Euphyllin long

Package leaflet: Information for the patient

Euphyllin long, 200 mg, modified-release hard capsules
Theophyllinum
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

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 medicine in the form of modified-release hard capsules for oral administration.
The active substance in this medicine is theophylline. Theophylline exerts a spasmolytic effect on smooth muscles of the bronchi and pulmonary blood vessels and inhibits the release of certain substances from cells involved in inflammatory reactions.
Additionally, theophylline causes vasodilation, stimulates skeletal muscles, increases heart rate and myocardial contractility, and enhances urinary excretion.
The exact mechanism of action of theophylline is not fully understood.
This medicine is used in the prevention and treatment of respiratory disorders caused by airway narrowing (bronchospasm) in bronchial asthma and chronic obstructive pulmonary disease.
This medicine is not intended for immediate relief of acute asthmatic attacks (severe asthma attacks) or sudden bronchospasm (acute episodes of breathlessness due to bronchial narrowing).
Theophylline should not be used as a first-line treatment for asthma in children.

2. Important information before using Euphyllin long

When not to use Euphyllin long

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

Warnings and precautions
Before starting treatment with Euphyllin long, discuss it with your doctor or pharmacist.
Euphyllin long should be used with caution and only when absolutely indicated in the following cases:

• Unstable angina pectoris;
• Risk of cardiac arrhythmias with increased heart rate;
• Severe hypertension;
• Hypertrophic cardiomyopathy with outflow tract obstruction;
• Hyperthyroidism;
• Epilepsy;
• Gastric or duodenal ulcer;
• Porphyria.

Information for diabetic patients
1 capsule of Euphyllin long 200 mg contains 13.5 mg of monohydrate lactose, equivalent 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 of age), in patients with other diseases, in those taking other medications, in critically ill patients, and/or in patients treated in intensive care units is associated with an increased risk of theophylline toxicity. In these patients, lower doses should be used and caution should be exercised when increasing the dose.
Fever reduces the rate of theophylline elimination from the body. In acute illness accompanied by fever, it may be necessary to reduce the dose to avoid intoxication.
Patients who:

• Smoke cigarettes,
• Have recently stopped smoking,
• Have recently been vaccinated against tuberculosis or influenza

should inform their doctor about these circumstances, as appropriate dose adjustment of Euphyllin long may be required.

Patients with liver or kidney disease
Euphyllin long should be used with caution in patients with impaired liver or kidney function. In these patients, lower doses should be used and particular 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 medicine are available which are more suitable for children under 6 years of age.

Euphyllin long and other medicines
Tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Theophylline may enhance the effects of other drugs containing xanthines (alkaloids used in obstructive lung diseases, e.g. theophylline), β-sympathomimetics (medicines used in obstructive lung diseases, e.g. salbutamol), caffeine, and similar substances.

The effectiveness of theophylline may be reduced in smokers and when taken concomitantly with aminoglutethimide (used in breast cancer treatment), barbiturates (sedative, hypnotic, and anticonvulsant drugs, e.g. phenobarbital, pentobarbital, and primidone), phenytoin, fosphenytoin, or carbamazepine (used in epilepsy treatment), rifampicin or rifapentine (antibiotics used in tuberculosis treatment), ritonavir (used in HIV infection treatment), sulfinpyrazone (used in gout treatment), and medicines containing hypericin (products containing St. John's wort). Therefore, in some cases, an increase in theophylline dose may be necessary.

There is an increased risk of overdose and adverse effects when theophylline is used concomitantly with the following medicines:
α-interferon (antiviral and anticancer agent), allopurinol (used in gout treatment), macrolide antibiotics (especially erythromycin and troleandomycin), quinolones (gyrase inhibitors, especially ciprofloxacin, enoxacin, and pefloxacin), cimetidine, ethylnedine, or ranitidine (used in treatment of heartburn or peptic ulcer disease), disulfiram (used in alcohol dependence), oral contraceptives, febuxostat (used in long-term treatment of elevated blood uric acid levels and gout), fluvoxamine (antidepressant), idrocilamide (used in muscle and joint pain), imipenem (β-lactam antibiotic), isoniazid (used in tuberculosis treatment), calcium channel blockers (used in hypertension, angina pectoris, cardiac arrhythmias, e.g. diltiazem or verapamil), mexiletine or propafenone (used in cardiac arrhythmias), peginterferon α-2 (used in viral hepatitis), propranolol (used in hypertension, angina pectoris, cardiac arrhythmias), influenza vaccines, thiabendazole (anthelmintic), ticlopidine (antiplatelet agent), zafirlukast and zileuton (used in asthma treatment). In such cases, a reduction in theophylline dose may be necessary.
During concomitant treatment with quinolones, frequent monitoring of theophylline blood levels is recommended.

