Memantine Hydrochloride Niche 10 mg film-coated tablets – patient leaflet, side effects, dosage

1.What Memantine hydrochloride Niche is and what it is used for

Memantine hydrochloride Niche

contains the active substance

memantine hydrochloride.

Memantine hydrochloride 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

Niche

Do not take Memantine hydrochloride Niche:

• 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

hydrochloride Niche if you:

• have a history of epileptic seizures

• 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 Niche 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 Niche

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

Other medicines and Memantine hydrochloride Niche

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. In particular, Memantine hydrochloride Niche 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 hydrochloride Niche. Memantine hydrochloride Niche 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 planing to have a baby, ask you doctor or pharmacist for advice before taking this medicine Pregnancy

The use of Memantine

hydrochloride Niche in pregnant women is not recommended. Breast-feeding

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

3.How to take Memantine hydrochloride Niche

Always take this medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The recommended treatment dose of 20 mg per day is achieved by a gradual increase of the Memantine hydrochloride Niche dose during the first 3 weeks of treatment. PACKAGE LEAFLET: INFORMATION FOR THE USER Memantine hydrochloride Niche 10 mg and 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. 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 10 mg tablet once a day (1x 5 mg) for the first week. This is increased to one 10 mg tablet once a day (1x 10 mg) in the second week and to one and a half 10 mg tablets (1 x 15 mg) once a day in the third week. From the fourth week on, the usual dose is two 10 mg tablets once a day (1x 20 mg) or one 20 mg tablet 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 Niche 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 Niche 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 Niche than you should

• In general, taking too much Memantine hydrochloride Niche should not result in any harm to you. You may experience increased symptoms as described in section

  1. 4. “Possible side effects”.
• If you take a large overdose of Memantine hydrochloride Niche, contact your doctor or get medical advice, as you may need medical attention.

If you forget to take Memantine hydrochloride Niche

• If you find you have forgotten to take your dose of Memantine hydrochloride Niche, 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 thoughts 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 information on the safety of this medicine.

5.How to store Memantine hydrochloride Niche

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.

Store below 25°C for the 10 mg tablet and store below 30°C for the 20 mg tablet.

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 to protect the environment.

6.Contents of the pack and other information

What Memantine hydrochloride Niche contains

The active substance is memantine hydrochloride. The 10 mg film-coated tablet contains 10 mg memantine hydrochloride

equivalent to 8.31 mg memantine. The 20 mg film-coated tablet contains 20 mg memantine hydrochloride equivalent to 16.62 mg memantine.

The other ingredients are

microcrystalline cellulose,

crospovidone, povidone K 29/32, colloidal anhydrous silica, purified talc and magnesium stearate, all in the tablet core; and hypromellose, macrogol 4000 and titanium dioxide (E171), all in the tablet coating. What Memantine hydrochloride Niche looks like and contents of the pack

The 10 mg film-coated tablets are presented as off white capsule shaped biconvex, film-coated tablets debossed with “M” and “10” on either side of the breakline on one side and breakline on the other side.

The 20 mg film-coated tablets are presented as off white oval shaped film-coated tablets with “U” debossed on one side and plain on the other side.

Memantine hydrochloride Niche 10 mg and 20 mg film-coated tablets are supplied in cartons containing 14, 28, 42, 56, 70, 84, 98 or 112 film-coated tablets in blisters of PVC/PE/PVdC and aluminium foil. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Niche Generics Limited, 1 The Cam Centre, Wilbury Way, Hitchin, Hertfordshire SG4 0TW, United Kingdom.

Manufacturer:

Niche Generics Ltd.

Unit 1, Waterloo Farm Courtyard, Stotfold Road,

Arlesey,

SG15 6XP,

United Kingdom.

This leaflet was last revised in February 2023