Lactulose

Description

What you will find in this leaflet

1. What Lactulosa Biomedica is and what it is used for
2. What you need to know before you take Lactulosa Biomedica
3. How to take Lactulosa Biomedica
4. Possible side effects
5. How to store Lactulosa Biomedica
6. Package contents and other information

1. What Lactulosa Biomedica is and what it is used for
Indication group
Osmotically acting laxative (laxative).

Characteristics
The product is an effective laxative that acts locally in the large intestine and is not absorbed. It increases the acidity of the intestinal contents, reduces the formation of ammonia and nitrates, causes softening of stool.
It does not interfere with the physiological activity of the intestines.
Lactulose also has a prebiotic effect (prebiotics are substances that selectively support the growth and activity of healthy bacteria living in the large intestine).

Indications
The product is used for chronic constipation caused mainly by a violation of the bowel reflex due to bad habits or when soft stools are needed. On the recommendation of a doctor, it is used for portosystemic encephalopathy (disorders of the central nervous system that accompany liver damage).

The product is suitable for both adults and children, it is given to children only on the recommendation of a doctor, for administration to children under one year there must be particularly compelling reasons.

2. What you need to know before you take Lactulosa Biomedica

Do not take Lactulosa Biomedica:
If you are allergic to the active substance or to any of the other ingredients of this medicine

(referred to in point 6).

In case of intestinal obstruction.

In case of lactose intolerance and galactosemia (a rare serious inherited disease in which

dairy diet is excluded) as the product contains less lactose and galactose.

Warnings and precautions

Ask your doctor or pharmacist for advice before taking Lactulosa Biomedica.

Caution should be exercised in diabetic patients as the product contains fewer co-formulants

free sugars (max. 12 g galactose and max. 8 g lactose in 100 ml syrup). At the usual dosage

constipation, this amount of sugar does not pose a risk to diabetics. However, galactose and lactose contents are needed

to be taken into account in liver diseases where higher doses are used.

It is recommended to drink plenty of fluids during treatment.

Do not take the product for more than 2 weeks without consulting your doctor, constipation may be a sign of another serious illness.

Other medicines and Lactulosa Biomedica
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines

which you may be taking or which you may be taking.

Drugs whose release depends on the pH of the colon may not be achieved

full bioavailability because lactulose reduces this pH.

Excessive use may cause lactulose administration to increase potassium losses caused by others

preparations (thiazide diuretics, corticoids, cardiac glycosides, carbenoxolone, amphotericin).

Lactulosa Biomedica with food and drink
The syrup can be served with water, tea or fruit juice, see also section 3.

Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving vehicles and operating machines
Lactulosa Biomedica has no or negligible influence on the ability to drive and use machines.

3. How to take Lactulosa Biomedica

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Usual doses for constipation or soft stools:

The dose is adjusted according to the individual patient's response, usually starting with a higher dose, which decreases after three days.

Adults initially take 1-3 tablespoons a day, 2-5 teaspoons a day for a long time.

Children from 7 to 15 years of age initially 1 tbsp, then 1-2 teaspoons daily.

Children from 1 to 6 years 1-2 teaspoons daily.

Children under 1 year 1 / 2-1 teaspoon daily.

In case of insufficient effect, the dose can be increased. Once the therapeutic effect is achieved, an appropriately reduced maintenance dose is administered.

The whole daily dose is usually taken after breakfast.

Liver disease (recommended by your doctor):

The dosage is determined by the doctor, follow his instructions exactly!

As a rule, take 2-6 tablespoons a day, divided into 3 portions after main meals; usually treatment is started with lower doses and gradually increased to the optimal dose, at which 2-3 soft stools occur daily; when diarrhea occurs, the dosage is reduced accordingly.

In children, the dose is usually halved.

The syrup can be served with water, tea or fruit juice.

It is recommended to drink plenty of fluids during treatment.

If you take more Lactulosa Biomedica than you should

In case of overdose or accidental ingestion of a large amount of the product, consult your doctor immediately.

Overdose will result in abdominal pain and diarrhea and subsequent loss of water and electrolytes. The problem can be corrected by adjusting the dose or temporarily stopping treatment.

If you forget to take Lactulosa Biomedica

Do not take a double dose to make up for a forgotten dose.

If you stop taking Lactulosa Biomedica

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Flatulence and flatulence may appear, especially at the beginning of treatment, but these usually disappear during further treatment.

Diarrhea and abdominal pain or cramps may occur at higher doses. In these cases, the dose should be reduced. At high doses of lactulose, the patient may suffer from electrolyte disturbances due to diarrhea.

Gastrointestinal disorders (Indigestion):
Flatulence, bloating, abdominal pain or cramps, nausea and vomiting. Diarrhea at high doses.

Abnormal laboratory findings not elsewhere classified:

Electrolyte disturbances caused by diarrhea.

If you get any side effects, talk to your doctor or pharmacist.

Do the same for any side effects not listed in this leaflet.

5. How to store Lactulosa Biomedica

Keep this medicine out of the sight and reach of children.

Store below 25 ° C in the original, tightly closed bottle in order to protect from light and moisture. Protect from frost.

Do not use this medicine after the expiry date which is stated on the label. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help to protect the environment.

6. Package contents and other information

What Lactulosa Biomedica contains

The active substance is 66.7 g of lactulose in 100 ml of solution.

The product does not contain any excipients.

What Lactulosa Biomedica looks like and contents of the pack

Lactulosa Biomedica is a clear, yellowish to yellow, syrupy liquid with a sweet taste, odorless.

Always take this medicine exactly as your doctor or pharmacist has told you.

Keep this leaflet. You may need to read it again.

Ask your pharmacist if you need more information or advice.

If you get any side effects, talk to your doctor or pharmacist. Do the same for any side effects not listed
in this leaflet.

If you do not feel better within 14 days or if you become overweight, you must consult a doctor.