LACTULOSE-RATIOPHARM 667MG/ML 500ML

ATC code: A06AD11 

Active substances: Lactulosum

Vendor, principal: Biogened Jsc, Polija. 
No prescription needed/Patient care products, dressings, gloves, medical devices,...

LACTULOSE-RATIOPHARM 667MG/1ML 300ML

Package leaflet: Information for the user Lactulose-ratiopharm 667 mg/ml, oral solution

Lactulose

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have 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. This includes any possible side effects not listed in this leaflet. See section 4.
-   You must talk to a doctor if you do not feel better or if you feel worse after several days.

What is in this leaflet

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

1. What Lactulose-ratiopharm is and what it is used for

Lactulose-ratiopharm contains a laxative called lactulose. It makes the stool softer and easier to pass, by drawing water into the bowel. It is not absorbed into the body.
Lactulose-ratiopharm is used to treat constipation.
Bowel function may be disrupted for many reasons including low fluid intake, lack of exercise, or sometimes due to surgery or drug therapy.
Constipation may occur in various forms: sometimes bowel movements stop completely, the stool may be hard and difficult to pass, or little stool may be passed. The cause of constipation must be determined first and eliminated if possible.
Lactulose-ratiopharm may be used in adults as directed by a doctor to treat hepatic encephalopathy (a liver disease causing confusion, tremor, decreased level of consciousness including coma).

2. What you need to know before you take Lactulose-ratiopharm Do not take Lactulose-ratiopharm

-   if you are allergic to lactulose or any of the other ingredients of this medicine (listed in section 6)
-   if you have been diagnosed with a hereditary defect of galactose metabolism (galactosaemia)
-   if you have been diagnosed with an intestinal blockage (cause by anything else but normal constipation)
-   if you have been diagnosed with digestive perforation or risk of digestive perforation.

Warnings and precautions

Talk to your doctor or pharmacist before taking Lactulose-ratiopharm
-   if you suffer from unexplained tummy ache
-   if you are lactose-intolerant
-   if you have been diagnosed with gastro-cardiac syndrome (Roemheld syndrome). If you take Lactulose-ratiopharm and get symptoms like flatulence or bloating, the dose should be reduced or the treatment should be discontinued
-   if you have diabetes.
In the treatment of constipation in diabetic individuals, normal doses do not usually affect blood sugar levels.
If you are treated for hepatic encephalopathy, your dose of Lactulose-ratiopharm will be high. This higher dose contains a large amount of sugar. Therefore, you may need to adjust the dose of your antidiabetic medicine.
Chronic use of incorrect doses and misuse can lead to diarrhoea and disturbance of the electrolyte balance.
During the treatment with laxatives you should drink sufficient amounts of fluids (1.5-2 l/day, equal to 6-8 glasses).
You must talk to a doctor if you do not feel better or if you feel worse after several days.

Children

In special circumstances your doctor may prescribe Lactulose-ratiopharm for a child, infant or baby. In these cases your doctor will supervise the treatment carefully. Lactulose-ratiopharm should only be given to infants and smaller children if indicated as it can influence the normal reflexes for passing stools.

Other medicines and Lactulose-ratiopharm

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
If the doses of Lactulose-ratiopharm oral solution you are using are so high that you have constant diarrhoea, this may lead to electrolyte (particularly potassium) depletion. This may enhance the effect of some medicines (digoxin) which are used to treat certain heart diseases such as heart insufficiency or rhythm disorder.
If Lactulose-ratiopharm is causing you constant diarrhoea and you are using digoxin or other similar medicines belonging to a group of cardiac glycosides, contact you doctor.

Lactulose-ratiopharm with food and drink

Lactulose-ratiopharm can be taken with or without food. There are no restrictions on what you can eat or drink.

Pregnancy, breast-feeding and fertility

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.
Lactulose-ratiopharm can be used during pregnancy and breast-feeding.
No effects on fertility are to be expected.

Driving and using machines

Lactulose-ratiopharm has no influence on the ability to drive or to use machines.

