Product Information for the User

Teromol Retard 300 mg Extended-Release Tablets

TheophyllineAnhydrous

Read this entire product information carefully before starting to take this medication, as it contains important information for you.

• Keep this product information, as you may need to refer to it again.

If you have any questions, consult your doctor or pharmacist.

• This medication has been prescribed to you alone, 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 adverse effects, consult your doctor or pharmacist, even if they are not listed in this product information. See section 4.

1. What is Teromol Retard and what is it used for.

2. What you need to know before starting to take Teromol Retard.

3. How to take Teromol Retard.

4. Possible adverse effects.

5. Storage of Teromol Retard.

6. Contents of the package and additional information.

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 reversible closure of the respiratory pathways (reversible bronchospasm) associated with lung diseases such as chronic bronchitis or emphysema and asthma.

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

Do not take Teromol Retard:

• 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 an abnormal heart rhythm (acute tachyarrhythmia).
• If you have recently had a heart attack.
• If you are a child under 6 months of age.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Teromol Retard if:

• You have any heart disease,
• You have very high blood pressure (severe hypertension),
• You have an overactive thyroid gland (hyperthyroidism),
• You have convulsive disorders (epilepsy),
• You have stomach and/or duodenal ulcers,
• You have porphyria (a disorder that affects the production of hemoglobin),
• You have liver and/or kidney problems (hepatic and/or renal insufficiency),
• You know that you do not eliminate theophylline correctly.

If you are a smoker, inform your doctor as it may be necessary to adjust your dose.

If you have a fever, consult your doctor as it may be necessary to adjust your dose.

Children and adolescents

Teromol Retard is not suitable for children under 12 years old as this medication cannot be administered in doses less than 300 mg of theophylline at a time.

Taking Teromol Retard with other medications

Inform your doctor or pharmacist if you are taking or have taken recently or may 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 together. Therefore, it is necessary to inform your doctor if you are taking:

- Other preparations containing theophylline or other xanthines (such as caffeine and similar substances),

- Beta2-adrenergic receptor inducers (beta2-agonists, generally used to treat asthma),

- Barbiturates, especially phenobarbital, pentobarbital, and primidone (used to produce sedation, relaxation),

- Carbamazepine (an anticonvulsant used to treat epilepsy),

- Phenytoin and fosphenytoin (used to treat epilepsy),

- Rifampicin and rifapentine (antibiotics),

- Sulfinpyrazone (used to treat gout),

- Products containing St. John's Wort (Hypericum),

- Oral contraceptives,

- Macrolide antibiotics (especially erythromycin, troleandomycin, clarithromycin, josamycin, and spiramycin),

- Quinolone antibiotics (inhibitors of the gyrase, especially ciprofloxacin, enoxacin, and pefloxacin),

- Imipenem (especially central nervous system adverse effects such as convulsions),

- Isoniazid (treatment of tuberculosis),

- Thiabendazole (treatment of fungi),

- Calcium channel blockers (e.g. verapamil and diltiazem) used to treat heart diseases,

- Propranolol (treatment of hypertension or high blood pressure),

- Mexiletine (treatment of heart problems),

- Propafenone (treatment of heart problems),

- Ticlopidine (prevention of blood coagulation),

- Cimetidine, ranitidine, and etintidine (prevent the production of acid in the stomach),

- Allopurinol, febuxostat (treatment of gout),

- Fluvoxamine (treatment of mental disorders),

- Interferon alpha and peginterferon alpha-2 (treatment of immunological disorders),

- Zafirlukast (treatment of asthma),

- Influenza vaccines,

- Idrocilamide (muscle treatments),

- Zileuton (treatment of asthma),

- Diuretics (furosemide),

- Halothane (general anesthetic),

- Digitalis (treatment of heart problems),

- Benzodiazepines (used to produce sedation, relaxation).

Interference with diagnostic tests

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

Taking Teromol Retard with food and drinks

Avoid taking large amounts of caffeine-containing beverages such as tea, coffee, cocoa, cola, and large amounts of chocolate. These products may increase the side effects of this medication.

Pregnancy and breastfeeding

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

Pregnancy

The use of theophylline during pregnancy is not recommended.

Breastfeeding

The use of theophylline during breastfeeding is not recommended.

Older adults

Do not use in people over 65 years old without consulting a doctor.

Driving and operating machinery

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

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

Your doctor will tell you the exact dose you should take. The doses will be taken at regular intervals of 12 hours. It is essential that you strictly follow what your doctor recommends you take, especially regarding the spacing of the doses.

The tablets should be taken without dissolving, chewing, or biting, and swallowed with sufficient liquid.

It is recommended to take this medication at night, before going to bed.

Adults and adolescents over 16 years old

The recommended dose is 1 tablet (300 mg of theophylline) every 12 hours. Your doctor may increase the dose depending on how you respond to the treatment.

Older patients

Your doctor will evaluate the dose that you should be administered.

Use in children and adolescents

The groove should not be used to split the tablet.

• Children under 12 years old

Teromol Retard is not suitable for children under 12 years old (see sectionChildren and adolescentsin section 2 of this leaflet).

• Adolescents between 12 and 16 years old

The recommended dose is 13 mg per kilogram of body weight per day. This amount will be divided into two doses.

If you take more Teromol Retard than 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.

If you forget to take Teromol Retard

Do not take a double dose to compensate for the missed doses. Take the next dose as indicated by your doctor, at the usual time.

If you interrupt the treatment with Teromol Retard

If you stop taking this medication, your condition may worsen. Do not stop taking the medication unless your doctor tells you to.

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

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

The known possible adverse effects are listed below:

Very frequent adverse effects (may affect more than 1 in 10 patients):

• Blood composition alterations: decreased potassium (hypokalemia), increased calcium (hypercalcemia), increased sugar (hyperglycemia), increased creatinine, increased uric acid (hyperuricemia), and changes in electrolytes.
• Increased urine production (diuresis).
• Skin eruptions.

Frequent adverse effects (may affect up to 1 in 10 patients):

• Changes in heart rhythm (tachycardia and arrhythmia) or worsening of pre-existing arrhythmias, palpitations, decreased blood pressure (hypotension).
• Gastrointestinal problems, nausea, vomiting, diarrhea.
• Headache (cephalalgia), states of excitement, tremors, agitation, nervousness, insomnia, convulsions, seizures, dizziness.

Rare adverse effects (may affect up to 1 in 100 patients):

• Increased stomach acid secretion after theophylline administration. Consequently, patients with peptic ulcers are at risk.
• Allergic reactions (hypersensitivity).

Adverse effects that are rare (may affect up to 1 in 1,000 patients):

• Esophageal ulcers.
• Allergic reactions such as: generalized eczema on the skin and contact dermatitis.

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 theSpanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.esBy 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.

No special storage conditions are required.

Store the tablets in the original packaging to protect them from light and moisture.

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 the packaging and unused medications at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Teromol Retard

• The active ingredient is anhydrous theophylline. Each tablet contains 300 mg of anhydrous theophylline.
• The other components are microcrystalline cellulose, low-viscosity hydroxypropylmethylcellulose, high-viscosity hydroxypropylmethylcellulose, and magnesium stearate.

Appearance of the product and contents of the packaging

Teromol Retardare prolonged-release, white, scored tablets.

The packaging contains 40 tablets.

Holder of the marketing authorization and responsible manufacturer

Laboratorio Aldo-Unión, S.L

Calle Baronesa de Maldá, 73

08950 Esplugues de Llobregat

Barcelona - Spain

Date of the last review of this leaflet:06/2022

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