Xaciato 2 % vaginal gel

Generic name:
Clindamycin single dose gel - vaginal

Pronunciation
(KLIN-da-MYE-sin)

Brand name(s)
Xaciato

This medication is used to treat a certain type of vaginal infection (bacterial vaginosis). Clindamycin is an antibiotic that works by stopping the growth of bacteria.

Read the Patient Information Leaflet and the Instructions for Use if available from your pharmacist before you start using clindamycin. If you have any questions, ask your doctor or pharmacist.

This product is for vaginal use only. Wash your hands before and after use. Avoid contact of this medication with your eyes, mouth, or skin.

Insert 1 applicatorful of this medication into your vagina as directed by your doctor. This product is used as a single (one-time) dose.

After filling the applicator as directed, lie on your back with your legs slightly bent. Gently insert the applicator filled with medication into the vagina as far as it will comfortably go. Slowly press the plunger to release all the medication into your vagina. Remove the empty applicator from your vagina and throw it away in your household trash. Do not save any medicine that may be left in the tube or applicator for future use.

Do not have vaginal intercourse or use products that go inside your vagina (such as tampons or douches) while using this medication and for 3 days after using it. These products may make this medication work less well. Unscented sanitary pads may be used to protect your clothing from leakage of the medication.

This medication may weaken polyurethane condoms. Do not use polyurethane condoms while using this medication and for 7 days after treatment, since they may not work properly to prevent pregnancy or protect against sexually transmitted diseases. Latex or polyisoprene condoms may be used instead. Ask your pharmacist if you have any questions about the types of condoms you may use.

Tell your doctor if your condition lasts, gets worse, or returns after treatment.

Vaginal itching, irritation, or a change in discharge may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly. These symptoms could also be due to a new vaginal infection (such as a yeast/fungal infection) and require other treatment.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A very small amount of this medication may be absorbed into your blood and may rarely cause a severe intestinal condition due to a bacteria called C. difficile. This condition may occur during treatment or weeks to months after treatment has stopped. Tell your doctor right away if you develop:

• diarrhea that doesn't stop
• abdominal or stomach pain/cramping
• blood/mucus in your stool

If you have these symptoms, do not use anti-diarrhea or opioid products because they may make symptoms worse.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or 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.

Before using clindamycin, tell your doctor or pharmacist if you are allergic to it; or to lincomycin; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• intestinal disease (such as ulcerative colitis, Crohn's disease)

During pregnancy, this medication should be used only when clearly needed. Antibiotics taken by mouth have been used to treat vaginal infections during pregnancy, especially high-risk pregnancies (such as if there is a risk of early childbirth). Consult your doctor for more details and to discuss the risks and benefits.

It is unknown if this medication passes into breast milk. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Do not share this medication with others.

Not applicable.

Store at room temperature. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.