Package Insert: Information for the User

Efedrine 50 mg Tablets

Efedrine Hydrochloride

Read this package insert carefully before taking this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.

• This medication has been prescribed for you only, and you should not give it to others who have the same symptoms as you, as it may harm them.

• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Efedrine hydrochloride belongs to a group of medications called alpha and beta adrenergic receptor agonists, which act as bronchodilators (widen the airways in the lungs).

This medication is used to prevent and treat bronchospasm (closure of the airways in the lungs) associated with acute asthma attacks, spasmodic bronchitis, or pulmonary emphysema.

Do not take Efedrina Level

• If you are allergic to ephedrine or any of the other components of this medication (listed in section 6).

• If you have any of the following conditions:

• If you are taking or have taken medications called IMAOs (including antidepressants such astranilciprominaandmoclobemida, Parkinson's disease medications such asselegilina, anticancer medications such asprocarbazina, or antifungal medications such aslinezolid) in the past two weeks.

• If you are taking other medications called indirect sympathomimetics such as phenylpropanolamine, pseudoephedrine, methylphenidate, and phenylephrine at the same time.

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Warnings and precautions

Consult your doctor or pharmacist before starting to take Efedrina Level.

This medication should be administered with caution in patients:

• with a history of heart disease,

• with cardiovascular diseases such as arrhythmias (abnormal heart rhythm), hypertension (high blood pressure) or vascular occlusive diseases (narrowing of the arteries),
• with diabetes (high blood sugar levels),

• with urinary retention (inability or difficulty urinating),

• with benign prostatic hyperplasia (enlargement of the prostate),

• with a predisposition to glaucoma (increased intraocular pressure),

• of advanced age (see section 3 of this leaflet).

Children and adolescents

They may be more sensitive to the adverse effects, including stimulation of the central nervous system (CNS).

Taking Efedrina Level with other medications

Inform your doctor or pharmacist if you are taking, have taken recently or may take any other medication.

In particular, if you are taking any of the following medications, as it may be necessary to modify your dose and/or additional monitoring by your doctor:

• tricyclic antidepressants,

• alkalinizing agents (sodium bicarbonate, citrates),

• beta-blockers (reduce blood pressure),

• inhaled anesthetics,

• glucosides (used to treat some heart problems),

• medications for migraine such as ergotamine or metisergide,

• atropine sulfate (used in emergency situations, when the heart beats too slowly and as an antidote in some cases of poisoning),

• theophylline derivatives (used to treat asthma),

• anti-hypertensives such as guanetidina, metildopa, reserpine, alpha-blockers, furosemide or other diuretics,

• stimulants of the CNS (amphetamine, xanthines),

• dexamethasone (corticosteroid with anti-inflammatory and immunosuppressive activity).

Pregnancy and breastfeeding

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

Pregnancy

Efedrina Level should not be used during the third trimester of pregnancy unless the woman's situation requires treatment with hydrochloride of ephedrine and there are no safer therapeutic alternatives.

Breastfeeding

Ephedrine hydrochloride is excreted in breast milk. It should be decided whether to interrupt breastfeeding or interrupt treatment after considering the benefit of breastfeeding for the child and the benefit of treatment for the mother.

Driving and operating machinery

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The influence of Efedrina Level on the ability to drive and operate machinery is moderate.

In case of adverse effects, it is recommended not to drive or operate hazardous machinery.

Use in athletes

It is reported to athletes that this medication contains a component that may result in a positive test in a doping control.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose in adults is 1 tablet (50 mg of hydrochloride of ephedrine) 2 to 3 times a day. Elderly patients may need a dose adjustment.

Use in children and adolescents

The safety and efficacy of this medication have not been established in children and adolescents.

If you take more Efedrina Level than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount used.

In case of severe poisoning, the stomach should be immediately emptied by aspiration and washing.

The insomnia and other stimulant effects of ephedrine on the central nervous system may be counteracted by the administration of hypnotics.

To control excitement, sedatives such as chlorpromazine may be administered at doses of 50 or 100 mg by intramuscular route or a barbiturate.

To control tachycardia, propranolol may be administered by slow intravenous route or cardioselective beta-adrenergic blockers (e.g. acebutolol, atenolol, metoprolol) in asthmatic patients.

The elimination of ephedrine may be facilitated by acidifying the urine with ammonium chloride.

If you forgot to take Efedrina Level

Do not take a double dose to compensate for the missed doses.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

• Nervous system disorders such as: anxiety, insomnia, headache, and dizziness.

• Muscular disorders such as: tremors and muscle weakness.

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• Cardiovascular disorders such as: tachycardia and palpitations (increased heartbeats), precordial pain (chest pain) and pallor, especially in hypersensitive patients.

• Gastrointestinal disorders: nausea, vomiting, and dry mouth.

• Renal and urinary disorders: urinary retention.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaram.es.By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Store below 30 °C.

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

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

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and

the medications you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and the medications you no longer need. By doing so, you will help protect the environment.

Efedrine Level Composition

• The active ingredient is efedrine hydrochloride. Each tablet contains 50 mg of efedrine hydrochloride.

• The other components are: microcrystalline cellulose, talc, magnesium stearate, and sodium carboxymethylcellulose (type A) (derived from potato starch).

Product Appearance and Packaging Contents

Efedrine Level is presented in a PVC-aluminum blister. Each package contains 24 tablets.

Marketing Authorization Holder

LABORATORIOS ERN, S.A.

Perú, 228 - 08020 Barcelona. Spain

Responsible for Manufacturing

LABORATORIOS ERN, S.A.

Gorgs Lladó, 188 – 08210 Barberá del Vallés, Barcelona. Spain

Last Review Date of this Leaflet: May 2020

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

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