Naratriptan patient counseling information

Naratriptan
NARATRIPTAN tablet® FDA Package Insert
Indications and Usage
Dosage and Administration
Dosage Forms and Strengths
Contraindications
Warnings and Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Overdosage
Description
Clinical Pharmacology
Nonclinical Toxicology
Clinical Studies
How Supplied/Storage and Handling
Patient Counseling Information
Labels and Packages
Clinical Trials on Naratriptan
ClinicalTrials.gov

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]

Patient Information

Naratriptan Tablets, USP

Read this Patient Information before you start taking naratriptan tablets and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or treatment.

What is the most important information I should know about naratriptan tablets?

Naratriptan tablets can cause serious side effects, including:

• Heart attack and other heart problems. Heart problems may lead to death.

• Stop taking naratriptan tablets and get emergency medical help right away if you have any of the following symptoms of a heart attack:

• Discomfort in the center of your chest that lasts for more than a few minutes, or that goes away and comes back.

• Chest pain or chest discomfort that feels like heavy pressure, squeezing, or fullness

• Pain or discomfort in your arms, back, neck, jaw, or stomach

• Shortness of breath with or without chest discomfort

• Breaking out in a cold sweat

• Nausea or vomiting

• Feeling lightheaded

Naratriptan tablets are not for people with risk factors for heart disease unless a heart exam is done and shows no problem. You have a higher risk for heart disease if you:

• Have high blood pressure

• Have high cholesterol levels

• Smoke

• Are overweight

• Have diabetes

• Have a family history of heart disease

• Are a female who has gone through menopause

• Are a male over age 40

• Serotonin syndrome. Serotonin syndrome is a serious and life-threatening problem that can happen in people taking naratriptan tablets, especially if naratriptan tablets are used with anti-depressant medicines called selective serotonin reuptake inhibitors (SSRIs) or selective norepinephrine reuptake inhibitors (SNRIs).

Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure.

Call your healthcare provider right away if you have any of the following symptoms of serotonin syndrome:

• Mental changes such as seeing things that are not there (hallucinations), agitation, or coma

• Fast heartbeat

• Changes in blood pressure

• High body temperature

• Tight muscles

• Trouble walking

• Nausea, vomiting, or diarrhea

What are naratriptan tablets?

Naratriptan tablets are a prescription medicine used to treat acute migraine headaches with or without aura in adults.

Naratriptan tablets are not used to prevent or decrease the number of migraine headaches you have.

Naratriptan tablets are not used to treat other types of headaches such as hemiplegic migraines (that make you unable to move on one side of your body) or basilar migraines (rare form of migraine with aura).

It is not known if naratriptan tablets are safe and effective to treat cluster headaches.

It is not known if naratriptan tablets are safe and effective in children under 18 years of age.

Who should not take naratriptan tablets?

Do not take naratriptan tablets if you have:

• Heart problems or a history of heart problems

• Narrowing of blood vessels to your legs, arms, stomach, or kidney (peripheral vascular disease)

• Uncontrolled high blood pressure

• Severe kidney problems

• Severe liver problems

• Hemiplegic migraines or basilar migraines. If you are not sure if you have these types of migraines, ask your healthcare provider.

• Had a stroke, transient ischemic attacks (TIAs), or problems with your blood circulation

• Taken any of the following medicines in the last 24 hours:

Almotriptan (AXERT®)

Eletriptan (RELPAX®)

Frovatriptan (FROVA®)

Rizatriptan (MAXALT®, MAXALT-MLT®)

Sumatriptan (IMITREX®, SUMAVEL® DosePro®)

Sumatriptan and naproxen (TREXIMET®)

Ergotamines (CAFERGOT®, ERGOMAR®, MIGERGOT®)

Dihydroergotamine (D.H.E. 45®, MIGRANAL®)

Ask your doctor if you are not sure if your medicine is listed above.

An allergy to naratriptan hydrochloride or any of the ingredients in naratriptan tablets. See the end of this leaflet for a complete list of ingredients in naratriptan tablets.

What should I tell my healthcare provider before taking naratriptan tablets?

• Before you take naratriptan tablets, tell your healthcare provider about all of your medical conditions, including if you:

• Have high blood pressure

• Have high cholesterol

• Have diabetes

• Smoke

• Are overweight

• Are a female who has gone through menopause

• Have heart disease or a family history of heart disease or stroke

• Have kidney problems

• Have liver problems

• Have had epilepsy or seizures

• Are not using effective birth control

• Are pregnant or plan to become pregnant. It is not known if naratriptan tablets will harm your unborn baby.

