PATIENT INFORMATION LEAFLET

BAMBEC 10 MG TABLETS

Bambuterol hydrochloride

1. What Bambec 10 mg tablets are and what they are used for

2.What you need to know before you start taking Bambec 10 mg tablets

3.How to take Bambec 10 mg tablets

4.Possible side effects

5.Storage of Bambec 10 mg tablets

6. Further information

Hidrocloruro de bambuterolbelongs to a group of medicines called bronchodilators. It is transformed inside the body into terbutalinaand acts by widening the airways and facilitating breathing. The effect lasts, at least, 24 hours.

Bambec 10 mg provides relief from symptoms such as difficulty breathing in patients with asthma or similar conditions. Bambec is used as regular treatment for the prevention of respiratory problems.However, Bambec does not alleviate an acute asthma attack when it has already begun.

Do not take Bambec 10 mg tablets

• If you are allergic (hypersensitive) to bambuterol, terbutalina, or any of the other components of Bambec 10 mg. (listed in section 6)

Warnings and precautions:

Consult your doctor or pharmacist before starting to take this medication

• If you have previously experienced any unusual reactions to other medications, mainly to Terbasmin (terbutalina), inform your doctor.
• Before starting treatment with Bambec, always inform your doctor of any other conditions you may have, especially if you have had any episodes of cardiac arrhythmias, irregular heart rhythm, angina pectoris, liver disease, diabetes, thyroid dysfunction (hyperthyroidism), predisposition to developing glaucoma, or impaired renal function.
• You should not start treatment with Bambec or increase the prescribed dose during an acute exacerbation of asthma.

Use of other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, or if you may need to take any other medication, including those obtained without a prescription. Some medications may alter the effect of Bambec 10 mg when used together, for example:

• Other sympathomimetic medications.
• Certain beta-blockers, used to increase blood pressure, cardiac conditions, or some eye drops.
• Bambec 10 mg prolongs the effect of some muscle relaxants, such as succinylcholine, used during operations. Therefore, if you are to undergo surgery while taking Bambec, you must inform your doctor.
• Bambec 10 mg may affect blood electrolyte balance, such as decreased potassium levels (hypokalemia), and this decrease may be increased if you take Bambec with other medications such as xanthine derivatives, steroids, and diuretics.This effect is usually insignificant, but in certain cases, it may affect heart rhythm.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

There is limited experience with Bambec 10 mg in pregnant women and breastfeeding women. Therefore, if you become pregnant, you must inform your doctor immediately.

This medication should be used with caution in the first trimester of pregnancy and in the final stage of pregnancy (inhibits uterine contractions).

Bambec passes into breast milk.

Use in athletes

Inform athletes that this medication contains a component that may produce a positive result in doping control tests.

Driving and operating machinery

Bambec does not affect the ability to drive and operate machinery.

Important information about some of the components of Bambec 10 mg tablets

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

Follow exactly the administration instructions forBambec 10 mgprescribed by your doctor. Do not interrupt your anti-inflammatory treatment when starting Bambec treatment, even if your asthma symptoms decrease. Consult your doctor or pharmacist if you have any doubts.

Form of use and administration route

Bambec10 mgis administered in a single dose per day, just before bedtime, accompanied by a glass of water. Each tablet is transversely scored to allow for easy breaking into two halves in case you need to administer a 5 mg dose or if it is difficult to take it whole.

Dosage, frequency of administration, and duration of treatment

Usual doses for adults:The recommended initial dose is 10 mg (one tablet), once a day. However, if necessary, the doctor may increase the dose up to 20 mg (two tablets), once a day.

Inpatients with renal insufficiency, the recommended initial dose is 5 mg (half a tablet), once a day.After 1 or 2 weeks of treatment, the doctor may increase the dose up to 10 mg (one tablet), once a day.

Usual doses forchildren aged 2 to 5 years: the recommended dose is 10 mg (one tablet) once a day, and in Oriental children it is 5 mg (half a tablet), once a day.

