Aurostop

Package leaflet: Information for the patient

Aurostop, 2 mg, hard capsules
Loperamide hydrochloride
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist.

Table of contents of the leaflet:

1. What Aurostop is and what it is used for
2. Important information before taking Aurostop
3. How to take Aurostop
4. Possible side effects
5. How to store Aurostop
6. Contents of the pack and other information

1. What Aurostop is and what it is used for

This medicine contains loperamide, which helps stop diarrhoea by making the stools firmer and reducing the number of bowel movements.
This medicine is used to treat sudden, short-term (acute) episodes of diarrhoea in adults and children over 12 years of age.
Please remember that this medicine only relieves the symptoms of diarrhoea, and it is important to drink enough fluids to replace water lost in loose stools.

2. Important information before using Aurostop

When not to use Aurostop

• If the patient is allergic to loperamide or any of the other ingredients of this medicine (listed in section 6).
• If the patient suffers from colitis or any other inflammatory bowel disease, such as ulcerative colitis.
• If the patient has severe antibiotic-associated diarrhoea.
• If the patient has stomach or abdominal swelling and (or) constipation.
• If the patient suffers from acute dysentery, which may include symptoms such as blood in stool and high fever.
• In children under 12 years of age.

If any of the above points apply to the patient, consult a doctor or pharmacist.

Warnings and precautions

Before starting to take Aurostop, discuss this with a doctor or pharmacist:

• If the patient has AIDS and experiences stomach swelling. Discontinue use immediately and contact a doctor.
• If the patient suffers from liver problems.
• If the patient has severe diarrhoea and is losing more fluids, sugars, and salts than normal.
• If diarrhoea lasts longer than 48 hours, stop taking the capsules and consult a doctor.
• If intestinal obstruction occurs, stop taking the capsules and consult a doctor.
• If the patient has an intolerance to certain sugars, unless otherwise advised by a doctor (this medicine contains lactose).

Never take this medicine for any indication other than described (see section 1), and never take more than the recommended dose (see section 3). Serious heart problems (such as rapid or irregular heartbeat) have been reported in patients who took excessive amounts of loperamide, the active substance in Aurostop.

Children

Not recommended for use in children under 12 years of age.

Aurostop and other medicines

Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, especially:

• Ritonavir (used in the treatment of HIV infection).
• Quinidine (used in the treatment of abnormal heart rhythms or malaria).
• Oral desmopressin (used in the treatment of excessive urination).
• Itraconazole or ketoconazole (used in the treatment of fungal infections).
• Gemfibrozil (used in the treatment of high blood lipid levels).
• Anticholinergic medicines.

Consult a doctor before using Aurostop if the patient is taking any of the medicines listed above.

Medicines with similar pharmacological properties are expected to enhance the effect of Aurostop, while medicines that accelerate gastrointestinal transit may reduce its effectiveness.

Aurostop with food and drink

Aurostop can be taken with food and drink.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.

Pregnancy

Aurostop should be avoided during pregnancy, particularly during the first trimester.

Breastfeeding

This medicine should not be used if the patient is breastfeeding, as small amounts of the medicine may pass into breast milk. Consult a doctor to determine appropriate treatment.

Driving and using machines

This medicine may cause dizziness, fatigue, or drowsiness. The patient may also lose consciousness, feel weak, or be less alert. If such symptoms occur, the patient should not drive or operate machinery.

Aurostop contains lactose

If the patient has previously been diagnosed with an intolerance to certain sugars, he or she should contact a doctor before taking this medicine.

3. How to take Aurostop

This medicine should always be taken according to the instructions provided by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
Adults, elderly and children over 12 years of age
How to take:
Swallow the capsules whole with water.
Dosage and frequency of administration:
After the first loose bowel movement (defecation), take 2 capsules with water.
After each subsequent loose bowel movement, take 1 capsule.
Oral rehydration sachets are available separately.

• Do not give to children under 12 years of age.
• Do not take more than 6 capsules within 24 hours.
• If symptoms persist for longer than 48 hours, discontinue use and consult your doctor.
• Replace lost fluids by drinking more than usual.
• DO NOT TAKE MORE THAN THE RECOMMENDED DOSE.

