PATIENT INFORMATION LEAFLET

Elixifilin 5.33 mg/mL oral solution

Theophylline anhydrous

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask 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.

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

It is indicated forthe 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.

Do not takeElixifilin

• If you are allergic to theophylline or any other medication in the same group or to any of the other components of this medication (listed in section 6).
• If you suffer from 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 conditions, you must inform your doctor as you may need a dose adjustment:

• If you have or have had heart disease: unstable angina, tachyarrhythmia (rapid heart rate), hypertrophic obstructive cardiomyopathy (abnormally thick heart muscle), heart failure.
• If you have high blood pressure.
• If you have glaucoma (eye disease characterized by increased pressure within the eyeball).
• If you have hyperthyroidism (excessive function of the thyroid gland).
• If you have epilepsy (you experience seizures).
• If you have severe hypoxemia or cor pulmonale (lung problems).
• If you have a gastric or duodenal ulcer.
• If you have liver insufficiency (your liver does not function properly).

You must exercise special caution when adjusting the dose of patients who meet the following conditions:

• If you drink alcohol, smoke or are an ex-smoker, please inform your doctor.
• If you are obese.
• If you are over 65 years old, or if you are going to administer this medication to a child, please note that your doctor must adjust the dose before prescribing this medication.
• If you are taking other medications, please inform your doctor.
• If you have a fever, you may need to reduce 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 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 using it in children and adolescents.

Other medications and Elixifilin

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

Theophylline may decrease or increase the effect of other medications, and the effect of theophylline may be decreased or increased by other medications, if taken concurrently. Therefore, you must 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 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 (inhibitors of the enzyme, especially ciprofloxacin, enoxacin and pefloxacin, imipenem (especially central nervous system adverse effects such as seizures),

• isoniazid (tuberculosis treatment),
• tiabendazole (fungal treatment),

• calcium channel blockers (for heart disease), such as verapamil and diltiazem,
• propranolol (high blood pressure treatment),
• mexiletine (high blood pressure treatment),
• propafenone (heart problems treatment),
• ticlopidine (blood clot prevention),
• cimetidine, ranitidine (acid production prevention in the stomach)
• allopurinol, febuxostat (gout treatment)
• fluvoxamine (mental health treatment),
• interferon alpha and peginterferon alpha-2 (immune system disorders treatment),
• zafirlukast (asthma treatment),
• influenza vaccines,
• zileuton (asthma treatment)
• 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

Avoid consuming large amounts of beverages containing caffeine, such as tea, coffee, cocoa, cola drinks or large amounts of chocolate. These products may increase the adverse reactions of this medication.

Pregnancy, breastfeeding and fertility

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

Pregnancy

The use of theophylline during pregnancy is not recommended.

Breastfeeding

The use of theophylline during breastfeeding is not recommended.

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 women or breastfeeding women.

Interference with diagnostic tests

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

Driving and operating machinery

This medication may alter your reaction time, so you must be cautious if you are going to drive and/or operate machinery, especially at the beginning of treatment, when modifying the dose or when taking it concurrently with other medications.

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

Elixifilin contains saccharose, ethanol and amarant (E123)

This medication contains saccharose. If your doctor has indicated that you have a certain sugar intolerance, consult with him before taking this medication.

This medication may cause tooth decay.

This medication contains 10.66% ethanol (alcohol), which corresponds to 2,575.2 mg of ethanol per dose of 30 ml, 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 women 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 amarant (E123).

This medication may cause asthma, especially in patients allergic to acetylsalicylic acid.

Follow exactly the administration instructions of this medication as 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 recommended average dose for an adult is 160 mg of theophylline equivalent to 30 ml (2 dosing caps) of oral solution three times a day, sufficiently spaced: upon waking, at noon, and at bedtime.

If blood theophylline levels are not monitored, 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-smokers should be carefully selected due to a possible change in theophylline dose.

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

Adultsand adolescentsTheophylline

over 16 yearsmg/Kg/day

Smokers15

Non-smokers11

Congestive heart failure, cor pulmonale,

Acute pulmonary edema7

Liver insufficiency5

Heart and liver insufficiency2

> 65 years9.5

Pediatric population

Children and adolescents between 1 and 16 years old

Theophylline metabolism changes during growth, becoming similar to that of an adult by 16 years old, the recommended maximum doses are:

Children and adolescentsTheophylline

between 1 and 16 years oldmg/Kg/day

1-9 years21

9-12 years18

12-16 years13

Children between 1 year and 6 months old

This medication is not recommended for use in children.

Children under 6 months

Elixifilin should not be used in children under 6 months of age.

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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

Intoxication may 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, it may also cause convulsions 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 compensate for the missed doses.

It is essential to continue taking Elixifilin until your doctor tells you otherwise.

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

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

During the period of use of theophylline, the following adverse effects have been observed, whose frequency has not been established from the available data, which manifest more frequently associated with plasma theophylline levels above 20 micrograms/ml.

Nervous System Disorders

Irritability, nervousness, headache, insomnia, hyperreflexia, 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 upper abdominal pain (in the epigastrium).

Skin and Subcutaneous Tissue Disorders:

Cutaneous eruptions.

Complementary Examinations:

Reduction of prothrombin time and increase of serum GOT.

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

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use (website:www.notificaRAM.es). By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

Do not store at a temperature above 25°C.

Keep in the outer packaging to protect it from light.

Do not usethis medicationafter 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 unused medications at the SIGREpoint of the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition ofElixifilin 5.33 mg/mL oral solution

• The active ingredient istheophylline. 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), antifoaming silicone, quinoline yellow (E104), purified water.

Appearance of the product and contents of the packaging

Amber glass bottle containing 250 mL of oral solution, includes a 15 mL dosing cap with measurements of2.5, 3.75, 5, 7.5, 10, and 15 mL.

Holder of the marketing authorization and responsible for manufacturing:

Holder of the marketing authorization

Tora Laboratories, S.L.U.

Avenida de Oporto, 60

28019 Madrid, Spain

Responsible for manufacturing

Farmasierra Manufacturing, S.L.

Carretera de Irún Km 26,200

San Sebastián de los Reyes

28709 Madrid

Spain

Date of the last review of this leaflet:October 2021

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