Package leaflet: Information for the patient

Gerolin 500 mg/4ml injectable solution, 1g/4ml injectable solution

sodium citicoline
Please read this leaflet carefully before you are given this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor, pharmacist or nurse.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any side effect, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

What Gerolin is and what it is used for
What you need to know before being given Gerolin
How Gerolin is administered
Possible side effects
How to store Gerolin
Contents of the pack and other information

1. What Gerolin is and what it is used for

Gerolin contains citicoline as the active ingredient, which belongs to a group of medicines called neurotrophic agents that improve brain cell functions. This medicine is indicated as an adjunctive treatment in parkinsonian syndromes (degenerative diseases of the central nervous system).

2. What you need to know before being administered Gerolin

Do not be administered Gerolin
if you are allergic to citicoline or to any of the other ingredients of this medicine (listed in
section 6).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before being administered Gerolin.

This medicine must be administered to you with caution especially in the following cases:
if you have fluid accumulation in the brain (severe cerebral edema), since you may need concomitant administration of medicines that reduce pressure inside the head, such as corticosteroids and mannitol;
if you have bleeding within the brain (intracranial hemorrhage), since in this case high single doses of Gerolin (above 500 mg) must not be administered due to the risk of increasing cerebral blood flow.

This medicine complements all indicated therapies for the various pathological conditions in which it is administered.

Other medicines and Gerolin
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.

Pay particular attention if you are taking levodopa (a medicine used for Parkinson's disease), since Gerolin may enhance its effect.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before being administered this medicine.

Avoid using Gerolin during pregnancy and while breastfeeding.

Driving and using machines
Gerolin has no effect or has a negligible effect on the ability to drive vehicles
or operate machinery.

Gerolin 500 mg/4 ml solution for injection contains sodium
This medicine contains 23.5 mg of sodium (the main component of table salt) per vial. This corresponds to 1.2% of the maximum daily recommended dietary intake for an adult.

Gerolin 1 g/4 ml solution for injection contains sodium
This medicine contains 47.1 mg of sodium (the main component of table salt) per vial. This corresponds to 2.4% of the maximum daily recommended dietary intake for an adult.

3. How Gerolin is administered

Gerolin will be administered by a doctor or nurse via intramuscular injection (injection into the muscle) or by slow intravenous injection (injection into the vein) or by infusion. If you have any doubts, consult your doctor or nurse.
The recommended dose is: 1 vial of 500 mg once or twice daily, or 1 vial of 1 g once daily by intramuscular, intravenous or infusion route.
In case of intravenous administration (direct injection into the vein), the medicine must be injected very slowly.
If you are given more Gerolin than you should
If you are accidentally given more Gerolin than prescribed, contact your doctor immediately or go to the nearest hospital.
If you forget to use Gerolin
If you miss an injection, you should receive it as soon as possible. However, if it is almost time for your next scheduled injection, skip the missed dose. Do not use a double dose (two injections together) to make up for a forgotten dose.
If you stop using Gerolin
Do not stop using Gerolin unless your doctor tells you to do so.
If you have any doubts about using this medicine, consult your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
No side effects related to the medicine have been reported.
Following the instructions in this leaflet reduces the risk of side effects.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please consult your doctor, pharmacist, or nurse. You may also report side effects directly through the national reporting system at the following website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Gerolin

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp.". The expiry date refers to the last day of that month. The shelf life applies to the product in its original, undamaged packaging, correctly stored.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Gerolin contains
Gerolin 500 mg/4 ml solution for injection

The active substance is citicoline sodium salt. One vial contains citicoline sodium salt equivalent to 500 mg of citicoline.
Other components are: water for injections, concentrated phosphoric acid.

Gerolin 1 g/4 ml solution for injection

The active substance is citicoline sodium salt. One vial contains citicoline sodium salt equivalent to 1000 mg of citicoline.
Other components are: water for injections, concentrated phosphoric acid.

Description of the appearance of Gerolin and contents of the pack
Gerolin is presented as a solution for injection.
Gerolin 500 mg/4 ml solution for injection: pack containing 3 vials or 5 vials.
Gerolin 1 g/4 ml solution for injection: pack containing 3 vials or 5 vials.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Laboratorio Farmaceutico C.T. S.r.l. - Via Dante Alighieri, 71 - Sanremo (IM)
Manufacturer
Laboratorio Farmaceutico C.T. S.r.l. - Via Dante Alighieri, 71 - Sanremo (IM)