Memantine Accord
5, 10, 15, and 20 mg film-coated tablet
memantine hydrochloride
What Memantine Accord is and what it is used for
How Memantine Accord works
Memantine Accord contains the active substance memantine hydrochloride.
Memantine Accord 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. Memantine Accord belongs to a group of medicines called NMDA receptor antagonists. Memantine Accord acts on these NMDA receptors by improving the transmission of nerve signals and memory.
What Memantine Accord is used for
Memantine Accord is used to treat patients with moderate to severe Alzheimer’s disease.
What you need to know before taking Memantine Accord
Do not use Memantine Accord
- if you are allergic to memantine hydrochloride or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
Talk to your doctor or pharmacist before taking Memantine Accord
- 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 Memantine Accord should be regularly assessed by your physician.
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.
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
Memantine Accord is not recommended for children and adolescents under 18 years of age
Other medicines and Memantine Accord
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Memantine Accord 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 Memantine Accord.
Memantine Accord with food and drink
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) or if you suffer from a condition of renal tubular acidosis (RTA, an excess on acid-forming substances in the blood due to kidney dysfunction (renal impairment)) or severe urinary tract infections ( cataracts ), as your doctor may need to adjust the dose of your medicine.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, 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 Memantine Accord should not breastfeed.
Driving and using machines
Your doctor will tell you if your illness allows you to drive and use machines safely. Memantine Accord may also alter your responsiveness, making it unsuitable to drive or use machines.
Memantine Accord contains lactose
This medicine contains lactose. If you have previously been told by your doctor that you have an intolerance to some sugars, contact your doctor before using this medicine. Your doctor will advise you.
How to take Memantine Accord
The Memantine Accord package for initiating treatment should only be used at the beginning of treatment with Memantine Accord.
Always use this medicine exactly as your doctor has told you. If you are not sure, talk to your doctor or pharmacist.
Dosage
The recommended treatment dose of 20 mg per day is achieved by gradually increasing the Memantine Accord dose during the first 3 weeks of treatment. The treatment schedule is also indicated on the package for initiating treatment. Take one tablet once a day.
Week 1 (days 1-7):
Take one 5 mg tablet once a day (white) for 7 days.
Week 2 (days 8-14):
Take a 10 mg tablet once a day (white with a scoreline) for 7 days.
Week 3 (day 15-21):
Take one 15 mg tablet once a day (orange to gray-orange) for 7 days.
Week 4 (day 22-28):
Take a 20 mg tablet once a day (pale red to gray-red, with break marks) for 7 days.
| week 1 | 5 mg tablet |
| week 2 | 10 mg tablet |
| week 3 | 15 mg tablet |
| week 4and thereafter | 20 mg tablets 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.
How to take the medicine
Memantine Accord 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
Continue to take Memantine Accord for as long as you benefit from it. Your doctor should regularly evaluate your treatment.
If you take more Memantine Accord than you should
- In general, it should not hurt you if you take too much Memantine Accord. You may experience increased symptoms as described in section 4. “Possible side effects”.
- If you are taking a large overdose of Memantine Accord, consult your doctor or seek medical advice, as you may need care.
If you forget to take Memantine Accord
- If you notice that you have forgotten to take your dose of Memantine Accord, 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.
Possible side effects
Like all medicines, Memantine Accord can cause side effects, although not everybody gets them.
In general, the side effects observed are mild to moderate.
Common (may affect up to 1 in 10 people):
- Headache, drowsiness, constipation, elevated liver function tests, dizziness, balance disorders, shortness of breath, high blood pressure and drug hypersensitivity.
Uncommon (may affect up to 1 in 100 people):
- Fatigue, fungal infections, confusion, hallucinations, vomiting, gait disorders, heart failure and blood clots in veins.
Very rare ( may affect up to 1 in 10,000 people):
- Cramps.
Has been reported (occurs in an unknown number of users):
- Pancreatitis, 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 memantine.
How to store Memantine Accord
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.
Contents of the pack 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 Memantine Accord are lactose monohydrate, microcrystalline cellulose, colloidal anhydrous silica, crospovidone, magnesium stearate, all in the tablet core; hypromellose, polysorbate 80, maktrogol 400, titanium dioxide (E 171) and for Memantine Accord 15 mg and Memantine Accord 20 mg film-coated tablets yellow and red iron oxide (E 172) all in the tablet coating.
What the medicine looks like and contents of the pack
Memantine Accord 5 mg coated tablets are white, oblong, marked “MT” on one side and marked “5” on the other side.
Memantine Accord 10 mg film-coated tablets are white, oblong, coated tablets with a scoreline, marked “MT” divided by the scoreline on one side and “10” divided by the scoreline, on the other side. The tablet can be divided into two equal doses.
Memantine Accord 15 mg film-coated tablets are orange to gray-orange, oblong, coated tablets, labeled “MT” on one side and labeled “15” on the other.
Memantine Accord 20 mg film-coated tablets are pale red to gray-red, oblong, coated tablets with a scoreline, marked “MT” divided by the scoreline on one side and “20” divided by the scoreline on the other side. The tablet can be divided into two equal doses.
One pack of initiation of treatment contains 28 tablets in 4 blisters with 7 tablets of Memantine Accord 5 mg, 7 tablets of Memantine Accord 10 mg, 7 tablets of Memantine Accord 15 mg, and 7 tablets of Memantine Accord 20 mg.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Accord Healthcare SLU
World Trade Center, Moll de Barcelona, s / n,
Edifici Est 6ª planta,
08039 Barcelona,
Spain
Manufacturer
Deloris Pharmaceuticals Ltd
17, Athinon Street
Ergates Industrial Area, 2643 Nicosia
Cyprus
Accord Healthcare Polska Sp.z oo,
ul. Lutomierska 50,95-200 Pabianice, Poland