10 mg, 20 mg Film-coated tablets
Memantine hydrochloride

What Memantine LEK is and what it is used for

How Memantine LEK works

Memantine LEK belongs to a group of medicines known as anti-dementia medicines. Memory loss in Alzheimer’s disease is due to a disturbance of message signals in the brain. The brain contains so-called NMDA receptors (N-methyl-D-aspartate) that are involved in the transmission of nerve signals that are important for learning and memory. Memantine LEK belongs to a group of medicines called NMDA receptor antagonists. Memantine LEK acts on these NMDA receptors by improving the transmission of nerve signals and memory.

What Memantine LEK is used for

Memantine LEK is used to treat patients with moderate to severe Alzheimer’s disease.

What you need to know before using Memantine LEK

Do not use Memantine LEK

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

Warnings and cautions

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

In these situations, treatment should be closely monitored and the clinical benefit of Memantine LEK should be regularly assessed by your physician.

If you suffer from impaired kidney function (kidney problems), your doctor should closely monitor your kidney function and, if necessary, adjust the memantine doses accordingly.

Concomitant use of drugs containing amantadine (for the treatment of Parkinson’s disease ), ketamine (a substance commonly used as an anesthetic), dextromethorphan (generally used to treat cough), and other NMDA antagonists should be avoided.

You should tell your doctor if you have recently changed or intend to change your diet significantly (eg from a regular diet to a vegetarian diet only) or if you suffer from a condition of renal tubular acidosis (RTA, an excess on acid-forming substances in the blood due to kidney dysfunction (impaired kidney function)) or severe urinary tract infection ( cataracts ), as your doctor may need to adjust the dose of your medicine.

Children and young people

Memantine LEK is not recommended for children and adolescents under 18 years of age.

Other medicines and Memantine LEK

Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines. This includes medicines, including over-the-counter ones.

Memantine LEK may particularly affect the effects of the following medicines and these doses may need to be changed by your doctor:

  • amantadine, ketamine, dextromethorphan
  • dantrolen, baklofen
  • cimetidine, ranitidine, procainamide , quinidine , quinine, nicotine
  • hydrochlorothiazide (or any combination with hydrochlorothiazide)
  • anticholinergics (substances commonly used to treat movement disorders or intestinal cramps)
  • antiepileptics (substances used to prevent and relieve seizures)
  • barbiturates (substances commonly used for insomnia)
  • dopaminergic agonists (substances such as L-dopa , bromocriptine)
  • neuroleptics (substances used in the treatment of mental illness)
  • oral anticoagulants

If you are hospitalized, tell your doctor that you are taking Memantine LEK.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

The use of memantine in pregnant women is not recommended.

Women taking Memantine LEK should not breastfeed.

Driving and using machines

Your doctor will tell you if your illness allows you to drive and use machines safely. Memantine LEK may also alter your ability to react, making it unsuitable to drive or use machines.

3. How to use Memantine LEK

Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

Dosage

The recommended dose of Memantine LEK for adults and elderly patients is 20 mg once a day. To reduce the risk of side effects, this dose is achieved gradually through the following daily treatment schedule:

Week 1 Half a 10 mg tablet
Week 2 One 10 mg tablet
Week 3 One and a half 10 mg tablets
Week 4 and beyond Two 10 mg tablets or one 20 mg tablet once a day

The usual starting dose is half a 10 mg tablet once a day (1 x 5 mg) for the first week. This is increased to one 10 mg tablet once a day (1 x 10 mg) during the second week and to 1 and a half 10 mg tablets once a day during the third week. The recommended maintenance dose is 20 mg once daily, which is reached at the beginning of the fourth week.

Dosage in patients with renal impairment

If you have impaired kidney function, your doctor will prescribe a dose that suits your condition. In this case, your doctor should examine your kidney function at certain intervals.

Administration

Memantine LEK should be taken orally once a day. For you to benefit from your medicine, you must take it regularly every day at the same time of day. The tablets should be swallowed with a little water. The tablets can be taken with or without food.

Treatment time

Continue to take Memantine LEK for as long as you benefit from it. Your doctor should regularly evaluate your treatment.

If you use more Memantine LEK than you should 

– In general, it should not hurt you if you take too much Memantine LEK. You may experience increased symptoms as described in section 4. “Possible side effects”.

– If you are taking a large overdose of Memantine LEK, contact your doctor or medical advice, as you may need care.

If you forget to use Memantine LEK

– If you find that you have forgotten to take your dose of Memantine LEK, wait and take your next dose at the usual time.

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

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

In general, the side effects observed are mild to moderate.

