Package Leaflet: Information for the User

Lonrela 20 mg Film-Coated Tablets EFG

Memantine Hydrochloride

Read 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 pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What is Lonrela and what it is used for

2. What you need to know before taking Lonrela

3. How to take Lonrela

4. Possible side effects

5. Storage of Lonrela

6. Contents of the pack and additional information

How Lonrela works

This medication contains the active ingredient hydrochloride of memantine.

This medication belongs to a group of medications called dementia medications.

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. This medication belongs to the group of medications called NMDA receptor antagonists. This medication acts on these NMDA receptors by improving the transmission of nervous signals and memory.

What Lonrela is used for

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

Do not take Lonrela

-if you are allergic to hydrochloride of memantine or to any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medication.

-if you have a history of epileptic seizures.

-if you have recently suffered a myocardial infarction (heart attack), if you have congestive heart failure or if you have uncontrolled high blood pressure.

In the above situations, treatment must be closely monitored and your doctor must reevaluate the clinical benefit of this medication regularly.

If you have 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.

Children and adolescents

This medication is not recommended for use in children and adolescents under 18 years old.

Taking Lonrela with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

In particular, the administration of this medication 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 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 this medication.

Taking Lonrela with food and drinks

You should inform your doctor if you have recently changed or intend to change your diet significantly (e.g. from a normal diet to a strict vegetarian diet) or if you have kidney tubular acidosis (ATR, excess of acid-producing substances in the blood due to renal dysfunction) or severe urinary tract infections, 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 or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

The use of memantine is not recommended in pregnant women.

Breastfeeding

Women taking this medication should discontinue breastfeeding.

Driving and operating machinery

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

This medication may also alter your reaction time, making driving or operating machinery unsuitable.

Lonrela contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per tablet; it is essentially "sodium-free".

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. Consult your doctor or pharmacist if you have any doubts.

Dosage:

The recommended dose of this medication in adult patients 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.There are tablets with different doses available to adjust the dose.

At the beginning of treatment, you will start taking memantine 5 mg film-coated tablets once a day. This dose will be increased weekly by 5 mg until the recommended maintenance dose is reached. 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 must monitor your renal function periodically.

Administration:

This medication 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 this medication as long as it is beneficial for you. Your doctor should evaluate the effects of your treatment periodically.

If you take more Lonrela than you should:

• Generally, taking an excessive amount of this medication should not cause any harm. You may experience an increase in the symptoms described in section 4 “Possible adverse effects”.
• In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: (91) 5620420, indicating the medication and the amount ingested.

If you forgot to take Lonrela:

• If you realize you have forgotten to take your dose of this medication, wait and take the next dose at the usual time.
• Do not take a double dose to make up for the missed doses.

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

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

Generally, adverse effects are classified as mild to moderate.

Frequent (may affect up to 1 in 10 people):

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

Poorly frequent (may affect up to 1 in 100 people):

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

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

• Seizures.

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

• Pancreatitis, 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 memantine.

Reporting Adverse Effects

If you experienceany 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 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 this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging and blister after “CAD”. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need atthe SIGRE Collection Pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Lonrela

The active ingredient is hydrochloride of memantine.

Each film-coated tablet contains 20 mg of hydrochloride of memantine, which is equivalent to16,62mg of memantine.

The components of the core of Lonrela 20 mg film-coated tablets are microcrystalline cellulose, sodium croscarmellose, anhydrous colloidal silica, and magnesium stearate. The components of the tablet coating are polyvinyl alcohol, titanium dioxide (E171), macrogol (3350), yellow and red iron oxide (E172), and talc.

Appearance of the product and content of the container

The blister packs contain 56 tablets per each blister pack (PVC/PE/PVDC and aluminum).

Only some container sizes may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

STADA Laboratorios, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern

(Barcelona) Spain

[email protected]

Responsible for manufacturing

STADA Arzneimittel AG

Stadastrasse 2 – 18

61118 Bad Vilbel

Germany

Last review date of this leaflet:January 2020

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/.