NORMASE

Package leaflet: Information for the patient

NORMASE 66.7 g/100 ml syrup

Lactulose
Please read all of this leaflet carefully before you start using this medicine, as it contains important information for you.
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 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 any improvement or if you notice worsening of symptoms after 7 days.

Contents of this leaflet:

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

1. What Normase is and what it is used for

Normase contains lactulose, a laxative that draws water into the intestine and softens the stool.
Normase is indicated for the short-term treatment of occasional constipation.
Consult your doctor if you or your child do not feel better or feel worse after 7 days.

2. What you need to know before using Normase

Do not use Normase if:

• you or your child 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 have episodes of nausea or vomiting;
• you have intestinal obstruction or narrowing (intestinal stenosis);
• you have rectal bleeding (from the final part of the intestine) of unknown origin;
• you are suffering from severe dehydration (excessive loss of body water);

Warnings and precautions
Talk to your doctor or pharmacist before using Normase.
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 provide a long-term solution to constipation.
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, consider that constipation occurs when bowel movements are reduced compared to your usual 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 recurrent constipation always requires medical supervision for diagnosis, prescription of medication, and monitoring during therapy.
Consult your doctor:

• if 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 if use of the laxative fails to produce an 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, electrolytes (especially potassium), and other essential nutrients. In 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 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 Normase
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 conditions);
• 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 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 if clearly necessary and under direct medical supervision.

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

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

Normase contains fructose.

3. How to use Normase

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.

Dosage

The correct dose is the lowest dose that produces easy passage of soft stools. It is recommended to start with the lowest recommended dose.

If necessary, the dose may be increased. Do not exceed the maximum recommended daily dose.

Adults

The recommended starting dose is 20 ml per day.

The maintenance dose is 10 ml per day.

If needed, you may start with a higher dose (30–40 ml), which should then be gradually reduced to 10 ml per day (maintenance dose).

Children

The recommended dose is 5–15 ml per day, depending on body weight.

Infants

The recommended dose is 0.5–1 ml per day for each kg of body weight.

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, take it preferably in the morning and evening.

Take with an adequate amount of water (a generous glass).

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.

If you use more Normase than you should

If you have taken more Normase than you should, speak to a doctor or go to hospital immediately. Take the medicine package with you.

In case of accidental ingestion/overdose, abdominal pain and diarrhoea may occur; in such cases, stop treatment and drink fluids to replace fluid and electrolyte losses (salts present in the blood).

If you forget to use Normase

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, this medicine can cause side effects, although not everybody gets them.
Occasionally, abdominal pain—more frequent in cases of severe constipation—and flatulence (gas) may occur.
These symptoms are mild in severity and resolve spontaneously after the first few days of treatment.
Allergic reactions, skin 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 effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly through 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

• 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 contains

• The active substance is lactulose. 100 ml of syrup contain 66.7 g of lactulose.
• The other components are citric acid, Curt Georgi flavour no. 7 bis, and purified water.

Description of the appearance of Normase and package contents
Syrup in a 200 ml bottle with a graduated dosing cup.
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 (FI)