670 mg / ml oral solution
Lactulose

What Lactulose Levolac is and what it is used for

Lactulose Levolac contains the laxative lactulose. It draws water into the intestine, which makes the stool softer and facilitates bowel emptying. It is not absorbed by the body.

Lactulose Levolac is used for treating constipation.

Lactulose Levolac can also be prescribed by a doctor to treat a liver problem called post-systemic encephalopathy (it is also known as liver coma).

Lactulose contained in Lactulose Levolac may also be approved for the treatment of other diseases not mentioned in this leaflet. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.

What you need to know before you take Lactulos Levolac

Do not take Lactulose Levolac

  • if you are allergic to lactulose or any of the other ingredients of this medicine (listed in section 6).
  • if you suffer fromgalactosemia (a serious genetic disease that prevents you from breaking down galactose)acute inflammatory bowel disease (such as Crohn’s disease or ulcerative colitis ), intestinal obstruction (in addition to normal constipation), cracks or the risk of cracking in the digestive tract or abdominal pain without a known cause.

Warnings and cautions

Talk to your doctor or pharmacist before taking Lactulose Levolac. If you suffer from a gastrointestinal disorder with concomitant cardiac dysfunction (Roemheld’s syndrome), tell your doctor before taking Lactulose Levolac. If you have this disease and get symptoms such as flatulence or bloating after using Lactulose Levolac, discontinue treatment and consult a doctor.

In these cases, your doctor will monitor your treatment closely.

Long-term use of unadjusted doses (which give more than 2-3 stools per day) or incorrect use can lead to diarrhea and a disturbed salt balance in the blood.

If you are elderly, or if you have a worsening of your general condition, and you are taking lactulose for a period longer than 6 months, your doctor will regularly check your salt balance in the blood.

Patients with hepatic systemic disease encephalopathy should avoid concomitant use of other laxatives, as this would make it difficult to determine the individual dose.

Do not use Lactulose Levolac for more than two weeks without consulting your doctor.

Lactulose Levolac may contain trace amounts of sugars formed during manufacture. If you have been told by your doctor that you have an intolerance to some sugars, ask your doctor for advice before taking this medicine.

During treatment with laxatives, you should drink sufficient amounts of fluid (about 2 liters/day, equivalent to 6-8 glasses).

Children

Lactulose Levolac should not normally be given to infants and young children, as it may interfere with the normal reflexes of bowel movements.

In special cases, your doctor may prescribe Lactulose Levolac to children, infants, or newborns. In these cases, your doctor will monitor your treatment closely.

Other medicines and Lactulose Levolac

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Lactulose may aggravate potassium deficiency caused by other medicines (eg thiazides, steroids, and amphotericin B). Concomitant use of cardiac glycosides may potentiate the effect of glycosides due to potassium deficiency.

With increasing dose er, a decreasing pH value in the colon has been observed. Thus, drugs whose release depends on the pH of the colon (eg 5-ASA) can be inactivated.

Lactulose Levolac with food and drink

Lactulose Levolac can be taken with or without food. Lactulose Levolac can be taken mixed with, for example, water, juice, chocolate, film milk, or porridge. There are no restrictions on what you can eat or drink.

Pregnancy and breastfeeding

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

Driving and using machines

Lactulose Levolac does not affect your ability to drive or use machines.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects.

Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Lactulose Levolac contains milk sugar (lactose), galactose or epilactose

Please read the “Warnings and Cautions” section.

15 ml Lactulose Levolac contains 42.7 KJ (10.2 kcal). You may need to consider diabetics when choosing a dosage.

How to take Lactulose Levolac

Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

Take your dose at the same time each day. Dose one can be given once daily, e.g. for breakfast, or divided into three doses a day.

Swallow the medicine in one gulp. It should not be kept in the mouth.

You can take Lactulose Levolac oral solution undiluted or mixed in a little liquid. Use the dosage measure provided.

During treatment with laxatives, you should drink sufficient amounts of fluid (about 2 liters/day, equivalent to 6-8 glasses).

The recommended dose is:

For constipation: Show larger

  Starting dose 2-4 days Maintenance dose
Adults and young people over 14 years 15–45 ml corresponding to 10–30 g of lactulose 15–30 ml corresponding to 10–20 g of lactulose

Thereafter, the dose can be reduced individually.

The entire daily dose can be taken, for example, in connection with breakfast, advantageously mixed in e.g. water, juice, chocolate, film milk, or porridge.

It may take 2-3 days before the desired effect is achieved because lactulose is not broken down until it reaches the colon.

In case of prolonged constipation, a doctor should be consulted.

Children

Treatment of children should only be done according to a doctor’s prescription.

For portal-systemic encephalopathy (brain effects due to liver disease)

Dose one is determined by the doctor who adjusts it individually for you.

There are no specific dosing recommendations for elderly patients or patients with renal or hepatic impairment.

Children and young people

Safety and efficacy in children aged 0-18 years have not been established.

If you take more Lactulos Levolac than you should

If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor, hospital, or the Poison Information Center (tel. 112) for risk assessment and advice. Bring this information and any remaining solution so that the healthcare staff knows exactly what you have taken.

In case of overdose, you may experience diarrhea and abdominal pain.

If you forget to take Lactulos Levolac

If you forget to take Lactulose Levolac, take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.

If you stop taking Lactulos Levolac

The desired effect of the drug may not be present.

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

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects have been reported with Lactulose Levolac:

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

  • Gases may occur during the first days of treatment. This usually disappears after a few days.
  • If you exceed the recommended dose , you may experience abdominal pain. In such cases, the dose should be reduced.

Common (may affect up to 1 in 10 people):

  • Nausea
  • Vomiting
  • When using a higher dose than recommended, you may experience diarrhea (sometimes including an imbalance in electrolyte levels). In such cases, the dose should be reduced.

How to store Lactulos Levolac

Do not store above 25 ° C.

Make sure the bottle is properly closed.

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

Do not use this medicine after the expiry date which is stated on the bottle label and/or the outer carton after “EXP”. The expiration date is the last day of the specified month.

Lactulose Levolac can be used for 1 year after the first opening.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Contents of the pack and other information

Content declaration

The active substance is lactulose (as liquid lactulose ).

One ml of Lactulose Levolac solution contains 670 mg of lactulose.

There are no other ingredients.

What the medicine looks like and contents of the pack

Lactulose Levolac is a clear, viscous, colorless, or slightly brownish-yellow liquid and is available without a prescription in the following pack sizes: Brown glass bottles and brown plastic bottles containing 100 ml, 200 ml, 250 ml, 300 ml, 500 ml, 1000 ml, and 10 x 100 ml with screw caps in polyethylene or child-resistant closure in polypropylene.

White plastic bottles: containing 100 ml, 200 ml, 300 ml, 500 ml, 1000 ml, and 10 x 100 ml with screw cap in polyethylene or child-resistant closure in polypropylene.

A dosing measure (polypropylene) with graduations is included.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Fresenius Kabi Austria GmbH

Hafnerstraße 36

8055 Graz, Austria

Tel .: +43 316 249 0

Fax: +43 316 249 1208

info-atgr@fresenius-kabi.com

Manufacturer

Fresenius Kabi Austria GmbH

Estermannstraße 17

4020 Linz, Austria

Tel .: +43 732 7651 0

Fax: +43 732 7651 2429

office@fresenius-kabi.com

For any information about this medicine, please contact the local representative of the Marketing Authorization Holder:

Bluefish Pharmaceuticals AB

Box 49013

100 28 Stockholm Sweden

Muhammad Nadeem

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