Theospirex retard 300 mg

Leaflet attached to the packaging: patient information

Theospirex retard 300 mg

300 mg, prolonged-release coated tablets

Anhydrous theophylline

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any further questions, you should ask your doctor or pharmacist.
• This medicine has been prescribed for a specific person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What Theospirex retard 300 mg is and what it is used for
• 2. Important information before taking Theospirex retard 300 mg
• 3. How to take Theospirex retard 300 mg
• 4. Possible side effects
• 5. How to store Theospirex retard 300 mg
• 6. Contents of the pack and other information

1. What Theospirex retard 300 mg is and what it is used for

Theospirex retard 300 mg is a medicine that contains theophylline in the form of prolonged-release coated tablets.
The medicine has a bronchodilator effect on the smooth muscles of the bronchi, bronchioles, and blood vessels, and inhibits the release of mediators from cells involved in inflammatory reactions.
The medicine also has a positive effect on the strength and duration of cardiac muscle contraction, increases urine excretion, and reduces edema.

Indications:

• Prevention of bronchospasm in asthma and chronic obstructive pulmonary disease.

Warning!

Medicines containing theophylline with prolonged release are not intended for the emergency treatment of acute asthma attacks or respiratory disorders caused by acute bronchospasm.
Theophylline should not be used as a first-line treatment for asthma in children.

2. Important information before taking Theospirex retard 300 mg

When not to take Theospirex retard 300 mg

Warnings and precautions

Before starting treatment with Theospirex retard 300 mg, you should discuss it with your doctor:

The medicine should be used with caution during vaccination and in the elderly.

The medicine should not be used in acute asthma attacks and status asthmaticus.

Fever reduces the rate of theophylline elimination from the body. In the case of acute illness with fever, it may be necessary to reduce the dose to avoid toxicity.

Children and adolescents

Theospirex retard 300 mg should not be used in children under 6 years old.
Other pharmaceutical forms of the medicine are available, which are more suitable for children under 6 years old.
Detailed information on the use of this medicine in children and adolescents is presented in section 3. "How to take Theospirex retard 300 mg".

Theospirex retard 300 mg and other medicines

You should tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.
In particular, you should inform about the use of any of the following medicines, as Theospirex retard 300 mg may affect their action and increase the risk of side effects:

• Theospirex retard 300 mg should not be used concomitantly with other xanthine and its derivative preparations.
• Ephedrine. Theophylline enhances the effect of ephedrine.
• Theophylline enhances the effect of sympathomimetics (such as salbutamol, formoterol) used in the treatment of bronchospasm, caffeine, and similar substances.
• Theophylline increases the renal excretion of lithium salts (used in the treatment of mania or depression), reduces its absorption, and concentration in the blood.
• Glycosides (cardiac stimulants). Through a positive effect on the strength and duration of cardiac muscle contraction, theophylline may enhance the effect of glycosides and lead to conduction disorders in the heart muscle.
• Theophylline may weaken the effect of beta-adrenergic blockers (medicines used, among others, in the treatment of hypertension), adenosine (a medicine used in arrhythmias), benzodiazepines (medicines with anxiolytic, sedative, hypnotic, anticonvulsant action), and pancuronium (a medicine used during general anesthesia to facilitate intubation and muscle relaxation during surgical procedures).
• Theophylline enhances the effect of diuretics.
• There is evidence that in people receiving ketamine (a rapidly acting anesthetic) concomitantly, the seizure threshold may be lowered.
• The use of halothane (an agent used for general anesthesia) in patients treated with theophylline may cause severe arrhythmias.

Lower theophylline concentrations are found in tobacco smokers.
In the case of medications that affect theophylline concentration in the blood, the dose should be adjusted accordingly.
You should inform about the use of medications that may enhancethe effect of Theospirex retard 300 mg and increase the risk of side effects:

