5 mg, 10 mg, 15 mg, 20 mg film-coated tablets
memantine hydrochloride
What Nemdatine is and what it is used for
How Nemdatine works
Nemdatine 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) which have to do with the transmission of nerve signals that are important for learning and memory. Nemdatine belongs to a group of medicines called NMDA receptor antagonists. Nemdatine acts on these NMDA receptors by improving the transmission of nerve signals and memory.
What Nemdatine is used for
Nemdatine is used to treat patients with moderate to severe Alzheimer’s disease.
What you need to know before using Nemdatine
Do not use Nemdatine
Do not use Nemdatine
- if you are allergic (hypersensitive) to memantine hydrochloride or to any of the other ingredients of Nemdatine film-coated tablets (see section 6).
Warnings and cautions
Talk to your doctor or pharmacist before using Nemdatine.
- 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 Nemdatine 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.
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
Nemdatine is not recommended for children and adolescents under 18 years of age.
Other medicines and Nemdatine
Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines, including medicines obtained without a prescription.
Nemdatine may particularly 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 Nemdatine.
Nemdatine with food and drink
You should tell your doctor if you have recently changed or plan to change your diet decisively (eg from a regular diet to a vegetarian diet only) or if you have renal tubular acidosis (RTA, an excess of acid-forming substances). in the blood as a result of renal dysfunction (poor kidney function)) or severe urinary tract infections, 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.
The use of memantine in pregnant women is not recommended.
Women taking Nemdatine should not breastfeed.
Driving and using machines
Your doctor will tell you if your illness allows you to drive and use machines safely. Nemdatine may also alter your reactivity, making it unsuitable to drive or use machines.
Nemdatine contains lactose monohydrate
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Nemdatine.
How to use Nemdatine
Always use Nemdatine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Nemdatine starter pack should only be used at the beginning of treatment with Nemdatine.
Dosage
The recommended treatment dose of 20 mg per day is achieved by gradually increasing the Nemdatine dose one 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 (day 1-7):
Take one 5 mg tablet once a day (white, oval) for 7 days.
Week 2 (days 8-14):
Take one 10 mg tablet once a day (white, capsule-shaped) for 7 days.
Week 3 (day 15-21):
Take a 15 mg tablet once daily (orange, oval) for 7 days.
Week 4 (day 22-28):
Take one 20 mg tablet per day (dark pink, oval) 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 daily |
Maintenance dose
The recommended daily dose is 20 mg once daily.
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. Your doctor should examine your kidney function at certain intervals.
Administration
Nemdatine 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 Nemdatine for as long as you can. Your doctor should regularly evaluate your treatment.
If you use more Nemdatine than you should
- In general, it is not harmful if you take too much Nemdatine. You may experience more severe symptoms from what is described in section 4. “Possible side effects”.
- If you have taken a large dose of Nemdatine, contact your doctor or doctor for medical advice, as you may need care.
If you forget to use Nemdatine
- If you notice that you have forgotten to take your dose of Nemdatine, 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 (affects 1 to 10 users in 100):
- Headache, drowsiness, constipation, elevated liver function tests, dizziness, balance disorders, shortness of breath, high blood pressure and drug hypersensitivity
Uncommon (affects 1 to 10 users in 1,000):
- Fatigue, fungal infections, confusion, hallucinations, vomiting, abnormal gait, heart failure and blood clots in veins
Very rare (affects less than 1 user in 10,000):
- Cramps
No known 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 self-loathing. These events have been reported in patients treated with Nemdatine.
How to store Nemdatine
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.
Do not store above 25 ° C.
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 of Nemdatine 5/10/15 and 20 mg film-coated tablets are: Tablet core: microcrystalline cellulose, crospovidone Type A, talc and magnesium stearate.
Tablet coating: Hypromellose 6cP, titanium dioxide (E 171), lactose monohydrate , macrogol 3350 and triacetin. Nemdatine 15 mg also contains yellow, red and black iron oxide (E172). Nemdatine 20 mg film-coated tablets also contain red and yellow iron oxide (E 172).
What the medicine looks like and contents of the pack
Nemdatine 5 mg film-coated tablets (tablets) are white, oval, biconvex, 8 mm x 4.5 mm in size, marked “M5” on one side.
Nemdatine 10 mg film-coated tablets (tablets) are white, capsule-shaped, oval, biconvex, 9.8 mm x 4.9 mm in size, with a scoreline, marked “M 10” on the page with a scoreline.
Nemdatine 15 mg film-coated tablets (tablets) are orange, oval, biconvex, 11.4 mm x 6.4 mm in size marked “M15” on one side.
Nemdatine 20 mg film-coated tablets (tablets) are dark pink, oval, biconvex, 12.6 mm x 7 mm in size, marked “M20” on one side.
A starter pack contains 28 tablets in 4 blisters in a wallet pack or multiple packs of 4 blisters in 4 separate inner packs and an outer pack of 7 tablets Nemdatine 5 mg, 7 tablets Nemdatine 10 mg, 7 tablets Nemdatine 15 mg, and 7 tablets Nemdatine 20 mg.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Actavis Group PTC EHF.
Reykjavíkurvegur 76‑78
220 Hafnarfjörður
Iceland
Manufacturer
Actavis hf.
Reykjavíkurvegur 78
220 Hafnarfjörður
Iceland
Actavis Group PTC EHF.
Reykjavikurvegur 76-78
220 Hafnarfjordur
Iceland
Actavis Ltd.
BLB 016 Bulebel Industrial Estate
Zejtun ZTN 3000
Malta
Manufacturing Packaging Farmacia (MPF) BV
Neptune 12,
Heerenveen 8448CN
Netherlands
Manufacturing Packaging Farmacia (MPF) BV
Appelhof 13,
Oudehask, 8465RX
Netherlands