Usual doses forchildren aged 6 to 12 years: the recommended initial dose is 10 mg (one tablet), once a day.After 1 or 2 weeks of treatment, the doctor may increase the dose up to 20 mg (two tablets), once a day, if necessary to control symptoms.

In Oriental children, a dose not exceeding 10 mg (one tablet) should not be administered once a day.

Usual doses for children over 12 years:The same dose as for adults.

If you estimate that the usual dose ofBambec10 mg does not provide adequate relief of your symptoms, inform your doctor or pharmacist urgently.You may need additional doses for adequate asthma control.Do not increase the number of doses withoutconsulting your doctor first.

If you take more Bambec 10 mg tablets than you should

Take only the number of tablets prescribed by your doctor, as taking more tablets will increase the risk of adverse effects.

The most common symptoms and signs that may occur after an overdose are:

• Nausea
• Nervousness, restlessness, tremors
• Headache
• Fast heart rate
• Muscle cramps in the hands, feet, or legs
• Unusual dizziness or somnolence

In some cases, a decrease in blood pressure or some alterations in laboratory tests may occur.

If you take more Bambec 10 mg tablets than you should, consult your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, consult the Toxicological Information Service. Phone: 91 5620420, indicating the medication and the amount taken/used. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you forgot to take Bambec 10 mg tablets

If you forget to take one of the doses ofBambec10 mg, follow the recommended treatment as soon as you remember. However, if it is close to the time for the next dose, it is best to wait for that moment. Do not take a double dose to compensate for the missed doses.

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

Like all medications,Bambec10 mg may cause side effects, although not everyone will experience them.

The side effects that may occur with the use of Bambec10 mgare those commonly observed with this type of anti-asthmatic medication, and usually disappear within 1-2 weeks of treatment. However, if any of these adverse reactions persist, or if you observe any other reaction not described in this leaflet, consult your doctor or pharmacist.

Very common side effects(affecting more than 1 in 10 patients/people)

• Neurological system disorders:

Tremors

Headache

• Psychiatric disorders:

Anxiety

Common side effects(affecting between 1 and 10 in 100 patients/people)

• Cardiac disorders:

Palpitations (noticing the heart beating)

• Musculoskeletal and connective tissue disorders:

Muscle cramps in hands, feet, legs

• Psychiatric disorders:

Difficulty sleeping

Rare side effects(affecting between 1 and 10 in 1,000 patients/people)

• Psychiatric disorders:

Agitation

• Cardiac disorders:

Fast heart rate

Irregular heart rate

Side effects of unknown frequency(cannot be estimated from available data)

• Gastrointestinal disorders:

Nausea

• Psychiatric disorders:

Hypervigilance

Dizziness

• Dermatological and subcutaneous tissue disorders:

Urticaria and exanthema (skin rash)

• Metabolic and nutritional disorders:

Hypokalemia: Decreased potassium levels in blood

Hypoglycemia: Increased glucose levels in blood

Although it is not known exactly how often it occurs, some people may occasionally experience chest pain (due to heart problems, such as angina or myocardial ischemia). If you experience these symptoms while receiving treatment with Bambec,inform your doctor, but do not stop using this medicationunless your doctor tells you to.

If you consider that any of the side effects you experience are severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through theSpanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es.By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keep out of sight and reach of children.

Do not store at a temperature above 30 °C.

Do not useBambec10 mg after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medicines that you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medicines that you no longer need. By doing so, you will help protect the environment.

Composition of Bambec

The active ingredient ishydrochloride of bambuterol;each tablet contains 10 milligrams of hydrochloride of bambuterol.

The other components are:monohydrate lactose, cornstarch, polyvinylpyrrolidone, microcrystalline cellulose (E460) and magnesium stearate.

Appearance of the product and contents of the package

Bambec 10 mg is presented in the form of scoredtablets,packaged in blisters of 30 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder:

Laboratorio Lailan, S.A.

C/ Puerto de Somport 21-23

28050 Madrid

Responsible for manufacturing:

AstraZeneca AB

Gärtunavägen

SE-152 57 Södertälje - Sweden

This prospectus was reviewed in June 2018.

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