Axura 10 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Axura 10 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 as you may need to read it again.

• If you have any questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only. Do not give it to anyone else, even if they have the same symptoms as you, because it may harm them.

• If you experience any adverse effects, consult your doctor or pharmacist, even if they are 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

• Consult your doctor or pharmacist before starting Axura
• if you have a history of epileptic seizures (convulsions)
• if you have recently suffered 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 supervised, and your doctor should regularly reassess the clinical benefit of Axura.

If you have renal impairment (kidney problems), your doctor should closely monitor your 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 medication), 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

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

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

• 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 stop 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 plan 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 use of machines

Your doctor will advise you whether your condition allows you to drive or operate machinery safely. Axura may affect your reaction ability, so driving or operating machinery may be inappropriate.

Axura contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; thus, for practical purposes, it is considered "sodium-free".

3. How to Take Axura

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

Dosage

The recommended dose of Axura in adult and elderly patients is 20 mg administered once daily. To reduce the risk of adverse effects, this dose should be reached gradually according to the following daily schedule:

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

Posology for patients with renal impairment

If you have kidney problems, your doctor will decide the appropriate dose for 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 must take it every day at the same time. The tablets should be swallowed with some water. The tablets may be taken with or without food.

Duration of treatment

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

If you take more Axura than you should

• In general, 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 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 mild to moderate in severity.

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, impaired gait, heart failure, and formation of 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 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 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 may also report them directly through the national reporting system listed 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 medicinal product after the expiry date stated on the carton and on the blister after EXP. The expiry date refers to the last day of the month indicated.

No special storage conditions are required.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at a SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the container and additional information

Composition of Axura

The active substance is memantine hydrochloride. Each film-coated tablet contains 10 mg of memantine hydrochloride, equivalent to 8.31 mg of memantine.

The other components are microcrystalline cellulose, sodium croscarmellose, colloidal anhydrous silica, and magnesium stearate in the tablet core; and hypromellose, titanium dioxide (E 171), macrogol 400, and yellow iron oxide (E 172) in the tablet coating.

Appearance of the product and contents of the container

Axura is available as film-coated tablets, pale yellow to yellow in color, oval-shaped, with the imprint “M” on both sides of the break line on one side, and the imprints “1” and “0” to the left and right of the break line on the other side. The tablet measures approximately 11.0 mm in length and 5.0 mm in width.

Axura tablets are available in packs of 14 tablets, 28 tablets, 30 tablets, 42 tablets, 50 tablets, 56 tablets, 98 tablets, 100 tablets, 112 tablets, and multipacks containing 840 (20 x 42) tablets, 980 (10 x 98) tablets, or 1000 (20 x 50) tablets.

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

Further information on this medicinal product is available upon request by contacting the local representative of the marketing authorization holder.

Date of latest review of this leaflet: (MM/YYYY).

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