EUPHYLLIN 300 mg Capsules

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Euphyllin long, 300 mg, Modified Release Hard Capsules
   1. Read the Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.
   2. Table of Contents of the Leaflet
3. What is Euphyllin long and what is it used for
4. Important information before taking Euphyllin long
   1. When not to take Euphyllin long
   2. Warnings and precautions
   3. Euphyllin long and other medications
   4. Pregnancy and breastfeeding
   5. Driving and using machines
   6. Euphyllin long contains lactose
   7. Euphyllin long contains sodium
5. How to take Euphyllin long
   1. How often and how many Euphyllin long 300 mg capsules should be taken
   2. Method of administration and duration of treatment
   3. Using a higher than recommended dose of Euphyllin long
   4. Missing a dose of Euphyllin long
6. Possible side effects
   1. Very common (occurring in more than 1 in 10 treated patients):
   2. Uncommon (occurring in less than 1 in 100 but more than 1 in 1000 treated patients):
   3. Frequency not known (frequency cannot be estimated from the available data):
   4. Reporting side effects
7. How to store Euphyllin long
8. Contents of the pack and other information
   1. What Euphyllin long contains
   2. What Euphyllin long looks like and what the pack contains
   3. Pack sizes:
   4. Marketing authorization holder and manufacturer
   5. Marketing authorization holder:
   6. Manufacturer:
   7. Date of last revision of the leaflet: September 2023

Package Leaflet: Information for the Patient

Euphyllin long, 300 mg, Modified Release Hard Capsules

Theophylline

Read the Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medication has been prescribed for a specific person. Do not pass it on to others. The medication may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Euphyllin long and what is it used for

Euphyllin long is a medication in the form of modified release hard capsules for oral use.
The active substance of this medication is theophylline. Theophylline acts as a bronchodilator on the smooth muscles of the bronchi and pulmonary vessels and inhibits the release of certain substances from cells involved in inflammatory reactions.
Additionally, theophylline has a vasodilating effect on blood vessels, a stimulating effect on skeletal muscles.
It increases the frequency and strength of heart contractions, increases urine excretion.
The mechanism of action of theophylline is not yet fully understood.
This medication is used to prevent and treat respiratory disorders caused by bronchial constriction (bronchospasm) in the course of asthma and chronic obstructive pulmonary disease (COPD).
This medication is not intended for the emergency treatment of an asthma attack (severe asthma attack) or sudden bronchospasm (breathlessness episodes caused by bronchial constriction).
Theophylline should not be used as a first-line treatment for asthma in children.

2. Important information before taking Euphyllin long

When not to take Euphyllin long

• If the patient is allergic to theophylline or any of the other ingredients of this medication (listed in section 6).
• If the patient has had a recent myocardial infarction.
• If the patient has acute arrhythmias with rapid heart rate.
• In children under 12 years of age.

Warnings and precautions

Before starting to take Euphyllin long, the patient should discuss it with their doctor or pharmacist.
Euphyllin long should be used with caution and only when absolutely necessary, in the case of:

• unstable angina pectoris;
• risk of arrhythmias with rapid heart rate;
• severe hypertension;
• hypertrophic cardiomyopathy with outflow obstruction;
• hyperthyroidism;
• epilepsy;
• gastric or duodenal ulcer;
• porphyria.

Information for patients with diabetes
1 capsule of Euphyllin long 300 mg contains 20.2 mg of lactose monohydrate, which corresponds to
0.001 bread units (see also section "Euphyllin long contains lactose").
Special patient groups
The use of Euphyllin long in patients with heart failure, severe hypoxia, pneumonia, or viral infections (especially influenza), in elderly patients (over 60 years), in patients with other diseases, in patients taking other medications, in severely ill patients and (or) patients treated in intensive care units is associated with an increased risk of toxic effects of theophylline. In these patients, smaller doses should be used and caution should be exercised when increasing the dosage.
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 intoxication.
Patient groups that should inform their doctor about their situation include:

• smokers,
• those who have recently quit smoking,
• those who have been recently vaccinated against tuberculosis and influenza, as their dosage may need to be adjusted.

Patient with liver or kidney disease
Euphyllin long should be used with caution in patients with liver or kidney function disorders. In these patients, smaller doses of the medication should be used and special caution should be exercised when increasing the dosage.
Children
Euphyllin long should not be used in children under 12 years of age.
Other pharmaceutical forms of the medication are available, which are more suitable for children under 6 years of age.