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

• Headache, drowsiness, constipation, elevated liver function tests, dizziness, balance disorders, shortness of breath, high blood pressure, and drug hypersensitivity

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

• Fatigue, fungal infections, confusion, hallucinations, vomiting, gait disorders, heart failure, and blood clots in veins

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

• Cramps

Has been reported (occurs in an unknown number of users):

• 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 LEK.

If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information.

How to store Memantine LEK

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

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. or EXP. The expiration date is the last day of the specified month.

No special storage instructions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Contents of the pack and other information

Content declaration

The active substance is memantine hydrochloride.

Each film-coated tablet contains 10 mg memantine hydrochloride equivalent to 8.31 mg memantine.

Each film-coated tablet contains 20 mg memantine hydrochloride equivalent to 16.62 mg memantine.

Other ingredients are:

Tablet core: microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica, and magnesium stearate.

10 mg:

Tablet coating: polyvinyl alcohol, titanium dioxide (E171), talc, macrogol 3350, and yellow iron oxide (E 172)

20 mg:

Tablet coating: polyvinyl alcohol, titanium dioxide (E171), talc, macrogol 3350, yellow iron oxide (E 172), and red iron oxide (E 172)

What the medicine looks like and contents of the pack

Memantine LEK 10 mg film-coated tablets are yellow, oval with a scoreline on one side.

The tablet can be divided into two equal parts.

Memantine LEK 20 mg film-coated tablets are pale red, oval with a scoreline on one side.

The notch is not intended for splitting the tablet

Memantine LEK 10 mg film-coated tablets are available as PVC / PVDC – Aluminum blister packs of 30, 42, 50, 56, 98, and 112 tablets.

Memantine LEK 10 mg film-coated tablets are available as PVC / PVDC – Aluminum blister packs of 28, 30, 42, 56, and 98 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder:

Pharmathen SA, 6, Dervenakion str., 15351 Pallini, Attiki, Greece

Manufacturer:

Pharmathen SA, 6, Dervenakion str., 15351 Pallini, Attiki, Greece

or

Pharmathen International SA, Industrial Park Sapes, Rodopi Prefecture, Block No 5, Rodopi 69300, Greece

or

J. Uriach y Compañía, SA, Av. Camí Reial 51-57, 08184 Palau-solità i Plegamans, Spanien

Further information on this medicine can be obtained from the representative of the marketing authorization holder.

Belgium / Belgique / BelgienSandoz nv / saTel: +32 2 722 97 81 Luxembourg / LuxemburgSandoz nv / saTel: + 32 2 722 97 81
BulgariaSandoz dd Representative officeTel: + 359 2 970 47 47 HungarySandoz Hungary Kft.Tel .: + 36 1 430 2896
Czech RepublicSandoz sroTel: + +420 221 421 658 MaltaCherubino LTDTel: + 356 21 343 270
DenmarkSandoz A / STel: + 45 6395 1000 The NetherlandsSandoz BVTel: + 31 (0) 36 5241600
GermanySandoz Pharmaceuticals GmbHTel: + 49 08024 902-4513 NorwaySandoz A / STel: + 45 6395 1000
Estonia (Estonia)Sandoz dd EstoniaTel: + 372 6652405 AustriaSandoz GmbHTel: + 43 5338 200
GreeceSambrook Pharmaceuticals Med SA800 110 0333 (toll free) / + 30-210-8194280 PolandLek SATel .: + 48/22/549 15 43, +48 / 22/549 07 24
SpainSandoz Pharmacéutica, SATel: + 34 91 740 12 92 PortugalSandoz Pharmacêutica Lda.Tel: + 351 21 000 87 81
FranceSandozTel: +33 1 49 64 48 21 RomaniaSandoz SRL RomaniaTel: + 40 21 407 51 83
IrelandROWEX LTDTel: + 353 27 50077 SloveniaLek Pharmaceuticals ddTel: + 386 1 580 3327
IcelandSandoz A / STel: + 45 6395 1000 Slovak RepublicSandoz dd organizacna zlozkaTel: + 421-2 / 48 200 600
ItalySandoz SpATel: + 39 02 96 54 3483 Finland / FinlandSandoz A / SPuh / Tel: + 45 6395 1000
.ΠροςPTHadjigeorgiou Co Ltd:Ηλ: + 357 – 25372425 SwedenSandoz A / STel: + 45 6395 1000
LatviaSandoz dd representative office Latvia.Tel: + 371 6789 2006 United KingdomSandoz LimitedTel: + 44 1276 698020
LithuaniaSandoz Pharmaceuticals ddTel: + 370 5 2636 037

Muhammad Nadeem

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