Patient Information Leaflet

Pantetina 300 mg soft capsules

Pantetina

Read all of 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 may be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Pantetina is and what it is used for
What you need to know before taking Pantetina
How to take Pantetina
Possible side effects
How to store Pantetina
Contents of the pack and other information

1. What Pantetina is and what it is used for

Pantetina contains the active ingredient pantethine, the active form of pantothenic acid, a vitamin that
acts by reducing fat levels in the blood (hypotriglyceridemic effect).
This medicine is indicated for the treatment of high levels of fats and cholesterol in the blood
(pure and combined hypertriglyceridemias), when diet alone is unable to control these conditions.

2. What you need to know before taking Pantetina

Do not take Pantetina

if you are allergic to pantethine or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before taking Pantetina.
Other medicines and Pantetina
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
No interactions between Pantetina and other medicines are known.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
This medicine does not affect the ability to drive or operate machinery.
Pantetina contains:

parahydroxybenzoates (methylparahydroxybenzoate sodium, propylparahydroxybenzoate sodium, ethylparahydroxybenzoate sodium). This medicine contains parahydroxybenzoates, which may cause allergic reactions (including delayed reactions). This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. it is essentially “sodium-free”.

3. How to take Pantetina

Take this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The recommended dose is 1-2 capsules, twice daily.
Your doctor may decide to adjust the dose according to your health condition.
If you take more Pantetina than you should
Cases of overdose are not known.
In case of accidental ingestion or intake of an excessive dose of Pantetina, inform your
doctor immediately or go to the nearest hospital.
If you forget to take Pantetina
Do not take a double dose to make up for the missed capsule.
Take only the next dose at your usual time.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Known individual hypersensitivity to the product.
Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. You may also report adverse reactions directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting adverse reactions, you can help provide further information on the safety of this medicine.

5. How to store Pantetina

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.
Store below 25°C.
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 Pantetina contains

The active substance is pantethine. Each soft capsule contains 300 mg of pantethine.
The other components are:
- Inner core: macrogol 400, glycerol, purified water, sodium propyl hydroxybenzoate, sodium methyl hydroxybenzoate;
- Capsule shell: gelatin, glycerol, sodium propyl hydroxybenzoate, sodium ethyl hydroxybenzoate, titanium dioxide (E 171), yellow iron oxide (E 172).

Description of the appearance of Pantetina and contents of the pack
Box containing 30 soft capsules.

Marketing Authorization Holder
PHARMAFAR S.r.l. – Corso Vittorio Emanuele II, 82 – Turin – Italy

Manufacturers
A. DOPPEL FARMACEUTICI – Via Martiri delle Foibe, 1 – 29016 Cortemaggiore (PC) – Italy
B. CATALENT ITALY S.p.A. – Via Nettunense, km. 20.1 – Aprilia (LT) – Italy

The product is manufactured and controlled in site A or site B respectively, as indicated by the letter A or B appearing on the packaging before the batch number.