1. WHAT IS MACROGOL BIOGARAN 10 g, powder for oral solution in sachet and WHAT IS IT USED FOR?
Pharmacotherapeutic class
MACROGOL BIOGARAN belongs to a group of medicines called osmotic laxatives. MACROGOL BIOGARAN helps to increase the amount of water in the faeces, which helps to solve problems associated with slow bowel movements. MACROGOL BIOGARAN is not absorbed into the bloodstream and is not modified in the body.
Therapeutic indications
MACROGOL BIOGARAN is indicated for the treatment of constipation in adults and children over 8 years of age.
This medicine comes in the form of a powder that should be dissolved in a glass of water (at least 50 ml) and drunk. Its effect is generally felt within 24 to 48 hours.
The treatment of constipation with medication must be combined with healthy lifestyle and diet.
2. WHAT YOU SHOULD KNOW BEFORE TAKING MACROGOL BIOGARAN 10 g, powder for drinkable solution in sachet-dose?
List of information needed before taking the medicine
Not applicable.
Contraindications
Never take MACROGOL BIOGARAN 10 g, powder for oral solution in a sachet if:
- - you are allergic (hypersensitive) to macrogol (polyethylene glycol) or any of the other components contained in the medicine which are listed in section 6 "Further information".
- - you have a disease such as severe bowel disease:
o inflammation of the intestine (such as ulcerative colitis, Crohn's disease),
o perforation of the bowel or risk of perforation of the bowel,
o Ileus or suspected obstruction of the bowel,
o Abdominal pain of undetermined cause.
Do not take this medicine if you have any of the above conditions. If in doubt, talk to your doctor or pharmacist before taking this medicine.
Precautions and special warnings
Warnings and precautions for use
Very rare cases of allergic reactions manifested by a rash on the skin and swelling of the face have been reported in adults after taking medicines containing Macrogol (polyethylene glycol).
Isolated cases of allergic manifestations leading to fainting or general malaise have been reported.
If you experience any of these symptoms, stop taking MACROGOL BIOGARAN and contact your doctor immediately.
As this medicine can sometimes cause diarrhea, contact your doctor or pharmacist before taking this medicine if
- - you have impaired kidney or liver function,
- - you are taking diuretics (drugs that increase urinary elimination) or you are elderly, as you may have decreased blood levels of sodium (salt) and potassium.
Interactions with other medicines
Other medicines and MACROGOL BIOGARAN
Talk to your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Interactions with food and drink
Not applicable.
Interactions with herbal products or alternative therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy and Lactation
MACROGOL BIOGARAN may be taken during pregnancy and while breastfeeding.
If you are pregnant or trying to become pregnant, or if you are breast-feeding, ask your doctor or pharmacist for advice before taking any medication.
Athletes
Not applicable.
Effects on ability to drive and use machines
Not applicable.
List of excipients with a known effect
Important information about certain ingredients of MACROGOL BIOGARAN
If your doctor has told you that you are intolerant to certain sugars (sorbitol), contact your doctor before taking this medicine. This medicine contains a small amount of a sugar called sorbitol which is converted in the body to fructose.
Due to the presence of sulphur dioxide, this medicine may cause rare cases of hypersensitivity reactions and bronchospasm.
MACROGOL BIOGARAN can be used if you are diabetic or if you are on a galactose-free diet.
3. HOW TO TAKE MACROGOL BIOGARAN 10 g, powder for oral solution in a sachet?
Instructions for proper use
When taking MACROGOL BIOGARAN, always follow your doctor's advice or what is stated in this leaflet. If in doubt, consult your doctor or pharmacist.
Dosage, Method and/or route of administration, Frequency of administration and Duration of treatment
Dosage
Adults and children over 8 years
The usual dose is 1 to 2 sachets per day, preferably taken once in the morning.
The daily dose may be adapted to the effect obtained and may vary from 1 sachet every 2 days (especially in children) to a maximum of 2 sachets per day.
Dissolve the contents of the sachet in a glass of water (at least 50 ml) immediately before taking MACROGOL BIOGARAN.
Note that:
- - MACROGOL BIOGARAN usually takes effect in 24 to 48 hours.
- - In children, the duration of treatment with MACROGOL BIOGARAN should not exceed 3 months.
