Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Memantine Glenmark 10mg/ml oral solution
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Memantine hydrochloride may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for
How does Memantine oral solution work Memantine oral solution 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 oral solution belongs to a group of medicines called NMDA-receptor antagonists. Memantine oral solution acts on these NMDA-receptors improving the transmission of nerve signals and the memory. What is Memantine oral solution used for Memantine oral solution is used for the treatment of patients with moderate to severe Alzheimer's disease.
What you need to know before you take it
e Memantine oral solution Do not take Memantine oral solution if you are allergic to memantine hydrochloride or any of the other ingredients of this medicine (listed in section 6). Warnings and precautions Talk to your doctor before taking Memantine oral solution 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 an uncontrolled hypertension (high blood pressure). In these situations the treatment should be carefully supervised, and the clinical benefit of Memantine oral solution 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. 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 oral solution is not recommended for children and adolescents under the age of 18 years. Other medicines and Memantine oral solution 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. In particular, Memantine oral solution 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 hydrochlorothiazide);
- 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 oral solution. Memantine oral solution with food and drink Inform your doctor if you have recently changed or intend to change your diet substantially (e.g. from normal diet to strict vegetarian diet) or 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), as your doctor may need to adjust the dose of your medicine. Pregnancy and breast-feeding Ask your doctor or pharmacist for advice before taking any medicine. 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 any medicine. The use of memantine in pregnant women is not recommended. Women taking Memantine oral solution 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 oral solution may change your reactivity, making driving or operating machinery inappropriate. Memantine oral solution contains sorbitol and potassium This medicinal product contains sorbitol. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. Your doctor will advise you. Furthermore, this medicine contains potassium, less than 1 mmol (39 mg) per dose, that is, essentially potassium-free. 3.
How to take it
Memantine oral solution
Always take Memantine oral solution exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Dosage One pump actuation contains 5 mg memantine hydrochloride. The recommended dose of Memantine oral solution for adults and elderly patients is four pump actuations, equivalent to 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
one pump actuation
week 2 week 3 week 4 and beyond
two pump actuations three pump actuations Four pump actuations
The usual starting dose is one pump actuation once daily (1x 5 mg) for the first week. This dose is increased in the second week to two pump actuations once daily (1 x 10 mg), and in the third week to three pump actuations once daily (1 x 15 mg). From the fourth week the recommended dose is four pump actuations once daily (1x 20 mg). Dosage in patients with impaired kidney function If you have problems with the way your kidneys work (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. Administration Memantine oral solution 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 solution should be taken with a little water. The solution can be taken with or without food. For detailed instructions on the preparation and handling of the product see end of this leaflet ("Instructions for proper use of the pump") Duration of treatment Continue to take Memantine oral solution as long as it is of benefit to you. Your doctor should assess your treatment on a regular basis. If you take more Memantine oral solution than you should In general, taking too much Memantine oral solution 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 oral solution, contact your doctor or get medical advice, as you may need medical attention. If you forget to take Memantine oral solution If you find you have forgotten to take your dose of Memantine oral solution, 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 1 to 10 users in 100): • Headache, sleepiness, constipation, elevated liver function tests, dizziness, balance disorders, shortness of breath, high blood pressure and drug hypersensitivity Uncommon (may affect 1 to 10 users in 1,000): • Tiredness, fungal infections, confusion, hallucinations, vomiting, abnormal gait, heart failure and venous blood clotting (thrombosis/thromboembolism) Very Rare (may affect less than 1 user in 10,000): • Seizures Not known (frequency cannot be estimated from the available data): • Inflammation of the pancreas, inflammation of the liver (hepatitis) and psychotic reactions Alzheimer's disease has been associated with depression, suicidal thoughts and suicide. These events have been reported in patients treated with memantine.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. 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. By reporting side effects you can help provide more information on the safety of this medicine. 5.
