Infloran

Package leaflet: Information for the user

Infloran

Hard capsules
Bifidobacterium bifidum + Lactobacillus acidophilus
Please read all of 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 you.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, contact your pharmacist.
• If you experience any of the side effects, 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 you notice worsening of symptoms after a few days.

Contents of this leaflet:

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

1. What Infloran is and what it is used for

Infloran contains Bifidobacterium bifidum and Lactobacillus acidophilus, microorganisms normally
present in the intestine that help balance and restore the "intestinal bacterial flora".
Infloran is used for:

• preventing alterations of the intestinal bacterial flora that may cause, for example, diarrhoea, stomach ache, bloating (gastrointestinal dysbiosis);
• treating:
  • diarrhoea, colitis, intestinal inflammations in adults and infants which may cause symptoms such as cramps, diarrhoea and absorption problems (non-specific enteritis);
  • intestinal flora disturbances due to antibiotics (antibiotic-induced dysbiosis);
  • digestive disorders in infants fed with artificial milk;
  • intestinal infections caused by antibiotic-resistant bacteria, in combination with other therapies.

Consult your doctor if you do not feel better or feel worse after a few days.

2. What you need to know before taking Infloran

Do not take Infloran

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

Warnings and precautions
Do not use for prolonged treatments; consult your doctor if you do not notice improvement after a few days of treatment.
Also consult your doctor if the condition recurs repeatedly or if you have noticed any recent change in symptoms.
Colour differences in the product between different packages may be observed: this is due to the other ingredients of this medicine (listed in section 6), and does not mean that the product is altered.

Children and adolescents
This medicine can be used in children and adolescents.

Other medicines and Infloran
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Infloran with food, drinks and alcohol
No interactions are known. For instructions on how to take the medicine, see section 3.

Pregnancy and breastfeeding
This medicine can be used during pregnancy and breastfeeding. If you have any doubts, ask your doctor or pharmacist for advice before using this medicine.

Driving and using machines
Infloran does not affect the ability to drive or operate machinery.

Infloran contains sucrose and lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.

3. How to take Infloran

Take this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
The recommended dose for adults is 1 capsule three times daily before meals.
Swallow the capsule with a small amount of non-hot drink.

Use in children
Follow the same dosing as indicated for adults.
For infants, pour the contents of the capsule into a small amount of non-hot drink or sugared water.

Duration of treatment: Use only for short periods.
Do not exceed the recommended doses without medical advice.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
No adverse reactions have been reported at the recommended doses.
Following the instructions provided in this leaflet reduces the risk of adverse reactions.
Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist.
You may also report adverse reactions directly via the website:
http://www.agenziafarmaco.gov.it/it/responsabili . By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. How to store Infloran

Store in the refrigerator (2°C / 8°C). Keep in the original packaging to protect the medicine from light.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after "Exp.". The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Infloran contains
In one capsule:

• The active substances are: lyophilized Bifidobacterium bifidum (viable) not less than 1,000 million, lyophilized Lactobacillus acidophilus (viable) not less than 1,000 million.
• The other components are sucrose, sodium citrate, magnesium stearate, dibasic potassium phosphate, monohydrate lactose. The capsule shell is composed of: gelatin, titanium dioxide (E171), erythrosine (E127), indigotine (E132), quinoline yellow (E104).

Description of the appearance of Infloran and contents of the pack
Infloran comes in a pack of 20 hard capsules in blisters.
Marketing Authorization Holder and Manufacturer
Laboratorio Farmaceutico SIT S.r.l. - Via Cavour, 70 – 27035 Mede (PV).