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|TheoCap Sustained-Release Capsules

TheoCap Sustained-Release Capsules

TheoCap Sustained-Release Capsules is used for:

Preventing and treating symptoms and blockage of airway due to asthma or other lung diseases such as emphysema or bronchitis. It may also be used for other conditions as determined by your doctor.

TheoCap Sustained-Release Capsules is a xanthine derivative. It works by relaxing the smooth muscle surrounding the bronchial tubes (air passages) of the lungs, allowing the tubes to widen, making breathing easier. TheoCap Sustained-Release Capsules improves contraction of the diaphragm (the major breathing muscle).

Do NOT use TheoCap Sustained-Release Capsules if:

• you are allergic to any ingredient in TheoCap Sustained-Release Capsules (including ethylenediamine), similar medicines (eg, aminophylline), or xanthines (eg, caffeine, chocolate)
• you are using large amounts of other products that contain xanthine (such as chocolate or caffeinated drinks)
• you are taking dipyridamole intravenously (IV), halothane, or St. John"s wort

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

Before using TheoCap Sustained-Release Capsules:

Some medical conditions may interact with TheoCap Sustained-Release Capsules. 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 heart problems (eg, congestive heart failure, cor pulmonale), an irregular heartbeat, ulcers or a history of ulcers, fluid in the lungs (pulmonary edema), liver problems, fever, viral infection, severe infection (eg, blood infection), thyroid problems, cystic fibrosis, increased acid levels in the body, brain or nerve problems, or seizures (eg, epilepsy)
• if you are in shock
• if you smoke, are stopping or starting smoking, or are exposed to the smoke from cigarettes or marijuana
• if you are in the last 3 months of pregnancy

Some MEDICINES MAY INTERACT with TheoCap Sustained-Release Capsules. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Aminoglutethimide, barbiturates (eg, phenobarbital), beta-blockers (eg, propranolol), carbamazepine, hydantoins (eg, phenytoin), isoproterenol, moricizine, propafenone, rifampin, St. John"s wort, or sulfinpyrazone because the effectiveness of TheoCap Sustained-Release Capsules may be decreased
• Allopurinol, cimetidine, disulfiram, enoxacin, estrogen, fluvoxamine, interferon alpha-a, macrolide antibiotics (eg, clarithromycin, erythromycin), methotrexate, mexiletine, oral contraceptives (birth control pills), pentoxifylline, quinolone antibiotics (eg, ciprofloxacin), tacrine, thiabendazole, ticlopidine, troleandomycin, verapamil, viloxazine, or zileuton because the risk of side effects of TheoCap Sustained-Release Capsules may be increased
• Ephedrine because side effects such as nausea, nervousness, and trouble sleeping may be increased
• Halothane because the risk of side effects such as irregular heartbeat may be increased
• Ketamine because the risk of seizures may be increased
• Adenosine, benzodiazepines (eg, diazepam, lorazepam), dipyridamole IV, lithium, midazolam, or nondepolarizing muscle relaxants (eg, pancuronium) because effectiveness may be decreased by TheoCap Sustained-Release Capsules

This may not be a complete list of all interactions that may occur. Ask your health care provider if TheoCap Sustained-Release Capsules 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 TheoCap Sustained-Release Capsules:

Use TheoCap Sustained-Release Capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Some foods may change the effectiveness or increase the side effects of TheoCap Sustained-Release Capsules. Talk to your doctor about how you should take TheoCap Sustained-Release Capsules with regard to food. Do not suddenly change your diet or eating habits without first checking with your doctor.
• Swallow TheoCap Sustained-Release Capsules whole. Do not break, crush, or chew before swallowing.
• Take TheoCap Sustained-Release Capsules at evenly spaced times throughout the day. Taking TheoCap Sustained-Release Capsules at the same time each day will help you remember to take it. Contact your doctor with any questions or concerns about the best way to take TheoCap Sustained-Release Capsules.
• If you miss a dose of TheoCap Sustained-Release Capsules, 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 TheoCap Sustained-Release Capsules.

Important safety information:

• Use of alcohol may increase the risk of side effects of TheoCap Sustained-Release Capsules. Talk to your doctor before drinking alcohol while you are taking TheoCap Sustained-Release Capsules.
• Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using TheoCap Sustained-Release Capsules.
• Carry an identification card at all times that says you are taking this medication.
• Avoid large amounts of caffeine-containing foods and beverages, such as coffee, tea, cocoa, cola drinks, and chocolate.
• Notify your doctor if you develop a new illness, especially if it is accompanied by fever; if a chronic illness becomes worse; if you start or stop smoking cigarettes or marijuana; or if another doctor prescribes a new medication or tells you to stop using a medication that you have already been taking.
• TheoCap Sustained-Release Capsules will not stop an asthma attack once one has started. Be sure to always carry appropriate rescue medicine (eg, bronchodilator inhaler) with you in case of an asthma attack.
• If you have more than one doctor, be sure to tell each of your doctors that you are taking TheoCap Sustained-Release Capsules.
• Diabetes patients - TheoCap Sustained-Release Capsules may affect your blood sugar. Check blood sugar levels closely and ask your doctor before adjusting the dose of your diabetes medicine.
• LAB TESTS, including blood theophylline levels, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.
• Use TheoCap Sustained-Release Capsules with caution in the ELDERLY because they may be more sensitive to its effects.
• Caution is advised when using TheoCap Sustained-Release Capsules in CHILDREN, especially newborns with kidney problems, because they may be more sensitive to its effects.
• PREGNANCY and BREAST-FEEDING: If you become pregnant while taking TheoCap Sustained-Release Capsules, discuss with your doctor the benefits and risks of using TheoCap Sustained-Release Capsules during pregnancy. TheoCap Sustained-Release Capsules is excreted in breast milk. If you are or will be breast-feeding while you are using TheoCap Sustained-Release Capsules, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of TheoCap Sustained-Release Capsules:

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:

Mild and temporary changes in behavior; temporary increased urination.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); confusion; diarrhea; dizziness; fast breathing; heart rhythm problems or irregular heartbeats; nausea; persistent headache; seizures; sleeplessness; tremors; vomiting.

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; chest pain; confusion; decreased urination; fast or irregular heartbeat; headache; increased thirst; irritability; loss of appetite; muscle pain or tenderness; nausea; nervousness; persistent increased urination; restlessness; seizures; severe or persistent diarrhea; stomach pain; tremors or twitching; vomiting, especially of blood.

Store TheoCap Sustained-Release Capsules at room temperature, between 59 and 86 degrees F (15 and 30 degrees C), in tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Do not refrigerate. Keep TheoCap Sustained-Release Capsules out of the reach of children and away from pets.

General information:

• If you have any questions about TheoCap Sustained-Release Capsules, please talk with your doctor, pharmacist, or other health care provider.
• TheoCap Sustained-Release Capsules 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 TheoCap Sustained-Release Capsules. 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.