MACROGOL - GENERIC DRUG - PACKAGE LEAFLET - LEAFLETS

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Macrogol - Generic Drug - Package Leaflet

Indications Contraindications Precautions for use Interactions Warnings Dosage and method of use Overdose Undesirable Effects Shelf Life and Storage

Active ingredients: Macrogol (Macrogol 3350)

MACROGOL CARLO ERBA 5.9 g powder for oral solution

Why is Macrogol - Generic Drug used? What is it for?

Pharmacotherapeutic group: osmotic laxative.

Treatment of occasional constipation.

MACROGOL CARLO ERBA is a mild laxative used to treat occasional constipation in adults. MACROGOL CARLO ERBA increases the flow of liquids in the intestine, making the stool softer and thus facilitating its transit. Furthermore, it contains some essential salts that supplement those that may be lost by the body during treatment.

Contraindications When Macrogol - Generic Drug should not be used

Do not take MACROGOL CARLO ERBA if you suffer from:

allergies to one of its excipients (see list in section 6);
bowel obstruction;
perforation of the intestinal wall;
inflammatory bowel disorders, such as ulcerative colitis and Crohn's disease;
toxic megacolon (a type of condition in which the colon expands abnormally and is no longer able to pass gas and feces);
paralytic ileus (paralysis of the intestinal muscles);
abdominal pain of unknown origin;
nausea or vomiting;
severe hemorrhoidal disorders;
severe dehydration.

If you think you have any of these conditions, consult your doctor or pharmacist before taking this medicine.

Precautions for use What you need to know before taking Macrogol - Generic Drug

Take special care with MACROGOL CARLO ERBA

MACROGOL CARLO ERBA is used to relieve constipation, but before taking it you should try to solve the problem by eating a suitable fiber-based diet and drinking plenty of fluids. Regular physical activity is also an aid.
If you are using MACROGOL CARLO ERBA for the first time and you see no improvement after two weeks, consult your doctor or pharmacist.
In case of diarrhea if you are predisposed to water and electrolyte balance disorders (for example if you are elderly, suffer from liver or kidney problems, if you are taking diuretics to control blood pressure).
One sachet contains approximately 274 mg of sodium. If you are on a low-sodium diet, consult your doctor before taking this medicine.
One sachet contains approximately 39 mg of potassium. If you are following a controlled potassium diet or have kidney problems, consult your doctor before taking this medicine.
This medicine contains polyethylene glycol (otherwise called macrogol). Rare cases of allergic reactions (1 to 10 out of 10,000 patients) and very rare cases of anaphylactic reactions (less than 1 patient) have been observed with high dosages of polyethylene glycol administered for bowel evacuation in the preparatory phase of colon diagnostics. out of 10,000).
Medical treatment is justified only if changes in diet and behavioral habits have no effect.

Interactions Which drugs or foods can modify the effect of Macrogol - Generic Drug

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Like other laxatives, the drug may temporarily reduce the absorption of other medicinal products administered over the same period of time. Caution should be exercised especially when MACROGOL CARLO ERBA is used with antiepileptics and immunosuppressive agents.

Taking with food and drink

This medicine can be taken near or between meals and drinks.

Warnings It is important to know that:

Pregnancy and breastfeeding

If you are pregnant or think you are pregnant, or if you are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Driving and using machines

No effect on the ability to drive or use machines was observed.

Dose, Method and Time of Administration How to use Macrogol - Generic Drug: Posology

Always take this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

MACROGOL CARLO ERBA should be taken for short periods of time.

The effects of MACROGOL CARLO ERBA usually appear after one or two days.

Adults over the age of 18 and the elderly

The normal dosage is 1 or 2 sachets per day in a single administration, preferably in the morning. The average dosage is 1 sachet per day.

Dissolve the contents of one sachet of MACROGOL CARLO ERBA in a glass of water (about 100 ml) and drink immediately.
Take the reconstituted solution once a day, preferably in the morning.
The dose can be increased up to two sachets. Wait a day or two for effects to occur before increasing the dose.
Do not take MACROGOL CARLO ERBA for more than two weeks, unless otherwise advised by your doctor. (See paragraph 2 - Take special care with MACROGOL CARLO ERBA).

If you forget to take MACROGOL CARLO ERBA

MACROGOL CARLO ERBA must always be taken at the same time, preferably in the morning. If you forget to take it, it can also be taken later in the day, but in this case the next dose will need to be taken at the same delayed time on the following days as well. Never take a double dose.

Overdose What to do if you have taken an overdose of Macrogol - Generic Drug

If you take too much of this medicine, contact a doctor and take this leaflet with you.

Side Effects What are the side effects of Macrogol - Generic Drug

Like all medicines, MACROGOL CARLO ERBA can cause side effects, although not everybody gets them.

If you experience any of the following side effects, stop using this medicine and contact your doctor or nearest emergency department immediately, taking this leaflet with you:

Allergic reactions, including wheezing of unknown origin, shortness of breath, unconsciousness or swelling of the face and throat.
Allergic reactions, including skin rashes, hives and itching.

These are very rare side effects (affecting less than 1 in 10,000 people).

