Patient leaflet - Memantine 10 mg orodispersible tablets
1. WHAT MEMANTINE IS AND WHAT IT IS USED FOR
Memantine contains the active substance memantine hydrochloride. It 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 N-methyl-D-aspartate (NMDA)-receptors that are involved in transmitting nerve signals important in learning and memory. Memantine belongs to a group of medicines called NMDA- receptor antagonists. Memantine acts on these NMDA-receptors improving the transmission of nerve signals and the memory.
Memantine is used for the treatment of patients with moderate to severe Alzheimer’s disease.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MEMANTINE
Do not take memantine
- if you are allergic to memantine or any of the other ingredients of this medicine (listed in section 6).
Warning and precautions
Talk to your doctor or pharmacist before taking memantine:
- if you have a history of epileptic seizures
- if you have recently experienced a myocardial infarction (heart attack), or if you are suffering from congestive heart failure or from uncontrolled hypertension (high blood pressure).
In these situations, the treatment should be carefully supervised, and the clinical benefit of memantine reassessed by your doctor on a regular basis. If you suffer from renal impairment (kidney problems), your doctor should closely monitor your kidney function and if necessary adapt the memantine doses accordingly.
If you are suffering from states of renal tubulary acidosis (RTA, an excess of acid-forming substances in the blood due to renal dysfunction (poor kidney function)) or severe infections of the urinary tract (structure that carries urine), your doctor may need to adjust the dose of your medicine.
The use of medicinal products called amantadine (for the treatment of Parkinson’s disease), ketamine (a substance generally used as an anaesthetic), dextromethorphan (generally used to treat cough) and other NMDA-antagonists at the same time should be avoided.
Children and adolescents
Memantine is not recommended for children and adolescents under the age of 18 years.
Other medicines and memantine
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
In particular, memantine may change the effects of the following medicines and their dose may need to be adjusted by your doctor:
- amantadine, ketamine, dextromethorphan
- dantrolene, baclofen
- cimetidine, ranitidine, procainamide, quinidine, quinine, nicotine
- hydrochlorothiazide (or any combination with hydrochlorothi-azide)
- anticholinergics (substances generally used to treat movement disorders or intestinal cramps)
- anticonvulsants (substances used to prevent and relieve seizures)
- barbiturates (substances generally used to induce sleep)
- dopaminergic agonists (substances such as L-dopa, bromocriptine)
- neuroleptics (substances used in the treatment of mental disorders)
- oral anticoagulants
If you go into hospital, let your doctor know that you are taking memantine.
Memantine with food and drink
You should inform your doctor if you have recently changed or intend to change your diet substantially (e.g. from normal diet to strict vegetarian diet), as your doctor may need to adjust the dose of your medicine.
Pregnancy and breast-feeding
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 memantine should not breast-feed.
Driving and using machines
Your doctor will tell you whether your illness allows you to drive and to use machines safely. Also, memantine may change your reactivity, making driving or operating machinery inappropriate.
Memantine contains aspartame (E-951)
This medicine contains 2.50 mg of aspartame in each tablet. Aspartame contains a source of phenylalanine. It may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly.
Memantine contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.
3. HOW TO TAKE MEMANTINE
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
CONSILIENT CODE : P1799
PLEASE NOTE : PAPER COPIES ARE SUPPLIED AS A VISUAL REFERENCE ONLY. DO NOT MATCH FOR COLOUR
Item(s): Memantine 10 & 20 mg Orodispersible Tablets
Size: 170 x 330 mm
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Date: 21 Nov 2025 How much and when to take
The recommended dose of memantine for adults and older people is 20 mg once a day. In order to reduce the risk of side effects this dose is achieved gradually by the following daily treatment scheme:
Week 1 5 mg once a day
Week 2 10 mg once a day
Week 3 15 mg once a day
Week 4 and beyond 20 mg once a day
Memantine orodispersible tablets cannot be split. For unavailable doses of memantine orodispersible tablets, the patient should use another medicine containing memantine whose dose is available.
