Leaflet: information for the user

Terbasmin Expectorant

0.3 mg/ml + 13.3 mg/ml oral solution

Terbutaline sulfate / Guaifenesin

Read this 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, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What is Terbasmin Expectorant and what it is used for

2. What you need to know before taking Terbasmin Expectorant

3. How to take Terbasmin Expectorant

4. Possible side effects

5. Storage of Terbasmin Expectorant

6. Contents of the pack and additional information

Terbasmin Expectorante is a medication that provides quick relief from symptoms such as difficulty breathing in patients with asthma or similar conditions. It also thins mucus.

Terbasmin Expectorante will be used regularly to prevent expected respiratory problems in this type of condition. It does not relieve an acute asthma attack once it has started.

Do not take Terbasmin Expectorante:

• If you are allergic to terbutaline sulfate or guaifenesin or any of the other components of this medication (listed in section 6).
• Do not use in children under 2 years.

Warnings and precautions

• Consult your doctor or pharmacist before starting to take Terbasmin Expectorante.
• Before starting treatment, inform your doctor if you have had any unusual reactions to this medication, terbutaline, or other medications.
• If you have other diseases, especially heart problems, diabetes, or thyroid disorders (hyperthyroidism), inform your doctor.

Use of Terbasmin Expectorante with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Certain medications used to treat high blood pressure, heart problems, and some eye drops, containing beta-blockers, may reduce or cancel the effect of Terbasmin Expectorante when taken together.

When used with other medications, Terbasmin Expectorante may cause low levels of potassium in the blood. Normally, this effect is insignificant, 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 medication.

No adverse effects have been observed during pregnancy. However, inform your doctor as soon as possible if you become pregnant during treatment with this medication.

No adverse effects have been observed during breastfeeding. Nevertheless, consult your doctor or pharmacist before taking this medication if you are breastfeeding your child.

Driving and operating machines

No effects of Terbasmin Expectorante on the ability to drive vehicles or operate machinery have been described at the recommended doses.

Use in athletes

Inform athletes that this medication contains a component that may result in a positive analytical control for doping as positive.

Terbasmin Expectorante contains sorbitol

If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

It may cause a mild laxative effect because it contains 2.5 g of sorbitol per 10 ml dose.

Caloric value: 2.6 Kcal/g of sorbitol.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of 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 old):The recommended dose will depend on the child's body weight as indicated in the following table:

If you take more Terbasmin Expectorant than you should

Consult your doctor or pharmacist immediately.

The most common symptoms and signs that may occur after an overdose are: nausea, headache, rapid or irregular heart rate, muscle cramps, nervousness, restlessness, tremors, dizziness, or unusual drowsiness.

In case of accidental overdose, go to your doctor or consult the Toxicological 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 compensate for the missed doses.

In case of forgetting a dose, take it as soon as you remember. If the next dose is close, wait until then.

If you interrupt treatment with Terbasmin Expectorant

Remember to take your medication. Your doctor will indicate the duration of your treatment with this medication. Avoid stopping treatment without consulting your doctor first.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

The frequency of adverse effects is as follows: Frequent (in at least 1 in 100 patients), infrequent (in at least 1 in 1,000 patients), rare (in at least 1 in 10,000 patients).

Adverse effects are of mild character and disappear within one or two weeks of treatment.

Inform your doctor about the following adverse effects that are bothersome or do not disappear:

• Frequent: Tremors, rapid heartbeat (tachycardia).
• Infrequent: Nausea, skin rash (urticaria), headache (cephalgia), muscle cramps. Difficulty sleeping and mood changes have been observed.
• Rare: Irregular heartbeat.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is about possible adverse effects that do not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep this medication out of the sight and reach of children.

No special storage conditions are required.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Terbasmin Expectorant

• The active principles 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 aroma, lemon aroma, and purified water.

Appearance of the product and contents of the packaging

Terbasmin Expectorant is an oral solution. It is presented in a 180 ml solution bottle, with an aluminum cap, along with a dosing cup.

Holder of the marketing authorization

Laboratorios ERN, S.A.

Perú, 228 - 08020 Barcelona, Spain

Manufacturing responsible parties

Laboratorios ERN, S.A.

Gorcs LLadó, 188 – 08210 Barberá del Vallés, Barcelona. Spain.

Last review date of this prospectus:October/2015

The detailed and updated information of this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/