Baladex

Package Leaflet: Information for the Patient

Baladex, (50 mg + 30 mg)/5 mL, Syrup

Theophylline + Guaifenesin

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 specifically for you. 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, inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Baladex and what is it used for

Baladex is a syrup that contains two active substances: theophylline and guaifenesin.
Theophylline has a bronchodilating effect, and guaifenesin has an expectorant effect.

Indications for Use

Treatment and prevention of shortness of breath:

• in the course of asthma, bronchitis;
• and in chronic obstructive pulmonary disease (chronic bronchitis, emphysema).

2. Important Information Before Taking Baladex

When Not to Take Baladex

• if you are allergic to theophylline or guaifenesin, or any of the other ingredients of this medication (listed in section 6);
• if you have stomach or duodenal ulcers;
• if you have had a heart attack, have heart rhythm disorders;
• if you have epilepsy, hyperthyroidism;
• if you have kidney function disorders;
• in children under 6 years of age.

Warnings and Precautions

Before starting to take Baladex, discuss it with your doctor:

• if you have cardiovascular diseases and hypertension;
• if you have respiratory diseases;
• if you have liver diseases;
• if you have alcoholism;
• if you have a fever that lasts more than 3 days;
• if you are obese;
• if you are over 55 years old.

The Medication Contains Theophylline and Guaifenesin

Due to the risk of overdose, before use, check if other medications you are taking do not contain theophylline and guaifenesin.

Children

Do not give this medication to children under 6 years of age.

Baladex and Other Medications

Tell your doctor or pharmacist about all medications you are taking, have recently taken, or plan to take.
If you are taking any of the following medications, tell your doctor:

• cimetidine (a medication used to treat stomach and duodenal ulcers);
• macrolide antibiotics;
• clindamycin, lincomycin (antibiotics from the lincosamide group);
• isoniazid (an anti-tuberculosis medication);
• quinolone derivatives (antibiotics with bactericidal action, e.g., pefloxacin);
• oral contraceptives;
• mexiletine (an anti-arrhythmic medication);
• allopurinol (a medication used to treat gout);
• furosemide (a diuretic medication);
• oral anticoagulants;
• halothane (used in inhalation anesthesia);
• sympathomimetics (e.g., ephedrine);
• digitalis glycosides (used to treat heart diseases);
• reserpine (used to treat hypertension);
• ketamine (used in anesthesia);
• nicotine;
• barbiturates (medications used to treat insomnia and epilepsy);
• rifampicin (an antibiotic used to treat tuberculosis);
• phenytoin (a medication used to treat epilepsy).
• Theophylline weakens the effect of lithium salts, propranolol, non-depolarizing muscle relaxants; enhances hypoglycemia occurring during the use of glucocorticosteroids, β-adrenomimetics (salbutamol, fenoterol), and diuretics.
• Medications that protect the gastric mucosa weaken the effect of guaifenesin. If you are not sure if you are taking any of the above medications, consult your doctor or pharmacist.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a child, consult your doctor or pharmacist before taking this medication.
Pregnancy
Baladex may be used during pregnancy only if the benefits to the mother outweigh the potential risk to the fetus.
Breastfeeding
Baladex may be used during breastfeeding only if the benefits to the mother outweigh the potential risk to the child. Theophylline passes into breast milk and may cause side effects in breastfed children.

Driving and Operating Machines

Do not drive or operate machines after taking this medication.
Baladex contains ethanol, glucose, sucrose, sodium benzoate, liquid sorbitol, and
sodium

Ethanol

This medication contains 618.8 mg of alcohol (ethanol) in each 5 mL of syrup, which is equivalent to 12.38% (v/v). The amount of alcohol in 5 mL of this medication is equivalent to 16 mL of beer or 7 mL of wine.
Alcohol in this medication may affect children. Symptoms may include: drowsiness and changes in behavior. It may also affect their ability to concentrate and physical activity.
The amount of alcohol in this medication may affect the ability to drive and operate machines, as it may affect judgment and reaction time.
If you have liver problems, consult your doctor or pharmacist before taking this medication.
The amount of alcohol in this medication may change the effect of other medications. If you are taking other medications, consult your doctor or pharmacist.
If you are pregnant or breastfeeding, consult your doctor or pharmacist before taking this medication.
If you are addicted to alcohol, consult your doctor or pharmacist before taking this medication.

