SEREQUR 320 mg SOFT CAPSULES

Introduction

Package Leaflet: Information for the User

Serequr 320 mg Soft Capsules

Lipidosterolic extract of Serenoa repens

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

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Serequr and what is it used for
2. What you need to know before taking Serequr
3. How to take Serequr
4. Possible side effects
5. Storage of Serequr
6. Contents of the pack and further information

1. What is Serequr and what is it used for

Serequr contains the active ingredient lipidosterolic extract of Serenoa repens.

It belongs to the group of medications used in benign prostatic hyperplasia and acts at the prostate level, improving symptoms associated with this disease thanks to its inhibitory action on 5-alpha reductase (decreases the formation of the hormone responsible for increasing prostate volume), its local anti-inflammatory and antiproliferative action (reduces the proliferation of prostate cells).

Serequr is used in adult men for the treatment of moderate urinary disorders associated with benign prostatic hyperplasia.

2. What you need to know before taking Serequr

Do not take Serequr

• if you are allergic to the active ingredient lipidosterolic extract of Serenoa repensor to any of the other components of this medication (listed in section 6).
• if you have liver failure.

Serequr should be discontinued two weeks before undergoing surgery.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Serequr.

During treatment, as a routine control of benign prostatic hyperplasia, the patient should be under continuous medical supervision.

Given its indications, the product is used only in male patients.

If symptoms worsen or if symptoms such as fever, spasms, or blood in the urine, pain when urinating, or urinary retention occur during use of the medication, you should consult a doctor or pharmacist.

Taking Serequr may cause gastrointestinal discomfort such as acidity and abdominal pain if taken on an empty stomach.

It is not indicated in women, children, or adolescents.

Other medications and Serequr

Tell your doctor or pharmacist if you are using or have recently used or may need to use any other medication.

No interactions have been described with other medications frequently used to treat this disease (urinary antibiotics, antiseptics, and anti-inflammatory medications). To avoid potential interactions between several medications, you should consult your doctor or pharmacist about any other treatment you are following.

Some cases of suspected interactions with warfarin have been reported.

Pregnancy, breastfeeding, and fertility

Serequr is not indicated for women.

Driving and using machines

No effects have been observed on the ability to drive and use machines.

It may produce allergic reactions (possibly delayed) because it contains ethyl parahydroxybenzoate, sodium salt (E-215) and propyl parahydroxybenzoate, sodium salt (E-217).

3. How to take Serequr

Follow exactly the administration instructions of this medication indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is the oral intake of 1 capsule of 320 mg once a day (during dinner).

Elderly patients

No dose adjustment is necessary in elderly patients.

Patients with renal insufficiency

No dose adjustment is necessary in patients with renal insufficiency.

If you take more Serequr than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Serequr

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

Continue treatment without changing the dosage.

.

If you stop taking Serequr

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

Method of administration

Oral route

Take with a glass of water

Do not chew.

4. Possible side effects

Like all medications, Serequr can cause side effects, although not all people experience them.

The side effects that may occur are:

Frequent (may affect up to 1 in 10 patients)

• Abdominal pain
• Headache

Uncommon (may affect up to 1 in 100 patients)

• Increased blood pressure
• Gynecomastia (enlargement of breast tissue in men). Reversible after treatment discontinuation.
• Nausea
• Moderate increase in transaminases or gamma-glutamyltransferase (liver enzymes)
• Redness of the skin (rash)

Rare (may affect up to 1 in 1,000 patients)

• Aerophagia, diarrhea, heartburn (acidity)

Very rare (may affect up to 1 in 10,000 patients)

• Edema

Frequency not known (frequency cannot be estimated from available data)

• Flaccid iris syndrome during cataract surgery
• Allergic reactions

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the Spanish Medication Monitoring System: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Serequr

Do not store above 30°C.

Keep in the original packaging.

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

Do not use this medication after the expiration date stated on the packaging. The expiration date is the last day of the month indicated after CAD.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy.In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Contents of the pack and further information

Composition of Serequr

• Each soft gelatin capsule contains 320 mg of lipidosterolic extract of Serenoa repensfruit (Bartram) Small (DER 9-11:1). Solvent ethanol 96% V/V.
• The other components (excipients) are: Gelatin, Glycerol (E-422), Titanium dioxide (E-171), ethyl parahydroxybenzoate, sodium salt (E-215), propyl parahydroxybenzoate, sodium salt (E-217), Red iron oxide (E 172), Brown iron oxide (E 172), Yellow iron oxide (E172).

Appearance of the product and contents of the pack

Each box contains 30 soft capsules, in 2 PVC/PVDC-AL/PVDC blisters of 15 soft capsules.

The soft capsules are oval and brown

Marketing authorization holder

Laboratorios Q Pharma, S.L.

C/ Moratín 15 Entlo, Oficinas 6-7

03008 Alicante

Spain

Manufacturer

Catalent Italy S.p.A.

Via Nettunense Km 20+100,

04011 Aprilia (LT)

Italy

Laboratorios BOHM S.A.

C/ Molinaseca 23, Polígono Industrial Cobo Calleja,

Fuenlabrada, 28947 Madrid (Spain)

Date of the last revision of this package leaflet:October 2019

“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/”