Package Insert: Information for the User

Axura 10 mg Film-Coated Tablets

Memantine Hydrochloride

Read this package insert carefully before starting to take the medication as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.

• This medication has been prescribed only for you, and you should not give it to others who may have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

How Axura works

Axura contains the active ingredient memantine hydrochloride.

Axura belongs to a group of medications known as dementia medications.

Memory loss in Alzheimer's disease is due to an alteration in brain signals. The brain contains called N-methyl-D-aspartate (NMDA) receptors that participate in the transmission of important nerve signals in learning and memory. Axura belongs to the group of medications called NMDA receptor antagonists. Axura acts on these receptors by improving the transmission of nerve signals and memory.

When is Axura used

Axura is used in the treatment of patients with moderate to severe Alzheimer's disease.

Do not take Axura

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

Warnings and precautions

• Consult your doctor or pharmacist before starting to take Axura
• if you have a history of epileptic seizures (convulsions)
• if you have recently had a myocardial infarction (heart attack), if you suffer from congestive heart failure or if you have uncontrolled hypertension (high blood pressure).

In the above situations, treatment must be closely monitored and your doctor must regularly reevaluate the clinical benefit of Axura.

If you have renal insufficiency (kidney problems), your doctor must closely monitor renal function and, if necessary, adjust the memantine dose.

Memantine should be avoided when used with other medications such as amantadine (for Parkinson's treatment), ketamine (a medication generally used for anesthesia), dextromethorphan (a medication for cough treatment) and other NMDA antagonists.

Children and adolescents

Axura is not recommended for use in children and adolescents under 18 years old.

Taking Axura with other medications

Inform your doctor or pharmacist if you are using, have recently used or may need to use any other medication.

Specifically, the administration of Axura may produce changes in the effects of the following medications, so your doctor may need to adjust the doses:

• 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 spasms)
• anticonvulsants (substances used to prevent and eliminate seizures)
• barbiturates (substances generally used to induce sleep)
• dopamine agonists (substances like L-dopa, bromocriptine)
• neuroleptics (substances used in the treatment of mental illnesses)
• oral anticoagulants

If you are admitted to a hospital, inform your doctor that you are taking Axura.

Taking Axura with food and drinks

You should inform your doctor if you have recently changed or intend to change your diet significantly (for example from a normal diet to a strict vegetarian diet) or if you have acidosis tubular renal (ATR, excess of acid-producing substances in the blood due to renal dysfunction [kidney problem]) or severe urinary tract infections, as your doctor may need to adjust the medication dose.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

Memantine is not recommended for use in pregnant women.

Breastfeeding

Women taking Axura should discontinue breastfeeding.

Driving and operating machinery

Your doctor will inform you if your condition allows you to drive and use machinery safely. Additionally, Axura may alter your reaction time, making driving or operating machinery unsuitable.

Axura contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is practically "sodium-free".

Follow exactly the administration instructions of this medication as indicated by your doctor. If in doubt, ask your doctor or pharmacist.

Dosage

The recommended dose of Axura in adult patients and elderly patients is 20 mg administered once a day. To reduce the risk of adverse effects, this dose is achieved gradually following the daily schedule below:

The normal starting dose is half a tablet once a day (1 x 5 mg) in the first week. It is increased to one tablet a day (1 x 10 mg) in the second week and to one and a half tablets once a day in the third week. From the fourth week onwards, the normal dose is two tablets administered once a day (1 x 20 mg).

Dosage for patients with renal insufficiency

If you have kidney problems, your doctor will decide on the appropriate dose for your condition. In this case, your doctor must monitor your renal function periodically.

Administration

Axura must be administered orally once a day. To get the most out of your medication, you should take it every day and at the same time. The tablets should be swallowed with a little water. The tablets can be taken with or without food.

Treatment duration

Continue taking Axura as long as it is beneficial for you. Your doctor should evaluate the effects of your treatment periodically.

If you take more Axura than you should

• Generally, taking an excessive amount of Axura should not cause you any harm. You may experience an increase in the symptoms described in section 4 “Possible adverse effects”.
• If you take an overdose of Axura, contact your doctor or seek medical advice, as you may need medical attention.