How to store it
Memantine oral solution
Keep this medicine out of the sight and reach of children. Do not use Memantine oral solution after the expiry date which is stated on the carton and the bottle label after EXP. The expiry date refers to the last day of that month. Do not store above 30 °C. Once opened, the contents of the bottle should be used within 3 months. The bottle with the mounted pump must be kept and transported in an upright position only. Do not throw away 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 oral solution contains The active substance is memantine hydrochloride. Each pump actuation delivers 0.5 ml of solution which contains 5 mg of memantine hydrochloride which is equivalent to 4.16 mg memantine. The other ingredients are potassium sorbate, sorbitol, hydrochloric acid for pH adjustment and purified water. What Memantine oral solution looks like and contents of the pack Memantine oral solution is presented as a clear, colourless to light yellowish solution. Memantine oral solution is available in bottles of 50 ml, 100 ml or 10 x 50 ml. Not all pack sizes may be marketed. Marketing Authorisation Holder Glenmark Pharmaceuticals Europe Limited Laxmi House, 2B Draycott Avenue Kenton, Middlesex, HA3 0BU United Kingdom Manufacturer ONE PHARMA S.A. 60th km. N.N.R Athinon-Lamias Sximatari Voiotias, 32009 Greece VIANEX S.A. PLANT A 12 Km National Road Athens – Lamia 1444 51 Metamorfossi Greece This leaflet was last revised in 09/2024
Instructions for proper use of the pump The solution must not be poured or pumped directly into the mouth from the bottle or pump. Measure the dose onto a spoon or into a glass of water, using the pump. 1. Take the screw cap off the bottle: The cap must be turned anticlockwise, unscrewed completely and removed (figure 1). Figure 1
2. Mounting the dosing pump on the bottle: Take the dosing pump out of the plastic bag (figure 2) and place it on top of the bottle. Slide the plastic dip tube carefully into the bottle. Hold the dosing pump onto the neck of the bottle and screw it clockwise until it fits firmly (figure 3). The dosing pump is only screwed on once when starting the use, and should never be unscrewed.
Figure 2
Figure 3
3. How the dosing pump works: The dosing pump head has two positions and is easy to turn:
- anticlockwise to unlock and
- clockwise to lock. The dosing pump head should not be pushed down while in the locked position. The solution may only be dispensed in the unlocked position. To unlock, turn the pump head in the direction of the arrow until it cannot be turned any further (figure 4). The dosing pump is then ready for use.
Figure 4
4. Preparing the dosing pump: When used for the first time, the dosing pump does not dispense the correct amount of oral solution. Therefore, the pump must be prepared (primed) by pushing the dosing pump head down completely six times in succession (figure 5). Figure 5
The solution thus dispensed is discarded. The next time the dosing pump head is pushed downwards completely (equivalent to one pump actuation), it dispenses the correct dose (figure 6). Figure 6
5. Correct use of the dosing pump:
Hold the bottle in a slightly tilted position. Hold a glass with a little water or a spoon below the nozzle. Push down the dosing pump head in a firm but calm and steady manner – not too slowly (figure 7, figure 8). Figure 7
Figure 8
The dosing pump head can then be released and is ready for the next pump actuation. The dosing pump must only be used with the Memantine oral solution in the bottle provided, not for other substances or containers. If the pump does not function properly, consult your doctor or a pharmacist. Lock the dosing pump after using Memantine oral solution.
Frequently asked questions about Memantine Glenmark 10mg/ml oral solution
How do I take Memantine Glenmark 10mg/ml oral solution?
Memantine Glenmark 10mg/ml oral solution comes as oral solution containing 10mg/ml. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Memantine Glenmark 10mg/ml oral solution?
The active substance in Memantine Glenmark 10mg/ml oral solution is memantine hydrochloride.
Are there equivalent medicines to Memantine Glenmark 10mg/ml oral solution?
Medicines with the same active substance, strength and form include: Memantine Hydrochloride 10mg/ml Oral Solution. They are interchangeable only if your prescriber or pharmacist says so.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Memantine Glenmark 10mg/ml oral solution, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Memantine Glenmark 10mg/ml oral solution without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: memantine hydrochloride
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Treatment of patients with moderate to severe Alzheimer's disease.
4.2. Posology and method of administration
Treatment should be initiated and supervised by a physician experienced in the diagnosis and treatment of Alzheimer's dementia. Therapy should only be started if a caregiver is available who will regularly monitor the intake of the medicinal product by the patient. Diagnosis should be made according to current guidelines. The tolerance and dosing of memantine should be reassessed on a regular basis, preferably within three months after start of treatment. Thereafter, the clinical benefit of memantine and the patient's tolerance of treatment should be reassessed on a regular basis according to current clinical guidelines. Maintenance treatment can be continued for as long as a therapeutic benefit is favourable and the patient tolerates treatment with memantine. Discontinuation of memantine should be considered when evidence of a therapeutic effect is no longer present or if the patient does not tolerate treatment.
Memantine oral solution should be taken once daily at the same time each day. The solution can be taken with or without food. The solution must not be poured or pumped into the mouth directly from the bottle or the pump, but should be dosed onto a spoon or into a glass of water using the pump.
For detailed instructions on the preparation and handling of the product see section 6.6.
