Label:Information for the User

MemantinePharmaCombix 10 mg Film-Coated Tablets

Memantine hydrochloride

Read this label carefully before starting to take this medication.

• Keep this label, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed for you and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you consider that any of the adverse effects you are experiencing are severe or if you notice any adverse effect not mentioned in this label, inform your doctor or pharmacist.Seesection4.

MemantinaPharmaCombix contains the active ingredient memantin hydrochloride. It belongs to a group of medicines known as dementia medicines.

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 PharmaCombix belongs to the group of medicines called NMDA receptor antagonists. MemantinaPharmaCombix acts on these receptors by improving the transmission of nervous signals and memory.

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

Do not take MemantinaPharmaCombix

• if you are allergic to memantine or any of the other components of this medication (see section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Memantina Pharma Combix:

• if you have a history of epileptic seizures.
• if you have recently had a myocardial infarction (heart attack), if you have congestive heart failure or if you have uncontrolled high blood pressure.

In these situations, treatment should be closely monitored and your doctor should reevaluate the clinical benefit of Memantina Pharma Combix regularly.

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

If you have tubular acidosis (excess acid-producing substances in the blood due to renal dysfunction) or severe urinary tract infections, your doctor may need to adjust the medication dosage.

Memantine should be avoided when used with other medications such as amantadine (for Parkinson's treatment), ketamine (usually used in anesthesia), dextromethorphan (usually used to treat cough), and other NMDA antagonists.

Children and adolescents

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

Taking Memantina Pharma Combix with other medications

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take other medications.

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

• 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 like 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 Pharma Combix.

Taking Memantina Pharma Combix with food and drinks

You should 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), as your doctor may need to adjust the medication dosage.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy:Memantine is not recommended for use in pregnant women.

Breastfeeding:Women taking Memantina Pharma Combix should not breastfeed.

Driving and operating machinery

Your doctor will inform you if your condition allows you to drive and use machinery safely. Additionally, Memantina Pharma Combix may alter your reaction time, making driving or operating machinery inappropriate.

Follow exactly the administration instructions forMemantinaPharmaCombixprescribed by your doctor. In case of doubt, consult your doctor or pharmacist again.

The recommended dose for adults and elderly patients is 20 mg of MemantinaPharmaCombixonce 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 5 mg) 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 in patients with renal insufficiency

If you have renal insufficiency, your doctor will decide on the appropriate dose for your condition. In this case, your doctor must monitor your renal function periodically.

Administration

MemantinaPharmaCombixmust 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 MemantinaPharmaCombixas long as it is beneficial for you. Your doctor should evaluate the effects of your treatment periodically.

If you take more MemantinaPharmaCombix than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20 indicating the medication and the amount ingested.

• Generally, taking an excessive amount of MemantinaPharmaCombixshould not cause you any harm. You may experience an increase in the symptoms described in section 4 “Possible adverse effects”.

If you forgot to take MemantinaPharmaCombix

• If you realize you have forgotten to take your dose of Memantina PharmaCombix, wait and take the next dose at the usual time.
• Do not take a double dose to compensate for the missed doses.

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

Like all medications, Memantina Pharma Combix can produce adverse effects, although not all people will experience them.

Adverse effects are generally classified as mild to moderate.

Frequent (affecting between 1 and 10 people in every 100):

• Headache, drowsiness, constipation, elevated liver function tests, dizziness, balance disorders, difficulty breathing, high blood pressure, and hypersensitivity to the medication.

Poorly frequent (affecting between 1 and 10 people in every 1,000):

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

Very rare (affecting fewer than 1 person in every 10,000):

• Seizures.

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

• Pancreatitis, hepatitis, and psychotic reactions.

Alzheimer's disease has been linked to depression, suicidal ideation, and suicide. These events have been reported in patients treated with Memantina Pharma Combix.

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es.By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep out of reach and sight of children.

Do not useMemantina PharmaCombixafter the expiration date that appears onthe box and on the blister pack after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medicines you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Memantine CompositionPharmaCombix

• The active ingredient is memantine hydrochloride.

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

• The other components are:

Tablet core:Calcium dihydrogen phosphate dihydrate (E341i), microcrystalline cellulose (Avicel PH101) (E460i), croscarmellose sodium, povidone K-90, anhydrous colloidal silica (Aerosil 200, pharma) (E551), magnesium stearate (E470b) and talc (E553b).

Tablet coating:Opadry white 03F58991 (hypromellose 6 cps (E464), macrogol 6000 (E1521), titanium dioxide (E171) and talc (E553b)).

Product appearance and packaging contents

Memantine Pharma Combix film-coated tablets are white or off-white, capsule-shaped, biconvex, scored on one side and smooth on the other. The tablet can be divided into equal doses.

Memantine Pharma Combix film-coated tablets are available in blisters in packaging sizes of 28, 56, 98, 100 and 112 tablets.

Only some packaging sizes may be marketed.

Marketing authorization holder and manufacturer responsible

Combix, S.L.U.

C/Badajoz . Edificio 2,

28223 Pozuelo de Alarcón (Madrid)

Spain

Manufacturer responsible

Zydus France

ZAC Les Hautes Patures

Parc d’activités des Peupliers

25 Rue des Peupliers

92000 Nanterre

France

or

Centre Spécialités Pharmaceutiques

ZAC des Suzots

35 rue de la Chapelle

63450 Saint Amant Tallende

France

This medicinal product is authorized in the member states of the European Economic Area with the following names:

SpainMemantine Pharma Combix 10 mg film-coated tablets EFG

FranceMemantine Zydus France 10 mg film-coated tablet

Last review date of this leaflet: June 2019.

For detailed and updated information on this medicinal product, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.