Taking more Aurostop than recommended
Contact your doctor or the nearest hospital emergency department
(in case of emergency), taking this leaflet with you.
If an excessive amount of Aurostop has been taken, contact your doctor or hospital immediately
for advice. Symptoms may include: increased heart rate, irregular heartbeat, changes in heart rhythm
(these symptoms may have potentially serious, life-threatening consequences), muscle stiffness,
incoordinated movements, drowsiness, constricted pupils, difficulty urinating, labored breathing, fainting.
Children react more strongly to large amounts of Aurostop than adults. If a child has taken too much of the medicine or
shows any of the above symptoms, contact a doctor immediately.
Information for the doctor in case of overdose
Symptoms of loperamide hydrochloride overdose may also occur after relative
overdose due to impaired liver function. Treatment depends on the symptoms of overdose
and clinical diagnosis.
During medical observation, ECG monitoring for QT interval prolongation should be initiated.
If central nervous system symptoms occur after overdose, naloxone, an opioid receptor antagonist,
can be administered as an antidote. Since loperamide has a longer duration of action than naloxone,
repeated doses of naloxone may be necessary. Therefore, the patient should be closely monitored
for at least 48 hours to detect possible onset or recurrence of overdose symptoms.
If a patient forgets to take Aurostop
This medicine should only be taken as directed in the dosing instructions. If a patient
forgets to take the medicine, take the dose after the next loose bowel movement (defecation).
Do not take a double dose to make up for a missed dose.
If you have any further questions about the use of this medicine, consult your
doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If any of the adverse symptoms worsen or if any adverse effects not listed in this leaflet occur,
you should inform your doctor or pharmacist.
If any of the following effects occur, stop taking the medicine
and seek immediate medical help:

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

• allergic reactions, including anaphylactic shock, unexplained wheezing, shortness of breath, facial or throat swelling;
• loss of consciousness or reduced level of consciousness (feeling weak or decreased alertness);
• skin rash, which may be severe and involve blistering and peeling of the skin.

Frequency unknown (frequency cannot be estimated from available data)
Upper abdominal pain, abdominal pain radiating to the back, tenderness when touching the abdomen, fever,
rapid pulse, nausea, vomiting – which may be symptoms of pancreatitis (acute pancreatitis).

Other adverse effects
If any of the following occur, stop taking the medicine
and contact your doctor:

Common: may affect up to 1 in 10 people

• headache, dizziness;
• nausea, constipation, flatulence.

Uncommon: may affect up to 1 in 100 people

• fatigue, drowsiness;
• abdominal pain, vomiting, indigestion and heartburn, dry mouth;
• rash.

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

• itching or urticaria;
• miosis (pupil constriction);
• difficulty in urination;
• abdominal distension, burning sensation in the mouth, lips or tongue;
• fatigue.

Reporting suspected adverse effects
If any adverse effects occur, including those not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Aurostop
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after EXP.
The expiry date refers to the last day of the stated month.
Store below 30°C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Aurostop contains

• The active substance is loperamide hydrochloride. One hard capsule contains 2 mg of loperamide hydrochloride.
• Other ingredients are:
  Capsule contents: monohydrate lactose, maize starch, talc, magnesium stearate.
  Capsule shell: titanium dioxide (E 171), gelatin.
  Printing ink: shellac (E 904), iron oxide black (E 172).

What Aurostop looks like and contents of the pack
Hard capsule.
White, opaque cap and white, opaque body; hard gelatin capsule of size '4', printed with "2" on the cap and "L" on the body in black ink, filled with white or almost white powder.
Aurostop hard capsules are available in aluminium/PVC/PVDC foil blisters in cardboard boxes.
Pack sizes:
6, 8, 10, 12, 15, 18, 20, 30 or 50 hard capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Aurovitas Pharma Polska Sp. z o.o.
Sokratesa 13D, lokal 27
01-909 Warsaw, Poland
Manufacturer/Importer:
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000, Malta
Generis Farmacêutica, S.A.
Rua João de Deus, n.º 19, Venda Nova
2700-487 Amadora, Portugal
This medicinal product is authorised in the European Economic Area countries under the following names:
Germany: Loperamid PUREN 2 mg Hartkapseln
Italy: Loperamide Aurobindo
Poland: Aurostop
United Kingdom: Loperamide 2 mg Hard Capsules
26.12.2022