DETAM 20 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Detam 20 mg film-coated tablets EFG

memantine hydrochloride

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again. If you have any questions, ask your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Detam and what is it used for
2. What you need to know before taking Detam
3. How to take Detam
4. Possible side effects
5. Storage of Detam
6. Contents of the pack and further information

1. What is Detam and what is it used for

Detam contains the active ingredient memantine hydrochloride. It belongs to a group of medications known as anti-dementia medications.

Memory loss in Alzheimer's disease is due to an alteration in brain signals. The brain contains so-called N-methyl-D-aspartate (NMDA) receptors that participate in the transmission of important nerve signals in learning and memory. Memantine belongs to the group of medications called NMDA receptor antagonists. Memantine acts on these receptors, improving the transmission of nerve signals and memory.

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

2. What you need to know before taking Detam

Do not take Detam:

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Detam:

? if you have a history of epileptic seizures.

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

In these situations, treatment should be carefully monitored, and your doctor should regularly reassess the clinical benefit of Detam.

You should inform your doctor if you have recently changed or plan to change your diet substantially (e.g., from a normal diet to a strict vegetarian diet) or if you suffer from renal tubular acidosis (RTA, excess of acid-producing substances in the blood due to kidney dysfunction) or severe urinary tract infections (structure that carries urine), as your doctor may need to adjust the dose of the medication.

If you have kidney problems, your doctor should closely monitor your kidney function and, if necessary, adjust the doses of memantine.

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

Children and adolescents

The use of this medication is not recommended in children and adolescents under 18 years of age.

Other medications and Detam

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

In particular, the administration of Detam 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),

? dopaminergic agonists (substances such as L-dopa, bromocriptine),

? neuroleptics (substances used in the treatment of mental illnesses),

? oral anticoagulants.

If you are hospitalized, inform your doctor that you are taking Detam.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan 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 Detam should not breastfeed.

Driving and using machines

Your doctor will inform you if your illness allows you to drive and use machines safely.

Additionally, Detam may alter your reaction ability, so driving or operating machines may be inappropriate.

Detam contains lactose

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

3. How to take Detam

Follow the administration instructions of this medication exactly as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The recommended dose for adults and elderly patients is 20 mg administered once a day.

To reduce the risk of side effects, this dose is achieved gradually following the daily treatment scheme indicated below. To adjust the dose, there are tablets with different doses.

The normal starting dose is half a 10 mg tablet once a day (1 x 5 mg) the first week. It is increased to one 10 mg tablet a day (1 x 10 mg) the second week and to one and a half 10 mg tablets once a day (1 x 15 mg) in the third week. From the fourth week onwards, the normal dose is two 10 mg tablets or one 20 mg tablet (1 x 20 mg), administered once a day.

The tablet can be divided into equal doses.

Use in 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 periodically monitor your kidney function.

Administration

Detam 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.

Duration of treatment

Continue taking Detam as long as it benefits you. Your doctor should periodically evaluate your treatment

If you take more Detam than you should

? In general, taking an excessive amount of Detam should not cause you any harm. You may experience an increase in the symptoms described in section 4 "Possible side effects".

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

If you forget to take Detam

? If you realize you have forgotten to take your dose of Detam, wait and take the next dose at the usual time.

? Do not take a double dose to make up for the forgotten dose.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

In general, side effects are classified as mild to moderate.

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

? headache,

? drowsiness,

? constipation,

? elevated liver function tests,

? dizziness,

? balance disorder,

? difficult breathing,

? high blood pressure,

? hypersensitivity to the medication.

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

? fatigue,

? fungal infections,

? confusion,

? hallucinations,

? vomiting,

? gait disturbance,

? heart failure and formation of blood clots in the venous system (thrombosis/venous thromboembolism).

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

? seizures

Frequency not known (frequency cannot be estimated from available data):

? pancreatitis,

? hepatitis (inflammation of the liver),

? 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 of side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: www.notificaRAM.es

By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Detam

Keep this medication out of the sight and reach of children.

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

This medication does not require any special storage temperature.

Keep the blister in the outer packaging to protect it from light.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Contents of the pack and further information

Composition of Detam

? The active ingredient is memantine hydrochloride. Each tablet contains 20 mg of memantine hydrochloride, equivalent to 16.62 mg of memantine.

? The other ingredients are: microcrystalline cellulose, crospovidone type B, anhydrous colloidal silica, magnesium stearate, lactose monohydrate (see section 2 "Detam contains"), hypromellose 6cP, macrogol 400, titanium dioxide (E171), and red iron oxide (E172)

Appearance of the product and contents of the pack

Detam 20 mg is a film-coated tablet, pink, oblong, biconvex, 12.5 mm x 5.6 mm, with a score line on both sides.

Detam 20 mg tablets are presented in packs of 56 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Devon Farmacéutica, S.A.

C/ José Rizal Nº 84

28043 Madrid

Spain

Manufacturer

Zaklady Farmaceutyczne POLPHARMA SA

(Pharmaceutical Works POLPHARMA SA)

19, Pelplinska Street

83-200 Starogard Gdanski

Poland

Date of the last revision of this package leaflet:July 2018

Other sources of information

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)