Euphyllin long and other medications

The patient should inform their doctor about all medications they are currently taking or have recently taken, as well as any medications they plan to take.
Theophylline enhances the effect of other medications containing xanthines (alkaloids used in obstructive pulmonary diseases, e.g., theophylline), β-sympathomimetics (medications used in obstructive pulmonary diseases, e.g., salbutamol), caffeine, and similar substances.
The effectiveness of theophylline may be reduced in smokers and in the case of concomitant use of aminoglutethimide (used in the treatment of breast cancer), barbiturates (medications with a sedative, hypnotic, and antiepileptic effect, e.g., phenobarbital, pentobarbital, and primidone); phenytoin, fosphenytoin, or carbamazepine (used in the treatment of epilepsy); rifampicin and rifapentine (antibiotics used in the treatment of tuberculosis); ritonavir (used in the treatment of HIV infection), sulfinpyrazone (used in the treatment of gout), and medications containing hypericum (products containing St. John's Wort). Therefore, in some cases, it may be necessary to increase the dose of theophylline.
There is an increased risk of overdose and side effects when theophylline is used concomitantly with the following medications:
α-interferon (a medication with antiviral and antitumor effects), allopurinol (used in the treatment of gout), macrolide antibiotics (especially erythromycin and troleandomycin), quinolones (gyrase inhibitors, especially ciprofloxacin, enoxacin, and pefloxacin), cimetidine, etintidine, or ranitidine (used in the treatment of heartburn or gastric and duodenal ulcers), disulfiram (used in alcoholism), oral contraceptives, febuxostat (used in the treatment of chronic hyperuricemia and gout), fluvoxamine (an antidepressant), idrocylamide (used in muscle and joint pain), imipenem (a β-lactam antibiotic), isoniazid (used in the treatment of tuberculosis), calcium channel blockers (used in the treatment of hypertension, angina pectoris, arrhythmias, e.g., diltiazem or verapamil), mexiletine or propafenone (used in arrhythmias), peginterferon α-2 (a medication used in viral hepatitis), propranolol (used in hypertension, angina pectoris, arrhythmias), influenza vaccines, tiabendazole (an antiparasitic medication), ticlopidine (an antiplatelet medication), zafirlukast, and zileuton (used in the treatment of asthma). In such cases, it may be necessary to reduce the dose of theophylline.
During concomitant treatment with quinolones, frequent monitoring of theophylline levels is recommended.
The effect of lithium carbonate (used in bipolar affective disorders) and β-adrenolytics (medications used in hypertension and arrhythmias) may be weakened when taken concomitantly with theophylline.
Theophylline enhances the effect of diuretic medications, such as furosemide.
Administration of halothane to patients taking theophylline may lead to severe arrhythmias.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, or thinks they may be pregnant or plans to have a child, they should consult their doctor or pharmacist before taking this medication.
There is insufficient information on the use of Euphyllin long in the first trimester of pregnancy, so the medication should be avoided during this period. In the second and third trimesters of pregnancy, Euphyllin long can be used only after careful consideration by the doctor of the risk and benefits.
During pregnancy, it may be necessary to reduce the dose of the medication to avoid side effects.
Theophylline passes into breast milk, so breastfeeding women should be given the lowest possible dose, and breastfeeding, if possible, should be done immediately before taking the medication.
The child should be closely monitored for signs of theophylline effects. If higher doses are necessary, breastfeeding should be discontinued.

Driving and using machines

The medication, even when taken as recommended, may affect reaction speed, impairing the ability to drive vehicles, operate machinery, or work without solid support for the legs.
This is especially true when theophylline is used in combination with other medications that affect reaction speed or with alcohol.

Euphyllin long contains lactose

If the patient has been diagnosed with an intolerance to some sugars, they should consult their doctor before taking the medication.

Euphyllin long contains sodium

Euphyllin long contains less than 1 mmol (23 mg) of sodium per capsule, which means the medication is considered "sodium-free".

3. How to take Euphyllin long

This medication should always be taken as recommended by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
The doctor will determine the dose of the medication individually for each patient, depending on the patient's age, body weight, and theophylline levels in the blood.
Theophylline levels in the blood should also be monitored in case of reduced efficacy or side effects.
If the patient has previously taken theophylline or its derivatives, this should be taken into account when determining the initial dose and the dose should be reduced accordingly.
The dose should be determined based on lean body weight, as theophylline does not penetrate fatty tissue.
The daily maintenance dose for adults is approximately 11 to 13 mg of theophylline per kilogram of body weight.
Any change in dosage: increase or decrease in dose can only be done after consulting a doctor.
Whenever possible, treatment should be started in the evening, shortly before bedtime, and the dose should be increased slowly over 2-3 days.
Euphyllin long 300 mg should not be used in children under 12 years of age.

