EZEMANTIS 10 mg, tabletten

How does EZEMANTIS work

EZEMANTIS 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.

issue date: 05-09-13

version: M1.3.1_03.MMN.hcl.tab.101.03.nl.2699.01 approved: CHo

Common Technical Document

Memantine HCl

Film-coated tablets

Module 1 - Section 3.1 SPC, Labelling
and Package Leaflet	page 2/9

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

What is EZEMANTIS used for

EZEMANTIS is used for the treatment of patients with moderate to severe Alzheimer’s disease.

Do not take EZEMANTIS

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 EZEMANTIS

Take special care with EZEMANTIS:

• 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 EZEMANTIS 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 EZEMANTIS 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.

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.

issue date: 05-09-13

version: M1.3.1_03.MMN.hcl.tab.101.03.nl.2699.01 approved: CHo

Common Technical Document

Memantine HCl

Film-coated tablets

Module 1 - Section 3.1 SPC, Labelling
and Package Leaflet	page 3/9

Children and adolescents

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

Other medicines and EZEMANTIS

EZEMANTIS 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

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

If you go into hospital, let your doctor know that you are taking EZEMANTIS.

<Memantime> with food and drink

Food does not influence the effect of EZEMANTIS.

Pregnancy and breast-feeding

The use of EZEMANTIS in pregnant women is not recommended. Women taking EZEMANTIS should not breast-feed.

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.

Driving and using machines

issue date: 05-09-13

version: M1.3.1_03.MMN.hcl.tab.101.03.nl.2699.01 approved: CHo

Common Technical Document

Memantine HCl

Film-coated tablets

Module 1 - Section 3.1 SPC, Labelling
and Package Leaflet	page 4/9

Your doctor will tell you whether your illness allows you to drive and to use machines safely. Moreover, EZEMANTIS may change your reactivity, making driving or operating machinery inappropriate.

EZEMANTIS 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.

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

<10 mg>

The recommended dose of EZEMANTIS for adults and elderly patients 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 tablet
week 4 and beyond	two 10 mg tablets once a day

The recommended dose can also be achieved by using a treatment initiation pack.

The usual starting dose is half a tablet once a day (1x 5 mg) for the first week. This is increased to one tablet once a day (1x 10 mg) in the second week and to 1 and a half tablet once a day in the third week. From the fourth week on, the usual dose is 2 tablets once a day (1x 20 mg).

<20 mg>

The recommended dose of EZEMANTIS for adults and elderly patients 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. For up-titration other tablet strengths are available.

At the beginning of treatment you will start by using EZEMANTIS 5 mg film-coated tablets once a day. This dose will be increased weekly by 5 mg until the recommended (maintenance) dose is reached. The recommended

issue date: 05-09-13

version: M1.3.1_03.MMN.hcl.tab.101.03.nl.2699.01 approved: CHo

Common Technical Document

Memantine HCl

Film-coated tablets

Module 1 - Section 3.1 SPC, Labelling
and Package Leaflet	page 5/9

maintenance dose is 20 mg once a day, which is reached at the beginning of the 4th week.

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.

<10 mg>

Breaking the tablet

Place the tablet with the round side on a hard surface, the score line should face upwards. Press with the forefinger and thumb of the same hand on either side of the score line and push down until the tablet breaks as shown in the illustration.

<20 mg>

Breaking the tablet

Place the tablet with the round side on a hard surface, the score line should face upwards. Press with the forefinger and thumb of the same hand on either side of the score line and push down until the tablet breaks as shown in the illustration.

Administration

EZEMANTIS 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

issue date: 05-09-13

version: M1.3.1_03.MMN.hcl.tab.101.03.nl.2699.01 approved: CHo

Common Technical Document

Memantine HCl

Film-coated tablets

Module 1 - Section 3.1 SPC, Labelling
and Package Leaflet	page 6/9
taken with or without food.
Duration of treatment

Continue to take EZEMANTIS as long as instructed by your doctor. He will assess your treatment on a regular basis.

