Macrogol Viatris 10 g is a laxative medication—that is, it helps speed up bowel movements—used to treat constipation (difficulty having a bowel movement). This laxative takes 24 to 48 hours to take effect, so you should not conclude that the treatment is ineffective before that time has elapsed.
There are many causes of constipation, and they are usually not serious. Fortunately, simple lifestyle changes are often very effective in treating this condition, which is particularly common among women.
Some cases of constipation result from a slowing of the movement of food through the colon (large intestine). In other cases, there are difficulties with passing stool in the rectum (the final section of the colon) and the anus (“terminal constipation”).
Macrogol Viatris 10gis alaxative medication—that is, one thataccelerates intestinal transit—used to treatconstipation(difficulty passing stool).
This laxative takes 24 to 48 hours to take effect, so one should not conclude that the treatment is ineffective before this time has elapsed. Its osmotic action helps hydrate the stool to speed up bowel movements.
The recommended dosage for treatment with Macrogol Viatris isone to two packets per day for adults and children over 8 years of age. The packets should be taken in the morning with a large glass of cool water.
In children, this laxative should be used only in exceptional cases and must be initiated and monitored by a doctor.
Laxative treatment should be part of abalanced diet, including an adequate intake of vitamins. Indeed, certain vitamins may be eliminated more quickly as a result of laxative treatment. Therefore, supplementation may sometimes be necessary.
Furthermore, constipation is primarily treated with a high-fiber diet that includes adequate fluid intake. It is sometimes helpful to drink magnesium-enriched water to help speed up bowel movements.
Macrogol Viatris may be used by pregnant or breastfeeding women, preferably under medical supervision.
Sodium saccharin (E954), Orange-grapefruit flavoring: Orange, Grapefruit, Orange, Citral, Acetic aldehyde, Linalool, Ethyl butyrate, Alpha-terpineol, Octanal, Beta-gamma-hexenol, Maltodextrin, Gum arabic (E414), Sorbitol (E420), Sulfur dioxide (E220)
Macrogolis a substance used to treat occasional constipation or fecal impaction (severe constipation resulting in an inability to pass stool, sometimes caused by the use of certain medications). In these situations, this substance may be combined with sodium bicarbonate and/or potassium. Macrogol is also used to prepare patients for surgery or a colonoscopy by flushing out the colon to remove all contents.
In the event of diarrhea, patients at risk of fluid and electrolyte imbalance (e.g., the elderly, patients with hepatic or renal insufficiency, or those receiving diuretic therapy) should be monitored, and electrolyte levels should be checked.
Medication for constipation is only an adjunct to lifestyle and dietary measures such as:
This medication contains sorbitol. Its use is not recommended in patients with fructose intolerance (a rare hereditary disorder).
This medication contains sulfur dioxide and may cause severe allergic reactions and bronchospasm.
Very rare cases of hypersensitivity reactions (rash, hives, edema) have been reported with medications containing macrogol (polyethylene glycol). Exceptional cases of anaphylactic shock have been reported.
Since Macrogol Viatris does not contain significant amounts of sugar or polyols, it may be prescribed to patients with diabetes or those on a galactose-free diet
Macrogol 4000 has not shown any teratogenic effects in rats and rabbits.
Since systemic exposure to Macrogol Viatris is negligible, no effects are expected during pregnancy. Macrogol Viatris may be used during pregnancy.
Breastfeeding
Since systemic exposure to Macrogol Viatris in breastfeeding women is negligible, no effects are expected in breastfed newborns or infants. Macrogol Viatris may be used during breastfeeding.
Box of 20 sachets.
We tend to overlook it, but it is also a digestive problem. Constipation is directly linked to our lifestyle and environment. Its causes are numerous and can sometimes be difficult to pinpoint in the most severe cases. It may have psychological or emotional origins. In most cases, it results from simple sluggishness of the digestive tract.
There are some easy-to-follow guidelines that can naturally help promote regular bowel movements:
Pharmacovigilance Report an adverse drug reaction(s)
NOTICE
ANSM - Last updated: 18/02/2015
Name of the medicinal product
MACROGOL BIOGARAN 10 g, powder for oral solution in sachet-dose
Macrogol 4000
framed
Read all of this leaflet carefully before you give this medicine to your child.
· Keep this leaflet, you may need to read it again.
· If you have any further questions, ask your doctor or pharmacist.
· If symptoms worsen or persist, consult a physician.
· If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Review summary
In this notice :
1. WHAT IS MACROGOL BIOGARAN 10 g, powder for oral solution in sachet-dose AND WHAT IS IT USED FOR?
2. BEFORE YOU TAKE MACROGOL BIOGARAN 10 g, powder for oral solution in sachet-dose?
3. HOW TO TAKE MACROGOL BIOGARAN 10 g powder for oral solution in sachet-dose?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE MACROGOL BIOGARAN 10 g powder for oral solution in a sachet-dose?
