Patient leaflet - Memantine Hydrochloride 10 mg film-coated tablets

1. What Memantine Hydrochloride is and what it is used for

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. 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

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 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).

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 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 Hydrochloride is not recommended for children and adolescents under the age of 18 years.

Other medicines and Memantine Hydrochloride

Tell your doctor or pharmacist if you are taking, have 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 hydrochlorothiazide)
anticholinergics (substances generally used to treat movement disorders or instestinal 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 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), 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 Hydrochloride 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 Hydrochloride may change your reactivity, making driving or operating machinery inappropriate.

Memantine Hydrochloride contains Lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Memantine Hydrochloride 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 Hydrochloride

Always take Memantine Hydrochloride exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

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:

Week 1	half a 10 mg tablet
Week 2	one 10 mg tablet
Week 3	one and a half 10 mg tablets
Week 4 and beyond	two 10 mg tablets once a day

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.
XXXXXXXXXXX The usual starting dose is half a tablet once a day (1x 5mg) for the first week. This is increased to one tablet once a day (1x10 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 (1x 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 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 (affects 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 (affects 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 (affects 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 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

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 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(s) is memantine hydrochloride. Each film-coated tablet contains 10 mg memantine hydrochloride equivalent to 8.31 mg memantine
The other ingredients are microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate, in the tablet core; and hypromellose, titanium dioxide, lactose monohydrate, macrogol, triacetin, in the tablet coating.

What Memantine Hydrochloride looks like and contents of the pack

Memantine Hydrochloride 10 mg film-coated tablets are presented as white to off-white, oval-oblong shaped film-coated tablet with breaking lines on both sides and imprint “M” & “2” on one side. The tablet can be divided into equal doses.

Memantine Hydrochloride 10 mg film-coated tablets are available in blister packs of 28 tablets, 56 tablets or 112 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Perennial Pharma Ltd

Titan Court, 2nd Floor,

3 Bishop Square,

Hatfield,

AL10 9NA

United Kingdom

Manufacturer

GMP Manufacturing Ltd.

Park Royal House and Marfleet House,

Valletta Street,

Hull,

HU9 5NP,