Osmolex ER

Osmolex ER is used to treat Parkinson's disease and "Parkinson-like" symptoms such as stiffness, tremors, shaking, and repetitive uncontrolled muscle movements that may happen due to the use of certain drugs.

Osmolex ER is also used to treat or prevent influenza A in adults and children. This medicine may not work every flu season because some strains of the virus may resist Osmolex ER. This medicine should not replace getting a yearly flu shot. The Centers for Disease Control recommends an annual flu shot to help protect you each year from new strains of the influenza virus.

Osmolex ER may also be used for purposes not listed in this medication guide.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

If you take Osmolex ER to treat influenza A, start taking the medicine within 24 to 48 hours after flu symptoms begin. Keep taking this medicine for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared.

You may take Osmolex ER with or without food. You may need to take this medicine only at bedtime. Follow your doctor's instructions.

Measure liquid medicine carefully. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

Swallow the capsule or tablet whole and do not crush, chew, or break it.

If you cannot swallow a capsule whole, open it and sprinkle the medicine into a spoonful of applesauce. Swallow the mixture right away without chewing. Do not save it for later use.

Call your doctor if your symptoms do not improve, or if you have a fever with a headache, cough, skin rash, or other new symptoms.

If you take Osmolex ER for Parkinson symptoms: You should not stop using this medicine suddenly or your condition may become worse. Stopping suddenly may also cause unpleasant withdrawal symptoms. Ask your doctor how to safely stop using this medicine.

Store at room temperature away from moisture, heat, and light. Keep the bottle tightly closed when not in use.

You should not use Osmolex ER if you received a nasal flu vaccine in the past 14 days.

Do not receive a nasal flu vaccine while taking Osmolex ER, and for at least 48 hours after your last dose. You may receive a flu shot (injection) while taking this medicine.

You should not use Osmolex ER if you are allergic to it, or if:

• you have severe kidney disease; or
• you received a "live" nasal flu vaccine (FluMist) within the past 14 days.

Tell your doctor if you have ever had:

• kidney disease;
• daytime drowsiness (caused by a sleep disorder or taking certain medicines);
• congestive heart failure;
• eczema;
• glaucoma;
• liver disease;
• a seizure;
• low blood pressure, fainting spells;
• alcoholism or drug addiction; or
• mental illness, psychosis, or suicidal thoughts or actions.

People with Parkinson's disease may have a higher risk of skin cancer (melanoma). Talk to your doctor about this risk and what skin symptoms to watch for.

It is not known whether Osmolex ER will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

You should not breast-feed while using this medicine.

Osmolex ER is not approved for influenza in a child younger than 1 year old. Gocovri is not approved for use by anyone younger than 18 years old.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Osmolex ER may cause serious side effects. Call your doctor right away if you experience:

• extreme drowsiness, suddenly falling asleep even after feeling alert;
• feeling light-headed, as if you might faint;
• shortness of breath (even with mild activity), swelling in your hands or feet;
• painful or difficult urination;
• depression, agitation, aggression, changes in behavior, hallucinations, thoughts of self-harm;
• a seizure; or
• a severe nervous system reaction—very stiff (rigid) muscles, high fever, sweating, confusion, rapid or uneven heartbeats, tremors.

You may experience increased sexual urges, unusual urges to gamble, or other strong urges while taking this medicine. Speak with your doctor if this happens.

Side effects may be more common in older adults.

Common side effects of Osmolex ER may include:

• dizziness, falls;
• dry mouth;
• swelling in your legs or feet;
• nausea, constipation; or
• sleep problems (insomnia).

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Skip the missed dose and take your next dose at the regular time. Do not take two doses at once.

Call your doctor if you miss multiple doses in a row.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of Osmolex ER can be fatal.

Overdose symptoms may include confusion, agitation, changes in behavior, hallucinations, severe headache or a pounding sensation in your ears, muscle stiffness, balance or walking problems, trouble breathing, fast heartbeats, or seizures.

Do not receive a nasal flu vaccine while using Osmolex ER, and for at least 48 hours after your last dose. The vaccine may not be as effective during this time and may not protect you from influenza.

Do not drink alcohol. Dangerous side effects could occur.

Avoid driving or operating machinery until you know how Osmolex ER will affect you. Osmolex ER may impair your thinking or reactions. Some people taking this medicine have fallen asleep during normal daytime activities such as working, talking, eating, or driving. You may fall asleep suddenly, even after feeling alert. Be careful if you drive or do anything that requires you to be alert.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy.

Avoid taking diet pills, caffeine pills, or other stimulants (such as ADHD medications) without your doctor's advice. Taking a stimulant together with Osmolex ER can increase your risk of unpleasant side effects.

Using Osmolex ER with other drugs that can make you sleepy may make this effect stronger. Talk to your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Inform your doctor about all your other medicines, especially:

• glaucoma medication; or
• medicine that has sodium bicarbonate (like Alka-Seltzer).

This list is not complete. Other drugs may affect Osmolex ER, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are mentioned here.