Microlax Rectal solution laxative 4 single doses

NOTICE

ANSM - Updated on: 08/08/2017

Name of the medicinal product

MICROLAX SORBITOL CITRATE AND SODIUM LAURILSULFOACETATE, rectal solution in single dose container

Sorbitol 70% crystallizable, sodium citrate, 70% sodium lauryl sulfate,

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Please read this leaflet carefully before you start using this medicine because it contains important information for you.

You should always take this medication exactly as prescribed in this leaflet or by your doctor or pharmacist.

· Keep this leaflet. You might need to read it again.

· Ask your pharmacist for advice or information.

· If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. See section 4.

· You should talk to your doctor if you do not feel better or feel less well.

What is in this leaflet?

1. What is MICROLAX SORBITOL CITRATE AND SODIUM LAURILSULFOACETATE, rectal solution in single-dose containers and in which cases is it used?

2. What should be known before using MICROLAX SORBITOL CITRATE AND SODIUM LAURILSULFOACETATE, rectal solution in a single-dose container?

3. How to use MICROLAX SORBITOL CITRATE AND SODIUM LAURILSULFOACETATE, rectal solution in single dose container?

4. What are the possible side effects?

5. How to store MICROLAX SORBITOL CITRATE AND SODIUM LAURILSULFOACETATE, rectal solution in a single-dose container?

6. Package contents and other information.

1. WHAT IS MICROLAX SORBITOL CITRATE AND SODIUM LAURILSULFOACETATE, rectal solution in single-dose containers AND WHAT CASES IS IT FOR?

Pharmacotherapeutic group: LAVEMENT, ATC code: A06AG11.

MICROLAX is a laxative. It softens the stool and triggers the evacuation reflex (defecation).

It is used to treat occasional constipation.

This medication is for adults only.

2. BEFORE YOU USE MICROLAX SORBITOL CITRATE AND SODIUM LAURILSULFOACETATE, rectal solution in a single-dose container?

Never use MICROLAX SORBITOL CITRATE AND SODIUM LAURILSULFOACETATE, rectal solution in single-dose containers:

· if you are allergic to any of the active ingredients (sorbitol, sodium citrate or sodium lauryl sulfate) or any of the other ingredients of this medication mentioned in section 6.

· if you suffer from abdominal pain you do not know the cause.

· if you are taking orally or rectally administered sulpho-calcium catioresin, a medication to treat hyperkalaemia (high potassium in the blood).

Warnings and Precautions

You should not use this medication without asking your doctor if you experience any of the following:

· you have a hemorrhoidal attack,

· you have an anal fissure (lesion located at the anus more or less painful during passage of the stool and persisting for several hours),

· you have ulcerative colitis (a disease with inflammation of the rectum and sometimes the large intestine manifested by stomach pains, diarrhea with mucus, blood and often fatigue).

· in combination with Sulfo Sodium Catioline (oral and rectal).

Talk to your doctor or pharmacist before using MICROLAX SORBITOL CITRATE AND SODIUM LAURILSULFOACETATE .

children

Not applicable.

Other medicines and MICROLAX SORBITOL CITRATE AND SODIUM LAURILSULFOACETATE, rectal solution in single dose container

MICROLAX is contraindicated in combination with Sulfo-calcium catioresine (oral and rectal).

MICROLAX is not recommended in combination with Sulfo Sodium Catioresin (oral and rectal).

Inform your doctor or pharmacist if you are using, have recently used or could use any other medicines.

MICROLAX SORBITOL CITRATE AND SODIUM LAURILSULFOACETATE, rectal solution in single-dose containers with food and beverages

Not applicable.

Pregnancy and breast feeding

If you are pregnant or breastfeeding, think you may be pregnant or plan a pregnancy, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

This medicinal product has no or negligible influence on the ability to drive and use machines.

3. HOW TO USE MICROLAX SORBITOL CITRATE AND SODIUM LAURILSULFOACETATE, rectal solution in single dose container?

Always use this medication exactly as prescribed in this leaflet or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.

Dosage

The recommended dose is 1 single dose container per day.

Administration mode

This drug is used rectally. It is not necessary that you lie down to administer this product or wait until it produces its effect.

This medication usually works within 5 to 20 minutes .

A longer delay (greater than 1 hour) can be observed in the persons who remain elongated for a long period.

Duration of treatment

You should not use this medication for long periods of time without seeking the advice of your doctor.

If you used more MICROLAX SORBITOL CITRATE AND SODIUM LAURILSULFOACETATE, rectal solution in single dose containers you should not have

Prolonged use can give rise to sensations of anal burns, and exceptionally congestive rectitions.

If you forget to use MICROLAX SORBITOL CITRATE AND SODIUM LAURILSULFOACETATE, rectal solution in single dose container

Do not take a double dose to make up for the missed dose.

If you stop using MICROLAX SORBITOL CITRATE AND SODIUM LAURILSULFOACETATE, rectal solution in single dose container

Not applicable.

If you have any further questions on the use of this medication, ask your doctor or pharmacist.

