What is the most important information you need to know about AMPYRA® (dalfampridine) Extended Release Tablets?
AMPYRA is indicated as a treatment to improve walking in patients with multiple sclerosis (MS). This was demonstrated by an increase in walking speed.
AMPYRA can cause seizures. Your chance of having a seizure is higher if you take too much AMPYRA or if you have kidney problems.
Do not take AMPYRA if you have ever had a seizure.
Do not take AMPYRA if you have certain types of kidney problems. Talk to your doctor if you have kidney problems. It is important to take AMPYRA exactly as prescribed by your doctor.
Stop taking AMPYRA and call your doctor right away if you have a seizure while taking AMPYRA.
What Are the Possible Side Effects of AMPYRA?
You may experience some side effects with AMPYRA®. These can include serious side effects, such as kidney or bladder infections.
The most common side effects of AMPYRA are:
- urinary tract infection
- trouble sleeping (insomnia)
- dizziness
- headache
- nausea
- weakness
- back pain
- problems with balance
- multiple sclerosis relapse
- burning, tingling or itching of the skin
- irritation in the nose and throat
- constipation
- indigestion
- pain in the throat
Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of AMPYRA. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Before you take AMPYRA, tell your doctor if you:
- have any other medical conditions
- are taking compounded 4-aminopyridine (fampridine,4-AP)
- are pregnant or plan to become pregnant. It is not known if AMPYRA will harm your unborn baby. You and your doctor will decide if you should take AMPYRA while you are pregnant
- are breast-feeding or plan to breast-feed. It is not known if AMPYRA passes into your breast milk. You and your doctor should decide if you will take AMPYRA or breast-feed. You should not do both
Never take more than one tablet of AMPYRA twice a day about 12 hours apart. Don’t take more than 2 tablets in a 24-hour period because it may increase the risk of seizures. If you miss a dose of AMPYRA don’t make up the missed dose.
What other safety information do you need to know about AMPYRA?
It's important to take AMPYRA as prescribed by your doctor.
Here are a few other things you need to know about AMPYRA:
- Do not divide, crush, chew, or dissolve tablets
- If you miss a dose, do not take a double dose. Wait until it's time for the next dose. Taking more than the recommended dose may put you at risk for seizures or other side effects
- Discuss all medications and supplements you're taking with your doctor, including other prescription medicines, non-prescription medicines, vitamins, and herbal supplements
- AMPYRA can be taken with or without food
- Store AMPYRA at 59°F to 86°F (15°C to 30°C)
- Safely throw away AMPYRA that is out of date or no longer needed
- Keep away from children
