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

What Laxiriva is and what it is used for

Laxiriva is a laxative for the temporary treatment of constipation in adults, adolescents, and the elderly. It is not recommended for children under 12 years.

Macrogol 3350 (one of the active substances in the medicine) softens your stools, makes it easier to have stools, and relieves constipation. The salts contained in the product helps maintain normal sodium, potassium, and fluid balance during treatment.

Macrogol 3350 contained in Laxiriva 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 using Laxiriva

Do not use Laxiriva

  • 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 your intestinal wall is perforated (a wound in the intestinal wall).
  • if you have intestinal obstruction (so-called intestinal obstruction, ileus ).
  • if you have a severe inflammatory bowel disease, such as ulcerative colitis , Crohn’s disease or toxic megacolon.

Talk to your doctor or pharmacist before taking this medicine.

Warnings and cautions

If you develop side effects such as swelling, shortness of breath, fatigue, dehydration (symptoms include increased thirst, dry mouth, and weakness), or heart problems, you should stop taking Laxiriva and contact your doctor immediately.

If you experience sudden abdominal pain or rectal bleeding while taking Laxiriva for bowel cleansing, you should contact a doctor immediately or seek medical attention.

Children

Do not give this medicine to children under 12 years of age.

Other medicines and Laxiriva

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

The effect of certain drugs, e.g. epilepsy medications, may be weaker than normal during treatment with Laxiriva. Therefore, other medicines should not be taken orally within one hour before and one hour after taking this medicine.

Pregnancy and breastfeeding

Laxiriva can be used during pregnancy and lactation. 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

This medicine 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 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.

Laxiriva contains sodium, sorbitol and potassium

This medicine contains 188 mg of 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.

When used to treat constipation, the highest recommended daily dose of this medicine is 564 mg of sodium (found in table salt). This corresponds to 28.2% of the highest recommended daily intake of sodium.

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

This medicine contains 0.6 mmol (or 24.4 mg) potassium per sachet. This should be considered by patients with impaired renal function or patients on a low-potassium diet.

The lemon and lime aromas in this medicine contain 0.8 mg sorbitol (E420) per sachet.

How to use Laxiriva

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

Constipation

A dose of Laxiriva is a sachet to be dissolved in 125 ml (half a glass) of water. Take this dose 1-3 times daily according to the severity of constipation.

The treatment with this drug usually lasts for about 2 weeks. If you need to take this medicine for a long time, see a doctor. If the constipation is caused by a disease, e.g. Parkinson’s disease or multiple sclerosis, or if you are taking medicines that cause constipation, your doctor may recommend that you take this medicine for more than 2 weeks. If you need to take this medicine for a long time, see a doctor. With long-term treatment, the dose can usually be reduced to 1 or 2 sachets daily.

Mixing the solution
Open a sachet and pour the contents into a drinking glass. Pour in about 125 ml (half a glass) of water. Stir well until all the powder has dissolved and the solution is clear or slightly cloudy, then drink the solution.

This medicine should be taken orally.

Use for children

Do not give this medicine to children under 12 years of age.

If you take more Laxiriva than you should

This can cause severe stomach pain and bloating vomiting (nausea), or diarrhea. Severe diarrhea can lead to dehydration. If this happens, stop taking this medicine and drink plenty of fluids. If you have any further questions, ask your doctor or pharmacist.

Possible side effects

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

If you get any of the following side effects, stop taking Laxiriva and contact your doctor immediately:

  • signs of allergy , such as rash, itching , redness of the skin, shortness of breath, difficulty breathing or swelling of the face, lips, tongue or throat
  • signs of changes in the body’s fluid or electrolyte balance, such as swelling (mainly in the ankles), feeling of weakness, dehydration, increasing fatigue or increased thirst in combination with headache. These symptoms may be a sign that the potassium levels in the blood are higher or lower than normal.

Other side effects are:

  • swollen hands, feet or ankles
  • headache
  • indigestion, stomach pain or rumbling stomach
  • bloating, flatulence, nausea or vomiting
  • tenderness around the rectal opening
  • diarrhea (when you start taking this medicine).
  • change in the body’s fluid or electrolyte levels (low level of potassium , low level of sodium ).

These side effects are usually alleviated if you reduce the dose of Laxiriva.

The frequency of occurrence of these side effects is not known (can not be calculated from the available data).

How to store Laxiriva

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.

The prepared solution with Laxiriva can be stored covered in a refrigerator (2 ° C – 8 ° C). The solution should be used within 24 hours. Any remaining solution should be discarded 24 hours after the powder has dissolved.

Do not use this medicine if you notice that any of the sachets are damaged.

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 substances in a sachet are:

macrogol 3350 13.125 g

sodium chloride 350.7 mg

sodium bicarbonate 178.5 mg

potassium chloride 46.6 mg

The other ingredients are colloidal anhydrous silica, saccharin sodium, orange aroma (orange aroma contains: flavoring substances and preparations, maltodextrin, acacia gum [E414], alpha-tocopherol [E307]), and lemon and lime aromas (lemon and lemon aroma, natural, lemon aroma, natural lime aroma powder, maltodextrin, mannitol [E421], gluconolactone [E575], sorbitol [E420], acacia rubber [E414], colloidal anhydrous silica [E551]).

What the medicine looks like and contents of the pack

Laxiriva is a white crystalline powder.

The sachet consists of PAP / ALU / PE.

Each sachet contains 13.8 g of powder and is supplied in cardboard boxes of 2, 6, 8, 10, 20, 30, or 50 sachets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Sandoz A / S, Edvard Thomsens Vej 14, 2300 Copenhagen, Denmark

Manufacturer

Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany

Muhammad Nadeem

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