO STORE EFEDRINE HYDROCHLORIDE ALTAN 10 mg/ml, Injection solution.
6. ADDITIONAL INFORMATION.

1. What Hidrocloruro de Efedrina Altan 10 mg/ml, injectable solution 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. Before using Ephedrine Hydrochloride Altan 10 mg/ml, injectable solution

Do not use EPHEDRINE HYDROCHLORIDE ALTAN 10 mg/ml Injectable Solution if:

• You are allergic (hypersensitive) to the active substance or to any of the other components of Ephedrine Hydrochloride Altan.
• 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 medicines.

Take special care with Ephedrine Hydrochloride Altan 10 mg/ml Injectable Solution if:

• You have severe cardiovascular disorders such as ischemia, arrhythmia, or tachycardia.
• You suffer from vascular problems such as arteriosclerosis, hypertension, or aortic aneurysm.
• You have diabetes.
• You have prostate problems.
• You have disorders related to muscle weakness.
• 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.

Use of other medicines:

Inform your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription, homeopathic remedies, herbal medicines, and other health-related products, as it may be necessary to discontinue treatment or adjust the dose of one of them.

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:

Consult your doctor or pharmacist before using any medicine.

EPHEDRINE HYDROCHLORIDE ALTAN must not be administered during pregnancy except in case of absolute necessity.

Breast-feeding:

Consult your doctor or pharmacist before using any medicine.

EPHEDRINE HYDROCHLORIDE ALTAN must not be administered to women who are breast-feeding. If considered appropriate, breastfeeding may be discontinued.

Driving and use of machines:

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

Important information about some components of Ephedrine Hydrochloride Altan 10 mg/ml Injectable Solution:

This medicine contains less than 23 mg of sodium per ampoule; hence, it is essentially sodium-free.

3. How to use Ephedrine Hydrochloride Altan 10 mg/ml, injectable solution

Follow exactly the administration instructions for Ephedrine Hydrochloride Altan 10 mg/ml injectable solution as indicated by your doctor.

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

This medicine is administered intravenously.

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

Adults

The dose is 10 to 25 mg, administered intravenously and repeated every 5 to 10 minutes as needed. The total daily dose should not exceed 150 mg in 24 hours.

Lack of efficacy should prompt reconsideration of the treatment choice.

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 10 mg/ml injectable 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 amount.

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, HIDROCLORURO DE EFEDRINA ALTAN may produce adverse effects, although not everyone experiences them.

Psychiatric disorders:

Common (may affect up to 1 in 10 patients): confusion, anxiety, depression, delirium, hallucinations, and mood disturbances.

Nervous system disorders:

Common (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, drowsiness, tremor, increased reflexes.

Cardiac disorders:

Common (may affect up to 1 in 10 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 up to 1 in 10 patients): difficulty breathing.

Gastrointestinal disorders:

Common (may affect up to 1 in 10 patients): nausea, vomiting, and stomach discomfort.

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 sensation of warmth, 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 consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

5. Storage of Ephedrine Hydrochloride Altan 10 mg/ml, injectable solution

Keep HIDROCHLORIDE OF EPHEDRINE ALTAN out of the reach and sight of children.

Do not store above 25°C. Do not freeze. Store protected from light.

Expiry:

Do not use HIDROCHLORIDE OF EPHEDRINE ALTAN after the expiry date stated on the container. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Additional information

Composition of EFEDRINE HYDROCHLORIDE ALTAN:

The active substance is ephedrine hydrochloride. Each millilitre contains 10 mg of ephedrine hydrochloride (50 mg/vial in a 5 ml ampoule).

The other components (excipients) are: sodium chloride, sodium hydroxide (for pH adjustment) and water for injections.

Appearance of the product and contents of the pack:

EFEDRINE HYDROCHLORIDE ALTAN is supplied in glass ampoules containing a sterile, clear, colourless solution free from particles, for intravenous administration.

Each pack contains 10 ampoules of 5 ml.

Marketing Authorisation Holder:

Altan Pharmaceuticals, S.A.

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

Las Rozas, 28230 Madrid

Spain

Manufacturer responsible for batch release:

Altan Pharmaceuticals S.A.

Poligono Industrial s/nº

Bernedo 01118 Spain

This leaflet was last approved in: June 2011