Memantine Sandoz
Italy
Table of Contents
Patient Information Leaflet: Information for the patient
Memantina Sandoz 10 mg film-coated tablets, 20 mg film-coated tablets
Equivalent medicine
Please read this leaflet carefully before taking this medicine because it contains important information for you.
- Keep this leaflet. 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. Never give it to others, even if their symptoms are the same as yours, as it could be harmful.
- If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contents of this leaflet:
- What Memantina Sandoz is and what it is used for
- What you need to know before taking Memantina Sandoz
- How to take Memantina Sandoz
- Possible side effects
- How to store Memantina Sandoz
- Package contents and other information
1. What Memantina Sandoz is and what it is used for
How Memantina Sandoz works
Memantina Sandoz belongs to a group of medicines known as anti-dementia drugs.
Memory loss in Alzheimer's disease is due to a disturbance in the transmission of messages in the brain. The brain contains so-called N-methyl-D-aspartate (NMDA) receptors, which are involved in the transmission of nerve signals important for learning and memory. Memantina Sandoz belongs to a group of medicines known as NMDA receptor antagonists. Memantina Sandoz acts on these NMDA receptors, improving the transmission of nerve signals and memory.
What Memantina Sandoz is used for
Memantina Sandoz is used for the treatment of patients with moderate to severe Alzheimer's disease.
2. What you need to know before taking Memantina Sandoz
Do not take Memantina Sandoz
- if you are allergic to memantine hydrochloride or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking Memantina Sandoz:
- if you have a history of epileptic seizures;
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- if you have recently had a myocardial infarction (heart attack), or if you suffer from congestive heart failure or uncontrolled hypertension (high blood pressure). In these cases, treatment must be closely monitored and the clinical benefits of Memantina Sandoz must be reassessed by your doctor at regular intervals.
If you have renal impairment (kidney problems), your doctor must carefully monitor your kidney function and, if necessary, adjust the memantine dosage accordingly.
Avoid concomitant use of medicines such as amantadine (used to treat Parkinson’s disease), ketamine (a substance generally used as an anaesthetic), dextromethorphan (commonly used to treat cough), and other NMDA antagonists.
Children and adolescents
Memantina Sandoz is not recommended for children and adolescents under 18 years of age.
Other medicines and Memantina Sandoz
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, the effects of the following medicines may be altered by Memantina Sandoz, and a dose adjustment may be necessary:
- amantadine, ketamine, dextromethorphan
- dantrolene, baclofen
- cimetidine, ranitidine, procainamide, quinidine, quinine, nicotine
- hydrochlorothiazide (or any combination containing hydrochlorothiazide)
- anticholinergics (substances generally used to treat motility disorders or intestinal cramps)
- anticonvulsants (substances used to prevent and treat epileptic seizures)
- barbiturates (substances generally used to induce sleep)
- dopaminergic agonists (substances such as L-dopa, bromocriptine)
- neuroleptics (substances used in the treatment of mental disorders)
- oral anticoagulants.
If you are admitted to hospital, inform your doctor that you are taking Memantina Sandoz.
Memantina Sandoz with food and drink
Inform your doctor if you have recently changed or plan to substantially change your diet (e.g. from a normal diet to a strictly vegetarian diet), or if you suffer from renal tubular acidosis (RTA, an excess of acid-forming substances in the blood due to kidney dysfunction (insufficient kidney function)) or severe urinary tract infections (the urinary elimination pathways), as your doctor may need to adjust the dose of the medicine accordingly.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
The use of Memantina Sandoz in pregnant women is not recommended.
Breastfeeding
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Women taking Memantina Sandoz must not breastfeed.
Driving and using machines
Your doctor will advise you whether your medical condition allows you to drive or operate machinery safely.
In addition, Memantina Sandoz may affect your reaction speed, making it advisable to avoid driving vehicles or operating machinery.
10 mg film-coated tablets:
Memantina Sandoz contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.
20 mg film-coated tablets:
Memantina Sandoz contains lactose and sodium
If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet, i.e. it is essentially “sodium-free”.
3. How to take Memantina Sandoz
Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Memantina Sandoz 10 mg film-coated tablets
Dosage
The recommended dose for adult and elderly patients is 20 mg once daily.
To reduce the risk of undesirable effects, this dose should be reached gradually according to the following daily treatment schedule:
| Period of administration | Daily dosage |
| 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 onwards | two 10 mg tablets |
Dosage in patients with reduced renal function
In case of reduced renal function, your doctor may determine a dosage appropriate for your
condition. In such cases, your doctor should monitor your renal function at regular intervals.
Administration
Memantina Sandoz should be taken orally once daily. To benefit from the medicine, you must take it regularly every day at the same time. The tablets should be swallowed with a glass of water. The tablets may be taken with or without food.
The tablet can be divided into two equal doses, as shown in the figure. If necessary, hold the tablet in hand and press downwards with the thumbs over the index fingers.
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Memantina Sandoz 20 mg film-coated tablets
Dosage
The recommended dose for adult and elderly patients is 20 mg once daily.