The usual starting dose is 5 mg once a day for the first week. This is increased to 10 mg once a day in the second week and to 15 mg once a day in the third week. From the fourth week on, the usual dose is 20 mg once a day.
Memantine should be administered orally once a day. To benefit from your medicine you should take it regularly every day at the same time of the day. The tablet should be placed on the tongue and allowed to dissolve before swallowing with or without water, as the patient prefers. The tablets can be taken with or without food.
Dosage in patients with impaired kidney function
If you have impaired kidney function, your doctor will decide upon a dose that suits your condition. In this case, monitoring of your kidney function should be performed by your doctor at specified intervals.
If you take more memantine than you should
- In general, taking too much memantine should not result in any harm to you. You may experience increased symptoms as described in section 4. “Possible side effects”.
- If you take a large overdose of memantine, contact your doctor or get medical advice, as you may need medical attention.
If you forget to take memantine
- If you find you have forgotten to take your dose of memantine, 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 medicine, 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 observed side effects are mild to moderate.
Common (may affect up to 1 in 10 people):
- headache,
- sleepiness,
- constipation,
- elevated liver function tests,
- dizziness,
- balance disorders,
- shortness of breath,
- high blood pressure,
- drug hypersensitivity
Uncommon (may affect up to 1 in 100 people):
- tiredness,
- fungal infections,
- confusion,
- hallucinations,
- vomiting,
- abnormal gait,
- heart failure
- venous blood clotting (thrombosis/thromboembolism)
Very Rare (may affect up to 1 in 10,000 people):
seizures
Not known (frequency cannot be estimated from the available data):
- inflammation of the pancreas,
- inflammation of the liver (hepatitis)
- psychotic reactions
Alzheimer’s disease has been associated with depression, suicidal ideation and suicide. These events have been reported in patients treated with memantine.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE MEMANTINE
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 the blister after EXP. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Memantine 10 mg & 20 mg orodispersible tablets contains
- The active substance is memantine hydrochloride.
- Each 10 mg orodispersible tablet contains 10 mg memantine hydrochloride equivalent to 8.31 mg memantine.
- Each 20 mg orodispersible tablet contains 20 mg memantine hydrochloride equivalent to 16.62 mg memantine.
- The other ingredients are microcrystalline cellulose, polacrilin potassium, croscarmellose sodium, peppermint flavor, aspartame (E-951), mannitol/maize starch mixture), saccharin sodium, colloidal anhydrous silica and magnesium stearate.
What Memantine 10 mg & 20 mg orodispersible tablets look like and contents of the pack
Memantine 10 mg orodispersible tablets are presented as white or almost white, round, flat, beveled, orodispersible tablets, debossed with “10” on one side and plain on the other side with a diameter of 9.1 mm.
Memantine 20 mg orodispersible tablets are presented as white or almost white, round, flat, beveled, orodispersible tablets, debossed with “20” on one side and plain on the other side with a diameter of 12.1 mm.
Memantine 10 mg orodispersible tablets are packed in Aluminum/Polyamide-Aluminum-PVC blister packs containing 28 or 112 tablets.
Memantine 20 mg orodispersible tablets are packed in Aluminum/Polyamide-Aluminum-PVC blister packs containing 28 or 56 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Consilient Health Limited,
Floor 3, Block 3,
Miesian Plaza,
Dublin 2, D02 Y754, Ireland
Manufacturer
NORMON LABORATORIES, SA
Ronda de Valdecarrizo, 6
28760 Tres Cantos,
Madrid, Spain.
This leaflet was last revised in November 2025.
P1799
CONSILIENT CODE : P1799
PLEASE NOTE : PAPER COPIES ARE SUPPLIED AS A VISUAL REFERENCE ONLY. DO NOT MATCH FOR COLOUR
Item(s): Memantine 10 & 20 mg Orodispersible Tablets
Size: 170 x 330 mm
Software: InDesign CC
Fonts
Helvetica Neue 9pt (min)
Designed by
Number: 02
Date: 21 Nov 2025