Package Leaflet: Information for the User

MemantineTarbis20 mg Film-Coated Tablets

Memantine, hydrochloride

Read this leaflet carefully before you start to take this medicinebecause 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 youonly, and you should not give it to others even if they have the same symptomsas you, as it may harm them.
• Ifyou experienceside effects,consult your doctor or pharmacist,even if they are not listed in this leaflet. See section 4.

How Memantina Tarbis works

Memantina Tarbis belongs to a group of medications known as dementia medications.

The 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 nervous signals in learning and memory. Memantina Tarbis belongs to the group of medications called NMDA receptor antagonists. Memantina Tarbis acts on these receptors by improving the transmission of nervous signals and memory.

What is Memantina Tarbis used for

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

Do not take Memantina Tarbis

• if you are allergictohydrochlorideofmemantinor to any of the othercomponents ofthis medication(including in thesection 6).

Warnings and precautions

Consult yourdoctor or pharmacist before starting to take Memantina Tarbis.

• if you have a history of epileptic seizures (convulsions).
• if you have recently had a myocardial infarction (heart attack), if you have 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 reevaluate the clinical benefit of Memantina Tarbis regularly.

If you have renal insufficiency (kidney problem), your doctor must closely monitor renal function and if necessary, adapt memantina doses.

Memantina should be avoided 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.

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

Use of Memantina Tarbis withother medications

Inform your doctor or pharmacist if you are using,have used recentlyor may have to use anyothermedication.

Specifically, the administration of Memantina Tarbis may produce changes in the effects of the following medications, so your doctor may need to adjust the dose:

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 such as 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 Memantina Tarbis.

Taking Memantina Tarbis with food and drinks

You must 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 renal tubular acidosis (ATR, excess of acid-producing substances in the blood due to a renal dysfunction [kidney problem]) or severe urinary tract infections, as your doctor may need to adjust the medication dose.

Pregnancy,breastfeedingand fertility

If you are pregnant or breastfeeding, think you may be pregnant or intend to become pregnant,consult your doctor or pharmacist before usingthismedication.

Memantina is not recommended for use in pregnant women.

Women taking Memantina Tarbis should discontinue breastfeeding.

Driving and operating machinery

Your doctor will inform you if your condition allows you to drive and use machinery safely.

Furthermore, Memantina Tarbis may alter your reaction time, so driving or operating machinery may be inappropriate.

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

Dosage

The recommended dose is 20 mg per day.

To reduce the risk of adverse effects, this dose should be achieved gradually by following a daily treatment schedule. There are tablets with different doses available to adjust the dose.

At the beginning of treatment, you will start taking half a tablet of Memantina Tarbis 10 mg coated tablets once a day. This dose will be increased weekly by 5 mg to reach the recommended maintenance dose. The recommended maintenance dose is 20 mg once a day, which is achieved at the beginning of the fourth week.

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 should monitor your renal function periodically.

Administration

Memantina Tarbis should be taken orally once a day. To get the most out of your medication, you should take it every day 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 Memantina Tarbis as long as it is beneficial for you. Your doctor should evaluate the effects of your treatment periodically.

If you take more Memantina Tarbis than you should

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

If you forgot to take Memantina Tarbis

• If you realize you have forgotten to take your dose of Memantina Tarbis, 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 other questions about the use of this medication, ask your doctor or pharmacist.

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

Generally, adverse effects are classified as mild to moderate.

Frequent (affects between 1 and 10 out of 100 patients):

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

Rare (affects between 1 and 10 out of 1,000 patients):

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

Very rare (affects fewer than 1 out of 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 linked to depression, suicidal ideation, and suicide. There have been reports of these events occurring in patients treated with Memantina Tarbis.

If you consider any of the adverse effects you are experiencing to be severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Sistema Español de Farmacovigilancia de Medicamentos de Uso Humano, www.notificaram.es . By reporting adverse effects, you can contribute to providing more information about the safety of this medication .

Keepthis medicationout ofsightandout of reach of children.

Do not usethis medicationafter the expiration date that appears onthe boxand on 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 pointat 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 Memantina Tarbis

The active ingredient ishydrochloride ofmemantina. Each tablet contains 20 mg ofhydrochloride ofmemantina, which is equivalent to 16.62 mg of memantina.

The other components are microcrystalline cellulose, sodium croscarmellose, colloidal anhydrous silica, magnesium stearate in the core; polyvinyl alcohol, macrogol 3350, talc, titanium dioxide (E171) and yellow iron oxide and red iron oxide (E 172) on the tablet coating.

Appearance of the product and content of the packaging

Memantina Tarbis 20 mg film-coated tablets have a pale red color, oval shape with a breaking line on one face.The groove serves to fraction and facilitate swallowing but not to divide into equal doses.

Memantina Tarbis film-coated tablets are presentedinpackaging of 56 tablets.

Holder of the marketing authorization

Tarbis Farma, S.L

Gran Vía Carlos III, 94

08028 Barcelona

Responsible for manufacturing

Noucor Health, S.A.

Av. Camí Reial 51-57

08184 Palau-solità i Plegamans (Spain)

This leaflet has been approved in:November 2013

The detailed and updated information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/