Package Insert: Information for the User

THEO-DUR 200mg prolonged-release tablets

Theophylline

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

• Keep this package insert, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only for you and should not be given 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 package insert. See section 4.

1. What Theo-Dur is and for what it is used

2. What you need to know before starting to take Theo-Dur

3. How to take Theo-Dur

4. Possible adverse effects

5. Storage of Theo-Dur

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 asthma or bronchial spasm associated with lung diseases such as chronic bronchitis or emphysema.

Do not take Theo-Dur

• If you are allergic to the active ingredient 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 irregular heartbeat (acute arrhythmia).
• If you have recently had a heart attack.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Theo-Dur if:

• You have any heart disease,
• You have high blood pressure (hypertension),
• You have an overactive thyroid gland (hyperthyroidism),
• You have convulsive disorders (epilepsy),
• You have a stomach ulcer (gastric and/or duodenal),
• You have porphyria (a deficiency in 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.

Children

The use of theophylline in children under one year is not recommended.

Taking Theo-Dur with other medications

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 together. For this reason, you must inform your doctor if you are taking:

• Other preparations containing theophylline or other xanthines (such as caffeine and similar substances),
• Inducers of beta2-adrenergic receptors (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),
• Phenitoin and fosphenitoin (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; see below),
• Imipenem (especially central nervous system adverse effects such as convulsions),
• Isoniazid (treatment of tuberculosis),
• Thiabendazole (treatment of fungi),
• Calcium antagonists (e.g. verapamil and diltiazem) used to treat heart disease,
• 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, 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),
• Digitals (treatment of heart problems),
• Benzodiazepines (used to produce sedation, relaxation).

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

Interaction 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 Theo-Dur 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 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.

Older adults

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

Driving and operating machinery

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

Theo-Dur contains lactose

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

Theo-Dur contains saccharose

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

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 indicate the exact dose you should take. Doses will be taken at regular intervals of 12 hours. It is essential to strictly follow the dosing schedule, especially regarding the spacing of doses.

As a guideline, the following dose can be followed, but remember that the dose should be the one recommended by your doctor.

Adults and adolescents over 16 years old

The recommended dose for adults is 200 mg (1 tablet) every 12 hours. Your doctor may increase the dose depending on how you respond to treatment.

Pediatric population (between 1 and 16 years old)

The recommended dose is 4 mg per kilogram of body weight per day. This amount will be divided into two doses every 12 hours each.

Geriatric patients

In the case of geriatric patients, your doctor will evaluate the dose that should be administered.

Administration form

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

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

If you take more Theo-Dur than you should

Consult your doctor or the nearest emergency service immediately or call the Toxicological Information Service, Telephone 915 620 420, indicating the medication and the amount taken. Bring the packaging and any remaining tablets with you.

If you forget to take Theo-Dur

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 treatment with Theo-Dur

If you stop taking Theo-Dur, 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 medication may produce adverse effects, although not all people will experience them.

The possible adverse effects are listed below:

• Tachycardia and arrhythmia (changes in heartbeats), palpitations, drop in blood pressure.
• Gastrointestinal problems, nausea, vomiting, diarrhea, stomach problems (weakness of the lower esophageal sphincter muscle tone) that may increase nocturnal acid reflux if you already have it.
• Allergic reactions (hypersensitivity).
• Blood alterations such as: potassium decrease (hypokalemia), calcium increase (hypercalcemia), glucose increase (hyperglycemia), creatinine increase, uric acid increase (hyperuricemia) and changes in electrolytes.
• Headache, states of excitement, tremors, nervousness, insomnia, convulsions.
• Increased urine production (diuresis).

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use (website:www.notificaRAM.es).

By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

No special storage conditions are required.

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

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Theo-Dur Composition

• The active principle is theophylline. Each tablet contains 200 mg of anhydrous theophylline.
• The other components are: acetoftalate cellulose, cetyl alcohol, myristic alcohol, white wax, diethyl phthalate, magnesium stearate, hydroxypropyl methylcellulose, anhydrous lactose, glyceryl monostearate, neutral pellets (cornstarch and sugar spheres [sucrose and cornstarch]).

Appearance of the product and content of the packaging

Theo-Dur 200 mg prolonged-release tablets are presented in the form of white, cylindrical, scored tablets. The containers contain 40 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

VEGAL FARMACEUTICA, S.L.

Vía de las Dos Castillas9C, portal 2, 2º C

28224 Pozuelo de Alarcón – Madrid. Spain.

Responsible for manufacturing

GENERIS FARMACÊUTICA, S.A.

Rua Joäo de Deus, 19, Venda Nova, 2700-487 Amadora – Portugal

or

COVEX, S.A.

Calle Acero 25, Polígono Industrial Sur

28770 Colmenar Viejo - Madrid. Spain

Other presentations

Theo-Dur 100 mg prolonged-release tablets: Container with 40 tablets.

Theo-Dur 300 mg prolonged-release tablets: Container with 40 tablets.

Last review date of this leafletSeptember 2013

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/