Efedrine Hydrochloride Altan 10 mg/ml Injectable Solution

2. Before using Ephedrine Hydrochloride Altan 10 mg/ml, injectable solution

Do not use EPHEDRINE HYDROCHLORIDE ALTAN 10 mg/ml injectable solution if:

• If you are allergic (hypersensitive) to the active ingredient or any of the other components of EPHEDRINE HYDROCHLORIDE ALTAN
• 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 closed-angle glaucoma.
• In combination with halogenated anesthetic medicines

Be especially careful with EPHEDRINE HYDROCHLORIDE ALTAN 10 mg/ml injectable solution if:

• 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 control test.

Use of other medicines:

Tell your doctor or pharmacist if you are using or have recently used any other medicine, including those obtained without a prescription, homeopathic medicines, herbal remedies, 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 medicines:

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

Pregnancy:

Consult your doctor or pharmacist before using any medicine.

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

Breastfeeding:

Consult your doctor or pharmacist before using any medicine.

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

Important information about some of the components of EPHEDRINE HYDROCHLORIDE ALTAN 2 mg/ml injectable solution:

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

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

Follow exactly the administration instructions of EPHEDRINE HYDROCHLORIDE ALTAN 10 mg/ml injectable solution indicated by your doctor

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.

Adults

The dose is 10 to 25 mg, intravenously repeated every 5 to 10 minutes, depending on needs. The total dose should be less than 150 mg every 24 hours.

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

Renal insufficiency

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

If you receive more EPHEDRINE HYDROCHLORIDE ALTAN 10 mg/ml injectable solution than you should:

This medicine will be administered to you 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 for you to receive symptomatic treatment

4. Possible adverse effects

Like all medicines, EPHEDRINE HYDROCHLORIDE ALTAN can cause adverse effects, although not all people will experience them.

Psychiatric disorders:

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

Nervous system disorders:

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

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

Cardiac disorders:

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

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

Respiratory and mediastinal disorders

Frequent (may affect up to one in 10 patients): breathing difficulties.

Gastrointestinal disorders:

Frequent (may affect up to one in 10 patients): nausea, vomiting, and stomach mouth 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

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

Other adverse effects:

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

If you consider that any of the adverse effects you are suffering from is serious or if you notice any adverse effect not mentioned in the leaflet, inform your doctor or pharmacist.

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

Keep EPHEDRINE HYDROCHLORIDE ALTAN out of the reach and sight of children.

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

Expiration date:

Do not use EPHEDRINE HYDROCHLORIDE ALTAN after the expiration date stated on the packaging. The expiration 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 the packaging and medicines you no longer need. This will help protect the environment.

6. Additional information

Composition of EPHEDRINE HYDROCHLORIDE ALTAN:

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

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

Appearance of the product and packaging contents:

EPHEDRINE HYDROCHLORIDE 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.

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:

Altan Pharmaceuticals S.A.

Poligono Industrial s/nº

Bernedo 01118 Spain

This leaflet was approved in: June 2011