Ephedrine Level 50 mg tablets
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Efedrina Level 50 mg tablets
Ephedrine hydrochloride
Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.
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Keep this leaflet, as you may need to read it again.
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If you have any questions, ask your doctor or pharmacist.
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This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
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If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Leaflet contents
- What Efedrina Level is and what it is used for
- What you need to know before taking Efedrina Level
- How to take Efedrina Level
- Possible adverse effects
- How to store Efedrina Level
- Contents of the pack and other information
1. What Efedrina Level is and what it is used for
Ephedrine hydrochloride belongs to a group of medicines called alpha and beta adrenergic receptor agonists, which act as bronchodilators (they widen the air passages in the lungs).
This medicine is used to prevent and treat bronchospasm (narrowing of the air passages in the lungs) associated with acute attacks of bronchial asthma, spasmodic bronchitis, or pulmonary emphysema.
2. What you need to know before taking Efedrina Level
Do not take Efedrina Level
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If you are allergic to ephedrine or to any of the other ingredients of this medicine (listed in section 6).
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If you have any of the following conditions:
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severe cardiovascular diseases, such as ischemic heart disease (narrowing of the arteries supplying the heart), coronary thrombosis (formation of blood clots in the heart), or severe arterial hypertension,
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hyperthyroidism or thyrotoxicosis (increased hormone production by the thyroid gland),
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closed-angle glaucoma (increased intraocular pressure),
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psychosis (severe mental illness).
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If you are taking or have taken within the past two weeks medicines known as MAO inhibitors (MAOIs), including antidepressants such as tranilcipromine and moclobemide, Parkinson's disease medications such as selegiline, anticancer agents such as procarbazine, or anti-infectives such as linezolid.
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If you are required to take, at the same time, indirect sympathomimetic agents 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 must be used with great caution in patients:
- with a history of heart disease,
- with cardiovascular diseases such as arrhythmias (abnormal heart rhythm), arterial hypertension (high blood pressure), or occlusive vascular diseases (narrowing of arteries),
- with diabetes (high blood sugar levels),
- with urinary retention (inability and/or difficulty in urinating),
- with prostate hypertrophy (enlarged prostate),
- with a predisposition to glaucoma (increased intraocular pressure),
- who are elderly (see section 3 of this leaflet).
Children and adolescents
They may exhibit increased sensitivity to adverse effects, including stimulation of the central nervous system (CNS).
Taking Efedrina Level with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
In particular, if you are taking any of the following medicines, as dose adjustments and/or additional monitoring by your doctor may be necessary:
- tricyclic antidepressants,
- urinary alkalinizing agents (sodium bicarbonate, citrates),
- beta-adrenergic blockers (which reduce blood pressure),
- inhaled anesthetics,
- cardiac glycosides (used to treat certain heart conditions),
- migraine treatments such as ergotamine or methysergide,
- atropine sulfate (used in emergencies when the heart beats too slowly and as an antidote in certain poisoning cases),
- theophylline derivatives (used to treat asthma),
- antihypertensive agents such as guanethidine, methyldopa, reserpine, alpha-adrenergic blockers, furosemide, or other diuretics,
- CNS stimulants (amphetamines, xanthines),
- dexamethasone (a corticosteroid with anti-inflammatory and immunosuppressive activity).
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.
Pregnancy
Efedrina Level should not be used during the third trimester of pregnancy unless the woman's condition requires treatment with ephedrine hydrochloride and no safer therapeutic alternatives are available.
Breastfeeding
Ephedrine hydrochloride is excreted in breast milk. A decision must be made whether to discontinue breastfeeding or discontinue the treatment, taking into account the benefits of breastfeeding for the child and the benefits 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.
If adverse effects occur, it is recommended not to drive or operate dangerous machinery.
Use in athletes
Athletes are advised that this medicine contains a component that may result in a positive doping test.
3. How to take Efedrina Level
Follow exactly the instructions for use of this medicine provided 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 ephedrine hydrochloride) 2 to 3 times daily. Elderly patients may require dose adjustment.
Use in children and adolescents
The safety and efficacy of this medicine 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 Toxicology Information Service, telephone: 91 562 04 20, indicating the medicine and the amount used.
In cases of severe poisoning, the stomach should be immediately emptied by aspiration and gastric lavage.
Insomnia and other central nervous system stimulant effects of ephedrine may be counteracted by administration of hypnotics.
To control excitement, sedatives such as chlorpromazine (50 or 100 mg) administered intramuscularly or a barbiturate may be given.
To control tachycardia, propranolol administered by slow intravenous injection or cardioselective beta-adrenergic blockers (e.g. acebutolol, atenolol, metoprolol) may be used in asthmatic patients.
Elimination of ephedrine may 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 missed doses.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine may produce adverse effects, although not everyone will experience them.
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Nervous system disorders such as: anxiety, insomnia, headache, and dizziness.
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Muscular disorders such as: tremors and muscle weakness.
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Cardiovascular disorders such as: tachycardia and palpitations (increased heart rate), precordial pain (chest pain), and pallor, especially in hypersensitive patients.
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Gastrointestinal disorders: nausea, vomiting, and dry mouth.
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Renal and urinary disorders: urinary retention.
Reporting of 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 leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Efedrina Level
Store below 30 °C.
Keep this medicine out of the sight and reach of children.
Do not use Efedrina Level after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater drains or household waste. Instead, return any unused medicines and their containers to the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This helps protect the environment.
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Composition of Efedrina Level
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The active substance is ephedrine hydrochloride. Each tablet contains 50 mg of ephedrine hydrochloride.
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The other components are: microcrystalline cellulose, talc, magnesium stearate and sodium carboxymethylstarch (type A) (derived from potato starch).
Appearance of the medicinal product and content of the container
Efedrina Level is presented in PVC-aluminum blisters. Each package contains 24 tablets.
Marketing Authorization Holder
LABORATORIOS ERN, S.A.
Perú, 228 - 08020 Barcelona. Spain
Manufacturer
LABORATORIOS ERN, S.A.
Gorgs Lladó, 188 – 08210 Barberà del Vallès, Barcelona. Spain
Date of the most recent revision of this leaflet: May 2020
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.
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