10 mg film-coated tablets
memantine hydrochloride
What Marbodin is and what it is used for
How Marbodin works
Marbodin 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. Marbodin belongs to a group of medicines called NMDA receptor antagonists. Marbodin acts on these NMDA receptors by improving the transmission of nerve signals and memory.
What Marbodin is used for
Marbodin is used to treat patients with moderate to severe Alzheimer’s disease.
Memantine hydrochloride contained in Marbodin may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professionals if you have any further questions, and always follow their instructions.
What you need to know before using Marbodin
Do not use Marbodin
- 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 Marbodin:
- if you have a history of epileptic seizures
- if you have recently had a heart attack (heart attack) or if you suffer from chronic heart failure or uncontrolled hypertension (high blood pressure ).
In these situations, treatment should be closely monitored and the clinical benefit of Marbodin should be regularly assessed by your doctor.
If you suffer from renal impairment (kidney problems), your doctor should closely monitor your renal function and, if necessary, adjust the dose of Marbodin 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
Marbodin is not recommended for children and adolescents under 18 years of age.
Other drugs and Marbodin
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Marbodin may in particular affect the effects of the following medicines and the doses of these 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 (blood thinners taken by mouth).
If you are hospitalized, tell your doctor that you are taking Marbodin.
Marbodin 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 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.
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 during pregnancy is not recommended.
Breast-feeding
Women taking Marbodin should not breastfeed.
Driving and using machines
Your doctor will tell you if your illness allows you to drive and use machines safely.
Marbodin may also alter 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.
Marbodin contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie essentially ‘sodium-free’. is next to “sodium-free”.
How to use Marbodin
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 Marbodin 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 | a 10 mg tablet |
| Week 3 | one and a half 10 mg tablet |
| Week 4 and beyond | two 10 mg tablets or one 20 mg tablet |
The usual starting dose is half a tablet once a day (1×5 mg) for the first week. This is increased to one tablet once a day (1×10 mg) during the second week and to one and a half tablets once a day during the third week. From the fourth week onwards, the usual dose is two tablets once a day (1×20 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
Marbodin should be taken by mouth, 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
Keep taking Marbodin for as long as you can. Your doctor should regularly evaluate your treatment.
If you use more Marbodin than you should
- Normally it should not harm you if you take too much Marbodin. You may experience increased symptoms as described in section 4. “Possible side effects”.
If you forget to use Marbodin
- If you find that you have forgotten to take your dose of Marbodin, 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):
- Pancreas, liver inflammation ( 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 hydrochloride.
How to store Marbodin
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.
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.
One film-coated tablet contains 10 mg memantine hydrochloride equivalent to 8.31 mg memantine.
The other ingredients are microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica, and magnesium stearate, all in the tablet core; and polyvinyl alcohol, titanium dioxide (E171), macrogol (3350), and talc, all in the tablet coating.
What the medicine looks like and contents of the pack
Marbodin 10 mg film-coated tablets are white, narrow in the middle, biconvex, 10 mm – 5.6 mm, film-coated tablets with a scoreline on both sides and marked ’10’ on one side.
The tablet can be divided into two equal doses.
Blister pack of 10, 14, 15 or 20 tablets per blister (PVC / PE / PVDC and Al). Pack sizes of 28, 30, 50, 56 or 100 film-coated tablets.
Blister pack of 10 x 1, 14 x 1, 15 x 1 or 20 x 1 tablets per blister (single-dose blisters PVC / PE / PVDC and Al).
Pack sizes of 28 x 1, 30 x 1, 50 x 1, 56 x 1, 98 x 1 or 100 x 1 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
Local representative
STADA Nordic ApS
Marielundvej 46A
2730 Herlev
Denmark