Memantine Hydrochloride Colonis 5 Mg + 10 Mg + 15 Mg + 20 Mg Soluble Tablets
Package leaflet: Information for the user Memantine hydrochloride Colonis 5 mg + 10 mg + 15 mg + 20 mg Soluble Tablets
Memantine hydrochloride
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Memantine soluble tablets are and what they are used for
2. What you need to know before you take Memantine soluble tablets
3. How to take Memantine soluble tablets
4. Possible side-effects
5. How to store Memantine soluble tablets
6. Contents of the pack and other information
1. What Memantine soluble tablets are and what they are used for
Memantine soluble tablets contain the active substance memantine hydrochloride which 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. Memantine soluble tablets belong to a group of medicines called NMDA-receptor antagonists. Memantine soluble tablets act on these NMDA-receptors improving the transmission of nerve signals and the memory.
Memantine soluble tablets are used for the treatment of patients with moderate to severe Alzheimer’s disease.
2. What you need to know before you take Memantine soluble tablets Do not take Memantine soluble tablets
- if you are allergic to memantine hydrochloride or any of the other ingredients of this medicine (listed in section 6). Warning and precautions
Talk to your doctor or pharmacist before taking Memantine soluble tablets:
- 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 your treatment should be carefully supervised, and the clinical benefit of this medicine 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.
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
Memantine soluble tablets are not recommended for children and adolescents under the age of 18 years.
Other medicines and Memantine soluble tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
In particular, Memantine soluble tablets may change the effects of the following medicines and their dose may need to be adjusted by your doctor:
- amantadine (substance used in the treatment of Parkinson’s disease)
- ketamine (an anaesthetic)
-dextromethorphan (substance used to treat coughs)
- dantrolene (substance used as a muscle relaxant)
- baclofen (substance used to relieve muscle spasms occurring in various illnesses such as cerebral palsy and multiple sclerosis)
- cimetidine, ranitidine (substances used in the treatment of indigestion, heartburn and gastric ulcers)
- procainamide, quinidine (substances used to treat irregular heartbeats)
- quinine (substance used to treat night time leg cramps)
- nicotine (substance used to help you stop smoking)
- hydrochlorothiazide (or any combination with hydrochlorothiazide - a diuretic used in the treatment of water retention and high blood pressure)
- 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 (such as L-dopa and bromocriptine which are used in Parkinson’s disease to stimulate your nerve cells)
- neuroleptics (substances used in the treatment of mental health disorders)
- oral anticoagulants (such as warfarin used to thin the blood)
If you go into hospital, let your doctor know that you are taking Memantine soluble tablets.
Memantine soluble tablets 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) or 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), 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 this medicine in pregnant women is not recommended.
Breast-feeding
Women taking this medicine 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, this medicine may change your reactivity, making driving or operating machinery inappropriate.
The “Memantine soluble tablets treatment initiation pack” is only to be used for the beginning of the treatment with Memantine soluble tablets.
Always take Memantine soluble tablets 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 Memantine soluble tablets 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.
• This pack contains 4 different blisters.
• Each blister is a different colour and contains either 5mg, 10mg, 15mg or 20mg strength tablets, which is stated on the blister.
|
Week 1 |
5 mg tablet |
Yellow blister |
|
Week 2 |
10 mg tablet |
Green blister |
|
Week 3 |
15 mg tablet |
Pink blister |
|
Week 4 and beyond |
20 mg tablet |
Blue blister |
• Each week’s tablet has a different colour and shape.
• To reduce the risk of side effects the recommended starting dose is 5 mg per day, which is stepwise increased over the first 3 weeks of treatment reaching the full strength (20mg) in the fourth week.
• It is important that you take the tablets in the correct order. The treatment scheme is also shown on the treatment initiation pack.
• Take one tablet once a day as follows:
Week 1 (day 1-7):
Take one 5 mg soluble tablet once a day (blue-coloured, oblong, biconvex tablet with length of 8.0 mm ± 0.2 mm and width of 3.75 mm - 4.35 mm) for 7 days.
Week 2 (day 8-14):
Take one 10 mg soluble tablet once a day (green-coloured, oblong, biconvex tablet with length of 11 mm ± 0.3 mm and width of 5.30 mm - 5.90 mm ) for 7 days.
Week 3 (day 15-21):
Take one 15 mg soluble tablet once a day (green-coloured, round, biconvex tablet of diameter 8.7 mm ± 0.2 mm) for 7 days.
