EFEDRINE LEVEL 50 mg TABLETS

Introduction

Package Leaflet: Information for the User

Efedrina Level 50 mg Tablets

Efedrine Hydrochloride

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What Efedrina Level is and what it is used for
2. What you need to know before you take Efedrina Level
3. How to take Efedrina Level
4. Possible side effects
5. Storage of Efedrina Level
6. Contents of the pack and other information

1. What Efedrina Level is and what it is used for

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

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

2. What you need to know before you take Efedrina Level

Do not take Efedrina Level

• If you are allergic to efedrine or any of the other ingredients of this medicine (listed in section 6).

• If you have any of the following diseases:

• severe cardiovascular diseases, such as ischemic heart disease (narrowing of the arteries that supply the heart), coronary thrombosis (formation of blood clots in the heart) or severe arterial hypertension,

• hyperthyroidism or thyrotoxicosis (increased production of thyroid hormones),
• angle-closure glaucoma (increased pressure in the eye),

• psychosis (severe mental illness).

• If you are taking or have taken in the last two weeks medicines called MAOIs (including antidepressants such as tranycypromine and moclobemide, medicines for Parkinson's disease such as selegiline, anticancer medicines such as procarbazine, or antibiotics such as linezolid).

• If you are going to take at the same time medicines called indirect sympathomimetics such as phenylpropanolamine, pseudoephedrine, methylphenidate and phenylephrine.

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Warnings and precautions

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

This medicine should be administered with caution in patients:

• with a history of heart disease,

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

• with urinary retention (inability and/or difficulty urinating),

• with prostatic hypertrophy (enlargement of the prostate),

• with a predisposition to glaucoma (increased pressure in the eye),

• 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 medicines

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

In particular, if it is one of the following medicines, as it may be necessary to modify the dose and/or have additional monitoring by the doctor:

• tricyclic antidepressants,

• urine alkalinizers (sodium bicarbonate, citrates),

• beta-blockers (act by reducing blood pressure),

• inhalation anesthetics,

• glycosides (used to treat some heart problems),

• medicines to treat migraines such as ergotamine or methysergide,

• 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),

• antihypertensive medicines such as guanethidine, methyldopa, reserpine, alpha-blockers, furosemide or other diuretics,

• CNS stimulants (amphetamines, xanthines),

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

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

Breastfeeding

Efedrine hydrochloride is excreted in breast milk. A decision must be made whether to discontinue breastfeeding or discontinue treatment, considering the benefit of breastfeeding for the child and the benefit of treatment for the mother.

Driving and using machines

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The influence of Efedrina Level on the ability to drive and use machines is moderate.

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

Use in athletes

Athletes are informed that this medicine contains a component that may result in a positive doping test.

3. How to take Efedrina Level

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are in doubt, consult your doctor or pharmacist again.

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

Use in children and adolescents

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

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 Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount used.

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

Insomnia and other stimulating effects of efedrine on the central nervous system can be counteracted by the administration of hypnotics.

To control excitement, sedatives such as chlorpromazine can be administered at a dose of 50 or 100 mg intramuscularly or a barbiturate.

To control tachycardia, propranolol can be administered intravenously slowly or beta-adrenergic blockers (e.g., acebutolol, atenolol, metoprolol) in asthmatic patients.

The elimination of efedrine can be facilitated by acidifying the urine with ammonium chloride.

If you forget to take Efedrina Level

Do not take a double dose to make up for forgotten doses.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

• Muscle disorders such as: tremors and muscle weakness.

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• Cardiovascular disorders such as: tachycardia and palpitations (increased heart rate), precordial pain (pain in the heart area) and paleness, especially in hypersensitive patients.

• Gastrointestinal disorders: nausea, vomiting and dry mouth.

• Renal and urinary disorders: urinary retention.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Efedrina Level

Keep below 30 ºC.

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

Do not use Efedrina Level after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

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Composition of Efedrina Level

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

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

Appearance and packaging

Efedrina Level is presented in PVC-aluminum blisters. Each pack contains 24 tablets.

Marketing authorization holder

LABORATORIOS ERN, S.A.

Perú, 228 - 08020 Barcelona. Spain

Manufacturer

LABORATORIOS ERN, S.A.

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

Date of last revision of this leaflet: May 2020

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.

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