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MEMANTINE 5 MG 10 MG 15 MG 20 MG FILM-COATED TABLETS

Active substance(s): MEMANTINE HYDROCHLORIDE

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Package leaflet: Information for the user
Memantine Amneal 5 mg film-coated tablets
Memantine Amneal 10 mg film-coated tablets
Memantine Amneal 15 mg film-coated tablets
Memantine Amneal 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, pharmacist or nurse.
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, pharmacist or nurse. This includes any
possible side effects not listed in this leaflet.

What is in this leaflet:
1.
What Memantine Amneal is and what it is used for
2.
What you need to know before you take Memantine Amneal
3.
How to take Memantine Amneal
4.
Possible side effects
5.
How to store Memantine Amneal tablets
6.
Contents of the pack and other information

1. What Memantine Amneal is and what it is used for
How does Memantine Amneal work
Memantine Amneal 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 Amneal belongs to a
group of medicines called NMDA-receptor antagonists. Memantine Amneal acts on these
NMDA-receptors improving the transmission of nerve signals and the memory.
What is Memantine Amneal used for
Memantine Amneal is used for the treatment of patients with moderate to severe Alzheimer’s
disease.
2. What you need to know before you take Memantine Amneal
Do not take Memantine Amneal
- 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, pharmacist or nurse before taking Memantine Amneal :
- 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 Amneal 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.

Memantine Amneal is not recommended for children and adolescents under the age of 18 years.
Other medicines and Memantine Amneal
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
In particular, Memantine Amneal 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 Amneal.
Memantine Amneal 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 (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. The use of memantine in
pregnant women is not recommended.
Women taking Memantine Amneal 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 Amneal may change your reactivity, making driving or operating machinery
inappropriate.
3. How to take Memantine Amneal
The Memantine Amneal treatment initiation pack is only to be used for the beginning of the
treatment with Memantine. Amneal
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your
doctor or pharmacist if you are not sure.
Dosage
The recommended treatment dose of 20 mg per day is achieved by a gradual increase of the
Memantine Amneal dose during the first 3 weeks of treatment. The treatment scheme is also
indicated on the treatment initiation pack. Take one tablet once a day.
Week 1 (day 1-7):
Take one 5 mg tablet once a day for 7 days.
Week 2 (day 8-14):
Take one 10 mg tablet once a day for 7 days.
Week 3 (day 15-21):
Take one 15 mg tablet once a day for 7 days.
Week 4 (day 22-28):
Take one 20 mg tablet once a day 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 a day
Maintenance dose
The recommended daily dose is 20 mg once a day.
For continuation of the treatment please consult your doctor.
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.

Memantine Amneal is not recommended for children and adolescents under the age of 18 years.
Administration
Memantine Amneal 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 Amneal as long as it is of benefit to you. Your doctor should assess
your treatment on a regular basis.
If you take more Memantine Amneal than you should
- In general, taking too much Memantine Amneal 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 Amneal, contact your doctor or get medical advice,
as you may need medical attention.
If you forget to take Memantine Amneal
- If you find you have forgotten to take your dose of Memantine Amneal, 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, pharmacist or
nurse.
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 Amneal.
If you get any side effects, talk to your doctor, pharmacist or nurse. 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, 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 at: 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 Memantine Amneal
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
The active substance is memantine hydrochloride. Each tablet contains 5 mg/10 mg/15 mg/20 mg
of memantine hydrochloride equivalent to 4.15 mg/8.31 mg/12.46 mg/16.62 mg memantine.
The other ingredients are:
Tablet core: Silica colloidal anhydrous, cellulose, microcrystalline, silicified microcrystalline
cellulose, sodium starch glycolate, talc, sodium stearyl fumarate.
Tablet film-coat: Hypromellose, macrogol 6000, talc, titanium dioxide (E 171), iron oxide yellow
(E 172) for 15 mg & 20 mg, iron oxide red (E 172) for 15 mg & 20 mg, iron oxide black (E 172)
for 15 mg.
What Memantine Amneal looks like and contents of the pack
Film-coated tablet.
Memantine Amneal 5 mg film-coated tablets:
White to off-white, modified caplet, film-coated tablets debossed with 'Z' on one side and' '01' on
other side.

Memantine Amneal 10 mg film-coated tablets:
White to off-white, centrally tapered oblong, biconvex, film-coated tablets with a single break
line on both sides and debossed with 'Z' and '03' on either side of break line on one side and plain
on other side. The tablet can be divided in equal doses.
Memantine Amneal 15 mg film-coated tablet:
Orange to grey-orange, oval oblong, film-coated tablets debossed with 'Z' on one side and '04' on
other side.
Memantine Amneal 20 mg film-coated tablets:
Pale-red to grey-red, oval oblong, film-coated tablets debossed with 'Z' on one side arid '06' on
other side.
Memantine Amneal tablets are available in clear PVC/PE/PVDC/Aluminium lidding foil blisters.
Initiation pack:
One treatment initiation pack contains 28 tablets in 4 blisters with 7 tablets of Memantine
Amneal 5 mg, 7 tablets of Memantine Amneal 10 mg, 7 tablets of Memantine Amneal 15 mg and
7 tablets of Memantine Amneal 20 mg.

Marketing Authorisation Holder

Amneal Pharma Europe Limited
70 Sir John Rogerson’s Quay,
Dublin 2,
Ireland.
Manufacturer
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate,
Hal Far, Birzebbugia, BBG 3000
Malta
This leaflet was last revised in 08.2014

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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