6. ADDITIONAL INFORMATION
1. WHAT IS MACROGOL BIOGARAN 10 g, powder for oral solution in sachet-dose AND WHAT IS IT USED FOR?
Pharmacotherapeutic group
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 related to a slowed intestinal transit. MACROGOL BIOGARAN is not absorbed into the bloodstream and is not altered in the body.
Therapeutic indications
MACROGOL BIOGARAN is indicated for the treatment of constipation in adults and children over 8 years of age.
This medication is in the form of a powder that must be dissolved in a glass of water (minimum 50 ml) and drink. Its effect usually manifests itself in 24 h to 48 h.
The treatment of constipation with a medication must be associated with healthy lifestyle and healthy eating.
2. BEFORE YOU TAKE MACROGOL BIOGARAN 10 g, powder for oral solution in sachet-dose?
List of information needed before taking the medication
Not applicable.
Cons-indications
Do not take MACROGOL BIOGARAN 10 g powder for oral solution in a sachet-dose if:
· you are allergic (hypersensitive) to macrogol (polyethylene glycol) or any of the other ingredients of the medication that are listed in section 6 "Additional Information" .
· you have a disease such as a severe bowel disease:
o inflammation of the intestine (such as ulcerative colitis, Crohn's disease),
o perforation of the intestine or risk of perforation of the intestine,
o Ileus or suspicion of obstruction of the intestine,
o abdominal pain of indeterminate cause.
Do not take this medication if you are suffering from any of the conditions listed above. In case of doubt, tell your doctor or pharmacist before taking this medicine.
Precautions for use; special warnings
Warnings and Precautions
Very rare cases of allergic manifestations of rash on the skin and swelling of the face have been reported in adults after taking Macrogol (polyethylene Glycol) medications.
Isolated cases of allergic manifestations leading to loss of consciousness or malaise and general feeling of malaise have been reported.
If you experience any of these symptoms, stop taking MACROGOL BIOGARAN and contact your doctor immediately.
To the extent that this medication may occasionally cause diarrhea, contact your doctor or pharmacist before taking this medication if:
· you have impaired renal or hepatic function,
· you are taking diuretics (medicines increasing urinary excretion) or you are elderly, as you are likely to have a decrease in your blood sodium (salt) and potassium levels.
Interaction with other medicines
Other drugs and MACROGOL BIOGARAN
If you are taking or have recently taken any other medicines, including medicines obtained without a prescription, talk to your doctor or pharmacist.
Interactions with food and beverages
Not applicable.
Interactions with Herbal Medicines or Alternative Therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy and breast feeding
MACROGOL BIOGARAN can be taken during pregnancy and lactation.
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 medicine.
Sport
Not applicable.
Effects on ability to drive or use machines
Not applicable.
List of excipients with known effect
Important information about some of the ingredients of MACROGOL BIOGARAN
If your doctor has told you that you are intolerant to some sugars (sorbitol), contact your doctor before taking this medicine. This medicine contains a small amount of sugar called sorbitol which is transformed into the body into fructose.
Due to the presence of sulfur dioxide (or sulfur dioxide), this drug may cause rare cases of hypersensitivity and bronchospasm.
MACROGOL BIOGARAN can nevertheless be used if you are diabetic or if you must follow a diet free of galactose.
3. HOW TO TAKE MACROGOL BIOGARAN 10 g powder for oral solution in sachet-dose?
Instructions for proper use
When taking MACROGOL BIOGARAN, always follow the advice of your doctor or what is stated in this leaflet. If in doubt, consult your doctor or pharmacist.
Dosage, Mode and / or route (s) 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 in single dose in the morning.
The daily dose can be adapted to the effect obtained and can vary from 1 sachet every 2 days (in children in particular) to 2 sachets per day at the most.
Dissolve the contents of the sachet in a glass of water (minimum 50 ml) immediately before taking MACROGOL BIOGARAN.
Note that:
· MACROGOL BIOGARAN usually operates within 24 hours at 48 hours.
· In children, the duration of treatment with MACROGOL BIOGARAN should not exceed 3 months.
· Improving your intestinal transit after taking MACROGOL BIOGARAN can be maintained by adopting lifestyle and diet rules.
Contact your pharmacist or doctor if symptoms worsen or persist.
Symptoms and Instructions for Overdose
If you take more MACROGOL BIOGARAN 10 g powder for oral solution in a sachet-dose than you should:
Taking too much MACROGOL BIOGARAN can cause diarrhea, which usually disappears when treatment is discontinued or the dose decreased.
If you suffer from severe diarrhea or vomiting, you should contact a doctor as soon as possible because you may need treatment to prevent loss of salts (electrolytes) due to fluid loss.
Instructions for omission of one or more doses
If you forget to take MACROGOL BIOGARAN 10 g, powder for oral solution in sachet-dose:
Take the dose but do not double it to compensate for the dose you have forgotten to take.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Description of adverse reactions
Like all medicines, this medication is likely to have side effects, although not everybody gets them.
