Serpens

Patient Information Leaflet

SERPENS 160 mg soft capsules

Lipido-sterolic extract of Serenoa Repens
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet. 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. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What SERPENS is and what it is used for

SERPENS contains a lipid-sterol extract of Serenoa Repens.
This medicinal product is indicated for the treatment of benign enlargement of the prostate in adult males (benign prostatic hyperplasia).
SERPENS is used to treat functional disorders associated with this condition, such as:

• frequent need to urinate (pollakiuria);
• frequent need to urinate during the night (nocturia);
• difficulty in passing urine (dysuria), sometimes accompanied by painful sensation in the area between the testicles and the anus (perineum);
• incomplete bladder emptying and consequent presence of residual urine (vesical residue);
• reduced force and volume of the urinary stream. SERPENS facilitates management in cases where the condition may require surgical therapeutic intervention.

2. What you need to know before taking SERPENS

Do not take SERPENS

• if you are allergic to Serenoa Repens or to any of the other ingredients of this medicine (listed in section 6);
• if you are a woman; due to its indications, this medicine is intended for use only in male patients.

Warnings and precautions
Talk to your doctor or pharmacist before taking SERPENS.
During treatment, you must:

• remain under continuous medical supervision, including routine monitoring of the disease,
• take SERPENS with meals, as nausea may occur if the product is taken on an empty stomach.

SERPENS does not replace surgical therapy if this becomes necessary.
Children and adolescents
This medicine must not be used in children and adolescents.
Other medicines and SERPENS
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
No interactions with other medicinal products have been reported.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
This medicine is intended for the treatment of a condition affecting only men. The product is not indicated during pregnancy and breastfeeding.
Driving and using machines
SERPENS does not affect the ability to drive or operate machinery.
SERPENS contains ethyl parahydroxybenzoate sodium and propyl parahydroxybenzoate sodium
SERPENS capsules contain ethyl parahydroxybenzoate sodium and propyl parahydroxybenzoate sodium, two preservatives that may cause allergic reactions (including delayed reactions).
SERPENS contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. essentially ‘sodium-free’.

3. How to take SERPENS

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Take one capsule twice daily (morning and evening) with meals.
The dosage may be adjusted at the doctor's discretion.
The duration of treatment should not be less than 30 days and, according to your doctor’s advice, may be repeated in multiple cycles.

Use in children and adolescents
Due to its indication, SERPENS must not be used in children.

If you take more SERPENS than you should
In case of overdose, transient gastrointestinal disturbances (abdominal pain) may occur. In the event of overdose or accidental ingestion, consult your doctor or pharmacist.

If you forget to take SERPENS
Do not take a double dose to make up for the forgotten dose.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

Common side effects (may affect from 1 to 10 out of 100 patients)

• Headache
• Abdominal pain

Uncommon side effects (may affect from 1 to 10 out of 1,000 patients)

• Nausea, especially when the product is administered on an empty stomach
• Increased gamma-glutamyl transferase, mild increase in transaminases (liver enzymes)
• Skin redness (rash)
• Excessive breast development (gynecomastia), reversible after discontinuation of treatment

Side effects with unknown frequency (frequency cannot be determined from the available data)

• Swelling

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly through the national reporting system at the following website: https://www.aifa.gov.it/content/segnalazioni--reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store SERPENS

This medicine does not require any special storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp.". The expiry date refers to the last day of that month.
The stated expiry date applies to the product if the packaging remains intact and is correctly stored.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What SERPENS contains
SERPENS 160 mg soft capsules:

• The active substance is lipidosterolic extract of Serenoa Repens. Each capsule contains 160 mg of lipidosterolic extract of Serenoa Repens.
• The other ingredients are gelatin, glycerin, titanium dioxide (E 171), red iron oxide (E 172), brown iron oxide (E 172), yellow iron oxide (E 172), ethyl p-hydroxybenzoate sodium (E 215), propyl p-hydroxybenzoate sodium (E 217), purified water.

