Package Leaflet: Information for the User

Memantine Cinfa5 mg/ pulse, Oral Solution EFG

Memantine Hydrochloride

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

6. Contents of the pack and additional information.

How memantine cinfa works

Memantine cinfa containsmemantine asthe active ingredient.

It belongs to a group of medications known as dementia medications.

Memory loss in Alzheimer's disease is due to an alteration in brain signals. The brain contains called N-methyl-D-aspartate (NMDA) receptors that participate in the transmission of important nervous signals in learning and memory.Memantinecinfa belongs to the group of medications called NMDA receptor antagonists.Memantinecinfa acts on these receptors by improving the transmission of nervous signals and memory.

What memantine cinfa is used for

Memantine cinfa is used in the treatment of patients with moderate to severe Alzheimer's disease.

Do not take memantine cinfa

• if you are allergic tomemantine hydrochlorideor any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take memantine cinfa:

• if you have a history of epileptic seizures (convulsions),
• if you have recently had a myocardial infarction (heart attack), if you have congestive heart failure or if you have uncontrolled hypertension (high blood pressure).

The treatment must be closely monitored and your doctor must regularly reevaluate the clinical benefit of memantine.

If you have renal insufficiency (kidney problems), your doctor must closely monitor your renal function and, if necessary, adjust the memantine dosage.

Memantine should be avoided when used with other medications such as amantadine (for Parkinson's treatment), ketamine (a medication generally used as an anesthetic), dextromethorphan (a medication for cough treatment) and other NMDA antagonists.

Children and adolescents

Memantine is not recommended for use in children and adolescents under 18 years old.

Taking memantine cinfa with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken or may need to take any other medicine.

Specifically, the administration of memantine may produce changes in the effects of the following medications and your doctor may need to adjust the dosage:

• 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 spasms),
• anticonvulsants (substances used to prevent and eliminate seizures),
• barbiturates (substances generally used to induce sleep),
• dopamine agonists (substances like L-dopa, bromocriptine),
• neuroleptics (substances used in the treatment of mental illnesses),
• oral anticoagulants.

If you are admitted to a hospital, inform your doctor that you are taking memantine.

Taking memantine cinfa with food and drinks

You must inform your doctor if you have recently changed or intend to change your diet significantly (for example from a normal diet to a strict vegetarian diet) or if you have acidosis tubular renal (ATR, excess acid-producing substances in the blood due to renal dysfunction) or severe urinary tract infections, as your doctor may need to adjust the medication dosage.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medicine. Memantine is not recommended for use in pregnant women.

Women taking memantine should discontinue breastfeeding.

Driving and operating machinery

Your condition may affect your ability to drive or operate machinery and you should not perform these activities unless your doctor tells you it is safe to do so.Memantinemay cause dizziness and somnolence, mainly at the start of treatment or when increasing the dosage. If you experience these effects, do not drive or operate machinery.

Memantine cinfa contains sorbitol

This medicine contains 100 mg of sorbitol in each ml.

Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to certain sugars, or have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disease in which the patient cannot break down fructose, consult your doctor (or your child) before taking this medicine.

Follow exactly the administration instructions of this medication as indicated by your doctor.In case of doubt, consult your doctor or pharmacist again.

Dosage

One pulse contains 5 mg of memantine hydrochloride.

The recommended dose of memantine in adult patients and elderly patients is four pulses, equivalent to 20 mg administered once a day. To reduce the risk of adverse effects, this dose is achieved gradually following the daily schedule below:

The usual starting dose is one pulse once a day (5 mg) in the first week. This dose is increased to two pulses once a day (10 mg) in the second week and to three pulses once a day (15 mg) in the third week. From the fourth week, the recommended dose is four pulses once a day (20 mg).

Instructions for the correct use of the dosifier:

Before the first use, the dosifier must be screwed onto the bottle. To remove the screw cap from the bottle, it must be turned in the opposite direction to the clock hands and unscrewed completely (fig.1).

Mounting the dosifier on the bottle:

The dosifier must be removed from the plastic bag (fig.2) and placed on top of the bottle, introducing the plastic tube into the bottle carefully. The dosifier must be kept on the bottle neck and turned in the direction of the clock hands until it is firmly attached (fig.3). For the desired use, the dosifier must only be screwed once at the start of use and must never be unscrewed.

