Axura 5 mg/dose, oral solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Axura 5 mg/dose oral solution

Memantine hydrochloride

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Axura is and what it is used for

How Axura works

Axura contains the active substance memantine hydrochloride.

Axura belongs to a group of medicines known as anti-dementia drugs.

Memory loss in Alzheimer's disease is due to disturbances in brain signaling. The brain contains so-called N-methyl-D-aspartate (NMDA) receptors, which are involved in the transmission of nerve signals important for learning and memory. Axura belongs to a group of medicines called NMDA receptor antagonists. Axura acts on these receptors, improving nerve signal transmission and memory.

What Axura is used for

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

2. What you need to know before taking Axura

Do not take Axura

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

Warnings and precautions

Talk to 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 have congestive heart disease, or if you have uncontrolled hypertension (high blood pressure).

In the above situations, treatment must be carefully monitored and your doctor should regularly re-evaluate the clinical benefit of Axura.

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

The use of memantine should be avoided together with other medicines such as amantadine (used to treat Parkinson's disease), ketamine (a drug generally used to induce anesthesia), dextromethorphan (a cough medicine), and other NMDA antagonists.

Children and adolescents

The use of Axura is not recommended in children and adolescents under 18 years of age.

Taking Axura with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.

Specifically, the administration of Axura may cause changes in the effects of the following medicines, and it may be necessary for your doctor to adjust the dosage:

• amantadine, ketamine, dextromethorphan
• dantrolene, baclofen
• cimetidine, ranitidine, procainamide, quinidine, quinine, nicotine
• hydrochlorothiazide (or any combination containing hydrochlorothiazide)
• anticholinergics (substances generally used to treat movement disorders or intestinal spasms)
• anticonvulsants (substances used to prevent and control seizures)
• barbiturates (substances generally used to induce sleep)
• dopaminergic agonists (substances such as L-dopa, bromocriptine)
• neuroleptics (substances used in the treatment of mental illnesses)
• oral anticoagulants

If you are admitted to 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 substantially change your diet (for example, from a normal diet to a strict vegetarian diet), or if you have renal tubular acidosis (RTA, excess 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 dose of the medicine.

Pregnancy and breastfeeding

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

Pregnancy

The use of memantine is not recommended in pregnant women.

Breastfeeding

Women taking Axura should discontinue breastfeeding.

Driving and using machines

Your doctor will advise you whether your condition allows you to drive and use machines safely. Furthermore, Axura may affect your reaction capabilities, so driving or operating machinery may be inappropriate.

Axura contains sorbitol

This medicine contains 100 mg of sorbitol per gram, equivalent to 200 mg/4 sprays. Sorbitol is a source of fructose. If your doctor has told you that you have an intolerance to certain sugars, or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which the patient cannot metabolize fructose, speak with your doctor before taking or receiving this medicine.

In addition, this medicine contains potassium, less than 1 mmol (39 mg) per dose, i.e., essentially potassium-free.

3. How to take Axura

Follow exactly the administration instructions for this medicine given by your doctor. If in doubt, ask your doctor or pharmacist.

Dosage

One press delivers 5 mg of memantine hydrochloride.

The recommended dose of Axura in adult and elderly patients is four presses, equivalent to 20 mg per day.

To reduce the risk of adverse effects, this dose should be reached gradually according to the following daily schedule:

The usual starting dose is one spray (1 x 5 mg) once daily during the first week. This dose is increased to two sprays once daily during the second week (1 x 10 mg), and to three sprays once daily during the third week (1 x 15 mg). From the fourth week onwards, the recommended dose is four sprays once daily (1 x 20 mg).

Dosage for patients with reduced renal function

If you have kidney problems, your doctor will decide the appropriate dose according to your condition. In this case, your doctor should periodically monitor your kidney function.

Administration

Axura should be administered orally once daily. To get the maximum benefit from your medication, you should take it every day at the same time. The solution should be taken with some water. The solution may be taken with or without food.

For detailed instructions on the preparation and handling of the product, see the end of this leaflet.

Duration of treatment

Continue taking Axura for as long as it benefits you. Your doctor should periodically evaluate your treatment.

If you take more Axura than you should

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

If you forget to take Axura

• If you realize you have forgotten to take your dose of Axura, wait and take the next dose at the usual time.
• Do not take a double dose to make up for the missed dose.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

In general, adverse effects are classified as mild to moderate.

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

• Headache, somnolence, constipation, elevated liver function tests, dizziness, loss of balance, shortness of breath, high blood pressure, and hypersensitivity to the medicine

Uncommon (may affect up to 1 in 100 people):

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

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

• Seizures

Frequency not known (frequency cannot be estimated from the available data):

• Inflammation of the pancreas, 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 of 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 leaflet. You can also report them directly through the national reporting system detailed in Annex V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Axura

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the carton and on the label of the bottle after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 30°C.

After opening, the contents of the bottle must be used within 3 months.

The bottle with the pump attached must be stored and transported in an upright position only.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are in doubt, please ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Axura

The active substance is memantine hydrochloride.

Each pump actuation delivers 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 pack

Axura, oral solution, is a clear, colourless to slightly yellowish solution.

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

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Merz Pharmaceuticals GmbH
Eckenheimer Landstr. 100
D-60318 Frankfurt/Main
Germany

Manufacturer

Merz Pharma GmbH + Co. KGaA
Eckenheimer Landstr. 100
D-60318 Frankfurt/Main
Germany

More information about this medicinal product is available upon request to the local representative of the Marketing Authorization Holder.

Date of the most recent review of this leaflet: (MM/YYYY).

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.

Instructions for the correct use of the dispenser

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

Removing the screw cap from the bottle:

The cap must be turned counterclockwise, completely unscrewed, and removed (fig. 1).

Assembling the dispenser onto the bottle:

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

How the dispenser works:

The dispenser head has two positions and rotates easily:

• counterclockwise direction to open
• clockwise direction to close.

The dispenser head must not be pressed down while in the closed position. The solution can only be dispensed in the open position. To open, rotate the dispenser head in the direction indicated by the arrow until it stops (approximately one-eighth turn, fig. 4). The dispenser is then ready for use.

Preparing the dispenser:

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

The solution dispensed during this process must be discarded. The next time the dispenser head is fully pressed down (equivalent to one press), it will dispense the correct dose (fig. 6).

Correct use of the dispenser:

Place the bottle on a flat, horizontal surface, for example on a table, and use only in an upright position. Place a glass containing a small amount of water or a spoon under the nozzle. Press the dispenser head down firmly, steadily, and smoothly—do not press too slowly (fig. 7, fig. 8).

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

The dispenser must only be used with the Axura solution provided in the bottle and must not be used for other products or containers. If the dispenser does not function properly, consult your doctor or pharmacist. Close the dispenser after using Axura.