PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

LACTULOSE PENSA 66.7 g/100 ml oral solution

Lactulose
Generic Medicine
Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Always use 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 side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Consult your doctor if you do not notice any improvement or if you notice worsening of symptoms after 7 days.

Contents of this leaflet:

What LACTULOSE PENSA is and what it is used for
What you need to know before using LACTULOSE PENSA
How to use LACTULOSE PENSA
Possible side effects
How to store LACTULOSE PENSA
Contents of the pack and other information

1. What LATTULOSIO PENSA is and what it is used for

LATTULOSIO PENSA contains lactulose, a laxative used to facilitate intestinal evacuation.
LATTULOSIO PENSA is indicated in adults and children for the short-term treatment of occasional constipation.
Consult your doctor if you and/or your child do not feel better or feel worse after 7 days.

2. What you need to know before using LACTULOSE PENSA

Do not use LACTULOSE PENSA if:

you are allergic to lactulose or to any of the other ingredients of this medicine (listed in section 6);
you have abdominal pain, even of unknown origin;
you are experiencing episodes of nausea or vomiting;
you have intestinal obstruction or narrowing of the intestine (intestinal stenosis);
you have unexplained rectal bleeding (from the last part of the intestine);
you are suffering from severe dehydration (excessive loss of water from the body).

Warnings and precautions
Talk to your doctor or pharmacist before using LACTULOSE PENSA.
Health education notes
First of all, it should be noted that, in most cases, a balanced diet rich in water and fibre (bran, vegetables and fruit) can permanently resolve constipation problems.
Many people believe they suffer from constipation if they cannot defecate every day.
This is a mistaken belief, as this condition is completely normal for a large number of individuals.
Instead, consider that constipation occurs when bowel movements are reduced compared to your own personal habits and are associated with the passage of hard stools.
If episodes of constipation recur frequently, you should consult your doctor.
The treatment of chronic or recurring constipation always requires medical supervision for diagnosis, prescription of medications and monitoring during therapy.
Before taking LACTULOSE PENSA, inform your doctor if you suffer from meteorism (excessive gas in the intestine). In such cases, treatment should begin with the lowest effective dose; your doctor may then increase the dose according to your response to therapy.
Treatment must be carried out under medical supervision, which will determine the most suitable dose for you.
Consult your doctor:

if you are elderly or in poor general health;
when the need for a laxative arises from a sudden change in previous bowel habits (frequency and characteristics of bowel movements) lasting more than two weeks, or when the use of a laxative fails to produce results.

Abuse of laxatives
Frequent or prolonged use, or excessive doses of laxatives, may cause persistent diarrhoea, resulting in loss of water, mineral salts (especially potassium) and other essential nutrients. In severe cases, dehydration (excessive loss of water from the body) or hypokalaemia (decreased potassium levels in the blood) may occur, which can lead to cardiac or neuromuscular disorders, particularly if you are also taking medications such as cardiac glycosides (medicines used to treat heart problems), diuretics (medicines that lower blood pressure) or corticosteroids (anti-inflammatory medicines). In severe cases, dehydration (excessive loss of water from the body) or hypokalaemia (decreased potassium levels in the blood) may occur.
Abuse of laxatives may lead to dependence (possible need to progressively increase the dosage), chronic constipation and intestinal atony (loss of normal intestinal function).

Other medicines and LACTULOSE PENSA
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Avoid taking laxatives together with other medicines: if you are taking another medicine, wait at least 2 hours before taking the laxative.
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, planning a pregnancy, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
The use of this medicine during pregnancy and breastfeeding should only be considered when strictly necessary and under direct medical supervision.

Driving and using machines
LACTULOSE PENSA does not impair the ability to drive or operate machinery.

LACTULOSE PENSA contains sodium benzoate
This medicine contains 1.18 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.

LACTULOSE PENSA contains sodium
This medicine contains less than 1 millimole of sodium per dose, i.e. essentially “sodium-free”.

LACTULOSE PENSA contains traces of lactose and galactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.

3. How to use LACTULOSE PENSA

Use this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you are in doubt, consult your doctor or pharmacist.
Dosage
The correct dose is the lowest amount needed to produce easy passage of soft stools.
It is recommended to initially use the lowest recommended doses. Do not exceed the maximum daily dose recommended.

Adults
The recommended dose is 15–30 ml (equivalent to 10–20 g of lactulose), taken in one or two doses per day.
When necessary, the dose may be increased.
The maximum daily dose is 45 ml (equivalent to 30 g of lactulose).

Adolescents and children > 10 years
The recommended dose is 15 ml (equivalent to 10 g of lactulose), taken in one or two doses per day.
The maximum daily dose is 15 ml.

Children 5 - < 10 years
The recommended dose is 10 ml (equivalent to 6.67 g of lactulose), taken in one or two doses per day.
The maximum daily dose is 10 ml.

Children >1 – < 5 years
The recommended dose is 5 ml (equivalent to 3.33 g of lactulose), taken in one or two doses per day.
The maximum daily dose is 5 ml.

Children 1 month - 1 year
The recommended dose is 2.5 ml (equivalent to 1.66 g of lactulose), taken as a single dose in the evening.
The maximum daily dose is 2.5 ml.

Duration of treatment
Laxatives should be used as infrequently as possible and for no longer than seven days. Prolonged use should only be prescribed after adequate clinical evaluation.

Method of administration
If taken once daily, it is preferable to take the dose in the evening. If the dose is divided into two administrations per day, it is preferable to take it in the morning and evening.
Shake the bottle before use.
Use the graduated dosing cup supplied with the package.

If you take more LACTULOSE PENSA than you should
In case of accidental ingestion/overdose, abdominal pain and diarrhoea may occur. In such cases, discontinue treatment and drink fluids to replace fluid and electrolyte losses (salts present in the blood).

If you forget to take LACTULOSE PENSA
Do not take a double dose to make up for the missed dose.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the following side effects, consult your doctor or pharmacist.
Very common (may affect more than 1 in 10 people):
Abdominal pain; flatulence (excessive intestinal gas production).
Common (may affect up to 1 in 10 people):
Abdominal distension; urgency to defecate; diarrhoea; nausea; reduced appetite; headache.
Uncommon (may affect up to 1 in 100 people):
Vomiting
Not known (frequency cannot be estimated from the available data):
Loss of electrolytes (salts in the blood)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. You may also report side effects directly via the national reporting system at the following 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 LACTULOSE PENSA

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 "Expiry".
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines 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 LATTULOSIO PENSA contains
The active substance is lactulose. 100 ml of syrup contain 66.7 g of lactulose.
The other components are: sodium benzoate and purified water.

Description of the appearance of LATTULOSIO PENSA and package contents
Amber glass bottle of 200 ml equipped with a polypropylene cap with child-resistant closure.
The bottle contains 180 ml of syrup.
A graduated polypropylene dosing cup, ranging from 2.5 ml to 30 ml, is included in the package.

Marketing Authorization Holder
Towa Pharmaceutical S.p.A. - Via Enrico Tazzoli, 6 - 20154 Milan – Italy

Manufacturer
ICE S.p.A.
Cantone Moretti, 29
10015 Ivrea (TO) – Italy