LOPERAMID

LOPERAMID akut-1A Pharma hard capsules

Important notes (mandatory information)

Loperamid akut - 1 A Pharma 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!


INSTRUCTIONS FOR USE: INFORMATION FOR THE USER

Loperamid akut - 1 A Pharma 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 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 even worse after 2 days, contact your doctor.

What this package leaflet contains

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

1. WHAT IS LOPERAMID AKUT - 1 A PHARMA AND WHAT IS IT USED FOR?

Loperamid akut - 1 A Pharma is a remedy for diarrhoea. 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 LOPERAMID AKUT - 1 A PHARMA?

Loperamid akut - 1 A Pharma 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 bowel activity should be avoided, e.g. distended abdomen, constipation and intestinal obstruction. Loperamid akut — 1 A Pharma 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 colitis).

Loperamid akut - 1 A Pharma may only be taken under medical prescription 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 under medical prescription. Due to the high active ingredient content, Loperamid akut - 1 A Pharma is not suitable for this age group. Other dosage forms are available for this purpose under medical prescription.

Warnings and precautions

Do not take this product for any purpose other than the intended use (see section 1) and never take more than the recommended amount (see section 3). Serious heart problems (including a fast or irregular heartbeat) have been seen in patients who have taken too much loperamide, the active ingredient in Loperamid akut - 1 A Pharma.

Please talk to your doctor or pharmacist before taking Loperamid akut - 1 A Pharma:

• if you have AIDS and are taking Loperamid akut — 1 A Pharma to treat diarrhoea. You should stop taking Loperamid akut — 1 A Pharma at the first sign of a distended abdomen and see your doctor. There are isolated 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 hydrochloride.
• if you have liver disease.

Ensure that 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 applies in particular to children. Loperamid akut - 1 A Pharma 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 - 1 A Pharma and the duration of use of 2 days must not be exceeded, as severe constipation may occur. If diarrhoea persists after 2 days of treatment with Loperamid akut - 1 A Pharma, Loperamid akut - 1 A Pharma must be discontinued and a doctor must be consulted.

Taking Loperamid akut - 1 A Pharma 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 a fungal infection).
• 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 Loperamid akut - 1 A Pharma can be expected to enhance its effect, and medicines that accelerate gastrointestinal passage can reduce its effect.

Pregnancy and

breastfeeding

Ask your doctor or pharmacist for advice before taking/using any 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 - 1 A Pharma during pregnancy, you should not take Loperamid akut - 1 A Pharma during pregnancy.

Breastfeeding

Since small amounts of the active ingredient of Loperamid akut - 1 A Pharma can pass into breast milk, you should not take Loperamid akut - 1 A Pharma during breastfeeding.

Driving and operating machinery

Diarrhoea or taking Loperamid akut - 1 A Pharma can cause dizziness, tiredness and drowsiness. Therefore, caution is advised when driving and operating machinery.

Loperamid akut - 1 A Pharma contains lactose

Please only take Loperamid akut - 1 A Pharma after consulting your doctor if you know that you suffer from an intolerance to certain sugars.

3. HOW TO TAKE LOPERAMID AKUT - 1 A PHARMA?

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

Loperamid akut - 1 A Pharma 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 Loperamid akut - 1 A Pharma for more than 2 days without medical advice. If diarrhoea persists after 2 days of treatment with Loperamid akut - 1 A Pharma, Loperamid akut - 1 A Pharma 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 - 1 A Pharma is too strong or too weak.

If you have taken more Loperamid akut - 1 A Pharma than you should

If you have taken too much Loperamid akut - 1 A Pharma, please seek the advice of a doctor or go to a hospital immediately. 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. Children react more strongly to large amounts of Loperamid akut - 1 A Pharma 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 (including a relative overdose due to hepatic dysfunction) may include CNS depression such as stupor (a state of bodily rigidity), miosis (pupil constriction) and increased muscle tone, as well as constipation and ileus. 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 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. 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 - 1 A Pharma

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.

The following frequency information is used to evaluate side effects:
Very common:	more than 1 in 10 treated persons
Common:	1 to 10 in 100 treated persons
Uncommon:	1 to 10 in 1,000 treated persons
Rare:	1 to 10 in 10,000 treated persons
Very rare:	less than 1 in 10,000 treated persons
Not known:	frequency cannot be estimated from the available data.

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:

• Constipation, nausea, flatulence
• Dizziness, headache

Uncommon:

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

Rare:

• bloated abdomen

The following side effects have been observed after market launch

Drowsiness, hypersensitivity reactions, anaphylactic reactions (including anaphylactic shock), anaphylactoid reactions, unconsciousness, stupor, clouded consciousness, increased muscle tension, muscle stiffness, coordination disorders, pupil constriction, intestinal obstruction (ileus, including paralytic ileus), enlargement of the colon (megacolon, including toxic megacolon), burning tongue, 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 to provide more information on the safety of this medicine.

5. HOW SHOULD LOPERAMID AKUT - 1 A PHARMA 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 the blister pack after "use by". The expiry date refers to the last day of the specified month. 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 stop using it. In this way, you help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Loperamid akut - 1 A Pharma contains

The active ingredient is loperamide hydrochloride. 1 hard capsule contains 2 mg loperamide hydrochloride. The other ingredients are: gelatine, lactose monohydrate, magnesium stearate (Ph.Eur.), maize starch, talc, iron(III) hydroxide oxide (E 172), iron(II,III) oxide (E 172), patent blue V (E 131), titanium dioxide (E 171).

What Loperamid akut - 1 A Pharma looks like and contents of the pack

Loperamid akut - 1 A Pharma are hard gelatine capsules; upper part: dark green opaque, lower part: grey opaque. Packs of 10 hard capsules.

Pharmaceutical entrepreneur

1 A Pharma GmbH
Keltenring 1 + 3
82041 Oberhaching
Telephone: (089) 6138825-0

Manufacturer

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

This leaflet was last revised in May 2017.

Source: Information from the package leaflet
Status: 01/2020
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.