Package Insert: Information for the User

Memantine Tarbis10 mg Film-Coated Tablets

Memantine, hydrochloride

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

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribedonlyfor you and should not be given to others even if they have the same symptomsas you, as it may harm them.
• Ifyou experience any adverse effects, consultyour doctor or pharmacist, even if they are not listed in this package insert. See section 4.

How Memantina Tarbis works

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

The loss of memory 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 allergictohydrochlorideof memantine or to any of the other ingredients 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).

The treatment must be closely monitored and your doctor must reevaluate the clinical benefit of Memantina Tarbis regularly in the above situations.

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

The use of memantine should be avoided with other medications such as amantadine (for the treatment of Parkinson's disease), ketamine (a medication generally used to induce anesthesia), dextromethorphan (a medication for the treatment of cough), and other NMDA antagonists.

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

Use of Memantina Tarbis with other medications

Inform your doctor or pharmacist if you are using,have recently usedor may need to use anyother medication.

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

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 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 dosage.

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 Tarbis 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 of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Dosage

The recommended dose of Memantina Tarbis in adult 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 5mg) 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 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 should monitor your renal function periodically.

Administration

Memantina Tarbis should 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 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

• In general, taking an excessive amount of Memantina Tarbis 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 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 compensate for the missed dose.

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

Like all medications,this medicationmay 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 of every 100 patients):

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

Rare (affects between 1 and 10 of every 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 in 10,000 people):

• Seizures.

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

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

There has been a reported association between Alzheimer's disease and depression, suicidal ideation, and suicide. These events have been reported 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 theSpanish System for Pharmacovigilance of Medicinal Products for Human Use,www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keepthis medicationout of the sight andreach 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 ofmemantine. Each film-coated tablet contains 10mg ofhydrochloride ofmemantine,which is equivalent to 8.31 mg of memantine.

The other components are microcrystalline cellulose, sodium croscarmellose, anhydrous colloidal silica, and magnesium stearate, in the tablet core; polyvinyl alcohol, titanium dioxide (E 171), talc, macrogol 3350, and yellow iron oxide (E 172) in the tablet coating.

Appearance of the product and contents of the packaging

Memantina Tarbis is presented in the form of film-coated oval-shaped tablets with a breaking line on one side, of yellow color.The tablet can be divided into two equal halves.

Memantina Tarbis film-coated tablets are presented in packaging of 30,56 or 112 tablets.

Only some packaging sizes may be commercially available.

Marketing Authorization Holder

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 was approved in: November 2013

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