Gelofen 400

Use Gelofen 400 capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Gelofen 400 capsules comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Gelofen 400 capsules refilled.
• Take Gelofen 400 capsules by mouth with or without food. It may be taken with food if it upsets your stomach. Taking it with food may not lower the risk of stomach or bowel problems (eg, bleeding, ulcers). Talk with your doctor or pharmacist if you have persistent stomach upset.
• Swallow Gelofen 400 capsules whole. Do not break, crush, or chew before swallowing.
• Take Gelofen 400 capsules with a full glass of water (8 oz/240 mL) as directed by your doctor.
• If you miss a dose of Gelofen 400 capsules 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. 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 the proper use of Gelofen 400 capsules.

Gelofen 400 is used to relieve pain from various conditions such as headache, dental pain, menstrual cramps, muscle aches, or arthritis. It is also used to reduce fever and to relieve minor aches and pain due to the common cold or flu. Gelofen 400 is a nonsteroidal anti-inflammatory drug (NSAID). It works by blocking your body's production of certain natural substances that cause inflammation. This effect helps to decrease swelling, pain, or fever.

If you are treating a chronic condition such as arthritis, ask your doctor about non-drug treatments and/or using other medications to treat your pain. See also Warning section.

This form of Gelofen 400 is intended for use by children. Do not give this medication to a child younger than 6 months unless directed by the doctor.

Check the ingredients on the label even if you have used the product before. The manufacturer may have changed the ingredients. Also, products with similar names may contain different ingredients meant for different purposes. Taking the wrong product could harm you.

How to use Gelofen 400

Read and follow all directions on the product package before using this medication. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth as directed by your doctor or the package label, usually every 6 to 8 hours as needed. Shake the bottle well before each dose. Carefully measure the dose using the provided dropper/syringe. Do not use a household spoon because you may not get the correct dose. If you have stomach upset while taking this medication, take it with food or milk.

The dosage is based on your medical condition and response to treatment. To reduce your risk of stomach bleeding and other side effects, take this medication at the lowest effective dose for the shortest possible time. Do not increase your dose or take this drug more often than directed by your doctor or the package label.

When Gelofen 400 is used by children, the dose is based on the child's weight. Read the package directions to find the proper dose for your child's weight. Consult the pharmacist or doctor if you have questions or if you need help choosing a nonprescription product.

If you are using this drug "as needed" (not on a regular schedule), remember that pain medications work best if they are used as the first signs of pain occur. If you wait until the pain has worsened, the medication may not work as well.

If your condition persists or worsens, or if you think you may have a serious medical problem, get medical help right away. If you are using the nonprescription product to treat yourself or a child for fever or pain, consult the doctor right away if fever worsens or lasts more than 3 days, or if pain worsens or lasts more than 10 days.

See also:
What other drugs will affect Gelofen 400?

Coumarin-Type Anticoagulants: Several short-term controlled studies failed to wshow that Gelofen 400 significantly affected prothrombin times or a variety of other clotting factors when administered to individuals on coumarin-type anticoagulants. However, because bleeding has been reported when Gelofen 400 and other nonsteroidal anti-inflammatory agents have been administered to patients on coumarin-type anticoagulants, the physician should be cautious when administering Gelofen 400 to patients on anticoagulants.

Aspirin: Animal studies wshow that aspirin given with nonsteroidal anti-inflammatory agents, including Gelofen 400, yields a net decrease in anti-inflammatory activity with lowered blood levels of the non-aspirin drug. Single dose bioavailability studies in normal volunteers have failed to wshow an effect of aspirin on Gelofen 400 blood levels. Correlative clinical studies have not been performed.

Methotrexate: Apo-Gelofen 400, as well as other nonsteroidal anti-inflammatory drugs, probably reduces the tubular secretion of methotrexate based on in vitro studies in rabbit kidney slices. This may indicate that Gelofen 400 could enhance the toxicity of methotrexate. Caution should be used if Gelofen 400 is administered concomitantly with methotrexate.

H-2 Antagonists: In studies with human volunteers, co-administration of cimetidine or ranitidine with Gelofen 400 had no substantive effect on Gelofen 400 serum concentrations.

Furosemide: Clinical studies, as well as random observations, have shown that Gelofen 400 can reduce the natriuretic effect of furosemide and thiazides in some patients. This response has been attributed to inhibition of renal prostaglandin synthesis. During concomitant therapy with Gelofen 400, the patient should be observed closely for signs of renal failure, as well as to assure diuretic efficacy.

Lithium: Apo-Gelofen 400 produced an elevation of plasma lithium levels and a reduction in renal lithium clearance in a study of eleven normal volunteers. The mean minimum lithium concentration increased 15% and the renal clearance of lithium was decreased by 19% during this period of concomitant drug administration.

This effect has been attributed to inhibition of renal prostaglandin synthesis by Gelofen 400. Thus, when Gelofen 400 and lithium are administered concurrently, subjects should be observed carefully for signs of lithium toxicity. (Read circulars for lithium preparation before use of such concurrent therapy).