- - The improvement in your bowel movements after taking MACROGOL BIOGARAN can be maintained by adopting healthy lifestyle and diet rules.
Contact your pharmacist or doctor if symptoms worsen or persist.
Symptoms and instructions in case of overdose
If you have taken more MACROGOL BIOGARAN 10 g, powder for oral solution in a sachet than you should have:
Taking too much MACROGOL BIOGARAN may cause diarrhea, which usually goes away when treatment is stopped or the dose is decreased.
If you experience severe diarrhea or vomiting you should contact a doctor as soon as possible as you may need treatment to prevent salt (electrolyte) loss due to fluid loss.
Instructions in case of missed dose(s)
If you forget to take MACROGOL BIOGARAN 10 g, powder for oral solution in a sachet:
Take the dose but do not double it to make up for the dose you forgot to take.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Description of side effects
Like all medicines, this drug may cause side effects, although not everyone is susceptible.
Undesirable effects usually moderate and of short duration include:
In children :
Common (affecting 1 to 10 of every 100 patients)
- - Abdominal pain.
- - Diarrhea which may result in pain in the anus.
Uncommon (affecting 1 to 10 in 1000 patients)
- - Nausea.
- - Vomiting.
- - Bloating.
Unknown frequency
- - Allergic (hypersensitivity) reaction.
In adults:
Common (affecting 1 to 10 of every 100 patients)
- - Abdominal pain and bloating.
- - Nausea.
- - Diarrhea.
Uncommon (affecting 1 to 10 in 1000 patients)
- - Vomiting.
- - Urgent need to have a bowel movement.
- - Fecal incontinence.
Very rare (affecting less than 1 in 10,000 patients) but potentially serious
- - Symptoms of an allergic reaction such as rash, itching, swelling of the face (as seen in angioedema) with swelling of the upper and/or lower lip and/or cheeks.
Unknown frequency
- - Hyponatremia, hypokalemia, possible dehydration due to severe diarrhea, especially in elderly patients.
Side effect reporting
If you experience any side effects, please tell your doctor, pharmacist or nurse. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system: Agence nationale de sécurité du médicament et des produits de santé (ANSM) and the network of Regional Pharmacovigilance Centres - Website: www.ansm.sante.fr
By reporting adverse reactions, you contribute to providing more information on the safety of the medicine.
5. HOW TO USE MACROGOL BIOGARAN 10 g, powder for oral solution in a sachet?
Keep out of the reach and sight of children.
Expiry date
Do not use MACROGOL BIOGARAN after the expiry date stated on the bottom of the box. The expiry date refers to the last day of the month.
Conditions of storage
MACROGOL BIOGARAN does not require special storage conditions.
If necessary, warnings against certain visible signs of deterioration
Medicines should not be disposed of down the drain or in the household waste. Ask your pharmacist what to do with unused medicines. This will help protect the environment.
6. ADDITIONAL INFORMATION
Full list of active ingredients and excipients
What does MACROGOL BIOGARAN, powder for oral solution in sachet, contain?
The active substance is Macrogol 4000, each bag containing 10.00 g.
The other components are: sodium saccharin (E954) and orange-grapefruit flavour (containing orange and grapefruit essential oils, concentrated orange juice, citral, acetic aldehyde, linalool, ethyl butyrate, alpha terpineol, octanal, beta gamma hexenol, maltodextrin, gum arabic, sorbitol (E420), BHA (E320) and sulphur dioxide (E 220)).
Pharmaceutical form and content
What is MACROGOL BIOGARAN 10 g, powder for oral solution in a sachet and what does it contain?
MACROGOL BIOGARAN is a whitish powder with an orange and grapefruit odour and taste, intended for reconstitution as a solution for drinking.
MACROGOL BIOGARAN is available in boxes of 10, 20, 50 and 100 sachets. Not all package sizes may be marketed.
Name and address of the marketing authorisation holder and of the manufacturing authorisation holder responsible for batch release, if different
Holder
IPSEN PHARMA
65, QUAI GEORGES GORSE
92100 BOULOGNE BILLANCOURT
Operator
BIOGARAN
15, BOULEVARD CHARLES DE GAULLE
92700 COLOMBES
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