5 mg +10 mg +15 mg + 20 mg film-coated tablets
Memantine hydrochloride
What Memantine Merz is and what it is used for
How Memantine Merz works
Memantine Merz contains the active substance memantine hydrochloride. Memantine Merz 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 Merz belongs to a group of medicines called NMDA receptor antagonists. Memantine Merz acts on these NMDA receptors by improving the transmission of nerve signals and memory.
What Memantine Merz is used for
Memantine Merz is used to treat patients with moderate to severe Alzheimer’s disease.
What you need to know before you use Memantine Merz
Do not use Memantine Merz
- if you are allergic (hypersensitive) 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 Merz
- 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 from uncontrolled hypotension (high blood pressure )
In these situations, treatment should be closely monitored and the clinical benefit of Memantine Merz 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 Merz is not recommended for children and adolescents under 18 years of age.
Other medicines and Memantine Merz
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, Memantine Merz may affect the effects of the following medicines and these doses may need to be changed by your doctor:
- amantadine, ketamine, dextromethorphan
- dantrolen, baklofen
- 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 Merz.
Memantine Merz 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) 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, breastfeeding and fertility
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 Merz should not breastfeed.
Driving and using machines
Your doctor will tell you if your illness allows you to drive and use machines safely. Memantine Merz can also change your reactivity, making it unsuitable to drive or use machines.
How to use Memantine Merz
The Memantine Merz package for initiation of treatment should only be used at the beginning of treatment with Memantine Merz.
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 Merz 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 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 a day (gray-orange, oblong) for 7 days.
Week 4 (day 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 | 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.
Administration
Memantine Merz 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 Memantine Merz for as long as you can. Your doctor should regularly evaluate your treatment.
If you use more Memantine Merz than you should
- In general, it should not harm you if you take too much Memantine Merz. You may experience increased symptoms as described in section 4. “Possible side effects”.
- If you are taking a large dose of Memantine Merz, contact your doctor or doctor for medical advice, as you may need care.
If you forget to use Memantine Merz
- If you find that you have forgotten to take your dose of Memantine Merz, 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, this medicine 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
No known frequency (frequency can not be calculated from the available data):
• 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 Merz.
How to store Memantine Merz
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
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 Merz 5/10/15 and 20 mg film-coated tablets are microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate, all in the tablet core; and hypromellose, maktrogol 400, titanium dioxide (E 171) and for Memantine Merz 10 mg film-coated tablets, in addition, yellow iron oxide (E172) and for Memantine Merz 15 mg and Memantine Merz 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 Merz 5 mg film-coated tablets are white to off-white, oblong, embossed 5 on one side, and embossed MEM on the other side.
Memantine Merz 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. The tablet can be divided into two equal parts.
Memantine Merz 15 mg film-coated tablets are orange to gray-orange, oblong, embossed on one side, and embossed MEM on the other side.
Memantine Merz 20 mg film-coated tablets are pale red to gray-red, oblong, embossed on one side, and embossed MEM on the other side.
One pack for initiating treatment contains 28 tablets in 4 blisters with 7 tablets of Memantine Merz 5 mg, 7 tablets of Memantine Merz 10 mg, 7 tablets of Memantine Merz 15 mg, and 7 tablets of Memantine Merz 20 mg.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Merz Pharmaceuticals GmbH
Eckenheimer Landstr. 100
D-60318 Frankfurt / Main
Germany
Manufacturer
Merz Pharma GmbH + Co. KGaA
Eckenheimer Landstr. 100
D-60318 Frankfurt / Main
Germany