ENDOLAC

BEFORE USE
READ CAREFULLY ALL THE INFORMATION CONTAINED
IN THIS LEAFLET
This is a self-medication product which can be used to treat mild and transient disorders
that are easily recognizable and resolvable without medical help.
It can therefore be purchased without a prescription, but must be used correctly to ensure its effectiveness
and reduce unwanted effects.

• For further information and advice, consult your pharmacist
• Consult a doctor if symptoms persist after a short period of treatment

ENDOLAC
10,000,000 UFC
5,000,000 UFC
4,000,000,000 UFC
Powder for oral suspension
10 Sachets
Lactobacillus acidophilus P-18806
Lactobacillus delbrueckii P-18805
Streptococcus thermophilus P-18807

What it is
Endolac consists of anti-diarrheal microorganisms (lactic acid bacteria).

Why it is used
Endolac is used in intestinal dysbiosis syndromes, i.e., diarrheal syndromes due to altered bacterial flora (diarrhea, non-specific enteritis, colitis), and intestinal dysbiosis caused by antibiotics.

When it must not be used
Endolac must never be used in cases of hypersensitivity to any component of the product or to any of the excipients or to other substances chemically related to them. Confirmed hypersensitivity to any milk component. (See also section “Important information”).

Precautions for use
The bacteria contained in ENDOLAC are sensitive to major antibiotics. Therefore, ENDOLAC should be taken at least 3 hours after antibiotic administration.

Which medicines or foods can affect the medicine’s action
Inform your doctor or pharmacist if you have recently taken any other medicine, including those without a prescription.
No interactions with other drugs are known.

Important information
Endolac may be used by individuals who are lactose intolerant, whereas patients with a confirmed allergy to any milk component should not use lactic acid bacteria-based products.
Due to the low amount of lactose contained in the product and its association with bacteria capable of metabolizing it, use of the product by lactose-intolerant individuals should not cause symptoms related to lactose intolerance.

Use during pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
There are no particular restrictions on the use of ENDOLAC during pregnancy and breastfeeding.

Effects on ability to drive and use machines
ENDOLAC does not impair the ability to drive or operate machinery.

Important information about certain excipients
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.

How to use this medicine

Dosage
Adults: 1 – 2 sachets per day
Warning: Do not exceed the recommended doses.
No data are available for children.

When and for how long
Warning: Use only for short-term treatment.
Consult your doctor if symptoms recur repeatedly or if you have noticed any recent changes in their characteristics.

How to take it
The sachets can be administered with a small amount of water, or their contents can be mixed into a small quantity of sweetened water or milk.

What to do if you take an excessive dose
No cases of overdose have been reported.
In case of accidental ingestion/overdose of ENDOLAC, contact your doctor immediately or go to the nearest hospital.

Undesired effects
Like all medicines, ENDOLAC can cause side effects, although not everybody will experience them.
No adverse effects have been reported in the literature.
Following the instructions in this leaflet reduces the risk of unwanted effects.

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can also be reported directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. Reporting adverse reactions helps provide more information on the safety of this medicine.

How to store ENDOLAC
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label after "Exp:". The expiry date refers to the last day of that month.
Do not use this medicine if you notice visible signs of deterioration.
Storage: Store the product at a temperature between +2°C and +8°C.
Occasional short-term exposure to room temperature does not significantly compromise the product's activity.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This helps protect the environment.

Packaging contents and other information

What ENDOLAC contains
Each sachet contains:
Active substances:
Lactobacillus acidophilus P-18806: at least 1 x 10 UFC/sachet
Lactobacillus delbrueckii P-18805: at least 5 x 10 UFC/sachet
Streptococcus thermophilus P-18807: at least 4 x 10 UFC/sachet

Excipients:
Silicic acid – Sodium saccharin – Banana flavor powder – Apricot flavor powder – Maltodextrins –
Cryoprotectant (Skimmed milk – Sucrose – Sorbitol – Sodium ascorbate – Tween 80) – Lactose not more than 270 mg

Description of ENDOLAC and contents of the pack
Powder for oral suspension; pack containing 10 sachets.

Marketing Authorization Holder
PROGE FARM S.r.l. – Largo Donegani, 4/A – 28100 Novara
Manufacturer S.I.I.T. S.r.l. - Servizio Internazionale Imballaggi Termosaldanti - Via Ariosto,
50/60 - Trezzano sul Naviglio (MI)