Terbasmin Expectorant 0.3 mg/ml + 13.3 mg/ml oral solution
Spain
Table of Contents
- Package leaflet: Information for the user
- Introduction
- 1. What Terbasmin Expectorant is and what it is used for
- 2. What you need to know before starting Terbasmin Expectorant
- 3. How to take Terbasmin Expectorant
- 4. Possible adverse effects
- 5. Storage of Terbasmin Expectorant
- 6. Contents of the pack and other information
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Terbasmin Expectorant
0.3 mg/ml + 13.3 mg/ml oral solution
Terbutaline sulfate / Guaifenesin
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 other people, even if they have the same symptoms as yours, as it may harm them.
- If you experience any adverse effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
Contents of the leaflet
- What Terbasmin Expectorant is and what it is used for
- What you need to know before taking Terbasmin Expectorant
- How to take Terbasmin Expectorant
- Possible side effects
- How to store Terbasmin Expectorant
- Contents of the pack and other information
1. What Terbasmin Expectorant is and what it is used for
Terbasmin Expectorant is a medicine that provides rapid relief of symptoms such as difficulty in breathing in patients with asthma or similar conditions. It also helps to liquefy mucus.
Terbasmin Expectorant is used regularly to prevent respiratory problems expected in these types of conditions. It does not relieve an acute asthma attack once it has started.
2. What you need to know before starting Terbasmin Expectorant
Do not take Terbasmin Expectorant:
- If you are allergic to terbutaline sulfate or guaifenesin or to any of the other ingredients of this medicine (listed in section 6).
- Not to be used in children under 2 years of age.
Warnings and precautions
- Consult your doctor or pharmacist before starting to take Terbasmin Expectorant.
- Before starting treatment, you must inform your doctor if you have previously experienced any unusual reaction to this medicine, to terbutaline, or to other medicines.
- If you currently have other medical conditions, especially heart problems, diabetes, or thyroid disorders (hyperthyroidism), you must inform your doctor.
Use of Terbasmin Expectorant with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Certain medicines used to treat hypertension, heart conditions, and some eye drops containing beta-blockers may reduce or counteract the effect of Terbasmin Expectorant when taken concomitantly.
When Terbasmin Expectorant is used together with other medicines, low blood potassium levels may occur. Normally this effect is not significant, but in some cases it may affect heart rhythm.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
No harmful effects have been observed during pregnancy. However, inform your doctor as soon as possible if you become pregnant while being treated with this medicine.
No harmful effects have been observed during breastfeeding. Nevertheless, consult your doctor or pharmacist before taking this medicine if you are breastfeeding your baby.
Driving and use of machines
No effects of Terbasmin Expectorant on the ability to drive vehicles or operate machinery have been reported at the recommended doses.
Use in athletes
Athletes are advised that this medicine contains a component that may lead to a positive analytical result in doping control tests.
Terbasmin Expectorant contains sorbitol
If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.
It may produce a mild laxative effect because it contains 2.5 g of sorbitol per 10 ml dose.
Calorific value: 2.6 kcal/g of sorbitol.
3. How to take Terbasmin Expectorant
Follow exactly the instructions for use of this medicine provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
Terbasmin Expectorant is administered orally.
The recommended dose is:
- Usual dose in adults: 10 to 15 ml of oral solution (3 to 4.5 mg of terbutaline sulfate) 3 times in 24 hours.
- Usual dose in children (from 2 years of age): The recommended dose will depend on the child's body weight as indicated in the following table:
Body weight (Kg) | Dosage | Body weight (Kg) | Dosage |
12 | 3 ml x 3 | 24 | 6 ml x 3 |
14 | 3.5 ml x 3 | 28 | 7 ml x 3 |
16 | 4 ml x 3 | 32 | 8 ml x 3 |
18 | 4.5 ml x 3 | 36 | 9 ml x 3 |
20 | 5 ml x 3 | 40 | 10 ml x 3 |
If you take more Terbasmin Expectorant than you should
Contact your doctor or pharmacist immediately.
The most common symptoms and signs that may occur after an overdose are: nausea, headache, fast or irregular heartbeat, muscle cramps, nervousness, restlessness, tremors, fainting, or unusual drowsiness.
In case of accidental overdose, see your doctor or contact the Toxicology Information Service, Telephone 91 562 04 20, indicating the product and the amount taken.
If you forget to take Terbasmin Expectorant
Do not take a double dose to make up for missed doses.
If you forget a dose, take it as soon as you remember. If the next dose is due soon, wait until then.
If you stop taking Terbasmin Expectorant
Remember to take your medicine. Your doctor will indicate how long you should take this medicine. Avoid stopping treatment without first consulting your doctor.
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 cause adverse effects, although not everyone experiences them.
The frequency of adverse effects is as follows: Frequent (at least 1 in 100 patients), uncommon (at least 1 in 1,000 patients), rare (at least 1 in 10,000 patients).
If adverse effects occur, they are usually mild in nature and disappear after one or two weeks of treatment.
Inform your doctor of any adverse effects that cause you discomfort or do not go away:
- Frequent: Tremors, fast heartbeat (tachycardia).
- Uncommon: Nausea, skin rash, headache (cephalalgia), muscle cramps. Difficulty sleeping and mood changes have also been observed.
- Rare: Irregular heartbeat.
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 Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Terbasmin Expectorant
Keep this medicine out of the sight and reach of children.
No special storage conditions are required.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.
Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.
6. Contents of the pack and other information
Composition of Terbasmin Expectorant
- The active substances are terbutaline sulfate and guaifenesin. Each ml contains 0.3 mg of terbutaline sulfate and 13.3 mg of guaifenesin.
- The other components are: Sorbitol (E-420), glycerol (E-422), citric acid, sodium hydroxide (E-524), sodium benzoate (E-211), disodium edetate, sodium saccharin, menthol, raspberry flavor, lemon flavor, and purified water.
Appearance of the medicine and contents of the pack
Terbasmin Expectorant is an oral solution. It is supplied in a 180 ml bottle of solution, with an aluminum cap and a dosing cup.
Marketing Authorization Holder
LABORATORIOS ERN, S.A.
Perú, 228 - 08020 Barcelona, Spain
Manufacturers
Laboratorios ERN, S.A.
Gorcs LLadó, 188 – 08210 Barberà del Vallès, Barcelona, Spain.
Date of the most recent revision of this leaflet: October 2015
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/