10 mg, 20 mg Memantine Sandoz
memantine hydrochloride

What Memantine Sandoz is and what it is used for

How Memantine Sandoz works

Memantine Sandoz 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 Sandoz belongs to a group of medicines called NMDA receptor antagonists. Memantine Sandoz acts on these NMDA receptors by improving the transmission of nerve signals and memory.

What Memantine Sandoz is used for

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

Memantine hydrochloride contained in Memantine Sandoz may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.

What you need to know before taking Memantine Sandoz

Do not take Memantine Sandoz

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

Warnings and cautions

Talk to your doctor or pharmacist before taking Memantine Sandoz:

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

In these situations, treatment should be closely monitored and the clinical benefit of Memantine Sandoz 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.

Children and young people

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

Other drugs and Memantine Sandoz

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Memantine Sandoz 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 Sandoz.

Memantine Sandoz with food and drink

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 [renal impairment]) or severe urinary tract infections, as your doctor may need to adjust the dose of your medicine.

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.

Pregnancy

The use of Memantine Sandoz in pregnant women is not recommended.

Breast-feeding

Women taking Memantine Sandoz should not breastfeed.

Driving and using machines

Your doctor will tell you if your illness allows you to drive and use machines safely. Memantine Sandoz can also change your reactivity, making it unsuitable to drive or use machines.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Memantine Sandoz contains excipients

10 mg film-coated tablets:

Memantine Sandoz contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

20 mg film-coated tablets:

Memantine Sandoz contains lactose and sodium

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

This medicine contains less than 1 mmol (23 mg) sodium per film-coated tablet, ie essentially ‘sodium-free’.

How to take Memantine Sandoz

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

Dosage

The recommended dose 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:

Treatment period Dose once a day
Week 1 Half a 10 mg tablet or a quarter 20 mg tablet
Week 2 One 10 mg tablet or half a 20 mg tablet
Week 3 One and a half 10 mg tablets or three quarters 20 mg tablets
Week 4 and beyond Two 10 mg tablets or one 20 mg tablet

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 Sandoz should be swallowed 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.

Memantine Sandoz 10 mg film-coated tablets

The tablet can be divided into two equal doses, as the picture shows. If necessary, you can hold the tablet between your thumbs and forefingers and break it apart.

The tablet can be divided into two equal doses, as the picture shows.  If necessary, you can hold the tablet between your thumbs and forefingers and break it apart.

Memantine Sandoz 20 mg film-coated tablets

The tablet can be divided into four equal doses, as the picture shows. If necessary, place the tablet on a flat surface with the notches facing up and divide it by pressing it with your thumb.

The tablet can be divided into four equal doses, as the picture shows.  If necessary, place the tablet on a flat surface with the notches facing up and divide it by pressing it with your thumb.

Treatment time

Keep taking Memantine Sandoz for as long as you can. Your doctor should regularly evaluate your treatment.

If you take more Memantine Sandoz than you should

  • In general, it should not hurt you if you take too much Memantine Sandoz. You may experience increased symptoms as described in section 4. “Possible side effects”.
  • If you are taking a large dose of Memantine Sandoz, contact your doctor or doctor for medical advice, as you may need care.

If you forget to take Memantine Sandoz

  • If you notice that you have forgotten to take your dose of Memantine Sandoz, 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 values, 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 (thrombosis / thromboembolism).

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 this drug.

How to store Memantine Sandoz

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

No special storage instructions.

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

HDPE cans: Used within 6 months after opening.

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.

Memantine Sandoz 10 mg film-coated tablets

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

Other ingredients are:

Lactose monohydrate, microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate in the tablet core; hypromellose (E464), lactose monohydrate, macrogol, triacetin, and titanium dioxide (E171) in the film coating.

Memantine Sandoz 20 mg film-coated tablets

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

Other ingredients are:

Lactose monohydrate, sodium starch glycolate (type A), microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate in the tablet core; polyvinyl alcohol, macrogol, titanium dioxide (E171), talc, red iron oxide (E172), and yellow iron oxide (E172) in the film coating.

What the medicine looks like and contents of the pack

Memantine Sandoz 10 mg film-coated tablets

White, oval (6.1 x 11.6 mm) with a break notch on both sides.

The film-coated tablet can be divided into two equal doses.

Memantine Sandoz 20 mg film-coated tablets

Brown-red, round (diameter 11.1 mm) with two intersecting breaking grooves on one side.

The film-coated tablet can be divided into four equal doses.

The film-coated tablets are packaged in PVC-Aclar / aluminum transparent blister and/or PVC-PVDC / aluminum transparent blister or HDPE cans with PP screw caps with safety closure and desiccant, and also in cardboard.

Pack sizes:

Blister: 7, 10, 14, 18, 20, 22, 28, 30, 40, 42, 45, 48, 49, 49 x 1, 50, 56, 56 x 1, 60, 70, 84, 90, 96, 98, 98 x 1, 100, 100 x 1, 112, 980 (10 x 98) or 1,000 (20 x 50) film-coated tablets. Jar: 28, 30, 56, 98, 100 or 112 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder:

Sandoz A / S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark

Manufacturer:

Lek Pharmaceuticals dd, Verovškova 57, 1526 Ljubljana, Slovenia

or

LEK SA, ul. Domaniewska 50 C, 02-672 Warsaw, Poland

or

Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany

or

SC Sandoz, SRL, Str. Livezeni no. 7A, RO-540472 Targu-Mures, Romania

Muhammad Nadeem

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