Pramosone E topical / rectal

Hydrocortisone is a steroid. It reduces the actions of chemicals in the body that cause inflammation.

Pramoxine is an anesthetic, or "numbing medicine." It works by interfering with pain signals sent from the nerves to the brain.

Hydrocortisone and pramoxine topical (for the skin) is a combination medicine used to treat itching and discomfort caused by allergic reactions, eczema, minor burns, insect bites, or other skin conditions.

Hydrocortisone and pramoxine rectal (for the rectum) is used to treat itching or swelling caused by hemorrhoids or other inflammatory conditions of the rectum or anus.

Hydrocortisone and pramoxine topical may also be used for other purposes not listed in this medication guide.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

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

Stop using this medication and call your doctor at once if you show signs of absorbing too much of the medicine through your skin, such as:

• blurred vision, eye pain, or seeing halos around lights;

• mood changes;

• sleep problems (insomnia);

• high blood sugar (increased thirst or urination, hunger, dry mouth, fruity breath odor,weight loss);

• weight gain, puffiness in your face; or

• muscle weakness, feeling tired.

Stop using the medicine and call your doctor if you have rectal bleeding or severe irritation in any treated skin.

Common side effects may include:

• mild redness or swelling of treated skin;

• thinning of treated skin; or

• numbness on areas where the medicine is accidentally applied.

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 FDA at 1-800-FDA-1088.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of a weak adrenal gland like a very bad upset stomach or throwing up, very bad dizziness or passing out, muscle weakness, feeling very tired, mood changes, not hungry, or weight loss.
• Signs of Cushing's disease like weight gain in the upper back or belly, moon face, very bad headache, or slow healing.
• Signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
• Irritation where this drug is used.
• Skin changes (pimples, stretch marks, slow healing, hair growth).
• Thinning of the skin.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Dry skin.
• Burning.
• Itching.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Applies to hydrocortisone / pramoxine topical: rectal cream, rectal foam, rectal kit, rectal lotion, topical cream, topical foam, topical gel, topical lotion, topical ointment

Dermatologic

Dermatologic side effects including burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, and miliaria have been reported.[Ref]

Hypersensitivity

Hypersensitivity side effects including allergic contact dermatitis have been reported.[Ref]

Some side effects of Pramosone E may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.