TERBASMIN EXPECTORANTE SOLUCION

Transcription

1 TERBASMIN EXPECTORANTE SOLUCION 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 Terbasmin Expectorante solución 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 Terbasmin Expectorante solución and what are they used for? 2. Before using Terbasmin Expectorante solución 3. How to use Terbasmin Expectorante solución 4. Possible side effects 5. Conservation of Terbasmin Expectorante solución Each dosed measure of 5ml contains 1.5mg of terbutaline sulphate and 66.6mg of guaifenesin. The other components (excipients) are: sorbitol (E420), glycerol (E422), citric acid, sodium hydroxide, sodium benzoate (E211), disodium edentate, sodium saccharin, menthol, aroma of raspberry, aroma of lemon-limette and purified water. 1. WHAT IS TERBASMIN EXPECTORANTE SOLUCION AND WHAT IS IT USED FOR? TERBASMIN EXPECTORANTE SOLUCION is an oral solution. It is presented in a 180ml solution container. TERBASMIN EXPECTORANTE SOLUCION is a systematic stimulant which dilates the respiratory paths facilitating breathing. TERBASMIN EXPECTORANTE SOLUCION proportions rapid relief of symptoms like breathing difficulty in patients with asthma or similar conditions. In the same way, TERBASMIN EXPECTORANTE SOLUCION fluidifies mucous, which allows the alleviation of a cough. TERBASMIN EXPECTORANTS SOLUCION will be employed regularly in order to prevent breathing problems expected in these types of conditions. TERBASMIN EXPECTORANTE SOLUCION does not alleviate an acute asthma attack when it has already started. 2. BEFORE TAKING TERBASMIN EXPECTORANTE SOLUCION Do not take TERBASMIN EXPECTORANTE SOLUCION: - If you are allergic to terbutaline or other components of this product. Be especially careful with TERBASMIN EXPECTORANTE: - If you have previously shown any unusual reaction to Terbasmin (terbutaline)or other medicines you must communicate this to your doctor.

2 - If you suffer from other conditions, especially if these are cardiac problems, diabetes or thyroid disorders (hyperthyroidism), you must communicate this to your doctor. Pregnancy: Consult your doctor or pharmacist before taking any medication. IMPORTANT FOR WOMEN If you are pregnant or think you may be, consult your doctor before taking this medication. The consumption of medicines during pregnancy may be dangerous for the embryo or fœtus and must be monitored by your doctor. Prejudicial effects during pregnancy have not been observed. Even so, tell your doctor as soon as possible if you become pregnant while being treated with Terbasmin. Breast feeding Consult your doctor or pharmacist before taking any medication. Prejudicial effects when breast feeding have not been observed. Sportspeople We inform sportspeople that this medicine contains a component that can establish positive results in analytic drug tests. Driving and using machines TERBASMIN EXPECTORANTE SOLUCION at recommended doses has not had any reported effects on driving capacity or the ability to use machines. Important information about some of the components of TERBASMIN EXPECTORANTE SOLUCION: As this medicine contains glycerol as an excipient it can be prejudicial at large doses. It can provoke headaches, stomach discomfort and diarrhoea. As it contains sodium benzoate as an excipient it can slightly irritate the eyes, skin and mucosa. It can increase the risk of yellow colouring of the skin (jaundice) in newborns. This medicine contains 1.25g of sorbitol as an excipient for each dosed measure of 5ml. It can cause stomach discomfort and diarrhoea. It must not be used with patients with a hereditary intolerance to fructose. Taking other medication Inform your doctor or pharmacist if you are taking or have recently taken any other medicine even those acquired without prescription. Bear in mind that these instructions may be applicable to medicines taken before or afterwards. Certain medicines for the treatment of hypertension, heart conditions and some antibiotics, the beta blockers, can reduce or cancel the effect of Terbasmin when administered in conjunction. It is also possible to observe low levels of potassium in the blood when Terbasmin is used with other medicines. Normally this effect is not important, but in some cases it can influence the cardiac rhythm.

3 3. HOW TO USE TERBASMIN EXPECTORANTE SOLUCION Follow these instructions unless your doctor has given you distinct indications. Remember to take your medicine. Your doctor will indicate the length of treatment with TERBASMIN EXPECTORANTE SOLUCION. Do not suspend the treatment without first consulting your doctor. If you feel that the effect of TERBASMIN EXPECTORANTE SOLUCION is too strong or weak communicate this to your doctor or pharmacist. TERBASMIN EXPECTORANTE SOLUCION is administered orally. Administration: Habitual dose for adults: 3-4.5mg (10-15ml) 3 times in 24 hours. Habitual dose for children: The dose will depend on the child s body weight as indicated on the following table: Recommended doses: Body weight (kg) Dosage Body weight (kg) Dosage 4 1ml x ml x ml x ml x 3 8 2ml x ml x ml x ml x ml x ml x ml x ml x ml x ml x 3 If you take more TERBASMIN EXPECTORANTE SOLUCION than you should, immediately consult your doctor or pharmacist. The most common symptoms and signs which can be produced after an overdose are: nausea, headaches, fast or irregular cardiac rhythm, muscular cramps, nervousness, uneasiness, trembling, fainting or unusual drowsiness. In the case of accidental overdose, consult the Toxicology Information Service, Telephone , indicating the product and amount administered. If you forgot to take TERBASMIN EXPECTORANTE SOLUCION Do not take a double dose to compensate the treatment with TERBASMIN EXPECTORANTE SOLUCION. In the case of forgetting a dose, take one as soon as you remember. However, if the next dose is very soon, wait till then. 4. POSSIBLE SIDE EFFECTS As with all medicines TERBASMIN EXPECTORANTE SOLUCION can produce side effects. If side effects are produced, these are weak and disappear after one or two weeks treatment. Even so, communicate the following side effects which cause discomfort or do not disappear to your doctor: Frequent side effects: Trembling Rapid cardiac rhythm

4 Infrequent side effects: Nausea Skin rashes Serious headaches Muscular cramps Difficulty sleeping and mood changes have been observed Rare side effects Irregular heartbeats have been registered If you observe any other side effect not mentioned in this information pamphlet, consult your doctor or pharmacist. 5. CONSERVATION OF TERBASMIN EXPECTORANTE SOLUCION Maintain TERBASMIN EXPECTORANTE SOLUCION out of reach and sight of children. It does not need special conditions for conservation. Expiry: Do not use TERBASMIN EXPECTORANTE SOLUCION after the expiry date indicated on the container. 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. Holder of the authorisation for the commercialisation and fabrication of the product. LABORATORIOS ERN, S.A. Pedro IV, Barcelona, España Responsable for fabrication. LABORATORIOS ERN, S.A. Pedro IV, Barcelona, España Laboratorios ERN, S.A. Gorcs i LLadó, Barberá del Vallés, Barcelona. España. This information pamphlet was approved in June Detailed and updated information about this product is available on the webpage of the Spanish Agency for Medicines and Health Products (AEMPS)

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