Potenciator 5g/10ml10ml#20a

Potenciator 5 g/10ml Oral solution

Arginine aspartate

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you.

-   Keep this leaflet. You may need to read it again.

-   Ask your pharmacist if you need more information or advice.

-   If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See Section 4.

-   You must talk to a doctor if you do not feel better or if you feel worse after 15 days.

What is in this leaflet

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

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

Potenciator 5 mg oral solution contains arginine aspartate as the drug substance. Arginine is an amino acid (a protein component) that intervenes in many processes in the human body. It is indicate for the prevention and treatment of conditions of amino acid deficiency when insufficient proteins are taken in a diet, imbalanced or restrictive diets (weight loss, vegetarian); convalescence.

Potenciator 5 g oral solution is indicated in adults and adolescents over 12 years of age.

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

Do not take Potenciator

-   If you are allergic to arginine aspartate or any of the other ingredients 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 breast-feeding - Infants under 12 years of age.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Potenciator oral solution. - Do not take more than the recommended doses and do not take this medicine continuously over long periods of time.

-  If you have a liver or kidney disease or diabetes, you should speak with your doctor before taking this medicine.

-  Patients with cystic fibrosis may suffer from digestive cramps, weight loss and abdominal swelling.

Children and adolescents

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

Other medicines and Potenciator

Tell your doctor or pharmacists if you are taking, have recently taken or may have to take any other medicines.

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

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

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, or you think you may be pregnant or planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Do not take Potenciator oral solution during pregnancy.

Women who are breast-feeding must not take this medicine.

Driving and using machines

Effects on these abilities have not 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). Consult your doctor before taking this medicine if you may be intolerant to certain sugars.

This medicine may induce allergic reactions (possibly of a delayed nature) because it contains methyl parahydroxybenzoate (E-218) and propyl parahydroxybenzoate (E-216).

3. How to take Potenciator oral solution

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose is:

Adults and adolescents (over 12 years of age): 1 drinkable ampoule once a day, during lunch.

Under normal circumstances, the treatment should not exceed 2 weeks.

For proper administration of this medicine, follow the instructions below:

1. Detach the ampoule
2. Tear off the tab at the top by twisting it 3. Turn the ampoule over, press it and pour the contents into a glass

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

Use in children

It should not be taken by children aged under 12 years.

If you take more Potenciator than you should

In the event of an overdose or if swallowed accidentally, consult your doctor or pharmacist, stating the medicine and the amount swallowed.

If you forget to take Potenciator oral solution

Do not take a double dose to make up for a forgotten one.

Consult your doctor or pharmacist if you have any further questions regarding the use of this product.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects have been described, although their frequency cannot be calculated from the available information:

Cases of thrombocytopenia (reduction in the number of platelets) and hematuria (presence of blood in urine) have been reported.

Allergic reactions (hypersensitivity) to one or more of the medicine components can appear on rare occasions.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. 

You can also report side effects directly via the Spanish System of Pharmacovigilance of Medicinal Products for Human Use: www.notificaRAM.es. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Potenciator oral solution

This medicine does not require any special storage conditions. 

Keep this medicine out of the sight and reach of children

Do not use this medicine after the expiry date which is stated on the packaging after EXP. The expiry date is the last day of the indicated month.

Do not throw away any medicines via wastewater or household waste.  Deposit any containers

and medicine you no longer need in the SIGRE point of your pharmacy. Ask your pharmacist how to throw away medicines you no longer use.These measures will help to protect the environment.

6. Contents of the pack and additional information What Potenciator 5 mg oral solution contains - The active substance is arginine aspartate.

 1 ampoule(10 ml)  contains 5 g of arginine aspartate.

- The other components (excipients) are: sorbitol (E-420) (solution at 70%), sucrose, monohydrate citric acid, sodium saccharin, caramel aroma, caramel colouring, potassium sorbate (E-202) methyl parahydroxybenzoate (E-218), propyl parahydroxybenzoate (E-216), deionised water.

What Potenciator 5 mg oral solution looks like and contents of pack

Potenciator is a brown oral solution that smells like caramel and is presented in plastic ampoules.

Each package contains 20 ampoules.

Marketing Authorisation Holder and Manufacturer: FAES FARMA, S.A.

Maximo Aguirre, 14

48940 Leioa (Vizcaya)

SPAIN

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