Euphyllin long

Package leaflet: Information for the patient

Euphyllin long, 300 mg, modified-release hard capsules
Theophyllinum
Please read carefully the entire leaflet before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any doubts, 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 identical.
• If you experience any adverse reactions, including any 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 medicine formulated as modified-release hard capsules for oral administration.
The active substance in this medicine is theophylline. Theophylline exerts a relaxant 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 has a vasodilatory effect, stimulates skeletal muscles, increases heart rate and force of myocardial contraction, and enhances urinary excretion.
The mechanism of action of theophylline is not yet fully understood.
This medicine is used for 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 attack (severe bronchial asthma attack) or sudden bronchospasm (acute episodes of breathlessness due to airway narrowing).
Theophyllines should not be used as first-line therapy in the treatment of 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 heart attack.
• If the patient has acute cardiac arrhythmias with rapid heart rate.
• In children under 12 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 tachycardia;
• Severe arterial hypertension;
• Hypertrophic cardiomyopathy with outflow tract obstruction;
• Hyperthyroidism;
• Epilepsy;
• Peptic ulcer of the stomach and/or duodenum;
• Porphyria.

Information for diabetic patients
1 capsule of Euphyllin long 300 mg contains 20.2 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), in patients with other diseases, in those taking other medications, in severely ill patients and/or patients treated in intensive care units is associated with an increased risk of theophylline toxicity. In such patients, lower doses should be used and caution exercised when increasing the dose.
Fever reduces the rate of theophylline elimination from the body. In acute illness accompanied by fever, dose reduction may be necessary to avoid intoxication.
Patients who:

• smoke cigarettes,
• have recently quit 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 such patients, lower doses should be administered and particular caution exercised when increasing the dose.

Children
Euphyllin long should not be used in children under 12 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
Inform your doctor about all medicines currently taken or recently taken, as well as any medicines planned for future use.

Theophylline enhances the effects of other drugs containing xanthines (alkaloids used in obstructive lung diseases, e.g. theophylline), β-sympathomimetics (drugs 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, 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), or products containing hypericin (St. John's wort-containing products). 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 antineoplastic agent), allopurinol (used in gout treatment), macrolide antibiotics (especially erythromycin and troleandomycin), quinolones (gyrase inhibitors, particularly ciprofloxacin, enoxacin and pefloxacin), cimetidine, ethylenediamine or ranitidine (used in heartburn or peptic ulcer disease), disulfiram (used in alcohol dependence), oral contraceptives, febuxostat (used in long-term hyperuricemia and gout), fluvoxamine (antidepressant), hydroxychloroquine (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 plasma levels is recommended.

The effect of lithium carbonate (used in bipolar affective disorders) and β-adrenolytics (drugs used in hypertension and cardiac arrhythmias) may be diminished when taken concomitantly with theophylline.

Theophylline enhances the effect of diuretics such as furosemide.

Administration of halothane to patients receiving 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 have a child, she should consult her doctor or pharmacist before using this medicine.

There is insufficient information regarding 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 of risks and benefits by the physician.

During pregnancy, 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 occur immediately before taking the medicine.

Infants breastfed by women taking theophylline should be closely monitored for possible signs of theophylline-related effects. If higher therapeutic doses are required, breastfeeding should be discontinued.

Driving and operating machinery

This medicine, even when taken as recommended, may affect reaction speed, impairing the ability to drive vehicles, operate machinery, or work at heights without secure support. This is especially relevant when theophylline is used concomitantly with other drugs 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 consult their doctor before taking this 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 exactly as prescribed by your doctor. If in doubt, consult your
doctor or pharmacist.
The doctor will determine the dose individually for each patient depending on age, body weight,
and serum theophylline concentration.
Serum theophylline concentration should also be monitored if reduced effectiveness occurs or
if adverse effects appear.
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 distribute into adipose tissue.
The usual maintenance dose for adults is approximately 11 to 13 mg of theophylline per kg of body weight per day.
Any change in dosing—either 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 gradually increased over 2–3 days.
Euphyllin long 300 mg capsules must 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 daily, not exceeding 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 dyspnea are advised to take the daily dose (maximum 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 either 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 a higher than recommended dose of Euphyllin long is taken, seek immediate medical advice from a doctor or pharmacist.
Symptoms of overdose include: nausea, stomach pain, vomiting, diarrhea, 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 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 must not be taken to make up for the missed dose.
If there are any further doubts regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

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

• 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 levels and increased calcium levels in serum, increased glucose levels and excessive uric acid levels in blood;
• headache, excitation, limb tremors, motor restlessness, insomnia;
• increased urine output, increased serum creatinine levels.

Uncommon (occur in less than 1 in 100 but more than 1 in 1,000 treated patients):

• hypersensitivity reactions.

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

• seizures.

Adverse reactions may be more pronounced in patients with hypersensitivity to theophylline or
in case of overdose.
High serum theophylline concentration may cause signs of toxicity 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 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
Phone: +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 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 wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

What Euphyllin long contains

• The active substance is theophylline. One modified-release capsule contains 300 mg of theophylline.
• The other ingredients are: methylcellulose 15 mPas, microcrystalline cellulose, sodium carboxymethylcellulose, cellulose acetate, triethyl citrate, lactose monohydrate, talc. Capsule shell composition: titanium dioxide (E 171), gelatin, water. Composition of the black printing 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 300".
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 manufacturing site
Lehnitzstrasse 70-98
16515 Oranienburg
Germany