MEMOX DROPS

Israel - English - Ministry of Health

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Active ingredient:
MEMANTINE HYDROCHLORIDE 10 MG/G
Available from:
UNIPHARM LTD
ATC code:
N06DX01
Pharmaceutical form:
DROPS
Administration route:
PER OS
Manufactured by:
TRIMA ISRAEL PHARMACEUTICAL PRODUCTS MAABAROT LTD, ISRAEL
Therapeutic group:
MEMANTINE
Therapeutic indications:
Treatment of patient with moderately severe to severe Alzheimer's disease.
Authorization number:
146103298100
Authorization date:
2011-05-01

Documents in other languages

Patient Information leaflet Patient Information leaflet - Arabic

23-01-2021

Patient Information leaflet Patient Information leaflet - Hebrew

23-01-2021

.اهب ىصوملا ةعرجلا زواجت عنم

ُ

ي

.ءاملا نم ليلقلا عم صرقلا علب بجي :لامعتسلاا ةقيرط .موي لك يف تقولا سفن يف ءاودلا لوانت بجي .مويلا يف ةدحاو ة

رم ءاودلا لوانت بجي .صارقلأا رطش وأ قحس نكمي ،موزللا دنع ،ا

ً

روف ،ه

ّ

جوتف أطخلا قيرط نع ءاودلا نم ةي

ّ

مك علاتباب لفط ماق اذإ وأ ةطرفم ةعرج تلوانت اذإ ةطرفم ةعرج لوانت .كعم ءاودلا ةبلع رضحأو ،ىفشتسملا يف ئراوطلا ةفرغ ىلإ وأ بيبطلا ىلإ

.)"ة

يبناج ضارعأ" دنبلا رظنأ( ة

يبناج ضارعأب رعشت نأ نكمملا نم نكل ،ا

ررض ب

بس

ي لا ةداع عونمم .داتع

ملا اهتقو يف ةيلاتلا ةعرجلا لوانتو رظتنا ،د

دح

ملا تقولا يف ءاودلا لوانت تيسن اذإ

يوس نيتعرج لوانت ا

قلاطإ .جلاع

ملا بيبطلا اهد

دح امك ةددحم تاقوأ يف ءاودلا اذه لامعتسا بجي عنم

ي ،ةي

حصلا كتلاح ىلع ن

سحت أرط اذإ ىتح .بيبطلا هب كاصوأ يذلا جلاعلا لامكإ كيلع بجي .بيبطلا ةراشتسا نودب ءاودلاب جلاعلا نع فقوتلا لوانتت ة

رم

لك يف ةيئاودلا ةعرجلا نمو ءاودلا ىلع قصلملا نم ق

قحت !ملاظلا يف ءاودلا لوانت عنم

.اهيلإ ةجاحب تنك اذإ ةي

بطلا تاراظنلا عض .ءاود اهيف

يلديصلا وأ بيبطلا ر

شتساف ءاودلا لامعتسا ىلإ ةبسنلاب ةيفاضإ ةلئسأ كيدل تناك اذإ

4

.

ةيبناجلا ضارعلأا مدصت لا .ءاودلا يلوانتم نم مسق ىدل ةيبناج ا

ضارعأ سكوميم لامعتسا ب

بسي دق ،ةيودلأا عيمجك .اهنم

ٍّ

يأ نم يناعت

لاأ لمتحملا نم .ةيبناجلا ضارعلأا ةمئاق ةءارق دنع :)جلاعتم ١٠٠: ١ ىتح اهعويش ةبسن( ةبراقتم نايحأ يف رهظت ة

ّ

يبناج ضارعأ صحف جئاتن يف عافترإ ،مدلا طغض عافترإ ،ساعن ،كاسمإ ،عادص ،نزاوتلا يف تابارطضإ ،راود .ءاودلل يسسحت لعف در ،سفنتلا يف قيض ،دبكلا فئاظو :)جلاعتم ١٠٠٠ :١ ىتح اهعويش ةبسن( ةدعابتم نايحأ يف رهظت ة

