ProstaMed, capsules

PROSPECTO: information for the user

• What isProstaMed capsulesand for what it is used
• What you need to know before starting to takeProstaMed capsule
• How to takeProstaMed capsules
• Possible adverse effects
• Storage ofProstaMed capsules
• Contents of the package and Additional information

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

This medication is indicated for adults suffering from age-related enlargement of the prostate (benign prostatic hyperplasia, BPH) who have been informed by their doctor that they do not have a serious clinical condition.

Do not take ProstaMed capsules if you:

• You are allergic to the fruit ofSabal serrulataor to any of the other ingredients in this medication.
• You have a serious disease related to the prostate.
• You are under 18 years old.
• 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 find out if the enlargement of the prostate responds to benign prostatic hyperplasia, to exclude a serious clinical situation.

• If symptoms worsen or no improvement is observed after 4 weeks of treatment, consult your doctor.
• If you observe blood in the urine (hematuria), fever, pain while urinating, or urinary retention, consult a doctor immediately.
• ProstaMed may cause mild stomach problems. These symptoms can be avoided by taking the medication with meals.
• This medication contains sorbitol. If your doctor has commented that you have intolerance to certain sugars, consult your doctor before using this medication.

Use of ProstaMed capsules with other medications:

There is no evidence thatSabal serrulatainteracts with other medications.

If you take a medication for prostate enlargement, consult your doctor before using ProstaMed, because 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 operating machinery:

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

This medication is taken orally.

Follow 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 elderly: take one capsule daily with one of the meals.

Children and adolescents

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

Duration of use

ProstaMed can be taken for a long period of time, however

after 4 weeks of treatment, consult your doctor to evaluate the convenience of continuing with the same.

If symptoms intensify or worsen 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 manifest.

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

If you forgot to take ProstaMed

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

If you interrupt treatment with ProstaMed

No special precautions are necessary to stop taking this medication.

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

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

• Adverse reactions are generally mild.
• In rare cases, they may occurgastrointestinal discomfort (nausea,abdominal pain) and flatulence
• In rare cases, they may occur allergic reactions such as skin rash(rash) pruritus.

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

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is possible adverse effects not listed in this prospectus. You can also report them directly through the national notification system. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Website: www.notificaRAM.es

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.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and unused medicines. This will help protect the environment.

A ProstaMed capsule contains as active ingredient:

• 320 mg of extract from the fruit ofSabal 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 contents of the packaging

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

It is presented in an amber glass bottle with 30 capsules.

For oral use only.

Holder of the marketing authorization and responsible for manufacturing

Bioforce España A.Vogel, S.A.

Platón 6,

08021-Barcelona

Spain

Tel 93 201 99 22

Fax 93 209 03 19

Responsible for Manufacturing

A. VOGEL B.V.

J.P. Broekhovenstraat 16

ELBURG - Netherlands

Last review date of this leaflet: January 2020

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