Important information about some of the ingredients of Lactulose-ratiopharm

Lactulose-ratiopharm contains galactose up to 110 mg/ml, lactose up to 60 mg/ml and small amounts of other sugars, such as epilactose, tagatose and fructose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Lactulose-ratiopharm

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you. Check with your doctor or pharmacist if you are not sure.
Always take Lactulose-ratiopharm at the same time of day, e.g. at breakfast.
Swallow the medicine quickly, without keeping it in your mouth.
Lactulose-ratiopharm can be taken undiluted or dissolved in a liquid (e.g. water, coffee, tea, juice, milk). The measuring cup that comes with Lactulose-ratiopharm may be used.

Dosage for constipation

Lactulose-ratiopharm may be taken as a single daily dose at breakfast, for example, or in two divided doses.
After a few days the starting dosage may be adjusted to the maintenance dose based upon treatment response. Several days (2-3 days) may be needed before treatment effect occurs.
The dose may be varied depending on individual response. The table below presents typical doses.

	Starting dose daily	Maintenance dose daily
Adults and adolescents	15 to 45 ml	15 to 30 ml
Children (7-14 years)	15 ml	15 ml
Children (1-6 years)	5 to 10 ml	5 to 10 ml
Infants under 1 year	2.5 to 5 ml	2.5 to 5 ml

Use in children
Use of laxatives in children, infants, and babies should be exceptional and under medical subervision because it can influence the normal reflexes for passing stools.
Please do not give Lactulose-ratiopharm to children (under 14 years) before consulting your doctor.

Dosage for hepatic encephalopathy (adults only)

The starting dose in the treatment of hepatic encephalopathy is 30 to 45 ml of solution 3 to 4 times per day.
The maintenance dose may be adjusted to achieve 2 to 3 soft stools a day.
Use in children
No information is available for treatment of children (newborn to 18 years of age) with hepatic encephalopathy.

Use in elderly patients and patients with renal or hepatic insufficiency

No special dosage recommendations exist.

If you take more Lactulose-ratiopharm than you should

If you have taken too much of the medicine, or perhaps a child has taken the medicine by mistake, always contact a doctor, hospital or the Poison Information Centre for risk evaluation and to receive further instructions. Overdose may cause diarrhoea and abdominal pain. Prolonged diarrhoea may cause electrolyte deficiency (particularly of potassium).

If you forget to take Lactulose-ratiopharm

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects have been reported:

Very common (may affect more than 1 in 10 people)

-   diarrhoea

Common (may affect up to 1 in 10 people)

-   flatulence (wind)
-   nausea (feeling sick)
-   vomiting
-   abdominal pain

Uncommon (may affect up to 1 in 100 people)

-   electrolyte imbalance due to diarrhoea
Flatulence often occurs during the first few days of treatment. As a rule it disappears after continuing treatment for a few days.
Abdominal pain and diarrhoea may occur particularly with high doses. In such a case the dosage should be decreased.
If you use high doses (normally only associated with hepatic encephalopathy) for an extended period of time, you may experience an electrolyte imbalance due to diarrhoea.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via www.ravimiamet.ee . By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Lactulose-ratiopharm

Keep this medicine out of the sight and reach of children.
Store below 25°C.
Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of the month.
HDPE bottle:
Shelf life after the first opening is 2 months.
PET bottle:
Shelf life after the first opening is 12 months.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Lactulose-ratiopharm contains

-   The active substance is lactulose.
1 ml of oral solution contains 667 mg lactulose.
-   The other ingredients are purified water, galactose up to 110 mg/ml and lactose up to 60 mg/ml and small amounts of fructose, epilactose and tagatose.

What Lactulose-ratiopharm looks like and contents of the pack

Colourless or pale brown-yellowish, clear, viscous liquid.
300 ml, 500 ml, 1000 ml in a bottle with measuring cup (30 ml cup with graduation by either 2.5 ml or 5 ml).
Not all pack sizes may be marketed.

Marketing Authorisation Holder

ratiopharm GmbH Graf-Arco-Strasse 3 89079 Ulm Germany

Manufacturer

Aurex BV Molenvliet 103 3335 LH Zwijndrecht The Netherlands

This leaflet was last approved in 04-2017

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