ELIXIFILIN 5.33 mg/ml ORAL SOLUTION

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Elixifilin 5.33 mg/ml oral solution

Anhydrous theophylline

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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get 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 pack:

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

1. What Elixifilin is and what it is used for

This medication belongs to a group of medications called bronchodilators, which means it dilates the bronchi and facilitates breathing.

It is indicated for the prevention and treatment of asthma or bronchial spasm associated with lung diseases such as chronic bronchitis or emphysema.

Theophylline should not be the first medication chosen to treat asthma in children.

2. What you need to know before you start taking Elixifilin

Do not takeElixifilin

• If you are allergic to theophylline or to any other medication in the same group or to any of the other components of this medication (listed in section 6).
• If you have acute tachyarrhythmia (rapid heart rate).
• If you have recently had a myocardial infarction.
• In children under 6 months of age.

Warnings and precautions

Consult your doctor before starting to take Elixifilin.

If you have any of the following diseases, you should inform your doctor as you may need a dose adjustment:

• If you have heart disease: unstable angina, tachyarrhythmia (rapid heart rate), hypertrophic obstructive cardiomyopathy (abnormally thick heart muscle), heart failure (poor heart function).
• If you have very high blood pressure.
• If you have glaucoma (eye disease characterized by increased pressure inside the eyeball).
• If you have hyperthyroidism (excess thyroid function).
• If you have epilepsy (seizures).
• If you have severe hypoxemia or cor pulmonale (lung problems).
• If you have gastric or duodenal ulcers.
• If you have liver failure (your liver does not function properly).

Special caution should be exercised when adjusting the dose for patients who meet the following conditions:

• If you drink alcohol, smoke, or are an ex-smoker, please inform your doctor.
• If you are an obese patient.
• If you are over 65 years old, or if you are going to administer it to a child, keep in mind that your doctor should make a dose adjustment before prescribing this medication.
• If you are taking other medications, please inform your doctor.
• If you have a fever, it may be necessary to decrease the dose of theophylline.
• If you visit another doctor or dentist, please inform them that you are taking this product.

Children and adolescents

Elixifilin is not recommended for use in children between 1 year and 6 months of age. Children under 6 months should not take this medication.

The alcohol content of this medication should be taken into account before it is used in children and adolescents.

Other medications and Elixifilin

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

Theophylline may decrease or increase the effect of other medications, and in turn, the effect of theophylline may be decreased or increased by other medications if taken together. For this reason, it is necessary to inform your doctor if you are taking:

• barbiturates (used to produce sedation, relaxation), such as phenobarbital, pentobarbital,
• medications for epilepsy (carbamazepine, phenytoin, and fosphenytoin),
• antibiotics (rifampicin and rifapentine),
• medications for high blood pressure (sulfinpyrazone),
• products containing hypericum (St. John's Wort).

The levels of theophylline may increase (with a high risk of overdose and adverse reactions) when taking Elixifilin simultaneously with:

• oral contraceptives,
• certain antibiotics (erythromycin, troleandomycin, clarithromycin, josamycin, and spiramycin),

quinolones (gyrase inhibitors, especially ciprofloxacin, enoxacin, and pefloxacin), imipenem (especially central nervous system adverse effects such as seizures),

• isoniazid (treatment of tuberculosis),
• tiabendazole (treatment of fungi),

• calcium channel blockers (for heart disease), such as verapamil and diltiazem,
• propranolol (treatment of hypertension or high blood pressure),
• mexiletine (treatment of hypertension or high blood pressure),
• propafenone (treatment of heart problems),
• ticlopidine (prevention of blood coagulation),
• cimetidine, ranitidine (prevention of acid production in the stomach)
• allopurinol, febuxostat (treatment of gout)
• fluvoxamine (treatment of mental illnesses),
• interferon alfa and peginterferon alfa-2 (treatment of immunological disorders),
• zafirlukast (treatment of asthma),
• influenza vaccines,
• zileuton (treatment of asthma).
• other products containing theophylline or other xanthines (such as caffeine and similar substances).

If you are taking any of the medications mentioned above, your doctor may prescribe another medication or adjust the dose of Elixifilin or another medication.

Taking Elixifilin with food, drinks, and alcohol

It should be avoided to ingest, in large quantities, beverages with caffeine, such as: tea, coffee, cocoa, cola drinks, or large amounts of chocolate. These products can increase the adverse reactions of this medication.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medication.

Pregnancy

The use of theophylline is not recommended during pregnancy.

Breastfeeding

The use of theophylline is not recommended during breastfeeding.

Consult your doctor or pharmacist before using any medication.

The alcohol content of this medication should be taken into account in the case of pregnant or breastfeeding women.

Interference with diagnostic tests

If you are going to undergo any diagnostic tests (including blood tests, urine tests, skin tests using allergens), inform your doctor that you are taking this medication, as it may alter the results.

