LOPERAMIDE 2 mg Liofilizat Doustny
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Treść ulotki
Loperamide Mylan 2 mg oral lyophilisate
loperamide hydrochloride
Read 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 have told you.
‐ Keep this leaflet. You may need to read it again.
‐ If you want more information or advice, ask your pharmacist.
‐ If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist
or nurse. See section 4.
‐ See a doctor if you do not feel better 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 you take 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 is Loperamide Mylan and what is it used for
This medicine contains loperamide hydrochloride which helps to stop diarrhoea by making the stools firmer and less frequent. This medicine is used for the treatment of sudden attacks of short-term (acute) diarrhoea in adults and children over 12 years of age. This medicine should not be used for more than 2 days unless advised by a doctor and with careful monitoring.
Contact your 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 in the following cases:
- patients with a known hypersensitivity to loperamide hydrochloride or to any of the other ingredients of this medicine (listed in section 6)
- children under 2 years of age
- patients with acute dysentery, which is characterized by blood in the stool and high body temperature
- patients with acute ulcerative colitis
- patients with bacterial enterocolitis caused by invasive organisms including Salmonella, Shigella and Campylobacter
- patients with pseudomembranous colitis associated with the use of broad-spectrum antibiotics
- in all cases where normal bowel movements should not be suppressed. Administration must be stopped immediately in case of constipation or abdominal bloating. If any of these cases apply to you, ask your doctor or pharmacist for advice before taking loperamide hydrochloride.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking this medicine, if
‐ you suffer from AIDS and your stomach becomes bloated, immediately stop taking the doses of
oral lyophilisate and contact your doctor immediately;
‐ you suffer from a liver disease
‐ the diarrhea lasts for more than 48 hours, stop taking the medicine and consult your doctor;
- you suffer from severe diarrhea, 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 especially high in young children and the elderly. Therefore, the first measures against diarrhea are: replenish and maintain fluids in the body. This means: drink plenty and supplement with sugar and salt. You can purchase a salt and sugar mixture at a pharmacy or drugstore, 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 abnormalities or malaria)
‐ desmopressin orally (used to treat excessive urination)
‐ itraconazole or ketoconazole (used to treat fungal infections)
‐ gemfibrozil (used to treat high cholesterol levels).
If you are not sure about any of the medicines you are taking, show the bottle or package to your
pharmacist. If any of these cases apply to you (now or in the past), talk to your doctor or pharmacist.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding with
breast milk, ask your doctor or pharmacist for advice 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 the most suitable treatment with your
doctor.
Driving and operating machinery
You may experience dizziness, fatigue or drowsiness in case of diarrhea. If these manifestations affect
you, you should not drive or operate machinery or perform certain activities where you could put yourself or
others at risk.
Excipients
This medicine contains less than 1 mmol of sodium (23 mg) per dose of oral lyophilisate, meaning 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 you have a build-up of phenylalanine because your body cannot remove it properly.
3. How to take Loperamide Mylan
Take this medicine following exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.
Check the table below to see how much medicine to take.
- Remove the coating and let the oral lyophilisate dose fall out. Do not push the oral lyophilisate doses through the coating.
- Place the correct number of oral lyophilisate doses on your tongue. The oral lyophilisate doses dissolve quickly in your mouth, so you do not need water to swallow them. Do not chew. For oral use only.
- Do not use a dose higher than that indicated in the tables.
- The oral lyophilisate doses are not for long-term treatment.
Short-term diarrhea
Do not exceed the maximum daily dose.
Do not take if the attacks persist for more than 2 days
Replenish lost fluids by drinking more liquids than usual
Elderly
No dose adjustment is necessary in the elderly.
Renal impairment
No dose adjustment is necessary in patients with renal impairment.
Hepatic impairment
If you suffer from hepatic insufficiency, ask your doctor or pharmacist before taking this medicine.
For how long to take Loperamide Mylan for short-term diarrhea
You can use this medicine for a maximum of 48 hours.
If the diarrhea attack lasts more than 48 hours, or if you suffer from recurrent diarrhea attacks or if the symptoms change,
stop taking 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 heartbeat (these symptoms may have potentially serious and
life-threatening consequences), muscle stiffness, uncoordinated movements, drowsiness, difficulty urinating or
weak breathing.
Children react more intensely to large amounts of loperamide hydrochloride than adults.
