HIPERCOL

In this Patient leaflet:
1. What Hipercol is and what it is used for
2. Before using Hipercol.
3. How to use Hipercol.
4. Possible side effects.
5. How to store Hipercol.

Name of the medical product
HIPERCOL
Active substance: Citicholine
Other substances (Excipients): Sorbitol, glycerin, nipagin, nipazol, alcohol, carboxymethylcellulose, sodium citrate, sodium saccarine, red Ponceau, strawberry essence, citric acid.

Name and address of the Market Authorisation Holder
ANGELINI FARMACÊUTICA, LDA. Rua João Chagas 53, Piso 3,
1495-072 Algés

1. WHAT HIPERCOL IS AND WHAT IT IS USED FOR?
HIPERCOL is a psychostimulant medicine, under the form of a clear, red strawberry odour, intended for oral administration. Each ml of oral solution contains 100 mg of Citicholine.
Packages with 1 vial containing 50 ml of oral solution and the respective dosing syringe.

Pharmacotherapeutic class
2.8- Psychostimulants and psychoanaleptics

Therapeutic indications
Cerebrovascular accidents and brain trauma.

2. BEFORE USING HIPERCOL
Contraindications
You should inform your doctor if you have history of allergy or hypersensitivity to any of the product’s components.

Drug interactions and other forms of interactions
Citicholine enhances the effects of L-Dopa. Citicholine does not present any significant interactions either with heparine or wafarin, or with acetylsalicylic acid (aspirine) or tissue plasminogen activator (tPA).
It should not be administered with medicines that contain Meclophenoxate because it might enhance its effect.

Special precautions for use
No special precautions are necessary to use the product.

Pregnancy and lactation
Since there are no studies available in pregnant and/or breast-feeding women, Hipercol should not be used in these situations.

Effects on the ability to drive and use machines
Hipercol does not affect the ability to drive and use machines

3. HOW TO USE HIPERCOL
Follow these instructions unless your doctor gave you other different instructions:

Usual posology, with reference to maximum dose
Hipercol should be administered by oral route.

Adults: 100 to 200 mg (1-2 ml) 2 to 3 times a day.
Children: 100 mg (1 ml) 2 to 3 times a day.
Each ml contains 100 mg of Citicholine.

These doses may be changed according to the doctor’s judgement.
The recommended dose for normal maintenance is 1 ml, 3 times a day.

Use
HIPERCOL is administered with the aid of a dosing syringe as indicated below:

1. Introduce the dosing syringe in the drug with the piston fully pressed down.

2. Take out the indicated dose by rotating the piston, so that the liquid contained in the syringe coincides exactly with the volume prescribed.

3. Administer the drug mixing it with a small amount of water.

After each administration, wash the dosing syringe with water.

Duration of the average treatment when it should be limited
The duration of the treatment will be established by your doctor.

What to do in case you forget to take one or more doses
If you forget to administer one or more doses, treatment must be continued according to the prescribed posology.

Indication of how to discontinue the treatment when its discontinuation causes withdrawal effects
No special precaution is necessary to suspend the treatment.

Measures to adopt in case of overdosage and/or intoxication, emergency measures and antidotes
Given the low toxicity of the drug it is not predictable the emergence of intoxication, even when, accidentally, the recommended doses are exceeded.

4. POSSIBLE SIDE EFFECTS
Hipercol may cause a mild decrease of the blood pressure at the beginning of the treatment. This effect is reversible on the short-term.

If you notice any side effect not mentioned in this leaflet, please inform your doctor or pharmacist.

5. HOW TO STORE HIPERCOL
Do not use this medicine after the expiry term stated on the package. After each use, check if the vial is tightly closed.
Always keep medicines out of reach and sight of children. Do not store above 25ºC.

Date of the revision of the leaflet
October 2003

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