How often and how many Euphyllin long 300 mg capsules should be taken

The usual dose of Euphyllin long 300 mg is 1-2 capsules once or twice a day, not more than 900 mg per day.
Depending on the age, the following maintenance doses are recommended:

In some patients, it may be necessary to reduce the dose - see the section "Special patient groups".
If symptoms of overdose occur, depending on the severity of the symptoms, the next dose should be skipped or reduced by half.
Patients with nocturnal dyspnea are advised to take the daily dose (maximum 2 capsules) of Euphyllin long in a single dose in the evening.

Method of administration and duration of treatment

• Euphyllin long capsules should be swallowed whole, with a large amount of liquid.
• Patients who have difficulty swallowing capsules can open them and swallow the entire contents, with a large amount of liquid.
• The daily dose is usually taken as a single dose in the evening or is divided into two doses, with the additional dose taken in the morning with breakfast.
• The duration of treatment depends on the type, severity, and course of the disease and is determined by the doctor.

Using a higher than recommended dose of Euphyllin long

In case of taking a higher than recommended dose of Euphyllin long, the patient should immediately consult their doctor or pharmacist.
Symptoms of overdose include: nausea, stomach pain, vomiting, diarrhea, restlessness, headache, insomnia, dizziness, arrhythmias, seizures, circulatory failure. The severity of these symptoms depends on the individual sensitivity of the patient and the concentration of the medication in the blood.
Treatment of theophylline poisoning depends on the severity and course of the poisoning, as well as the symptoms that occur in the patient.

Missing a dose of Euphyllin long

If the patient forgets to take a dose of Euphyllin long, they should take the next dose at the scheduled time. A double dose should not be taken to make up for the missed dose.
In case of any further doubts about the use of this medication, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medications, Euphyllin long can cause side effects, although not everybody gets them.
Possible side effects include:

Very common (occurring in more than 1 in 10 treated patients):

• rapid or irregular heartbeat, palpitations, decreased blood pressure;
• nausea, vomiting, diarrhea, worsening of existing gastroesophageal reflux at night;
• changes in electrolyte levels in the serum;
• decreased potassium and increased calcium levels in the serum, increased glucose and excessive uric acid levels in the blood;
• headache, excitement, tremor, restlessness, insomnia;
• increased urine excretion, increased creatinine levels in the serum.

Uncommon (occurring in less than 1 in 100 but more than 1 in 1000 treated patients):

• hypersensitivity reactions.

Frequency not known (frequency cannot be estimated from the available data):

• seizures.

Side effects may be more severe in patients with hypersensitivity to theophylline or in case of overdose.
High concentrations of theophylline in the blood can cause symptoms of toxicity, such as seizures, sudden drop in blood pressure, ventricular arrhythmias, and severe gastrointestinal symptoms (e.g., gastrointestinal bleeding). Overdose can also lead to muscle damage.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should inform their doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C
02-222 Warsaw
Phone: +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, more information can be collected on the safety of the medication.

5. How to store Euphyllin long

Store in a temperature not exceeding 25°C. Protect from light.
The medication should be stored in a place that is out of sight and reach of children.
Do not use this medication after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Medications should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Euphyllin long contains

• The active substance of the medication is theophylline. One modified release capsule contains 300 mg of theophylline.
• Other ingredients are: methylcellulose 15 mPas, microcrystalline cellulose, sodium carmellose, cellulose acetate, triethyl citrate, lactose monohydrate, talc. Hard gelatin capsule shell:titanium dioxide (E 171), gelatin, water. Black ink:Opacode S-1-277002 black (shellac, iron oxide black (E 172), propylene glycol, concentrated ammonia).

What Euphyllin long looks like and what the pack contains

The capsules are opaque, white, and have the inscription Eu 300.

Pack sizes:

• 20 modified release capsules
• 30 modified release capsules
• 100 modified release capsules

Marketing authorization holder and manufacturer

Marketing authorization holder:

pharmaand GmbH
Taborstrasse 1
1020 Vienna
Austria

Manufacturer:

Takeda GmbH
Manufacturing site Oranienburg
Lehnitzstrasse 70-98
16515 Oranienburg
Germany

Date of last revision of the leaflet: September 2023