LOPERAMIDE 2 mg Hard Capsules

Зміст інструкції

1. Loperamide Aurobindo 2 mg hard capsules
   1. What is Loperamide Aurobindo and what is it used for
   2. What you need to know before taking Loperamide Aurobindo
   3. How to take Loperamide Aurobindo
   4. Possible side effects
   5. How to store Loperamide Aurobindo
   6. Contents of the pack and other information

Loperamide Aurobindo 2 mg hard capsules

Generic medicine

Read this leaflet carefully before you start to take this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Loperamide Aurobindo is and what it is used for
• 2. What you need to know before you take Loperamide Aurobindo
• 3. How to take Loperamide Aurobindo
• 4. Possible side effects
• 5. How to store Loperamide Aurobindo
• 6. Contents of the pack and other information

1. What is Loperamide Aurobindo and what is it used for

This medicine contains loperamide which helps to stop diarrhoea by making the stools firmer and less
frequent.
This medicine is used for the treatment of sudden, short-lived (acute) episodes in adults
and in children over 12 years of age.

This medicine only relieves the symptoms of diarrhoea and it is important to drink sufficient amounts of
liquids to replace the water lost with loose stools.

2. What you need to know before taking Loperamide Aurobindo

Do not take Loperamide Aurobindo:

• if you are allergic to loperamide or any of the other ingredients of this medicine (listed in section 6).
• if you suffer from colitis (inflammation of the colon) or any other inflammatory disease of the intestine, such as ulcerative colitis.
• if you suffer from severe diarrhea after taking antibiotics.
• if you suffer from a swollen stomach or abdomen, and/or constipation.
• if you suffer from acute dysentery whose symptoms may include blood in the stool and high fever.
• if you are a child under 12 years of age.

If any of these applies to you, ask your doctor or pharmacist for advice.

Warnings and precautions
Talk to your doctor or pharmacist before taking Loperamide Aurobindo.

• if you have AIDS and your stomach becomes swollen. Stop taking the capsules immediately and contact your doctor.
• if you suffer from liver problems.
• if you suffer from severe diarrhea as your body loses more fluids, sugars and salts than usual.
• if the diarrhea lasts for more than 48 hours, stop taking the capsules and consult your doctor.
• if an intestinal obstruction develops, stop taking the capsules and consult your doctor.
• if you suffer from intolerance to certain sugars, unless your doctor tells you otherwise (this medicine contains lactose). Do not take this medicine for uses other than those intended (see section 1) and never take a dose higher than the recommended one (see section 3). In patients who have taken an excessive dose of loperamide, the active ingredient of Loperamide Aurobindo, serious heart problems have been reported (with symptoms including a rapid or irregular heartbeat).

Children
Not recommended for children under 12 years of age.

Other medicines and Loperamide Aurobindo
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicine.

• ritonavir (used to treat HIV)
• quinidine (used to treat heart rhythm abnormalities or malaria)
• desmopressin orally (used to treat excessive urination)
• itraconazole or ketoconazole (used to treat fungal infections)
• gemfibrozil (used to treat high levels of lipids in the blood)
• anticholinergic drugs. If you are using any of these medicines, consult a doctor before taking Loperamide Aurobindo.

It is predictable that medicines with a mechanism of action similar to Loperamide Aurobindo may
increase its effect and medicines that accelerate gastrointestinal transit may reduce its effect.

Loperamide Aurobindo with food and drink
You can take Loperamide Aurobindo with food and drink.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, ask your doctor for advice before
taking this medicine.

Pregnancy:The use of Loperamide Aurobindo should be avoided during pregnancy, especially
during the first trimester of pregnancy.

Breastfeeding:Do not take this medicine if you are breastfeeding as small amounts may
pass into breast milk. Discuss the most suitable treatment with your doctor.

Driving and using machines
This medicine may cause you to feel dizzy, or tired or sleepy. You may also lose
consciousness, feel faint or feel less alert. In this case, do not drive vehicles and do not use machines.

Loperamide Aurobindo contains lactose
If your doctor has diagnosed you with intolerance to certain sugars, contact him/her before taking
this medicine.

3. How to take Loperamide Aurobindo

Take this medicine following the instructions of your doctor or pharmacist exactly as given. If you have
any doubts, ask your doctor or pharmacist.

Adults, the elderly and children over 12 years of age
How to take Loperamide Aurobindo:
The capsules must be swallowed whole with water.

