Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - axura

Document Subject

Generated Narrative: MedicinalProductDefinition mpdec3a1f5841f1029014aecf2cec0d0c8

identifier: http://ema.europa.eu/identifier/EU/1/02/218/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Axura 10 mg film-coated tablets

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

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part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-dec3a1f5841f1029014aecf2cec0d0c8

identifier: http://ema.europa.eu/identifier/EU/1/02/218/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - axura

Attesters

What is in this leaflet

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

How does Axura work Axura contains the active substance memantine hydrochloride. Axura 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. Axura belongs to a group of medicines called NMDA- receptor antagonists. Axura acts on these NMDA-receptors improving the transmission of nerve signals and the memory.

What is Axura used for Axura is used for the treatment of patients with moderate to severe Alzheimer s disease.

Do not take Axura

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

Warning and precautions Talk to your doctor or pharmacist before taking Axura

• 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 Axura 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.

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

Other medicines and Axura Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

In particular, Axura 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 Axura.

Axura with food and drink 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.

Pregnancy and breast-feeding 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 Axura should not breast-feed.

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

Axura contains Sodium This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially sodium- free .

Always take Axura exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Dosage The recommended dose of Axura for adults and older people 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:

week 1

half a 10 mg tablet

week 2

one 10 mg tablet

week 3

one and a half 10 mg tablet

week 4
and beyond two 10 mg tablets once a day

The usual starting dose is half a tablet once a day (1x 5 mg) for the first week. This is increased to one tablet once a day (1x 10 mg) in the second week and to 1 and a half tablet once a day in the third week. From the fourth week on, the usual dose is 2 tablets once a day (1x 20 mg).

Dosage in patients with impaired kidney function 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.

Administration Axura 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.

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

If you take more Axura than you should

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

If you forget to take Axura

• If you find you have forgotten to take your dose of Axura, 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 have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

In general, the observed side effects are mild to moderate.

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

• Headache, sleepiness, constipation, elevated liver function tests, dizziness, balance disorders, shortness of breath, high blood pressure and drug hypersensitivity

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

• Tiredness, fungal infections, confusion, hallucinations, vomiting, abnormal gait, heart failure and venous blood clotting (thrombosis/thromboembolism)

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

• Seizures

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

• Inflammation of the pancreas, inflammation of the liver (hepatitis) 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 side effects 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 national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

Keep out of the sight and reach of children.

Do not use Axura after the expiry date which is stated on the carton and the blister after EXP. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

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

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

What Axura looks like and contents of the pack Axura film-coated tablets are presented as pale yellow to yellow, oval shaped film-coated tablet with breaking line and engravings "1-0" on one side and "M M" on the other side.

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

Not all pack sizes may be marketed.

Marketing Authorisation Holder Merz Pharmaceuticals GmbH Eckenheimer Landstr. D-60318 Frankfurt/Main

Germany

Manufacturer Merz Pharma GmbH & Co. KGaA Eckenheimer Landstr. D-60318 Frankfurt/Main Germany

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.

Belgi /Belgique/Belgien Merz Pharmaceuticals GmbH T l/Tel: +49 (0)69 1503-0

Lietuva Merz Pharmaceuticals GmbH Tel: +49 (0)69 1503-0

Merz Pharmaceuticals GmbH Te .: +49 (0)69 1503-0

Luxembourg/Luxemburg HANFF Global Health Solutions s. r.l. T l/Tel: +352 45 07 07-1 esk republika Merz Pharmaceuticals GmbH Tel: +49 (0)69 1503-0

Magyarorsz g Merz Pharmaceuticals GmbH Tel: +49 (0)69 1503-0

Danmark Merz Pharmaceuticals GmbH Tlf: +49 (0)69 1503-0

Malta Clinipharm Co. Ltd Tel: +356 21 43 74 Deutschland Merz Pharmaceuticals GmbH Tel: +49 (0)69 1503-0 Nederland Merz Pharmaceuticals GmbH Tel: +49 (0)69 1503-0

Eesti Merz Pharmaceuticals GmbH Tel: +49 (0)69 1503-0

Norge Merz Pharmaceuticals GmbH Tlf: +49 (0)69 1503-0

Merz Pharmaceuticals GmbH : +49 (0)69 1503-0

sterreich Merz Pharma Austria GmbH Tel.: +43 1 865 88 Espa a Merz Therapeutics Iberia, S.L.U. Tel. +34 91 117 89 Polska Centrala Farmaceutyczna CEFARM SA Tel: +48 22 634 02 France Merz Pharmaceuticals GmbH T l: +49 (0)69 1503-0

Portugal Merz Therapeutics Iberia, S.L.U. Tel. +34 91 117 89 Hrvatska Merz Pharmaceuticals GmbH Tel: +49 (0)69 1503-0

Rom nia Merz Pharmaceuticals GmbH Tel.: +49 (0)69 1503-0

Ireland Merz Pharmaceuticals GmbH Tel: +49 (0)69 1503-0

Slovenija Merz Pharmaceuticals GmbH Tel: +49 (0)69 1503-0 sland Merz Pharmaceuticals GmbH Slovensk republika Merz Pharmaceuticals GmbH

S mi.: +49 (0)69 1503-0

Tel: +49 (0)69 1503-0

Italia Merz Pharmaceuticals GmbH Tel: +49 (0)69 1503-0 Suomi/Finland Merz Pharmaceuticals GmbH Puh/Tel: +49 (0)69 1503-0

Merz Pharmaceuticals GmbH : +49 (0)69 1503-0 Sverige Merz Pharmaceuticals GmbH Tel: +49 (0)69 1503-0

Latvija Merz Pharmaceuticals GmbH Tel: +49 (0)69 1503-0

This leaflet was last revised in MM/YYYY. Detailed information on this medicine is available on the European Medicines Agency (EMA) web side: http://www.ema.europa.eu.

Package leaflet: Information for the user

Axura 5 mg/pump actuation, oral solution Memantine hydrochloride

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• 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.