LOPERAMID

LOPERAMID AbZ akut 2 mg Hartkapseln

Important notes (mandatory information)

Loperamide AbZ akut 2 mg hard capsules. Active ingredient: Loperamide hydrochloride. Areas of application: for the symptomatic treatment of acute diarrhoea in adults and children/adolescents from 12 years of age, if 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

Loperamide AbZ akut 2 mg hard capsules for use in adults and children/adolescents from 12 years of age
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 even worse after 2 days, contact your doctor.

What this leaflet contains

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

1. WHAT IS LOPERAMIDE ABZ AKUT AND WHAT IS IT USED FOR?

Loperamide AbZ akut is a medicine for diarrhoea. Loperamide AbZ akut is used for the symptomatic treatment of acute diarrhoea in adults and children/adolescents from 12 years of age, if 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 LOPERAMIDE ABZ AKUT?

Loperamide AbZ 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 under "Children").
• in conditions where slowing down of bowel activity should be avoided because of the possible risk of sequelae, e.g. distended abdomen, constipation and intestinal obstruction. Loperamide AbZ akut must be discontinued immediately if constipation, distended abdomen or intestinal obstruction occurs.
• in diarrhoea accompanied by fever and/or bloody stools.
• in diarrhoea occurring during or after taking antibiotics (pseudomembranous [antibiotic-associated] colitis).
• in bacterial intestinal inflammation caused by pathogens that penetrate the intestinal wall (e.g. Salmonella, Shigella and Campylobacter).
• in chronic diarrhoeal diseases (These diseases should only be treated with Loperamide under medical prescription).
• in an acute episode of ulcerative colitis (ulcerative colitis).

Warnings and precautions

Please talk to your doctor or pharmacist before taking Loperamide AbZ akut. The following describes when you should only use Loperamide AbZ akut under certain conditions and only with special caution. Please consult your doctor about this. This also applies if these statements have applied to you in the past. In the case of diarrhoea, especially in children, large amounts of fluid and salts can be lost. Therefore, the most important treatment measure for diarrhoea is to ensure that fluids and salts (electrolytes) are taken in.

Special caution is required if you have AIDS and are taking Loperamide AbZ akut for the acute treatment of diarrhoea. You should stop taking Loperamide AbZ 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 infectious colitis caused by viral and bacterial pathogens and were treated with Loperamide. Loperamide AbZ akut 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 use (see section 1. "What is Loperamide AbZ akut and what is it used for?"). The recommended dosage of Loperamide AbZ akut and the duration of use of 2 days (see section 3. "How to take Loperamide AbZ akut?") must not be exceeded, as severe constipation may occur. Serious heart problems (including a fast or irregular heartbeat) have been observed in patients who have taken too much loperamide, the active ingredient in Loperamide AbZ akut.

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

Children

Children under 2 years of age must not be treated with medicines containing loperamide. Children between 2 and 12 years of age must only be treated with medicines containing loperamide under medical prescription. Due to the high active ingredient content, Loperamide AbZ akut is not suitable for this age group. Other dosage forms are available for this purpose under medical prescription.

Patients with impaired liver function

Loperamide AbZ akut should only be used under medical prescription if you have or have had liver disease, as the breakdown of Loperamide may be delayed and the risk of side effects may be increased in severe liver disease. Talk to your doctor before taking Loperamide AbZ akut if you have liver disease.

Taking Loperamide AbZ 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 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 Loperamide AbZ 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 become pregnant, 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 Loperamide AbZ akut during pregnancy, you should not take Loperamide AbZ akut during pregnancy.

Breastfeeding

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

Driving and using machines

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

Loperamide AbZ akut contains lactose

Please only take Loperamide AbZ akut after consulting your doctor if you know that you suffer from an intolerance to certain sugars.