Adults:
Dose titration
The maximum daily dose is 20 mg per day. In order to reduce the risk of undesirable effects, the maintenance dose is achieved by upward titration of 5 mg per week over the first 3 weeks as follows:
Week 1 (day 1-7):
The patient should take 0.5 ml solution (5 mg) equivalent to one pump actuation per day for 7 days.
Week 2 (day 8-14):
The patient should take 1 ml solution (10 mg) equivalent to two pump actuations per day for 7 days.
Week 3 (day 15-21):
The patient should take 1.5 ml solution (15 mg) equivalent to three pump actuations per day for 7 days.
From Week 4 on:
The patient should take 2 ml solution (20 mg) equivalent to four pump actuations once a day.
Maintenance dose
The recommended maintenance dose is 20 mg per day.
Elderly: On the basis of the clinical studies, the recommended dose for patients over the age of 65 years is 20 mg per day (2 ml solution, equivalent to four pump actuations) as described above.
Paedriatic population: The safety and efficacy of Memantine oral solutionin children below 18 years old has not yet been established.
Renal impairment: In patients with mildly impaired renal function (creatinine clearance 50 – 80ml/min) no dose adjustment is required. In patients with moderate renal impairment (creatinine clearance 30 – 49 ml/min) daily dose should be 10 mg (1 ml solution, equivalent to two pump actuations). If tolerated well after at least 7 days of treatment, the dose could be increased up to 20 mg/day according to standard titration scheme. In patients with severe renal impairment (creatinine clearance 5 – 29 ml/min) daily dose should be 10 mg (1 ml solution, equivalent to two pump actuations).
Hepatic impairment: In patients with mild or moderate hepatic impaired function (Child-Pugh A and Child-Pugh B), no dose adjustment is needed. No data on the use of memantine in patients with severe hepatic impairment are available. Administration of Memantine oral solutionis not recommended in patients with severe hepatic impairment.
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
4.4. Special warnings and precautions for use
Caution is recommended in patients with epilepsy, former history of convulsions or patients with predisposing factors for epilepsy.
Concomitant use of N-methyl-D-aspartate (NMDA)-antagonists such as amantadine, ketamine or dextromethorphan should be avoided. These compounds act at the same receptor system as memantine, and therefore adverse reactions (mainly central nervous system (CNS)-related) may be more frequent or more pronounced (see also section 4.5).
Some factors that may raise urine pH (see section 5.2 “Elimination”) may necessitate careful monitoring of the patient. These factors include drastic changes in diet, e.g. from a carnivore to a vegetarian diet, or a massive ingestion of alkalising gastric buffers. Also, urine pH may be elevated by states of renal tubulary acidosis (RTA) or severe infections of the urinary tract with Proteus bacteria.
In most clinical trials, patients with recent myocardial infarction, uncompensated congestive heart failure (NYHA III-IV), or uncontrolled hypertension were excluded. As a consequence, only limited data are available and patients with these conditions should be closely supervised.
Excipients: the oral solution contains sorbitol. Patients with rare hereditary problems of fructose intolerance should not take this medicine
4.5. Interaction with other medicinal products and other forms of interaction
Due to the pharmacological effects and the mechanism of action of memantine the following interactions may occur:
• The mode of action suggests that the effects of L-dopa, dopaminergic agonists, and anticholinergics may be enhanced by concomitant treatment with NMDA-antagonists such as memantine. The effects of barbiturates and neuroleptics may be reduced. Concomitant administration of memantine with the antispasmodic agents, dantrolene or baclofen, can modify their effects and a dose adjustment may be necessary.
• Concomitant use of memantine and amantadine should be avoided, owing to the risk of pharmacotoxic psychosis. Both compounds are chemically related NMDA-antagonists. The same may be true for ketamine and dextromethorphan (see also section 4.4). There is one published case report on a possible risk also for the combination of memantine and phenytoin.
• Other active substances such as cimetidine, ranitidine, procainamide, quinidine, quinine and nicotine that use the same renal cationic transport system as amantadine may also possibly interact with memantine leading to a potential risk of increased plasma levels.
• There may be a possibility of reduced serum level of hydrochlorothiazide (HCT) when memantine is co-administered with HCT or any combination with HCT.
• In post-marketing experience, isolated cases with international normalized ratio (INR) increases have been reported in patients concomitantly treated with warfarin. Although no causal relationship has been established, close monitoring of prothrombin time or INR is advisable for patients concomitantly treated with oral anticoagulants.
In single-dose pharmacokinetic (PK) studies in young healthy subjects, no relevant active substance-active substance interaction of memantine with glyburide/metformin or donepezil was observed.