If you become pregnant while taking naratriptan tablets, talk to your healthcare provider.

Are breastfeeding or plan to breastfeed. Naratriptan passes into your breast milk and may harm your baby. Talk with your healthcare provider about the best way to feed your baby if you take naratriptan tablets.

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

Naratriptan tablets and other medicines may affect each other, causing side effects.

Especially tell your healthcare provider if you take anti-depressant medicines called:

• Selective serotonin reuptake inhibitors (SSRIs)

• Serotonin norepinephrine reuptake inhibitors (SNRIs)

• Monoamine oxidase inhibitors (MAOIs)

Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure.

Know the medicines you take. Keep a list of them to show your healthcare provider or pharmacist when you get a new medicine.

How should I take naratriptan tablets?

Certain people should take their first dose of naratriptan tablets in their healthcare provider’s office or in another medical setting. Ask your healthcare provider if you should take your first dose in a medical setting.

Take naratriptan tablets exactly as your healthcare provider tells you to take it.

Your healthcare provider may change your dose. Do not change your dose without first talking with your healthcare provider.

Take naratriptan tablets with water or other liquids.

If you do not get any relief after your first naratriptan tablet, do not take a second tablet without first talking with your healthcare provider.

If your headache comes back or you only get some relief from your headache, you can take a second tablet 4 hours after the first tablet.

Do not take more than a total of 5 mg of naratriptan tablets in a 24-hour period.

Some people who take too many naratriptan tablets may have worse headaches (medication overuse headache). If your headaches get worse, your healthcare provider may decide to stop your treatment with naratriptan tablets.

If you take too many naratriptan tablets, call your healthcare provider or go to the nearest hospital emergency room right away.

You should write down when you have headaches and when you take naratriptan tablets so you can talk with your healthcare provider about how naratriptan tablets are working for you.

What should I avoid while taking naratriptan tablets?

Naratriptan tablets can cause dizziness, weakness, or drowsiness. If you have these symptoms, do not drive a car, use machinery, or do anything where you need to be alert.

What are the possible side effects of naratriptan tablets?

Naratriptan tablets may cause serious side effects. See “What is the most important information I should know about naratriptan tablets?”

These serious side effects include:

• Changes in color or sensation in your fingers and toes (Raynaud’s syndrome)

• Stomach and intestinal problems (gastrointestinal and colonic ischemic events). Symptoms of gastrointestinal and colonic ischemic events include:

• Sudden or severe stomach pain

• Stomach pain after meals

• Weight loss

• Nausea or vomiting

• Constipation or diarrhea

• Bloody diarrhea

• Fever

• Problems with blood circulation to your legs and feet (peripheral vascular ischemia).

• Symptoms of peripheral vascular ischemia include:

• Cramping and pain in your legs or hips

• Feeling of heaviness or tightness in your leg muscles

• Burning or aching pain in your feet or toes while resting

• Numbness, tingling, or weakness in your legs

• Cold feeling or color changes in 1 or both legs or feet

• Shortness of breath or wheezing

• Hives (itchy bumps); swelling of your tongue, mouth, or throat

• The most common side effects of naratriptan tablets include:

• Dizziness

• Warm, hot, burning feeling to your face (flushing)

• Cold and hot temperature sensations

• Sensitivity to light or vision problems

• Ear, nose, and throat infections

• Feeling weak, drowsy, or tired

• Decrease in saliva

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of naratriptan tablets. For more information, ask your healthcare provider or pharmacist.

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

How should I store naratriptan tablets?

Store at 20° to 25°C (68° to 77°F).

Keep naratriptan tablets and all medicines out of the reach of children.

General information about the safe and effective use of naratriptan tablets.

Medicines are sometimes prescribed for purposes other than those listed in Patient Information leaflets. Do not use naratriptan tablets for a condition for which it was not prescribed. Do not give naratriptan tablets to other people, even if they have the same symptoms you have. It may harm them.

This Patient Information leaflet summarizes the most important information about naratriptan tablets. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about naratriptan tablets that is written for healthcare professionals.

For more information, call Sandoz Inc. at 1-800-525-8747.

What are the ingredients in naratriptan tablets?

Active ingredient: naratriptan hydrochloride

Inactive ingredients: anhydrous lactose, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, lactose monohydrate, hypromellose, titanium dioxide and triacetin.

2.5 mg tablets also contain iron oxide yellow and FD&C blue No.2 aluminum lake.

The brands listed are registered trademarks of their respective owners.

This Patient Information has been approved by the U.S. Food and Drug Administration.

References

Adapted from the FDA Package Insert.