Driving and using machines

This medication may alter your reaction speed, so you should be careful when driving and/or using machines, especially at the start of treatment, when changing the dose, or when administering it together with other medications.

Due to its ethanol content, it is recommended not to drive or operate hazardous machinery.

Elixifilin contains sucrose, ethanol, and amaranth (E123)

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

It may cause cavities.

This medication contains 10.66% ethanol (alcohol), which corresponds to an amount of 2,575.2 mg of ethanol per 30 ml dose, equivalent to 64 ml of beer or 27 ml of wine.

This medication is harmful to people with alcoholism.

The alcohol content should be taken into account in the case of pregnant or breastfeeding women, children, and high-risk groups, such as patients with liver disease or epilepsy.

This medication may cause allergic reactions because it contains amaranth (E123).

It can cause asthma, especially in patients allergic to acetylsalicylic acid.

3. How to take Elixifilin

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is:

Adults and adolescents over 16 years old

A medium recommended dosage for an adult is 160 mg of theophylline equivalent to 30 ml (2 dose measuring caps) of oral solution three times a day, sufficiently spaced: in the morning, at noon, and at bedtime.

If theophylline blood levels are not controlled, you should never take more than 20 mg/kg/day of theophylline.

Smoking patients may require higher doses of the preparation and/or shorter intervals. The dose for ex-smoking patients should be carefully selected due to a possible change in the theophylline dose.

In the case of patients with liver failure, congestive heart failure, over 65 years old, and obese patients, lower doses should be used.

Adults and adolescents Theophylline

over 16 years old mg/Kg/day

Smokers 15

Non-smokers 11

• cardiac, cor pulmonale,

acute pulmonary edema 7

• hepatic 5
• cardiac and hepatic 2

over 65 years old 9.5

Pediatric population

Children and adolescents between 1 and 16 years old

The metabolism of theophylline changes during growth, becoming similar to that of an adult around 16 years old. The maximum recommended doses are:

Children and adolescents Theophylline

between 1 and 16 years old mg/Kg/day

1-9 years 21

9-12 years 18

12-16 years 13

Children between 1 year and 6 months old

The use of this medication is not recommended.

Children under 6 months old

Elixifilin should not be used in children under 6 months old.

How to take Elixifilin:

This medication is taken orally.

If you experience digestive discomfort with this medication, you can take it with food.

If you take moreElixifilinthan you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

Intoxication can manifest with agitation, logorrhea (excessive and disordered use of words when speaking), mental confusion, vomiting, fever, rapid heart rate, and very low blood pressure. In adults, there may also be seizures and cardiac arrest.

If you forget to takeElixifilin

If you forget to take a dose of this medication, take the next dose as prescribed. Do not take a double dose to make up for forgotten doses.

It is important that you continue taking Elixifilin until your doctor tells you otherwise.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone gets them.

During the period of use of theophylline, the following side effects have been observed, whose frequency could not be established from the available data. These are more frequently associated with theophylline plasma levels above 20 micrograms/ml.

Nervous system disorders

Irritability, nervousness, headache, insomnia, hyperexcitability, muscle contractions, seizures, behavioral changes.

Cardiac disorders:

Palpitations, sinus or ventricular tachycardia, extrasystoles or ventricular arrhythmia.

Vascular disorders:

Peripheral vasodilation and hypotension.

Gastrointestinal disorders:

Nausea, vomiting, diarrhea, and pain in the upper abdomen (epigastrium).

Skin and subcutaneous tissue disorders:

Skin rashes.

Complementary tests:

Reduction of prothrombin time and increase of serum GOT.

When overdose is suspected, a control of theophylline plasma concentration should be requested. If this is not possible, the dose should be reduced or administration should be suspended, depending on the severity of the symptoms.

Reporting of 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 the Spanish Pharmacovigilance System for Human Use Medicines (website: www.notificaRAM.es). By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Elixifilin

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

Do not store above 25°C.

Keep in the outer packaging to protect from light.

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

Medications should not be disposed of through wastewater or household waste. Place the packaging and medications you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition ofElixifilin 5.33 mg/ml oral solution

• The active ingredient is theophylline. Each milliliter contains 5.33 mg of theophylline.
• The other components (excipients) are: citric acid monohydrate (E330), ethanol, sucrose, cherry flavor, ethyl vanillin, glycerol (E422), amaranth (E123), sodium saccharin (E954), silicone antifoam, quinoline yellow (E104), purified water.

Appearance of the product and packaging contents

Brown glass bottle containing 250 ml of oral solution, including a 15 ml dose measuring cap with measures of 2.5, 3.75, 5, 7.5, 10, and 15 ml.

Marketing authorization holder and manufacturer:

Marketing authorization holder

Tora Laboratories, S.L.U.

Avenida de Oporto, 60

28019 Madrid, Spain

Manufacturer

Farmasierra Manufacturing, S.L.

Carretera de Irún Km 26,200

San Sebastián de los Reyes

28709 Madrid

Spain

Date of the last revision of this leaflet:October 2021

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