Theophillinum Tramco

Leaflet attached to the packaging: information for the user

Theophyllinum Tramco 1.2 mg/ml, solution for infusion
Theophyllinum

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Theophyllinum Tramco and what is it used for
• 2. Important information before using Theophyllinum Tramco
• 3. How to use Theophyllinum Tramco
• 4. Possible side effects
• 5. How to store Theophyllinum Tramco
• 6. Contents of the pack and other information

1. What is Theophyllinum Tramco and what is it used for

Theophyllinum Tramco belongs to a group of medicines called xanthines, which relax and dilate the airways in the lungs and make breathing easier.
Theophyllinum Tramco is used to treat symptoms of breathing problems caused by diseases that involve:

• difficulty breathing, shortness of breath, chest tightness (acute asthma attack),
• wheezing or coughing (bronchospasm),
• asthma,
• chronic bronchitis,
• pulmonary disease that makes breathing difficult (pulmonary emphysema),
• acute asthma attack (acute asthmatic state).

2. Important information before using Theophyllinum Tramco

When not to use Theophyllinum Tramco:

• in children under 6 months of age,

Warnings and precautions

Before starting to use Theophyllinum Tramco, discuss it with your doctor or pharmacist:

Your doctor will monitor you during the infusion. The concentration of theophylline in the blood will be controlled.

Children

Do not give this medicine to children under 6 months of age.
Caution is recommended when using in children under 1 year of age.

Using Theophyllinum Tramco in patients with kidney and/or liver function disorders

Caution is recommended when using in patients with liver and/or kidney failure.

Using Theophyllinum Tramco in elderly patients

Caution is recommended when using in elderly patients.

Theophyllinum Tramco and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as any medicines you plan to take, including those available without a prescription.
The action of any of these medicines or Theophyllinum Tramco may be altered, especially if you are taking:

• ephedrine or other bronchodilators, halothane, digitalis glycosides, reserpine - these medicines may increase the toxicity of theophylline;
• macrolide antibiotics, cimetidine, furosemide, enoxacin, ciprofloxacin, clindamycin, lincomycin, fluconazole, calcium channel blockers (e.g. verapamil, diltiazem), allopurinol, propranolol, fluvoxamine, mexiletine, ticlopidine, viloxazine, methotrexate, interferon, oral contraceptives, influenza vaccines - these medicines increase the concentration of theophylline in the blood;
• barbiturates, carbamazepine, primidone, rifampicin, sulfinpyrazone, St. John's Wort, smoking - these decrease the concentration of theophylline in the blood;
• the action of other xanthines, phenytoin, non-depolarizing muscle relaxants, lithium salts, cortisol may be decreased or increased if given simultaneously with theophylline.

Theophyllinum Tramco with food and drink

It is recommended not to give this medicine with coffee, tea, chocolate, and paracetamol, as they may cause false results of theophylline concentration test in the blood.

Pregnancy, breastfeeding, and fertility

Theophylline may be used during pregnancy only if the doctor considers that the benefit to the mother outweighs the potential risk to the fetus.
Theophylline should not be used in the third trimester of pregnancy, as its administration in the late stages of pregnancy may cause hyperactivity and accelerated heart rate in newborns.
Theophylline should not be used during breastfeeding, as it passes into breast milk and may cause toxic effects in breastfed children.
If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor before using this medicine.

Driving and using machines

No effect of theophylline on the ability to drive or use machines is expected.

Theophyllinum Tramco contains glucose

This medicine contains glucose. If you have been diagnosed with intolerance to some sugars, consult your doctor or pharmacist before taking this medicine.
250 ml of the solution contains 13.5 mg of glucose. This should be taken into account in patients with diabetes.

