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|Tussionex Pennkinetic Extended-Release Suspension

Tussionex Pennkinetic Extended-Release Suspension

Tussionex Pennkinetic Extended-Release Suspension is used for:

Treating symptoms of the common cold, flu, or hayfever, and other upper respiratory allergies such as cough, runny nose, sneezing, itching of the nose and throat, and itchy, watery eyes. It may also be used for other conditions as determined by your doctor.

Tussionex Pennkinetic Extended-Release Suspension is a narcotic antitussive (cough suppressant) and antihistamine combination. The antitussive works by suppressing the cough center in the brain. The antihistamine works by blocking the action of histamine, which reduces the symptoms of an allergic reaction such as itch, watery eyes and runny nose.

Do NOT use Tussionex Pennkinetic Extended-Release Suspension if:

• you are allergic to any ingredient in Tussionex Pennkinetic Extended-Release Suspension or any other codeine- or morphine-related medicine (eg, codeine, oxycodone)
• you have diarrhea associated with poisoning, antibiotic use, or a bacterial infection (from eating or drinking contaminated food or water)
• you are taking sodium oxybate (GHB)

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

Before using Tussionex Pennkinetic Extended-Release Suspension:

Some medical conditions may interact with Tussionex Pennkinetic Extended-Release Suspension. 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 or have ever had a history of alcohol or substance abuse or narcotic dependence, or if you consume more than 3 alcohol-containing drinks per day
• if you have had suicidal thoughts or behaviors
• if you have increased pressure in the eyes, glaucoma, or you are at risk for glaucoma
• if you have acute head injury, increased pressure in the head, brain injury or tumor, epilepsy or seizures, or Reye syndrome
• if you are having an asthma attack or have lung disease, including shortness of breath or sleep apnea
• if you have a stomach or intestinal problem, chronic inflammation and ulceration of the bowel; chronic constipation; difficulty urinating; an enlarged prostate gland; heart problems, including heart failure; low blood pressure; liver problems; Parkinson disease; the blood disorder porphyria; stomach, intestinal, or urinary blockage; or thyroid problems
• if you have had recent surgery

Some MEDICINES MAY INTERACT with this medicine. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Barbiturate anesthetics (eg, thiopental), cimetidine, ketorolac, naltrexone, or sodium oxybate (GHB) because the risk of side effects of Tussionex Pennkinetic Extended-Release Suspension, including dangerous sleepiness and a decrease in the ability to breathe, may be increased
• Rifampin or risperidone because they may decrease Tussionex Pennkinetic Extended-Release Suspension"s effectiveness
• Hydantoins (eg, phenytoin) because their actions and the risk of their side effects may be increased by Tussionex Pennkinetic Extended-Release Suspension
• Mexiletine because its effectiveness may be decreased by Tussionex Pennkinetic Extended-Release Suspension
• Naltrexone because the effectiveness of Tussionex Pennkinetic Extended-Release Suspension will be decreased and withdrawal symptoms may occur in patients who have become physically dependent on opioids. You must not take naltrexone until you have stopped taking Tussionex Pennkinetic Extended-Release Suspension for 7 to 10 days and after a naloxone challenge test is negative

This may not be a complete list of all interactions that may occur. Ask your health care provider if Tussionex Pennkinetic Extended-Release Suspension 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 Tussionex Pennkinetic Extended-Release Suspension:

Use Tussionex Pennkinetic Extended-Release Suspension as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Tussionex Pennkinetic Extended-Release Suspension by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
• Shake well before each use.
• Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.
• If you miss a dose of Tussionex Pennkinetic Extended-Release Suspension 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 Tussionex Pennkinetic Extended-Release Suspension.

Important safety information:

• Tussionex Pennkinetic Extended-Release Suspension may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Tussionex Pennkinetic Extended-Release Suspension 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 Tussionex Pennkinetic Extended-Release Suspension; 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.
• Tell your doctor or dentist that you take Tussionex Pennkinetic Extended-Release Suspension before you receive any medical or dental care, emergency care, or surgery.
• Use Tussionex Pennkinetic Extended-Release Suspension with caution in the ELDERLY; they may be more sensitive to its effects, especially possible breathing problems and drowsiness.
• Caution is advised when using Tussionex Pennkinetic Extended-Release Suspension in CHILDREN with lung or breathing problems (eg, croup); they may be more sensitive to its effects.
• Tussionex Pennkinetic Extended-Release Suspension should be used with extreme caution in CHILDREN younger than 6 years old; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: Tussionex Pennkinetic Extended-Release Suspension has been shown to cause harm to the fetus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Tussionex Pennkinetic Extended-Release Suspension while you are pregnant. Tussionex Pennkinetic Extended-Release Suspension is found in breast milk. If you are or will be breast-feeding while you use Tussionex Pennkinetic Extended-Release Suspension, check with your doctor. Discuss any possible risks to your baby.

When used for long periods of time or at high doses, Tussionex Pennkinetic Extended-Release Suspension may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if Tussionex Pennkinetic Extended-Release Suspension stops working well. Do not take more than prescribed.

Some people who use Tussionex Pennkinetic Extended-Release Suspension for a long time without a break may develop a physical need to continue taking it. This is known as physical DEPENDENCE. The early sign of addiction is medicine ineffectiveness. Dependence is not an issue in terminal illness where pain relief is more important. If using Tussionex Pennkinetic Extended-Release Suspension for an extended period of time, do not suddenly stop taking Tussionex Pennkinetic Extended-Release Suspension without your doctor"s approval. If you suddenly stop taking Tussionex Pennkinetic Extended-Release Suspension, you may experience WITHDRAWAL symptoms, including anxiety; diarrhea; fever; runny nose or sneezing; goose bumps and abnormal skin sensations; nausea and vomiting; pain; rigid muscles; seeing, hearing, or feeling things that are not there; shivering or tremors; sweating; trouble sleeping. Contact your doctor if you notice any of these symptoms after stopping this medication.

Possible side effects of Tussionex Pennkinetic Extended-Release Suspension:

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, throat, or nose; excitement; nausea; stomach upset; thickening or mucus in nose or throat.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); difficulty urinating; flushing or redness of face; rapid or pounding heartbeat.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include agitation; coma; confusion; deep sleep or loss of consciousness; difficulty breathing; diminished mental alertness; hallucinations; hot or cold skin; large and unchanging pupils; sedation; seizures; shaking; sleeplessness; slowed breathing; slow heartbeat.

Store Tussionex Pennkinetic Extended-Release Suspension at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Tussionex Pennkinetic Extended-Release Suspension out of the reach of children and away from pets.

General information:

• If you have any questions about Tussionex Pennkinetic Extended-Release Suspension, please talk with your doctor, pharmacist, or other health care provider.
• Tussionex Pennkinetic Extended-Release Suspension is 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.

This information is a summary only. It does not contain all information about Tussionex Pennkinetic Extended-Release Suspension. 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.