Papaverine Hydrochloride Oral capsule, extended-release

What is this medicine?

PAPAVERINE (pa PAV er een) is a vasodilator. It relaxes the blood vessels which makes it easier for blood to pass through them. It is used to treat certain conditions that cause blood vessels to spasm. This medicine is also used to treat irregular heartbeats caused by decreased blood flow to the heart.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• heart disease or irregular heartbeats

• an unusual or allergic reaction to papaverine, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Do not chew, open, break or crush the capsules. Take your doses at regular intervals. Do not take your medicine more often than directed.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

• barbiturate medicines for inducing sleep or treating seizures

• levodopa

• medicines for anxiety or sleeping problems like diazepam or temazepam

• prescription pain medicines

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may increase dizziness and drowsiness. Avoid alcoholic drinks.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• feeling faint or lightheaded, falls

• stomach pain

• vomiting

• yellowing or the eyes or skin

Side effects that usually do not require medical attention report to your doctor or health care professional if they continue or are bothersome):

• decreased appetite

• diarrhea or constipation

• headache

• nausea

• sweating or flushing

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medicine after the expiration date.

Papaverine Hydrochloride Solution for injection

What is this medicine?

PAPAVERINE (pa PAV er een) is a vasodilator. It relaxes the blood vessels which makes it easier for blood to pass through them. It is used to treat certain conditions that cause blood vessels to spasm. This medicine may also be used to relieve the spasms associated with urinary tract, gallbladder or stomach.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• heart disease

• an unusual or allergic reaction to papaverine, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

This medicine is for injection into a vein or muscle. It is given by a health care professional in a hospital or clinic setting.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

This does not apply.

What may interact with this medicine?

• barbiturate medicines for inducing sleep or treating seizures

• levodopa

• medicines for anxiety or sleeping problems like diazepam or temazepam

• prescription pain medicines

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Your condition will be monitored carefully while you are receiving this medicine.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may increase dizziness and drowsiness. Avoid alcoholic drinks.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• fast or irregular heartbeat

• feeling faint or lightheaded, falls

• stomach pain

• vomiting

• yellowing or the eyes or skin

Side effects that usually do not require medical attention report to your doctor or health care professional if they continue or are bothersome):

• decreased appetite

• diarrhea or constipation

• headache

• nausea

• sweating or flushing

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

This drug is given in a hospital or clinic and will not be stored at home.