Taro-Fampridine: Uses, Side Effects and Dosage

What is Taro-Fampridine used for?

Taro-Fampridine is used to improve walking in adults with multiple sclerosis (MS) related walking disability.

How does Taro-Fampridine work?

In MS, inflammation destroys the protective layer around the nerves. This leads to muscle weakness, muscle stiffness and difficulty walking.

Taro-Fampridine contains the active substance fampridine, which belongs to a group of medicines called potassium channel blockers. It works by stopping potassium leaving the nerve cells which may have been damaged by MS. is thought to work by letting signals pass down the nerve more normally, which allows you to walk better.

What are the ingredients in Taro-Fampridine?

Medicinal ingredient: fampridine.

Non-medicinal ingredients: ammonium hydroxide, ethyl cellulose, hypromellose, iron oxide black, magnesium stearate, microcrystalline cellulose, povidone, propylene glycol, shellac glaze, talc, triacetin and titanium dioxide.

Taro-Fampridine comes in the following dosage forms:

Extended-release tablets: 10 mg.

Do not use Taro-Fampridine if:

• you are allergic to fampridine or any of the other ingredients in Taro-Fampridine or its packaging
• you are taking 4-aminopyridine (4-AP) compounded by your pharmacist.
• you are taking any other medicine containing fampridine. This may increase your risk of serious side effects
• Your healthcare professional has told you that you have moderate or severe kidney problems. Have a seizure or ever had a seizure (also referred to as a fit or convulsion).
• you are taking medicines that will reduce the elimination of Taro-Fampridine from your body, which may increase your risk of serious side effects. Some of these medicines include cimetidine, and quinidine.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Taro-Fampridine. Talk about any health conditions or problems you may have, including if you:

• have any factors or are taking any medicines which affect your risk of seizures.
• have heart rhythm or conduction problems.
• are prone to infections.
• use a walking aid, such as a cane. Taro-Fampridine may make you feel dizzy or unsteady and may increase your risk of falling. If you use a walking aid, you should continue to use it as needed.
• have a history of nerve pain in the face (trigeminal neuralgia). Taro-Fampridine may make your condition worse.

• Are taking medicines that may affect your kidney function, such as:

  • beta blockers, which are medicines used to treat high blood pressure such as carvedilol, pindolol, propranolol.
  • procainamide, a medicine used to treat abnormal heart rhythms.
  • metformin, a medicine used to treat type 2 diabetes.
  • ranitidine, a medicine used to treat ulcers of the stomach or intestines.
  • varenicline, a medicine used to help you stop smoking.

Other warnings you should know about:

Taro-Fampridine can cause serious side effects, including:

• Seizures (fits): Your risk of seizures increases when you take Taro-Fampridine, especially if you:

  • take more than the prescribed dose of Taro-Fampridine.
  • do not take Taro-Fampridine as prescribed.
  • take certain medicines at the same time (e.g. bupropion, tramadol, tapentadol, or preparations used for colon cleansing).
  • Have kidney problems or other factors that increases your risk of seizures as determined by a healthcare professional.
• Allergic reactions: Serious allergic reactions have been observed in patients treated with fampridine. Symptoms include rash, itching, difficulty breathing, swelling of the face, lips, tongue or throat. In several cases, these reactions occurred after the first dose. If you experience an allergic reaction, stop taking Taro-Fampridine and tell your healthcare professional right away.

See the Serious side effects and what to do about them table, below, for more information on these and other serious side effects.

Urinary tract infection (UTI): An increase in UTIs has been noted in patients taking Taro-Fampridine. If you experience signs of a UTI, such as difficult or painful urination, bladder pain, or abdominal pain, tell your healthcare professional right away.

Infection: Fampridine may reduce the number of cells that fight infection in the body (white blood cells). This can make you more likely to get an infection. Tell your healthcare professional right away if you notice signs of an infection, such as fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or apathy.

Driving and using machines: fampridine may cause dizziness, balance problems, or fatigue. You should not drive or use tools or machinery until you know how you respond to Taro-Fampridine

Pregnancy: Taro-Fampridine is not recommended during pregnancy. If you become pregnant or think you are pregnant while taking Taro-Fampridine, contact your healthcare professional right away. Your healthcare professional will consider the benefit of you being treated with Taro-Fampridine against the risk to your baby.

