LOPERAMID

LOPERAMIDE acute Aristo 2 mg tablets

Important notes (mandatory information)

Loperamid akut Aristo 2 mg Tablets. Active ingredient: Loperamide hydrochloride. Areas of application: for the symptomatic treatment of acute diarrhoea for adults and children aged 12 and over, 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

Loperamid akut Aristo 2 mg Tablets, for use in adults and children aged 12 and over
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 LOPERAMID AKUT ARISTO AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING LOPERAMID AKUT ARISTO?
3. HOW SHOULD LOPERAMID AKUT ARISTO BE TAKEN?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD LOPERAMID AKUT ARISTO BE STORED?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS LOPERAMID AKUT ARISTO AND WHAT IS IT USED FOR?

Loperamid akut Aristo is a medicine for diarrhoea. For the symptomatic treatment of acute diarrhoea for adults and children aged 12 and over, provided that no causal therapy is available. Treatment with Loperamid for more than 2 days should only be carried out under medical prescription and monitoring. If you do not feel better or if you feel worse after 2 days, contact your doctor.

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING LOPERAMID AKUT ARISTO?

Loperamid akut Aristo 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 section 2. "Children");
• if you suffer from conditions in which a slowing down of intestinal activity should be avoided because of the possible risk of sequelae, e.g. distended abdomen, constipation and intestinal obstruction. Loperamid akut Aristo must be discontinued immediately if constipation, distended abdomen or intestinal obstruction occurs.
• if you suffer from bacterial intestinal inflammation caused by pathogens that penetrate the intestinal wall (e.g. Salmonella, Shigella and Campylobacter);
• if you suffer from diarrhoea accompanied by fever and/or bloody stools;
• if you suffer from diarrhoea that occurs during or after taking antibiotics (pseudomembranous [antibiotic-associated] colitis);
• if you suffer from chronic diarrhoeal diseases (These diseases may only be treated with Loperamid under medical prescription.
• if you suffer from an acute episode of ulcerative colitis (ulcerative inflammation of the colon).

Warnings and precautions

Please talk to your doctor or pharmacist before taking Loperamid akut Aristo.

Special care should be taken when taking Loperamid akut Aristo:

• if you have AIDS and are taking Loperamid akut Aristo for acute diarrhoea. You should stop taking Loperamid akut Aristo for acute diarrhoea 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 distension 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 Loperamid.
• if you suffer from a liver disease, consult your doctor before taking it. Loperamid akut Aristo may only be used under medical prescription if you have or have had a liver disease, because the breakdown of Loperamid can be delayed in severe liver diseases and the risk of side effects can be increased.

Make sure 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. Loperamid akut Aristo stops diarrhoea, but does not eliminate the cause. If possible, the cause should also be treated. Therefore, talk to your doctor. The recommended dosage of Loperamid akut Aristo and the duration of use of 2 days (see also section 3. "How should Loperamid akut Aristo be taken?") must not be exceeded, as severe constipation may occur. If diarrhoea persists after 2 days of treatment with Loperamid akut Aristo, Loperamid akut Aristo must be discontinued and a doctor must be consulted.

Children

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

Taking Loperamid akut Aristo 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 medicines/active ingredients regularly or occasionally:

• Ritonavir (a medicine for treating HIV infection)
• Itraconazole, Ketoconazole (medicines for treating fungal infections)
• Quinidine (a medicine for treating heart rhythm disorders)
• Gemfibrozil (a medicine for treating elevated blood lipids)
• Desmopressin (a medicine for treating increased urination).

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

Taking Loperamid akut Aristo with alcohol

You must not drink alcohol while taking Loperamid akut Aristo.

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

Even though no clear evidence of a harmful effect on the foetus was found in a limited number of women (approx. 800) who took the active ingredient of Loperamid akut Aristo during pregnancy, you should not take Loperamid akut Aristo during pregnancy.

Breast-feeding

As small amounts of the active ingredient of Loperamid akut Aristo can pass into breast milk, you should not take Loperamid akut Aristo while breast-feeding.

