Rozex Topical

In the U.S.

• Metrocream
• Metrogel
• Metrolotion
• Noritate
• Rosadan
• Rosadan Cream Kit
• Rozex
• Vitazol

Available Dosage Forms:

• Cream
• Lotion
• Gel/Jelly
• Emulsion

Therapeutic Class: Antiacne Antibacterial

Chemical Class: Nitroimidazole

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Dry skin
• redness or other signs of skin irritation not present before use of this medicine
• stinging or burning of the skin
• watering of eyes

• Metallic taste in the mouth
• nausea
• tingling or numbness of arms, legs, hands, or feet

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Consult your pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Consult your pharmacist.

Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

Applies to metronidazole topical: topical cream, topical emulsion, topical gel/jelly, topical lotion

Other dosage forms:

• vaginal cream, vaginal gel/jelly, vaginal suppository

Along with its needed effects, metronidazole topical (the active ingredient contained in Rozex) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Some side effects of metronidazole topical may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Dry skin
• redness or other signs of skin irritation not present before use of this medicine
• stinging or burning of the skin
• watering of eyes

• Metallic taste in the mouth
• nausea
• tingling or numbness of arms, legs, hands, or feet

Applies to metronidazole topical: topical cream, topical gel, topical kit, topical lotion, vaginal gel with applicator

General

Topical: The most frequently reported side effects were nasopharyngitis, upper respiratory tract infection, and headache.

Vaginal: The most frequently reported side effects were fungal infection, vulvovaginal candidiasis, headache, vulvovaginal pruritus, nausea, diarrhea, metrorrhagia, breast pain, infection, rash, pharyngitis, abdominal pain, pruritus, and dysmenorrhea.[Ref]

Local

Very common (10% or more): Mild dryness (17.1%), mild scaling (16.2%)
Common (1% to 10%): Moderate dryness, moderate scaling, mild pruritus, moderate pruritus, severe pruritus, mild stinging/burning, moderate stinging/burning, severe stinging/burning, local allergic reaction
Uncommon (0.1% to 1%): Severe dryness, severe scaling
Frequency not reported: Application site reaction, condition aggravated, transient redness[Ref]

Genitourinary

Common (1% to 10%): Dysmenorrhea, breast pain, metrorrhagia, vulvovaginal candidiasis, vulvovaginal pruritus, urinary tract infection, vaginal itching/irritation/burning/numbness, pelvic discomfort, vaginal discharge
Uncommon (0.1% to 1%): Vaginal mycosis, urine discolored, vulva edema, menstrual discomfort/irregularities, vaginal spotting/bleeding
Frequency not reported: Breast enlargement, dysuria, female lactation, labial edema, leucorrhoea, menorrhagia, salpingitis, urinary frequency, vaginitis, vulvovaginal disorder[Ref]

Gastrointestinal

Common (1% to 10%): Abdominal pain, nausea, diarrhea, gastritis, tooth disorder, gastrointestinal discomfort, abdominal cramps, vomiting
Uncommon (0.1% to 1%): Constipation, dry mouth, abdominal bloating/noise
Frequency not reported: Dyspepsia, flatulence, gingivitis[Ref]

Nervous system

Common (1% to 10%): Headache, dizziness
Uncommon (0.1% to 1%): Tingling/numb extremities, taste metallic, dysgeusia, paresthesia, hypothesia
Frequency not reported: Peripheral neuropathy, ataxia
Postmarketing reports: Taste perversion[Ref]

Respiratory

Common (1% to 10%): Pharyngitis, bronchitis, nasopharyngitis, sinusitis, upper respiratory tract infection, nasal congestion
Frequency not reported: Asthma, rhinitis[Ref]

Cardiovascular

Common (1% to 10%): Hypertension[Ref]

Dermatologic

Common (1% to 10%): Pruritus, rash, contact dermatitis, dry skin, skin discomfort, burning/stinging, erythema, worsening of rosacea, skin irritation
Frequency not reported: Acne, sweating, urticaria, skin exfoliation, facial edema, zoster lesion, nose pustule, vesicular bullous eruption
Postmarketing reports: Hyperpigmentation, pigmentation disorder, hypertrichosis[Ref]

Other

Very common (10% or more): Fungal infection (12%), flu syndrome (up to 11%)
Common (1% to 10%): Infection, influenza, abscess, pain
Uncommon (0.1% to 1%): Fatigue
Frequency not reported: Mucous membrane disorder[Ref]

Psychiatric

Uncommon (0.1% to 1%): Depression, difficult sleep, irritability
Frequency not reported: Insomnia[Ref]

Musculoskeletal

Uncommon (0.1% to 1%): Back pain, cramp[Ref]

Oncologic

Uncommon (0.1% to 1%): Basal cell carcinoma
Frequency not reported: Skin cancer[Ref]

Ocular

Frequency not reported: Eye irritation, watery eye
Postmarketing reports: Eyelid edema[Ref]

Hepatic

Frequency not reported: Liver function test abnormal[Ref]

Immunologic

Frequency not reported: Allergic reaction[Ref]

Metabolic

Common (1% to 10%): Appetite decreased
Frequency not reported: Anorexia, hypomagnesemia[Ref]

Renal

Frequency not reported: Pyelonephritis[Ref]

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