Patient leaflet - Memantine DR Reddys 20 mg film-coated tablets
1. What Memantine hydrochloride is and what it is used for
recently taken or might take any other medicines.
In particular, Memantine hydrochloride 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
Memantine hydrochloride 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 hydrochloride belongs to a group of medicines called NMDA-receptor antagonists.
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
Memantine hydrochloride acts on these
NMDA-receptors improving the transmission of nerve signals and the memory.
Memantine hydrochloride is used for the treatment of patients with moderate to severe Alzheimer’s disease.
2. What you need to know before you take Memantine hydrochloride
Do not take Memantine hydrochloride
mental disorders)
- oral anticoagulants.
If you go into hospital, let your doctor know that you are taking Memantine hydrochloride.
Memantine hydrochloride 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) or if you are suffering from states of renal tubulary acidosis
if you are allergic to memantine or any of the other
ingredients of this medicine (listed in section 6). Warnings and precautions
Talk to your doctor or pharmacist before taking Memantine hydrochloride
- 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).
(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
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.
In these situations the treatment should be carefully supervised, and the clinical benefit of Memantine hydrochloride 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 hydrochloride doses accordingly.
Pregnancy
The use of memantine hydrochloride in pregnant women is not recommended.
Breast-feeding
Women taking Memantine hydrochloride should not breast-feed.
Driving and using machines
Your doctor will tell you whether your illness allows you
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 hydrochloride is not recommended for children and adolescents under the age of 18 years.
to drive and to use machines safely. Also, Memantine hydrochloride may change your reactivity, making driving or operating machinery inappropriate.
3. How to take Memantine hydrochloride
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Dosage
The recommended dose of Memantine hydrochloride 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:
The usual starting dose is half a tablet once a day (1 x 5 mg) for the first week. This is increased to one tablet once a day (1 x 10 mg) in the second week and to 1 and a half tablets once a day in the third week. From the fourth week on, the usual dose is 2 tablets once a day (1 x 20 mg).
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. Administration
Memantine hydrochloride 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 tablets should be swallowed with some water. The tablets can be taken with or without food.
Duration of treatment
Continue to take Memantine hydrochloride as long as it is of benefit to you. Your doctor should assess your treatment on a regular basis.
If you take more Memantine hydrochloride than you should
In general, taking too much Memantine
hydrochloride 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
hydrochloride, contact your doctor or get medical advice, as you may need medical attention. If you forget to take Memantine hydrochloride
If you find you have forgotten to take your dose of
Memantine hydrochloride, 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 and drug hypersensitivity
Uncommon (may affect up to 1 in 100 people):
Tiredness, fungal infections, confusion,
hallucinations, vomiting, abnormal gait, heart failure and 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) 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
hydrochloride.
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 at:
www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more in formation on the safety of this medicine.
week 1
week 2
week 3
week 4
and beyond
half a 10 mg tablet
one 10 mg tablet
one and a half 10 mg tablets
two 10 mg tablets once a day
5. How to store Memantine hydrochloride
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 hydrochloride contains
The active substance is memantine hydrochloride. Memantine hydrochloride 10 mg film-coated tablets
contain 10 mg memantine hydrochloride equivalent to 8.31 mg memantine.
Memantine hydrochloride 20 mg film-coated tablets contain 20 mg memantine hydrochloride equivalent to 16.62 mg memantine.
The other ingredients are microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica and magnesium stearate, povidone (K-30), all in the tablet core; and hypromellose, macrogol 400, titanium dioxide
(E171) and iron oxide yellow (E172) and red iron oxide (only in 20 mg film-coated tablet), all in the tablet coating.
What Memantine hydrochloride tablets look like and contents of the pack
Memantine hydrochloride 10 mg film-coated tablets are pale yellow to yellow, oval shaped film-coated tablets with breaking line and engravings “1 0” on one side and “R R” on the other side.
The tablet can be divided into equal doses.
Memantine hydrochloride 20 mg film-coated tablets are pale red to grey red, oval shaped film-coated tablets with breaking line and engravings “2 0” on one side and “R R” on the other side.
The tablet can be divided into equal doses.
Memantine hydrochloride film-coated tablets are available in blister packs of 7, 28, 42, 56, 98 and 112 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Dr. Reddy’s Laboratories (UK) Ltd,
410 Cambridge Science Park, Milton Road, Cambridge, CB4 0PE, United Kingdom
This leaflet was last revised in 06/2022
PACKAGE LEAFLET: INFORMATION FOR THE USER Memantine hydrochloride 10 mg Film-Coated Tablets Memantine hydrochloride 20 mg Film-Coated Tablets
Memantine hydrochloride Read all of this leaflet carefully before you start taking this medicine because it contains important
information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs
of illness are the same as yours.
If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in
this leaflet. See section 4.
160 mm
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Submission
Implementation Date: xx xxx xxxx Brand:
Country:
Product Name:
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160 x 300 mm Cambridge Project:
DR Reddy’s
UK
Memantine Hydrochloride
10 mg
Film Coated Tablets
Leaflet
28s
xx xxx xxx
26 JUL 2022