3. How to use Theophyllinum Tramco

Theophyllinum Tramco will be administered by a doctor or nurse.
The doctor will decide what dose to use and when to administer it. This depends on the patient's age, weight, clinical condition, and reason for treatment. The dose may also depend on other therapies used at the same time.
Theophylline will be administered by intermittent or continuous, slow intravenous infusion.
The doctor will monitor the concentration of theophylline in the blood.
After the initial dose, a maintenance dose will be administered, depending on the current concentration of theophylline in the blood.
Theophyllinum Tramco will be administered to patients using sterile equipment (so-called infusion set) and aseptic techniques.
If you notice any changes in your well-being after receiving or during the administration of the medicine, inform your doctor or nurse immediately. The doctor may stop the infusion and start appropriate treatment.
If another medicine is added to the Theophyllinum Tramco solution, the symptoms that occur during the infusion may be related to the added medicine.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects have been reported for other medicines with a similar composition.
Inform your doctor or nurse immediately if you experience any of the following side effects during or after the administration of the medicine:

• rapid heart rate (tachycardia);
• feeling of rapid or strong heart rate (palpitations);
• irregular heart rhythm (arrhythmia);
• chest pain (angina pectoris);
• excessive stimulation;
• anxiety;
• difficulty sleeping (insomnia);
• headaches;
• dizziness;
• tremors;
• nightmares;
• seizures;
• feeling of dizziness;
• disorientation;
• low blood pressure (hypotension);
• nausea (nausea);
• vomiting;
• gastroesophageal reflux;
• abdominal pain;
• diarrhea;
• increased acidity in the stomach and ulcers;
• high levels of protein in the urine (albuminuria);
• increased urine production (diuresis);
• blood in the urine (hematuria);
• fever;
• rapid breathing.

The doctor may decide to stop the infusion and start appropriate treatment.
Theophylline side effects most often result from overdose.
In some people, other side effects may occur during the use of Theophyllinum Tramco. If you experience other side effects not listed in this leaflet, inform your doctor.

Reporting side effects

If you experience any side effects, including those not listed in the leaflet, inform your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products,
Jerozolimskie Avenue 181 C
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.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Theophyllinum Tramco

Keep the medicine out of the sight and reach of children.
Protect from light.
Do not use this medicine after the expiry date stated on the bottle and carton after:
“EXP”. The expiry date refers to the last day of the month.
Do not store or reuse opened packaging.
Do not use this medicine if you notice thatthe solution is not clear or the glass bottle is damaged.
Medicines should not be disposed of via wastewater or household waste. 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 Theophyllinum Tramco contains

• The active substance is theophylline.
• The other ingredients are glucose and water for injections.

1 ml of the solution contains 1.2 mg of theophylline.
250 ml of the solution contains 300 mg of theophylline.

What Theophyllinum Tramco looks like and contents of the pack

This medicine is a clear, colorless solution for infusion in a clear glass bottle with a capacity of 250 ml, closed with a gray rubber stopper and an aluminum cap.
Theophyllinum Tramco, 1.2 mg/ml, solution for infusion is available in cartons containing 20 glass bottles of 250 ml.

Marketing authorization holder

Tramco Sp. z o.o.
Wolska Street 14
05-860 Płochocin
[Logo of the marketing authorization holder]

Manufacturer:

Bieffe Medital S.p.A.
Via Nuova Provinciale
23034 Grosotto (So)
Italy

Date of last revision of the leaflet:

Information intended for healthcare professionals only:
The total dose should be determined according to the following scheme:
Patients not currently receiving other theophylline preparations:

Method of administration and procedure

Administer immediately after setting up the infusion set.
Additional medicinal products should be introduced through the injection port of the bottle where the infusion device is located.
Shake well.
Follow aseptic procedures.
Do not store solutions to which additional medicinal products have been added.
Medicines for parenteral administration should be visually inspected for particulate matter or color change before administration.
Theophylline should not be administered with infusion fluids containing ascorbic acid, chlorpromazine, codeine, corticotropin, adrenaline, hydralazine, insulin, methadone, methycillin, morphine, noradrenaline, oxytetracycline, papaverine, penicillin G, potassium, phenobarbital sodium, phenytoin, procaine, promazine, promethazine, tetracycline, vitamin B complex with ascorbic acid.