In a clinical study in young healthy subjects, no relevant effect of memantine on the pharmacokinetics of galantamine was observed.
Memantine did not inhibit CYP 1A2, 2A6, 2C9, 2D6, 2E1, 3A, flavin containing monooxygenase, epoxide hydrolase or sulphation in vitro.
4.6. Pregnancy and lactation
For memantine, no clinical data on exposed pregnancies are available. Animal studies indicate a potential for reducing intrauterine growth at exposure levels, which are identical or slightly higher than at human exposure (see section 5.3). The potential risk for humans is unknown. Memantine should not be used during pregnancy unless clearly necessary.
It is not known whether memantine is excreted in human breast milk but, taking into consideration the lipophilicity of the substance, this probably occurs. Women taking memantine should not breast-feed.
4.7. Effects on ability to drive and use machines
Moderate to severe Alzheimer's disease usually causes impairment of driving performance and compromises the ability to use machinery. Memantine oral solution has minor to moderate influence on the ability to drive and use machines such that outpatients should be warned to take special care.
4.8. Undesirable effects
In clinical trials in mild to severe dementia, involving 1,784 patients treated with memantine and 1,595 patients treated with placebo, the overall incidence rate of adverse reactions with memantine did not differ from those with placebo; the adverse reactions were usually mild to moderate in severity. The most frequently occurring adverse reactions with a higher incidence in the memantine group than in the placebo group were dizziness (6.3% vs 5.6%, respectively), headache (5.2% vs 3.9%), constipation (4.6% vs 2.6%), somnolence (3.4% vs 2.2%) and hypertension (4.1% vs 2.8%).
The following Adverse Reactions listed in the Table below have been accumulated in clinical studies with memantine and since its introduction in the market. Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Adverse reactions are ranked according to system organ class, using the following convention: very common (≥1/10), common (≥1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥1/10,000 to <1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data).
Infections and infestations
Uncommon
Fungal infections
Immune system disorders
Common
Drug hypersensitivity
Psychiatric disorders
Common
Uncommon
Uncommon
Not known
Somnolence
Confusion
Hallucinations1
Psychotic reactions2
Nervous system disorders
Common
Dizziness
Common
Balance disorders
Uncommon
Gait abnormal
Very rare
Seizures
Cardiac disorders
Uncommon
Cardiac failure
Vascular disorders
Common
Hypertension
Uncommon
Venous thrombosis/thromboembolism
Respiratory, thoracic and mediastinal disorders
Common
Dyspnoea
Gastrointestinal disorders
Common
Constipation
Uncommon
Vomiting
Not known
Pancreatitis2
Hepatobiliary disorders
Common
Elevated liver function test
Not known
Hepatits
General disorders and administration site conditions
Common
Headache
Uncommon
Fatigue
1Hallucinations have mainly been observed in patients with severe Alzheimer's disease.
2Isolated cases reported in post-marketing experience.
Alzheimer's disease has been associated with depression, suicidal ideation and suicide. In post-marketing experience these events have been reported in patients treated with memantine.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme. Website: www.mhra.gov.uk/yellowcard
4.9. Overdose
Only limited experience with overdose is available from clinical studies and post-marketing experience.
Symptoms: Relative large overdoses (200 mg and 105 mg/day for 3 days, respectively) have been associated with either only symptoms of tiredness, weakness and/or diarrhoea or no symptoms. In the overdose cases below 140 mg or unknown dose the patients revealed symptoms from central nervous system (confusion, drowsiness, somnolence, vertigo, agitation, aggression, hallucination, and gait disturbance) and/or of gastrointestinal origin (vomiting and diarrhoea).
In the most extreme case of overdose, the patient survived the oral intake of a total of 2000 mg memantine with effects on the central nervous system (coma for 10 days, and later diplopia and agitation). The patient received symptomatic treatment and plasmapheresis. The patient recovered without permanent sequelae.
In another case of a large overdose, the patient also survived and recovered. The patient had received 400 mg memantine orally. The patient experienced central nervous system symptoms such as restlessness, psychosis, visual hallucinations, proconvulsiveness, somnolence, stupor, and unconsciousness.
Treatment: In the event of overdose, treatment should be symptomatic. No specific antidote for intoxication or overdose is available. Standard clinical procedures to remove active substance material, e.g. gastric lavage, carbo medicinalis (interruption of potential entero-hepatic recirculation), acidification of urine, forced diuresis should be used as appropriate.
In case of signs and symptoms of general central nervous system (CNS) overstimulation, careful symptomatic clinical treatment should be considered.
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Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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