Lactulose Aurobindo

Package leaflet: Information for the patient

Lactulose Aurobindo 66.7 g/100 ml oral solution

Generic medicine
Please read this leaflet carefully before taking 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 you.

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

Contents of this leaflet

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

1. What Lactulose Aurobindo is and what it is used for

Lactulose Aurobindo contains the active substance lactulose, a laxative that stimulates intestinal motility.
Lactulose Aurobindo is indicated in adults and children for the short-term treatment of occasional constipation.
Consult your 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 Lactulose Aurobindo

Do not use Lactulose Aurobindo 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;
• have episodes of nausea or vomiting;
• have intestinal obstruction or narrowing of the intestine (intestinal stenosis);
• have unexplained rectal bleeding;
• are suffering from severe dehydration (excessive loss of water from the body).

Warnings and precautions
Talk to your doctor or pharmacist before using Lactulose Aurobindo.
Health education notes
First of all, it should be borne in mind 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 are unable to defecate every day.
This is a mistaken belief, as this condition is completely normal for many individuals.
Instead, constipation should be considered when bowel movements are reduced compared to your usual habits and are associated with the passage of hard stools.
If episodes of constipation occur repeatedly, you should consult your doctor.
The treatment of chronic or recurrent constipation always requires medical intervention for diagnosis, prescription of medicines 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 the use of the laxative fails to produce any effect;
• if you are elderly or in poor general health.

Abuse of laxatives
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 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, 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).
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 Lactulose Aurobindo
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicine.
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 or 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, are planning to become pregnant, 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 if clearly needed and under direct medical supervision.
Driving and using machines
Lactulose Aurobindo does not affect the ability to drive or operate machinery.
Lactulose Aurobindo contains:

• Traces of galactose and lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.
• Sodium benzoate. This medicine contains 17.7 mg of sodium benzoate per dose (15 ml), equivalent to 1.18 mg/ml. Sodium benzoate may increase jaundice (yellowing of the skin and eyes) in newborns up to 4 weeks of age.

3. How to use Lactulose Aurobindo

Use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Dosing instructions
The correct dose is the lowest amount needed to produce easy passage of soft stools.
It is recommended to start with the lowest recommended dose.
Do not exceed the maximum daily recommended dose.
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 to <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 to <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 to 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 beyond this period requires a doctor's prescription following appropriate clinical evaluation.
Method of administration
Shake the bottle before use.
If taking once daily, it is preferable to take the dose in the evening. If the dose is divided into two daily administrations, it is preferable to take it in the morning and evening.
If you take more Lactulose Aurobindo than you should
Accidental ingestion or intake of an excessive dose may cause abdominal pain and diarrhoea. In such cases, stop treatment and drink fluids to replace fluid and electrolyte losses (salts present in the blood).
If you have any doubts about how to use 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):
Electrolyte loss (blood salts), allergic reactions, skin rash, itching, urticaria.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. You can also report side effects directly via 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 Lactulose Aurobindo

Keep this medicine out of 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.
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 Lactulose Aurobindo contains
The active substance is lactulose.
100 ml of oral solution contain 66.7 g of lactulose.
The other components are: sodium benzoate, purified water.
Description of the appearance of Lactulose Aurobindo and contents of the pack
Amber glass bottle of 200 ml equipped with a polypropylene screw-cap with child-resistant closure.
The bottle contains 180 ml of oral solution.
A graduated polypropylene dosing cup, ranging from 2.5 ml to 30 ml, is included in the package.
Marketing Authorization Holder
Aurobindo Pharma (Italia) S.r.l., via San Giuseppe, 102 - 21047 Saronno (VA)
Manufacturer
ICE S.p.A.
Cantone Moretti, 29
10015 (TO) – Ivrea – Italy