3. HOW TO TAKE LOPERAMIDE ABZ 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

Adults

At the start of treatment for acute diarrhoea, 2 hard capsules of Loperamide AbZ akut (corresponding to 4 mg loperamide hydrochloride), then 1 hard capsule of Loperamide AbZ akut (corresponding to 2 mg loperamide hydrochloride) after each unformed stool. A daily dose of 6 hard capsules of Loperamide AbZ akut (corresponding to 12 mg loperamide hydrochloride) must not be exceeded.

Children/adolescents from 12 years of age

At the start of treatment for acute diarrhoea and after each unformed stool, 1 hard capsule of Loperamide AbZ akut (corresponding to 2 mg loperamide hydrochloride). A daily dose of 4 hard capsules of Loperamide AbZ akut (corresponding to 8 mg loperamide hydrochloride) must not be exceeded.

Children under 12 years of age

Loperamide AbZ 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

The hard capsules should be swallowed whole with some liquid (e.g. 1 glass of water).

Duration of use

The duration of use of Loperamide AbZ akut is a maximum of 2 days (see section 2. under "Warnings and precautions"). If diarrhoea persists after 2 days of treatment with Loperamide AbZ akut, Loperamide AbZ akut must be discontinued and a doctor 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 Loperamide AbZ akut is too strong or too weak.

If you have taken more Loperamide AbZ akut than you should

If you have taken too much Loperamide AbZ akut, please seek medical advice immediately or contact a hospital. The following symptoms may occur: 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 or shallow breathing. In addition, cramps, apathy, constipation, intestinal obstruction, pupil constriction or a stiffening of the entire body while remaining awake (stupor) may occur. Children react more strongly to large amounts of Loperamide AbZ akut than adults. If a child takes too much or shows any of the above symptoms, call a doctor immediately. In the event of overdose symptoms, the doctor will initiate appropriate countermeasures. The treatment depends on the overdose symptoms and the clinical picture.

If you forget to take Loperamide AbZ 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

Common (may affect up to 1 in 10 people):

• Constipation, nausea, flatulence
• Dizziness, headache

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

• Pain and discomfort in the gastrointestinal tract, dry mouth, vomiting, indigestion
• Skin rash

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

• Bloated abdomen

The following side effects have been observed after marketing:

• Hypersensitivity reactions, anaphylactic reactions (including anaphylactic shock), anaphylactoid reactions
• Drowsiness, unconsciousness, stiffening of the entire body while remaining awake (stupor), clouding of consciousness, increased muscle tension, coordination disorders
• Pupil constriction
• Intestinal obstruction (ileus, including paralytic ileus), colon enlargement as a complication of chronic inflammatory bowel disease (megacolon, including toxic megacolon), burning tongue
• Severe skin disease with blistering (e.g. 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 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 TO STORE LOPERAMIDE ABZ AKUT?

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 packs after "Use by". The expiry date refers to the last day of the month indicated. Do not store above 30°C. 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 no longer use it. You thus help to protect the environment. Further information can be found at www.bfarm.de/arzneimittelentsorgung.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Loperamide AbZ akut contains

The active ingredient is loperamide hydrochloride. Each hard capsule contains 2 mg loperamide hydrochloride. The other ingredients are: Lactose monohydrate, pregelatinised starch (maize), talc, magnesium stearate (Ph.Eur.), indigo carmine, titanium dioxide, iron(III) hydroxide oxide x H2O, iron(III) oxide, gelatine.

What Loperamide AbZ akut looks like and contents of the pack

Hard capsules with green top and grey bottom. Loperamide AbZ akut is available in blister packs of 10 hard capsules.

Pharmaceutical entrepreneur

AbZ-Pharma GmbH
Graf-Arco-Str. 3
89079 Ulm

Manufacturer

Merckle GmbH
Ludwig-Merckle-Str. 3
89143 Blaubeuren

This leaflet was last revised in May 2020.

Source: Information from the package leaflet
Status: 11/2020
Active ingredient: Loperamide hydrochloride. Areas of application: for the symptomatic treatment of acute diarrhoea in adults and children/adolescents from 12 years of age, if no causal therapy is available.