LACTULOSE-

LACTULOSE-1A Pharma Syrup

Important notes (mandatory information)

Lactulose - 1 A Pharma, syrup. Indications: for constipation (irregular bowel movements, hard and dry stools) that cannot be adequately influenced by a diet rich in fiber and other general measures, for conditions that require easier bowel movements (e.g. hemorrhoids or operations in the rectum or anal area) and for the prevention and treatment of portocaval encephalopathy (i.e. disorders of brain function due to chronic liver diseases that can lead to impaired thinking, tremors and lowered consciousness up to a coma).

For risks and side effects, read the package leaflet and consult your doctor or pharmacist!


PACKAGE LEAFLET: INFORMATION FOR THE USER

Lactulose - 1 A Pharma, syrup
Active ingredient: Lactulose 66.7 g/100 ml syrup

Read the entire package leaflet carefully before you start taking this medicine, because it contains important information. Always take this medicine exactly as described in this package leaflet or exactly as directed by your doctor or pharmacist.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you experience any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. See section 4.
• If you do not feel better or even worse after a few days, contact your doctor.

What this package leaflet contains

1. WHAT IS LACTULOSE — 1 A PHARMA AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING LACTULOSE — 1 A PHARMA?
3. HOW TO TAKE LACTULOSE — 1 A PHARMA?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE LACTULOSE — 1 A PHARMA?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS LACTULOSE - 1 A PHARMA AND WHAT IS IT USED FOR?

Lactulose - 1 A Pharma contains a laxative called lactulose. It softens your stools by drawing water into your bowel; this makes it easier to pass stools. Lactulose is not absorbed by your body. Lactulose - 1 A Pharma is used for constipation (irregular bowel movements, hard and dry stools) that cannot be adequately influenced by a diet rich in fiber and other general measures, for conditions that require easier bowel movements (e.g. hemorrhoids or operations in the rectum or anal area) and for the prevention and treatment of portocaval encephalopathy (i.e. disorders of brain function due to chronic liver diseases that can lead to impaired thinking, tremors and lowered consciousness up to a coma).

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING LACTULOSE - 1 A PHARMA?

Lactulose - 1 A Pharma must not be taken:

• if you are allergic to lactulose or any of the other ingredients of this medicine listed in section 6.
• in the case of an intestinal obstruction (ileus).
• in the case of sugar intolerance (hereditary galactose intolerance, e.g. galactosemia).
• in the case of a bowel perforation or an increased risk of bowel perforation.
• in the case of fructose intolerance (hereditary fructose intolerance).

Warnings and precautions

Please talk to your doctor or pharmacist before taking Lactulose - 1 A Pharma if you suffer from abdominal pain of unknown cause, cannot digest milk sugar (lactose intolerance) or suffer from gastrocardial syndrome (Roemheld syndrome). If you experience symptoms such as flatulence or a feeling of bloating after taking it, discontinue treatment and consult your doctor. In these cases, the doctor will carefully monitor the treatment. You should not take Lactulose - 1 A Pharma if you suffer from an absorption disorder for glucose and galactose (hereditary glucose/galactose malabsorption), in the case of disorders of the water and salt (electrolyte) balance and in the case of acute inflammations of the gastrointestinal tract (with the symptoms of abdominal pain, vomiting and fever). If you have been suffering from constipation for a long time, you should consult your doctor for advice and examination before starting therapy with Lactulose - 1 A Pharma, because chronic disorders or impairments of bowel movements can be signs of a more serious illness! During treatment with laxatives, you should drink sufficient amounts of fluid (1.5 - 2 liters per day, corresponding to 6 - 8 glasses). If you have been taking Lactulose - 1 A Pharma for several days and do not feel any improvement or if your symptoms worsen, please contact your doctor. If you have persistent loose stools during long-term use of Lactulose - 1 A Pharma, you should stop taking Lactulose - 1 A Pharma and consult your doctor. If you are an elderly patient or a patient in poor general condition and have been taking Lactulose - 1 A Pharma for more than 6 months, your doctor will check your blood electrolytes regularly.