• cimetidine (a medicine used in the treatment of gastric and duodenal ulcer disease),
• allopurinol (a medicine that reduces the content of uric acid in the blood and urine, inhibits the formation of urate stones in the urinary tract, prevents the deposition of urate in muscles and kidneys),
• fluoroquinolone antibiotics (enoxacin, lomefloxacin, ciprofloxacin, norfloxacin, ofloxacin). It is recommended to frequently monitor theophylline concentrations in patients treated with such antibiotics,
• macrolide antibiotics (erythromycin, clarithromycin),
• disulfiram (a medicine used in the treatment of alcohol dependence),
• estrogens (hormonal medicines used, among others, in hormone replacement therapy),
• fluvoxamine (an antidepressant from the group of selective serotonin reuptake inhibitors),
• interferon-alpha (a medicine used in the treatment of cancer),
• isoniazid (a medicine used in the prevention and treatment of tuberculosis),
• methotrexate (a medicine used in the treatment of cancer),
• mexiletine and propafenone (medicines used in arrhythmias),
• rofecoxib (a medicine used in the treatment of pain in rheumatic diseases),
• propranolol (a medicine used, among others, in hypertension),
• ticlopidine (a medicine that prevents the formation of blood clots),
• calcium channel blockers (verapamil, diltiazem) used in heart diseases,
• viloxazine (an antidepressant). In such cases, the doctor may recommend reducing the dose of Theospirex retard 300 mg.

Alcohol causes an increase in theophylline concentration in the blood, so during treatment with Theospirex retard 300 mg, you should not consume alcoholic beverages.
You should inform about the use of medications that may weakenthe effect of Theospirex retard 300 mg and reduce its effectiveness:

• aminoglutethimide (a medicine used in the treatment of certain prostate cancers),
• carbamazepine (a medicine used in the treatment of epilepsy),
• isoprenaline (a medicine used in asthma),
• phenobarbital (an antiepileptic medicine),
• phenytoin (a medicine with anticonvulsant action),
• primidone (an antiepileptic medicine),
• rifampicin (a medicine used in tuberculosis),
• sucralfate (a medicine used in gastric and duodenal ulcer disease),
• sulfinpyrazone (a medicine that increases the excretion of uric acid in the urine, used in gout),
• medicines containing St. John's wort (Hypericum perforatum). If the patient is taking any of the above medications, the doctor may recommend increasing the dose of Theospirex retard 300 mg.

Theospirex retard 300 mg with food and drink

A low-carbohydrate (sugar) and high-protein diet, as well as parenteral nutrition and consumption of large amounts of grilled beef, reduce the amount of theophylline in the body and weaken its effect.
A high-carbohydrate and low-protein diet may lead to an increase in theophylline concentration in the body, enhancement of its effect, and an increased risk of side effects.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects that she may be pregnant, or plans to have a child, she should consult her doctor or pharmacist before taking this medicine.
Pregnancy
The safety of theophylline use during pregnancy has not been established, as no adequate studies have been conducted.
Theophylline crosses the placental barrier and may cause side effects in the fetus.
Theophylline should not be used during pregnancy, especially in the first three months, unless it is absolutely necessary. In the second and third trimesters of pregnancy, theophylline may be used only when the benefits to the mother outweigh the risk to the fetus.
The degree of theophylline binding to plasma proteins and clearance may decrease during pregnancy. It may be necessary to reduce the dose to avoid side effects.
The use of theophylline in late pregnancy may inhibit uterine contractions. Close monitoring of newborns exposed to theophylline in late pregnancy is necessary to detect any symptoms caused by its action.
Breastfeeding
The medicine should not be used during breastfeeding.
Theophylline passes into breast milk and during breastfeeding may cause side effects in breastfed infants. Its concentration in breast milk of a nursing mother may be 60-90% of the concentration of this medicine in the blood.

Driving and using machines

Theophylline may affect the ability to drive and use machines. You should be cautious due to the possibility of drowsiness and dizziness.
The medicine contains less than 1 mmol (23 mg) of sodiumin the maximum daily dose, which means that the medicine is considered "sodium-free".

3. How to take Theospirex retard 300 mg

This medicine should always be taken exactly as directed by your doctor. If you are unsure, you should ask your doctor or pharmacist.
The dose of theophylline should be adjusted individually, taking into account the effectiveness of the medicine and its tolerance by the patient. The dosage is best determined after measuring the theophylline concentration in the serum (therapeutic concentration range: 8-20 μg/ml). Monitoring the theophylline concentration in the serum is particularly recommended in case of side effects or insufficient response to treatment.
If the patient has previously taken theophylline or its derivatives, this should be taken into account when determining the initial dose and it should be reduced accordingly. The dose should be calculated based on the lean body mass, as theophylline does not penetrate fat tissue.

Dosage

The daily maintenance dose of theophylline in adults is approximately 11-13 mg/kg body weight.
This corresponds to a total daily dose of 900 mg (3 tablets).

