Patient leaflet - Memantine Accord 5 mg / 10 mg / 15 mg / 20 mg film-coated tablets

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

How does Memantine Accord work

Memantine Accord contains the active substance memantine hydrochloride.

Memantine Accord 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 Accord belongs to a group of medicines called NMDA-receptor antagonists. Memantine Accord acts on these NMDA-receptors improving the transmission of nerve signals and the memory.

What is Memantine Accord used for

Memantine Accordis used for the treatment of patients with moderate to severe Alzheimer’s disease.

2. What you need to know before you take Memantine Accord

Do not take Memantine Accord:

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 or pharmacist before taking Memantine Accord

if you have a history of epileptic seizures
if you have recently experienced a myocardial infarction (heart attack), or if you are suffering rom 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

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

Other medicines and Memantine Accord

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

In particular, Memantine Accord 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 Accord.

Memantine Accord 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.

Pregnancy

The use of memantine in pregnant women is not recommended.

Breast-Feeding

Women taking Memantine Accord 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 Accord may change your reactivity, making driving or operating machinery inappropriate.

Memantine Accord contains lactose

This medicinal product contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, please contact your doctor before taking this medicinal product. Your doctor will advise you.

3. How to take Memantine Accord

The Memantine Accord treatment initiation pack is only to be used for the beginning of the treatment with Memantine Accord.

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 treatment dose of 20 mg per day is achieved by a gradual increase of the Memantine Accord 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 (white) for 7 days.

Week 2 (day 8-14):

Take one 10 mg tablet once a day (white, scored) for 7 days.

Week 3 (day 15-21):

Take one 15 mg tablet once a day (orange to grey-orange) for 7 days.

Week 4 (day 22-28):

Take one 20 mg tablet per day (pale red to greyred, scored) for 7 days.

week 1	5 mg tablet
week 2	10 mg tablet
week 3	15 mg tablet
week 4 and beyond	20 mg tablets 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.

Administration

Memantine Accord 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 a little water. The tablets can be taken with or without food.

Duration of treatment

Continue to take Memantine Accord as long as it is of benefit to you. Your doctor should assess your treatment on a regular basis.

If you take more Memantine Accord than you should

In general, taking too much Memantine Accord 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 Accord, contact your doctor or get medical advice, as you may need medical attention.

If you forget to take Memantine Accord

If you find you have forgotten to take your dose of Memantine Accord, 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 test, 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 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.

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 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 Accord

Keep this medicine out of the sight and reach of children.

Do not use Memantine Accord 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 Accord contains

The active substance is memantine hydrochloride. Each film-coated tablet contains 5/10/15/20 mg of memantine hydrochloride equivalent to 4.15/8.31/12.46/16.62 mg memantine
The other ingredients are lactose monohydrate, microcrystalline cellulose, colloidal anhydrous silica, crospovidone, magnesium stearate, all in the tablet core; hypromellose, polysorbate 80, macrogol 400, titanium dioxide (E 171), and additional for Memantine Accord 15 mg and Memantine Accord 20 mg film-coated tablets iron oxide yellow and red (E 172), all in the tablet coating

What Memantine Accord looks like and contents of the pack

Memantine Accord 5 mg film-coated tablets are presented as white, oblong, coated tablet, debossed with “MT” on one side and “5” on the other side.

Memantine Accord 10 mg film-coated tablets are presented as white, oblong, coated and scored tablet, debossed with “MT” divided by the score on one side and “10” divided by the score on the other side. The tablet can be divided into equal doses.

Memantine Accord 15 mg film-coated tablets are presented as orange to grey-orange, oblong, coated tablet, debossed with “MT” on one side and “15” on the other side.

Memantine Accord 20 mg film-coated tablets are presented as pale red to greyred, oblong, coated and scored tablet, debossed with “MT” divided by the score on one side and “20” divided by the score on the other side. The tablet can be divided into equal doses.

One treatment initiation pack contains 28 tablets in 4 blisters with 7 tablets of Memantine Accord 5 mg, 7 tablets of Memantine Accord 10 mg, 7 tablets of Memantine Accord 15 mg and 7 tablets of Memantine Accord 20 mg.

Marketing Authorisation Holder

Accord Healthcare Limited

Sage House, 319 Pinner Road

North Harrow, Middlesex, HA1 4HF

United Kingdom

Manufacturer