Description of the appearance of SERPENS and contents of the pack
SERPENS 160 mg soft capsules are presented in a cardboard box containing 3 blisters of 10 soft capsules each.
Marketing Authorization Holder and Manufacturer
S&R Farmaceutici S.p.a.
Via dei Pioppi n.2,
06083 Bastia Umbra (PG) - Italy
Manufacturer
CATALENT ITALY S.p.A.
Via Nettunense Km 20,100 - Aprilia (LT)

Package leaflet: information for the patient

SERPENS 320 mg soft capsules

Lipidosterolic extract of Serenoa Repens
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What SERPENS is and what it is used for

SERPENS contains a lipid-sterol extract of Serenoa Repens.
This medicinal product is used in the treatment of benign enlargement of the prostate gland in adult males (benign prostatic hyperplasia).
SERPENS is used to treat functional disorders associated with this condition, such as:

• frequent need to urinate (pollakiuria);
• frequent need to urinate during the night (nocturia);
• difficulty in passing urine (dysuria), sometimes accompanied by painful sensation in the area between the testicles and the anus (perineum);
• incomplete bladder emptying and resulting presence of residual urine (vesical residual);
• reduced force and volume of the urinary stream. SERPENS facilitates management in cases where the condition may require a surgical therapeutic solution.

2. What you should know before taking SERPENS

Do not take SERPENS

• if you are allergic to Serenoa repens or to any of the other ingredients of this medicine (listed in section 6);
• if you are a woman, as this medicine is indicated only for male patients.

Warnings and precautions
Talk to your doctor or pharmacist before taking SERPENS.
During treatment, you must:

• remain under continuous medical supervision, including routine monitoring of the disease;
• take SERPENS with meals, as nausea may occur if the product is taken on an empty stomach.

SERPENS does not replace surgical therapy if this becomes necessary.
Children and adolescents
This medicine must not be used in children and adolescents.
Other medicines and SERPENS
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
No interactions with other medicinal products have been reported.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
This medicine is intended for the treatment of a condition affecting only men. The product is not indicated during pregnancy and breastfeeding.
Driving and using machines
SERPENS does not affect the ability to drive or operate machinery.
SERPENS contains ethyl p-hydroxybenzoate sodium and propyl p-hydroxybenzoate sodium.
SERPENS capsules contain ethyl p-hydroxybenzoate sodium and propyl p-hydroxybenzoate sodium, two preservatives that may cause allergic reactions (including delayed reactions).
SERPENS contains sodium.
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. essentially 'sodium-free'.

3. How to take SERPENS

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
In cases of benign enlargement of the prostate (prostatic hypertrophy) with mild or moderate symptoms, it is recommended to take one 320 mg capsule daily (during the evening meal).
In the presence of more severe symptoms, your doctor may prescribe one 320 mg capsule twice daily (with meals).
The duration of treatment should not be less than 30 days and, according to your doctor's advice, may be repeated for several cycles.
Use in children and adolescents
Due to its indication, SERPENS must not be used in children.
If you take more SERPENS than you should
In case of overdose, transient gastrointestinal disturbances (abdominal pain) may occur. In case of overdose or accidental ingestion, consult your doctor or pharmacist.
If you forget to take SERPENS
Do not take a double dose to make up for the forgotten dose.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common side effects (may affect from 1 to 10 people in 100)

• Headache.
• Abdominal pain.

Uncommon side effects (may affect from 1 to 10 people in 1,000)

• Nausea, especially when the product is administered on an empty stomach.
• Increase in gamma-glutamyl transferase, mild increase in transaminases (liver enzymes).
• Skin redness (rash).
• Excessive breast development (gynecomastia), reversible after discontinuation of treatment. Side effects with unknown frequency (frequency cannot be determined from the available data)
• Swelling.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist.
You may also report side effects directly via the national reporting system at the following website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store SERPENS

This medicine does not require any special storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp.". The expiry date refers to the last day of that month.
The stated expiry date refers to the product in its original, unopened packaging, correctly stored.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What SERPENS contains
SERPENS 320 mg soft capsules:

• The active substance is the lipidosterolic extract of Serenoa Repens. Each capsule contains 320 mg of lipidosterolic extract of Serenoa Repens.
• The other ingredients are gelatin, glycerol, ethyl-p-hydroxybenzoate sodium (E 215), propyl-p-hydroxybenzoate sodium (E 217), titanium dioxide (E 171), red iron oxide (E 172), brown iron oxide (E 172), yellow iron oxide (E 172).

Description of the appearance of SERPENS and package contents
SERPENS 320 mg soft capsules come in a cardboard box containing 2 blisters of 8 soft capsules each.
Marketing Authorization Holder and Manufacturer
S&R Farmaceutici S.p.a.
Via dei Pioppi n.2,
06083 Bastia Umbra (PG) – Italy
Manufacturer
CATALENT ITALY S.p.A.
Via Nettunense Km 20,100 - Aprilia (LT)