SABA 320 mg Soft Capsule

Зміст інструкції

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

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

1. What is SABA and what is it used for

SABA contains lipid-sterolic extract of Serenoa Repens.
This medicine is used in the treatment of disorders associated with benign prostatic enlargement
(prostatic hypertrophy).

2. What you need to know before you take SABA

Do not take SABA

• if you are allergic to the active ingredient 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 product is only used in male patients.

Warnings and precautions
Consult your doctor or pharmacist before taking SABA.

Other medicines and SABA
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
This medicine is intended for the treatment of a disease that affects only men, therefore it should not
be used in women.
Driving and operating machinery
SABA does not interfere with the ability to drive vehicles and operate machinery.
The SABA capsules contain ethyl p-hydroxybenzoate sodium and propyl p-hydroxybenzoate sodium,
two preservatives that may cause allergic reactions (even delayed).

3. How to take SABA

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 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
Given its indication, SABA should not be used in children.
If you take more SABA than you should
If you take a dose of SABA, higher than that prescribed immediately inform your doctoror go to the
nearest hospital. Bring this leaflet with you.

If you forget to take SABA
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.
In some cases, nausea has been reported, especially if the medicine is taken on an empty stomach.

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 via the website:
http://www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store SABA

Store at a temperature below 30°C.
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date that is stated on the pack after “Exp.”. 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 SABA contains
SABA 320 mg soft capsules:

• 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 components are gelatin, glycerol, ethyl p-hydroxybenzoate sodium, propyl p-hydroxybenzoate sodium, titanium dioxide (E 171), red iron oxide (E 172), brown iron oxide (E 172), yellow iron oxide (E 172).

Description of the appearance of SABA and contents of the pack
SABA 320 mg soft capsules are presented in a cardboard box containing 16, 30soft capsules.

Marketing Authorisation Holder
LAMPUGNANI FARMACEUTICI S.P.A. – Via Gramsci 4 – 20014 Nerviano – Milan

Manufacturer
CATALENT ITALY S.p.A.
Via Nettunense Km 20,100 - Aprilia (LT)