Very common (affects more than 1 in 10 people)

High doses can cause mild diarrhea or runny stools. This problem usually subsides by lowering the dose, although it sometimes takes a day or two for it to go away.

Common (affects less than 1 in 10 people)

Stomach pain or discomfort.

Nausea.

Uncommon (affects less than 1 in 100 people)

He retched.

Urgency to defecate.

Faecal incontinence.

Not known

Electrolyte disturbances (hyponatremia, hypokalaemia) and / or dehydration, especially in elderly patients.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system at “www.agenziafarmaco.gov.it/it/responsabili.” By reporting side effects you can help provide more information on the safety of this medicine.

Expiry and Retention

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 sachets and carton after EXP :. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.

Other_information "> Other information

What MACROGOL CARLO ERBA contains

The active substance is macrogol 3350 (5.9 g per sachet).

The other ingredients are: sodium chloride, anhydrous sodium sulfate, potassium chloride, sodium hydrogen carbonate, sodium saccharinate, anhydrous colloidal silica and lemon and mango flavors (containing: maltodextrin, acacia gum, propylene glycol and ascorbic acid).

Description of the appearance of MACROGOL CARLO ERBA and contents of the pack

MACROGOL CARLO ERBA sachets contain a white or almost white powder. MACROGOL CARLO ERBA is authorized in packs of 2, 8, 10, 20, 24, 30 or 50 sachets.

Not all pack sizes may be marketed.

Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.

More information on Macrogol - Generic Drug can be found in the "Summary of Characteristics" tab. 01.0 NAME OF THE MEDICINAL PRODUCT - 02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION - 03.0 PHARMACEUTICAL FORM - 04.0 CLINICAL PARTICULARS - 04.1 Therapeutic indications - 04.2 Posology and method of administration - 04.3 Contraindications - 04.4 Special warnings and appropriate precautions for use - 04.5 Interactions with other medicinal products and other forms of interaction - 04.6 Pregnancy and lactation - 04.7 Effects on the ability to drive and use machines - 04.8 Undesirable effects - 04.9 Overdose - 05.0 PHARMACOLOGICAL PROPERTIES - 05.1 "Pharmacodynamic properties - 05.2 Pharmacokinetic properties" - 05.3 Preclinical safety data - 06.0 PHARMACEUTICAL PARTICULARS - 06.1 Excipients - 06.2 Incompatibility "- 06.3 Shelf life" - 06.4 Special precautions for storage - 06.5 Nature of the primary packaging and contents of the package - 06.6 Instructions for use and handling - 07.0 AUTHORIZATION HOLDER ALL "PLACING ON THE MARKET - 08.0 MARKETING AUTHORIZATION NUMBER - 09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION - 10.0 DATE OF REVISION OF THE TEXT - 11.0 FOR RADIO DRUGS, COMPLETE DATA ON INTERNAL RADIATION DOSIMETRY - 12.0 INSTRUCTIONS FOR RADIOPHONES ON EXTEMPORARY PREPARATION AND QUALITY CONTROL -

01.0 NAME OF THE MEDICINAL PRODUCT -

MACROGOL CARLO ERBA 5.9 G POWDER FOR ORAL SOLUTION

02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION -

One sachet contains

Macrogol 3350 5.9 g.

This medicine contains sodium (274.4 mg / sachet) and potassium (39.1 mg / sachet).

For the full list of excipients, see section 6.1.

03.0 PHARMACEUTICAL FORM -

Powder for oral solution in single-dose sachets.

White or almost white powder.

04.0 CLINICAL INFORMATION -

04.1 Therapeutic indications -

Symptomatic treatment of occasional constipation in adults.

04.2 Posology and method of administration -

Adults over 18 years and the elderly 1-2 sachets per day in a single administration, preferably in the morning.

Children and adolescents under 18 years: not recommended.

Elderly, patients with kidney disease or hepatic insufficiency: it is not necessary to change the dosage.

Administration:

Dissolve each sachet in 100 ml of water, the equivalent of a glass. The solution should be swallowed immediately after preparation. The effects of MACROGOL 3350 occur within 24-48 hours after administration.

Treatment should be continued for as short a time as possible (see section 4.4).

04.3 Contraindications -

• Hypersensitivity to MACROGOL 3350 or to any of the excipients.

• Paralytic ileus or suspected bowel obstruction or symptomatic stenosis.

• Severe inflammation of the gut (eg acute ulcerative colitis, Crohn's disease) and toxic megacolon.

• Intestinal perforation or risk of perforation.

• Acute or unknown abdominal pain, nausea or vomiting, intestinal stricture, rectal bleeding of unknown origin, acute haemorrhoidal crisis, pain and bleeding or severe dehydration.

04.4 Special warnings and appropriate precautions for use -

The treatment of constipation with a medicine is only an adjunct to good hygiene practices and an appropriate diet by the patient (greater intake of liquids and dietary fiber, suitable physical activity and rehabilitation for defecation).

Medical treatment is justified only if changes in diet and behavioral habits have no effect.

Patients using this medicine for the first time should consult a doctor if they do not experience improvement in symptoms after two weeks.

In case of diarrhea, caution should be exercised in patients predisposed to fluid and electrolyte disturbances (eg the elderly, patients with hepatic or renal insufficiency or in patients who have taken diuretics) and an electrolyte check should be considered.

The drug contains polyethylene glycol. Some rare allergic manifestations and very exceptional cases of anaphylactic reactions have been observed only with high dosages of polyethylene glycol administered in the preparatory phase of colon diagnostic tests.

Patients on a low-sodium diet (heart failure, hypertension) must take into account the sodium content (274.4 mg / sachet).

This medicine contains potassium (39.1 mg / sachet). Patients with impaired renal function or on a controlled potassium diet should be taken into account.

04.5 Interactions with other medicinal products and other forms of interaction -

There are no clinical or trial data on the interactions of MACROGOL 3350 with other medicinal products.

Like other laxatives, the drug may temporarily reduce the absorption of other medicinal products administered over the same period of time.

Caution should be exercised when MACROGOL 3350 is used with drugs with a narrow therapeutic index (e.g. antiepileptics and immunosuppressive agents).

04.6 Pregnancy and breastfeeding -

Pregnancy

No clinical data are available on the use of MACROGOL 3350 during pregnancy.

Animal studies did not show teratogenic effects.

Therefore, considering the poor absorption of MACROGOL 3350, the use of MACROGOL CARLO ERBA can be considered when necessary.

Feeding time

No clinical data are available on the excretion of MACROGOL 3350 in human milk. Since MACROGOL 3350 is poorly absorbed, the use of MACROGOL CARLO ERBA may be considered when necessary.

04.7 Effects on ability to drive and use machines -

No effect on the ability to drive and use machines was observed.

04.8 Undesirable effects -

Reactions are listed below by System Organ Class, using MedDRA terminology, and by absolute frequency.

Frequencies in patients are defined as follows:

Very common ≥1 / 10

Common ≥1 / 100,

Uncommon ≥1 / 1,000,

Rare ≥1 / 10,000,

Very rare

Not known (frequency cannot be estimated from the available data), including isolated reports.

Body system Incidence Adverse events reported Gastrointestinal disorders Very common Mild diarrhea Liquid stools common Nausea Abdominal pain Abdominal distension Uncommon He retched Urgency to defecate Faecal incontinence Disorders of the immune system Very rare Anaphylactic reactions Hypersensitivity reactions such as hives, rash, itching or edema Metabolism and nutrition disorders Not known Electrolyte disturbance (hyponatremia, hypokalaemia) Dehydration

Mild diarrhea is a very common side effect, particularly if the dosage is too high. These effects generally disappear within 24 to 48 hours after stopping treatment. Treatment can then be continued with a lower dose. In controlled studies with MACROGOL 3350, 5.9 g, up to 40% of patients have reported at least one episode of diarrhea or liquid stools.

Electrolyte disturbances (hyponatremia, hypokalaemia) and / or dehydration may also occur, especially in elderly patients.

Abdominal pain and distension are common side effects particularly in people with functional bowel disorders.

Reporting of suspected adverse reactions

Reporting of suspected adverse reactions occurring after authorization of the medicinal product is important as it allows continuous monitoring of the benefit / risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system. "address" www.agenziafarmaco.gov.it/it/responsabili ".

04.9 Overdose -

Overdose causes diarrhea which disappears with temporary interruption of treatment or dose reduction. Excessive fluid loss caused by diarrhea may require correction of the electrolyte imbalance.

Cases of aspiration have been reported when high volumes of polyethylene glycol and electrolytes were administered with a nasogastric tube.

05.0 PHARMACOLOGICAL PROPERTIES -

05.1 "Pharmacodynamic properties -

Pharmacotherapeutic group: laxatives with osmotic action.

ATC code: A06A D15.

MACROGOL CARLO ERBA is an iso-osmotic laxative consisting of a mixture of MACROGOL 3350 and electrolytes.

High molecular weight MACROGOLs are long linear chain polymers that retain water molecules by means of hydrogen bonds. When administered orally, they lead to an increase in the volume of intestinal fluids.

MACROGOL CARLO ERBA is a blend of MACROGOL 3350 and electrolytes that maintains iso-osmotic flow along the entire length of the intestinal tract.

The volume of unabsorbed intestinal fluid determines the laxative properties of the solution.

05.2 "Pharmacokinetic properties -

MACROGOL CARLO ERBA is neither absorbed nor metabolised. Once dissolved in water, MACROGOL 3350 5.9 g is iso-osmotic to plasma. The electrolyte concentration of the reconstituted solution is such that the exchange of electrolytes between the intestine and the blood is negligible.

Pharmacokinetic data confirmed that MACROGOL 3350 is not subject to gastrointestinal resorption or biotransformation after oral administration.

05.3 Preclinical safety data -

Two teratogenicity studies were performed, one in rats and one in rabbits. MACROGOL 3350 was administered orally at doses up to 2000 mg / kg / day between the 6th and 17th day of gestation in rats, and between the 6th and 18th day of gestation in rabbits. The results of both studies did not reveal any maternotoxic or teratogenic effects in the presence of doses up to 2,000 mg / kg / day.