Package Insert: Information for the User

Serequr 320 mg Soft Capsules

Phytosterol Extract of Serenoa repens

Read this package insert carefully before you start taking this medicine, as it contains important information for you.

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

Serequr contains as its active ingredient lipidosterolic extract ofSerenoa repens.

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

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

Do not take Serequr

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

Serequrshould 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 must be under continuous medical supervision.

Considering 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 while urinating, or urinary retention occur during use of the medication, you should consult a doctor or pharmacist.

The taking of Serequr may cause gastrointestinal discomfort such as heartburn and abdominal pain if taken on an empty stomach.

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

Other medications and Serequr

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

No interactions with other frequently used medications for this disease (urinary antibiotics, antiseptics, and anti-inflammatory agents) have been described. To avoid potential interactions between several medications, you should consult with your doctor or pharmacist 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 operating machines

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

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

Follow exactly the administration instructions for this medication as indicated by your doctor. If in 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).

Patients with advanced age

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 Toxicological Information Service, phone: 91 562 04 20 indicating the medication and the amount ingested.

If you forgot to take Serequr

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

Continue treatment without changing the dosage regimen.

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If you interrupt treatment with Serequr

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

Administration form

Oral route

Take with a glass of water

Do not chew.

Like all medications, Serequr may produce adverse effects, although not all people will experience them.

The adverse effects that may occur are:

Frequent (may affect up to 1 in 10 patients)

- Abdominal pain

- Headache.

Possible (may affect up to 1 in 100 patients)

- Increased blood pressure.

- Gynecomastia (enlargement of breast tissue in men). Reversible upon discontinuation of treatment.

- Nausea

-Increased moderate levels of transaminases or gamma-glutamyltransferase (liver enzymes).

- Skin redness (rash).

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

- Aerophagia, diarrhea, pyrosis (heartburn).

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

- Edema

Unknown frequency (frequency cannot be estimated from available data)

- Flaccid iris syndrome during cataract extraction

- Allergic reactions

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Do not store at a temperature above 30°C.

Store in the original packaging.

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

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

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at your pharmacy.pharmacy.In case of doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Serequr

• Each soft gelatin capsule contains 320 mg of liposterolic extract from the fruit ofSerenoa repens(Bartram) Small (DER 9-11:1). Solvent ethanol 96% V/V.
• The other components (excipients) are: Gelatin, Glycerol (E-422), Dioxide of titanium (E-171), ethyl parahydroxybenzoate, sodium chloride (E-215), propyl parahydroxybenzoate, sodium chloride (E-217), Red iron oxide (E 172), Brown iron oxide (E 172), Yellow iron oxide (E172).

Appearance of the product and content of the container

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

The soft gelatin capsules are oval and brown.

Holder of the marketing authorization

Laboratorios Q Pharma, S.L.

C/ Moratín 15 Entlo, Offices 6-7

03008 Alicante

Spain

Responsible for manufacturing

Catalent Italy S.p.A.

Via Nettunense Km 20+100,

04011 Aprilia (LT)

Italy

Laboratorios BOHM S.A.

C/ Molinaseca 23, Industrial Polygon Cobo Calleja,

Fuenlabrada, 28947 Madrid(Spain)

Last review date of this leaflet:October 2019

“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/”