Leaflet: information for the user

Arginine aspartate 5 g oral solution

Aspartate of arginine

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

Follow exactly the administration instructions of the medicine contained in this leaflet or those indicated by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if you get worse or do not improve after 15 days.

1.What is Arginine aspartate oral solution and for what it is used

2.What you need to know before starting to take Arginine aspartate oral solution

3.How to use Arginine aspartate oral solution

4.Possible side effects

5.Storage of Arginine aspartate oral solution

6.Contents of the pack and additional information

Potenciator 5g oral solution contains arginine aspartate as the active ingredient. Arginine is an amino acid (protein component) that is involved in many processes in the human body.

It is indicated for the prevention and treatment of amino acid deficiency states when insufficient protein is taken in the diet, due to unbalanced or restrictive diets (weight loss, vegetarian); convalescence.

Potenciator 5g oral solution is indicated for adults and adolescents over 12 years old.

Do not take Potenciator

• If you are allergic to aspartate arginine or any of the other components of this medication (listed in section 6).
• If you are pregnant.

Due to the high dose it contains, do not take it:

• If you are breastfeeding.
• Children under 12 years old.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Potenciator oral solution.

• Do not exceed the recommended doses and do not take this medication continuously for long periods of time.
• If you have any liver or kidney disease, or diabetes, you must consult your doctor before taking this medication.
• In patients with cystic fibrosis, digestive cramps, weight loss, and abdominal swelling may occur.

Children and adolescents

This medication is contraindicated in children under 12 years old.

Taking Potenciator with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

The active ingredient of this medication interacts with the following medications:

• Potassium-sparing diuretics (used for hypertension) such as amiloride, spironolactone, or triamterene.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Do not take Potenciator oral solution during pregnancy.

Women who are breastfeeding should not take this medication.

Driving and operating machinery

No effects have been observed that affect these abilities.

Potenciator oral solution contains saccharose, sorbitol (E-420), methyl parahydroxybenzoate (E-218), and propyl parahydroxybenzoate (E-216)

This medication contains saccharose and sorbitol (E-420). If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medication.

It may produce allergic reactions (possibly delayed) because it contains methyl parahydroxybenzoate (E-218) and propyl parahydroxybenzoate (E-216).

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

The recommended dose is:

Adults and adolescents (12 years and older):1 drinkable ampule per day, during meals.

The treatment in general should not exceed 2 weeks.

To administer this medication correctly, follow the instructions indicated below:

The contents of the ampule can be taken alone or with water or fruit juice.

Use in children

Do not administer to children under 12 years.

If you take more Potenciator oral solution than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or go to a medical center, or call the Toxicological Information Service Telephone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Potenciator oral solution

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

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

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

The following adverse effects have been described, but their frequency cannot be estimated from the available data:

There have been reports of thrombocytopenia (a decrease in platelet count) and hematuria (the presence of blood in the urine).

In rare cases, allergic reactions (hypersensitivity) to one of the medication components may appear.

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:www.notificaRAM.es

By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

This product does not require special conservation conditions.

Keep this medication out of the sight and reach of children.

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

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Potenciator 5 g oral solution

• The active ingredient is aspartate arginine. Each 10 ml ampule contains 5 g of aspartate arginine.
• The other components (excipients) are: sorbitol (E-420) (solution at 70%), sucrose, citric acid monohydrate, sodium saccharin, caramel flavor, caramel color, potassium sorbate (E-202), methyl parahydroxybenzoate (E-218), propyl parahydroxybenzoate (E-216), deionized water.

Appearance of the product and content of the packaging

Potenciator is a brown-colored oral solution with a caramel odor that is presented in plastic ampules.

Each package contains 20 ampules.

Holder of the marketing authorization

Faes Farma, S.A.

Autonomia Etorbidea, 10

48940 Leioa (Bizkaia)

Spain

Responsible for manufacturing

Faes Farma, S.A.

Maximo Agirre Kalea, 14

48940 Leioa (Bizkaia)

Spain

O

Faes Farma, S.A.

Parque Científico y Tecnológico de Bizkaia

Ibaizabal Bidea, Edificio 901

48160 Derio (Bizkaia)

Spain

Last review date of this leaflet: July 2014.

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