Loperamide Mylan

Package leaflet: Information for the user

Loperamide Mylan 2 mg oral lyophilisate

loperamide hydrochloride
Please read all of this leaflet carefully before taking this medicine because it contains important
information for you.
Always take this medicine exactly as described in this leaflet or as your doctor,
pharmacist or nurse has told you to do.
‐ Keep this leaflet. You may need to read it again.
‐ If you need more information or advice, consult your pharmacist.
‐ If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor, pharmacist or nurse. See section 4.
‐ Contact your doctor if you do not notice any improvement or if your symptoms worsen after 2 days.

Contents of this leaflet

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

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

This medicine contains loperamide hydrochloride, which helps stop diarrhoea by making the stools more solid and less frequent. This medicine is used to treat sudden attacks of short-term (acute) diarrhoea in adults and children over 12 years of age. This medicine must not
be used for more than 2 days unless advised by a doctor and under close medical supervision.
Consult a doctor if you do not notice any improvement or if your symptoms worsen after 2 days.

2. What you need to know before taking Loperamide Mylan

Do not take Loperamide Mylan:

• if you are hypersensitive to loperamide hydrochloride or to any of the other ingredients of this medicine (listed in section 6)
• if children are under 2 years of age
• if you suffer from acute dysentery, which is characterized by blood in the stools and elevated body temperature
• if you have acute ulcerative colitis
• if you have bacterial enterocolitis caused by invasive organisms including Salmonella, Shigella, and Campylobacter
• if you have pseudomembranous colitis associated with the use of broad-spectrum antibiotics
• in any cases where normal intestinal motility should not be suppressed. Treatment must be stopped immediately if constipation or abdominal distension occurs.

If any of these apply to you, consult a doctor or pharmacist before taking loperamide hydrochloride.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before taking this medicine if:

• you have AIDS and your stomach swells, stop taking the oral lyophilisate immediately and contact your doctor without delay;

• you have liver disease;

• your diarrhoea lasts more than 48 hours, stop taking the medicine and consult your doctor;

• if you have severe diarrhoea, you will lose a lot of fluids (dehydration). With these fluids, you will also lose other important substances. Symptoms of dehydration may include dry mouth and/or dizziness. Vomiting can lead to dehydration. The risk of dehydration is particularly high in young children and the elderly. Therefore, the first measures against diarrhoea are: replenishing and maintaining body fluids. This means: drink plenty of fluids and replace sugar and salt. In pharmacies or parapharmacies, you can purchase a salt-and-sugar mixture, which must be dissolved in water. Ask your doctor or pharmacist for advice.

Other medicines and Loperamide Mylan

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. In particular, if you are taking any of the following medicines:

• ritonavir (used to treat HIV)
• quinidine (used to treat heart rhythm disorders or malaria)
• oral desmopressin (used to treat excessive urination)
• itraconazole or ketoconazole (used to treat fungal infections)
• gemfibrozil (used to treat high cholesterol levels).

If you are unsure about any of the medicines you are taking, show the container or packaging to your pharmacist. If any of these apply to you (now or in the past), discuss them with a doctor or pharmacist.

Pregnancy, breastfeeding and fertility

If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

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

Breastfeeding: Small amounts may pass into breast milk. Discuss with your doctor the most appropriate treatment.

Driving and using machines

In case of diarrhoea, you may experience dizziness, fatigue, or drowsiness. If you experience any of these symptoms, you must not drive or operate machinery, or perform any activities where you could endanger yourself or others.

Excipients

This medicine contains less than 1 mmol of sodium (23 mg) per dose of oral lyophilisate, i.e. it is essentially “sodium-free”.

This medicine contains 1.0 mg of aspartame in each dose of oral lyophilisate. Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot remove it properly.

3. How to take Loperamide Mylan

Take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
If you are in any doubt, consult your doctor or pharmacist.
Check the table below to see how much medicine to take.

• Remove the protective film and push the oral lyophilisate doses out through the bottom of the blister. Do not push the oral lyophilisate doses through the film.
• Place the correct number of oral lyophilisate doses on the tongue. The oral lyophilisate doses dissolve rapidly in the mouth, so you do not need water to swallow them. Do not chew. For oral use only.
• Do not use a higher dose than indicated in the tables.
• The oral lyophilisate doses are not intended for long-term treatment.

