Rynatan Chewable Pediatric Tablets

General: Antihistamines are more likely to cause dizziness, sedation and hypotension in elderly patients. Antihistamines may cause excitation, particularly in children, but their combination with sympathomimetics may cause either mild stimulation or mild sedation.

Information for patients: Caution patients against drinking alcoholic beverages or engaging in potentially hazardous activities requiring alertness, such as driving a car or operating machinery while using this product. Patients should be warned not to use this product if they are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If patients are uncertain whether a prescription drug contains an MAOI, they should be instructed to consult a health professional before taking such a product.

Drug interactions: MAO inhibitors may prolong and intensify the anticholinergic effects of antihistamines and the overall effects of sympathomimetic agents.

Carcinogenesis, mutagenesis, impairment of fertility: No long term animal studies have been performed with Rynatan® Chewable Pediatric Tablets.

Pregnancy: Teratogenic effects: Pregnancy Category C. Animal reproduction studies have not been conducted with Rynatan® Chewable Pediatric Tablets. It is also not known whether Rynatan® Chewable Pediatric Tablets can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Rynatan® Chewable Pediatric Tablets should be given to a pregnant woman only if clearly needed.

Nursing mothers: Rynatan® Chewable Pediatric Tablets should not be administered to a nursing woman.

To report SUSPECTED ADVERSE REACTIONS, contact Meda Pharmaceuticals Inc. at 1-800-526-3840 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Adverse effects associated with the Rynatan® Chewable Pediatric Tablets antihistamine and sympathomimetic ingredients at recommended doses have been minimal. The most common have been drowsiness, sedation, dryness of mucous membranes, and gastrointestinal effects. Serious side effects with oral antihistamines or sympathomimetics have been rare.

Signs & symptoms: May vary from CNS depression to stimulation (restlessness to convulsions). Antihistamine overdosage in young children may lead to convulsions and death. Atropine-like signs and symptoms may be prominent.

Treatment: Induce vomiting if it has not occurred spontaneously. Precautions must be taken against aspiration especially in infants, children and comatose patients. If gastric lavage is indicated, isotonic or half-isotonic saline solution is preferred. Stimulants should not be used. If hypotension is a problem, vasopressor agents may be considered.

Administer the recommended dose every 12 hours.

Rynatan® Chewable Pediatric Tablets: Children over six years of age – 1 to 2 chewable tablets; Children two to six years of age – 1/2 or 1 chewable tablet.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Dizziness.
• Feeling nervous and excitable.
• Not able to sleep.
• Feeling sleepy.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Applies to chlorpheniramine / phenylephrine: oral capsule extended release, oral drops, oral elixir, oral liquid, oral suspension, oral suspension extended release, oral syrup, oral tablet, oral tablet chewable, oral tablet extended release

General

General side effects including drowsiness, lassitude, giddiness, and increased irritability or excitement have been reported.[Ref]

Gastrointestinal

Gastrointestinal side effects including nausea and dryness of mouth have been reported.[Ref]

Cardiovascular

Cardiovascular side effects including palpitations and flushing have been reported.[Ref]

Some side effects of Rynatan Pediatric may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.