10 mg / ml oral solution
memantine hydrochloride
What Memantin STADA is and what it is used for
Memantine Stada contains the active substance memantine hydrochloride.
What Memantine Stada is used for
Memantine Stada is used for treating patients with moderate to severe Alzheimer’s disease in adults.
How Memantin Stada works
Memantine Stada 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 the transmission of nerve signals that are important for learning and memory. Memantine Stada belongs to a group of medicines called NMDA receptor antagonists. Memantine Stada acts on these NMDA receptors by improving the transmission of nerve signals and memory.
Memantine hydrochloride contained in Memantin Stada may also be approved for the treatment of other conditions not mentioned in this leaflet. 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 Memantin STADA
Do not use Memantin STADA
- 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 Memantine Stada
- if you have a history of epileptic seizures
- if you have recently had a myocardial infarction (heart attack) or if you suffer from untreated heart failure or uncontrolled hypertension (high blood pressure ).
In these situations, treatment should be closely monitored and the clinical benefit of Memantine Stada should be regularly assessed by your physician.
If you suffer from impaired kidney function (kidney problems), your doctor should closely monitor your kidney function and, if necessary, adjust the memantine doses 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
Memantine Stada is not recommended for children and adolescents under 18 years of age.
Other medicines and Memantin STADA
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Memantine Stada may particularly affect the effects of the following medicines and these doses 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
If you are hospitalized, tell your doctor that you are taking Memantine Stada.
Memantin STADA 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 (poor kidney function)) or severe urinary tract infections, 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.
The use of memantine in pregnant women is not recommended.
Women taking Memantine Stada should not breastfeed.
Driving and using machines
Your doctor will tell you if your illness allows you to drive and use machines safely. Memantine Stada may also alter your ability to react, 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.
Memantin STADA contains sorbitol
This medicine contains 100 mg sorbitol per ml oral solution.
How to use Memantin STADA
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Dosage
(a) Pump pack of 5 mg / pump:
One pump contains 5 mg memantine hydrochloride.
The recommended dose of Memantine Stada for adults and elderly patients is four pumps, equivalent to 20 mg once daily. To reduce the risk of side effects, this dose is achieved gradually through the following daily treatment schedule:
| Treatment schedule pump packaging | |
|---|---|
| week 1 | one pumping (equivalent to 0.5 ml) |
| week 2 | two pumps (equivalent to 1 ml) |
| week 3 | three pumps (equivalent to 1.5 ml) |
| week 4 and thereafter | four pumps (equivalent to 2 ml) |
The usual starting dose is pumping once daily (1 x 5 mg) for the first week. This is increased during the second week to two pumps once daily (1 x 10 mg) and during the third week to three pumps once daily (1 x 15 mg). From the fourth week, the recommended dose is four pumps once daily (1 x 20 mg).
(b) Dosage pipettes:
| Treatment schedule dosing pipette | |
|---|---|
| week 1 | 0.5 ml |
| week 2 | 1 ml |
| week 3 | 1.5 ml |
| week 4 and thereafter | 2 ml |
The usual starting dose is 0.5 ml once daily (1 x 5 mg) for the first week. This is increased during the second week to 1 ml once daily (1 x 10 mg) and during the third week to 1.5 ml once daily (1 x 15 mg). From the fourth week, the recommended dose is 2 ml once daily (1 x 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
Memantine Stada should be taken orally once a day. For you to benefit from your medicine, you must take it regularly every day at the same time of day. The solution should be taken with a little water. The solution can be taken with or without food.
For detailed instructions on the preparation and handling of the product, see the end of the package leaflet.
Treatment time
Keep taking Memantine Stada for as long as you can. Your doctor should regularly evaluate your treatment.
If you use more Memantin STADA than you should
In general, it should not hurt you if you take too much Memantine Stada. You may experience increased symptoms as described in section 4. “Possible side effects”.
If you forget to use Memantin STADA
If you notice that you have forgotten to take your dose of Memantine Stada, 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 stop using Memantin STADA
Talk to your doctor or pharmacist if you want to stop treatment.
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 (affects 1 to 10 users in 100):
Headache, drowsiness, 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):
Fatigue, fungal infections, confusion, hallucinations, vomiting, gait disorders, heart failure, and blood clots in veins
Very rare (affects less than 1 user in 10,000):
Cramps
No known frequency (can not be calculated from the available data):
Pancreatitis, 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 Stada.
How to store Memantin STADA
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 bottle label after EXP. The expiration date is the last day of the specified month.
Memantine Stada does not require any special storage instructions.
The contents of the opened bottle should be used within 12 weeks.
The bottle with a mounted pump must be stored and transported in an upright position.
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.
Pump: Each activation of the pump (one pump) gives 0.5 ml of a solution containing 5 mg memantine hydrochloride, equivalent to 4.15 mg memantine.
Dosage pipette: 0.5 ml contains 5 mg memantine hydrochloride, equivalent to 4.16 mg memantine.
One milliliter solution contains 10 mg memantine hydrochloride.
The other ingredients are potassium sorbate (E202), sorbitol, liquid (non-crystallizing) (E420), and purified water.
What the medicine looks like and contents of the pack
Memantine Stada oral solution is a clear, colorless to a slightly yellowish solution.
Memantine Stada oral solution is available in bottles of 50 ml, 100 ml, or 10 x 50 ml.
A pump or dosing pipette is provided. The dosing pipette is printed in 0.5 ml scale division.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
STADA Arzneimittel AG
Stadastrasse 2 – 18
61118 Bad Vilbel
Germany
Manufacturer
Chanelle Medical
Loughrea, Co. Galway
Ireland
Local representative
STADA Nordic ApS
Marielundvej 46 A
2730 Herlev
Denmark