LAXOFALK

LAXOFALK 10 g powder for the preparation of a solution for oral use. Sachets

Important notes (mandatory information)

Laxofalk 10 g powder. Active ingredient: Macrogol 4000. Areas of application: used for chronic constipation in adults.

For risks and side effects, read the package leaflet and ask your doctor or pharmacist.


PACKAGE LEAFLET: INFORMATION FOR THE USER

Laxofalk 10 g powder for oral solution
Active ingredient: Macrogol 4000 (polyethylene glycol 4000)

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 your doctor or pharmacist has told you.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you get 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 if you feel worse after using it, contact your doctor.

What this package leaflet contains

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

1. WHAT IS LAXOFALK AND WHAT IS IT USED FOR?

Laxofalk is a laxative. Laxofalk is used for chronic constipation in adults. Treatment with Laxofalk complements your efforts to counteract constipation by changing your dietary habits and lifestyle: For example, pay attention to a high fiber content in your food and drink plenty of fluids (e.g. mineral water, fruit juices). Sports and exercise also support your digestion.

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING LAXOFALK?

Laxofalk must not be taken:

• in severe intestinal inflammations such as ulcerative colitis, Crohn's disease or in severe, pathological enlargement of the colon (toxic megacolon), in connection with a narrowing of the intestine.
• in the case of a stomach, intestinal perforation or risk of a stomach, intestinal perforation.
• in the case of intestinal narrowing or suspected intestinal obstruction.
• in the case of abdominal pain of unclear cause.
• if you are allergic to macrogol or any of the other ingredients of this medicine listed in section 6.

Warnings and precautions

If you are prone to water and mineral imbalances (e.g. because you are an elderly patient, your heart, liver or kidney function is impaired or you are taking diuretics), you should only use Laxofalk on explicit medical advice and with increased caution. If you experience diarrhea, your doctor should check your water or mineral balance. Very rarely, cases of hypersensitivity reactions (skin rash, hives (urticaria), water retention (edema) have been reported with the use of macrogol-(polyethylene glycol-) containing medicines. Isolated cases of anaphylactic shock have been observed. Since Laxofalk does not contain significant amounts of sugar or polyol (e.g. sugar substitutes), you can take Laxofalk even if you have diabetes or need to follow a galactose-free diet.

Taking Laxofalk 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. If you take other medicines together with Laxofalk at the same time, the absorption of these medicines may be reduced. Therefore, a staggered intake of 2 hours is advisable.

Taking Laxofalk with food and drink

No special precautions.

Pregnancy and

breastfeeding

If you are pregnant or breastfeeding, or if you suspect you may be pregnant or intend to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Studies in animals have shown no evidence of harmful effects on the unborn child. Macrogol 4000 is absorbed from the gastrointestinal tract in negligible amounts only. Laxofalk can be used during pregnancy.

Breastfeeding

Macrogol 4000 passes into breast milk in negligible amounts only. Laxofalk can be used during breastfeeding.

Driving and using machines

Laxofalk has no or negligible influence on the ability to drive and use machines.

Laxofalk contains sorbitol

Please only take Laxofalk after consulting your doctor if you know that you suffer from an intolerance to certain sugars.

3. HOW TO TAKE LAXOFALK?

Always take this medicine exactly as described in this package leaflet or exactly as agreed with your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure. The recommended dose is 1 to 2 sachets 1 to 2 times a day.

Use in children

Laxofalk should not be given to children as there is no experience in this regard.

Method of application

Dissolve the contents of one sachet in a glass of water (approx. 125 ml) and drink the liquid as soon as possible. When taking other medicines, a staggered intake of at least 2 hours is recommended.

Duration of use

Laxofalk should not be taken for more than 4 weeks unless directed by your doctor. If there is no improvement after two weeks of use, you should see your doctor. Please talk to your doctor or pharmacist if you have the impression that the effect of Laxofalk is too strong or too weak.

If you have taken more Laxofalk than you should

Overdosage can cause abdominal pain, diarrhea and vomiting. In this case, you should discontinue use, drink plenty of fluids and consult your doctor in any case. If very large amounts of polyethylene glycol and minerals are incorrectly administered to you via a stomach tube, this can lead to life-threatening fluid ingress into the respiratory tract (aspiration).

If you forget to take Laxofalk

Do not take twice the amount if you have forgotten to take the previous dose.

If you stop taking Laxofalk

If you stop or discontinue treatment with Laxofalk, constipation may recur. In this case, you should discuss the further procedure with your doctor.

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

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, Laxofalk can have side effects, although not everybody gets them.

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

• Feeling of fullness, flatulence, passing of intestinal gas
• Abdominal pain, nausea
• Diarrhea

Uncommon side effects (may affect up to 1 in 100 people):

• Vomiting, upper abdominal pain, stomach irritation
• Involuntary bowel movements, painful urge to defecate
• Headache and dizziness

Very rare side effects (may affect up to 1 in 10,000 people):

• Hypersensitivity reactions such as spasms of the bronchial muscles, swelling in the face (facial edema)

Not known (frequency cannot be estimated from the available data):

• Diarrhea, which can lead to a disturbance in the water and mineral balance (drop in blood levels of potassium and sodium) or dehydration, especially in elderly patients.
• Anaphylactic shock
• Hypersensitivity reactions such as hives, itching, transient skin rash, skin redness, life-threatening swelling of the skin and mucous membranes including tongue and larynx (angioedema)

Other possible side effects

Laxofalk can rarely cause hypersensitivity reactions and bronchial spasms (bronchospasms).

Reporting of side effects

If you get 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 LAXOFALK?

Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the carton and the sachet foil after "use by". The expiry date refers to the last day of the month indicated.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Laxofalk contains

The active ingredient of Laxofalk is Macrogol 4000. Each sachet with 10.167 g contains: 10.0 g Macrogol 4000 (polyethylene glycol 4000). The other ingredients are: Saccharin sodium, orange-grapefruit flavor (contains sorbitol and sulfur dioxide (E220) as well as orange and grapefruit oils, concentrated orange juice, citral, acetaldehyde, linalool, ethyl butyrate, alpha-terpineol, octanal, ß-y-hexenol, maltodextrin, gum arabic, butylhydroxyanisole (Ph. Eur.) (E320)).

What Laxofalk looks like and contents of the pack

Laxofalk is a white or almost white powder with an orange and grapefruit smell. Laxofalk is available in packs of 10 sachets (N1), 30 sachets (N2) and 50 sachets (N3).

Pharmaceutical entrepreneur and manufacturer

Dr. Falk Pharma GmbH
Leinenweberstr. 5
79108 Freiburg
Germany
Tel.: 0761/1514-0
Fax: 0761/1514-321
E-Mail: zentrale@drfalkpharma.de
www.drfalkpharma.de

This package leaflet was last revised in September 2015.

Source: Information from the package leaflet
Status: 02/2017
Active ingredient: Macrogol 4000. Areas of application: used for chronic constipation in adults.