Sustained release capsules

Box, 5 blisters @ 10 capsules

ON MEDICAL PRESCRIPTION ONLY

Each capsule contains:

• Immediate release
  • Loratadine 5 mg
  • Pseudoephedrine HCl 60 mg
• Sustained release
  • Pseudoephedrine HCl 60 mg

• Loratadine is a potent long-acting tricyclic antihistamine with selective peripheral H1-receptor antagonistic activity.
  
  
• Pseudoephedrine (d-isoephedrine) is a stereoisomer of ephedrine which is a sympathomimetic agent with direct effects on adrenergic receptors which give decongestant effect.
  
  
• In a sustained release capsule, pseudoephedrine may exert its effects for at least 12 hours.

Relief of symptoms associated with allergic rhinitis, such as sneezing, nasal congestion, rhinorrhea and nasal pruritus. This drug is recommended when both of antihistaminic effect of loratadine and decongestant effect of pseudoephedrine are needed.

• Sympathomimetic agents are contraindicated in patients with cardiovascular diseases such as coronary insufficiency, arrhythmia and severe hypertension.

• Patients receiving monoamine oxidase (MAO) inhibitor therapy or within 10 days of discontinuing such treatment and in patients with narrow-angle glaucoma, urinary retention, severe hypertension, severe coronary artery disease and hyperthyroidism.
  
  
• Hypersensitivity to pseudoephedrine and loratadine.
  
  
• Administration concomitantly with ketokonazole and azole derivates or macrolide group.
  
  
• Respiratory failure.
  
  
• Patients who have shown hypersensitivity or idiosyncrasy to their components, to adrenergic agents or to other drugs of similar chemical structure.

• Should be used with caution in patients with hypertension and diabetes mellitus.

• Safe use of Rhinos SR in pregnancy has not been established, it should be used only if the potential benefit justifies the potential risk to the fetus.
  
  
• Since loratadine and pseudoephedrine HCl are excreted in breast milk, it should be used with caution if used in nursing women.
  
  
• Sympathomimetic agents should be used with caution in patients receiving digitalis.
  
  
• Sympathomimetic agents may cause CNS stimulation, exitability, convulsions and/or cardiovascular collapse with accompanying hypotension.
  
  
• In patients 60 years or older, sympathomimetic agents may cause confusion, hallucinations, convulsions, CNS depression and death, therefore the administration of formulation, which has repeated effects should be used cautiously in elderly.
  
  
• This drug should be avoided in patients with hepatic insufficiency.
  
  
• Patients with renal insufficiency (GFR < 30 ml/minute) should be given a lower initial dose because they have reduced clearance of loratadine and pseudoephedrine.
  
  
• Drug abuse and dependence: there is no data available to indicate that abuse or dependency occurs with loratadine.
  
  
• Pseudoephedrine like other CNS stimulants has been abused. At high doses, subjects commonly experience an elevation of mood, decreased appetite and a sense of increased physical energy, mental capacity and alertness.
  
  
• Anxiety, irritability and loquacity also have been experienced. With continued use, tolerance develops; the user increases the dose and ultimately toxicity occurs. Depression may follow rapid withdrawal.
  
  
• Use in children: safety and efficacy in children < 12 years have not been established.
  
  
• Sympathomimetics should be used with caution in patients with glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction, prostatic hypertrophy or bladder neck obstruction, cardiovascular disease, and increased intraocular pressure.

• Gastrointestinal tract disturbance: anorexia, nausea, vomiting, gastric pain and dry mouth.

• Cardiovascular: palpitations, tachycardia and extrasystoles.
  
  
• Other adverse events which have been reported: abdominal pain and dyspepsia, alopecia, anaphylaxis reaction, angioedema, cardiac arrhythmias, bronchospasm, mood disturbance, convulsion, depression, dizziness, headache, insomnia, jaundice hepatic dysfunction including increase of transaminase, menstrual disturbance, musculoskeletal pain, nightmare, rash, diaphoresis, tremor and visual disturbance.

• When sympathomimetics are given to patients receiving MAOIs, hypertensive crisis may occur.

• Antacids increase the rate of pseudoephedrine absorption; kaolin decreases it.
  
  
• When administered concomitantly wiyh alcohol, loratadine has no potentiating effect as measured by psychomotor performance studies.
  
  
• The antihypertensive effects of methyldopa, mecamylamine, reserpine and veratrum alkaloids may be reduced by sympayhomimetics. Drug interactions between beta-adrenergic blocking agents with sympathomimetics could be occurred. Increased ectopic pacemaker activity can occur when pseudoephedrine is used concomitantly with digitalis

PT FERRON PAR PHARMACEUTICALS
JAKARTA - INDONESIA

For:
PT. DEXA MEDICA
Jl. Bambang Utoyo 138
Palembang - INDONESIA.