Laxoberal – Sodium picosulphate uses, dose and side effects

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7.5 mg/ml oral drops of
sodium picosulphate

What Laxoberal is and what it is used for

Laxoberal is used for temporary constipation and to facilitate bowel emptying in hemorrhoids and wounds around the rectal opening. The active substance in Laxoberal, sodium picosulphate, is converted in the large intestine to an active substance that initiates the movements of the large intestine so that the intestinal contents are transported faster. The use does not affect how much nutrition is absorbed into the body from the small intestine. Laxoberal has no calorie-reducing effect.

What you need to know before using Laxoberal

Do not use Laxoberal

  • If you are allergic (hypersensitive) to sodium picosulphate or to any of the other ingredients of this medicine (listed in section 6).
  • If you have severe stomach pain, intestinal obstruction, inflammatory bowel disease or severe stomach pain with fever, nausea or vomiting.
  • If you have severe dehydration.

Warnings and cautions

  • If laxatives are used regularly for more than a week, a doctor should be consulted. Prolonged and excessive use can lead to disturbed fluid balance and lack of potassium in the blood.
  • Dizziness and fainting have been reported by patients using Laxoberal, but this has probably been due to exercise during bowel movements or was an effect of abdominal pain caused by constipation.

Stop taking Laxoberal and contact a doctor immediately if you get any of the following symptoms ( angioedema ):

  • swelling of the face, tongue or throat
  • difficulty swallowing
  • hives and difficulty breathing.

Children and young people

Laxoberal should not be used by children under 12 years of age without a doctor’s recommendation.

Other medicines and Laxoberal

Concomitant use of diuretic or cortisone-like drugs and high doses of Laxoberal may increase the risk of disturbances in the body’s salt balance. Concomitant use of antibiotics may reduce the laxative effect of Laxoberal.

If you are not sure, talk to your doctor or pharmacist before taking Laxoberal.

Salmon overall with food and drink

Laxoberal can be mixed with food or drink.

Pregnancy and breastfeeding

There are no modern studies on pregnant women. Long experience has not shown any harmful or unwanted effect during pregnancy. During pregnancy, however, Laxoberal, like all medicines, should only be taken on medical advice.
Ask your doctor or pharmacist for advice before taking any medicine.

Sodium picosulfate does not pass into breast milk. Laxoberal can therefore be used during breastfeeding.

Driving and using machines

Dizziness and fainting may occur when using Laxoberal, most likely due to a reflex that may occur with abdominal pain or bowel movements. Therefore, if you suffer from abdominal pain, you should be careful about driving and handling 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. The description 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.

Laxoberal contains sorbitol

This medicine contains 450 mg sorbitol per ml. Sorbitol is a source of fructose. If you (or your child) do not tolerate certain sugars, or if you (or your child) have been diagnosed with hereditary fructose intolerance, a rare, inherited disease that prevents fructose from being broken down, consult a doctor before using this medicine.

Laxoberal contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per unit volume, it is essentially ‘sodium-free.

How to use Laxoberal

Always use this medicine exactly as described in this leaflet or as your doctor advised. Ask your doctor or pharmacist if you are unsure.

Recommended dose:

Adults: 10-20 drops once a day. The drops should be taken in the evening for bowel movements the following morning.

Start with 10 drops in the evening. Dose one can then be reduced or increased so that the stool becomes reasonably soft. Do not take more than 20 drops per day. After bowel movements, it may take longer than usual for you to have a bowel movement again (see When to stop using Laxoberal).

Laxoberal can be mixed with food or drink.

Prolonged constipation should be treated in consultation with a physician. Therefore, over-the-counter daily use of Laxoberal for a maximum of one week is recommended. After that, you may be able to treat with Laxoberal every other day for a week, every three days during the third week, and then end the treatment during the fourth week. Your doctor may suggest that you take a different dose or treatment period.

10 drops of Laxoberal is equivalent to 5 mg of sodium picosulphate.

Instructions for use

Turn the bottle upside down and tap the bottom to get the first drop.

Possible side effects

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

Very common (more than 1 person in 10): Diarrhea.

Common (more than 1 person in 100 but less than 1 person in 10): 

Stomach cramps, abdominal pain, discomfort in the abdomen.

Uncommon (more than 1 in 1,000 but less than 1 in 100) :

Dizziness, vomiting, nausea.

No known frequency (can not be calculated from the available data):

Hypersensitivity, allergic reactions including rash, itching, and swelling of the tongue, lips, or face ( angioedema ), fainting.

How to store Laxoberal

Do not store above 30 ° C.

Keep out of sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and bottle after EXP. data. The expiration date is the last day of the specified month.

The medicine 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 sodium picosulphate 7.5 mg per ml.
  • The other ingredients are sodium benzoate ( preservative E 211), liquid sorbitol (E420) sodium citrate dihydrate, citric acid monohydrate, purified water.

What the medicine looks like and contents of the pack

Colorless to the pale yellow-brown solution.

Drip bottle of 15 ml in polyethylene

30 ml dropper bottle in polyethylene

Not all pack sizes may be marketed.

Marketing Authorisation Holder:

Sanofi AB

Box 30052

104 25 Stockholm

Manufacturer:

Instituto De Angeli Srl

Loc. Paul 103 / C

I-50066 Reggello (FI)

Italy

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