powder for oral solution 
macrogol 3350, sodium chloride, sodium bicarbonate, potassium chloride

What Laximyl is and what it is used for

Laximyl is a laxative (laxative) used for the temporary treatment of constipation in adults, adolescents and the elderly. This medicine is not recommended for children under 12 years.

Laximyl helps you to have a pleasant bowel function even if you have been constipated for a long time. Laximyl can also be used after a doctor’s prescription for very severe constipation, so-called fecalom (a condition in which a large amount of faeces is stored in the rectum and / or colon).

The active substances contained in Laximyl may also be approved for the treatment of other diseases not mentioned in this product information. 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 Laximyl

Do not take Laximyl

  • if you are allergic to macrogol 3350, sodium chloride, sodium bicarbonate, potassium chloride or any of the other ingredients of this medicine (listed in section 6).
  • if you have a blockage in the intestine (intestinal constriction, intestinal obstruction).
  • if you have ulcers in the intestinal wall.
  • if you have a severe inflammatory bowel disease, such as ulcerative colitis , Crohn’s disease or toxic megacolon.

If any of these apply to you, talk to your doctor or pharmacist for further advice.

Warnings and cautions

Talk to your doctor or pharmacist before taking Laximyl.

If you have heart problems and are taking this medicine for the treatment of faeces, follow the special instructions in section 3.

During treatment

When you take Laximyl, you should continue to drink a lot. The liquid content of the mixed solution does not replace a normal liquid intake.

If you notice any signs of electrolyte changes in your blood, such as swelling in the body, shortness of breath, fatigue, dehydration (symptoms include increased thirst, dry mouth and feeling weak) or heart problems, stop taking Laximyl and talk to your doctor immediately (see section 4). Possible side effects ).

Children

This medicine should not be given to children under 12 years of age.

Other medicines and Laximyl

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.

Some medicines, such as epilepsy , may not work as well with Laximyl.

Pregnancy and breastfeeding

Laximyl can be taken during pregnancy and lactation.

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 and using machines

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. 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.

Laximyl contains sorbitol, sodium and potassium

The lemon / lime flavor in Laximyl contains 0.76 mg sorbitol per sachet . Additive effect of concomitantly administered drugs containing sorbitol (or fructose) and food intake of sorbitol (or fructose) should be considered. Content of sorbitol in oral medicinal products may affect the bioavailability of any other oral medicinal product administered concomitantly.

This medicine contains 8.1 mmol (187.7 mg) sodium (the main ingredient in table salt / table salt) per sachet . This corresponds to 9.4% of the highest recommended daily intake of sodium for adults.

The maximum recommended daily dose of one of these medicines (8 sachets) contains 1,501.6 mg of sodium (ingredient in table salt). This corresponds to 75% of the maximum recommended daily intake of sodium for adults .

Consult a doctor or pharmacist if you need 3 or more sachets daily for an extended period of time, especially if you have been prescribed a low-salt (sodium-poor) diet.

This medicine contains 0.63 mmol (24 mg) potassium per sachet . This should be considered by patients with impaired renal function or patients on a low-potassium diet.

How to take Laximyl

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you. Ask your doctor or pharmacist if you are unsure.

Adults, children (at least 12 years) and older:

The recommended dose for the treatment of constipation is one sachet 1 to 3 times daily.

This medicine can be taken at any time, regardless of food or drink.

Constipation:

One dose of Laximyl is 1 sachet .

Take this 1-3 times daily depending on how severe your constipation is.

Fecal:

8 sachets Laximyl per day is necessary for the treatment of fecal matter.

The 8 sachets should be taken within 24 hours for up to 3 days if necessary.

If you have heart disease, do not take more than 2 sachets per hour.

To mix the solution:

Open the sachet and pour the contents into a glass. Top up with about 125 ml of water. Stir until all the powder has dissolved and the Laximyl solution is clear or slightly cloudy and drink.

If you are taking Laximyl for the treatment of fecaloma, it may be easier to dissolve 8 sachets in 1 liter of water. Cover the solution and store in the refrigerator for up to 24 hours. After 24 hours, discard any unused solution.

Treatment time

Constipation:

Treatment with Laximyl normally lasts about 2 weeks.

If symptoms worsen or do not improve within 14 days, consult a doctor.

If your constipation is caused by a disease such as Parkinson’s disease or multiple sclerosis (MS), or if you are taking medicines that cause constipation, your doctor may recommend that you use Laximyl for longer than 14 days.

In long-term treatment, the dose can usually be reduced to 1 or 2 sachets daily.

Fecal:

Laximyl treatment can last for up to 3 days.

Possible side effects

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

If you get any of these side effects , stop taking this medicine and contact a doctor immediately or go to the nearest emergency department:

Has been reported (occurs in an unknown number of users)

  • severe allergic reaction that gives sudden signs of allergy , such as shortness of breath, difficulty breathing or swelling of the face, lips, tongue, throat or other parts of the body ( anaphylaxis , angioedema ).
  • changes in the body’s fluid or electrolyte levels (low levels of potassium , low levels of sodium ). You may experience fatigue, dehydration, shortness of breath, swelling of the feet and legs due to fluid retention, or heart problems.

Other possible side effects are

Has been reported (occurs in an unknown number of users)

  • rash, itching , redness or hives
  • swollen hands, feet or ankles
  • respiratory distress
  • headache
  • high or low potassium levels in the blood
  • indigestion, abdominal pain or stomach noise, bloating, gas
  • nausea or vomiting
  • tenderness around the rectal opening or rectum
  • diarrhea. You may get mild diarrhea while taking Laximyl. This side effect is generally better if you reduce the amount of Laximyl you use.

How to store Laximyl

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 carton and sachet after EXP. The expiration date is the last day of the specified month.

Do not store above 25 ° C.

Do not use this medicine if any of the sachets look damaged.

The reconstituted solution should be stored in a refrigerator (2 ° C – 8 ° C) and used within 24 hours. After 24 hours, discard any unused solution.

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

Active substances in a sachet:

Macrogol 3350 13.125 g

Sodium chloride 350.7 mg

Sodium bicarbonate 178.5 mg

Potassium chloride 46.6 mg

After dissolving in 125 ml of water, each sachet gives:

Sodium 65 mmol / l

Chloride 53 mmol / l

Hydrogen carbonate 17 mmol / l

Potassium 5 mmol / l

The other ingredients are colloidal anhydrous silica, saccharin sodium, orange flavoring (containing flavoring and flavoring agents, maltodextrin, acacia, alpha-tocopherol) and lemon / lime flavoring (containing flavoring, maltodextrin, mannitol, gluconolaxone, sorbitol, sodium and potassium ”), acacia rubber, colloidal anhydrous silica).

What the medicine looks like and contents of the pack

Laximyl is a white powder.

Each sachet contains 13.8 g of powder and is supplied in the following pack sizes:

Over-the-counter: cartons of 20, 30 or 50 sachets.

Prescription: carton with 100 sachets or in multi-pack with 100 consisting of 2 cartons, each containing 50 sachets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Manufacturer

Klocke Pharma-Service GmbH

Strassburger Strasse 77

77767 Appenweier

Germany

Hermes Pharma Ges.mbH

Allgäu 36

9400 Wolfsberg

Austria

Muhammad Nadeem

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