5 mg, 10 mg, 15 mg and 20 mg Film-coated tablets 
Memantine hydrochloride

1. What Ebixa is and what it is used for

Ebixa contains the active substance memantine hydrochloride and belongs to a group of medicines known as anti-dementia medicines. Memory loss in Alzheimer’s disease is due to a disturbance of message signals in the brain. The brain contains so-called NMDA receptors (N-methyl-D-aspartate) that are involved in the transmission of nerve signals that are important for learning and memory. Ebixa belongs to a group of medicines called NMDA receptor antagonists. Ebixa acts on these NMDA receptors by improving the transmission of nerve signals and memory.

Ebixa is used to treat patients with moderate to severe Alzheimer’s disease.

2. What you need to know before using Ebixa

Do not use Ebixa

  • if you are allergic to memantine or any of the other ingredients of this medicine (listed in section 6).

Warnings and cautions

Talk to your doctor or pharmacist before taking Ebixa:

  • if you have a history of epileptic seizures
  • if you have recently had a myocardial infarction (heart attack) or if you suffer from untreated heart failure or uncontrolled hypertension (high blood pressure ).

In these situations, treatment should be closely monitored and the clinical benefit of Ebixa should be regularly assessed by your doctor.

If you suffer from impaired kidney function (kidney problems), your doctor should closely monitor your kidney function and, if necessary, adjust the memantine doses accordingly.

If you suffer from a condition of renal tubular acidosis (RTA, an excess of acid-forming substances in the blood due to kidney dysfunction (impaired kidney function)) or severe urinary tract infections, your doctor may need to adjust the dose of your medicine.

Concomitant use of drugs containing amantadine (for the treatment of Parkinson’s disease ), ketamine (a substance commonly used as an anesthetic), dextromethorphan (generally used to treat cough), and other NMDA antagonists should be avoided.

Children and young people

Ebixa is not recommended for children and adolescents under 18 years of age.

Other medicines and Ebixa

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Ebixa may particularly affect the effects of the following medicines and these doses may need to be changed by your doctor:

  • amantadine, ketamine, dextromethorphan
  • dantrolene, baclofen
  • cimetidine, ranitidine, procainamide , quinidine , quinine, nicotine
  • hydrochlorothiazide (or any combination with hydrochlorothiazide)
  • anticholinergics (substances commonly used to treat movement disorders or intestinal cramps)
  • antiepileptics (substances used to prevent and relieve seizures)
  • barbiturates (substances commonly used for insomnia)
  • dopaminergic agonists (substances such as L-dopa, bromocriptine)
  • neuroleptics (substances used in the treatment of mental illness)
  • oral anticoagulants

If you are hospitalized, tell your doctor that you are taking Ebixa.

Ebixa with food, drink, and alcohol

You should tell your doctor if you have recently changed or intend to change your diet significantly (eg from a regular diet to a vegetarian diet only), as your doctor may need to adjust the dose of your medicine.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

The use of memantine in pregnant women is not recommended.

Breast-feeding

Women taking Ebixa should not breast-feed.

Driving and using machines

Your doctor will tell you if your illness allows you to drive vehicles and use machines safely. Ebixa may also alter your responsiveness, making it unsuitable to drive or use machines.

3. How to use Ebixa

Ebixa starter pack should only be used at the beginning of treatment with Ebixa.

Always use Ebixa exactly as your doctor has told you. If you are not sure, talk to your doctor or pharmacist.

The recommended treatment dose of 20 mg per day is achieved by gradually increasing the Ebixadose during the first 3 weeks of treatment. The treatment schedule is also stated on starter pack one. Take one tablet once a day.

Week 1 (days 1-7):

Take one 5 mg tablet once a day (white to off-white, oblong) for 7 days.

Week 2 (days 8-14):

Take a 10 mg tablet once a day (pale yellow to yellow, oval) for 7 days.

Week 3 (day 15-21):

Take one 15 mg tablet once daily (gray-orange, oblong) for 7 days.