Week 4 (day 22-28):
Take one 20 mg soluble tablet once a day (blue-coloured round, flat tablet of diameter 11.0 mm ± 0.2 mm) for 7 days.
Maintenance dose (for the fourth week and after this pack has been finished)
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 (poor) 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.
Method of administration
• This medicine should be administered orally (by mouth) once a day.
• To benefit from your medicine you should take it regularly every day at the same time of the day.
• The tablets can be taken with or without food.
• The tablets are best taken dissolved in a glass of water, however, they can also be taken whole, with a drink of water.
• Dissolve the tablet, that your doctor has told you to take, in a glass of water, and then drink all of it immediately.
• Do not leave your drink where someone else may drink it as your medicine could harm them.
Duration of treatment
Continue to take this medicine as long as it is of benefit to you.
Your doctor should assess your treatment on a regular basis.
If you take more Memantine soluble tablets than you should
- In general, taking more Memantine soluble tablets than you have been prescribed 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 Memantine soluble tablets, contact your doctor or get medical advice, as you may need medical attention.
If you forget to take Memantine soluble tablets
- If you find you have forgotten to take your dose of Memantine soluble tablets, 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 (may affect up to 1 in 10people):
• Headache.
• Sleepiness.
• Constipation.
• Elevated liver function test results.
• Dizziness, problems with your balance.
• Shortness of breath.
• High blood pressure.
• Drug hypersensitivity.
Uncommon (may affect up to 1 in 100people):
• Tiredness.
• Fungal infections.
• Confusion.
• Hallucinations.
• Being sick (vomiting).
• Abnormal gait.
• Heart failure.
• Blood clots in your veins (thrombosis/thromboembolism).
Very Rare (may affect up to 1 in 10,000people):
• Seizures.
Not known (frequency cannot be estimated from the available data):
• Inflammation of the pancreas.
• Inflammation of the liver (hepatitis).
• Psychotic reactions.
Alzheimer’s disease has been associated with depression, suicidal thoughts and suicide. These problems have been experienced by patients being treated with this medicine.
Reporting of side effects
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.
• You can also report side effects directly via the Yellow Card Scheme: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Memantine soluble tablets
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 temperature storage conditions.
Store in the original package in order to protect from moisture.
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 Memantine soluble tablets contain
- The active substance is memantine hydrochloride. Dependent on the strength of the tablet (stated on the blister pack), each soluble tablet contains:
5 mg of memantine hydrochloride equivalent to 4.15 mg memantine 10 mg of memantine hydrochloride equivalent to 8.31 mg memantine 15 mg of memantine hydrochloride equivalent to 12.46 mg memantine 20 mg of memantine hydrochloride equivalent to 16.62 mg memantine.
The other ingredients are:
Disodium Hydrogen Citrate Citric Acid Anhydrous Mannitol
Sodium Bicarbonate Sodium Benzoate Macrogol6000 (PEG 6000)
Soluble tablets 5, 20 mg Briliant Blue FCF (E 133)
Soluble tablets 10, 15 mg
Quinoline Yellow (E 104) and Patent Blue V (E 131)
What Memantine soluble tablets look like and contents of the pack
Memantine soluble tablets are supplied in packs of 28 tablets containing 4 PA/Al/PVC/Al blisters. Each blister contains 7 tablets. This treatment initiation pack consists of 4 blisters of 4 different strengths which is stated on the blister. One each of the following:
• 7 tablets of 5 mg blue-coloured, oblong, biconvex tablets with length of 8.0 mm ± 0.2 mm and width of 3.75 mm - 4.35 mm. The colour of the blister is yellow.
• 7 tablets of 10 mg green-coloured, oblong, biconvex tablets with length of 11 mm ± 0.3 mm and width of 5.30
mm - 5.90 mm. The colour of the blister is green.
• 7 tablets of 15 mg green-coloured, round, biconvex tablets of diameter 8.7 mm ± 0.2 mm. The colour of the blister is pink.
• 7 tablets of 20 mg blue-coloured round, flat tablets of diameter 11.0 mm ± 0.2 mm. The colour of the blister is blue.
Marketing Authorisation Holder
Glenmark Pharmaceuticals Europe Limited Laxmi House, 2B Draycott Avenue,
Kenton, Middlesex, HA3 0BU United Kingdom
Manufacturer
RAFARM S.A.
Thesi Pousi-Xatzi, Agiou Louka, Paiania, Attiki, TK 19002, Greece.
Marketed and Distributed By
Quantum Pharmaceutical Limited
Hobson Industrial Estate
Burnopfield
County Durham
NE16 6EA
United Kingdom