Patient information: uses, side effects, how to take - Solosec

What is SOLOSEC?

SOLOSEC is a prescription medicine used to treat:

bacterial vaginal infections in females 12 years of age and older.
trichomoniasis, a common sexually transmitted infection (STI), in people 12 years of age and older. Sexual partners should be treated at the same time. People should avoid having sex until they and their sex partners are treated (for example, when therapy has been completed and any symptoms have resolved) to help prevent reinfection.

It is not known if SOLOSEC is safe and effective in children under 12 years of age.

Do not take SOLOSEC if you:

are allergic to secnidazole or other nitroimidazole medicines.
have Cockayne syndrome.

Before taking SOLOSEC, tell your healthcare provider about all of your medical conditions, including if you:

are pregnant or plan to become pregnant. It is not known if SOLOSEC will harm your unborn baby. Tell your healthcare provider if you become pregnant during treatment with SOLOSEC.
are breastfeeding or plan to breastfeed. You should not breastfeed for 96 hours (4 days) after taking SOLOSEC. SOLOSEC may pass into breast milk. Talk with your healthcare provider about the best way to feed your baby while taking SOLOSEC.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How should I take SOLOSEC?

See the Instructions for Use at the end of this Patient Information leaflet for instructions on how to take SOLOSEC.
Take SOLOSEC exactly as your healthcare provider tells you to. Do not take SOLOSEC more often than it is prescribed.

What should I avoid while taking SOLOSEC?

Avoid drinking alcohol during treatment with SOLOSEC and for 2 days (48 hours) after you take SOLOSEC because the following side effects may happen:

nausea
vomiting

diarrhea
stomach (abdominal) pain

dizziness
headache

What are the possible side effects of SOLOSEC?

SOLOSEC can cause side effects including vaginal yeast infections. Symptoms of a vaginal yeast infection include white or yellowish discharge (discharge may be lumpy or look like cottage cheese) and vaginal itching.

The most common side effects of SOLOSEC include headache, nausea, vomiting, diarrhea, abdominal pain, vaginal itching and a bad, bitter or metallic taste in your mouth (dysgeusia).

These are not all of the possible side effects of SOLOSEC. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of SOLOSEC.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use SOLOSEC for a condition for which it was not prescribed. Do not give SOLOSEC to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about SOLOSEC that is written for health professionals.

What are the ingredients in SOLOSEC?

Active ingredient: secnidazole

Inactive ingredients: Eudragit NE30D (ethyl acrylate methyl methacrylate copolymer), polyethylene glycol 4000, povidone, sugar spheres, and talc.

Contains no ingredient made from a gluten-containing grain (wheat, barley, or rye).

For more information, visit www.solosec.com or contact Evofem at 1-833-EVFMBIO (1-833-383-6246).

INSTRUCTIONS FOR USE

SOLOSEC ^®

(SO-lo-sec)

(secnidazole) oral granules

For oral use (by mouth) only.

How to take SOLOSEC?

1. Open the SOLOSEC packet by folding over the corner marked by an arrow (see diagram) and tearing across the top.
2. Sprinkle the entire contents of the SOLOSEC packet onto applesauce, yogurt or pudding. The granules will not dissolve. Take within 30 minutes without chewing or crunching the granules.
3. You can drink a glass of water after taking SOLOSEC to help with swallowing.
4. You should not try to dissolve the medicine in water or any other liquid.

Important Information

SOLOSEC may be taken before, after or during a meal.
Take 1 entire packet of SOLOSEC at one time. Do not take only part of the medicine and save a portion for later.
Avoid drinking alcohol during treatment with SOLOSEC and for 2 days (48 hours) after you take SOLOSEC.

How should I store SOLOSEC?

Store SOLOSEC at room temperature between 68°F to 77°F (20°C to 25°C).
Keep SOLOSEC and all medicines out of the reach of children.

This Patient Information and Instructions for Use have been approved by the US Food and Drug Administration. Issued: 10/2024

Manufactured for Evofem, Inc., a wholly owned subsidiary of Evofem Biosciences, Inc.

San Diego, CA 92130

PN-5055 R02

Solosec (Secnidazole): Uses, Side Effects and Dosage