Glucose

The medication contains 260 mg of glucose in each 5 mL of syrup. If you have previously been diagnosed with intolerance to some sugars, consult your doctor before taking the medication.

Sucrose

The medication contains 2.5 g of sucrose in each 5 mL of syrup. This should be taken into account in patients with diabetes. If you have previously been diagnosed with intolerance to some sugars, consult your doctor before taking the medication.

Sodium Benzoate

The medication contains 10 mg of sodium benzoate in each 5 mL of syrup.

Liquid Sorbitol, Non-Crystallizing

The medication contains 250 mg of liquid sorbitol, non-crystallizing, which is equivalent to 165.6 mg of pure sorbitol in each 5 mL of syrup and is equivalent to 0.01 w/w.
Sorbitol is a source of fructose. If you have previously been diagnosed with intolerance to some sugars or have been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which the body does not break down fructose, consult your doctor before taking the medication or giving it to a child.

Sodium

The medication contains 11.38 mg of sodium (the main component of common salt) in each 5 mL of syrup. This is equivalent to 0.57% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to Take Baladex

Always take this medication exactly as your doctor has told you. If you are not sure, consult your doctor or pharmacist.
The medication is for oral use.
The dosage is determined by the doctor individually, depending on the patient's response to treatment.
To measure the dose, use the measuring cup provided with the packaging. This allows for accurate dosing.
Recommended dose:
Adults and children over 6 years of age with a body weight over 40 kg: 5 to 10 mL (50 to 100 mg of theophylline) 2 to 3 times a day.
Children over 6 years of age with a body weight under 40 kg: 11 to 16.5 mg/kg of body weight of theophylline per day, divided into 2 or 3 doses.

Use in Children

Do not use in children under 6 years of age.

Overdose of Baladex

If you have taken more than the recommended dose, consult your doctor. After overdose of the syrup, the following may occur: seizures, severe heart rhythm disorders with cardiac arrest.

Missing a Dose of Baladex

Continue taking the medication, without increasing the next dose.
Do not take a double dose to make up for a missed dose.
If you have any further doubts about the use of this medication, consult your doctor or pharmacist.

4. Possible Side Effects

Like all medications, Baladex can cause side effects, although not everybody gets them.
The following side effects may occur:

• nausea, vomiting, diarrhea;
• headache, anxiety, agitation, tonic-clonic seizures, especially with significant overdose;
• hypotension (low blood pressure - significant decrease in blood pressure);
• circulatory failure;
• heart rhythm disorders, tachycardia (rapid heart rate);
• rash;
• hypokalemia (low potassium level in the blood);
• hyperglycemia (high blood sugar level).

Reporting Side Effects

If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist.
Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of 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
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 medication.

5. How to Store Baladex

Keep the medication out of the sight and reach of children.
Store in a temperature below 25°C.
Shelf life after first opening the bottle – 28 days.
Do not use this medication after the expiry date stated on the label and carton.
The expiry date refers to the last day of the month.
Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medications no longer required. This will help protect the environment.

6. Contents of the Pack and Other Information

What Baladex Contains

• The active substances are theophylline and guaifenesin. 5 mL of syrup contains 50 mg of theophylline and 30 mg of guaifenesin.
• The other ingredients are: citric acid, ethanol 96%, glucose, glycerol, sodium saccharin, liquid sorbitol, non-crystallizing, sodium citrate, sodium benzoate, sucrose, levomenthol, purified water.

What Baladex Looks Like and Contents of the Pack

The medication is a syrup.
The packaging of the medication is: a brown glass bottle containing 150 mL of syrup, closed with a white aluminum cap with a measuring cup, placed in a cardboard box.

Marketing Authorization Holder

Aflofarm Farmacja Polska Sp. z o.o.
ul. Partyzancka 133/151
95-200 Pabianice
Phone: (42) 22-53-100

Manufacturer

Aflofarm Farmacja Polska Sp. z o.o.
ul. Krzywa 2
95-030 Rzgów

Date of Last Revision of the Leaflet: