Memantine Hydrochloride Cipla 20 Mg Film-Coated Tablets
Package Leaflet - Information for the user Memantine Hydrochloride Cipla 10 mg film-coated tablets Memantine Hydrochloride Cipla 20 mg film-coated 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 Hydrochloride Cipla tablet is and what it is used for
2. What you need to know before you take Memantine Hydrochloride Cipla tablets
3. How to take Memantine Hydrochloride Cipla tablets
4. Possible side effects
5. How to store Memantine Hydrochloride Cipla tablets
6. Contents of the pack and other information
Memantine Hydrochloride Cipla tablet 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. Memantine Hydrochloride Cipla tablets belongs to a group of medicines called NMDA-receptor antagonists. Memantine Hydrochloride Cipla tablets acts on these NMDA-receptors improving the transmission of nerve signals and the memory.
Memantine Hydrochloride Cipla tablets are used for the treatment of patients with moderate to severe Alzheimer’s disease.
Do not take Memantine Hydrochloride Cipla tablets:
• if you are allergic to memantine or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking Memantine Hydrochloride Cipla 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 the treatment should be carefully supervised, and the clinical benefit of Memantine Hydrochloride Cipla tablets 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.
Other medicines and Memantine Hydrochloride Cipla tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
In particular, Memantine Hydrochloride Cipla tablets 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 Memantine Hydrochloride Cipla tablets.
Memantine Hydrochloride Cipla 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 memantine in pregnant women is not recommended.
Breast-feeding
Women taking Memantine Hydrochloride Cipla tablets 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, Memantine Hydrochloride Cipla tablets may change your reactivity, making driving or operating machinery inappropriate.
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose of Memantine Hydrochloride Cipla tablets for adults and older people is 20 mg once a day. In order to reduce the risk of side effects this dose is achieved gradually by the following daily treatment scheme:
|
Week 1 |
half a 10 mg tablet (5 mg) per day for 7 days |
|
Week 2 |
one 10 mg tablet per day for 7 days |
|
Week 3 |
one and a half 10 mg tablets (15 mg) per day for 7 days |
|
Week 4 and beyond |
two 10 mg tablets/one 20 mg tablets (20 mg) once a day |
The usual starting dose is half a tablet once a day (1x 5 mg) for the first week. This is increased to one tablet once a day (1x 10 mg) in the second week and to 1 and a half tablets once a day (15 mg) in the third week. From the fourth week on, the usual dose is two 10 mg tablets or one 20 mg tablet once a day (1x 20 mg).
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
Memantine Hydrochloride Cipla tablets 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 Memantine Hydrochloride Cipla tablets as long as it is of benefit to you. Your doctor should assess your treatment on a regular basis.
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If you take more Memantine Hydrochloride Cipla tablets than you should
- In general, taking too much Memantine Hydrochloride Cipla tablets 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 Hydrochloride Cipla tablets, contact your doctor or get medical advice, as you may need medical attention.
If you forget to take Memantine Hydrochloride Cipla tablets
- If you find you have forgotten to take your dose of Memantine Hydrochloride Cipla 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.
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 Memantine Hydrochloride Cipla tablets. Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
• 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 after EXP. The expiry date refers to the last day of the month.
• This medicinal product does not require any special temperature storage conditions.
• Store in the original package in order to protect from light.
• 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.
What Memantine Hydrochloride Cipla tablets contains
• The active substance is memantine.
• Memantine Hydrochloride Cipla 10 mg film-coated tablet: Each film-coated tablet contains 10 mg of memantine hydrochloride equivalent to 8.31 mg memantine.
• Memantine Hydrochloride Cipla 20 mg film-coated tablet: Each film-coated tablet contains 20 mg of memantine hydrochloride equivalent to 16.62 mg memantine.
• The other ingredients are:
- Tablets cores for 10 mg and 20 mg film-coated tablets: cellulose microcrystalline, crospovidone (Type B), silica, colloidal anhydrous, talc, magnesium stearate,
- Tablets coat for 10 mg and 20 mg film-coated tablets: hypromellose 2910 (6cps), macrogol 400, titanium dioxide (E171).
- Additional for 20 mg film-coated tablets: iron oxide yellow (E172), iron oxide red (E172). What Memantine Hydrochloride Cipla tablets looks like and contents of the pack
Memantine Hydrochloride Cipla 10 mg film-coated tablet are white to off-white colored, oval shaped, biconvex, bevel edged, film coated tablets, debossed ‘10’ on one side and break line on other side.
Length: 13.00mm ± 0.20mm
Width: 5.50mm ± 0.20mm
The tablet can be divided into equal doses.
Memantine Hydrochloride Cipla 20 mg film-coated tablet are pale red to grey red colored, oval shaped, biconvex, bevel edged, film coated tablets with debossed ‘20’ on one side and plain on other side.
Length: 15.30mm ± 0.20mm Width: 6.20mm ± 0.20mm
Contents of the pack
Memantine Hydrochloride Cipla 10 mg and 20 mg film-coated tablet are available in PVC/PVdC-Aluminum blister packs containing either 7, 10, 14 or 20 tablets per blister strip Pack sizes of 1x7t, 2x7t, 4x7t, 6x7t, 7x7t, 8x7t, 10x7t, 12x7t, 14x7t, 1x10t, 1x14t, 2x14t, 3x14t, 4x14t, 5x14t, 6x14t, 7x14t, 8x14t, 3x10t ,5x10t,10x10t.
Bulk blister: multiplication of 20 nos (e.g. 20x7t, 20x10t, 20x14t) in a manual carton pack.
Not all pack sizes may be marketed.
Marketing Authorisation Holder Cipla Europe NV,
Uitbreidingstraat 80,
2600 Antwerp,
Belgium.
Manufacturer
CIPLA (EU) Limited
20 Balderton Street,
London,, W1K 6TL United Kingdom
Cipla Europe NV
Uitbreidingstraat 80,
2600 Antwerp,
Belgium
S&D Pharma CZ, spol. s r.o,
Theodor 28, 273 08 Pchery (Pharmos a. s. facility), Czech Republic This leaflet was last revised in 01/2016
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