TERBASMIN 0.3 mg/ml ORAL SOLUTION

Introduction

Package Leaflet: Information for the User

Terbasmin 0.3 mg/ml

oral solution

Terbutaline sulfate

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, do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the package leaflet

1. What is Terbasmin and what is it used for
2. What you need to know before taking Terbasmin
3. How to take Terbasmin
4. Possible side effects
5. Storage of Terbasmin
6. Contents of the pack and further information

1. What is Terbasmin and what is it used for

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

Terbasmin will be 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 taking Terbasmin

Do not take Terbasmin

• If you are allergic to terbutaline sulfate or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

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

Using Terbasmin 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 when taken together.

When Terbasmin is used with other medicines, low potassium levels in the blood may appear. 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 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 during treatment with the medicine.

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

Driving and using machines

No effect of Terbasmin on the ability to drive vehicles or operate machinery has 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 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 1.5 g of sorbitol per 10 ml dose.

Caloric value: 2.6 Kcal/g of sorbitol.

3. How to take Terbasmin

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Terbasmin is administered orally.

The recommended dose is:

• Usual dose in adults: 10 to 15 ml (3 to 4.5 mg of terbutaline sulfate) 3 times in 24 hours.
• Usual dose in children: The recommended dose will depend on the child's body weight as indicated in the following table:

If you take more Terbasmin 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

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

Remember to take your medicine. Your doctor will indicate the duration of your treatment with Terbasmin. 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 of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare 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

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 which is stated on the carton after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Terbasmin

• The active ingredient is terbutaline sulfate. Each ml contains 0.3 mg of terbutaline sulfate.
• The other ingredients are: Sorbitol (E-420), glycerol (E-422), sodium citrate (E-331), sodium benzoate (E-211), disodium edetate, raspberry flavor, lemon flavor, and purified water.

Appearance and packaging of the product

Terbasmin is an oral solution. It is presented 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 i LLadó, 188 – 08210 Barberá del Vallés, Barcelona, Spain.

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

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