If you forget to take Axura

• If you realize you have forgotten to take your Axura dose, wait and take the next dose at the usual time.

• Do not take a double dose to compensate for the missed dose.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people may experience them.

Adverse effects are generally classified as mild to moderate.

Frequent (may affect up to 1 in 10 people):

• Headache, drowsiness, constipation, elevated liver function tests, dizziness, balance disorder, shortness of breath, high blood pressure, and hypersensitivity to the medication

Poorly Frequent (may affect up to 1 in 100 people):

• Fatigue, fungal infections, confusion, hallucinations, vomiting, gait disturbance, heart failure, and formation of blood clots in the venous system (venous thrombosis/thromboembolism)

Very Rare (may affect up to 1 in 10,000 people):

• Seizures

Unknown Frequency (frequency cannot be estimated from available data):

• Pancreatitis, hepatitis (liver inflammation), and psychotic reactions

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

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the national notification system included in theAnexo V. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep out of sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging and in the blister after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medicines at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medicines. By doing so, you will help protect the environment.

Composition of Axura

The active ingredient is memantine hydrochloride.

Each pump of the dosifier releases 0.5 ml of solution containing 5 mg of memantine hydrochloride, equivalent to 4.16 mg of memantine.

The other components are potassium sorbate, sorbitol E 420, and purified water.

Appearance of the product and contents of the package

Axura, oral solution, is a transparent, colorless to slightly yellowish solution.

Axura, oral solution, is available in 50 ml, 100 ml, or a multiple pack with 500 ml (10 x 50 ml).

Only some package sizes may be marketed.

Marketing Authorization Holder

Merz Pharmaceuticals GmbH

Eckenheimer Landstr. 100

D-60318 Frankfurt/Main

Germany

Responsible for manufacturing

Merz Pharma GmbH + Co. KGaA

Eckenheimer Landstr. 100

D-60318 Frankfurt/Main

Germany

For more information about this medicinal product, please contact the local representative of the marketing authorization holder.

Last update of this leaflet: (MM/YYYY).

For detailed information on this medicinal product, please visit the website of the European Medicines Agency:http://www.ema.europa.eu.

Instructions for the correct use of the dosifier

The solution must not be poured or dispensed directly into the mouth from the bottle or dosifier. Measure the dose in a spoon or in a glass of water using the dosifier.

Removing the cap from the bottle:

The cap must be turned in the opposite direction to the clock, unscrewed completely, and removed (fig. 1).

Mounting the dosifier on the bottle:

Remove the dosifier from the plastic bag (fig. 2) and place it on top of the bottle. Carefully insert the plastic tube into the bottle. Hold the dosifier on the bottle neck and turn it clockwise until it is securely attached (fig. 3). The dosifier should only be screwed on once at the start of use and should never be unscrewed.

How the dosifier works:

• Turn the dosifier head in the opposite direction to the clock to open
• Turn the dosifier head in the direction of the clock to close.

The dosifier head should not be pressed down while it is in the closed position. The solution can only be dispensed in the open position. To open, turn the dosifier head in the direction indicated by the arrow until it cannot be turned any further (about one-eighth of a turn, fig. 4). The dosifier is then ready for use.

Preparing the dosifier.

When used for the first time, the dosifier does not dispense the correct amount of oral solution. Therefore, it must be prepared (primed) by pressing the dosifier head down completely five times in a row (fig. 5).

The solution dispensed in this way should be discarded. The next time the dosifier head is pressed down completely (equivalent to one press), it will already dispense the correct dose (fig. 6)

Correct use of the dosifier.

Place the bottle on a flat, horizontal surface, for example on a table, and it should only be used in an upright position. Place a glass with a little water or a spoon under the nozzle. Press the dosifier head down firmly but calmly and sustainably-not too slowly (fig. 7, fig. 8).

The head can then be released and is ready for the next press.

The dosifier should only be used with Axura solution in the provided bottle, not for other products or containers. If the dosifier does not work correctly, consult your doctor or pharmacist. Close the dosifier after using Axura.