IMODIUM

IMODIUM acute hard capsules

Important notes (mandatory information)

Imodium akut 2 mg hard capsules. Active ingredient: Loperamide hydrochloride. Areas of application: for the symptomatic treatment of acute diarrhoea for adolescents from 12 years of age and adults, provided that no causal therapy is available. Warning: Contains lactose.

For risks and side effects, read the package leaflet and consult your doctor or pharmacist.


PACKAGE LEAFLET: INFORMATION FOR USERS

Imodium akut 2 mg hard capsules for use in adolescents from 12 years of age and adults
Active ingredient: Loperamide hydrochloride

Read the entire package leaflet carefully before you start using this medicine, because it contains important information. Always take this medicine exactly as described in this package leaflet or exactly as directed by your doctor or pharmacist.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you experience any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. See section 4.
• If you do not feel better or if you feel worse after 2 days, contact your doctor.

What this package leaflet contains

1. WHAT IS IMODIUM AKUT AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING IMODIUM AKUT?
3. HOW TO TAKE IMODIUM AKUT?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD IMODIUM AKUT BE STORED?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS IMODIUM AKUT AND WHAT IS IT USED FOR?

Imodium akut contains the active ingredient loperamide hydrochloride. Loperamide hydrochloride is an antidiarrheal agent. For the symptomatic treatment of acute diarrhoea for adolescents from 12 years of age and adults, provided that no causal therapy is available. Treatment with loperamide for more than 2 days should only be carried out under medical supervision and monitoring of the course of the disease.

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING IMODIUM AKUT?

Imodium akut 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 (See also "What should be considered in children?").
• if you suffer from conditions in which a slowing down of intestinal activity should be avoided, e.g. distended abdomen, constipation and intestinal obstruction. Imodium akut must be discontinued immediately if constipation, 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 diarrheal diseases (These diseases may only be treated with loperamide hydrochloride under medical supervision).
• if you suffer from an acute attack of ulcerative colitis (ulcerative inflammation of the colon).

Imodium akut may only be taken on doctor's orders if you have or have had liver disease, because the breakdown of loperamide can be delayed in severe liver disease and the risk of side effects can be increased.

What should be considered in children?:
Children under 2 years of age must not be treated with loperamide-containing medicines. Children between 2 and 12 years of age may only be treated with loperamide-containing medicines on doctor's orders. Due to the high active ingredient content, Imodium akut is not suitable for acute diarrhoea in this age group. Other dosage forms are available for this purpose on doctor's orders.

Warnings and precautions

Please talk to your doctor or pharmacist before taking Imodium akut:

• if you have AIDS and want to take Imodium akut for acute diarrhoea to treat diarrhoea. You should stop taking Imodium akut for acute diarrhoea at the first sign of a distended abdomen and see 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 infectious inflammation of the colon (colitis) caused by viral and bacterial pathogens and were treated with loperamide hydrochloride.
• if you have liver disease.

Make sure you replace fluids and salts (electrolytes) sufficiently. This is the most important treatment measure for diarrhoea, as it can lead to major fluid and salt losses. This is especially important for children.

Imodium akut stops diarrhoea, but does not eliminate the cause. If possible, the cause should also be treated. Therefore, talk to your doctor. Only take Imodium akut for the areas of application described in section 1. The recommended dosage of Imodium akut (see section 3) and the duration of use of 2 days must not be exceeded, as severe constipation or serious heart problems (including a fast or irregular heartbeat) can occur. If diarrhoea persists after 2 days of treatment with Imodium akut, Imodium akut must be discontinued and a doctor must be consulted.

Taking Imodium akut for acute diarrhoea together 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 regularly or occasionally:

• Ritonavir (a medicine to treat HIV infection).
• Itraconazole, ketoconazole (medicines to treat fungal infections).
• Quinidine (a medicine to treat heart rhythm disorders).
• Gemfibrozil (a medicine to treat elevated blood fats).
• Desmopressin (a medicine to treat increased urination).

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

Pregnancy and

breastfeeding

If you are pregnant or breastfeeding, 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

Although no clear evidence of a harmful effect on the foetus has been found in a limited number of women (approx. 800) who took the active ingredient of Imodium akut during pregnancy, you should not take Imodium akut during pregnancy.

Breastfeeding

Since small amounts of the active ingredient of Imodium akut can pass into breast milk, you should not take Imodium akut while breastfeeding.

Driving and operating machinery

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

Imodium akut contains lactose

This medicine contains lactose. Therefore, please only take Imodium akut after consulting your doctor if you are aware that you suffer from an intolerance to certain sugars.