If you take more EZEMANTIS than you should

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

If you forget to take EZEMANTIS

If you have forgotten to take your dose of EZEMANTIS, wait and take your next dose at the usual time.

Do not take a double dose to make up for the forgotten dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

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 • high blood pressure • shortness of breath • drug hypersensitivity

Uncommon (may affect up to 1 in 100 people)

Tiredness • fungal infections • confusion • hallucinations • vomiting • abnormal gait • heart failure • 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)

issue date: 05-09-13

version: M1.3.1_03.MMN.hcl.tab.101.03.nl.2699.01 approved: CHo

Common Technical Document

Memantine HCl

Film-coated tablets

Module 1 - Section 3.1 SPC, Labelling
and Package Leaflet	page 7/9

Inflammation of the pancreas • inflammation of the liver (hepatitis) • Psychotic reactions

Alzheimer's disease has been associated with depression, suicidal thoughts and suicide. These events have been reported in patients treated with EZEMANTIS.

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 Nederlands Bijwerkingen Centrum Lareb Website: www.lareb.nl. By reporting side effects you can help provide more information on the safety of this medicine.

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 blister and carton after ‘EXP’. The first two digits indicate the month and the last four digits indicate the year. 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.

• • The active substance is memantine hydrochloride. Each tablet contains 10 20 mg of memantine hydrochloride equivalent to 8.31 16.62 mg memantine.
  • The other ingredients are lactose monohydrate, microcrystalline cellulose, colloidal anhydrous silica, talc and magnesium stearate, all in the tablet core; and lactose monohydrate, hypromellose, titanium dioxide (E171), iron oxide yellow (E172), iron oxide red (E172) and macrogol 4000, all in the tablet coating.

issue date: 05-09-13

version: M1.3.1_03.MMN.hcl.tab.101.03.nl.2699.01 approved: CHo

Common Technical Document

Memantine HCl

Film-coated tablets

Module 1 - Section 3.1 SPC, Labelling
and Package Leaflet	page 8/9

What EZEMANTIS looks like and contents of the pack

<10 mg>

Memantine 10 mg tablets are presented as white, round, biconvex tablets (8 mm) with a score line on one side and debossed with ‘M9MN’ and ‘10’ on the other side. The tablet can be divided into equal halves.

Memantine tablets are available in blister packs of: blisters containing 56 tablets

Not all pack sizes may be marketed. <20 mg>

Memantine 20 mg tablets are presented as pink, oval, biconvex tablets (13.5 x 6.6 mm) with a score line on one side and debossed with ‘M9MN 20’ on the other side. The tablet can be divided into equal halves.

Memantine tablets are available in blister packs of: blisters containing 28 tablets

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

FB Health SpA

Via dei Sabini 28, 63100 ASCOLI PISCENO

Italië

Manufacturer(s):

Synthon BV

Microweg 22

6545 CM Nijmegen

Nederland

Synthon Hispania S.L. Castelló, 1

Polígono Las Salinas

08830 Sant Boi de Llobregat Spanje

In het register ingeschreven onder:

RVG 112105

issue date: 05-09-13

version: M1.3.1_03.MMN.hcl.tab.101.03.nl.2699.01 approved: CHo

Common Technical Document

Memantine HCl

Film-coated tablets

Module 1 - Section 3.1 SPC, Labelling
and Package Leaflet	page 9/9

RVG 112106

This medicinal product is authorised in the Member States of the EEA under the following names:

<{Name of the Member State}> <{Name of the medicinal product}> <{Name of the Member State}> <{Name of the medicinal product}> <…>

Deze bijsluiter is voor het laatst goedgekeurd in oktober 2013.

issue date: 05-09-13

version: M1.3.1_03.MMN.hcl.tab.101.03.nl.2699.01 approved: CHo