The active ingredient is memantin hydrochloride.

Other ingredients contained in the tablet are: lactose monohydrate, microcristalline cellulose, colloidal silicium dioxide, talc and magnesium stearate; and in the coating are: methacryl acid - ethyl acrylate copolymer (1:1), sodium dodecyl sulphate, polysorbate 80, talc, triacetin and simethicone emulsion.

What is AXURA and what are the indications for its Use? What is AXURA?

AXURA tablets are white to shaded white long coated tablets with notches on both top and bottom. Each tablet contains 10 mgs of memantin hydrochloride.
AXURA tablets are available in blister packages of 50 or 100 tablets.

What are indications for the use of AXURA?

AXURA is to be used for treating patients with moderately severe to severe Alzheimer's disease.
Memory loss associated with Alzheimer's is caused by a disruption in the transmission of brain signals. So-called NMDA receptors in the brain assist in transmission of nerve signals essential to learning and memory functions. AXURA belongs to a group of medications called NMDA receptor antagonists. AXURA stimulates these NMDA receptors and improves transmission of nerve signals and thereby the memory.

What should you consider before taking AXURA?

Prior to taking AXURA, it is important that you carefully read the following paragraphs and discuss any questions you may have with your doctor. You may wish to go through all the details you would like to discuss first with your carer.

AXURA must not be taken:

If you have had allergic reactions to memantin hydrochloride or any of the other ingredients of AXURA tablets listed above.

Particular caution is required when taking AXURA:

If you have a history of epileptic seizures
If you have recently suffered a myocardial infarction (heart attack) or if you suffer from under-compensated cardiac insufficiency or untreated high blood pressure.
Under these circumstances treatment must be carefully monitored and the clinical use of AXURA regularly re-evaluated by your doctor.
If you suffer from moderately severe kidney dysfunction, your doctor should carefully monitor your kidney function and adapt the memantin dosage appropriately. The use of memantin is not recommended for patients with severe kidney dysfunction.
Simultaneous use of medications with active ingredients such as amantadine, ketamine, dextromethorphane as well as other NMDA antagonists should be avoided.
The use of AXURA is not recommended for children or anyone under the age of 18.

Taking AXURA with food and drink

Please inform your doctor if you have recently undergone major dietary changes (for example from a normal diet to a strictly vegetarian diet) or if you intend to do so, if you suffer from renal tubular acidosis (RTA - an excess of acid forming substances in the blood due to kidney dysfunction) or a severe infection of the urinary tract. Your doctor may need to adjust the dosage of your medication in such circumstances.

Pregnancy

Tell your doctor if you are pregnant or wish to become pregnant. The use of memantin is not recommended during pregnancy.

Breast-feeding

Women must not breast-feed while taking AXURA.

Operating vehicles or machinery:

Your doctor will advise you whether your condition allows you to drive or operate machinery without danger to yourself or others.
Moreover, taking AXURA may alter your reaction time significantly, so that safe driving and safe operation of machinery may no longer be possible.

Interaction with other medications

Please inform your doctor or pharmacist if you are taking other medications or have done so until recently, even if these are not prescription medicines.
The following medications specifically may be affected by taking AXURA and necessitate an adjustment to your dosage by your doctor:
Amantadine, ketamine, dextromethorphane
Dantrolen, baclofen
Cimetidine, ranitidine, procainamide, quinidine, quinine, nicotine
Hydrochlorothiazide (or combined preparations containing hydrochlorothiazide)
Anticholinergics (substances normally prescribed to treat motor dysfunction or enterospasm)
Anticonvulsives (substances used to prevent or treat cramping)
Barbiturates (substances normally used to induce sleep)
Dopaminergic antagonists (substances such as L-dopa and bromocriptine)
Neuroleptics (substances that treat mental dysfunction)
If you are admitted to hospital, inform the hospital doctor that you are taking AXURA.

How should AXURA be taken?

Always follow your doctor's instructions when taking AXURA. You should take the medication regularly on a daily basis for optimum effect. Please ask your doctor or pharmacist if you have any doubts.

Dosage

The recommended AXURA dose for adults and older patients is 20 mgs (2 x 1 tablet) every day. In order to lower the risk of side effects, this dose should be introduced gradually according to the following daily treatment plan:

The usual starting dose consists of half a tablet (1 x 5mgs) once a day during the first week. This dose is increased to a half a tablet twice a day (2 x 5 mgs) in the second week and to one tablet (1 x 10mgs) and a half tablet (1 x 5mgs) daily at different times during the third week. Starting in the fourth week the normal dose will be one tablet twice a day (2 x 10mgs).
Dosage for patients with decreased kidney function
If you suffer from kidney dysfunction, your doctor must decide what dosage is appropriate for your disease. In this case, kidney function should be monitored by your doctor at regular intervals.
Instructions for use
AXURA should be taken orally twice a day (except for the first week of treatment). Tablets should be swallowed with water. The tablets may be taken with or without food.
Duration of treatment
Continue taking AXURA as long as the medication helps and you are not experiencing any unacceptable side effects. Treatment should be regularly assessed by a doctor.

If you have taken a larger dose of AXURA than required:

In general, taking more AXURA than prescribed should not have any adverse effects. It is possible that you may experience a more severe form of the symptoms detailed in paragraph 4 - "What are the potential side effects?"
If you have taken a large overdose of AXURA, consult your doctor or seek other medical advice, as you may require medical treatment.

If you have forgotten to take AXURA:

If you realize that you have forgotten to take your dose of AXURA, wait and take your next dose at the usual time.
Do not double your dose to compensate for the missed dose.

What are the potential side effects?

As with all medications, AXURA can produce side effects.
In general, side effects have been observed to be weak or only moderately severe. Most frequent side effects (frequency of 2% or less) include hallucinations, confusion, dizziness, headache and fatigue. Occasional side effects include anxiety, hyper tonus (heightened muscle tension), vomiting, bladder infections and increased sexual drive.
If you have a history of epileptic seizures, there is a slight chance that AXURA may increase the probability of an attack.
Please inform your doctor or pharmacist should you experience side effects not included in this pamphlet.

How should AXURA be stored?

Keep medications out of the reach of children.
There are no specific storage instructions applicable to this medication.
Do not use this medication after the expiration date shown on the box and the blister package.