Cambia

Cambia

What is Cambia?

Cambia oral powder is used to treat migraine headache attacks with or without aura in adults 18 years of age and older. It is not used to prevent migraine headaches. Do not use Cambia to treat cluster headaches.

Cambia only treats headaches that have already begun. It will not prevent headaches or reduce the number of attacks.

Warnings

You should not use Cambia if you have had an allergic reaction to aspirin or NSAIDs (non-steroidal anti-inflammatory drugs) in the past.

Diclofenac may increase your risk of a fatal heart attack or stroke, especially if you use it for a long time or take high doses, or if you have heart disease. Do not use this medicine immediately before or after heart bypass surgery (coronary artery bypass grafting, or CABG).

Cambia can also cause stomach or intestinal bleeding, which can be fatal. These conditions may occur without warning while using Cambia, especially in older adults.

Before you take this medicine

Cambia can cause stomach or intestinal bleeding, which can be fatal. These conditions may occur without warning while using Cambia, especially in older adults.

Diclofenac may also increase your risk of a fatal heart attack or stroke, even if you have no risk factors. Do not use this medicine immediately before or after heart bypass surgery (coronary artery bypass grafting, or CABG).

You should not use Cambia if you are allergic to diclofenac or if you have ever had an asthma attack or severe allergic reaction after taking aspirin or an NSAID.

Do not use Cambia to treat cluster headaches.

To make sure this medicine is safe for you, tell your doctor if you have:

• heart disease, high blood pressure;

• ulcers or bleeding in the stomach;

• Asthma;

• liver or kidney disease; or

• if you smoke.

Diclofenac can affect ovulation and it may be more difficult to get pregnant while you are taking this medicine.

If you are pregnant, you should not take Cambia unless your doctor recommends it.Taking an NSAID during the last 20 weeks of pregnancy can cause serious heart or kidney problems in the unborn baby and possible complications during pregnancy.

Breastfeeding may not be safe while using this medication. Ask your doctor about any risks.

Cambia is not intended for use by anyone under the age of 18.

How should I take Cambia?

Take Cambia oral powder exactly as your doctor has told you. Follow all instructions on your prescription label. Your doctor may occasionally change your dose to ensure you get the best results. Do not take this medicine in larger amounts or for longer than recommended. Use the lowest dose that is effective to treat your condition.

Take a dose of Cambia to treat your migraine headaches:

• Entfernen Sie eine Einzeldosispackung aus einem Satz von drei Packungen
• Öffnen Sie die Packung erst, wenn Sie sie verwenden möchten
• Leeren Sie den Inhalt der Packung in 1 bis 2 Unzen oder 2 bis 4 Esslöffel (30 bis 60 ml) Wasser. Verwenden Sie keine andere Flüssigkeit
• Gut vermischen und die Wasser-Pulver-Mischung trinken
• Entsorgen Sie leere Packungen an einem sicheren Ort und außerhalb der Reichweite von Kindern
• Die Einnahme von Cambia zusammen mit einer Mahlzeit kann im Vergleich zur Einnahme von Cambia auf nüchternen Magen zu einer verminderten Wirksamkeit führen.

Call your doctor if your headache doesn't go away completely after taking Cambia.Do not take a second dose without your doctor's advice.Overuse of migraine medications can make headaches worse. Tell your doctor if the medicine no longer seems to be effective in treating your migraine attacks

If you use Cambia for a long time, you may need frequent medical checks.

Store at room temperature, protected from moisture and heat. Keep the bottle tightly closed when not in use.

Read all patient information, medication guides and instructions for use provided to you. If you have any questions, contact your doctor or pharmacist.

Dosage information

Usual adult dosage for migraines:

Diclofenac potassium for oral solution packets: 50 mg (1 packet) once orally

Notes: This medication is not indicated for prophylactic therapy of migraine or for use in cluster headaches; The safety and effectiveness of a second dose have not been established.

Application: For the acute treatment of migraines with or without aura.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for the next scheduled dose. Do not take extra medicine to make up for a missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help hotline at 1-800-222-1222.

What to avoid

Avoid alcohol. It may increase your risk of stomach bleeding.

Avoid taking aspirin or other NSAIDs unless directed to do so by your doctor.

Ask a doctor or pharmacist before taking other medicines for pain, fever, swelling, or cold/flu symptoms. They may contain ingredients similar to diclofenac (e.g. aspirin, ibuprofen, ketoprofen or naproxen).

Cambia side effects

If necessary, get emergency medical helpSigns of an allergic reaction to Cambia(hives, difficulty breathing, swelling of the face or throat)or a severe skin reaction(Fever, sore throat, burning eyes, skin pain, red or purple rash with blistering and peeling).

Stop using Cambia and seek medical attention if you experience a serious drug reaction that may affect many parts of your body.Symptoms may include rash, fever, swollen glands, muscle pain, severe weakness, unusual bruising, or yellowing of your skin or eyes.

If necessary, get emergency medical helpSigns of a heart attack or stroke:Chest pain spreading to the jaw or shoulder, sudden numbness or weakness on one side of the body, slurred speech, shortness of breath.

Stop using Cambia and call your doctor immediately if you have:

• the first sign of a rash, no matter how mild;

• flu-like symptoms;

• Heart problems– Swelling, rapid weight gain, shortness of breath;

• Kidney problems- little or no urination, painful or difficult urination, swelling of the arms or legs, tiredness or shortness of breath;

• Liver problems- Nausea, diarrhea, stomach pain (top right), tiredness, itching, dark urine, jaundice (yellowing of the skin or eyes); or

• Signs of stomach bleeding- bloody or tarry stools, coughing up blood, or vomit that looks like coffee grounds.

Common side effects of Cambia may include:

• indigestion, flatulence, nausea, vomiting, stomach pain;

• diarrhea, constipation;

• headache, dizziness, drowsiness;

• abnormal laboratory tests;

• itching, sweating;

• stuffy nose;

• increased blood pressure; or

• Swelling or pain in your arms or legs.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You can report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Cambia?

Before using Cambia, consult your doctor if you are taking an antidepressant.Taking certain antidepressants with an NSAID may cause easy bruising or bleeding.

Tell your doctor about all other medicines you are taking, especially:

• heart or blood pressure medications, including a diuretic or “water pill”;

• other forms of diclofenac (Arthrotec, Flector, Pennsaid, Solaraze, Voltaren Gel);

• a blood thinner– Warfarin, Coumadin, Jantoven; or

• other NSAIDs– Aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib (Celebrex), indomethacin, meloxicam and others.

This list is not complete. Other medications may interact with diclofenac, including prescription and over-the-counter medications, vitamins, and herbal products. Not all possible drug interactions are listed here.