Week 4 (days 22-28):

Take one 20 mg tablet per day (gray-red, oblong) for 7 days.


Week 1
5 mg tablet
Week 2 10 mg tablet
Week 3 15 mg tablet
Week 4 and beyond 20 mg tablet once a day

Maintenance dose

The recommended daily dose is 20 mg once a day.

To continue treatment, consult your doctor.

Dosage in patients with renal impairment

If you have impaired kidney function, your doctor will prescribe a dose that suits your condition. In this case, your doctor should examine your kidney function at certain intervals.

Administration

Ebixa should be taken orally once a day. For you to benefit from your medicine, you must take it regularly every day at the same time of day. The tablets should be swallowed with a little water. The tablets can be taken with or without food.

Treatment time

Keep taking Ebixa for as long as you benefit from it. Your doctor should regularly evaluate your treatment.

If you use more Ebixa than you should  

  • In general, it should not hurt you if you take too much Ebixa. You may experience increased symptoms as described in section 4. “Possible side effects”.
  • If you are taking a large dose of Ebixa, contact your doctor or doctor for medical advice, as you may need care.

If you forget to use Ebixa

  • If you notice that you have forgotten to take your dose of Ebixa, wait and take your next dose at the usual time.
  • Do not take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

In general, the side effects observed are mild to moderate.

Common (affects 1 to 10 users in 100):

  • Headache, drowsiness, constipation, elevated liver function tests, dizziness, dysfunction, shortness of breath, high blood pressure, and drug hypersensitivity

Uncommon (affects 1 to 10 users in 1,000):

  • Fatigue, fungal infections, confusion, hallucinations, vomiting, gait disorders, heart failure, and blood clots in veins (thrombosis/turbo embolism)

Very rare (affects less than 1 user in 10,000):

• Cramps

No known frequency (cannot be calculated from the available data):

• pancreas, liver inflammation ( hepatitis ), and psychotic reactions

Alzheimer’s disease has been associated with depression, suicidal ideation, and suicide. These events have been reported in patients treated with Ebixa.

5. How to store Ebixa

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiration date is the last day of the specified month.

No special storage instructions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

The active substance is memantine hydrochloride. Each film-coated tablet contains 5/10/15/20 mg memantine hydrochloride equivalent to 4.15 / 8.31 / 12.46 / 16.62 mg memantine.

The other ingredients for Ebixa 5/15 and 20 mg film-coated tablets are microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate, all in the tablet core; and hypromellose, macrogol 400, titanium dioxide (E 171) and for Ebixa 15 mg and Ebixa 20 mg film-coated tablets also yellow and red iron oxide (E 172) all in the tablet coating.

The other ingredients for Ebixa 10 mg film-coated tablets are microcrystalline cellulose, colloidal anhydrous silica, talc, and magnesium stearate, all in the tablet core; and methacrylic acid-ethyl acrylate copolymer (1: 1), sodium lauryl sulfate, polysorbate 80, talc, triacetin, and simethicone emulsion, all in the tablet coating.

What the medicine looks like and the contents of the pack

Ebixa 5 mg film-coated tablets are white to off-white, oblong, marked “5” on one side and “MEM” on the other side.

Ebixa 10 mg film-coated tablets are pale yellow to yellow, oval with a scoreline, marked “1 0” on one side and “MM” on the other side. The tablet can be divided into two equal doses.

Ebixa 15 mg film-coated tablets are orange to gray-orange, oblong, marked “15” on one side and “MEM” on the other side.

Ebixa 20 mg film-coated tablets are pale red to gray-red, oblong, marked “20” on one side and “MEM” on the other side.

A starter pack contains 28 tablets in blisters 4 of 7 tablets of Ebixa 5 mg, 7 tablets of Ebixa 10 mg, 7 tablets of Ebixa 15 mg, and about 7 tablets Ebixa 20 mg.

Marketing Authorization Holder and Manufacturer

H. Lundbeck A / S

Ottiliavej 9

2500 Valby

Denmark

Muhammad Nadeem

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