Usually moderate and short-term adverse events include:
In children:
Common (affecting 1 to 10 patients in 100)
· Abdominal pain.
· Diarrhea that can cause pain in the anus.
Uncommon (affecting 1 to 10 patients in 1000)
· Nausea.
· Vomiting.
· Bloating.
Unknown frequency
· Allergic reaction (hypersensitivity).
In adults:
Common (affecting 1 to 10 patients in 100)
· Abdominal pain and bloating.
· Nausea.
· Diarrhea.
Uncommon (affecting 1 to 10 patients in 1000)
· Vomiting.
· Impressive need to go to the saddle.
· Fecal incontinence.
Very rare (affecting less than 1 in 10,000 patients) but potentially severe
· Symptoms of an allergic reaction such as rash, itching, swelling, swelling of the face (as seen in angioedema) with swelling of the upper and / or lower lip and / or cheeks.
Unknown frequency
· Hyponatremia, hypokalaemia, possible dehydration caused by severe diarrhea, especially in the elderly.
Declaration of side effects
If you experience any side effects, talk to 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: National Agency for the Safety of Medicines and Health Products (ANSM) and network of Regional Centers of Pharmacovigilance
By reporting adverse reactions, you are helping to provide more information about the safety of the drug.
5. HOW TO STORE MACROGOL BIOGARAN 10 g powder for oral solution in a sachet-dose?
Keep out of the reach and sight of children.
Expiration date
Do not use MACROGOL BIOGARAN after the expiry date which is stated on the bottom of the box. The expiry date refers to the last day of the month.
Storage conditions
MACROGOL BIOGARAN does not require special storage conditions.
If necessary, warnings against visible signs of deterioration
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist what to do with unused medications. These measures will help protect the environment.
6. ADDITIONAL INFORMATION
Full list of active substances and excipients
What does MACROGOL BIOGARAN contain, powder for oral solution in a sachet-dose?
The active substance is : Macrogol 4000, each sachet containing 10.00 g.
The other components are : sodium saccharin (E954) and orange-grapefruit flavoring (containing orange and grapefruit essential oils, concentrated orange juice, citral, aldehyde acetic acid, linalool, ethyl butyrate , alpha terpineol, octanal, beta gamma hexenol, maltodextrin, gum arabic, sorbitol (E420), BHA (E320) and sulfur dioxide (E 220).
Pharmaceutical form and content
What is MACROGOL BIOGARAN 10 g powder for oral solution in sachet-dose and contents of the pack?
MACROGOL BIOGARAN is in the form of a whitish powder which has an odor and a taste of orange and grapefruit and is intended to be reconstituted as a drinkable solution.
MACROGOL BIOGARAN comes in boxes of 10, 20, 50 and 100 sachets. Not all pack sizes may be marketed.
Name and address of the marketing authorization holder and the holder of the manufacturing authorization responsible for the release of the lots, if different
Holder
IPSEN PHARMA
65, QUAI GEORGES GORSE
92100 BOULOGNE BILLANCOURT
exploiting
BIOGARAN
15, BOULEVARD CHARLES DE GAULLE
92700 COLOMBES
Maker
BEAUFOUR IPSEN INDUSTRIE
STREET VIRTON
28100 DREUX
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
Date of approval of the notice
The last date on which this leaflet was approved is {date}.
AMM under exceptional circumstances
Not applicable.
Internet Information
Detailed information on this medicine is available on the Afssaps website (France).
Information for health professionals only
Not applicable.
Other
ABOUT CONSTIPATION
Occasional constipation:
It may be related to a recent change in lifestyle (eg travel).
The drug may be an aid in short treatment. Any recent constipation unexplained by the change in lifestyle, constipation accompanied by pain, fever, swelling of the stomach should have the advice of your doctor.
Chronic constipation (long-term constipation):
It can be linked to two causes:
· or to a bowel disease that requires treatment by the physician,
· or an imbalance in intestinal function due to dietary habits and lifestyle.
Treatment includes:
· an increase in dietary intakes of vegetable products (green vegetables, raw vegetables, wholemeal bread, fruit ...),
· an increase in the consumption of water and fruit juices,
· an increase in physical activities (sports, walking ...),
· a rehabilitation of the defecation reflex.
If you notice any side effects not listed in this leaflet, or if any of the side effects gets serious, contact your doctor or pharmacist.
Osmotic laxative
This medication is a generic of FORLAX
. Presentations . Composition . Indications . Contraindications . Warning . Pregnancy and breastfeeding . Directions for use and dosage . Advice . Undesirable effects . Lexicon
MACROGOL BIOGARAN 10 g: powder for oral solution (orange-grapefruit aroma); box of 20 bags.
Refunded at 30%. - price: 2,41 euro (s).
Biogaran Laboratory
| p sachet | |
| Macrogol 4000 | 10 g |
Usual dosage:
