Terbasmin 0.3 mg/ml oral solution
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Terbasmin 0.3 mg/ml
oral solution
Terbutaline sulfate
Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, consult your doctor or pharmacist.
- This medicine has been prescribed for you; do not give it to others, even if they have the same symptoms as you, as it could harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if the effects are not listed in this leaflet. See section 4.
Leaflet contents
- What Terbasmin is and what it is used for
- What you need to know before taking Terbasmin
- How to take Terbasmin
- Possible adverse effects
- How to store Terbasmin
- Contents of the pack and other information
1. What Terbasmin is and what it is used for
Terbasmin is a medicine that provides rapid relief of symptoms such as difficulty in breathing in patients with asthma or similar conditions.
Terbasmin will be used regularly to prevent breathing 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 taking Terbasmin
Do not take Terbasmin
- If you are allergic to terbutaline sulfate or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
- Consult your doctor or pharmacist before starting to take Terbasmin.
- 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 have other medical conditions before taking this medicine, especially heart problems, diabetes, or thyroid disorders (hyperthyroidism), you must inform your doctor.
Taking Terbasmin 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 high blood pressure, heart problems, and some eye drops containing beta-blockers may reduce or counteract the effect of Terbasmin when taken concomitantly.
When Terbasmin is used together with other medicines, low levels of potassium in the blood 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 plan 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 nursing your baby.
Driving and using machines
No effects of Terbasmin on the ability to drive 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 finding in doping controls.
Terbasmin contains Sorbitol
If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.
It may cause a mild laxative effect because it contains 1.5 g of sorbitol per 10 ml dose.
Calorific value: 2.6 Kcal/g of sorbitol.
3. How to take Terbasmin
Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
Terbasmin is administered orally.
The recommended dose is:
- Usual adult dose: 10 to 15 ml (3 to 4.5 mg of terbutaline sulfate) three times in 24 hours.
- Usual pediatric dose: The recommended dose depends on the child's body weight as indicated in the following table:
Body weight (Kg) | Dosage | Body weight (Kg) | Dosage |
4 | 1 ml x 3 | 18 | 4.5 ml x 3 |
6 | 1.5 ml x 3 | 20 | 5 ml x 3 |
8 | 2 ml x 3 | 24 | 6 ml x 3 |
10 | 2.5 ml x 3 | 28 | 7 ml x 3 |
12 | 3 ml x 3 | 32 | 8 ml x 3 |
14 | 3.5 ml x 3 | 36 | 9 ml x 3 |
16 | 4 ml x 3 | 40 | 10 ml x 3 |
If you take more Terbasmin than you should
Contact your doctor or pharmacist immediately.
The most common symptoms and signs that may occur after an overdose are: nausea, headache, rapid or irregular heartbeat, muscle cramps, nervousness, restlessness, tremors, fainting, or unusual drowsiness.
In case of accidental overdose, go to your doctor or contact the Toxicology Information Service at telephone number 91 562 04 20, indicating the product and the amount taken.
If you forget to take Terbasmin
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
Remember to take your medication. Your doctor will indicate how long your treatment with Terbasmin should last. Avoid stopping the 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 about any adverse effects that are bothersome 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.
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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
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 refers to the last day of the month indicated.
Medicines should not be disposed of via wastewater 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 dispose of unused medicines and their containers. This will help protect the environment.
6. Contents of the pack and other information
Composition of Terbasmin
- The active substance is terbutaline sulfate. Each ml contains 0.3 mg of terbutaline sulfate.
- The other components are: Sorbitol (E-420), glycerol (E-422), sodium citrate (E-331), sodium benzoate (E-211), disodium edetate, raspberry flavour, lemon flavour, and purified water.
Nature of the product and pack contents
Terbasmin is an oral solution. It is supplied in a 180 ml bottle containing the solution, with an aluminium cap and a dosing cup.
Marketing Authorization Holder
LABORATORIOS ERN, S.A.
Perú, 228 - 08020 Barcelona, Spain
Manufacturers
Laboratorios ERN, S.A.
Gorcs i 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 medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/