ّ

يبناج ضارعأ .بلق روصق ،ةيديرو ةطلج ،ةيرطف ىوادع ،تاؤيقت ،يشملا يف تابارطضإ ،قاهرإ ،كابترإ ،ةسوله :)جلاعتم ١٠٠٠ :١ نم لقأ اهعويش ةبسن( ةردان ةيبناج ضارعأ .تاجلاتخإ دبكلا باهتلإ ،سايركنبلا باهتلإ ،ةيناهذ لعف دودر :ةفورعم ريغ اهعويش ةبسن ةيبناج ضارعأ

.)hepatitis(

ضيأ هذهك ثادحأ نع غيلبتلا

مت .راحتناو ةيراحتنا راكفأ ،بائتكلااب ا

ضيأ رمياهزللأا ضرم طبترا .سكوميم اولوانت نيجلاعتم ىدل ةروكذم ريغ ةيبناج ضارعأ نم تيناع اذإ وأ ةيبناجلا ضارعلأا دحأ مقافت اذإ ،يبناج ضرع رهظ اذإ .بيبطلا ةراشتسا كيلعف ،ةرشنلا يف طب ا رل ا ىلع طغضلا للاخ نم ة

يبناج ضارعأ نع ة

حصلا ةرازو غيلبت نكمملا نم

ةرازو عقوم يف ةيسيئرلا ةحفصلا ىلع دوجوملا ״ةيودلأاب جلاع ةجيتن ة

يبناج ضارعأ نع غيلبتلا״ نم ،كلذ نم

لادب .ة

يبناجلا ضارعلأا نع غيلبتلل ة

دعم ة

صاخ ةرامتسإ ىلإ كل

وحي يذلا ة

حصلا .״مرافينوأ״ ةكرش غيلبت نكمملا

5

.

؟ءاودلا نزخي فيك

يديأ لوانتم نع ا

ديعب ،قلغم ناكم يف ،رخآ ءاود

لكو ،ءاودلا اذه ظفح بجي !م

مستلا ب

نجت .ﺐﻴﺒﻄلا ﻦم ةﺤيﺮص تاﻤﻴلعت نوﺪب ؤ

يقتلا ﺐّﺒﺴت لا .م

مستلا ب

نجتت اذكهو ،لافطلأا وأ/و دلاولأا

ءاهتنا خيرات .ة

وبعلا ىلع رهاظلا )exp. date( ةيحلاصلا ءاهتنا خيرات دعب ءاودلا لوانت عنم

.هتاذ رهشلا يف ريخلأا مويلا ىلإ بسني ةيحلاصلا

.ءوضلا نم يمحم ناكم يفو ٢٥˚C ـلا تحت ةرارح ةجردب ءاودلا ظفح بجي

٦

.

ةيفاضإ تامولعم

ضيأ ،ءاودلا يوتحي ،ةلا

عفلا ة

داملا ىلإ ةفاضلإاب

Microcrystalline Cellulose, Lactose Anhydrous, Magnesium Stearate, Opadry

White.

وبعلا يوحت اذامو ءاودلا ودبي فيك نم ةمزر لك يف .نوترك ة

وبع لخاد ةدوجوملا )تارتسيلب( طئارش لخاد ةموزرم سكوميم صارقأ

صرق ٢٨ دجوي ٢٠ سكوميم نم ةمزر لك يفو ،ا

صرق ٥٦ دجوي ١٠ سكوميم .ةدحاو ةهج نم رطشلل طخ عم نيتهجلا نم ةبدحم ،ضيبأ نول تاذ ،ة

يلطم ةريدتسم صارقأ يه ١٠ سكوميم رطشلل طخ عم نيتهجلا نم ةبدحم ،ضيبأ نول تاذ ،ة

يلطم ةيوضيب صارقأ يه ٢٠ سكوميم .ةدحاو ةهج نم .٦١٢١٣٠١ بيبأ-لت ،٢١٤٢٩ .ب.ص ،.ض.م مرافينوأ :ليجستلا بحاص مسا .ليئارسإ ،توربعم ستوبيك ،.ض.م اميرت :هناونعو جتنملا مسا .٢٠١٦ زو

مت :خيرات يف ة

حصلا ةرازو لب

ق نم اهيلع قيدصتلاو ةرشنلا هذه صحف

مت

ّ

حصلا ةرازو يف

ّ

يمسرلا ةيودلأا

ّ

لجس يف ءاودلا ليجست مقر ١٣٣ ١٦ ٣١١١٧ ٠١ :١٠ سكوميم ١٤٦ ٠٩ ٣٢٩٦٥ ٠٠ :٢٠ سكوميم .نيسنجلا لاكل

