TERBASMIN EXPECTORANT 0.3 mg/ml + 13.3 mg/ml ORAL SOLUTION

Introduction

Package Leaflet: Information for the User

Terbasmin Expectorant

0.3 mg/ml + 13.3 mg/ml Oral Solution

Terbutaline sulfate / Guaifenesin

Read this package leaflet carefully before starting to take this medicine, as it contains important information for you.

• Keep this package leaflet, as 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; do 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 package leaflet. See section 4.

Contents of the Package Leaflet

1. What Terbasmin Expectorant is 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 further information

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

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

Terbasmin Expectorant 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.

2. What you need to know before taking Terbasmin Expectorant

Do not take Terbasmin Expectorant:

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

Warnings and precautions

• Consult your doctor or pharmacist before starting to take Terbasmin Expectorant.
• Before starting treatment, inform your doctor if you have had any unusual reactionto this medicine, terbutaline, or other medicines.
• If you have other illnesses before taking the medicine, especially if it is heart problems, diabetes, or thyroid disorders(hyperthyroidism), inform your doctor.

Using Terbasmin Expectorant with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Certain medicines used to treat high blood pressure, heart problems, and in some eye drops, which contain beta-blockers, may reduce or cancel the effect of Terbasmin Expectorant when taken together.

When Terbasmin Expectorant is used with other medicines, low potassium levels in the blood may occur. This effect is usually unimportant, but in some cases, it may affect the heart rhythm.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

No harmful effects have been observed during pregnancy. Nevertheless, inform your doctor as soon as possible if you become pregnant during treatment with the medicine.

No harmful effects have been observed during breastfeeding. However, consult your doctor or pharmacist before taking a medicine if you are breastfeeding your child.

Driving and using machines

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

Use in athletes

Athletes are informed that this medicine contains a component that may result in a positive doping test.

Terbasmin Expectorant contains sorbitol

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

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

Caloric value: 2.6 Kcal/g of sorbitol.

3. How to take Terbasmin Expectorant

Follow exactly the administration instructions of this medicine 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 of age): 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 heartbeat, muscle cramps, nervousness, restlessness, tremors, fainting, or unusual drowsiness.

In case of accidental overdose, go to your doctor or consult the Toxicology Information Service, Phone 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 forgotten doses.

If you forget a dose, take it as soon as you remember. If the next dose is near, wait until then.

If you stop taking Terbasmin Expectorant

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

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The frequency of side 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 side effects occur, they are usually mild and disappear after one or two weeks of treatment.

Tell your doctor about the following side effects that bother you or do not disappear:

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

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side 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 expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines in the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and further information

Composition of Terbasmin Expectorant

• The active ingredients 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 and packaging of the product

Terbasmin Expectorant is an oral solution. It is presented in a 180 ml bottle of solution, with an aluminum cap and a measuring cup.

Marketing authorization holder

LABORATORIOS ERN, S.A.

Perú, 228 - 08020 Barcelona, Spain

Manufacturers

Laboratorios ERN, S.A.

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

Date of the last revision of this package leaflet:October 2015

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/