Patient leaflet - Ebixa 5 mg 10 mg 15 mg 20 mg film-coated tablets
1. What Ebixa is and what it is used for
Ebixa contains the active substance memantine hydrochloride. It 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 transmitting nerve signals important in learning and memory. Ebixa belongs to a group of medicines called NMDA-receptor antagonists. Ebixa acts on these NMDA-receptors improving the transmission of nerve signals and the memory.
Ebixa is used for the treatment of patients with moderate to severe Alzheimer’s disease.
2. What you need to know before you take Ebixa
Do not take Ebixa
if you are allergic to memantine or any
of the other ingredients of this medicine (listed in section 6).
Warning and precautions
Talk to your doctor or pharmacist before taking Ebixa:
- if you have a history of epileptic seizures
if you have recently experienced a
myocardial infarction (heart attack), or if you are suffering from congestive heart failure or from an uncontrolled hypertension (high blood pressure).
In these situations the treatment should be carefully supervised, and the clinical benefit of Ebixa reassessed by your doctor on a regular basis.
If you suffer from renal impairment (kidney problems), your doctor should closely monitor your kidney function and if necessary adapt the memantine doses accordingly.
If you are suffering from states of renal tubulary acidosis (RTA, an excess of acid-forming substances in the blood due to renal dysfunction (poor kidney function)) or severe infections of the urinary tract (structure that carries urine), your doctor may need to adjust the dose of your medicine.
The use of medicinal products called amantadine (for the treatment of Parkinson’s disease), ketamine (a substance generally used as an anaesthetic), dextromethorphan
(generally used to treat cough) and other NMDA-antagonists at the same time should be avoided.
Children and adolescents
Ebixa is not recommended for children and adolescents under the age of 18 years.
Other medicines and Ebixa
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines,.
In particular, Ebixa may change the effects of the following medicines and their dose may need to be adjusted by your doctor:
- amantadine, ketamine, dextromethorphan
- dantrolene, baclofen
cimetidine, ranitidine, procainamide,
quinidine, quinine, nicotine
hydrochlorothiazide (or any combination
with hydrochlorothiazide)
anticholinergics (substances generally
used to treat movement disorders or intestinal cramps)
anticonvulsants (substances used to
prevent and relieve 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 go into hospital, let your doctor know that you are taking Ebixa.
Ebixa with food and drink
You should inform your doctor if you have recently changed or intend to change your diet substantially (e.g. from normal diet to strict vegetarian diet), as your doctor may need to adjust the dose of your medicine.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding. 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 in pregnant women is not recommended.
Breast-feeding
Women taking Ebixa should not breast-feed.
Driving and using machines
Your doctor will tell you whether your illness allows you to drive and to use machines safely. Also, Ebixa may change your reactivity, making driving or operating machinery inappropriate.
Ebixa contains Sodium
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.
3. How to take Ebixa
The Ebixa treatment initiation pack is only to be used for the beginning of the treatment with Ebixa.
Always take Ebixa exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
The recommended treatment dose of 20 mg per day is achieved by a gradual increase of the Ebixa dose during the first 3 weeks of treatment. The treatment scheme is also indicated on the treatment initiation pack. Take one tablet once a day.
Week 1 (day 1-7):
Take one 5 mg tablet once a day (white to off-white, oval-oblong) for 7 days.
Week 2 (day 8-14):
Take one 10 mg tablet once a day (pale yellow to yellow, oval shaped) for 7 days.
Week 3 (day 15-21):
Take one 15 mg tablet once a day (grey-orange, oval-oblong) for 7 days.
Week 4 (day 22-28):
Take one 20 mg tablet per day (grey-red, oval-oblong) for 7 days.
week 1 5 mg tablet week 2 10 mg tablet week 3 15 mg tablet week 4
and beyond
20 mg tablets once a day
Maintenance dose
The recommended daily dose is 20 mg once a day.
For continuation of the treatment please consult your doctor.