Notes for diabetics and patients with other carbohydrate metabolism disorders

This medicine contains small amounts of digestible carbohydrates due to the manufacturing process, but these are only absorbed from the intestine into the body to a relatively small extent and therefore have almost no nutritional value. Nevertheless, please note that Lactulose - 1 A Pharma contains a maximum of 1.67 g of digestible carbohydrates, e.g. fructose (fruit sugar), galactose, lactose (milk sugar) in 10 ml of syrup, which corresponds to a maximum of 0.14 BE. Particularly when treating portocaval encephalopathy, higher amounts of Lactulose - 1 A Pharma are required, and an adjustment of your antidiabetic medication may be necessary. Continuous use of inappropriate dosages (exceeding 2-3 soft stools per day) or improper use can lead to diarrhea and electrolyte imbalances.

Children

In special circumstances, your doctor may prescribe Lactulose - 1 A Pharma for your child. In these cases, your doctor will carefully monitor the treatment. Lactulose - 1 A Pharma should not normally be given to newborns or infants, as it can interfere with normal bowel reflexes.

Taking Lactulose - 1 A Pharma with other medicines

Tell your doctor or pharmacist if you are taking/using, have recently taken/used or intend to take/use any other medicines. Lactulose - 1 A Pharma can increase the loss of potassium caused by other medicines taken at the same time. These include certain diuretics and adrenal hormones (corticosteroids) and the antifungal amphotericin B. In the case of potassium deficiency, the sensitivity to cardiac glycosides (e.g. digitoxin) is increased. At higher doses, the pH value in the colon decreases. This can lead to the inactivation of medicines that are released in the colon in a pH-dependent manner (e.g. 5-ASA).

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, or if you suspect you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. No harmful effects of lactulose have been reported when taken during pregnancy and breast-feeding. Lactulose can also be taken during pregnancy and breast-feeding. No effects on fertility are to be expected.

Driving and using machines

Lactulose - 1 A Pharma has no or negligible influence on your ability to drive safely or operate machines.

Lactulose - 1 A Pharma contains galactose, fructose and lactose

Please only take Lactulose - 1 A Pharma after consulting your doctor if you know that you suffer from an intolerance to certain sugars.

3. HOW TO TAKE LACTULOSE - 1 A PHARMA?

Always take this medicine exactly as described in this package leaflet or exactly as agreed with your doctor. Check with your doctor or pharmacist if you are not sure. The following information applies unless your doctor has prescribed Lactulose - 1 A Pharma differently. Please follow the instructions for use, otherwise Lactulose - 1 A Pharma syrup will not work properly! Also bear in mind that it takes a considerable time, which often varies from patient to patient, after taking the specified doses of Lactulose - 1 A Pharma for the desired effect to appear. For example, the laxative effect of Lactulose - 1 A Pharma can occur after 2 - 10 hours, but it can also take 1 - 2 days until the first bowel movement, especially if the dosage is still insufficient. Lactulose - 1 A Pharma must be dosed differently depending on the area of application. The dosages given here can only serve as a guide and may need to be changed to achieve the desired effect.

The recommended dose is

For constipation and when soft stools are of medical benefit:

• Adults: 1 — 2—times daily 7.5 — 15 ml Lactulose — 1 A Pharma (corresponding to 5 — 10 g lactulose).

• Children

  1 — 2—times daily 4.5 — 9 ml Lactulose — 1 A Pharma (corresponding to 3 — 6 g lactulose).

The use of laxatives in children, newborns and babies should only be used in exceptional cases and under medical supervision, as this can interfere with normal bowel movements. Please do not give Lactulose - 1 A Pharma to children (under 14 years of age) without first contacting a doctor. The dose can be taken once a day, e.g. during breakfast or divided into 2 doses per day. Please use the measuring cup for dosing. Especially at the beginning of the treatment of constipation, larger doses of Lactulose - 1 A Pharma are often required. In general, this slightly higher initial dose can be reduced after 3-4 days.

In the case of portocaval encephalopathy, i.e. in the case of impaired brain function in the context of a liver disease:

• Adults: At the beginning of treatment, 3 — 4—times daily 7.5 — 15 ml Lactulose — 1 A Pharma (corresponding to 5 — 10 g lactulose) should be taken. The dose should then be slowly and carefully increased to 3 — 4—times daily 30 — 45 ml Lactulose — 1 A Pharma (corresponding to 20 — 30 g lactulose). The dosage should be adjusted so that 2 — 3 soft stools are passed daily.
• Children and adolescents: There are no data on the treatment of children (up to 18 years of age) with portocaval encephalopathy.

