Phlemex Forte

Phlemex Forte is part of the drug classes:

• Opium alkaloids and derivatives

• Expectorants

• Adrenergic and dopaminergic agents

• Sympathomimetics

• Sympathomimetics excl. antiglaucoma preparations

• Sympathomimetics used as decongestants

• Sympathomimetics, combinations excl. corticosteroids

• Sympathomimetics, plain

Dextromethorphan is a cough suppressant. It affects the signals in the brain that trigger cough reflex.

Guaifenesin is an expectorant. It helps loosen congestion in your chest and throat, making it easier to cough out through your mouth.

Phenylephrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

Dextromethorphan, guaifenesin, and phenylephrine is a combination medicine used to treat cough, stuffy nose, sinus congestion and chest congestion caused by allergies, the common cold, or the flu.

There are many brands and forms of this medicine available. Not all brands are listed on this leaflet.

This medicine will not treat a cough that is caused by smoking, asthma, or emphysema.

Dextromethorphan, guaifenesin, and phenylephrine may also be used for purposes not listed in this medication guide.

You should not use this medicine if you are allergic to dextromethorphan, guaifenesin, or phenylephrine.

Do not use this medicine if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine.

Ask a doctor or pharmacist if it is safe for you to take dextromethorphan, guaifenesin, and phenylephrine if you have:

• high blood pressure or coronary artery disease;

• diabetes;

• glaucoma;

• epilepsy or other seizure disorder;

• enlarged prostate or urination problems;

• pheochromocytoma (an adrenal gland tumor); or

• cough with mucus, or cough caused by emphysema or chronic bronchitis.

It is not known whether dextromethorphan, guaifenesin, and phenylephrine will harm an unborn baby. Do not use this medicine without a doctor's advice if you are pregnant.

This medicine may pass into breast milk and may harm a nursing baby. Decongestants may also slow breast milk production. Do not use this medicine without a doctor's advice if you are breast-feeding a baby.

Artificially sweetened cold medicine may contain phenylalanine. If you have phenylketonuria (PKU), check the medication label to see if the product contains phenylalanine.

Since this medicine is taken when needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

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.

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 dextromethorphan / guaifenesin / phenylephrine: oral capsule, oral liquid, oral suspension, oral suspension extended release, oral syrup, oral tablet, oral tablet extended release

Cardiovascular

Cardiovascular side effects have included palpitations, tachycardia, and cardiovascular collapse and death.[Ref]

Gastrointestinal

Gastrointestinal side effects have included nausea and vomiting.[Ref]

Nervous system

Nervous system side effects have included nervousness, dizziness, sleeplessness, light-headedness, tremor, hallucinations, convulsions, CNS depression, fear, anxiety, headache, and increased irritability or excitement.[Ref]

Respiratory

Respiratory side effects have included respiratory difficulties.[Ref]

General

General side effects have included weakness and slight drowsiness.[Ref]

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