4. WHAT ARE POSSIBLE SIDE EFFECTS?

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

The following undesirable effects have been reported with an unknown frequency:

· Abdominal pain

· Discomfort in the anus and / or rectum

· Liquid stools

· Allergic reactions (urticaria)

Declaration of side effects

If you experience any side effects, talk to your doctor or pharmacist. 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 - Website: www.ansm.sante.fr

By reporting adverse reactions, you are helping to provide more information about the safety of the drug.

5. HOW TO STORE MICROLAX SORBITOL CITRATE AND SODIUM LAURILSULFOACETATE, rectal solution in a single-dose container?

Keep this medicine out of the reach and sight of children.

Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month .

No special storage conditions.

Do not throw any medicines into drains or rubbish. Ask your pharmacist to remove any medications you are no longer using. These measures will help protect the environment.

6. PACKAGE CONTENTS AND OTHER INFORMATION

What MICROLAX SORBITOL CITRATE AND SODIUM LAURILSULFOACETATE contains, rectal solution in single dose containers

· The active substances are:

Sorbitol with 70% crystallizable ............................................. ........................................... 4,4650 g

Sodium citrate ............................................... .................................................. ....... 0.4500 g

Sodium Laurilsulfoacetate 70% ............................................ ................................. 0.0645 g

For a single-dose container.

· The other components are sorbic acid, glycerol, purified water.

6.45 g = 5 ml of rectal solution

What is MICROLAX SORBITOL CITRATE AND SODIUM LAURILSULFOACETATE, rectal solution in single-dose containers and contents of the pack

This medication is in the form of a rectal solution in a single-dose container (PE). Box of 4, 6, 12, 50 or 200.

Marketing Authorization Holder

JOHNSON & JOHNSON SANTE BEAUTE FRANCE

1, RUE CAMILLE DESMOULINS

92130 ISSY-LES-MOULINEAUX

Marketing Authorization Operator

JOHNSON & JOHNSON SANTE BEAUTE FRANCE

1, RUE CAMILLE DESMOULINS

92130 ISSY-LES-MOULINEAUX

Maker

FAMAR ORLEANS

5, AVENUE DE CONCYR

45071 ORLEANS CEDEX 2

Names of the medicinal product in the Member States of the European Economic Area

Not applicable.

The last date on which this leaflet was revised is:

[to be completed later by the holder]

Other

Detailed information on this medicine is available on the ANSM website (France).

Health Education Council:

ABOUT CONSTIPATION

What there is to know

Constipation is defined by the decrease in the frequency of bowel movements below 3 per week. This definition is not an absolute rule. Indeed, the usual duration of transit (feeding along the length of the intestine) and therefore the frequency of stools varies greatly from one individual to another. It is therefore important to take into account the feeling of malaise or the disturbances associated with this slowing of transit.

In the case of constipation, there may be discomfort in the abdomen (belly). It is difficult, if not painful, to go to the saddle. The expulsion of the stool seems incomplete. The stools are hard, scanty. Cramping or bloating may occur.

Occasional constipation is usually due to a change in daily habits (travel abroad, diet modification, stress ...) or to "restrain" oneself. Eating habits and lifestyle (physical inactivity) can also cause an imbalance in intestinal function that can lead to constipation over a longer period of time (chronic constipation).

Other situations may lead to constipation: taking certain medicines (some anti-pain, antidepressants, antitussives, antacids based on aluminum ...); in women: certain periods of the menstrual cycle, pregnancy or menopause.

What you should not do

Do not take yourself for a treatment against constipation if:

· You are suffering from a bowel or colon disease (eg Crohn's disease, ulcerative colitis),

· You have severe kidney disease, severe dehydration,

· You suffer from pain in the stomach whose cause is not determined,

· You are pregnant or nursing,

· You assume that your constipation is related to taking certain medications.

Constipation should not be continued if symptoms persist or if constipation is accompanied by other disorders such as: persistent pain in the abdomen, alternation of constipation / diarrhea, mucus, involuntary defecation ( unintentional loss of stool).

In all these cases, seek the advice of your pharmacist or doctor.

Signs of warning: if constipation is accompanied by: blood in the stool, vomiting and stoppage of gas (occlusion), severe pain in the stomach, fever, loss of weight.

It is necessary to consult your doctor, indeed these signs can be the symptoms of a more serious illness.

What you can do yourself

Isolated, though unpleasant, constipation is trivial.

Some simple advice of hygiene of life most often allow to facilitate the intestinal transit and the emission of the saddles:

· Eat green vegetables, high in fiber, and fresh fruits, which promote transit.

You can also consume bread or biscuits with bran or whole grains in a progressive way and without abusing it.

· Avoid foods that are too greasy and too sweet.

· Drink enough and regularly during the day (at least 1.5 liters / day): consume water, fruit juices and soups at will;

· Introduce yourself to the toilet at a fixed time (usually 30 to 60 minutes after meals) without making too much effort to "push". Your organization will get used to a regular schedule. It is also important that you take your time.

· Do not forget gymnastics and physical exercise like walking, excellent ways to combat constipation.

VIDAL OF THE FAMILY

Microlax