Imodium acute 2 mg melting tablets

Imodium akut is a medicine for diarrhoea and contains the active substance loperamide hydrochloride.

Application

1. What is Imodium acute and what is it used for?

Imodium acute is a medicine for diarrhoea.

It is used for the symptomatic treatment of acute diarrhoea for adolescents
12 years and older and adults when no causative therapy is available.

Treatment with loperamide hydrochloride for more than 2 days must be prescribed by a doctor and monitored by him/her.

If you do not feel better or even worse after 2 days, consult your doctor.

How is it applied?

What is Imodium acute and what is it used for?

Imodium acute is a medicine for diarrhoea and contains the active substance loperamide hydrochloride.

It is used for the symptomatic treatment of acute diarrhoea for adolescents from
12 years of age and adults, if no causative therapy is available.

Treatment with loperamide hydrochloride lasting longer than 2 days may only be given under a doctor's prescription and follow-up.

If you do not feel better or even worse after 2 days, consult your doctor.

What should you pay attention to before taking it?

What should you be aware of before taking Imodium akut?
Imodium acute must not be taken,
● if you are allergic to loperamide hydrochloride or any of the other ingredients of this medicine listed in section 6.

.

• of children under 12 years of age.
• If you have conditions where slowing down of bowel movement is to be avoided, e.g. distended abdomen, constipation and bowel obstruction. Imodium acute must be discontinued immediately in the event of constipation, distended abdomen or intestinal obstruction (ileus).

● if you suffer from diarrhoea accompanied by fever and/or bloody stools.

• if you suffer from diarrhoea that occurs during or after taking antibiotics.
• If you suffer from chronic diarrhoea. (These diseases may only be treated with loperamide hydrochloride after a doctor's prescription)
.

● if you are suffering from an acute episode of ulcerative colitis (ulcerative colitis).
● in bacterial intestinal inflammation caused by pathogens invading the intestinal wall.

Warnings and precautions.
Please talk to your doctor or pharmacist before taking Imodium acute,
● if you have AIDS and want to take Imodium acute for diarrhoea treatment. You should stop taking Imodium acute at the first sign of a distended abdomen and consult your doctor. There are individual reports of constipation with an increased risk of severe inflammatory dilatation of the colon (toxic megacolon) in AIDS patients. They suffered from colitis caused by viral and bacterial pathogens and were treated with loperamide.
● if you have liver disease.

Imodium acute should only be taken as prescribed by a doctor if you have or have had liver disease, because in severe liver disease the breakdown of loperamide may be delayed and the risk of side effects increased.
Make sure you have sufficient replacement of fluids and salts (electrolytes). This is the most important treatment for diarrhoea, as it can lead to large fluid and salt losses. This is especially true for children.

Imodium acute leads to a cessation of the diarrhoea, although the cause is not eliminated. If possible, the cause should also be treated. Therefore, talk to your doctor.

Do not take this product for any purpose other than that for which it is intended (see section 1) and never take more than the recommended amount (see
Section 3). The application period of 2 days must not be exceeded. Serious heart problems (including a fast or irregular heartbeat) and severe constipation have been observed in patients who have taken too much loperamide, the active ingredient in Imodium acute.

If the diarrhoea persists after 2 days of treatment with Imodium acute, Imodium acute must be discontinued and a doctor consulted.

Taking Imodium acute with other medicines.
Inform your doctor or pharmacist if you are taking/using, have recently taken/used or intend to take/use any other medicines.

Please talk to your doctor especially if you need to take one or more of the following:

• Ritonavir (medicinal product for the treatment of HIV infection)
• Chinidine (medicinal product for the treatment of cardiac arrhythmias and malaria)
• Desmopressin (medicinal product to control thirst behaviour and
  urine production in patients with diabetes insipidus)
.
• Itraconazole or Ketoconazole (medicines used to treat a fungal infection)
.
• Gemfibrozil (medicinal product for the treatment of increased blood lipids)
.

It is to be expected that medicinal products with a similar mechanism of action to Imodium acute may increase its effect and medicinal products that accelerate gastrointestinal passage may decrease its effect.

Pregnancy and breastfeeding.
If you are pregnant or breast-feeding, or if you suspect you are pregnant or intend to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
Please consult your doctor if you are pregnant or think you may be pregnant. Your doctor will then decide whether you can take Imodium acute.

Breastfeeding time
Since small amounts of loperamide hydrochloride can pass into breast milk, Imodium acute should not be taken during breast-feeding.

Driving ability and ability to operate machinery.
Caution: This medicinal product may impair the ability to react and drive.

Due to diarrhoea or as a result of taking Imodium acute, fatigue, dizziness or drowsiness may occur. Therefore, caution is advised in road traffic and when working with machines.

