ACTION AND MECHANISM

- Anti-prostatic adenoma. The sterolic lipid extract of Serenoa repens fruits has anti-androgenic and anti-proliferative effects.

SPECIAL WARNINGS

Before starting treatment, a digital rectal exam will be performed to rule out prostate cancer. Periodic PSA tests may be necessary.

- Monitoring:

* Baseline PSA levels and levels throughout treatment.

PATIENT ADVICE

- Take it with food to reduce the occurrence of nausea or abdominal pain.

- Tell your doctor and/or pharmacist if symptoms continue or worsen while using this medicine.

CONTRAINDICATIONS

- Hypersensitivity to Serenoa repens or any other component of the medication.

ADVANCED AGE

No specific problems have been described in the elderly that would require a dosage adjustment.

EFFECTS ON DRIVING

It does not appear to negatively affect the ability to drive.

PREGNANCY

Serenoa repens is not indicated for women.

Effects on fertility : no specific studies have been conducted.

INDICATIONS

PROSTAMED :

- Relief of lower urinary tract symptoms related to urine elimination function, such as increased frequency of urination, especially at night (nocturia), bladder tenesmus (difficulty urinating), weak urinary flow, or a feeling of incomplete bladder emptying.

- [BENIGN PROSTATE HYPERPLASIA], once the doctor has ruled out a serious clinical situation.

Its use is based exclusively on traditional use.

INTERACTIONS

- Oral anticoagulants. Increased INR has been observed in patients treated with Serenoa repens extract. Monitor INR and adjust the anticoagulant dose if necessary.

No interactions have been found with antibiotics, urinary antiseptics, or anti-inflammatories.

LACTATION

Serenoa repens is not indicated for women.

CHILDREN

Safety and efficacy have not been evaluated in children and adolescents < 18 years, therefore its use is not recommended.

GUIDELINES FOR PROPER ADMINISTRATION

Swallow with a glass of water, without chewing.

Administration with food: administer with food to reduce the incidence of digestive adverse reactions.

POSOLOGY

PROSTAMED :

- Adults: 320 mg/24 h.

- Children and adolescents < 18 years: not recommended.

- Elderly: no dosage adjustment required.

Duration of treatment: If symptoms persist or worsen after 1 month of treatment, consult your doctor and/or pharmacist.

Missed dose: Take the next dose at the usual time. Do not double the next dose.

DOSAGE IN HEPATIC INSUFFICIENCY

No specific dosage recommendations have been made.

DOSAGE IN RENAL INSUFFICIENCY

No specific dosage recommendations have been made.

PRECAUTIONS

Before starting treatment, it is advisable to rule out other possible causes of urinary obstruction, such as genitourinary infection, prostate cancer, or neurogenic bladder. A digital rectal examination may be necessary, and if required, a prostate-specific antigen (PSA) test may be performed at the start of treatment and periodically throughout its duration.

PRECAUTIONS RELATING TO EXCIPIENTS

This medicine contains sorbitol. Patients with hereditary fructose intolerance should not take this medicine.

ADVERSE REACTIONS

Adverse reactions are described according to each frequency interval, being considered very common (>10%), common (1-10%), uncommon (0.1-1%), rare (0.01-0.1%), very rare (<0.01%) or of unknown frequency (cannot be estimated from the available data).

- Digestive: frequent [ABDOMINAL PAIN]; infrequent [NAUSEA]; rare [FLATULENCE].

- Hepatic: infrequent [INCREASE TRANSAMINASES].

- Neurological/psychological: frequent [HEADACHE]

- Genitourinary: infrequent [GYNECOMASTIA] reversible after discontinuing treatment.

- Dermatological: uncommon [SKIN ERUPTIONS]; rare [PRURITUS].

- General: unknown frequency [EDEMA].

ADVERSE REACTIONS RELATED TO EXCIPIENTS

This medicine contains sorbitol. Daily doses above 10 g of sorbitol taken orally may have a mild laxative effect and lead to diarrhea.

OVERDOSE

Symptoms: there is no clinical experience.

Treatment: symptomatic.