Imodium 2 mg capsules

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

Application

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

Imodium is a medicine for diarrhoea.

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

Treatment with loperamide hydrochloride for more than 2 days should only be carried out under medical prescription and monitoring.

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

How is it used?

What is Imodium and what is it used for?

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

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

Treatment with loperamide hydrochloride for more than 2 days should only be carried out under medical prescription and monitoring.

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

What should you consider before taking it?

What should you consider before taking Imodium?

Imodium must not be taken,

• if you are allergic to loperamide hydrochloride or any of the other ingredients of this medicine listed in section 6.
• by children under 12 years of age.
• if you suffer from conditions in which a slowing down of bowel activity should be avoided, e.g. distended abdomen, constipation and intestinal obstruction. Imodium must be discontinued immediately if constipation (obstipation), distended abdomen or intestinal obstruction (ileus) occurs.
• 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 diarrhoeal diseases. (These diseases may only be treated with loperamide hydrochloride after medical prescription.)
• if you suffer from an acute attack of ulcerative colitis (ulcerative
  inflammation of the colon).
• in the case of a bacterial intestinal inflammation caused by pathogens that penetrate the intestinal wall.

Warnings and precautions

Please talk to your doctor or pharmacist before taking Imodium,
● if you have AIDS and want to take Imodium to treat diarrhoea. You should stop taking
Imodium 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 enlargement of the colon (toxic megacolon) in AIDS patients. These patients suffered from inflammation of the colon caused by viral and bacterial pathogens and were treated with loperamide.
● if you suffer from a liver disease.

Imodium may only be taken after medical prescription if you have or have had a liver disease, because in severe liver diseases the breakdown of loperamide can be delayed and the risk of side effects can be increased.
Make sure that you replace sufficient fluids and salts (electrolytes). This is the most important treatment measure for diarrhoea, as it can lead to major fluid and salt losses. This applies in particular to children.

Imodium stops diarrhoea, but does not eliminate the cause. If possible, the cause should also be treated. Therefore, talk to your doctor.

Do not take this product for any purpose other than the intended purpose (see section 1) and never take more than the recommended amount (see
section 3). The duration of use 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.

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

Taking Imodium with other medicines

Tell 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 have to take one or more of the following active ingredients:

• Ritonavir (medicine for treating HIV infection)
• Quinidine (medicine for treating heart rhythm disorders and malaria)
• Desmopressin (medicine for controlling thirst and urine production in patients with diabetes insipidus)
• Itraconazole or ketoconazole (medicines for treating fungal infections)
• Gemfibrozil (medicine for treating elevated blood fats)

Medicines with a similar mechanism of action to Imodium can be expected to enhance its effect and medicines that accelerate gastrointestinal passage can reduce its effect.


Pregnancy and breast-feeding

If you are pregnant or breast-feeding, or if you suspect you may be pregnant or are planning to have a baby, 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 may take Imodium.

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

Driving and using machines

Caution: This medicine may impair your reactions and ability to drive.


Diarrhoea or taking Imodium can cause tiredness,
dizziness or drowsiness. Therefore, caution is advised when driving and operating machinery.

Imodium 2 mg capsules contain lactose
Please only take Imodium 2 mg capsules after consulting your doctor if you know that you suffer from a sugar intolerance.

How is the medicine to be taken?

How is Imodium to be taken?

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

The recommended dose is

Age	Initial dose	Repeat dose Maximum daily dose
Adolescents from
1 hard capsule	1 hard capsule	4 hard capsules
12 years
Adults	2 hard capsules	1 hard capsule	4 hard capsules

The initial dose is taken at the start of treatment for acute diarrhoea. Thereafter, the repeat dose should be taken after each unformed stool. The recommended maximum daily dose must not be exceeded.

Children under 12 years of age
Imodium must not be taken by children under 12 years of age.

Elderly patients and patients with impaired kidney function
No dose adjustment is necessary for elderly patients or for patients with impaired kidney function.

Patients with impaired liver function
If you have severe impaired liver function, you may only take Imodium after medical prescription.

Method of administration
For oral use.
The hard capsules are taken whole with some liquid.

Duration of use
Do not take Imodium for more than 2 days without medical advice.
If diarrhoea persists after 2 days of treatment with Imodium, Imodium must be discontinued and a doctor must be consulted.
Treatment with loperamide-containing medicines for more than 2 days should only be carried out under medical prescription and monitoring.

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

If you have taken more Imodium than you should
If you have taken too much Imodium, please seek the advice of a doctor or hospital immediately. The following symptoms
may occur:

• Stiffness of the body
• increased heart rate, irregular heartbeat, changes in your heartbeat (these symptoms can potentially have serious, life-threatening consequences)
• Muscle stiffness, uncoordinated movements, drowsiness
• Difficulty urinating
• shallow breathing
• dry mouth
• gastrointestinal complaints, nausea, vomiting
• constipation, life-threatening disturbance of the bowel due to intestinal paralysis
• pupil constriction

Children react more strongly to large amounts of Imodium 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 an overdose of loperamide hydrochloride can also occur after a relative overdose due to impaired liver function.
Treatment depends on the overdose symptoms and the clinical picture.

ECG monitoring for QT interval prolongation should be carried out under medical supervision.
If CNS symptoms occur after overdose, the opioid antagonist naloxone can be used as an antidote on a trial basis. Since loperamide has a longer duration of action than naloxone (1 – 3 hours), repeated administration of naloxone may be indicated. The patient should therefore be closely monitored for at least 48 hours to detect a possible (re-)occurrence of overdose symptoms.

If you forget to take Imodium
Take one hard capsule after the next unformed stool. Do not take double the amount if you have forgotten the previous dose.

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

What side effects are possible?

How is Imodium to be stored?

Do not store below 15 °C and above 30 °C.

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 on the blister pack. The expiry date refers to the last day of the month indicated.

Do not dispose of medicines in wastewater or household waste. Ask your pharmacist how to dispose of the medicine when you no longer use it. You help to protect the environment.

Special storage instructions

5. How is Imodium to be stored?

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 on the blister pack. The expiry date refers to the last day of the month indicated.

Do not store below 15 °C and above 30 °C.

Do not dispose of medicines in wastewater or household waste. Ask your pharmacist how to dispose of the medicine when you no longer use it. You help to protect the environment.

Special notes on the content

Contents of the pack and further information

What Imodium contains

The active ingredient is: Loperamide hydrochloride.
Each hard capsule contains 2 mg loperamide hydrochloride.

The other ingredients are:
Capsule contents: Lactose, maize starch, talc, magnesium stearate,
Capsule shell: Gelatine, colourings [titanium dioxide (E 171), yellow and black iron oxide (E 172), indigotine (E 132), erythrosine (E 127)].

What Imodium looks like and contents of the pack

Imodium are small, green-dark grey hard capsules containing a white powder.
Available in PVC/AI blister packs of 10 and 20 hard capsules.