Package leaflet: Information for the patient

LAEVOLAC 66.7 g/100 ml syrup

Lactulose
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 told you to.

Keep this leaflet. You may need to read it again.
If you would like more information or advice, please ask your pharmacist.
If you or your child experience any side effects, including those not listed in this leaflet, please tell your doctor or pharmacist. See section 4.
Please consult your doctor if you do not notice any improvement or if symptoms worsen after 7 days.

Contents of this leaflet:

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

1. What LAEVOLAC is and what it is used for

Laevolac contains lactulose, a laxative that stimulates intestinal motility.
Laevolac is indicated in adults and children for the short-term treatment of occasional constipation.
Consult a doctor if you and/or the child do not feel better or feel worse after 7 days.

2. What you need to know before using LAEVOLAC

Do not use LAEVOLAC if you and/or your child:

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

Warnings and precautions
Talk to your doctor or pharmacist before using LAEVOLAC.
Health education notes
First of all, it should be kept in mind that, in most cases, a balanced diet rich in water and fibre (bran, vegetables and fruit) can provide a lasting solution to constipation.
Many people believe they suffer from constipation if they do not have a bowel movement every day.
This is a mistaken belief, as going less frequently than daily is perfectly normal for many individuals.
Constipation should instead be considered present when bowel movements are less frequent than your usual pattern and are associated with the passage of hard stools.
If episodes of constipation recur frequently, you should consult your doctor.
Treatment of chronic or recurrent constipation always requires medical supervision for diagnosis, prescription of medications, and monitoring during therapy.
Consult your doctor:

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 use of the laxative fails to produce an effect.
if you are elderly or in poor general health.

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

Other medicines and LAEVOLAC
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 need to take 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 conditions).

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
The use of this medicine during pregnancy and breastfeeding should only be considered if clearly necessary and under the direct supervision of a doctor.

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

LAEVOLAC contains galactose and lactose.
If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.

LAEVOLAC contains fructose.

3. How to use LAEVOLAC

Use this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Dosing
The correct dose is the lowest amount needed to produce easy evacuation 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 divided 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 divided 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 divided 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 divided 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. Use for longer periods requires a doctor's prescription following appropriate clinical evaluation.
Method of administration
If taking a single daily dose, it is preferable to take it in the evening. If the dose is divided into two administrations per day, it is preferable to take it in the morning and evening.
If you take more LAEVOLAC 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 LAEVOLAC
Do not take a double dose to make up for the missed dose.
If you stop using LAEVOLAC
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 gas production in the intestine).
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):
Electrolyte loss (blood salts), allergic reactions, skin rash, itching, urticaria.
Reporting of side effects
If you get any side effects, 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 LAEVOLAC

Store below 25°C.
Shelf life after first opening of the bottle: 12 months if stored below 25°C.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the bottle after “Exp.”
The expiry date refers to the last day of that month.
Do not use this medicine if you notice any obvious signs of damage or tampering with the bottle.
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 LAEVOLAC contains
The active substance is lactulose 66.7 g in 100 ml of syrup.
Excipients: none
Description of the appearance of LAEVOLAC and contents of the pack
Syrup in a 180 ml bottle with a graduated polypropylene dosing cup ranging from 2.5 ml to 30 ml.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Chiesi Italia S.p.A. – Via G. Chiesi, 1 – 43122 Parma, Italy
Manufacturer
Fresenius Kabi Austria GmbH - Estermannstraße 17 - 4020 Linz, Austria