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Methscopolamine/ phenylephrine extended-release tablets

Generic Name: methscopolamine/phenylephrine (METH-skoe-POL-a-meen/FEN-il-EF-rin)
Brand Name: Extendryl PEM

Methscopolamine/ phenylephrine extended-release tablets are used for:

Relieving congestion, sneezing, runny nose, and itchy, watery eyes due to colds, flu, or hay fever. It may also be used for other conditions as determined by your doctor.

Methscopolamine/phenylephrine extended-release tablets are an anticholinergic and decongestant combination. It works by blocking histamine, a substance in the body that causes sneezing, runny nose, and watery eyes. It also relieves nasal congestion by shrinking the nasal mucous membranes, which promotes nasal drainage, and dries the chest by decreasing lung secretions.

Do NOT use methscopolamine/ phenylephrine extended-release tablets if:

  • you are allergic to any ingredient in methscopolamine/phenylephrine extended-release tablets
  • you are taking sodium oxybate (GHB) or droxidopa, or you have taken furazolidone or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) in the last 14 days
  • you have narrow-angle glaucoma; a blockage of the bladder, stomach, or intestines; peptic ulcer disease; severe bowel problems (eg, ulcerative colitis); inflammation of the esophagus from reflux disease; difficulty swallowing; myasthenia gravis (muscle weakness); or uncontrolled bleeding
  • you have severe heart disease, severe high blood pressure, severe heart blood vessel problems, or a rapid heartbeat, or you are unable to urinate
  • you are having an asthma attack

Contact your doctor or health care provider right away if any of these apply to you.

Before using methscopolamine/ phenylephrine extended-release tablets:

Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have an adrenal gland tumor, asthma, bladder or kidney problems, blood clots, blood vessel problems, breathing problems during sleep, an enlarged prostate, heart problems (eg, ischemic heart disease, irregular heartbeat), a hiatal hernia, high blood pressure, increased glaucoma, lung problems (eg, emphysema), a history of diabetes, nerve problems, an overactive thyroid, pressure in the eye, risk factors for glaucoma, seizures, stroke, or trouble urinating
  • if you have diarrhea

Some MEDICINES MAY INTERACT with methscopolamine/phenylephrine extended-release tablets.

  • Sodium oxybate (GHB) because the risk of severe drowsiness or coma may be increased
  • Furazolidone or MAOIs (eg, phenelzine) because severe high blood pressure, fast or irregular heartbeat, or seizures may occur
  • Alpha-blockers (eg, prazosin), anesthetics (eg, chloroform, lidocaine), anticholinergics (eg, atropine, benztropine, dicyclomine), beta-blockers (eg, propranolol), carbonic anhydrase inhibitors (eg, acetazolamide), diuretics (eg, furosemide, hydrochlorothiazide), ergotamine, tricyclic antidepressants (eg, amitriptyline), or urinary alkalinizers (eg, sodium bicarbonate) because they may increase the risk of methscopolamine/phenylephrine extended-release tablets's side effects
  • Bromocriptine, catechol-O-methyltransferase (COMT) inhibitors (eg, entacapone), certain stimulants (eg, doxapram, pseudoephedrine), cocaine, digoxin, droxidopa, or potassium chloride because the risk of their side effects may be increased by methscopolamine/phenylephrine extended-release tablets
  • Clonidine, guanethidine, guanfacine, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by methscopolamine/phenylephrine extended-release tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if methscopolamine/phenylephrine extended-release tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use methscopolamine/ phenylephrine extended-release tablets:

Use methscopolamine/phenylephrine extended-release tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Take methscopolamine/phenylephrine extended-release tablets by mouth with or without food.
  • Swallow methscopolamine/phenylephrine extended-release tablets whole. Do not break, crush, or chew before swallowing. Some brands of methscopolamine/phenylephrine extended-release tablets may be broken in half before taking. If you have difficulty swallowing the whole tablet, ask your pharmacist if your brand of medicine may be broken in half.
  • Do not take methscopolamine/phenylephrine extended-release tablets at the same time as antacids, certain medicines for diarrhea (eg, kaolin, pectin, attapulgite, bismuth), or ketoconazole. Take these medicines 2 or 3 hours before or after you take methscopolamine/phenylephrine extended-release tablets.
  • If you miss a dose of methscopolamine/phenylephrine extended-release tablets and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use methscopolamine/phenylephrine extended-release tablets.