Short-term diarrhoea

Do not exceed the maximum daily dose.
Do not take if episodes persist for more than 2 days.
Replace lost fluids by drinking more liquids than usual.
Elderly
In elderly patients, dose adjustment is not necessary.
Renal dysfunction
In patients with renal dysfunction, dose adjustment is not necessary.
Hepatic dysfunction
If you suffer from hepatic insufficiency, consult your doctor or pharmacist before taking this medicine.
How long to take Loperamide Mylan for short-term diarrhoea
You may use this medicine for up to 48 hours.
If the episode of diarrhoea lasts longer than 48 hours, or if you experience repeated episodes of diarrhoea or if symptoms change,
discontinue loperamide hydrochloride and consult your doctor.
If you take more Loperamide Mylan than you should
If you have taken too much loperamide hydrochloride, contact a doctor or hospital immediately for advice.
Symptoms may include: increased heart rate, irregular heartbeat, changes in heart rhythm (these symptoms may have potentially serious and life-threatening consequences), muscle stiffness, uncoordinated movements, drowsiness, difficulty urinating, or weak breathing.
Children react more strongly to large amounts of loperamide hydrochloride than adults.
If a child takes too much medicine or shows any of the symptoms listed above, seek medical advice immediately.
If you forget to take Loperamide Mylan
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 episode of loose stools (bowel movement). Do not take a double dose to make up for the missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Most are generally mild in severity.
Contact a doctor immediately
Common: (may affect up to 1 in 10 people)

• Feeling unwell, constipation or flatulence.
• Headache.

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

• Itching or hives.
• Stomach pain or stomach swelling.
• Dizziness or drowsiness.
• Vomiting, indigestion.
• Dry mouth.

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

• Allergic reactions including unexplained wheezing, shortness of breath, fainting, or swelling of the face and throat.
• Skin rashes, which may be severe and include blisters or peeling of the skin.
• Loss of consciousness or reduced level of consciousness (fainting, feeling faint or decreased alertness), uncoordinated movements.
• Difficulty passing urine.
• Severe constipation.
• Burning or tingling sensation of the tongue.
• Miosis (constriction of the pupils of the eye).
• Fatigue.

Not known: (frequency cannot be estimated from the available data)

• Upper abdominal pain, abdominal pain radiating to the back, abdominal tenderness, fever, rapid pulse, nausea, vomiting, which may be symptoms of inflammation of the pancreas (acute pancreatitis).

If you experience any of these symptoms, stop using the medicine and contact your doctor immediately.
Talk to a doctor as soon as possible.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system at the website https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Loperamide Mylan

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the carton and blister after Exp.
The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Loperamide Mylan contains
The active substance is loperamide hydrochloride.
Each oral lyophilisate dose contains 2 mg of loperamide hydrochloride.
The other excipients are: pullulan (E1204), mannitol (E421), sodium hydrogen carbonate (E500), aspartame
(E951), polysorbate 80 (E433), peppermint flavour (maize maltodextrins, flavouring ingredients, and modified waxy maize starch, 1450).
Description of the appearance of Loperamide Mylan and the contents of the pack
Oral lyophilisate.
Blister packs containing 6 or 12 doses of oral lyophilisate and 10 doses of oral lyophilisate.
Blister composed of a PVC/polyamide/aluminium/PVC blister with removable cover made of paper/PET/aluminium foil.
It is possible that not all pack sizes are marketed.
Marketing Authorisation Holder
Mylan S.p.A., Via Vittor Pisani 20, 20124 Milano
Manufacturer
SANTA SA
Str. Panselelor nr. 25, nr. 27, and nr. 29
Brasov, Jud. Brasov - 500419
Romania
Misom Labs Ltd
Malta Life Sciences Park,
LS2.01.06 Industrial Estate,
San Gwann SGN 3000, Malta
Fairmed HealthCare GmbH
Maria-Goeppert-Strasse 3
23562 Lubeck, Germany