PROSTAMED CAPSULES

Introduction

ProstaMed, capsules

PACKAGE LEAFLET: information for the user

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

This medication can be obtained without a prescription. However, before using this medication, you must have been informed that you suffer from benign prostatic hyperplasia and your doctor must have diagnosed the severity of the existing clinical situation.

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist.

• Keep this package leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are not described in this package leaflet.
• You should consult a doctor if your symptoms worsen or do not improve after 4 weeks of treatment.

Contents of the package leaflet:

• What ProstaMed capsulesare and what they are used for
• What you need to know before starting to take ProstaMed capsules
• How to take ProstaMed capsules
• Possible side effects
• Storage of ProstaMed capsules
• Package contents and additional information

1. What ProstaMed capsules are and what they are used for

ProstaMed capsules are a traditional herbal medicinal product used for the relief of symptoms of the lower urinary tract, related to the function of urination, such as frequent need to urinate, especially at night (nocturia), difficulty urinating, weak urinary flow, sensation of incomplete emptying of the bladder, based on traditional use.

This medication is indicated in adults who suffer from age-related enlarged prostate (benign prostatic hyperplasia, BPH) and have been informed by their doctor that they do not have a severe clinical condition.

2. What you need to know before starting to take ProstaMed capsules

Do not take ProstaMed capsules if you:

• Are allergic to the fruit of Sabal serrulataor to any of the other ingredients of this medication.
• Suffer from a severe prostate-related disease.
• Are under 18 years of age.
• Do not take this medication if you have been informed that you suffer from liver or kidney deficiency.

Warnings and precautions

Before starting to take this medication, consult your doctor to determine if the enlarged prostate is due to benign prostatic hyperplasia, to rule out a severe clinical condition.

• If your symptoms worsen or do not improve after 4 weeks of treatment, you should consult your doctor.
• If you notice blood in your urine (hematuria), fever, pain while urinating, or urinary retention, you should consult a doctor immediately.
• ProstaMed may cause mild stomach disorders. These symptoms can be avoided by taking the medication with meals.
• This medication contains sorbitol. If your doctor has told you that you have an intolerance to certain sugars, you should consult your doctor before using this medication.

Using ProstaMed capsules with other medications:

There is no evidence that Sabal serrulatainteracts with other medications.

If you are taking a medication for enlarged prostate, consult your doctor before using ProstaMed, as it may not be suitable for you.

Pregnancy, breastfeeding, and fertility

This medication should not be used during pregnancy and breastfeeding.

ProstaMed is not a product designed for use in women.

Driving and using machinery:

The ability to drive vehicles and use machinery is not affected.

3. How to take ProstaMed capsules

This medication is taken orally.

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

The recommended dose is:

Adults and elderly: take one capsule daily with one of the meals.

Children and adolescents

Do not administer this medication to children under 18 years of age.

Duration of use

ProstaMed can be taken for a long period of time; however, after 4 weeks of treatment, you should consult your doctor to evaluate the convenience of continuing with the same treatment.

If your symptoms worsen or persist after 4 weeks of treatment, you should consult your doctor.

If you take more ProstaMed capsules than you should:

It is unlikely that symptoms or toxicity will occur.

In case of overdose or accidental ingestion, go to a medical center or consult the Toxicology Information Service, phone 91 562 0420, indicating the medication and the amount used.

If you forget to take ProstaMed

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

If you stop taking ProstaMed

You do not need to take special precautions to stop taking this medication.

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

4. Possible side effects

Like all medications, ProstaMed capsules can have side effects, although not everyone will experience them.

• Adverse reactions are generally mild.
• Rarely, gastrointestinal disorders (nausea, abdominal pain) and flatulence may occur.
• Rarely, allergic reactions such as skin rash (rash) and pruritus may occur.

If you experience side effects, consult your doctor or pharmacist, even if they are not described in this package leaflet.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that is not described in this package leaflet. You can also report them directly through the national reporting system. By reporting side effects, you can help provide more information on the safety of this medication.

Website: www.notificaRAM.es

5. Storage of ProstaMed capsules

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

Store at room temperature. No special storage conditions are required.

Do not use ProstaMed capsules after the expiration date indicated on the packaging.

Medications should not be disposed of through wastewater or household waste. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

One ProstaMed capsule contains as an active ingredient:

• 320 mg of extract from the fruit of Sabal serrulata (or Serenoa repens)

The other components are excipients:

• Gelatin
• Glycerol
• Sorbitol
• Red iron oxide
• Black iron oxide
• Yellow iron oxide
• Purified water

Appearance of the product and package contents

ProstaMed capsules are soft, oval-shaped capsules, dark brown in color, containing a translucent, yellowish-brown oil.

They are presented in an amber glass bottle with 30 capsules.

For oral use only.

Marketing authorization holder and manufacturer

Bioforce España A.Vogel, S.A.

Platón 6,

08021-Barcelona

Spain

Tel 93 201 99 22

Fax 93 209 03 19

Manufacturer

• VOGEL B.V.

J.P. Broekhovenstraat 16

ELBURG - Netherlands

Date of the last revision of this package leaflet: January 2020

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