Genac

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. This medicine is usually taken only for a short time until your symptoms clear up.

Measure liquid medicine with a special dose-measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Do not take for longer than 7 days in a row. Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache or skin rash.

Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children.

Do not crush, chew, break, or open an extended-release tablet or capsule. Swallow it whole. Breaking or opening the pill may cause too much of the drug to be released at one time.

If you need surgery or medical tests, tell the surgeon or doctor ahead of time if you have taken this medicine within the past few days.

Store at room temperature away from moisture and heat. Do not allow the liquid form of this medicine to freeze.

Ask a doctor or pharmacist before using this medicine if you regularly use other medicines that make you sleepy (such as narcotic pain medication, sedatives, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety). They can add to sleepiness caused by triprolidine.

Ask a doctor or pharmacist if it is safe for you to take pseudoephedrine and triprolidine if you are also using any of the following drugs:

• atropine (Atreza, Sal-Tropine);

• benztropine (Cogentin);

• topiramate (Topamax);

• zonisamide (Zonegran);

• anti-nausea medications such as belladonna (Donnatal), dimenhydrinate (Dramamine), methscopolamine (Pamine), or scopolamine (Transderm Scop);

• bladder or urinary medications such as darifenacin (Enablex), flavoxate (Urispas), oxybutynin (Ditropan, Oxytrol), solifenacin (Vesicare), tolterodine (Detrol), or Urogesic Blue;

• bronchodilators such as ipratropium (Atrovent) or tiotropium (Spiriva);

• irritable bowel medications such as dicyclomine (Bentyl), hyoscyamine (Hyomax), or propantheline (Pro Banthine); or

• ulcer medicine such as glycopyrrolate (Robinul) or mepenzolate (Cantil).

This list is not complete and other drugs may interact with pseudoephedrine and triprolidine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Applies to pseudoephedrine / triprolidine: oral liquid, oral suspension extended release, oral syrup, oral tablet, oral tablet extended release

Cardiovascular

Pseudoephedrine causes vasoconstriction which generally does not produce hypertension, but may be problematic for patients with preexisting hypertension. Arrhythmias may be produced in predisposed patients. Rarely, pseudoephedrine has been reported to cause coronary artery spasm and chest pain.

One report evaluated the effect with 60 mg of pseudoephedrine on individuals in a hyperbaric chamber at 1 atmosphere (simulated scuba dive to 66 feet of sea water). Pseudoephedrine and depth (stimulated) were found to have significant but opposite effects on heart rate, although these effects were unlikely to be clinically significant during diving.[Ref]

Cardiovascular side effects of pseudoephedrine have included tachycardia. Some patients have developed hypertension and/or arrhythmias.[Ref]

Nervous system

Nervous system side effects of pseudoephedrine have included insomnia in up to 30% of patients. Tremor, anxiety, nervousness, and headache have also been reported with the use of pseudoephedrine. Antihistamines such as triprolidine have been reported to cause drowsiness.[Ref]

Gastrointestinal

Gastrointestinal side effects of pseudoephedrine have included anorexia and gastric irritation in approximately 5% of patients. Dry mouth, nose, or throat have occurred in up to 15% of patients receiving pseudoephedrine. Antihistamines such as triprolidine have also been reported to cause dry mouth. Pseudoephedrine-triprolidine may cause diarrhea.[Ref]

Hypersensitivity

Hypersensitivity side effects with the use of pseudoephedrine have included fixed drug eruptions.[Ref]

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