If a child takes too much medicine or shows any of the above symptoms,
consult a doctor 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 loose stool (bowel
movement). Do not take a double dose to make up for a missed dose.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Most are generally mild.
| Age | Initial dose | Repeated dose | o Maximum daily dose |
| Children and adolescents from 12 years of age | 1 dose of oral lyophilisate | 1 dose of oral lyophilisate after each loose stool, not before 1 hour after taking the initial dose | c 4 doses of oral lyophilisate |
| Adults | 2 doses of oral lyophilisate | 1 dose of oral lyophilisate after each loose stool, not before 1 hour after taking the initial dose | m 6 doses of oral lyophilisate r |
Seek immediate medical assistance
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 bloating.
- 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 can 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.
If you experience any of these symptoms, stop using the medicine and seek immediate medical
assistance. Talk to your doctor as soon as possible.
Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor, pharmacist or nurse. You can also report side effects directly through the
national reporting system at the web address 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 which is stated on the package and on the blister after Exp.
The expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater 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 Loperamide Mylan contains
The active ingredient is loperamide hydrochloride.
Each oral lyophilisate dose contains 2 mg of loperamide hydrochloride.
The other excipients are: pullulan (E1204), mannitol (E421), sodium bicarbonate (E500),
aspartame (E951), polysorbate 80 (E433), peppermint aroma (corn maltodextrins, flavoring
ingredients and modified waxy corn starch, 1450).
Description of the appearance of Loperamide Mylan and contents of the pack
Oral lyophilisate
Blisters in packs of 6 or 12 oral lyophilisate doses and 10 oral lyophilisate doses.
Blister composed of a PVC/polyamide/aluminum/PVC blister with a removable covering in
paper/PET/aluminum foil.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Mylan S.p.A., Via Vittor Pisani 20, 20124 Milan
Manufacturer
S.C. SANTA S.A.
Str. Carpatilor nr. 60
Obiective Nr. 47, 48, 58, 133
Brasov, Jud. Brasov - 500269
Romania
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- Kraj rejestracji
- Postać farmaceutycznaOral lyophilized, 2 MG
- Kod ATCA07DA03
- Substancja czynna
- Wymaga receptyNie
- Producent
- Te treści mają charakter wyłącznie informacyjny i nie zastępują konsultacji lekarskiej.
- Zamienniki LOPERAMIDE MYLANPostać farmaceutyczna: Hard capsule, 1.5 MGSubstancja czynna: loperamideProducent: GIULIANI SPABez receptyPostać farmaceutyczna: Coated tablet, 2 MGSubstancja czynna: loperamideProducent: SPA SOCIETA' PRODOTTI ANTIBIOTICI S.P.A.Bez receptyPostać farmaceutyczna: Tablet, 2 MGSubstancja czynna: loperamideProducent: SPA SOCIETA' PRODOTTI ANTIBIOTICI S.P.A.Wymaga recepty
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LOPERAMIDE MYLAN nie wymaga recepty w Włochy. Możesz skonsultować się z lekarzem online, aby sprawdzić, czy ten lek może być odpowiedni w Twojej sytuacji.
Substancją czynną w LOPERAMIDE MYLAN jest loperamide. Informacja ta pomaga rozpoznać leki o tym samym składzie, ale pod różnymi nazwami handlowymi.
LOPERAMIDE MYLAN jest produkowany przez MYLAN S.P.A.. Nazwy handlowe i opakowania mogą się różnić w zależności od dystrybutora.
Lekarze, tacy jak Lekarze rodzinni, Psychiatrzy, Dermatolodzy, Kardiolodzy, Endokrynolodzy, Gastroenterolodzy, Pulmonolodzy, Nefrolodzy, Reumatolodzy, Hematolodzy, Zakaźnicy, Alergolodzy, Geriatrzy, Pediatrzy, Onkolodzy, mogą ocenić, czy stosowanie LOPERAMIDE MYLAN jest odpowiednie w Twoim przypadku, w zależności od sytuacji klinicznej i lokalnych przepisów. Możesz umówić konsultację online, aby omówić objawy i możliwe dalsze kroki.
Polska posiada dobrze rozwiniętą infrastrukturę ochrony zdrowia w dużych miastach, takich jak Warszawa, Kraków, Wrocław i Gdańsk. Apteki są łatwo dostępne i działają zgodnie z obowiązującymi przepisami, zapewniając dostęp do leków na receptę.
Możesz kupić LOPERAMIDE MYLAN w Warszawie, Krakowie, Wrocławiu lub Gdańsku w każdej aptece, posiadając ważną receptę.
Aby uzyskać receptę, możesz skorzystać z Oladoctor:
Inne leki zawierające tę samą substancję czynną (loperamide) to m.in. DIARSTOP, DISSENTEN ANTIDIARREA, DISSENTEN. Mogą one różnić się nazwą handlową lub postacią, ale zawierają ten sam składnik terapeutyczny. Przed zmianą lub rozpoczęciem nowego leku skonsultuj się z lekarzem.
