Package leaflet: Information for the patient

NORMASE EPS 66.7 g/100 ml syrup

Lactulose
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, consult 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, because it could be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Normase EPS is and what it is used for

Normase EPS contains lactulose, a substance that in the intestine reduces the production of toxic substances, such as ammonia.
Normase EPS is indicated for the treatment of:

portosystemic encephalopathy (a disturbance in brain function caused by the accumulation of toxic substances that are not removed by the liver);
hepatic cirrhosis (a serious liver disease).

2. What you need to know before taking Normase EPS

Do not take Normase EPS if:

you are allergic to lactulose or to any of the other ingredients of this medicine (listed in section 6);
you have abdominal pain;
you have episodes of nausea or vomiting.

Warnings and precautions
Talk to your doctor or pharmacist before taking Normase EPS.
Before taking Normase EPS, inform your doctor if you suffer from flatulence (excessive intestinal gas). In this case, at the beginning of treatment the lowest effective dose should be used; your doctor may then increase the dose according to your response to therapy.
Treatment must be supervised by your doctor, who will determine the most suitable dose for you.
During treatment, hypokalaemia (low blood potassium levels) may occur, which can cause neuromuscular and heart disturbances, especially if you are also taking medicines such as cardiac glycosides (medicines used to treat heart problems), diuretics (medicines that lower blood pressure), or corticosteroids (anti-inflammatory medicines).

Other medicines and Normase EPS
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.
Inform your doctor if you are taking:

neomycin and other antibiotics (medicines used to treat bacterial infections);
digitalis (a medicine used to treat heart diseases);
diuretics (medicines used to reduce blood pressure);
corticosteroids (medicines used to treat allergies and inflammation).

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.
There are no available data on the use of NORMASE EPS during pregnancy and breastfeeding.

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

Normase EPS contains sodium benzoate
This medicine contains 1.2 mg of sodium benzoate per 1 ml. It may increase jaundice (yellowing of the skin and eyes) in newborns up to 4 weeks of age.

Normase EPS contains sodium
This medicine contains less than 1 millimole of sodium per dose, i.e., essentially "sodium-free".

Normase EPS contains lactose and galactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

3. How to take Normase EPS

Take this medicine exactly as instructed by your doctor or pharmacist.
The recommended dose is 90–190 ml of syrup (corresponding to 60–127 g of lactulose) per day, divided into 2–3 doses.
Do not exceed the maximum recommended dose.
If you take more Normase EPS than you should
If you accidentally ingest or take too much, diarrhea may occur. In this case, stop treatment and drink fluids to replace fluid and electrolyte losses (salts present in the blood).
If you forget to take Normase EPS
Do not take a double dose to make up for the missed dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Normase EPS can cause side effects, although not everybody gets them.
The following side effects have been reported:

intestinal cramps,
diarrhoea,
flatulence (),
gas (air),
loss of electrolytes (salts in the blood).
Hypersensitivity reactions, rash, itching and urticaria have been reported with unknown frequency (frequency cannot be estimated from the available data).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at the website
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 Normase EPS

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”.
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 Normase EPS contains

The active substance is lactulose. 100 ml of syrup contain 66.7 g of lactulose.
The other components are: citric acid, sodium benzoate, cream flavour, purified water.

Description of the appearance of Normase EPS and contents of the pack
Syrup in 200 ml or 400 ml bottles.
A graduated dosing cup is included in the package.

Marketing Authorisation Holder and Manufacturer
L. Molteni & C. dei F.lli Alitti Società di Esercizio S.p.A., Strada Statale 67, Fraz. Granatieri, 50018
Scandicci (Florence)