Leaflet: information for the user

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

1. What Detam is and for what it is used

2. What you need to know before starting to take Detam

3. How to take Detam

4. Possible side effects

5. Storage of Detam

6. Contents of the pack and additional information

Detam contains the active ingredienthydrochlorideof memantine. It belongs to a group of medications known as 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. Memantine belongs to a group of medications called NMDA receptor antagonists. Memantine acts on these receptors by improving the transmission of nervous signals and memory.

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

Do not take Detam:

?If you are allergic to memantine or any of the other components 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 had 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 regularly reevaluate the clinical benefit of Detam.

You must inform your doctor if you have recently changed or plan to change your diet substantially (for example from a normal diet to a strict vegetarian diet) or if you have renal tubular acidosis (excess acid-producing substances in the blood due to renal dysfunction) or severe urinary tract infections, as your doctor may need to adjust the medication dose.

If you have renal insufficiency, your doctor must closely monitor renal function and, if necessary, adapt memantine doses.

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

Children and adolescents

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

Other medications and Detam

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

Specifically, 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),

?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 Detam.

Pregnancy and breastfeeding

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

Pregnancy

Memantine is not recommended for use in pregnant women.

Breastfeeding

Women taking Detam should not breastfeed.

Driving and operating machinery

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

Additionally, Detam may alter your reaction time, making driving or operating machinery inappropriate.

Detam contains lactose

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

Follow exactly the administration instructions of this medication as indicated by your doctor.This medicationindicated by your doctor.Consult your doctor or pharmacist again if you are unsure.

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

To reduce the risk of adverse effects, this dose is achieved gradually by following the daily treatment schedule indicated below. Dose adjustment is available in tablets with different doses.

The usual starting dose is half a tablet of 10 mg once a day (1 x 5 mg) in the first week. It is increased to one tablet of 10 mg a day (1 x 10 mg) in the second week and to one and a half tablets of 10 mg once a day (1 x 15 mg) in the third week. From the fourth week onwards, the usual dose is two tablets of 10 mg or one tablet of 20 mg (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 must monitor your renal function periodically.

Administration

Detam must 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 evaluate your treatment periodically

If you take more Detam than you should

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

?If you have taken too much Detam or have ingested it accidentally, consult your doctor or pharmacist immediately or call the Toxicological 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 Detam dose, 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 questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Generally, side effects are classified as mild to moderate.

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

?headache,

?sleep,

?constipation,

?increased liver function tests,

?dizziness,

?balance disorder,

?difficulty breathing,

?high blood pressure,

?hypersensitivity to the medication.

Less frequent (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 (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 (inflammation of the liver),

?psychotic reactions.

Alzheimer's disease has been associated with depression, suicidal ideation, and suicide. There have been reports of these events in patients treated with memantine.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es

By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears onthe packaging and on the blisterpack after CAD. The expiration date is the last day of the month indicated.

This medication does not require any special storage temperature.

Store the blister pack in the outer packaging to protect it from light.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE point of the pharmacy.Ask your pharmacisthow to disposeofthepackaging and of themedications that you no longerneed.This will help protect the environment.

Composition of Detam

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

?The other components 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 iron oxide red (E172)

Appearance of the product and contents of the packaging

Detam 20 mg is a film-coated tablet, of pink color, oblong, biconvex, 12.5 mm by 5.6 mm, with a breaking line on both faces.

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

Holder of the marketing authorization and manufacturer responsible

Holder of the marketing authorization

Devon Farmacéutica, S.A.

C/ José Rizal Nº 84

28043 Madrid

Spain

Manufacturer responsible

Zaklady Farmaceutyczne POLPHARMA SA

(Pharmaceutical Works POLPHARMA SA)

19, Pelplinska Street

83-200 Starogard Gdanski

Poland

Date of the last review of this leaflet:july 2018

Other sources of information

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