Breast-feeding: It is not known if fampridine can pass into breast milk and harm your baby. Therefore, Taro-Fampridine should not be used during breast-feeding. Talk to your healthcare professional about ways to feed your baby while taking Taro-Fampridine.

Check-ups and testing:

• Your healthcare professional will evaluate your risk of seizures before you are prescribed Taro-Fampridine. They will tell you if it is right for you.
• Your healthcare professional will assess your walking ability before you start Taro-Fampridine and within the first 4 weeks of treatment. If you and your healthcare professional decide there has not been any improvements during this period, the treatment will be stopped. If the decision is to continue treatment, you and your healthcare professional will continue to regularly monitor your walking ability. Your treatment will be stopped if you are not experiencing any benefit.
• Your healthcare professional may also do blood tests before you start Taro-Fampridine and regularly during treatment. This is to check if your kidneys are working properly.

Tell your healthcare professional about all of the medicines you take including any drugs, vitamins, minerals, natural supplements, or alternative medicines.

The following may interact with Taro-Fampridine:

• other medicines containing fampridine.
• 4-aminopyridine (4-AP), a medicine compounded by a pharmacist that manages some of the symptoms of MS, and improves the ability to walk in adults.
• medicines that will reduce the elimination of Taro-Fampridine from your body, such as cimetidine and quinine

• medicines that affect your kidney function such as:

  • beta blockers which are medicines used to treat high blood pressure such as (carvedilol, pindolol, propranolol)
  • procainamide, a medicine used to treat abnormal heart rhythms.
  • metformin, a medicine used to treat type 2 diabetes.
  • ranitidine, a medicine used to treat ulcers of the stomach or intestines.
  • varenicline a medicine used to help you stop smoking.
• medicines that may affect your risk of seizures, such as bupropion, tramadol, tapentadol, or preparations used for colon cleansing.

Ask your healthcare professional if you are not sure whether the medicines you take are in the list above.

How to take Taro-Fampridine:

• Take Taro-Fampridine exactly as your healthcare professional tells you. Do not take more than the prescribed dose.

• Take Taro-Fampridine without food.

• Swallow tablet whole, with a drink of water. If you cannot swallow Taro-Fampridine tablets whole, tell your healthcare professional.
• Do not divide, crush, dissolve, suck or chew the tablet. A broken tablet can release too much of the medicine at one time. This can increase your risk of having a seizure.

Usual dose:

Take one 10 mg tablet of Taro-Fampridine in the morning and one 10 mg tablet in the evening. You must leave 12 hours between each tablet. Do not take a tablet more often than every 12 hours.

Overdose:

Symptoms of an overdose include:

• confusion
• excessive sweating
• seizures
• memory loss (amnesia)
• involuntary movements, shaking or twitching
• abnormal heart rhythms
• high blood pressure

Missed Dose:

If you forget or miss a dose of Taro-Fampridine, skip the missed dose and take the next dose as scheduled. Do not double the dose to make up for the missed dose. You must always leave 12 hours between each tablet. Taking more than your prescribed dose can increase the risk of experiencing serious side effects.

What are possible side effects from using Taro-Fampridine?

These are not all the possible side effects you may feel when taking Taro-Fampridine. If you experience any side effects not listed here, tell your healthcare professional.

Very common side effects:

• Urinary tract infection

Common side effects:

• feeling unsteady
• dizziness
• headache
• feeling weak and tired
• difficulty sleeping
• anxiety
• tremor (minor shaking)
• numbness or tingling of the skin
• sore throat
• feeling sick (nausea)
• being sick (vomiting)
• constipation
• upset stomach
• back pain
• Vertigo

Uncommon side effects:

• Worsening of nerve pain in the face (trigeminal neuralgia).

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting Side Effects

Storage:

• Store Taro-Fampridine at room temperature (between 15 to 30° C).
• Store the tablets in the original bottle to protect them from light and moisture. Keep blister in the outer container. Do not remove blister until dosing. Do not take your medicine after the expiry date shown on the bottle or carton.
• Keep out of reach and sight of children.

If you want more information about Taro-Fampridine:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html; the manufacturer’s website www.taro.ca, or by calling 1-800-268-1975

130 East Drive, Brampton, Ontario L6T 1C1

TARO is a registered trademark of Taro Pharmaceuticals Inc.

Last revised: NOV 08, 2024