In this manual :
1. WHAT IS MICROLAX, rectal solution in a single-dose container AND WHAT IS IT USED FOR?
2. WHAT DO YOU NEED TO KNOW BEFORE USING MICROLAX, rectal solution in a single-dose container?
3. HOW DO I USE MICROLAX, rectal solution in a single-dose container?
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
5. HOW TO USE MICROLAX, rectal solution in a single-dose container?
6. ADDITIONAL INFORMATION
1. WHAT IS MICROLAX, rectal solution in a single-dose container AND WHAT IS IT USED FOR?
Pharmacotherapeutic class
WASHING
MICROLAX is a laxative. It softens the stool and triggers the evacuation reflex (defecation).
It is used to treat occasional constipation.
This medicine is for adults only.
2. WHAT YOU SHOULD KNOW BEFORE USING MICROLAX rectal solution in a single dose container
List of information needed before taking the medicine
Not applicable.
Never use MICROLAX
If you have abdominal pain for which you do not know the cause.
If you are allergic (hypersensitive) to any of the active ingredients (sorbitol, sodium citrate or lauryl sulfoacetate) or to any of the other components contained in this medicine. For a list of ingredients, see section 6.
Precautions for use; special warnings
Be careful with MICROLAX
Do not use this medicine without asking your doctor if any of the following apply to you:
- you have a hemorrhoidal attack,
- you have an anal fissure (a lesion in the anus that is more or less painful during the passage of stools and lasts for several hours),
- you have haemorrhagic rectocolitis (a disease with an inflammation of the rectum and sometimes of the large intestine manifested by stomach pains, diarrhoea with mucus, blood and often fatigue).
In combination with Catioresin sulfo sodium (oral and rectal).
Interactions with other drugs
Taking or using other drugs
MICROLAX is not recommended in combination with Catioresin sulfo sodium (oral and rectal).
TO AVOID POSSIBLE INTERACTIONS BETWEEN SEVERAL DRUGS, ALWAYS INFORM YOUR DOCTOR OR PHARMACIST OF ANY OTHER TREATMENT IN PROGRESS.
Interactions with food and drink
Not applicable.
Interactions with herbal products or alternative therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy
This medicine should only be used during pregnancy on the advice of your doctor.
If you discover that you are pregnant during treatment, consult your doctor, as only he or she can decide whether you should continue treatment.
Ask your doctor or pharmacist for advice before taking any medicine.
Breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
Not applicable.
Effects on ability to drive and use machines
Not applicable.
List of excipients with a known effect
Not applicable.
3. HOW TO USE MICROLAX rectal solution in a single-dose container
Instructions for proper use
Not applicable.
Dosage, Method and/or route(s) of administration, Frequency of administration and Duration of treatment
Dosage
The dose to be used is 1 tube per day.
Method of administration
This medicine is used rectally. You do not need to lie down to administer this product or wait for it to take effect.
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How to use it
1. Break off the tip and press the tube gently to release a drop.
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2. Lubricate the cannula with this drop.
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3. Insert the cannula into the rectum.
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4. Empty all the contents of the tube by pressure.
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5. Remove the cannula without releasing the pressure on the tube.
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This medication usually takes effect in 5 to 20 minutes.
A longer delay (more than 1 hour) can be observed in people who lie down for a long time.
Duration of treatment
You should not use this medicine for a long time without consulting your doctor.
Symptoms and instructions in case of overdose
If you have used more MICROLAX rectal solution in a single-dose container than you should : prolonged use may result in anal burning and, in rare cases, congestive rectitis.
Instructions in case of missed doses
Not applicable.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Description of side effects
Like all medicines, MICROLAX may have side effects, although not everyone is likely to have them.
The following side effects may occur with prolonged use of this medication:
- a burning sensation in the anus,
- exceptionally, inflammation of the rectum.
If you notice any side effects not mentioned in this leaflet, or if any side effects become serious, please tell your doctor or pharmacist.
5. HOW TO USE MICROLAX rectal solution in a single-dose container
Keep out of the reach and sight of children.
Do not use MICROLAX after the expiry date stated on the carton. The expiry date refers to the last day of the month.
No special storage precautions.