Use of the dosifier for dispensing:

The dosifier head has two positions and turns easily – in the opposite direction to the clock hands (open position) and in the direction of the clock hands (closed position). The dosifier head must not be pressed while it is in the closed position. The solution must be dispensed in the open position. To do this, the dosifier head must be turned a quarter turn in the direction indicated by the arrow, until resistance is felt (fig.4). The dosifier is then ready for use.

Preparation of the dosifier:

When used for the first time, the dosifier does not dispense the correct amount of oral solution. It must therefore be prepared (primed) by pressing the dosifier head down completely five times in succession (fig.5).

The solution dispensed must be discarded. The next time the dosifier head is pressed down completely (equivalent to one pulse), it already dispenses the correct dose (one pulse is equivalent to 0.5 ml of oral solution and contains 5 mg of the active ingredient memantine hydrochloride; fig.6).

Correct use of the dosifier:

A glass with a little water or a spoon must be placed under the nozzle and the dosifier head must be pressed down firmly but calmly and steadily (not too slowly) until the end (fig.7, fig.8).

The head can then be released and is ready for the next pulse.

The dosifier must only be used with memantine cinfa 5 mg/pulse, oral solution in the bottle provided, not for other products or containers. If the dosifier does not function correctly as described during use and in accordance with the instructions, the patient should consult their doctor or pharmacist. The dosifier must be closed after use.

Dosage for patients withrenal insufficiency

Ifyou have kidney problems, your doctor will decide on the appropriate dose for your condition. In this case, your doctor must monitor your renal function regularly.

Dosage for patients with liver insufficiency

Consult your doctor if you have liver problems.

Administration

Memantine cinfa must be administered orally once a day. To get the most out of your medication, you must take it every day and at the same time. The solution must be taken with a little water. The solution can be taken with or without food.

Treatment duration

Continue taking memantine as long as it benefits you. Your doctor must evaluate your treatment regularly.

If you take more memantine cinfa than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, telephone 91 562 04 20, indicating the medication and the amount ingested. It is recommended to bring the leaflet and the packaging of the medication to the healthcare professional.

Generally, taking an excessive amount of memantine should not harm you. You may experience an increase in the symptoms described in section 4 “Possible adverse effects”.

If you forgot to take memantine cinfa

If you realize you have forgotten to take your dose of memantine, wait and take the next dose at the usual time.

Do not take a double dose to compensate for the missed doses.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Adverse effects are generally classified as mild to moderate.

Frequent (may affect up to 1 in 10 patients):

• Headache, drowsiness, constipation, elevated liver function tests, dizziness, balance disorder, shortness of breath, high blood pressure, and hypersensitivity to the medication.

Poorly frequent (may affect up to 1 in 100 patients):

• Fatigue, fungal infections, confusion, hallucinations, vomiting, gait disorder, heart failure, and formation of blood clots in the venous system (venous thromboembolism).

Very rare (may affect up to 1 in 10,000 patients):

• Seizures.

Unknown frequency (cannot be estimated from 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.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keepthis medicationout of the sightof children.

Do not use this medication after the expiration date that appears on the packaging and on the label of the bottle after CAD. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.Once opened, the contents of the bottle must be used within 12 weeks.

The bottle with the dosifier mounted must be stored and transported only in a vertical position.

Medicines should not be thrown down the drains or in the trash. Dispose of the packaging and medicines that you do not need at the SIGRE point of the pharmacy.In case of doubt, ask your pharmacist how to dispose of the packaging and medicines that you do not need. In this way, you will help protect the environment.

Composition of memantine cinfa

The active ingredient is memantine hydrochloride.

Each pump of the dosifier (one pump)releases 0.5 ml of solution containing 5 mg of memantine hydrochloride, equivalent to 4.16 mg of memantine.Each ml of solution contains 10 mg of memantine hydrochloride.

The other components are potassium sorbate (E-202), non-crystallizable liquid sorbitol (E-420) and purified water.

Appearance of the product and contents of the packaging

Memantine cinfa oral solution is a transparent, colorless to slightly yellowish solution.

Memantine cinfa oral solution is presented in amber-colored glass bottles of 100 ml..A dosifier is included.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Industrial Estate Areta.

31620 Huarte (Navarra)-Spain

Responsible for manufacturing

Chanelle Medical Unlimited Company

Dublín Road

Loughrea

Co. Galway (Ireland)

Last review date of this leaflet: May 2020

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

You can access detailed and updated information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the leaflet and packaging. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/78316/P_78316.html

QR code to:https://cima.aemps.es/cima/dochtml/p/78316/P_78316.html