The effect of lithium carbonate (used in bipolar affective disorders) and β-adrenolytics (medicines used in hypertension and cardiac arrhythmias) may be reduced when taken concomitantly with theophylline.
Theophylline enhances the effect of diuretics such as furosemide.
Administration of halothane to patients taking theophylline may lead to severe cardiac arrhythmias.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult her doctor or pharmacist before using this medicine.
There is insufficient information on the use of Euphyllin long in women during the first trimester of pregnancy; therefore, use of Euphyllin long should be avoided during this period. In the second and third trimesters of pregnancy, Euphyllin long may be used only after careful evaluation by the doctor of the risks and benefits.
During pregnancy, a dose reduction may be necessary to avoid adverse effects.
Theophylline passes into breast milk; therefore, breastfeeding women should receive the lowest possible therapeutic dose, and breastfeeding (if possible) should be performed immediately before taking the medicine.
The infant breastfed by a woman taking theophylline should be closely observed for possible symptoms caused by theophylline. If higher therapeutic doses are required, breastfeeding should be discontinued.

Driving and operating machinery
This medicine, even when taken as directed, may affect reaction speed, impairing the ability to drive vehicles, operate machinery, or work without secure foot support. This is especially relevant when theophylline is used in combination with other medicines affecting reaction speed or with alcohol.

Euphyllin long contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact the doctor before taking the medicine.

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

3. How to use Euphyllin long

This medicine should always be used as directed by the physician. If in doubt, consult
your doctor or pharmacist.
The doctor will determine the individual dose for each patient depending on age, body weight,
and serum theophylline concentration.
Serum theophylline concentration should also be monitored in case of reduced efficacy or
if adverse effects occur.
If the patient has previously been treated with theophylline or its derivatives, this should be taken into account when determining the initial dose, which should be adjusted accordingly.
The dose should be calculated based on lean body weight, as theophylline does not penetrate
adipose tissue.
The daily maintenance dose for adults is approximately 11 to 13 mg of theophylline per kg of body weight.
Any change in dosing—increasing or decreasing the dose—should only be made after
consultation with a doctor.
Whenever possible, treatment should be initiated in the evening, shortly before going to bed,
and the dose should be increased gradually over 2–3 days.
Euphyllin long must 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 theophylline) once
or twice daily. Do not exceed 900 mg per day.
Depending on age, the following maintenance doses are recommended:

In some patients, dose reduction may be necessary – see section "Special patient groups".
If symptoms of overdose occur, depending on their severity, the next dose should be omitted or halved.
Patients experiencing nocturnal dyspnoea are advised to take the daily dose (up to 2 capsules) of Euphyllin long as a single evening dose.

Method of administration and duration of treatment

• Euphyllin long capsules should be swallowed whole with plenty of fluid.
• Patients who have difficulty swallowing the capsules may open them and swallow the entire contents with plenty of fluid.
• The daily dose is usually taken as a single evening dose or 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 physician.

Use of a higher than recommended dose of Euphyllin long
If more than the recommended dose of Euphyllin long has been taken, seek immediate advice from a doctor or pharmacist.
Symptoms of overdose include: nausea, stomach pain, vomiting, diarrhoea, restlessness, headache, insomnia, dizziness, cardiac arrhythmias, seizures, circulatory failure. The severity of these symptoms depends on individual patient sensitivity and on the drug concentration in plasma.
Management of theophylline poisoning depends on the severity and course of intoxication and on the symptoms present in the patient.

Missed dose of Euphyllin long
If a patient forgets to take 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 concerning the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
The adverse reactions that may occur are:
Very common (affect more than 1 in 10 patients treated):

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

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

• hypersensitivity reactions.

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

• seizures.

Adverse reactions may be more pronounced in patients hypersensitive to theophylline or in cases of overdose.
High serum theophylline concentration may cause signs of toxic effects such as seizures, sudden drop in blood pressure, ventricular arrhythmias, and severe gastrointestinal symptoms (e.g. gastrointestinal bleeding). Overdose may also lead to muscle damage.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder. Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Euphyllin long

Store at a temperature not exceeding 25°C. Protect from light.
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via the sewage system or in household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Euphyllin long contains

• The active substance is theophylline. One modified-release capsule contains 200 mg of theophylline.
• Other ingredients are: methylcellulose 15 mPas, microcrystalline cellulose, sodium carboxymethylcellulose, cellulose acetate, triethyl citrate, lactose monohydrate, talc. Composition of the hard gelatin capsule: titanium dioxide (E 171), gelatin, water. Composition of the black ink: Opacode S-1-277002 black (shellac, iron oxide black (E 172), propylene glycol, concentrated ammonium hydroxide).

What Euphyllin long looks like and contents of the pack
The capsules are opaque, white in colour, printed with "Eu 200".
Pack sizes:

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

Marketing authorisation holder and manufacturer
Marketing authorisation holder:
pharmaand GmbH
Taborstrasse 1
1020 Vienna
Austria
Manufacturer:
Takeda GmbH
Oranienburg site
Lehnitzstrasse 70-98
16 515 Oranienburg
Germany