EFEDRINE HYDROCHLORIDE ALTAN

10 mg/ml, Injectable Solution

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

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

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

• You are allergic (hypersensitive) to the active ingredient or to any of the other components of HYDROCHLORIDE EFEDRINE ALTAN
• You are taking medications called sympathomimetics.
• You have been taking monoamine oxidase inhibitors (MAOIs) in the last two weeks
• You have thyroid disorders.
• You have severe cardiovascular diseases.
• You have closed-angle glaucoma.
• You are taking anesthetics with halogenated compounds

Be especially careful with HYDROCHLORIDE EFEDRINE ALTAN 10 mg/ml Injectable Solution if:

• You have severe cardiovascular diseases such as ischemia, arrhythmia, or tachycardia
• You have vascular problems, such as arteriosclerosis, hypertension, and aortic aneurysm
• You have diabetes
• You have prostate problems.
• You have muscle weakness disorders.
• 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 result in a positive analytical test for doping control.

Use of other medications:

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

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

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

Pregnancy:

Consult your doctor or pharmacist before using any medication.

HYDROCHLORIDE EFEDRINE ALTAN should not be administered during pregnancy except in cases of absolute necessity.

Lactation:

Consult your doctor or pharmacist before using any medication.

HYDROCHLORIDE EFEDRINE ALTAN should not be administered to women in the lactation phase. If considered necessary, breastfeeding may be suppressed.

Driving and operating machinery:

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

Important information about some of the components of HYDROCHLORIDE EFEDRINE ALTAN 2 mg/ml Injectable Solution:

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

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

This medication should 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

Adults

The dose is 10 to 25 mg, administered intravenously repeated every 5 to 10 minutes, as needed. The total dose should be less than 150 mg per 24 hours.

The absence of efficacy should make 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, efedrine hydrochloride should be avoided in patients with moderate to severe renal insufficiency or undergoing dialysis

If you receive more Altan Efedrina Hydrochloride 10 mg/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, HYDROCHLORIDE EFEDRINE ALTAN can produce adverse effects, although not all people may experience them.

Mental health disorders:

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

Nervous system disorders:

Common (may affect up to one 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 dullness, confusional state, drowsiness, tremor, increased reflexes.

Cardiac disorders:

Common (may affect up to one in 10 patients): palpitations and tachycardia, chest pain.

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

Respiratory and mediastinal disorders

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

Gastrointestinal disorders:

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

Renal and urinary disorders:

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

General disorders and administration site conditions

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

If you consider that any of the adverse effects you are experiencing are severe or if you notice any adverse effect not mentioned in the prospectus, inform your doctor or pharmacist.

Keep Efedrina Altan Hydrochloride out of the reach and sight of children.

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

Expiration Date:

Do not use Efedrina Altan Hydrochloride after the expiration date appearing on the packaging. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through the drains or in the trash. Ask your pharmacist how to dispose of the packaging and medicines that you no longer need. This will help protect the environment.

Composition of HYDROCHLORIDE OF EFEDRINE ALTAN:

The active ingredient is hydrochloride of ephedrine. Each milliliter contains 10 mg of hydrochloride of ephedrine (50 mg/ampoule of 5 ml).

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

Appearance of the product and contents of the package:

HYDROCHLORIDE OF EFEDRINE 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 5 ml.

Manufacturer:

Altan Pharmaceuticals, S.A.

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

The Rozas, 28230 Madrid

Spain

Responsible for manufacturing:

Altan Pharmaceuticals S.A.

Industrial Polygon s/nº

Bernedo 01118 Spain

This prospectus has been approved in: June 2011