Driving and using machines

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

3. HOW SHOULD LOPERAMID AKUT ARISTO BE TAKEN?

Always take this medicine exactly as described in this 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:

• Adults: Initial dose: 2 tablets (equivalent to 4 mg loperamide hydrochloride), repeat dose: 1 tablet (equivalent to 2 mg loperamide hydrochloride), maximum daily dose: 6 tablets (equivalent to 12 mg loperamide hydrochloride).
• Adolescents aged 12 and over: Initial dose: 1 tablet (equivalent to 2 mg loperamide hydrochloride), repeat dose: 1 tablet (equivalent to 2 mg loperamide hydrochloride), maximum daily dose: 4 tablets (equivalent to 8 mg loperamide hydrochloride).

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

Use in children under 12 years of age

Loperamid akut Aristo 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

Please take the tablets unchewed with sufficient liquid (preferably a glass of water).

Duration of use

Do not take Loperamid akut Aristo for more than 2 days without medical advice. If diarrhoea persists after 2 days of treatment with Loperamid akut Aristo, Loperamid akut Aristo 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 Loperamid akut Aristo is too strong or too weak.

If you have taken more Loperamid akut Aristo than you should

See a doctor as soon as possible, especially if you experience unusual symptoms (see information for the doctor).

Information for the doctor

Signs of an overdose of loperamide hydrochloride (including relative overdose due to hepatic dysfunction) may include CNS depression such as stupor (a state of immobility of the body), abnormal coordination, somnolence (drowsiness), miosis (pupil constriction), increased muscle tone and respiratory depression (reduced breathing) as well as constipation, ileus and urinary retention. Children may be more sensitive to the CNS effects than adults. Treatment depends on the overdose symptoms and the clinical picture.

Under medical monitoring, the opioid antagonist naloxone can be used as an antidote on a trial basis. Since Loperamid 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. To remove any active ingredient residues still present in the stomach, gastric lavage may be performed if necessary.

If you forget to take Loperamid akut Aristo

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.

Possible side effects

Data from clinical trials: The most commonly reported adverse reactions in clinical trials were constipation, flatulence, headache, nausea and dizziness. The following side effects were observed in clinical trials

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

• Constipation, nausea, flatulence
• Dizziness, headache

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

• Pain and discomfort in the gastrointestinal tract, dry mouth
• Pain in the upper abdomen, vomiting
• Indigestion
• Skin rash

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

• distended abdomen

The following side effects have been observed after market launch:

• Hypersensitivity reactions, anaphylactic reactions (including anaphylactic shock), anaphylactoid reactions
• Drowsiness, unconsciousness, immobility of the entire body while remaining awake (stupor), clouded consciousness, increased muscle tone, muscle stiffness, coordination disorders
• Pupil constriction
• Intestinal obstruction (ileus, including paralytic ileus), distension of the colon (megacolon, including toxic megacolon), burning tongue
• severe skin disease with blistering (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 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 to provide more information on the safety of this medicine.

5. HOW SHOULD LOPERAMID AKUT ARISTO 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 blister and the folding box after "Use by:". The expiry date refers to the last day of the month indicated. Storage conditions: This medicinal product does not require any special storage conditions. Do not dispose of medicines in wastewater. Ask your pharmacist how to dispose of the medicine when you no longer use it. You help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Loperamid akut Aristo 2 mg Tablets contain

The active ingredient is: Loperamide hydrochloride. 1 tablet contains 2 mg loperamide hydrochloride. The other ingredients are: Magnesium stearate (Ph. Eur.), microcrystalline cellulose, highly dispersed silicon dioxide, croscarmellose sodium.

What Loperamid akut Aristo 2 mg Tablets look like and contents of the pack

Loperamid akut Aristo 2 mg Tablets are white tablets with an oval shape and a break notch. Loperamid akut Aristo 2 mg Tablets are available as an original pack of 10 tablets.

Pharmaceutical entrepreneur and manufacturer

Aristo Pharma GmbH
Wallenroder Straße 8-10
13435 Berlin
Tel.: +49 30 71094-4200
Fax: + 49 30 71094-4250

This leaflet was last revised in June 2015.

Source: Information from the package leaflet
Status: 11/2016
Active ingredient: Loperamide hydrochloride. Areas of application: for the symptomatic treatment of acute diarrhoea for adults and children aged 12 and over, provided that no causal therapy is available.