Symbicort 160/4.5 mcg Inhalation powder, pre-dispensed with inhaler 60 doses

Symbicort 160/4.5 mcg Inhalation powder, pre-dispensed with inhaler 60 doses

Composition:

Active Ingredients: Each delivered dose (the dose leaving the mouthpiece) contains 
Micronized Budesonide — 160 mcg and Formoterol Fumarate Dihydrate — 4.5 mcg.
Excipients:
Lactose monohydrate — 730 mcg (contains residual amounts of milk proteins).

Product Description:

• Symbicort Turbuhaler is a combination medication for the treatment of airway diseases containing an inhaled corticosteroid (budesonide) and a selective long-acting β₂-adrenoreceptor agonist (formoterol).
• The mechanism of action of the components exhibits an additive effect, reducing the frequency of asthma exacerbations and improving lung function.
• Budesonide exerts a pronounced anti-inflammatory action in the airways, reducing the severity of symptoms and the frequency of exacerbations.
• Formoterol induces rapid and long-lasting relaxation of bronchial smooth muscle (onset of action within 1–3 minutes after inhalation, duration of at least 12 hours).

Indications for Use:

• Bronchial Asthma:
  To achieve overall disease control, including prevention and relief of symptoms, as well as reducing the risk of exacerbations.
  Treatment of bronchial asthma of any severity when the use of inhaled corticosteroids is appropriate (as maintenance therapy and for symptom/attack relief, or as maintenance therapy alone).
• Chronic Obstructive Pulmonary Disease (COPD):
  Symptomatic treatment in patients with severe COPD (post-bronchodilator FEV₁ <70% of predicted) and a history of repeated exacerbations despite regular long-acting bronchodilator therapy.

Method of Administration and Dosage:

• Intended for inhalation use only.
• Dose selection is individualized based on disease severity.
• Instructions for Using the Turbuhaler Device:
  Unscrew and remove the protective cap.
  Hold the inhaler upright with the red grip at the bottom.
  Turn the grip as far as it will go in one direction, then turn it back to its original position until a click is heard (the dose is now loaded).
  Breathe out gently (away from the mouthpiece).
  Place the mouthpiece tightly between your lips and take a strong, deep breath in through your mouth.
  Remove the inhaler from your mouth and hold your breath for 5–10 seconds.
  After inhalation, rinse your mouth with water (do not swallow) to reduce the risk of oral candidiasis.
• Dosing Regimen:
  Adults (18 years and older): 1–2 inhalations twice daily. If necessary, the number of inhalations may be temporarily increased up to a maximum dose of 4 inhalations twice daily.
  Adolescents (12–17 years): 1–2 inhalations twice daily.
  Children (6–11 years): In this age group, Symbicort 80 mcg / 4.5 mcg strength is recommended at 2 inhalations twice daily.
  Children under 6 years: Symbicort Turbuhaler is not recommended for children under 6 years of age.

Contraindications:

Hypersensitivity to budesonide, formoterol, or inhaled lactose.
Children under 6 years of age (for this strength — under 12 years of age for self-administration of maintenance and reliever therapy).
Hereditary galactose intolerance, severe lactase deficiency, or glucose-galactose malabsorption.

Precautions:

• Use with Caution: Pulmonary tuberculosis (active or inactive forms), fungal, viral, or bacterial respiratory tract infections, thyrotoxicosis, pheochromocytoma, diabetes mellitus, severe cardiovascular disorders (ischemic heart disease, tachyarrhythmias, severe heart failure), hypokalemia.
• Therapy Monitoring: Patients should remain under medical supervision for regular evaluation of treatment efficacy and dose adjustment. Do not abruptly discontinue Symbicort treatment.
• Risk of Paradoxical Bronchospasm: If paradoxical bronchospasm occurs, discontinue the medication immediately and re-evaluate the treatment regimen.
• Oral Hygiene: Always rinse the mouth with water after each inhalation to prevent oral mucosal candidiasis and hoarseness.

Adverse Reactions / Side Effects:

• Nervous System: Frequently — headache; uncommonly — psychomotor agitation, anxiety, nausea, dizziness, sleep disturbances, muscle cramps.
• Cardiovascular System: Frequently — palpitations; uncommonly — tachycardia; rarely — arrhythmias, angina pectoris.
• Respiratory System: Frequently — candidiasis of the oral and pharyngeal mucosa, cough, voice hoarseness, mild throat irritation; very rarely — paradoxical bronchospasm.
• Allergic Reactions: Rarely — immediate and delayed hypersensitivity reactions (urticaria, angioedema, anaphylactic reactions).
• Metabolism: Uncommonly — hypokalemia; very rarely — hyperglycemia.

Pregnancy and Lactation:

During pregnancy and lactation, Symbicort should be prescribed only when the expected benefit to the mother outweighs the potential risk to the fetus or child.
The lowest effective dose of budesonide required to maintain adequate asthma control should be used.

Storage Conditions:

Store in a dry, dark place at a temperature not exceeding 30 °C.
Keep out of reach of children.

Packaging:

Plastic Turbuhaler inhaler containing 60 doses of the drug, equipped with tamper-evident protection (protective film indicating the opening location).
1 inhaler together with a patient information leaflet in a cardboard pack.