LOPEDIUM

LOPEDIUM acute for acute diarrhea hard capsules

Important notes (mandatory information)

Lopedium akut for acute diarrhoea 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.

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Lopedium akut for acute diarrhoea 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 taking this medicine, as it contains important information. Always take this medicine exactly as described in this 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 leaflet. See section 4.
• If you do not feel better or if you feel worse after 2 days, contact your doctor.

What this leaflet contains

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

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

Lopedium akut contains the active ingredient loperamide hydrochloride. Loperamide hydrochloride is an anti-diarrhoea 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 prescription and monitoring.

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING LOPEDIUM AKUT?

Lopedium 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. Lopedium 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 diarrhoeal diseases (These diseases may only be treated with loperamide hydrochloride under medical prescription.).
• if you suffer from an acute attack of ulcerative colitis (ulcerative inflammation of the colon).

Lopedium akut may only be taken under medical prescription if you have or have had liver disease, because the breakdown of loperamide may be delayed in severe liver disease and the risk of side effects may 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 under medical prescription. Due to the high active ingredient content, Lopedium akut is not suitable for this age group. Other dosage forms are available for this purpose under medical prescription.

Warnings and precautions

Take Lopedium akut only for the indications described in section 1. The recommended dosage of Lopedium 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) may occur.

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

• if you have AIDS and want to take Lopedium akut to treat diarrhoea. You should stop taking Lopedium akut at the first signs 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 an infectious inflammation of the colon (colitis) caused by viral and bacterial pathogens and were treated with loperamide hydrochloride.
• if you have liver disease.

Ensure that you replace fluids and salts (electrolytes) adequately. This is the most important treatment measure for diarrhoea, as it can lead to major fluid and salt losses. This is particularly important for children. Dry mouth can also be a sign of fluid loss. You or your child may feel light-headed and start vomiting. In this case, too, the most important treatment measure is adequate replacement of fluids and salts (oral rehydration therapy). Lopedium akut stops diarrhoea, but does not eliminate the cause. If possible, the cause should also be treated. Therefore, talk to your doctor.

Stop taking Lopedium akut:

• if diarrhoea persists after 2 days of treatment with Lopedium akut, and consult a doctor.
• as soon as the stool becomes firmer and the last bowel movement was more than 12 hours ago.
• if constipation occurs.
• if distended abdomen, abdominal pain, cramps, nausea, constipation and impaired passage of intestinal gas (signs of intestinal obstruction) occur.

Taking Lopedium akut 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 in particular 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 Lopedium 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 Lopedium akut during pregnancy, you should not take Lopedium akut during pregnancy.

Breastfeeding

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

Driving and using machines

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

Lopedium akut contains lactose and sodium

Please only take Lopedium akut after consulting your doctor if you know that you suffer from an intolerance to certain sugars. This medicine contains less than 1 mmol (23 mg) sodium per hard capsule, i.e. it is almost "sodium-free".

3. HOW TO TAKE LOPEDIUM AKUT?

Always take this medicine exactly as described in this leaflet or exactly as directed by 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

Lopedium 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 under medical prescription.

Method of administration

Swallow the hard capsules whole with sufficient liquid (e.g. with a glass of water).

Duration of use

Do not take Lopedium akut for more than 2 days without medical advice. If diarrhoea persists after 2 days of treatment with Lopedium akut, Lopedium 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 prescription and monitoring.

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

If you have taken more Lopedium akut than you should

See a doctor or go to a hospital as soon as possible, especially if you experience the following symptoms:

• Stupor, uncoordinated movements, drowsiness, constriction of the pupils (miosis), 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 (ileus), difficulty urinating.

Children react more strongly to large amounts of Lopedium 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 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 overdose, the opioid antagonist naloxone can be used as an antidote on a trial basis. Since loperamide hydrochloride 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 the effect is insufficient, other causes should be considered. In the event of respiratory depression, artificial respiration may be necessary. A gastric lavage may be performed to remove any active substance residues still present in the stomach.

If you forget to take Lopedium akut

Do not take twice the amount if you have forgotten to take the previous 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.

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
• Pain in the upper abdomen, 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, stupor, 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
• Burning tongue
• Muscle stiffness

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 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 LOPEDIUM 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 pack after "use by" or "use by". The expiry date refers to the last day of the month indicated. This medicinal product does not require any special storage conditions. Do not dispose of medicines via wastewater (e.g. not via the toilet or sink). Ask your pharmacist how to dispose of the medicine when you stop using it. In this way, you help to protect the environment. Further information can be found at www.bfarm.de/arzneimittelentsorgung.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Lopedium akut contains

The active ingredient is loperamide hydrochloride. Each hard capsule contains 2 mg loperamide hydrochloride. The other ingredients are: Gelatin, lactose monohydrate, magnesium stearate (Ph.Eur.) [vegetable], maize starch, talc, iron(III) hydroxide oxide x H2O (E 172), iron(II,III) oxide (E 172), patent blue V (E 131) (contains sodium), titanium dioxide (E 171).

What Lopedium akut looks like and contents of the pack

Hard capsules with a grey capsule base and a green cap. Packs of 10 hard capsules.

Pharmaceutical entrepreneur

Hexal AG
Industriestraße 25
83607 Holzkirchen
Telephone: (08024) 908-0
Telefax: (08024) 908-1290
E-mail: service@Hexal.com

Manufacturer
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben

This leaflet was last revised in May 2020.

Source: Information from the package leaflet
Status: 09/2021
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.