Memantine STADA 10 mg/ml drank

<Invented Name> contains the active substance memantine hydrochloride.

What is <Invented Name> used for

<Invented Name> is used to treat patients with moderate to severe Alzheimer’s disease in adults.

How <Invented Name> works

<Invented Name> 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. <Invented Name> belongs to a group of medicines called NMDA-receptor antagonists. <Invented Name> acts on these NMDA-receptors improving the transmission of nerve signals and the memory.

Do not take <Invented Name>- if you are allergic (hypersensitive) to memantine hydrochloride or any of the other ingredients of this medicine. (See section 6).

Warnings and precautions

Talk to your doctor or pharmacist before taking <Invented Name>

ID: PL 167M

Version: 01

Review Date: 13/06/13

• 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 uncontrolled hypertension (high blood pressure).

In these situations the treatment should be carefully supervised, and the clinical benefit of <Invented Name> 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 adolesents

<Invented Name> is not recommended for children and adolescents under the age of 18 years.

Other medicines and <Invented Name>

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

In particular, <Invented Name> 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 <Invented Name>.

<Invented Name> with food, drink and alcohol

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, breast-feeding and fertility

If you are pregnant or breast feeding, think you may be pregnant or 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 <Invented Name> 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, <Invented Name> may change your reactivity, making driving or operating machinery inappropriate.

<Invented Name> contains Sorbitol

ID: PL 167M

Version: 01

Review Date: 13/06/13

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. Your doctor will advise you.

Always take <Invented Name> exactly as your doctor or pharmacist has told you. You should check with your doctor or pharmacist if you are not sure.

Dosage

(a)Pump pack of 5mg/pump actuation:

One pump actuation contains 5 mg memantine hydrochloride.

The recommended dose of <Invented Name> for adults and elderly patients is four pump actuations, equivalent to 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	one downward pump
	(equivalent to 0.5 ml)
week 2	Two downward pumps
	(equivalent to 1ml)
week 3	Three downward pumps
	(equivalent to 1.5ml)
week 4	Four downward pumps
and beyond	(equivalent to 2ml)

The usual starting dose is one pump actuation once daily (1x 5 mg) for the first week. This dose is increased in the second week to two pump actuations once daily (1 x 10 mg), and in the third week to three pump actuations once daily (1 x 15 mg). From the fourth week the recommended dose is four pump actuations once daily (1x 20 mg).

(b)Dosing Pipette:
week 1	0.5 ml
week 2	1 ml
week 3	1.5 ml
week 4 and beyond	2 ml

The usual starting dose is 0.5 ml once daily (1x 5 mg) for the first week. This dose is increased in the second week to 1 ml once daily (1 x 10 mg), and in 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 (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

<Invented Name> 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 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 end of this leaflet.

ID: PL 167M

Version: 01

Review Date: 13/06/13

Duration of treatment

Continue to take <Invented Name> as long as it is of benefit to you. Your doctor should assess your treatment on a regular basis.

If you take more <Invented Name> than you should

In general, taking too much <Invented Name> 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 <Invented Name>, contact your doctor or get medical advice, as you may need medical attention.

If you forget to take <Invented Name>

If you find you have forgotten to take your dose of <Invented Name>, 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 taking <Invented Name>

If you want to stop the treatment before finishing the course of treatment discuss with your doctor or pharmacist first.

If you have any further questions on the use of this product, 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 <Invented Name>.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

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 national reporting system listed in Appendix V*. By reporting side effects you can help provide more information on the safety of this medicine.

ID: PL 167M

Version: 01

Review Date: 13/06/13

5. HOW TO STORE

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 bottle label after EXP. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

Once opened, the contents of the bottle should be used within 12 weeks.

If using the bottle with the mounted pump the bottle must be kept and transported in an upright position only.

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 <Invented Name> contains

The active substance is memantine hydrochloride.

Pump: Each pump actuation (one downward pump) delivers 0.5 ml of solution containing 5 mg of memantine hydrochloride equivalent to 4.16 mg memantine.

Dosing Pipette: 0.5 ml contains 5 mg of memantine hydrochloride equivalent to 4.16 mg of memantine.

Each ml of solution contains 10 mg of Memantine Hydrochoride.

The other ingredients are potassium sorbate E202, sorbitol E420 and purified water.

What <Invented Name> looks like and contents of the pack

<Invented Name> oral solution is presented as a clear, colourless to light yellowish solution. <Invented Name> 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 graduations. Not all pack sizes may be marketed.

Houder van de vergunning voor het in de handel brengen en fabrikant:

STADA Arzneimittel AG Stadastrasse 2 – 18 61118 Bad Vilbel Duitsland

Fabrikant:

Chanelle Medical

Loughrea, Co. Galway

Ierland

In het register ingeschreven onder:

RVG 112067

ID: PL 167M

Version: 01

Review Date: 13/06/13

This medicinal product is authorised in the Member States of the EEA under the following names:

< See Module 1.2 – Annex 5.19 for proposed invented names >

Deze bijsluiter is voor het laatst goedgekeurd in november 2013.

Instruction for proper use of the pump

The solution must not be poured or pumped directly into the mouth from the bottle or pump. Measure the dose onto a spoon or into a glass of water, using the pump.

Take the screw cap off the bottle:

The cap must be turned anticlockwise, unscrewed completely and removed (fig. 1).

Mounting the dosing pump on the bottle:

Take the dosing pump out of the plastic bag (fig. 2) and place it on top of the bottle. Slide the plastic dip tube carefully into the bottle. Hold the dosing pump onto the neck of the bottle and screw it clockwise until it fits firmly (fig. 3). The dosing pump is only screwed on once when starting the use, and should never be unscrewed.

ID: PL 167M

Version: 01

Review Date: 13/06/13

How the dosing pump works:

The dosing pump head has two positions and is easy to turn: -anticlockwise to unlock and

-clockwise to lock.

The dosing pump head should not be pushed down while in the locked position. The solution may only be dispensed in the unlocked position. To unlock, turn the pump head in the direction of the arrow until it cannot be turned any further (about one eighth of a turn, fig. 4). The dosing pump is then ready for use.

Preparing the dosing pump:

When used for the first time, the dosing pump does not dispense the correct amount of oral solution. Therefore, the pump must be prepared (primed) by pushing the dosing pump heads down completely five times in succession (fig 5.)

ID: PL 167M

Version: 01

Review Date: 13/06/13

The solution thus dispensed is discarded. The next time the dosing pump head is pushed downwards completely (equivalent to one pump actuation), it dispenses the correct dose (fig 6.)

Correct use of the dosing pump:

Hold a glass with a little water or a spoon below the nozzle. Push down the dosing pump head in a firm but calm and steady manner-not too slowly (fig. 7, fig. 8).

The dosing pump head can then be released and is ready for the next pump compression. The dosing pump must only be used with the <Invented Name> solution in the bottle provided, not for other substances or containers. If the pump does not function properly, consult your doctor or pharmacist. Lock the dosing pump after using <Invented Name>.

Instruction for proper use of the dosing pipette

Remove the cap from the bottle by turning it anti-clockwise. (fig. 1)

ID: PL 167M

Version: 01

Review Date: 13/06/13

Insert the pipette into the bottle. While holding the bottom ring, pull the top ring up to the mark that corresponds to the number of millilitres or milligrams you need to give. (fig 2)

Holding the bottom ring, remove the entire pipette from the bottle.

The solution must not be pipetted into the mouth directly from the bottle but should be dosed onto a spoon or into a glass of water using the pipette.(fig 3)