Saba
Italy
Table of Contents
Package leaflet: Information for the patient
SABA 320 mg soft capsules
Lipido-sterolic 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 other people, 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
- What SABA is and what it is used for
- What you need to know before taking SABA
- How to take SABA
- Possible side effects
- How to store SABA
- Contents of the pack and other information
1. What SABA is and what it is used for
SABA contains a lipidosterolic extract of Serenoa Repens.
This medicinal product is used for the treatment of disorders associated with benign enlargement of the prostate (benign prostatic hyperplasia).
2. What you need to know before taking SABA
Do not take SABA
- if you are allergic to the active substance Serenoa Repens or to any of the other ingredients of this medicine (listed in section 6);
- if you are a woman, as due to its indications, this product is intended for use only in male patients.
Warnings and precautions
Talk to 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
medicine.
No interactions with other medicinal products have been reported.
Pregnancy and breastfeeding
This medicine is intended for the treatment of a condition affecting only men; therefore, it must not be used in women.
Driving and using machines
SABA does not affect the ability to drive or operate machinery.
SABA capsules contain ethyl p-hydroxybenzoate sodium and propyl p-hydroxybenzoate sodium,
two preservatives that may cause allergic reactions (including delayed reactions).
3. How to take SABA
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, the recommended dosage is one 320 mg capsule daily (taken during the evening meal).
In cases of more severe symptoms, your doctor may prescribe one 320 mg capsule twice daily (during meals).
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
Due to its indication, SABA must not be used in children.
If you take more SABA than you should
If you take more SABA than prescribed, inform your doctor immediately or go to the nearest hospital. Take this leaflet with you.
If you forget to take SABA
Do not take a double dose to make up for a 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.
Nausea has been reported in some cases, especially if the medicine is taken on an empty stomach.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist.
You may 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 below 30°C.
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after "Exp.". The expiry date refers to the last day of that month.
The expiry date shown refers to the product in its original 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 SABA contains
SABA 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 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 package contents
SABA 320 mg soft capsules are presented in a cardboard box containing 16 or 30 soft capsules.
Marketing Authorization Holder
LAMPUGNANI FARMACEUTICI S.P.A. – Via Gramsci 4 – 20014 Nerviano – Milano
Manufacturer
CATALENT ITALY S.p.A.
Via Nettunense Km 20,100 - Aprilia (LT)