Imodium acute contains aspartame and sodium.
This medicinal product contains 0.75 mg aspartame per melting tablet corresponding to 5 mg/g. Aspartame is a source of phenylalanine. It can be harmful if you have phenylketonuria (PKU), a rare congenital disorder in which phenylalanine accumulates because the body cannot break it down properly.
This medicine contains less than 1 mmol sodium (23 mg) per meltable tablet, i.e. it is almost "sodium-free".

How should the medicine be taken?

How to take Imodium acute?

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose is

age .First dose Repeat dose Maximum daily doseYouth

.

1 melting tablet

1 melting tablet

4 melting tablets

from 12 years
2 melting tablets 1 melting tablet 4 melting tabletsAdults

At the beginning of the treatment of acute diarrhoea, the first dose is taken.Thereafter, the repeat dose should be taken after each unformed stool.The recommended maximum daily dose must not be exceeded.

Children under 12 years
Imodium acute must not be taken by children under 12 years of age.
Older patients and patients with renal dysfunction
Dose adjustment is not necessary for elderly patients or for patients with renal impairment.

Patients with liver dysfunction
If you have severe liver dysfunction, you must only take Imodium acute as prescribed by a doctor.

Type of application
For ingestion.
To remove the meltable tablet, completely remove the foil strip on the back of the blister pack. Do not push the meltable tablet through the blister pack as this may damage it.
Place Imodium Acute on the tongue. The melting tablet melts immediately on the tongue and is swallowed with the saliva.

Duration of use
Do not take Imodium acute for more than 2 days without medical advice.
If the diarrhoea persists after 2 days of treatment with Imodium acute, Imodium acute must be discontinued and a doctor consulted.
Treatment with loperamide-containing medicinal products lasting longer than 2 days may only be carried out under a doctor's prescription and monitoring of the course of treatment.

Please talk to your doctor or pharmacist if you have the impression that the effect of Imodium acute is too strong or too weak.

If you have taken a larger amount of Imodium acute than you should.
If you have taken too much of Imodium acute, please seek the advice of a doctor or go to hospital immediately. The following complaints may occur:

• Starvation of the body
• Increased heart rate, irregular heartbeat, changes in your heartbeat (these complaints can have potentially serious, life-threatening consequences)
.
• Muscle stiffness, uncoordinated movements, drowsiness
.
• Difficulty urinating
.
• Weak breathing
• Dry mouth
• Gastrointestinal complaints, nausea, vomiting
.
• Constipation, life-threatening disorder of the intestine due to intestinal paralysis
.
• Pupil constriction

Children react more strongly to large amounts of Imodium acute than adults. If a child takes too much or shows any of the above symptoms, call a doctor immediately.

Notes for the doctor
Signs of loperamide hydrochloride overdose may also occur after a relative overdose due to liver dysfunction.
The treatment depends on the overdose symptoms and the clinical picture.
Under medical supervision, ECG monitoring should be carried out with regard to prolongation of the QT interval.
If CNS complaints occur after overdose, the opioid antagonist naloxone can be used as an antidote on a trial basis. As loperamide has a longer duration of action than naloxone (1 - 3 hours), repeated administration of naloxone may be indicated. The patient should therefore be monitored closely for at least 48 hours to detect a possible (re)occurrence of overdose symptoms.

If you forget to take Imodium acute.
Take one melting tablet after the next unformed stool. Do not take double the amount if you have forgotten to take it before.

If you have any further questions about taking this medicine, ask your doctor or pharmacist.

What are the possible side effects?

How to store Imodium acute?

Keep this medicine out of the reach of children.

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

Store in the original packaging to protect the contents from moisture.

Do not dispose of medicines in waste water or household waste. Ask your pharmacist how to dispose of the medicine when you stop using it. In doing so, they contribute to the protection of the environment.

Special instructions for storage

5. How to store Imodium acute?

Keep this medicine out of the reach of children.

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

Store in the original packaging to protect the contents from moisture.

Do not dispose of medicines in waste water or household waste. Ask your pharmacist how to dispose of the medicine when you stop using it. In doing so, they contribute to the protection of the environment.

Special notes on the content

Contents of the pack and other information
What Imodium akut contains
The active substance is: loperamide hydrochloride.
Each meltable tablet contains 2 mg loperamide hydrochloride.

The other ingredients are:
Gelatin, mannitol (Ph. Eur.) (E 421), aspartame (E 951), sodium hydrogen carbonate, peppermint flavouring.

This medicinal product is lactose- and gluten-free.

What Imodium akut looks like and contents of the pack
White to cream-coloured, round, freeze-dried, meltable tablets in an aluminium/aluminium blister pack of 10 or 20 meltable tablets.