TEROMOL RETARD 300 mg PROLONGED-RELEASE TABLETS

Package Leaflet: Information for the User

Teromol Retard 300 mg Prolonged-Release Tablets

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

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

This medicine belongs to a group of medicines called bronchodilators, which means they dilate the bronchi and facilitate breathing.

It is indicated for the prevention and treatment of reversible airway obstruction (reversible bronchospasm) associated with lung diseases such as chronic bronchitis or emphysema and asthma.

Theophylline should not be the first choice of medication for treating asthma in children.

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

Do not take Teromol Retard:

• If you are allergic to theophylline or any other medicine of the same group or to any of the other ingredients of this medicine (listed in section 6).
• If you have acute heart rhythm disorders (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 taking 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 seizure disorders (epilepsy),
• you have stomach ulcers and/or duodenal ulcers,
• you have hemoglobin production deficiencies (porphyria),
• you have liver and/or kidney problems (hepatic and/or renal insufficiency),
• you know you do not eliminate theophylline correctly.

If you are a smoker, inform your doctor as you may need a dose change.

If you have a fever, consult your doctor as you may need a dose change.

Children and adolescents

Teromol Retard is not suitable for children under 12 years of age as this medicine cannot be administered in quantities less than 300 mg of theophylline in a single dose.

Taking Teromol Retard with other medicines

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

Theophylline may decrease or increase the effect of other medicines, and the effect of theophylline may be decreased or increased by other medicines if taken together. For this reason, 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 for sedation, relaxation),
• carbamazepine (anticonvulsant used for epilepsy),
• phenytoin and fosphenytoin (used for epilepsy),
• rifampicin and rifapentine (antibiotics),
• sulfinpyrazone (used to treat gout),
• products containing hypericum (St. John's Wort),
• oral contraceptives,
• macrolide antibiotics (especially erythromycin, troleandomycin, clarithromycin, josamycin, and spiramycin),
• quinolone antibiotics (gyrase inhibitors, especially ciprofloxacin, enoxacin, and pefloxacin),
• the antibiotic imipenem (especially central nervous system side effects such as seizures),
• isoniazid (treatment for tuberculosis),
• tiabendazole (treatment for fungal infections),
• calcium channel blockers (e.g., verapamil and diltiazem) used for heart disease,
• propranolol (treatment for high blood pressure),
• mexiletine (treatment for heart problems),
• propafenone (treatment for heart problems),
• ticlopidine (prevention of blood coagulation),
• cimetidine, ranitidine, etintidine (preventing stomach acid production),
• allopurinol, febuxostat (treatment for gout),
• fluvoxamine (treatment for mental illnesses),
• interferon alfa and peginterferon alfa-2 (treatment for immunological disorders),
• zafirlukast (treatment for asthma),
• influenza vaccines,
• hydroxylamide (muscle treatments),
• zileuton (treatment for asthma),
• diuretics (furosemide),
• halothane (general anesthetic),
• digitalis (treatment for heart problems),
• benzodiazepines (used for sedation, relaxation).

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 medicine as it may alter the results.

Taking Teromol Retard with food and drinks

You should avoid taking high amounts of caffeinated beverages such as tea, coffee, cocoa, cola, and large amounts of chocolate. These products can increase the side effects of this medicine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

The use of theophylline is not recommended during pregnancy.

Breastfeeding

The use of theophylline is not recommended during breastfeeding.

Elderly

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

Driving and using machines

This medicine may affect your reaction time, so you should be careful when driving and/or using machines. This is especially important at the start of treatment, when changing the dose, or when taking it together with other medicines.

3. How to take Teromol Retard

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

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

The tablets should be taken without dissolving, without chewing or biting, swallowing them with sufficient liquid.

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

Adults and adolescents over 16 years

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 treatment.

Elderly patients

Your doctor will assess the dose to be administered.

Use in children and adolescents

The score line should not be used to divide the tablet.

• Children under 12 years

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

• Adolescents between 12 and 16 years

The recommended dose is 13 mg per kg 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 Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Teromol Retard

Do not take a double dose to make up for forgotten doses. Take the next dose as your doctor has indicated, at the usual time.

If you stop taking Teromol Retard

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

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The possible side effects known are listed below:

Very common side effects (may affect more than 1 in 10 people):

• Blood composition changes: low potassium levels (hypokalemia), high calcium levels (hypercalcemia), high sugar levels (hyperglycemia), high creatinine levels, high uric acid levels (hyperuricemia), and changes in electrolytes.
• Increased urine production (diuresis).
• Skin rashes.

Common side effects (may affect up to 1 in 10 people):

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

Uncommon side effects (may affect up to 1 in 100 people):

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

Rare side effects (may affect up to 1 in 1,000 people):

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

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 Health Products Agency (AEMPS) website: www.notificaRAM.es By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Teromol Retard

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

No special storage conditions are required.

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

Do not use this medicine after the expiry date which is stated on the packaging after EXP. The expiry date is the last day of the month shown.

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 other information

Teromol Retard composition

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

Appearance and packaging of the product

Teromol Retard are white, prolonged-release tablets with a score line.

The pack contains 40 tablets.

Marketing authorization holder and manufacturer

Laboratorio Aldo-Unión, S.L.

Calle Baronesa de Maldá, 73

08950 Esplugues de Llobregat

Barcelona - Spain

Date of last revision of this leaflet:06/2022

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