If necessary, warnings against certain visible signs of deterioration
Do not dispose of medicines down the drain or in the household waste. Ask your pharmacist what to do with unused medicines. This will help to protect the environment.
6. ADDITIONAL INFORMATION
Full list of active ingredients and excipients
What it contains MICROLAX rectal solution in single-dose container?
The active ingredients are :
Sorbitol 70% crystallizable ........................................................................................................... 4.4650 g
Sodium citrate ........................................................................................................................... 0.4500 g
Sodium Laurilsulfoacetate 70% ................................................................................................ 0.0645 g
for a single-dose container
Excipients: Sorbic acid, glycerol, purified water.
6,45 g = 5 ml rectal solution
Pharmaceutical form and content
What is MICROLAX, rectal solution in a single-dose container and contents of the pack
This medicinal product is presented as a rectal solution in a single-dose container (PE).
Name and address of the marketing authorisation holder and of the manufacturing authorisation holder responsible for batch release, if different
Holder
McNEIL
1, rue Camille Desmoulins
TSA 20005
92787 Issy les Moulineaux Cedex 9
Operator
MCNEIL sante grand public
1, rue Camille Desmoulins
92130 issy-les-moulineaux
Manufacturer
McNEIL AB
Norrbroplatsen 2
251 09 HELSINGBORG
SWEDEN
or
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.
Date of approval of the package leaflet
The last date on which this package insert was approved was {date}.
MA under exceptional circumstances
Not applicable.
Detailed information on this medicinal product is available on the website of Afssaps (France).
Information reserved for health professionals
Not applicable.
ABOUT CONSTIPATION
What you should know
Constipation is defined as a decrease in the frequency of bowel movements to less than 3 per week.
This definition is not an absolute rule. In fact, the usual duration of transit (food moving through the intestine) and therefore the frequency of stools varies widely from one individual to another. It is therefore important to take into account the feeling of discomfort or the disorders associated with this slowed transit.
In case of constipation, there may be discomfort in the abdomen (belly). It is difficult or even painful to have a bowel movement. The expulsion of the stool seems incomplete. The stools are hard, not very abundant. Cramping or bloating may occur.
Occasional constipation is generally due to a change in daily habits (travel abroad, change in diet, stress, etc.) or to "holding back".
Dietary habits and lifestyle (sedentary lifestyle) can also be the cause of an imbalance in intestinal function that can lead to constipation over a longer period (chronic constipation).
Other situations are likely to lead to constipation: taking certain medications (certain painkillers, antidepressants, cough suppressants, aluminium-based antacids, etc.); in women: certain periods of the menstrual cycle, pregnancy or the menopause.
What not to do
- You should not take constipation medication on your own if:
- You have a bowel or colon disease (e.g. Crohn's disease, ulcerative colitis),
- You have severe kidney disease, severe dehydration,
- You have pain in your belly for which the cause is not known,
- You are pregnant or breastfeeding,
- You suspect that your constipation is related to the use of certain medications.
- Do not continue treatment for constipation if the symptoms persist or if the constipation is accompanied by other problems such as: persistent pain in the stomach, alternating episodes of constipation/diarrhoea, mucus, involuntary defecation (involuntary loss of stools).
In all these cases, ask your pharmacist or doctor for advice.
Warning signs: if constipation is accompanied by: blood in the stools, vomiting and cessation of gas (obstruction), severe stomach pains, fever, weight loss.
It is necessary to consult your doctor, as these signs may be symptoms of a more serious illness.
What you can do yourself
Isolated constipation, although unpleasant, is harmless.
A few simple lifestyle tips can often facilitate intestinal transit and stool output:
- Eat green vegetables, rich in fiber, and fresh fruit, which promote transit.
You can also eat bread or biscuits made from bran or wholegrain cereals, gradually and without overdoing it.
- Avoid foods that are too fatty and too sweet.
- Drink sufficiently and regularly throughout the day (at least 1.5 litres/day): drink water, fruit juices and soups as much as you like;
- Go to the toilet at a fixed time (generally 30 to 60 minutes after meals) without making too much effort to "push". This will help your body get used to a regular schedule. It is also important that you take your time.
- Don't forget about exercise, such as walking, which is an excellent way to combat constipation.
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