10 mg and 20 mg film-coated tablet
memantine hydrochloride

What Mentixa is and what it is used for

The active substance memantine in Mentixa 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 N-methyl-D-aspartate (NMDA) receptors that are involved in the transmission of nerve signals that are important for learning and memory. Mentixa belongs to a group of medicines called NMDA receptor antagonists. Mentixa acts on these NMDA receptors by improving the transmission of nerve signals and memory.

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

Memantine hydrochloride contained in Mentixa may also be approved for the treatment of other conditions not mentioned in this leaflet. 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 using Mentixa

Do not use Mentixa

  • 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, pharmacist, or nurse before taking Mentixa:

  • 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 Mentixa should be regularly assessed by your doctor.

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.

The 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 with Mentixa should be avoided.

Children and young people

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

Other medicines and Mentixa

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

Mentixa may in particular 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 Mentixa.

Mentixa with food, drink and alcohol

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 of acid formation). substances in the blood due to kidney dysfunction (impaired kidney function)) or severe urinary tract infection (the structure that directs the urine), 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 for advice before taking this medicine. The use of memantine in pregnant women is not recommended. Women taking Mentixa should not breastfeed.

Driving and using machines

Your doctor will tell you if your illness allows you to drive and use machines safely. Mentixa may also alter your ability to react, 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.

Mentixa contains lactose and sodium

Mentixa 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.

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

How to use Mentixa

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

Dosage

The recommended dose of Mentixa 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 tablet
Week 4 Two 10 mg tablets or one 20 mg tablet

The usual starting dose is half a 10 mg film-coated tablet once a day (1 x 5 mg) for the first week. This is increased to a 10 mg film-coated tablet once a day (1 x 10 mg) during the second week and to one and a half 10 mg film-coated tablets once a day (1 x 15 mg) during the third week. From the fourth week onwards, the usual dose is one 10 mg film-coated tablet or one 20 mg film-coated tablet once a day (1 x 20 mg).

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

Mentixa 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 10 mg tablet can be divided into two equal doses. The tablets can be taken with or without food.

Treatment time

Keep taking Mentixa for as long as your doctor tells you to. Your doctor should regularly evaluate your treatment.

If you use more Mentixa than you should 

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

If you forget to use Mentixa

  • If you notice that you have forgotten to take your dose of Mentixa, 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 (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 Mentixa.

How to store Mentixa

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. The expiration date is the last day of the specified month.

No special storage instructions.

Tablet jar:

After the first opening of the jar, the contents must be consumed within 3 months. Do not store above 25 ° C.

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 hydrochlorideMentixa 10 mg film-coated tabletsEach film-coated tablet contains 10 mg memantine hydrochloride equivalent to 8.31 mg memantine.Mentixa 20 mg film-coated tabletsEach film-coated tablet contains 20 mg memantine hydrochloride equivalent to 16.62 mg memantine.
  • Other ingredients (excipients) are:Tablet core : Lactose monohydrate , microcrystalline cellulose (E460), colloidal anhydrous silica, talc (E553b) and magnesium stearate (E470b).Film coating : Methacrylic acid – ethyl acrylate copolymer (1: 1), sodium lauryl sulfate, polysorbate 80, talc (E553b), triacetin and simethicone emulsion (contains dimethicone, colloidal aqueous silica, macrogol stearyl ether, hydrogen peroxide , sorbic acid, water). See section 2 “Mentixa contains lactose and sodium”.

What the medicine looks like and contents of the pack

Mentixa 10 mg film-coated tablets

The tablets are white, oval, biconvex film-coated tablets with a scoreline on one side (tablet length: 12.2 – 12.9 mm, thickness: 3.5 – 4.5 mm).

The tablets can be divided into equal doses.

Mentixa 20 mg film-coated tablets

The tablets are white, oval, biconvex film-coated tablets (tablet length: 15.7 – 16.4 mm, thickness: 4.7 – 5.7 mm).

Mentixa is available in packs of:

  • 14, 28, 30, 42, 50, 56, 60, 70, 84, 90, 98, 100 and 112 film-coated tablets in blisters.
  • 100 film-coated tablets in a tablet jar with a safety seal.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

KRKA, dd, Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer

KRKA dd, Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

TAD Pharma GmbH, Heinz-Lohmann-Straße. 5, 27472 Cuxhaven, Germany

Muhammad Nadeem

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