Important safety information:

  • Methscopolamine/phenylephrine extended-release tablets may cause blurred vision, dizziness, or drowsiness. These effects may be worse if you take it with alcohol or certain medicines. Use methscopolamine/phenylephrine extended-release tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using methscopolamine/phenylephrine extended-release tablets; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
  • If your symptoms do not get better within 7 days or if you develop a high fever or persistent headache, check with your doctor.
  • Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.
  • Methscopolamine/phenylephrine extended-release tablets may cause dry mouth. To relieve dry mouth, suck on sugarless hard candy or ice chips, chew sugarless gum, drink water, or use a saliva substitute.
  • Methscopolamine/phenylephrine extended-release tablets may make your eyes more sensitive to sunlight. It may help to wear sunglasses.
  • Methscopolamine/phenylephrine extended-release tablets may reduce sweating. Do not become overheated in hot weather or while you are being active; heatstroke may occur.
  • Do not take diet or appetite control medicines while you are taking methscopolamine/phenylephrine extended-release tablets without checking with your doctor.
  • Methscopolamine/phenylephrine extended-release tablets has phenylephrine in it. Before you start any new medicine, check the label to see if it has phenylephrine in it too. If it does or if you are not sure, check with your doctor or pharmacist.
  • If you have trouble sleeping, ask your doctor or pharmacist about the best time of the day to take methscopolamine/phenylephrine extended-release tablets.
  • Tell your doctor or dentist that you take methscopolamine/phenylephrine extended-release tablets before you receive any medical or dental care, emergency care, or surgery.
  • Diabetes patients - Methscopolamine/phenylephrine extended-release tablets may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
  • Methscopolamine/phenylephrine extended-release tablets may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking methscopolamine/phenylephrine extended-release tablets.
  • Use methscopolamine/phenylephrine extended-release tablets with caution in the ELDERLY; they may be more sensitive to its effects, especially confusion, hallucinations, and seizures.
  • Methscopolamine/phenylephrine extended-release tablets should not be used in CHILDREN younger than 6 years old; safety and effectiveness in these children have not been confirmed.
  • Caution is advised when using methscopolamine/phenylephrine extended-release tablets in CHILDREN; they may be more sensitive to its effects, especially excitability.
  • PREGNANCY and BREAST-FEEDING: It is not known if methscopolamine/phenylephrine extended-release tablets can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using methscopolamine/phenylephrine extended-release tablets while you are pregnant. It is not known if this medicine is found in breast milk. If you are or will be breast-feeding while you use methscopolamine/phenylephrine extended-release tablets, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of methscopolamine/ phenylephrine extended-release tablets:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; dizziness; drowsiness; dry mouth, nose, or throat; excitability or irritability (especially in children); flushing; headache; nausea; nervousness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (difficulty breathing; hives; itching; rash; swelling of the mouth, tightness in the chest; face, lips, or tongue); blurred vision; clumsiness; difficulty swallowing; fast or irregular heartbeat; hallucinations; mental or mood changes; seizures; tremor; trouble sleeping; trouble urinating; unusual bleeding or bruising; vomiting.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include deep sleep or loss of consciousness; hallucinations; hot or cool skin; irregular heartbeat; irritability, anxiety, or panic; large pupils; numbness or tingling in the arms or legs; seizures; slowed or shallow breathing; vomiting.

Proper storage of methscopolamine/phenylephrine extended-release tablets:

Store methscopolamine/phenylephrine extended-release tablets at room temperature, between 68 and 77 degrees F (20 and 15 degrees C), in a tightly closed container. Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep methscopolamine/phenylephrine extended-release tablets out of the reach of children and away from pets.

General information:

  • If you have any questions about methscopolamine/phenylephrine extended-release tablets, please talk with your doctor, pharmacist, or other health care provider.
  • Methscopolamine/phenylephrine extended-release tablets are to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about methscopolamine/phenylephrine extended-release tablets. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: June 3, 2015

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.