Memantine hydrochloride 20 mg film-coated tablets

• 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.

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

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

Memantine is used for the treatment of patients with moderate to severe Alzheimer's disease.

• if you are allergic to memantine hydrochloride or any of the other ingredients of this medicine (listed in section 6).

Talk to your doctor or pharmacist before taking Memantine

Take special care with Memantine:

• 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 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.

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.

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

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

Memantine 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.

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.

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 should not breast-feed.

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

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

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

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.

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.

Memantine 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.

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

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

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

• The active substance is memantine hydrochloride. Each film-coated tablet contains 20 mg of memantine hydrochloride equivalent to 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.

Memantine 20 mg film-coated 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 film-coated tablets are available in blister packs of:

blisters containing 10, 14, 20, 28, 30, 42, 50, 56, 60, 90,98,100, 112 or 120 tablets and a Unit dose blister containing 30x1 tablet

Not all pack sizes may be marketed.

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