Dosage in patients with impaired kidney function
If you have impaired kidney function, your doctor will decide upon a dose that suits your condition. In this case, monitoring of your kidney function should be performed by your doctor at specified intervals.
Administration
Ebixa should be administered orally once a day. To benefit from your medicine you should take it regularly every day at the same time of the day. The tablets should be swallowed with some water. The tablets can be taken with or without food.
Duration of treatment
Continue to take Ebixa as long as it is of benefit to you. Your doctor should assess your treatment on a regular basis.
If you take more Ebixa than you should
- In general, taking too much Ebixa should not result in any harm to you. You may experience increased symptoms as described in section 4. ”Possible side effects”.
- If you take a large overdose of Ebixa, contact your doctor or get medical advice, as you may need medical attention.
If you forget to take Ebixa
- If you find you have forgotten to take your dose of Ebixa, 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 medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
In general, the observed side effects are mild to moderate.
Common (affects 1 to 10 users in 100):
- Headache, sleepiness, constipation, elevated liver function tests, dizziness, balance disorders, shortness of breath, high blood pressure and drug hypersensitivity
Uncommon (affects 1 to 10 users in 1,000):
- Tiredness, fungal infections, confusion, hallucinations, vomiting, abnormal gait, heart failure and venous blood clotting (thrombosis/thromboembolism)
Very Rare (affects less than 1 user in 10,000):
- 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 Ebixa.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacis. This includes any possible side effects not listed in this leaflet. You can also Package leaflet: Information for the user
0603 -
Ebixa_tablets_PL_230x400 (mz630)
230x400
REG
REG
2021-10-26 / 08.15 / aami GB-638610 MZ
5 mg film-coated tablets 10 mg film-coated tablets 15 mg film-coated tablets 20 mg film-coated tablets
Memantine hydrochloride
400 mm
230 mm
H. Lundbeck A/S Ottiliavej 9
2500 Valby
Denmark
Mail:
CREATOR AT A&MD COLOUR SPECIFICATIONS NEW MATERIAL
report side effects directly via:
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Ebixa
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 the blister after EXP. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Ebixa contains
The active substance is memantine
hydrochloride. Each tablet contains 5/10/15/20 mg ofmemantine
hydrochloride equivalent to
4.15/8.31/12.46/16.62 mg memantine.
- The other ingredients for Ebixa 5/10/15 and 20 mg film-coated tablets are microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate, all in the tablet core; and hypromellose, macrogol 400, titanium dioxide (E 171) and additional for Ebixa 10 mg film-coated tablets is iron oxide yellow (E172) and for Ebixa 15 mg and Ebixa 20 mg film-coated tablets are iron oxide yellow and red (E 172), all in the tablet coating.
What Ebixa looks like and contents of the pack
Ebixa 5 mg film-coated tablets are presented as white to off-white, oval-oblong with imprint ‘5’ on one side and imprint ‘MEM’ on the other side.
Ebixa 10 mg film-coated tablets are presented as pale yellow to yellow, oval shaped film-coated tablet with breaking line and engravings ‘1 0’ on one side and ‘M M’ on the other side. The tablet can be divided into equal doses.
Ebixa 15 mg film-coated tablets are presented as orange to grey-orange, oval-oblong with imprint ‘15’ on one side and imprint ‘MEM’ on the other side.
Ebixa 20 mg film-coated tablets are presented as are pale red to grey-red, oval-oblong with imprint ‘20’ on one side and imprint ‘MEM’ on the other side.
One treatment initiation pack contains 28 tablets in 4 blisters with 7 tablets of Ebixa 5 mg, 7 tablets of Ebixa 10 mg, 7 tablets of Ebixa 15 mg and 7 tablets of Ebixa 20 mg.
Marketing Authorisation Holder and Manufacturer
H. Lundbeck A/S
Ottiliavej 9
2500 Valby
Denmark.
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
United Kingdom
Lundbeck Limited
Tel: +44 1908 64 9966
This leaflet was last revised in July 2021
GB-638610 MZ