Lactulose Almus

Package leaflet: Information for the patient

LACTULOSE ALMUS 66.7% syrup

Equivalent Medicine
Please read this leaflet carefully before 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, contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice any improvement or if your symptoms worsen after 7 days.

Contents of this leaflet:

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

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

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

2. What you need to know before using LACTULOSE ALMUS

Do not use LACTULOSE ALMUS 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 rectal bleeding of unknown origin;
• are suffering from severe dehydration (excessive loss of body water).

Warnings and precautions
Talk to your doctor or pharmacist before using LACTULOSE ALMUS.
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.
Many people believe they are constipated if they cannot have a bowel movement every day.
This is a mistaken belief, as this condition is completely normal for many people.
Instead, constipation should be considered 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.
The treatment of chronic or recurrent constipation always requires medical supervision for diagnosis, prescription of medication, 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 at 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 body water) or hypokalaemia (low 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 ALMUS
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 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 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 clearly needed and under direct medical supervision.
Driving and using machines
This medicine does not impair the ability to drive or operate machinery.
LACTULOSE ALMUS contains galactose and lactose.
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.
LACTULOSE ALMUS contains fructose.

3. How to take LACTULOSE ALMUS

Use 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.
Dosing
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.
Use in adults
The recommended initial dose is 1 tablespoon of syrup (15 ml = 10 g of lactulose) per day, followed by
half a tablespoon (5 g of lactulose) per day as the maintenance dose. In some cases, a higher initial dose up to 2 tablespoons (20 g of lactulose) per day may be required, which should then be gradually reduced to the normal maintenance dose. In sensitive patients, a lower dose may be necessary.
Use in children
This medicine should be used in children only when absolutely necessary and under medical prescription.
In children aged 6 to 14 years, the recommended initial dose is 3 coffee spoons (15 ml = 10 g of
lactulose) per day, followed by 2 coffee spoons (approximately 6 g of lactulose) per day as the maintenance dose.
In children aged 1 to 5 years, the recommended dose is 1–2 coffee spoons (approximately 3–6 g of lactulose).
In infants, the recommended dose is 1 coffee spoon (5 ml = 3.3 g of lactulose) per day.
Duration of treatment
Laxatives should be used as infrequently as possible and for no longer than seven days. Use for longer periods requires medical prescription following 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 daily administrations, it is preferable to take it in the morning and in the evening.
If you take more LACTULOSE ALMUS 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 ALMUS
Do not take a double dose to make up for the missed dose.
If you stop treatment with LACTULOSE ALMUS
If you have any doubts about using 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 (salts in the blood); 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 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 ALMUS

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.
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 LATTULOSE ALMUS contains
The active substance is lactulose. 100 ml of syrup contain 66.7 g of lactulose.
The other components are: potassium sorbate, orange flavour, purified water.
Description of the appearance of LATTULOSE ALMUS and the contents of the pack
Pack containing one 200 ml glass bottle of syrup.
Marketing Authorisation Holder
Almus S.r.l. - Via Cesarea, 11/10 - 16121 Genoa
E-mail: [email protected]
Manufacturer
ABC Farmaceutici S.p.A. - Canton Moretti 29 - 10090 S. Bernardo d'Ivrea (TO)