EUPHYLLIN 200 mg Capsules

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Euphyllin long, 200 mg, Modified-Release Hard Capsules
   1. Read the Package 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 operating machinery
   6. Euphyllin long contains lactose
   7. Euphyllin long contains sodium
5. How to take Euphyllin long
   1. How often and how many Euphyllin long 200 mg capsules should be taken
   2. Method of administration and duration of treatment
   3. Taking a higher dose of Euphyllin long than recommended
   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, 200 mg, Modified-Release Hard Capsules

Theophylline

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed specifically for you. Do not pass it on to others. The medication may harm another person, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, inform your 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 muscle 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 you are allergic to theophylline or any of the other ingredients of this medication (listed in section 6).
• If you have recently had a heart attack.
• If you have acute arrhythmias with rapid heart rate.
• In children under 6 years of age.

Warnings and precautions

Before starting to take Euphyllin long, discuss it with your 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 200 mg contains 13.5 mg of lactose monohydrate, which corresponds to
0.001 bread units (see also section "Euphyllin long contains lactose").
Special patient groups
Using 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 dose.
Fever reduces the rate of theophylline elimination from the body. In the case of an acute illness with fever, it may be necessary to reduce the dose to avoid intoxication.
Patients:

• smoking,
• who have quit smoking,
• who have been recently vaccinated against tuberculosis and influenza should inform their doctor about these situations, as in their case, it is necessary to adjust the dosage of Euphyllin long.

Patients with liver or kidney disease
Euphyllin long should be used with caution in patients with impaired liver or kidney function. In these patients, smaller doses of the medication should be used and special caution should be exercised when increasing the dose.
Children
Euphyllin long should not be used in children under 6 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

Tell your doctor about all medications you are currently taking or have recently taken, as well as medications you 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 concurrent 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 concurrently 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 long-term elevated uric acid levels in the blood and gout), fluvoxamine (an antidepressant), idrocylamide (used in muscle and joint pain), imipenem (a β-lactam antibiotic), isoniazid (used in the treatment of tuberculosis), medications blocking calcium channels (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), vaccines against influenza, 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 concurrent 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 concurrently with theophylline.
Theophylline enhances the effect of diuretic medications, such as furosemide.
Administering halothane to patients taking theophylline may lead to severe arrhythmias.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medication.
There is insufficient information on the use of Euphyllin long in the first trimester of pregnancy, so it 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 therapeutic dose, and breastfeeding (if possible) should be done immediately before taking the medication.
The child breastfed by a woman taking theophylline should be closely monitored for possible symptoms caused by theophylline. If it is necessary to use higher doses, breastfeeding should be discontinued.

Driving and operating machinery

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 you have previously been diagnosed with intolerance to some sugars, you should consult your 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 according to the doctor's recommendations. If you have any doubts, consult your 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 the occurrence of side effects.
If you have previously taken theophylline or its compounds, this should be taken into account when determining the initial dose and it 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 made 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 should not be used in children under 6 years of age.

How often and how many Euphyllin long 200 mg capsules should be taken

The usual dose of Euphyllin long 200 mg is 1-2 capsules (200 or 400 mg of theophylline) once or twice a day. Do not take more than 900 mg per day.
Depending on 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 these 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 having difficulty swallowing capsules may 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.

Taking a higher dose of Euphyllin long than recommended

In the event of taking a higher dose of Euphyllin long than recommended, consult your doctor or pharmacist immediately.
Symptoms of overdose include: nausea, stomach pain, vomiting, diarrhea, anxiety, headache, insomnia, dizziness, arrhythmias, seizures, circulatory failure. The severity of these symptoms depends on the individual patient's sensitivity 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 you miss a dose of Euphyllin long, take the next dose at the scheduled time. Do not take a double dose to make up for the missed dose.
If you have any further doubts about taking this medication, consult your doctor or pharmacist.

4. Possible side effects

Like all medications, Euphyllin long can cause side effects, although not everybody gets them.
Side effects that may occur 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 the case of overdose.
High levels of theophylline in the blood may 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 you experience any side effects, including those not listed in this leaflet, inform your 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, you can help provide more information on the safety of this 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 invisible and inaccessible to children.
Do not use this medication after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
Medications should not be disposed of via wastewater or household waste containers. Ask your 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 200 mg of theophylline.
• Other ingredients are: methylcellulose 15 mPas, microcrystalline cellulose, sodium carmellose, cellulose acetate, triethyl citrate, lactose monohydrate, talc. Hard 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 solution).

What Euphyllin long looks like and what the pack contains

The capsules are opaque, white, and have the inscription Eu 200.

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