To reduce the risk of undesirable effects, this dose should be reached gradually according to the following daily treatment schedule:
| Period of administration | Daily dosage |
| week 1 | one quarter of a 20 mg tablet |
| week 2 | half of a 20 mg tablet |
| week 3 | three quarters of a 20 mg tablet |
| week 4 and onwards | one 20 mg tablet |
Dosage in patients with reduced renal function
If you have reduced kidney function, your doctor may determine a dosage appropriate for your condition. In such cases, your doctor should monitor your kidney function at regular intervals.
Administration
Memantina Sandoz should be taken orally once daily. To benefit from this medicine, you must take it regularly every day at the same time. The tablets should be swallowed with some water. The tablets may be taken with or without food.
The tablet can be divided into four equal parts, as shown in the figure below. If necessary, place the tablet on a flat surface with the score lines facing upwards and apply pressure with your thumb on the tablet.
Duration of treatment
Continue taking Memantina Sandoz for as long as you benefit from it. Your doctor will review your treatment at regular intervals.
If you take more Memantina Sandoz than you should
- In general, taking more Memantina Sandoz than prescribed is not harmful. However, you may experience an increased number of symptoms described in section 4, “Possible side effects”.
- In case of a significant overdose of Memantina Sandoz, contact your doctor, as medical intervention may be necessary.
If you forget to take Memantina Sandoz
- If you realize you have missed a dose, wait and take the next dose at the usual time.
- Do not take a double dose to make up for the missed dose.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.
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4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody will experience 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 test values, dizziness, balance disorders, shortness of breath, hypertension, and hypersensitivity to the medicine.
Uncommon – may affect up to 1 in 100 people:
- Fatigue, fungal infections, confusion, hallucinations, vomiting, gait disturbances, heart failure, and venous thrombosis (thrombosis/thromboembolism).
Very rare – may affect up to 1 in 10,000 people:
- Seizures
Not known – frequency cannot be estimated from the available data:
- Inflammation of the pancreas, inflammation of the liver (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 medicine.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at the following website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Memantina Sandoz
Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Memantina Sandoz 10 mg and 20 mg film-coated tablets
Do not use this medicine after the expiry date stated on the blister and on the carton after
Exp. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.
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6. Package contents and other information
What Memantina Sandoz contains
Memantina Sandoz 10 mg film-coated tablets
The active substance is memantine.
Each film-coated tablet contains 10 mg of memantine hydrochloride, equivalent to 8.31 mg of
memantine.
The other components are:
monohydrate lactose, microcrystalline cellulose, anhydrous colloidal silica, magnesium stearate in the core.
hypromellose (E464), monohydrate lactose, macrogol, triacetin and titanium dioxide (E 171) in the
coating.
Memantina Sandoz 20 mg film-coated tablets
The active substance is memantine.
Each film-coated tablet contains 20 mg of memantine hydrochloride, equivalent to 16.62 mg of
memantine.
The other components are:
monohydrate lactose, sodium starch glycolate (type A), microcrystalline cellulose, anhydrous colloidal silica,
magnesium stearate in the core.
polyvinyl alcohol, macrogol, titanium dioxide (E 171), talc, red iron oxide (E172) and yellow iron oxide (E172) in the
coating.
Description of the appearance of Memantina Sandoz and the package contents
Memantina Sandoz 10 mg film-coated tablets:
White, oval tablets (6.1 x 11.6 mm) with a break line on both sides.
The film-coated tablet can be divided into equal doses.
Memantina Sandoz 20 mg film-coated tablets:
Brick-red, round tablets (diameter 11.1 mm) with two crossed break lines on one side.
The film-coated tablet can be divided into equal doses.
Memantina Sandoz 10 mg film-coated tablets:
The film-coated tablets are packaged in transparent PVC-Aclar/aluminum and/or transparent PVC-PVDC/aluminum blisters and placed in a cardboard box.
Pack sizes:
Blister packs: 28 or 56 film-coated tablets.
Memantina Sandoz 20 mg film-coated tablets:
The film-coated tablets are packaged in transparent PVC-Aclar/aluminum and/or transparent PVC-PVDC/aluminum blisters and placed in a cardboard box.
Pack sizes:
Blister packs: 28 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
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Sandoz S.p.A., L.go U. Boccioni 1, 21040 Origgio (VA), Italy
Manufacturers
Lek Pharmaceuticals d.d., Verovškova 57, 1526 Ljubljana, Slovenia
LEK S.A., ul. Domaniewska 50 C, 02-672 Warszawa, Poland
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany
S.C. Sandoz, S.R.L., Str. Livezeni nr. 7A, RO-540472 Targu-Mures, Romania
Weimer Pharma GmbH, Im Steingerüst 30, 76437 Rastatt, Germany
This medicinal product is authorized in the European Economic Area countries under the following names:
Netherlands Memantine Sandoz 10 mg, filmomhulde tabletten
Memantine Sandoz 20 mg, filmomhulde tabletten
Memantine Sandoz 10 mg/ml, drank
Italy Memantina Sandoz
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