Memocit

Package Leaflet: Information for the Patient

Memocit, 1000 mg/10 ml, Oral Solution

Citicolinum

Read the Package Leaflet Carefully Before Using the Medicinal Product

• Keep this package leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicinal product has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this package leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Memocit and What is it Used For
• 2. Important Information Before Using Memocit
• 3. How to Use Memocit
• 4. Possible Side Effects
• 5. How to Store Memocit
• 6. Contents of the Package and Other Information

1. What is Memocit and What is it Used For

Memocit contains citicoline as the active substance, which belongs to the group of psychostimulant and nootropic medicinal products (so-called "memory enhancers"). These medicinal products work by improving brain function.
Memocit is used to treat neurological and cognitive disorders caused by:

• interruptions in blood supply to the brain due to the formation of a blood clot or damage to blood vessels in the brain (e.g., stroke);
• head injuries (e.g., resulting from a blow).

2. Important Information Before Using Memocit

When Not to Use Memocit

• if you are allergic to citicoline or any of the other ingredients of this medicinal product (listed in section 6);
• if you have increased parasympathetic nervous system tone, which is a serious disease characterized by low blood pressure, excessive sweating, rapid heartbeat, and fainting.

Warnings and Precautions

Before starting to use Memocit, discuss it with your doctor:

• if you are allergic to acetylsalicylic acid, as this medicinal product may cause asthma attacks.

Children

There is a lack of sufficient data on the use of Memocit in children, therefore this medicinal product may only be administered when the doctor decides it is necessary.

Memocit and Other Medicinal Products

Inform your doctor about all the medicinal products you are currently taking or have recently taken, as well as any medicinal products you plan to take.
Citicoline enhances the effects of L-dopa (also known as levodopa, used in the treatment of Parkinson's disease), therefore the simultaneous use of these medicinal products may only be decided by a doctor.
Concomitant use of citicoline with meclofenoxate (a medicinal product that stimulates brain activity) is not recommended.

Using Memocit with Food and Drink

Memocit can be taken on an empty stomach or with food.

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 for advice before using this medicinal product.

Driving and Using Machines

Memocit does not affect the ability to drive and use machines.

Memocit Contains Sorbitol Liquid, Non-Crystallizing (E 420)

Sorbitol is a source of fructose. If you have been diagnosed with intolerance to some sugars or have been diagnosed with hereditary fructose intolerance, a rare genetic disease in which your body does not break down fructose, you should consult your doctor before taking this medicinal product or giving it to your child.
If you have been diagnosed with intolerance to some sugars, you should consult your doctor before taking this medicinal product.

Memocit Contains Propyl Parahydroxybenzoate (E 216), Methyl Parahydroxybenzoate (E 218), and Ponceau 4R (E 124)

This medicinal product may cause allergic reactions (possible late reactions).
Memocit contains 77 mg of sodium (the main component of common salt) in each sachet.This corresponds to 3.85% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to Use Memocit

This medicinal product should always be used in accordance with the doctor's recommendations. In case of doubts, consult your doctor or pharmacist.
The recommended dose for adults is 1 to 2 sachets per day, depending on the severity of the disease symptoms.
This medicinal product can be taken directly from the sachet or after dissolving in half a glass of water (about 120 ml), during or between meals.

• 1. Hold the Memocit 1000 mg sachet and shake it vigorously.
• 4. After dissolving in half a glass of water (120 ml).
• 2. With the other hand, tear the sachet along the line marked with arrows.
• 3. The medicinal product can be taken directly or

Overdose of Memocit

In case of overdose, consult your doctor immediately.
Take the package or this package leaflet with you to inform medical personnel which medicinal product was taken.

Missed Dose of Memocit

Take the dose as soon as possible.
Do not take a double dose to make up for the missed dose.

Stopping Use of Memocit

Your doctor will determine how long you should use Memocit. Do not stop using the medicinal product without consulting your doctor.
If you have any further doubts about using this medicinal product, consult your doctor.

4. Possible Side Effects

Like all medicinal products, this medicinal product can cause side effects, although not everybody gets them.
Side effects that occur very rarely(less often than 1 in 10,000 people):

• hallucinations,
• headaches, dizziness,
• changes in blood pressure (increased or decreased blood pressure),
• breathing difficulties (dyspnea),
• nausea, vomiting, diarrhea,
• redness, hives, rash, petechiae,
• edema,
• chills.

Reporting Side Effects

If you experience any side effects, including those not listed in this package leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181 C
02-222 Warsaw
tel.: +48 22 49 21 301
fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicinal product.

5. How to Store Memocit

Keep this medicinal product out of the sight and reach of children.
Do not use this medicinal product after the expiry date stated on the carton and sachet.
The expiry date refers to the last day of the month stated.
The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation LOT/Lot means the batch number.
There are no special precautions for storage.
Medicinal products should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicinal products that are no longer needed. This will help protect the environment.

6. Contents of the Package and Other Information

What Memocit Contains

• The active substance is citicoline. Each milliliter of solution contains 100 mg of citicoline (in the form of sodium salt). Each sachet (10 ml solution) contains 1000 mg of citicoline (in the form of sodium salt).
• The other ingredients are: sorbitol liquid, non-crystallizing (E 420), glycerol, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), potassium sorbate, sodium saccharin, glycerol formal, Ponceau 4R (E 124), citric acid, sodium citrate, strawberry flavor (contains propylene glycol (E 1520), flavoring substances), purified water.

What Memocit Looks Like and Contents of the Package

Memocit is a clear, pink oral solution with a strawberry flavor and aroma.
The medicinal product is packaged in sachets made of PET/PX/Aluminum/RT containing 10 ml of solution, placed in a cardboard box.
The package contains 10 sachets of 10 ml solution each.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Polpharma S.A.
Pelplińska 19, 83-200 Starogard Gdański
tel. +48 22 364 61 01

Manufacturer

SAG Manufacturing S.L.U.
Crta N-I, Km 36
San Agustin de Guadalix
28750 Madrid
Spain
Galenicum Health, S.L.
Avda. Cornellá 144, 7º-1ª, Edificio Lekla
Esplugues de Llobregat
08950 Barcelona
Spain

Date of Last Revision of the Package Leaflet: