Morelac
Italy
Table of Contents
Package leaflet: Information for the patient
MORELAC 10,000,000 CFU - 5,000,000 CFU - 4,000,000,000 CFU oral suspension powder
Lactobacillus acidophilus P-18806, Lactobacillus delbrueckii P-18805 and Streptococcus thermophilus P-18807
Please read this leaflet carefully before taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed.
- Keep this leaflet. You may need to read it again.
- If you need more information or advice, consult your pharmacist.
- If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
- Contact your doctor if you do not notice improvement or if your symptoms worsen after a short time.
Contents of this leaflet:
- What MORELAC is and what it is used for
- What you need to know before taking MORELAC
- How to take MORELAC
- Possible side effects
- How to store MORELAC
- Contents of the pack and other information
1. What MORELAC is and what it is used for
MORELAC contains as active substances Lactobacillus acidophilus P-18806, Lactobacillus delbrueckii P-18805, and Streptococcus thermophilus P-18807.
MORELAC is indicated for disturbances of intestinal bacterial flora caused by diarrhoeal and dyspeptic syndromes (with difficult digestion), enteritis and colitis (inflammation of the intestine), and the use of antibiotics (medicines used to treat bacterial infections).
Consult your doctor if you do not feel better or if you feel worse after a short period.
2. What you should know before taking MORELAC
Do not take MORELAC
- If you are allergic to any of the ingredients of this medicine (listed in section 6);
- if you have or suspect an allergy to milk proteins (see “MORELAC contains sucrose, sorbitol and lactose” and “Warnings and precautions”).
Warnings and precautions
Talk to your doctor or pharmacist before taking MORELAC.
This medicine contains milk proteins. If your doctor has diagnosed or suspects you have an allergy to
cow's milk proteins, contact them before taking this medicine.
Children
There are no data available on the use of this medicine in children.
Other medicines and MORELAC
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
Take MORELAC at least 3 hours after taking medicines used to treat bacterial infections (antibiotics). MORELAC contains bacteria that are sensitive to these medicines and may therefore lose effectiveness.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
MORELAC may be taken during pregnancy or while breastfeeding.
Driving and using machines
MORELAC does not affect the ability to drive vehicles or operate machinery.
MORELAC contains sucrose, sorbitol and lactose
This medicine contains sucrose and lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
This medicine contains 6 mg of sorbitol per sachet.
This medicine contains less than 1 mmol (23 mg) of sodium per sachet, i.e. essentially ‘sodium-free’.
3. How to take MORELAC
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 sachets per day.
Dissolve the contents of the sachet in a small amount of water, sweetened water, or milk.
If you take more MORELAC than you should
Cases of overdose are not known.
In the event of accidental ingestion of an excessive dose of MORELAC, contact your doctor immediately or go to the nearest hospital.
If you forget to take MORELAC
Do not take a double dose to make up for the forgotten sachet.
If you stop treatment with MORELAC
If you have any doubts about using this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody will experience them.
No side effects have been reported with the use of this medicine.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please contact your doctor or pharmacist.
You may 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 MORELAC
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 in a refrigerator, between +2°C and +8°C. The medicine may be stored for short periods at room temperature (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 MORELAC contains
- The active substances are Lactobacillus acidophilus P-18806, Lactobacillus delbrueckii P-18805 and Streptococcus thermophilus P-18807. Each sachet contains:
o at least 10,000,000 colony forming units (CFU) of Lactobacillus acidophilus P-18806;
o at least 5,000,000 colony forming units (CFU) of Lactobacillus delbrueckii P-18805;
o at least 4,000,000,000 colony forming units (CFU) of Streptococcus thermophilus P-18807. - The other components are: silicic acid, sodium saccharin, banana flavour powder, apricot flavour powder, maltodextrins, cryoprotectant (skimmed milk, sucrose, sorbitol, sodium ascorbate, Tween 80), lactose.
Description of the appearance of MORELAC and contents of the pack
Pack of 10 sachets in paper/Al/polyethylene laminate, packed in a printed cardboard carton.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Proge Farm S.r.l. - Largo Donegani 4/A - 28100 Novara - Italy
Manufacturer
S.I.I.T. S.r.l. – Servizio Internazionale Imballaggi Termosaldanti – Via Ariosto, 50/60 – Trezzano sul Naviglio (MI) – Italy