Potenciator 5 g oral solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Potenciator 5 g oral solution

Arginine aspartate

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

Follow exactly the instructions for administration of the medicine contained in this leaflet or as 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 adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.
• You should consult a doctor if your condition worsens or if you do not improve after 15 days.

Contents of the leaflet

1. What Potenciator oral solution is and what it is used for
2. What you need to know before taking Potenciator oral solution
3. How to use Potenciator oral solution
4. Possible adverse effects
5. How to store Potenciator oral solution
6. Contents of the pack and other information

1. What Potenciator oral solution is and what it is used for

Potenciator 5g oral solution contains arginine aspartate as the active substance. Arginine is an amino acid (a component of proteins) that participates in many processes in the human body.

It is indicated for the prevention and treatment of amino acid deficiency states when insufficient proteins are consumed 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 of age.

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

Do not take Potenciator

• If you are allergic to arginine aspartate or to any of the other components of this medicine (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 of age.

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 medicine continuously for long periods of time.
• If you have any liver or kidney disease, or diabetes, you should consult your doctor before taking this medicine.
• In patients with cystic fibrosis, gastrointestinal cramps, weight loss, and abdominal swelling may occur.

Children and adolescents

This medicine is contraindicated in children under 12 years of age.

Taking Potenciator with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.

The active substance in this medicine interacts with the following medicines:

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

Pregnancy, breastfeeding, and fertility

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

You must not take Potenciator oral solution during pregnancy.

Women who are breastfeeding must not take this medicine.

Driving and using machines

No effects affecting these abilities have been observed.

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

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

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

3. How to take Potenciator oral solution

Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

The recommended dose is:

Adults and adolescents (from 12 years of age): 1 drinkable ampoule per day, taken during a meal.

Treatment should generally not exceed 2 weeks.

For correct administration of this medicine, follow the instructions indicated below:

The contents of the ampoule may be taken alone or with water or fruit juice.

Use in children

Do not administer to children under 12 years of age.

If you take more Potenciator oral solution than you should

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

If you forget to take Potenciator oral solution

Do not take a double dose to make up for missed doses.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everybody gets them.

The following adverse effects have been reported, the frequency of which cannot be estimated from the available data:

Cases of thrombocytopenia (reduced platelet count) and haematuria (presence of blood in the urine) have been reported.

Rarely, allergic reactions (hypersensitivity) to one of the components of the medicine may occur.

Reporting of 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 leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Potenciator oral solution

No special storage conditions are required.

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 the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Potenciator 5 g oral solution

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

Appearance of the product and contents of the pack

Potenciator is a brown-coloured oral solution with a caramel odour, supplied in plastic ampoules.

Each pack contains 20 ampoules.

Marketing Authorisation Holder

Faes Farma, S.A.

Autonomia Etorbidea, 10

48940 Leioa (Bizkaia)

Spain

Manufacturer

Faes Farma, S.A.

Maximo Agirre Kalea, 14

48940 Leioa (Bizkaia)

Spain

Or

Faes Farma, S.A.

Parque Científico y Tecnológico de Bizkaia

Ibaizabal Bidea, Edificio 901

48160 Derio (Bizkaia)

Spain

Date of the most recent revision of this leaflet: July 2014.

Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.