دعم ءاودلاف اذه عم .ر

كذملا ةغيصب

صنلا درو اهليهستو ةرشنلا هذه ةءارق طيسبتل

Patient leaflet in accordance with the Pharmacists’ Regulations

)Preparations( - 1986

The dispensing of this medicine requires a doctor’s prescription

MEMOX 10;20

TABLETS

Composition:

Each Memox 10 tablet contains: Memantine Hydrochloride 10 mg

Each Memox 20 tablet contains: Memantine Hydrochloride 20 mg

Inactive ingredients: See Section 6 ‘Additional Information’.

Read the entire leaflet carefully before using this medicine. This

leaflet contains concise information about this medicine. If you have

further questions, refer to your doctor or pharmacist.

This medicine has been prescribed to treat your illness. Do not pass it

on to others. It may harm them, even if it seems to you that their illness

is similar to yours.

This medicine is not intended for children and adolescents under 18

years old.

1. What is this medicine intended for?

Memox is indicated for the treatment of moderate to severe Alzheimer’s

disease.

Memox belongs to a class of drugs that are used to treat dementia.

Memory loss that is typical of Alzheimer’s disease is caused by a

disruption in transmission of neural signals in the brain.

In the brain there is a type of receptors, called NMDA receptors. These

receptors are involved in transmitting neural signals that are important to

learning and memory. By acting on NMDA receptors, Memox improves

neural signal transmission and memory.

Therapeutic group: NMDA receptor antagonist.

2. Before using this medicine

Do not use this medicine if:

You are sensitive )allergic( to the active ingredient or to any of the

other ingredients that this medicine contains )see Section 6 for a

list of inactive ingredients(.

Special warnings about using this medicine

Before using Memox, tell your doctor if:

You have a history of epilepsy )epileptic seizures(

You are suffering, or have suffered in the past, from impaired function

of the heart and/or vascular system )heart attack, heart failure,

hypertension(.

In any of the conditions listed above, your doctor will carefully monitor

your treatment with this medicine, and will regularly evaluate its efficacy.

You are suffering, or have suffered in the past, from impaired kidney

function. Your doctor will have to carefully monitor your kidney function

and adjust the dose if necessary.

You have recently made or intend to make extreme changes in your

daily diet )such as shifting from a regular diet to a vegetarian diet(,

or you consume large quantities of antacids.

You are hospitalized. It is important to inform the doctor at the hospital

that you are taking Memox.

Avoid taking the following medicines while taking Memox:

Amantadine )for treating Parkinson's disease(

Ketamine )a general anesthetic(

Dextromethorphan )a cough medicine(

Other NMDA antagonists

If you are taking or have recently taken other medicines, including

nonprescription medications and nutritional supplements, tell your

doctor or pharmacist. In particular tell the doctor or pharmacist if you

are taking:

Amantadine, ketamine, dextromethorphan )see section ‘Special

warnings about using this medicine’(

Dantrolene, baclofen )antispastic(

Cimetidine, ranitidine, procainamide, quinidine, quinine, nicotine

Hydrochlorothiazide

Anticholinergic medicines )usually used to treat involuntary movements

and intestinal colic(

Medicines for treating epilepsy

Barbiturates )sedatives or sleeping pills(

Dopamine agonists such as L-DOPA, bromocriptine )for treating

Parkinson’s disease(

Neuroleptics )for treating mental disorders(

Anticoagulant medicines

Using the medicine and food

You can take this medicine with or without food.

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant or

are planning to get pregnant consult your doctor or pharmacist before

taking this medicine.

Pregnancy

Memox is not recommended for pregnant women.

Breast-feeding

Do not breastfeed if you are taking Memox.

Driving and using machines

Your doctor will tell you if your medical condition allows you to safely

drive or operate machinery.

In addition, do not drive, or operate dangerous machines while using

this medicine, because your alertness and response time may be

affected by the medicine.

3. How to use this medicine?

Always use according to the doctor’s instructions. Check with your

doctor or pharmacist if you are not sure.

Your doctor will determine your dose and how you should take the

medicine. The recommended dose is usually:

Recommended dose for adult and elderly patients: 20 mg/day.

