Aurostop

Package Leaflet: Information for the Patient

Aurostop, 2 mg, Hard Capsules

Loperamide Hydrochloride

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this package leaflet, please inform your doctor or pharmacist.

Package Leaflet Contents:

• 1. What is Aurostop and what is it used for
• 2. Important information before taking Aurostop
• 3. How to take Aurostop
• 4. Possible side effects
• 5. How to store Aurostop
• 6. Package contents and other information

1. What is Aurostop and what is it used for

The medicine contains loperamide, which helps to stop diarrhea by making the stool more solid and reducing the number of bowel movements.
The medicine is used to treat sudden, short-term (acute) attacks of diarrhea in adults and children over 12 years of age.

Remember that this medicine only treats the symptoms of diarrhea and it is important to drink plenty of fluids to replace the lost water.

2. Important information before taking Aurostop

When not to take Aurostop

• If you are allergic to loperamide or any of the other ingredients of this medicine (listed in section 6).
• If you have inflammation of the colon or any other inflammatory bowel disease, such as ulcerative colitis.
• If you have severe diarrhea after taking antibiotics.
• If you have stomach or abdominal swelling and (or) constipation.
• If you have acute dysentery, whose symptoms may include blood in the stool and high fever.
• In children under 12 years of age.

If any of the above points apply to you, consult your doctor or pharmacist before taking the medicine.

Warnings and precautions

Before taking Aurostop, discuss with your doctor or pharmacist:

• If you have AIDS and stomach swelling occurs. You should stop taking the medicine immediately and contact your doctor.

and contact your doctor.

• If you have liver problems.
• If you have severe diarrhea and lose more fluids, sugars, and salts than normal.
• If the diarrhea lasts longer than 48 hours, you should stop taking the capsules and consult your doctor.
• If you experience intestinal obstruction, you should stop taking the capsules and consult your doctor.
• If you have intolerance to some sugars, unless your doctor advises otherwise (this medicine contains lactose).

Never take this medicine for any other indication 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 have taken too much loperamide, the active substance of Aurostop.

Children

Aurostop is not recommended for children under 12 years of age.

Aurostop and other medicines

Tell your doctor or pharmacist about all the medicines you are taking now or have recently taken, as well as any medicines you plan to take, especially:

• Ritonavir (used to treat HIV infection).
• Quinidine (used to treat irregular heart rhythms or malaria).
• Oral desmopressin (used to treat excessive urination).
• Itraconazole or ketoconazole (used to treat fungal infections).
• Gemfibrozil (used to treat high blood lipid levels).
• Anticholinergic medicines.

Before taking Aurostop, consult your doctor if you are taking any of the above medicines.
It is expected that medicines with similar pharmacological properties may enhance the effect of Aurostop, and medicines that accelerate gastrointestinal passage may weaken its effect.

Aurostop with food and drink

Aurostop can be taken with food and drink.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Avoid taking Aurostop during pregnancy, especially during the first trimester of pregnancy.

Breastfeeding

Do not take this medicine if you are breastfeeding, as small amounts of the medicine may pass into breast milk. Consult your doctor to choose an appropriate treatment.

Driving and using machines

This medicine may cause dizziness, tiredness, or drowsiness. You may also lose consciousness, feel weak, or be less alert. If you experience any of these symptoms, do not drive or operate machinery.

Aurostop contains lactose

If you have been diagnosed with intolerance to some sugars, consult your doctor before taking this medicine.

3. How to take Aurostop

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

Adults, elderly, and children over 12 years

How to take:

Swallow the capsules whole with water.

Dosage and frequency of administration:

After the first loose stool (bowel movement), take 2 capsules and drink water.
After each subsequent loose stool, take 1 capsule.
Rehydration sachets are available separately.

• Do not give to children under 12 years of age.
• Do not take more than 6 capsules in 24 hours.
• If symptoms persist for more than 48 hours, stop taking the capsules and consult your doctor.
• Replace lost fluids by drinking more fluids than usual.
• DO NOT TAKE A HIGHER DOSE THAN RECOMMENDED.

Overdose of Aurostop

Contact your doctor or the nearest hospital emergency department (in case of an emergency) and take this package leaflet with you.
If you have taken too much Aurostop, contact your doctor or hospital immediately for advice. Symptoms may include: increased heart rate, irregular heartbeat, changes in heartbeat (these symptoms may have potentially serious, life-threatening consequences), muscle stiffness, uncoordinated movements, drowsiness, reduced pupil size, difficulty urinating, severe breathing difficulties, fainting.
Children react more strongly to high doses of Aurostop than adults. If a child has taken too much medicine or shows any of the above symptoms, contact your doctor immediately.
Information for the doctor in case of overdose
Symptoms of loperamide hydrochloride overdose may also occur after relative overdose due to liver function disorders. Treatment depends on the symptoms of overdose and clinical diagnosis.
During medical observation, EKG monitoring should be started to check for QT interval prolongation.
If symptoms from the central nervous system 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 administration of naloxone may be necessary. Therefore, the patient should be closely monitored for at least 48 hours to diagnose possible occurrence/recurrence of overdose symptoms.

If you forget to take Aurostop

Take this medicine only as described in the dosage instructions. If you forget to take a dose, take it after the next loose stool (bowel movement).
Do nottake 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. Possible side effects

Like all medicines, Aurostop can cause side effects, although not everybody gets them.
If any of the side effects get serious, or if you notice any side effects not listed in this package leaflet, please tell your doctor or pharmacist.

If you experience any of the following, stop taking the medicine and seek immediate medical attention:

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

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

Frequency not known (cannot be estimated from the available data)

Abdominal pain, radiating back pain, abdominal tenderness, fever, rapid pulse, nausea, vomiting, which may be symptoms of pancreatitis (acute pancreatitis).

Other side effects

If you experience any of the following, stop taking the medicine and contact your doctor:

Common: may affect up to 1 in 10 people

• headache, dizziness;
• nausea (nausea), constipation, bloating (gas).

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 hives;
• pupil constriction;
• difficulty urinating;
• abdominal swelling, burning sensation in the mouth, lips, or tongue;
• fatigue.

Reporting suspected adverse reactions

If you experience any side effects, including those not listed in this package leaflet, please inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Adverse Reaction Monitoring 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 reactions can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Aurostop

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP.
The expiry date refers to the last day of that month.
Store in a temperature 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. These measures will help protect the environment.

6. Package contents and other information

What Aurostop contains

• The active substance is loperamide hydrochloride. One hard capsule contains 2 mg of loperamide hydrochloride.
• The other ingredients are: capsule contents:lactose monohydrate, corn 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, size 4 hard gelatin capsule with "2" printed on the cap and "L" printed on the body with black ink and filled with white or off-white powder.
Aurostop hard capsules are available in aluminum/PVC/PVDC blisters in a cardboard box.

Pack sizes:

6, 8, 10, 12, 15, 18, 20, 30, or 50 hard capsules.
Not all pack sizes may be marketed.

Marketing authorization holder:

Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lokal 27
01-909 Warsaw

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 authorized in the Member States of the European Economic Area under the following names:

Germany:
Loperamid PUREN 2 mg Hartkapseln
Italy:
Loperamide Aurobindo
Poland:
Aurostop
United Kingdom:
Loperamide 2 mg Hard Capsules

Date of last revision of the package leaflet:

• 26.12.2022