Teromol Retard 300 mg prolonged-release tablets
SpainTable of Contents
Package Leaflet: Information for the User
Introduction
Package Leaflet: Information for the User
Teromol Retard 300 mg prolonged-release tablets
Anhydrous theophylline
Read the entire 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 only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Leaflet Contents:
- What Teromol Retard is and what it is used for.
- What you need to know before taking Teromol Retard.
- How to take Teromol Retard.
- Possible adverse effects.
- How to store Teromol Retard.
- 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, emphysema, and asthma.
Theophylline should not be the first-choice medicine for treating asthma in children.
2. What you need to know before taking Teromol Retard
Do not take Teromol Retard:
- If you are allergic to theophylline or to any other medicine of the same group, or to any of the other components of this medicine (listed in section 6).
- If you have a heart rhythm disorder (acute tachyarrhythmia).
- If you have recently had a myocardial infarction.
- If you are a child under 6 months of age.
Warnings and precautions
Talk to your doctor or pharmacist before starting Teromol Retard if:
- you have any heart disease,
- you have very high blood pressure (severe hypertension),
- you have overactive thyroid gland (hyperthyroidism),
- you have seizure disorders (epilepsy),
- you have gastric (stomach) and/or duodenal ulcers,
- you have deficiencies in hemoglobin production (porphyria),
- you have liver and/or kidney problems (hepatic and/or renal insufficiency),
- you know that you do not eliminate theophylline properly from your body.
If you are a smoker, inform your doctor, as your dose may need to be adjusted.
If you have a fever, consult your doctor, as your dose may need to be adjusted.
Children and adolescents
Teromol Retard is not suitable for children under 12 years of age, as doses lower than 300 mg of theophylline cannot be administered with this medicine in a single dose.
Taking Teromol Retard with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Theophylline may decrease or increase the effect of other drugs, and likewise, the effect of theophylline may be decreased or increased by other drugs when taken concomitantly. For this reason, it is essential to inform your doctor if you are taking:
- other preparations containing theophylline or other xanthines (such as caffeine and similar substances),
- beta2-adrenergic receptor agonists (beta2-agonists, commonly used to treat asthma),
- barbiturates, especially phenobarbital, pentobarbital, and primidone (used to induce sedation and relaxation),
- carbamazepine (an anticonvulsant used for epilepsy),
- phenytoin and fosphenytoin (used for epilepsy),
- rifampicin and rifapentine (antibiotics),
- sulfinpyrazone (used to treat gout),
- products containing St. John’s wort (Hypericum perforatum),
- oral contraceptives,
- macrolide antibiotics (especially erythromycin, troleandomycin, clarithromycin, josamycin, and spiramycin),
- quinolone-type antibiotics (gyrase inhibitors, especially ciprofloxacin, enoxacin, and pefloxacin),
- the antibiotic imipenem (especially central nervous system adverse effects such as seizures),
- isoniazid (treatment for tuberculosis),
- thiabendazole (treatment for fungal infections),
- calcium channel blockers (e.g., verapamil and diltiazem) used for heart conditions,
- propranolol (treatment for hypertension or high blood pressure),
- mexiletine (treatment for heart problems),
- propafenone (treatment for heart problems),
- ticlopidine (prevention of blood clotting),
- cimetidine, ranitidine, etintidine (reduce stomach acid production),
- allopurinol, febuxostat (treatment for gout),
- fluvoxamine (treatment for mental disorders),
- interferon alfa and peginterferon alfa-2 (treatment for immunological disorders),
- zafirlukast (treatment for asthma),
- influenza vaccines,
- idrocilamide (muscle treatments),
- zileuton (treatment for asthma),
- diuretics (furosemide),
- halothane (general anesthetic),
- digitalis glycosides (treatment for heart problems),
- benzodiazepines (used to induce sedation and relaxation).
Interference with diagnostic tests
If you are scheduled to undergo any diagnostic tests (including blood and urine tests, skin tests using allergens), inform your doctor that you are taking this medicine, as it may alter test results.
Taking Teromol Retard with food and drinks
You should avoid consuming large amounts of caffeine-containing beverages such as tea, coffee, cocoa, cola, and large quantities of chocolate. These products may increase the side effects of this medicine.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.
Pregnancy
The use of theophylline during pregnancy is not recommended.
Breastfeeding
The use of theophylline during breastfeeding is not recommended.
Elderly people
Do not use in patients over 65 years of age without consulting a doctor.
Driving and using machines
This medicine may affect your reaction speed; therefore, exercise caution when driving and/or operating machinery. This is especially important at the beginning of treatment, when adjusting the dose, or when taking it concomitantly with other medicines.
3. How to take Teromol Retard
Follow exactly the administration instructions for this medicine as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
Your doctor will determine the exact dose you should take. Doses should be taken at regular 12-hour intervals. It is important that you strictly follow your doctor's recommendations, especially regarding the timing of doses.
The tablets must be taken whole, without dissolving, chewing or biting, swallowed 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 theophylline) every 12 hours. Your doctor may increase the dose depending on your response to treatment.
Elderly patients
Your doctor will evaluate the appropriate dose for you.
Use in children and adolescents
The tablet's notch must 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 2, Children and adolescents in this leaflet).
- Adolescents between 12 and 16 years
The recommended dose is 13 mg per kg of body weight per day. This amount should be divided into two daily doses.
If you take more Teromol Retard than you should
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 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 missed doses. Take the next dose as directed by your doctor, at your usual time.
If you stop taking Teromol Retard
If you discontinue treatment with this medicine, your condition may worsen. Do not stop taking the medicine unless instructed by your doctor.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.
The known possible adverse effects are listed below:
Very common adverse effects (may affect more than 1 in 10 patients):
- Changes in blood composition: decreased potassium (hypokalaemia), increased calcium (hypercalcaemia), increased blood sugar (hyperglycaemia), increased creatinine, increased uric acid (hyperuricaemia), and changes in electrolytes.
- Increased urine production (diuresis).
- Skin rashes.
Common adverse effects (may affect up to 1 in 10 patients):
- Changes in heart rhythm (tachycardia and arrhythmia) or worsening of pre-existing arrhythmias, palpitations, drop in blood pressure (hypotension).
- Gastrointestinal problems, nausea, vomiting, diarrhoea.
- Headache (cephalalgia), states of excitement, limb tremors, agitation, nervousness, insomnia, seizures, epileptic crises, dizziness.
Uncommon adverse effects (may affect up to 1 in 100 patients):
- Increased secretion of acid in the stomach following the administration of theophylline. Consequently, patients with peptic ulcer are at risk.
- Allergic reactions (hypersensitivity).
Rare adverse effects (may affect up to 1 in 1,000 patients):
- Oesophageal ulcerations.
- Allergic reactions such as: generalized eczema and contact dermatitis.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Teromol Retard
Keep this medicine 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 use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.
6. Contents of the pack and other information
Composition of Teromol Retard
- The active substance 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 pack contents
Teromol Retard are prolonged-release white tablets, scored.
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 the most recent review of this leaflet: 06/2022
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/