Prostamed capsules

Package leaflet: Information for the user

Introduction

ProstaMed, capsules

PACKAGE LEAFLET: Information for the user

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

This medicine is available without a prescription. However, before using this medicine, you must have been informed that you have benign prostatic hyperplasia, and the severity of your clinical condition must have been diagnosed by your doctor.

Follow exactly the instructions for taking this medicine provided in this leaflet or as directed by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, consult your pharmacist.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if these effects are not listed in this leaflet.
• You should consult a doctor if your condition worsens, or if you do not improve after 4 weeks of treatment.

Leaflet contents:

• What ProstaMed capsules are and what they are used for
• What you need to know before taking ProstaMed capsules
• How to take ProstaMed capsules
• Possible adverse effects
• Storage of ProstaMed capsules
• Contents of the pack and other information

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

ProstaMed capsules is a traditional herbal medicinal product used for the relief of lower urinary tract symptoms related to urinary voiding function, such as frequent urge to urinate, especially during the night (nocturia), difficulty urinating, weak urinary stream, and sensation of incomplete bladder emptying, based on its traditional use.

This medicine is indicated for adults suffering from age-related enlargement of the prostate (benign prostatic hyperplasia, BPH), in whom the physician has confirmed the absence of serious underlying medical conditions.

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 serrulata or to any of the other ingredients of this medicine.
• Have a serious prostate-related disease.
• Are under 18 years of age.
• Do not take this medicine if you have been diagnosed with hepatic or renal deficiency.

Warnings and precautions

Before starting to take this medicine, consult your doctor to determine whether prostate enlargement is due to benign prostatic hyperplasia, in order to rule out a serious clinical condition.

• If symptoms worsen or no improvement is observed after 4 weeks of treatment, consult your doctor.
• If you notice blood in the urine (hematuria), fever, pain when urinating, or urinary retention, consult a doctor immediately.
• ProstaMed may cause mild gastrointestinal disturbances. These symptoms can be avoided by taking the medicine with food.
• This medicine contains sorbitol. If your doctor has informed you that you have an intolerance to certain sugars, consult your doctor before using this medicine.

Use of ProstaMed capsules with other medicines:

There is no evidence that Sabal serrulata interacts with other medicines.

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

Pregnancy, breastfeeding, and fertility

This medicine must not be used during pregnancy or breastfeeding.

ProstaMed is not a product designed for use in women.

Driving and using machines:

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

3. How to take ProstaMed capsules

This medicine is for oral use.

Follow the administration instructions provided in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Recommended dose:

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

Children and adolescents

Do not administer this medicine to individuals under 18 years of age.

Duration of treatment

ProstaMed may be taken for a long period of time; however, after 4 weeks of treatment, a doctor should be consulted to assess whether continued treatment is appropriate.

If symptoms worsen, intensify, or persist after 4 weeks of treatment, 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 contact the Toxicology Information Service, telephone 91 562 0420, indicating the medicine and the amount taken.

If you forget to take ProstaMed

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

If you stop taking ProstaMed

No special precautions are required when discontinuing this medicine.

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

4. Possible adverse effects

Like all medicines, ProstaMed capsules may have adverse effects, although not everyone will experience them.

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

If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.

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

Website: www.notificaRAM.es

5. Storage of ProstaMed capsules

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

Store at room temperature. No special storage conditions required.

Do not use ProstaMed capsules after the expiry date stated on the packaging.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

One capsule of ProstaMed contains the following active substance:

• 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

Product appearance and pack contents

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

Packaged in an amber glass bottle containing 30 capsules.

For oral use only.

Marketing Authorization Holder and Manufacturer Responsible

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 - The Netherlands

Date of latest review of this leaflet: January 2020

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/