4 g powder for oral solution, sachet
macrogol 4000
What Omnilax is and what it is used for
Omnilax contains the active substance macrogol 4000 (polyethylene glycol = PEG) and belongs to a group of medicines called osmotically active laxatives. They work by increasing the fluid volume of the stool, which helps against problems caused by very slow bowel movements.
Omnilax is used to treat constipation in children aged 6 months to 8 years. This medicine is a powder that should be dissolved in a glass of water (about 50 ml) and that your child should drink. It usually takes 1 to 2 days before it takes effect.
Treatment of constipation with medication should be temporary and only take place in addition to a healthy lifestyle and healthy diet.
Macrogol 4000 contained in Omnilax may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professionals if you have any further questions, and always follow their instructions.
What you need to know before using Omnilax
Do not give Omnilax
- if your child is allergic to macrogol (polyethylene glycol = PEG) or any of the other ingredients of this medicine (listed in section 6)
- if your child has a serious intestinal disease such as:
- inflammatory bowel disease (eg ulcerative colitis , Crohn’s disease )
- perforation (hole) in the gastrointestinal tract, or risk of this
- if you have a bowel obstruction or a suspected bowel obstruction
- if your child has abdominal pain for no known reason.
If you are not sure, talk to your doctor or pharmacist before taking this medicine.
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before giving Omnilax.
Cases of allergic reactions with rash and swelling of the face and neck ( angioedema ) have been reported in the treatment of adults with medicinal products containing macrogol (polyethylene glycol). Occasional severe cases of severe allergic reactions have been reported to cause lethargy, collapse or difficulty breathing, and general malaise. If your child experiences any of these symptoms, the child should stop taking Omnilax and you should seek medical attention immediately.
If you get diarrhea after treatment with Omnilax, there may be a risk of electrolyte disturbances (a decrease in certain salts in the blood). This risk is greater if you are elderly or if you have liver or kidney problems or are taking diuretics (diuretics). If any of these apply to you and you have diarrhea, you should see a doctor have your electrolyte levels checked with a blood test.
Children
You should talk to your child’s doctor or pharmacist before giving Omnilax to your child about your child:
- have impaired liver or kidney function
- take diuretics (diuretics), as the child is then at risk of getting low levels of sodium (salt) or potassium in the blood.
After 3 months of treatment, your doctor should evaluate your child’s clinical condition.
Other medicines and Omnilax
Tell your doctor or pharmacist if your child is taking, has recently taken, or might take any other medicines.
Pregnancy and breastfeeding
Omnilax can be used during pregnancy and breastfeeding.
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
Omnilax has no known effect on the 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.
Omnilax contains sorbitol
This medicine contains 0.28 mg sorbitol per sachet.
How to give Omnilax
Always give this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
The recommended dose depends on the age of your child.
- From 6 months to 1 year of age: 1 sachet per day.
- Between 1 and 4 years of age: 1-2 sachets per day.
- From 4 to 8 years of age: 2-4 sachets per day.
Dissolve the contents of the bag in a glass of water (approximately 50 ml) and then let your child drink the solution. Give Omnilax to your child in the morning if dose one is 1 sachet per day. If the dose is more than 1 sachet per day, give half in the morning and a half in the evening.
Note the following:
- Omnilax usually works within 24-48 hours.
- Children should not be treated with Omnilax for more than 3 months.
- After treatment with Omnilax, the improvement of bowel movements can be maintained with a healthy lifestyle and healthy diet.
- The treatment should be stopped gradually and resumed if the constipation returns.
If your child has taken too much Omnilax
Too much Omnilax can cause diarrhea, stomach pain, or vomiting. Diarrhea usually disappears when treatment is stopped or if the dose is reduced.
If your child has severe diarrhea or vomiting, consult a doctor as soon as possible as your child may need treatment to prevent salt deficiency caused by fluid loss.
If you have ingested too much medicine or if e.g. a child inadvertently ingested the medicine immediately contact a doctor or hospital for risk assessment and advice.
If you forget to give Omnilax
Give the next dose as soon as you remember, but do not give a double dose to make up for a forgotten dose.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects that are usually mild and transient are:
In children
Common (may affect up to 1 in 10 people):
- Stomach pain
- Diarrhea that can also cause soreness around the rectal opening
Uncommon (may affect up to 1 in 100 people):
- Vomiting
- Nausea
- Inflated stomach
Has been reported (occurs in an unknown number of users):
- Allergic reactions (hypersensitivity) such as skin rash, itching , hives ( urticaria ), swelling of the face or throat, difficulty breathing, dizziness or collapse
If you experience any of these symptoms, stop taking this medicine and seek medical attention immediately.
In adults
Common (may affect up to 1 in 10 people):
- Stomach pain
- Inflated stomach
Uncommon (may affect up to 1 in 100 people):
- Urgent need for bowel movements
- Stool incontinence
- Diarrhea
- Nausea
Very rare (may affect up to 1 in 10,000 people):
- Allergic reactions (hypersensitivity) such as skin rash, itching , hives ( urticaria ), swelling of the face or throat, difficulty breathing, dizziness or collapse
Has been reported (occurs in an unknown number of users):
- Low levels of sodium in the blood which can cause fatigue and confusion, muscle twitching, seizures and coma
- Low levels of potassium in the blood which can cause muscle weakness, twitching or abnormal heart rhythm
- Dehydration due to severe diarrhea especially in the elderly
How to store Omnilax
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 after EXP. The expiration date is the last day of the specified month.
No special storage instructions.
The reconstituted solution is stored well covered in a refrigerator (2ºC-8 ° C) and is stable for 6 hours.
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 substance is macrogol. One sachet contains 4 g macrogol 4000.
- The other ingredients are saccharin sodium (E954) and flavoring (orange grapefruit flavor containing maltodextrin, sorbitol (E420), butylhydroxyanisole (E320) and acacia gum (E414)).
What the medicine looks like and contents of the pack
Off-white powder in a sachet to be dissolved in a drink that tastes like orange-grapefruit.
Omnilax is available in pack sizes: 10, 20, 30, or 50 sachets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Manufacturer:
Lamp San Prospero SpA
Via Della Pace 25 / a
San Prospero
41030 (Modena)
Italy