Prospectus: User information Astenolit solución oral

Transcription

1 Prospectus: User information Astenolit solución oral Read the whole of this prospectus in detail, because it contains information that will be important to you. This medication can be obtained without a prescription for the treatment of minor afflictions without the intervention of a doctor. However, you must use Astenolit solución oral with care to obtain the best results. -Keep this prospectus; you may need to read it again. -If you have any doubts, consult your doctor or pharmacists. This medicine has been prescribed to you and must not be given to others. It may harm them, even when their symptoms are the same as yours. In this prospectus: 1. What are Astenolit solución oral and what are they used for? 2. Before using Astenolit solución oral 3. How to use Astenolit solución oral 4. Possible adverse effects 5. Storage of Astenolit solución oral 1.What is Astenolit oral solution and what is it used for? Astenolit contains group B vitamins, amino acids and minerals. Astenolit is indicated in: Treatments when there is a lack of vitamins, amino acids and minerals contained in this medicine, for adults and children older than 14 in: - Periods of weakness, intense activity or convalescence. - Situations such as unbalanced or restrictive diets (weight loss, vegetarians...) 2.What do you need to know before starting to take Astenolit solución oral Do not take Astenolit -If you are allergic to the principal ingredients or any of the other components of this medicine (including those in section 6). -If you suffer from a kidney illness. -If you are being treated with levodopa (medicine for treating Parkinson). Warnings and precautions Consult your doctor or pharmacist before starting taking Astenolit. -Do not exceed the recommended dose (see section 3). -If you suffer from a kidney illness you may be more sensitive to the side effects. -If you suffer from epilepsy you need to be careful, as carnitine could increase the chances of convulsions. -You must be careful if you suffer from Leber s illness (hereditary atrophy of the optic nerve) due to the presence of cyanocobalamin.

2 Children Do not administer to those below 14 years old as there is a lack of data as to its safety and efficacy. Taking Astenolit with other medicines Inform your doctor or pharmacist if you are taking, have taken recently or may have to take any other medication. The principal ingredients of Astenolit interact with the ingredients of the following medicines. Medicines which can have their operation altered when used in conjunction with Astenolit: Astenolit can decrease the effect of the following medicines. -Levodopa (for Parkinson s disease), unless Levodopa is associated with carbidopa (for Parkinson). -Altretamine (for cancer). -Tetracyclines (to treat infections). Administration must be separated by two hours. Astenolit can increase the effect of the following medicines: -Oral anticoagulants (acenocumarole or warfarin) (medicines that help avoid the formation of blood clots). -Neuromuscular blockers (used in anaesthetics). -Medicines with potassium or that increase the amount of potassium. Others: -Amiodarone (for the heart). It could increase the possibility of photosensibility (allergic reaction to sunlight) due to the pyridoxine this medicine contains. Medicines which can modify the effect of Astenolit: -Pholic acid (group B vitamin), when used in high doses. -Medicines used in the treatment of tuberculosis (cycloserine, isionazid, ethiomanide). -Chloranfenicole (to treat some infections). -Bone marrow depressors (medicines that decrease the capacity to produce blood cells). -Diuretics (for hypertension). -Medicines that decrease the amount of acid in the stomach (gastric antisecretors), like femotidine, ranitidine, omeprazole. -Neomicine (to treat some infections). -Anticonvulsant medication (for epilepsy), like phenitoine, phenobarbital, primidone. -Radiation with cobalt. -Metformine (for diabetes). -Colchicine (for the treatment of gout). -Hydralazine (to treat high blood pressure). -Immunosuppressive medication (which suppress the immune system s response), corticosteroids (reduce inflammation), azatioprine and cyclosporine. -Cyclophosphamide (for some types of cancer). -Penicilamine (to treat some types of arthritis). -Oral forms of contraception. -Mesalazine (for illnesses of the intestine). -Ascorbic acid supplement (Vitamin C) in high doses. Taking Astenolit with alcohol Excessive consumption of alcohol decreases the absorption of vitamin B 12.