In order to reduce the risk of side effects, gradually increase the dose

according to the following program:

Week 1

5 mg

Week 2

10 mg

Week 3

15 mg

Week 4 and on

20 mg

The initial dose is half a tablet of Memox 10 once a day for the first week.

During the second week, one Memox 10 tablet once a day.

During the third week, one and a half tablets of Memox 10 once a day.

From the fourth week onward, one Memox 20 tablet or two Memox 10

tablets once a day.

Dose for patients with impaired kidney function:

In patients with mild renal failure )creatinine clearance 50-80 ml/min(,

no adjustment of the dose is necessary.

In patients with moderate renal failure )creatinine clearance

30-49 ml/min(, the daily dose is 10 mg/day. If the medicine is tolerated

after 7 days of treatment, the dose can be increased to 20 mg/day.

In patients with severe renal failure )creatinine clearance 5-29 ml/min(,

the daily dose is 10 mg/day.

Do not exceed the recommended dose.

Directions for use: Swallow the medicine with some water.

Take the medicine once a day. Take the medicine at the same time

every day.

You may crush or split the tablets if necessary.

If you have taken an overdose, or if a child has accidentally

swallowed some medicine, go immediately to a hospital emergency

room and bring the medicine package with you.

Usually, taking an overdose does not do any harm, but you may

experience side effects )see section ‘Side effects’(.

If you forget to take this medicine at the scheduled time, wait and take

the next dose at the regular time, but never take two doses together!

Take this medicine at regular intervals as your attending doctor has

prescribed.

Persist with the treatment as recommended by the doctor. Even if your

health improves, do not stop taking this medicine without consulting

your doctor.

Do not take medicines in the dark! Check the label and dose each time

you take the medicine. Wear glasses if you need them.

If you have any further questions about using this medicine, consult

your doctor or the pharmacist.

4. Side effects

Like all medicines, taking Memox may cause side effects in some users.

Do not be alarmed by this list of side effects. You may not experience

any of them.

Common side effects )appear in up to 1:100 patients(:

Dizziness, balance disorders, headache, constipation, sleepiness,

hypertension, elevated liver function test results, shortness of breath,

allergic reaction to the medicine.

Uncommon side effects )appear in up to 1:1000 patients(:

Hallucinations, confusion, fatigue, walking disorders, vomiting, fungal

infections, venous thrombosis, heart failure.

Rare side effects )appear in less than 1:1000 patients(:

Seizures.

Side effects of unknown frequency: Psychotic reactions, pancreatitis,

hepatitis.

Alzheimer's disease is also associated with depression, suicidal ideation,

and suicide. Such events have also been reported in patients who were

taking Memox.

If you experience any side effect, if any side effect gets worse, or if you

experience a side effect not mentioned in this leaflet, consult your doctor.

You can report side effects to the Ministry of Health )MoH( by following

the link ‘Reporting Side Effects of Medication’ on the MoH home page

which links to an online form for reporting side effects. You can also

report to Unipharm company.

5. How to store the medicine?

Prevent poisoning! To prevent poisoning, keep this, and all other

medicines, in a closed place out of reach of children and/or infants.

Do not induce vomiting unless explicitly instructed to do so by a doctor.

Do not use the medicine after the expiry date )exp. date( appearing

on the package. The expiry date refers to the last day of that month.

Store below 25˚C and in a place protected from light.

6. Additional information

In addition to the active ingredient this medicine also contains:

Microcrystalline cellulose, lactose anhydrous, magnesium stearate, opadry

white.

What the medicine looks like and what are the contents of the package:

Memox tablets are packed in blister trays in a cardboard box. There

are 56 tablets in each package of Memox 10, There are 28 tablets in

each package of Memox 20.

Memox 10 are round, white, film-coated, bi-convex tablets with a score

line on one side.

Memox 20 are oval, white, film-coated, bi-convex tablets with a score

line on one side.

Registration holder:

Unipharm Ltd., P.O.B. 21429, Tel-Aviv 6121301.

Manufacturer name and address:

Trima Ltd., Kibbutz Maabarot, Israel.

This leaflet was reviewed and approved by the Ministry of Health in:

July 2016

Registration number of the medicine in the National Drug Registry

of the Ministry of Health:

Memox 10: 133 16 31117 01

Memox 20: 146 09 32965 00

118438010

0716K

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