• Adults and adolescents over 16 years old (8-12 mg/kg body weight per day): 300 mg of theophylline (1 tablet) every 12 hours (morning and evening).
• Children over 6 years old (10-15 mg/kg body weight per day): 150 mg of theophylline (half a tablet) every 12 hours (morning and evening).

In case of insufficient improvement after three days of treatment, the dose should be gradually increased by half a tablet:

• in children: up to a daily dose of 20 mg/kg body weight
• in adults: up to a daily dose of 15 mg/kg body weight

In case it is not possible to monitor the blood concentration of the medicine, the daily dose should not be exceeded:

• in children aged 6-9 years: 600 mg (2 tablets),
• in children aged over 9-12 years: 750 mg (2.5 tablets),
• in adolescents over 12 years old and adults: 900 mg (3 tablets).

In case it is necessary to maintain the above maximum doses, it is recommended to monitor the theophylline concentration in the blood.
If a medicine containing theophylline with unmodified release is to be replaced with a medicine with modified release, it may be necessary to reduce the daily dose.
In case of a change in the theophylline-containing medicine, the doctor will monitor the treatment, controlling the theophylline concentration in the serum.
Children under 6 years old
Theospirex retard 300 mg should not be used in children under 6 years old.
Smoking
Smokers, due to faster theophylline elimination, should be given a higher dose of theophylline, taking into account their body weight, than non-smoking adult patients.
Particular caution should be exercised when adjusting the dose in smokers who are quitting, as the theophylline concentration in the serum is higher in them compared to non-smokers.
Special patient groups
Generally, theophylline elimination is slower in patients with heart failure, severe hypoxia, chronic obstructive pulmonary disease, pneumonia, acute pulmonary edema, viral infections (especially influenza), untreated fever, in the elderly, in patients taking certain medications (see section 2. "Theospirex retard 300 mg and other medicines"), and in people who consume large amounts of alcohol. Therefore, such patients require the use of lower theophylline doses and special caution when deciding to increase the dose used.
It has also been reported that theophylline elimination decreases after influenza and tuberculosis vaccination.
In such cases, it may be necessary to reduce the theophylline dose.
Patients with hepatic and/or renal impairment
Very often, in patients with liver disorders, theophylline elimination is slower.
In patients with severe renal impairment, theophylline metabolites may accumulate. Therefore, in these patients, lower doses should be used and special caution should be exercised when increasing the dose.

Method of administration

Tablets should be taken orally, after a meal.
Single doses should be taken at equal intervals throughout the day. When the medicine is administered twice a day, the dose is usually taken in the morning and evening.
Tablets can be divided into two equal doses along the dividing line.

Tablets should not be chewed or crushed.

Duration of treatment

The duration of treatment is determined by the doctor, depending on the type, severity, and course of the disease.

Use of a higher than recommended dose of Theospirex retard 300 mg

Symptoms of overdose
Symptoms of theophylline overdose may occur if its serum concentration is higher than 20 μg/ml, and they worsen with higher concentrations.
Usually, the first symptom to appear is tachycardia (rapid heart rate), followed by gastrointestinal symptoms (nausea, vomiting, bloody vomiting, stomach pain, diarrhea), central nervous system stimulation (anxiety, headaches, insomnia, dizziness), excessive thirst, tinnitus, and arrhythmias. Excessive sweating and muscle tremors may also occur.
In the case of significant overdose (theophylline serum concentration is higher than 25 μg/ml), seizures, circulatory failure, hyperthermia (elevated body temperature), severe arrhythmias, including ventricular arrhythmias, and even cardiac arrest and death may occur.
In patients with increased sensitivity to theophylline, severe overdose symptoms may occur even when the theophylline serum concentration is less than 20 μg/ml.
Procedure in case of overdose

In case of any symptoms of overdose, you should immediately contact a doctor or the emergency department of the nearest hospital. In case of life-threatening symptoms, you should immediately call the emergency services.

In case of mild overdose symptoms:
You should stop taking the medicine and measure the theophylline concentration in the serum. If treatment is resumed, the dose should be reduced accordingly.
If symptoms from the central nervous system occur (e.g., anxiety and seizures):

• you should administer diazepam intravenously at a dose of 0.1-0.3 mg/kg body weight, up to a maximum of 15 mg.

If overdose symptoms are potentially life-threatening, you should:

• monitor vital functions and maintain airway patency,
• administer oxygen,
• if necessary, administer intravenous fluids to increase blood volume,
• monitor and correct, if necessary, fluid and electrolyte deficiencies,
• use hemoperfusion (see below).