3 Pregnancy, breast feeding and fertility. If you are pregnant, breast feeding, think you could be pregnant or have the intention of becoming so, consult your doctor or pharmacist before using this medication. You should not use this medicine during pregnancy or when breast feeding. Driving and using machines No effect which alters driving capacity or the ability to use machines has been described. Astenolit solución oral contains ethanol, methyl parahydroxybenzoate (E-218), propyl parahydroxybenzoate (E-216), sucrose and sodium. This medicine contains 5% ethanol (alcohol), which corresponds to a quantity of 402mg per bottle, which is equivalent to 8 ml of beer or 3.3 ml of wine. This medicine is prejudicial to people suffering from alcoholism. The alcohol content needs to be taken into account in the case of pregnant women or those breast feeding, children and high risk groups, such as patients with liver illnesses or epilepsy. It can produce allergic reactions (possibly delayed) because it contains methyl parahydroxybenzoate and propyl parahydroxybenzoate. This medicine contains sucrose. If your doctor has indicated that you suffer from intolerance to certain sugars, consult with him/her before taking this medicine. Patients with low sodium diets need to bear in mind that this medicine contains mg (4 mmol) of sodium per bottle. 3.How to take Astenolit solución oral Follow the instructions indicated in this pamphlet, or those indicated by your doctor or pharmacist exactly. In case of doubt consult with your doctor or pharmacist. The recommended dose is: -Adults and children oler than 14: The normal dose is one bottle per day, preferably in the morning with breakfast, for a period of 1 to 2 weeks. You must not exceed the recommended dose. Treatment of more than 2 weeks is not recommended. If symptoms worsen or persist after 14 days you should consult a doctor. Oral ingestion. Instructions for the correct administration of the substance: Dilute the bottle in half a glass of water. Always break the superior part fixed in a vertical position. Use the bottle opener to facilitate the opening of the bottles. Use in children Do not use with children under 14 (see section 2). If you take more Astenolit than you should If you have taken more Astenolit than recommended (overdose), you may suffer gastrointestinal discomfort (diarrhoea, nausea, vomiting) headaches or aches in the joints. Other symptoms of overdose are: sensibility to sunlight (photosensibility), disorders of the nervous system such as alterations or reduced sensibility, numbness in feet and hands, sleepiness, lethargy.

4 In case of overdose or accidental ingestion, immediately consult your doctor or pharmacist or phone the Toxicology Information Service, telephone , indicating the medicine and the amount ingested (or go to a medical centre). If you forgot to take Astenolit Do not take a double dose to compensate the forgotten doses. If you have any other doubt about the use of this medicine, ask your doctor or pharmacist. 4.Possible side effects As with all medicines Astenolit can produce side effects although not everyone suffers from them. The following side effects caused by the use of this medicine have been reported, the frequency of which have not been able to be verified with the data available. The possibility of allergic reactions could exist. Slight stomach or intestine disorders could appear (gastrointestinal) like diarrhoea, alterations in taste, nausea, vomiting, heartburn. With high doses disorders that affect the nerves could appear (see section If you take more Astenolit...) Convulsions in patients with a history of these (see section Warnings and precautions) and could rarely occur in patients without a previous history of these. Alterations of the parathyroid gland (intervenes in the metabolism with calcium and vitamin D), increase in calcium in the blood (hypercalcemia), muscular weakness, body odour, sensibility to sunlight (photosensibility) with reddening, blisters etc; in very rare cases more serious skin injuries could appear. If you experience adverse effects consult your doctor or pharmacist even if they do not appear in this pamphlet. 5.Conservation of Astenolit solución oral It does not require special conditions for conservation. Keep out of sight and reach of children. Do not use this medicine after the expiry date which appears on the container after CAD. The expiry date is the last day of the month indicated. Medicines must not be disposed of in the drains or thrown away. Leave unwanted medicines and containers at the SIGRE point in a chemist. Ask your pharmacist how to dispose of any containers or unneeded medicines. This way you will help look after the environment. 6.Container contents and additional information Composition of Astenolit solución oral -The principal components are: DL-Carnitine 815.5mg (like carnitine hydrochloride, 1000mg), glutamine 38.8mg (acetilglutamine 50mg), acetylsalicylic acid70mg, inositole 30mg, timine (vitamin B 1 ) 40.5mg (like timaine mononitrate, 50 mg) pyridoxine (vitamin B 6 ) 41.1mg (like pyridoxine hydrochloride, 50 mg), cyanocobalamine (vitamin B 12 ) 50 micrograms,

5 magnesium 5.6mg (like L-magnesium aspartate, 75mg), potassium 16.3mg (like L- potassium aspartate, 75mg). -The other components (excipients) are: Sodium saccharin, sodium hydroxide, methyl parahydroxybenzoate (E-218), propyl parahydroxybenzoate (E-216), ethanol (2mg ethanol/bottle), essence of pineapple, sucrose, sodium citrate, caramelized sugar and purified water. Product appearance and container contents It is an oral solution (a clean, dark and transparent solution) in brown bottles screenprinted in white, with two points, contents 10ml solution. Container with 12 bottles. Holder of the authorisation for the commercialisation and fabrication of the product. LABORATORIOS ERN, S.A. Pedro IV, Barcelona, España Date of the last revision of this pamphlet: October 2012 Detailed and updated information about this product is available on the webpage of the Spanish Medicine and Health Products webpage (AEMPS)