SERPENS 160 mg Soft Capsule

Зміст інструкції

1. SERPENS 160 mg soft capsules
   1. What is SERPENS and what is it used for
   2. What you need to know before you take SERPENS
   3. How to take SERPENS
   4. Possible side effects
   5. How to store SERPENS
   6. Contents of the pack and other information
2. SERPENS 320 mg soft capsules
   1. What is SERPENS and what is it 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. Package Contents and Other Information

SERPENS 160 mg soft capsules

Lipid-sterolic extract of Serenoa Repens
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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If any side effects occur, including those not listed in this leaflet, tell 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 you take 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 is SERPENS and what is it used for

SERPENS contains lipid-sterolic extract of Serenoa Repens.
This medicine is used in the treatment of benign prostatic hyperplasia in adult males.
SERPENS is used for the treatment of functional disorders related to this disease, such as:

• frequent need to urinate (pollakiuria);
• frequent need to urinate during the night (nicturia);
• difficult urination (dysuria), sometimes accompanied by a painful sensation in the area between the testicles and the anus (perineum);
• incomplete bladder emptying and consequent presence of urine (residual urine);
• decreased force and volume of the urine stream. SERPENS facilitates surgical intervention in cases where the disease requires a surgical therapeutic solution.

2. What you need to know before you take 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, given its indications, the medicine is only used in male patients.

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

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

SERPENS does not replace surgical therapy if this proves necessary.

Children and adolescents
This medicine should not be used in children and adolescents.

Other medicines and SERPENS
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
No interactions with other drugs have been reported.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, or are planning to become pregnant, or if you are breastfeeding,
ask your doctor or pharmacist for advice before using this medicine.
This medicine is intended for the treatment of a disease that only affects men. The product is not
indicated during pregnancy and breastfeeding.

Driving and using machines
SERPENS does not impair the ability to drive vehicles or operate machinery.

SERPENS contains ethyl para-hydroxybenzoate sodium and propyl para-hydroxybenzoate sodium
The SERPENS capsules contain ethyl para-hydroxybenzoate sodiumand propyl para-hydroxybenzoate sodium, two preservatives that may cause allergic reactions (including delayed reactions).
SERPENS contains sodium
This medicine contains less than 1mmol (23mg) of sodium per capsule, which is essentially ‘sodium-free’.

3. How to take SERPENS

Take this medicine following the instructions of your doctor exactly. If you have any doubts, consult your
doctor or pharmacist.
Take one capsule twice a day (morning and evening) with meals.
The dosage may be varied at the doctor’s discretion.
The duration of therapy should not be less than 30 days and, according to your doctor’s opinion, may be
repeated for multiple cycles.

Use in children and adolescents
Given its indication, SERPENS should not be used in children.
If you take more SERPENS than you should
In case of overdose, transient gastrointestinal disorders (abdominal pain) may occur. In
case of overdose or accidental ingestion, contact your doctor or pharmacist.

If you forget to take SERPENS
Do not take a double dose to make up for a missed dose.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Common side effects(may affect up to 1 in 10 people)

• Headache.
• Abdominal pain. Uncommon side effects(may affect up to 1 in 1,000 people)
• Nausea, especially in cases where the product is administered on an empty stomach.
• Increased gamma-glutamyl transferase, moderate increase in transaminases (liver enzymes).
• Skin redness (rash).
• Excessive development of the breasts (gynecomastia), reversible after discontinuation of treatment. Side effects with unknown frequency(frequency cannot be estimated based on available data)
• Swelling.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your
doctor or pharmacist.
You can also report side effects directly through the national reporting system
at 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 particular storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after “Scad.”. The expiry date
refers to the last day of that month.
The expiry date indicated refers to the product in intact packaging, correctly stored.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What SERPENS
SERPENS 160 mg soft capsules contain:

• The active ingredient is the lipid-sterolic extract of Serenoa Repens. Each capsule contains 160 mg of lipid-sterolic 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 sodium p-hydroxybenzoate (E 215), propyl sodium p-hydroxybenzoate (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.

Marketing Authorisation 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)

SERPENS 320 mg soft capsules

Lipid-sterolic extract of Serenoa Repens
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, ask your doctor or pharmacist.
• This medicine has been prescribed only for you. Do not give it to other people, even if their symptoms are the same as yours, as it could be dangerous.
• If any side effects occur, including those not listed in this leaflet, tell 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 you take 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 is SERPENS and what is it used for

SERPENS contains lipid-sterolic extract of Serenoa Repens.
This medicine is used in the treatment of benign prostatic hyperplasia in adult males.
SERPENS is used for the treatment of functional disorders related to this disease, such as:

• frequent need to urinate (pollakiuria);
• frequent need to urinate during the night (nicturia);
• difficult urination (dysuria), sometimes accompanied by a painful sensation in the area between the testicles and the anus (perineum);
• incomplete bladder emptying and subsequent presence of urine (residual urine);
• decreased force and volume of the urine stream. SERPENS facilitates surgery in cases where the disease requires a surgical therapeutic solution.

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, given its indications, the medicine is only used in male patients.

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

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

SERPENS does not replace surgical therapy if this proves necessary.

Children and adolescents
This medicine should not be used in children and adolescents.

Other medicines and SERPENS
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicine.
No interactions with other drugs have been reported.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding,
ask your doctor or pharmacist for advice before using this medicine.
This medicine is intended for the treatment of a disease that only affects men. The product is not
indicated in pregnancy and during breastfeeding.

Driving and operating machinery
SERPENS does not impair the ability to drive vehicles or operate machinery.

SERPENS contains ethyl parahydroxybenzoate sodium and propyl parahydroxybenzoate sodium.
The SERPENS capsules contain ethyl parahydroxybenzoate sodium and propyl parahydroxybenzoate sodium, two preservatives that may cause allergic reactions (including delayed ones).
SERPENS contains sodium.
This medicine contains less than 1mmol (23mg) of sodium per capsule, i.e. essentially ‘sodium-free’.

3. How to take SERPENS

Take this medicine following the instructions of your doctor exactly. If you have any doubts, consult your
doctor or pharmacist.
In cases of benign prostatic hyperplasia (prostatic hypertrophy) with mild or moderate symptoms, it is
recommended to administer one 320 mg capsule per day (during the evening meal).
If more severe symptoms are present, your doctor may prescribe the administration of one 320 mg capsule 2
times a day (during meals).
The duration of therapy should not be less than 30 days and, according to your doctor's opinion, it may be
repeated for multiple cycles.

Use in children and adolescents
Given its indication, SERPENS should 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, contact your doctor or pharmacist.

If you forget to take SERPENS
Do not take a double dose to make up for a missed 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.
manifest.

Common side effects(may affect up to 1 in 10 people)

• Headache.
• Abdominal pain.

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

• Nausea, especially in cases where the product is administered on an empty stomach.
• Increased gamma-glutamyl transferase, moderate increase in transaminases (liver enzymes).
• Skin redness (rash).
• Excessive development of the breasts (gynecomastia), reversible after discontinuation of treatment. Side effects with frequency not known(frequency cannot be estimated on the basis of the available data)
• Swelling.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist.
You can also report side effects directly through the national reporting system
at 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 which is stated on the pack after “Scad.”. The expiry date
refers to the last day of that month.
The expiry date indicated refers to the product in intact packaging, correctly stored.
Do not dispose of any medicine in 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
SERPENS 320 mg soft capsules contain:

• The active ingredient is the lipid-sterolic extract of Serenoa Repens. Each capsule contains 320 mg of lipid-sterolic 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 are presented in a cardboard box containing 2 blisters of 8 soft capsules.

Marketing Authorisation 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)