Dosage and frequency of administration:
After the first loose stools (bowel movement), take 2 capsules with water.
After each subsequent bowel movement, take 1 capsule.
Separate sachets for rehydration are available.

• Do not administer 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.
• Replenish lost fluids by drinking more liquids than usual.
• DO NOT EXCEED THE RECOMMENDED DOSE.

If you take more Loperamide Aurobindo than you should
If you have taken too much Loperamide Aurobindo, 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 and life-threatening consequences), muscle stiffness,
uncoordinated movements, drowsiness, constricted pupils, difficulty urinating or weak breathing,
fainting.
Compared to adults, children react more strongly to high doses of Loperamide Aurobindo. If a
child takes excessive amounts or exhibits some of the above symptoms, contact
a doctor immediately.
Information for the doctor in case of overdose
Signs of loperamide hydrochloride overdose may also occur after a relative overdose
due to hepatic dysfunction. Treatment depends on the symptoms of overdose and clinical diagnosis.
During medical follow-up, ECG monitoring should be initiated for QT interval prolongation.
If central nervous system symptoms occur after overdose, the opioid antagonist
naloxone may be administered as an antidote. Because loperamide has a longer duration of effect
than naloxone, repeated naloxone administration may be necessary. The patient must
then be closely monitored for at least 48 hours, in order to be able to recognize the possible
onset/recurrence of overdose symptoms.

If you forget to take Loperamide Aurobindo
You should take the medicine as needed, carefully following the dosage instructions. If you forget
to take a dose, take a dose after the next loose stool (bowel movement). Do not
take a double dose to make up for a missed dose.
If you have any questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If any of the side effects gets worse, or if you notice any side effect not listed here

If you experience any of the following side effects, stop taking this medicine and
seek immediate medical attention:
Rare: may affect up to 1 in 1,000 people

• Allergic reactions including unexplained breathlessness, shortness of breath, swelling of the face and throat.
• Loss of consciousness or reduced level of consciousness (feeling faint or less alert).
• Skin rashes that can be severe and include blisters and peeling of the skin.

Not known (frequency cannot be estimated from the available data)
Upper abdominal pain, abdominal pain radiating to the back, tenderness to the touch
of the abdomen, fever, rapid pulse, nausea, vomiting, which may be symptoms of inflammation of the
pancreas (acute pancreatitis).

Other side effects:
If you experience any of the following side effects, stop taking this medicine and talk to
your doctor:
Common: may affect up to 1 in 10 people

• Headache, dizziness.
• Nausea (feeling sick), constipation, flatulence (wind).

Uncommon: may affect up to 1 in 100 people

• Fatigue, drowsiness.
• Stomach pains, vomiting, indigestion and heartburn, dry mouth.
• Skin rash.

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

• Itching or hives.
• Narrowing of the pupil.
• Difficulty passing urine.
• Swollen stomach, a burning sensation in the mouth, on the lips or on the tongue.
• Fatigue.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system at
www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side effects you can help to provide
more information on the safety of this medicine.

5. How to store Loperamide Aurobindo

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 pack after EXP. The expiry date refers to the last day of that month.
Store at a temperature below 30  C.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What this medicine contains:

• The active ingredient is loperamide hydrochloride. Each hard capsule contains 2 mg of loperamide hydrochloride.
• Other ingredients are: Capsule contents: lactose monohydrate, corn starch, talc, magnesium stearate. Capsule shell: titanium dioxide (E171), gelatin. Printing ink: shellac, black iron oxide (E172).

Description of the appearance of this medicine and contents of the pack:
Hard capsules.
Hard gelatin capsules, with opaque white cap/opaque white body, size “4”, with “2” printed on the cap and “L” on the body in black ink, containing a white to off-white powder.
Loperamide Aurobindo hard capsules are available in blister packs of transparent PVC/aluminium.

Pack sizes:
Blister packs: 6, 8, 10, 12, 15, 18, 20, 30 & 50 hard capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Aurobindo Pharma (Italia) S.r.l.
Via San Giuseppe, 102

• 21047 - Saronno (VA)

Manufacturer
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far,
Birzebbugia, BBG 3000
Malta
Generis Farmacêutica, S.A.
Rua João de Deus, 19
2700-487 Amadora
Portugal

This medicinal product is authorised in the Member States of the European Economic Area with the following
names:
Germany: Loperamid Puren 2 mg Hard Capsules
Italy: Loperamide Aurobindo
Poland: Aurostop
United Kingdom: Loperamide 2 mg Hard Capsules