This product is used to treat a certain problem in the anal area (anal fissure). It can help decrease pain in the area and help the anal fissure to heal. This product contains 2 drugs: nifedipine and lidocaine. Nifedipine belongs to a class of drugs known as calcium channel blockers. It works by relaxing the muscles around the anus. Lidocaine belongs to a class of drugs known as local anesthetics. It works by temporarily numbing the area.

Read the Patient Information Leaflet if available from your pharmacist before you start using this product and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Follow all instructions in the product package for using the applicator tip/cap/nozzle. Before use, clean the affected area with mild soap and water, rinse well, and pat dry. Gently insert the applicator tip up to 0.5 inch (1 centimeter) inside the anus and apply the product in and around the anal opening as directed by your doctor, usually twice daily.

Wash hands immediately after use. Avoid getting the product in your eyes, nose, ears, or mouth. If the medication gets in one of these areas, rinse the area immediately with clean water.

Use this medication regularly to get the most benefit from it. To help you remember, use it at the same times each day.

Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase.

Tell your doctor if your condition does not get better or if it gets worse.

Redness, burning, or itching at the application site, headache, nausea, or vomiting may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

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.

Tell your doctor right away if you have any serious side effects, including:

• dizziness
• rectal bleeding

Get medical help right away if you have any very serious side effects, including:

• slow/shallow breathing
• unusual tiredness
• fainting
• seizures
• pale/bluish/gray skin
• shortness of breath
• fast/slow/irregular heartbeat

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 this product, tell your doctor or pharmacist if you are allergic to nifedipine or lidocaine; or to other calcium channel blockers (such as amlodipine, felodipine); or to other amide anesthetics (such as bupivacaine, prilocaine); 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:

• low blood pressure
• heart disease (such as heart failure, aortic stenosis, chest pain, recent heart attack)
• a certain blood disorder (methemoglobinemia)
• injury/infection in the rectal area
• liver disease
• kidney disease

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the side effects of this medication.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

Nifedipine and lidocaine pass 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.

Lab and/or medical tests (such as blood pressure, heart rate) may be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.

This medication has been prescribed for your current condition only. Do not use it later for another condition unless your doctor tells you to.

If you miss a dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

Store at room temperature away from light. Do not freeze. 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.