Elderly patients and patients with impaired liver or kidney function

There are no special dosage recommendations.

Method of administration

Always take Lactulose - 1 A Pharma at the same time of day. Please measure the dose of Lactulose - 1 A Pharma you need with the enclosed measuring cup (graduations for 2.5 ml, 4.5 ml, 5 ml, 9 ml, 10 ml, 15 ml, 20 ml, 25 ml, 30 ml). This can be taken undiluted or diluted with water or mixed with warm drinks, e.g. coffee or tea, or stirred into yoghurt, muesli or porridge and taken together with these foods. If taken undiluted, Lactulose - 1 A Pharma should be swallowed directly and not kept in the mouth for longer. Lactulose can be taken independently of meals. If a single dose of Lactulose - 1 A Pharma is sufficient for the successful treatment of constipation, it has proven to be particularly well tolerated when taken in the morning after breakfast.

Duration of use

The duration of treatment depends on the development of the respective clinical picture. If there is no improvement or a worsening of the symptoms after taking Lactulose - 1 A Pharma in the recommended dose even after a few days, please inform your doctor. Please talk to your doctor or pharmacist if you have the impression that the effect of Lactulose - 1 A Pharma is too strong or too weak.

If you have taken more Lactulose - 1 A Pharma than you should

If Lactulose - 1 A Pharma has been taken in too large quantities, nausea, abdominal pain, vomiting, diarrhea and loss of water and electrolytes (especially potassium and sodium) may occur, which may have to be compensated for by drug therapy. Inform your doctor if such symptoms have occurred in the event of an overdose. He will then also decide on any treatment measures to be initiated.

If you forget to take Lactulose - 1 A Pharma

If you have forgotten to take a dose of Lactulose - 1 A Pharma, please continue the therapy as recommended without increasing the dose yourself. Do not take twice the amount of Lactulose - 1 A Pharma, but take the next dose at the usual time.

If you stop taking Lactulose - 1 A Pharma

Please contact your doctor before interrupting or changing the treatment.

If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

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

The following frequency information is used to evaluate side effects:
Very common:	more than 1 in 10 treated persons
Common:	1 to 10 in 100 treated persons
Uncommon:	1 to 10 in 1,000 treated persons
Rare:	1 to 10 in 10,000 treated persons
Very rare:	less than 1 in 10,000 treated persons
Not known:	frequency cannot be estimated from the available data.

Possible side effects

Very common:

• Diarrhea

Common:

• Flatulence
• Nausea
• Vomiting
• Abdominal pain

Uncommon:

• Electrolyte imbalances due to diarrhea

In the case of long-term use of Lactulose - 1 A Pharma in a dosage that leads to persistently loose stools, the usual electrolyte imbalances caused by laxatives (increased excretion of potassium, sodium and water) and their consequences must be expected. In rare cases, hypernatremia (increased serum sodium concentration) has been reported in the treatment of portocaval encephalopathy.

Countermeasures

If diarrhea and subsequent electrolyte imbalances occur while taking Lactulose - 1 A Pharma, these may have to be treated with medication and any deficiency of water, potassium or sodium salts must be compensated for. A reduction in the amount of Lactulose - 1 A Pharma to be taken is often also necessary. If you experience these undesirable effects, please inform your doctor. He will then also decide whether a reduction or, in rare cases, discontinuation of Lactulose - 1 A Pharma is necessary.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. of Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE LACTULOSE - 1 A PHARMA?

Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the label and carton after "use by". The expiry date refers to the last day of the month indicated. Do not store above 25°C. Keep the container tightly closed. Shelf life after opening: After opening the pack, Lactulose - 1 A Pharma can be stored for 12 months if stored properly, up to the printed expiry date. Do not dispose of medicines in wastewater. Ask your pharmacist how to dispose of the medicine when you stop using it. In this way, you help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Lactulose - 1 A Pharma contains

The active ingredient is lactulose. 100 ml Lactulose - 1 A Pharma syrup contains 66.7 g lactulose. The other ingredient is: purified water. Note: Contains small amounts of other sugars such as fructose, galactose, lactose and epilactose due to the manufacturing process.

What Lactulose - 1 A Pharma looks like and contents of the pack

Lactulose - 1 A Pharma is a colorless to yellowish brown liquid