3. HOW TO TAKE IMODIUM AKUT?

Always take this medicine exactly as described in this package leaflet or exactly as agreed with your doctor or pharmacist. 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 12 years of age	1 hard capsule (= 2 mg loperamide hydrochloride)	1 hard capsule (= 2 mg loperamide hydrochloride)	4 hard capsules (= 8 mg loperamide hydrochloride)
Adults	2 hard capsules (= 4 mg loperamide hydrochloride)	1 hard capsule (= 2 mg loperamide hydrochloride)	6 hard capsules (= 12 mg loperamide hydrochloride)

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 akut is not suitable for children under 12 years of age due to the high active ingredient content. Other dosage forms are available for this purpose on doctor's orders.

Method of administration

The hard capsules are swallowed whole with some liquid.

Duration of use

Do not take Imodium akut for more than 2 days without medical advice. If diarrhoea persists after 2 days of treatment with Imodium akut, Imodium akut 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 supervision and monitoring of the course of the disease.

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

If you have taken more Imodium akut than you should

See a doctor as soon as possible, especially if you experience the following symptoms:

• Stiffness of the body, coordination disorders, drowsiness, constriction of the pupils, muscle stiffness, weak breathing.
• increased heart rate, irregular heartbeat, changes in your heartbeat (these symptoms can potentially have serious, life-threatening consequences).
• Constipation, intestinal obstruction, difficulty urinating.

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

Information 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. An ECG should be monitored for QT interval prolongation under medical supervision. If CNS symptoms occur after an 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, 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 akut

Do not take a double dose to make up for a forgotten dose.

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

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, this medicine can cause side effects, although not everybody gets them. If any of these side effects occur, stop taking the medicine and seek medical help immediately

Not known (frequency cannot be estimated from the available data):

• Upper abdominal pain, abdominal pain radiating to the back, tenderness to the touch, fever, rapid pulse, nausea, vomiting, which may be symptoms of inflammation of the pancreas (acute pancreatitis).

Possible side effects

The most commonly reported adverse reactions in clinical studies were constipation, flatulence, headache, nausea and dizziness.

The following side effects have been observed in clinical studies and after market introduction:

• Common (may affect up to 1 in 10 people):
• Constipation, nausea, flatulence.
• Dizziness, headache.

Uncommon (may affect up to 1 in 100 people):

• Drowsiness.
• Pain and discomfort in the gastrointestinal tract, dry mouth.
• Upper abdominal pain, vomiting.
• Indigestion.
• Skin rash.

Rare (may affect up to 1 in 1,000 people):

• Distended abdomen.
• Hypersensitivity reactions, anaphylactic reactions (including anaphylactic shock), anaphylactoid reactions.
• Unconsciousness, stiffness of the body, clouded consciousness, increased muscle tension, coordination disorders.
• Constriction of the pupils.
• Intestinal obstruction (ileus, including paralytic ileus), enlargement of the colon (megacolon, including toxic megacolon).
• Blistering skin diseases (including Stevens-Johnson syndrome, toxic epidermal necrolysis and erythema multiforme), swelling of the skin or mucous membranes due to fluid accumulation in the tissue (angioedema), hives, itching.
• Urinary retention.
• Fatigue.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. of Pharmacovigilance, Kurt-Georg-Kiesinger-Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW SHOULD IMODIUM AKUT 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 blister. The expiry date refers to the last day of the month indicated. This medicinal product does not require any special storage conditions. Medicines should be disposed of in accordance with local requirements. Ask your pharmacist how to dispose of the medicine when you no longer use it. You will help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Imodium akut contains: The active ingredient is: Loperamide hydrochloride. One hard capsule contains 2 mg loperamide hydrochloride. The other ingredients are: Lactose monohydrate, maize starch, talc, magnesium stearate (Ph. Eur.), gelatine, capsule shell colourants (titanium dioxide, indigo carmine, iron(III) hydroxide-oxide, iron(II,III) oxide, erythrosine).

What Imodium akut looks like and contents of the pack

Imodium akut are small, green-dark grey hard capsules. Imodium akut is packed in PVC/Al blisters and is available in packs of 6 and 12 hard capsules. Not all pack sizes may be marketed.

Pharmaceutical entrepreneur and manufacturer

Johnson & Johnson GmbH
Johnson & Johnson Platz 2
41470 Neuss
Tel.: 00800 260 260 00 (free of charge)

Manufacturer

Janssen-Cilag S.p.A.
Via C. Janssen
04100 Borgo S. Michele (LT)
Italy

This package leaflet was last revised in March 2022.

Source: Information from the package leaflet
Status: 11/2023
Active ingredient: Loperamide hydrochloride. Areas of application: for the symptomatic treatment of acute diarrhoea for adolescents from 12 years of age and adults, provided that no causal therapy is available. Warning: Contains lactose.