In case of life-threatening arrhythmias:

• in patients who do not have asthma, you should administer propranolol intravenously: 1 mg in adults; 0.02 mg/kg body weight in children. The dose can be repeated every 5-10 minutes until a normal heart rhythm is restored, up to a maximum dose of 0.1 mg/kg body weight.

Warning:

In patients with asthma, propranolol may cause severe bronchospasm, so in these patients, verapamil should be administered instead.
In very severe cases of poisoning, when the above procedure is ineffective, and in patients with very high theophylline concentrations, rapid and complete detoxification can be achieved through hemoperfusion or hemodialysis. In most cases, this is not necessary, as theophylline is metabolized sufficiently quickly.

Missing a dose of Theospirex retard 300 mg

You should not take a double dose to make up for a missed dose.

Stopping treatment with Theospirex retard 300 mg

If you have any further doubts about the use of this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
During treatment with Theospirex retard 300 mg, the following side effects may occur:
Gastrointestinal disorders:
Very common (in more than 1 in 10 patients): irritation of the gastrointestinal tract mucosa, nausea, vomiting, stomach pain, diarrhea, loss of appetite, anorexia. Bloody vomiting has been reported after theophylline administration. Existing gastroesophageal reflux may worsen at night due to the relaxation of the esophageal sphincter.
Nervous system and psychiatric disorders:
Very common (in more than 1 in 10 patients): central nervous system stimulation: headaches, irritability, anxiety, insomnia, dizziness, increased reflexes, muscle tremors, and seizures.
Cardiac disorders:
Very common (in more than 1 in 10 patients): arrhythmias, rapid heart rate, extra beats, and ventricular arrhythmias, palpitations.
Respiratory, thoracic, and mediastinal disorders:
Very common (in more than 1 in 10 patients): rapid breathing.
Vascular disorders:
Very common (in more than 1 in 10 patients): decreased blood pressure.
Renal and urinary disorders:
Very common (in more than 1 in 10 patients): increased urine excretion related to the diuretic effect of theophylline, proteinuria, and hematuria may occur. The syndrome of inappropriate antidiuretic hormone secretion (SIADH) has also been observed.
Immune system disorders:
Uncommon (in less than 1 in 100 but more than 1 in 1,000 patients): hypersensitivity reactions, urticaria, generalized itching, angioedema – allergic reactions, such as skin reactions and sudden swelling of the skin and mucous membranes (e.g., throat or tongue), breathing difficulties, and (or) itching and rash.
Diagnostic tests:
Very common (in more than 1 in 10 patients): increased glucose concentration in the blood, decreased potassium concentration in the blood, increased creatinine concentration in the blood, changes in electrolyte concentrations in the blood, increased uric acid concentration in the blood.
Side effects may be more severe in patients with hypersensitivity to theophylline or in case of overdose (theophylline concentration in the serum is higher than 20 mg/l).
In particular, when the theophylline concentration in the serum is higher than 25 mg/l, toxic effects may occur, such as seizures, sudden drop in blood pressure, ventricular arrhythmias, and severe gastrointestinal symptoms (including gastrointestinal bleeding).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C
02-222 Warsaw
tel.: +48 22 49 21 301
fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of the medicine.

5. How to store Theospirex retard 300 mg

The medicine should be stored out of sight and reach of children.
Store at a temperature below 25°C.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Theospirex retard 300 mg contains

• The active substance of the medicine is anhydrous theophylline. One prolonged-release coated tablet contains 300 mg of anhydrous theophylline.
• The other ingredients are: ammonio methacrylate copolymer (type B) (Eudragit RSPO), povidone 25, talc, magnesium stearate, purified water, hypromellose HPMC 5-6, hypromellose HPMC 2910, titanium dioxide (E171), indigo carmine (E132), macrogol 4000, macrogol 6000.

What Theospirex retard 300 mg looks like and what the pack contains

Blue, elongated, coated tablets with a dividing line on both sides.
Tablets are packaged in aluminum/PVC blisters, placed in a cardboard box.
The pack contains 50 tablets (5 blisters of 10 tablets each).

Marketing authorization holder and manufacturer

Biofarm Sp. z o.o.
Wałbrzyska Street 13
60-198 Poznań
Tel.: +48 61 66 51 500
Fax: +48 61 66 51 505

Date of the last update of the leaflet: