NOTICE
ANSM - Updated on: 12/08/2019
Name of the drug
LOPERAMIDE MYLAN PHARMA 2 mg, capsule
Loperamide hydrochloride
Box
Read all of this leaflet carefully before taking this medicine as it contains important information for you.
You should always take this medicine by carefully following the information provided in this leaflet or by your doctor, pharmacist or nurse.
· Keep this leaflet. You might need to read it again.
· Ask your pharmacist for advice or information.
· If you get any side effects, talk to your doctor, pharmacist or nurse. This also applies to any side effect that is not mentioned in this leaflet. See section 4.
· You should talk to your doctor if you do not feel better or if you feel worse after 2 days.
What does this booklet contain ?
1. What LOPERAMIDE MYLAN PHARMA 2 mg capsule is and what it is used for
2. What you need to know before you take LOPERAMIDE MYLAN PHARMA 2 mg hard capsule?
3. How to take LOPERAMIDE MYLAN PHARMA 2 mg, capsule?
4. What are the possible side effects?
5. How to store LOPERAMIDE MYLAN PHARMA 2 mg, capsule?
6. Contents of the pack and other information.
1. WHAT LOPERAMIDE MYLAN PHARMA 2 mg capsule IS AND WHAT IT IS USED FOR?
Pharmacotherapeutic group: ANTI-DIARRHEIC - ATC code: A07DA03 (A: digestive system and metabolism).
Short-term treatment of transient acute diarrhea in adults and children from 15 years of age.
This treatment is a complement to the dietary measures: read the chapter "Warnings and precautions" carefully.
You should talk to your doctor if you do not feel better or if you feel worse after 2 days.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LOPERAMIDE MYLAN PHARMA 2 mg hard capsules?
Never take LOPERAMIDE MYLAN PHARMA 2 mg, capsule:
· If you are allergic to the active substance or to any of the other ingredients of this medicine, listed in section 6,
· If blood is present in your stool and / or if you have a high fever,
· If you have chronic bowel and colon disease, especially during acute attacks of ulcerative colitis (inflammatory bowel disease with bleeding),
· If you suffer from inflammation of the intestine with diarrhea and pain following the use of antibiotics (pseudomembranous colitis),
· If you suffer from inflammation of the intestine due to invasive bacteria ( bacterial enterocolitis),
· In children under 15 years of age.
This medication should not be used when stopping or decreasing bowel movement is to be avoided.
Treatment should be discontinued if constipation, abdominal distension or intestinal obstruction occurs.
IN CASE OF DOUBT, YOU MUST ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking LOPERAMIDE MYLAN PHARMA 2 mg hard capsules.
You should stop treatment and consult your doctor promptly in the following cases:
· If you do not notice improvement after 2 days of treatment ,
· In case of fever or vomiting during treatment ,
· If there is blood or mucus in the stool,
· In case of intense thirst, feeling of dry tongue. Indeed, these signs show the beginning of dehydration, that is to say, significant loss of fluid due to diarrhea. Your doctor will then judge the need to prescribe rehydration which can be done orally or intravenously ,
· If you are infected by the Human Immunodeficiency Virus (HIV), immediately stop treatment at the 1 st signs of abdominal distension (resulting in swelling of the abdomen)
In case of liver failure (malfunction of the liver), tell your doctor; close medical supervision may be necessary when taking this medicine.
You must follow the following dietary rules during treatment:
· rehydrate yourself with abundant drinks, salty or sweet, to compensate for the loss of fluids due to diarrhea (the average daily ration of water for adults is 2 liters)
· eat enough for diarrhea ,
o avoiding certain intakes and especially milk, raw vegetables, fruits, green vegetables, spicy dishes, as well as frozen foods or drinks.
o favoring grilled meats, rice.
Take this product only for the use for which it is intended (see section 1) and never take more than the recommended dose (see section 3). Serious heart problems (symptoms may include a fast or irregular heartbeat) have been reported in patients who have taken too much loperamide, the active substance in LOPERAMIDE MYLAN PHARMA 2 mg capsule.
Children and adolescents
Not applicable.
Other medicines and LOPERAMIDE MYLAN PHARMA 2 mg, capsule
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines , including :
· itraconazole or ketoconazole (used to treat fungal infections),
· gemfibrozil (used to treat high levels of fat in the blood),
· oral desmopressin (used in particular to limit thirst and urine production in patients with diabetes insipidus).
This medicine contains LOPERAMIDE . Other drugs contain it. Do not combine them, so as not to exceed the maximum recommended doses (see How to take LOPERAMIDE MYLAN PHARMA 2 mg, capsule?). |
LOPERAMIDE MYLAN PHARMA 2 mg hard capsule with food, drink and alcohol
Not applicable.
Pregnancy and breast feeding
Do not take this medication without asking your doctor or pharmacist for advice. This medication will only be used during pregnancy on the advice of your doctor. |
If you discover that you are pregnant during treatment, consult your doctor as only he can judge the need to continue it.
Breastfeeding is not recommended when taking this medication.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Be careful. Do not drive without reading the manual.
This medication may cause drowsiness, dizziness, or tiredness. Because of these risks, caution is advised when driving vehicles or operating machinery.
LOPERAMIDE MYLAN PHARMA 2 mg, capsule contains lactose.
If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. HOW TO TAKE LOPERAMIDE MYLAN PHARMA 2 mg capsule?
Always take this medication exactly as instructed in this leaflet or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
Dosage
Reserved for adults and children from 15 years old.
Start with 2 capsules in a single dose (i.e. 4 mg loperamide hydrochloride ),
If the diarrhea continues: after each unmolded stool, take 1 additional capsule but:
· never exceed 6 capsules per day,
· never exceed 2 days of treatment.
Administration mode
Oral use.
Swallow the capsules with a glass of water.
Duration of the treatment
The duration of use is limited to 2 days.
If you take more LOPERAMIDE MYLAN PHARMA 2 mg capsule than you should:
If you take too much LOPERAMIDE MYLAN PHARMA 2 mg hard capsules, seek medical advice immediately from a doctor or hospital. Symptoms may include: increased heart rate, irregular heartbeat, changes in your heart rate (these symptoms may have potentially serious and life-threatening consequences), muscle stiffness, uncoordinated movements, drowsiness, difficulty urinating or respiratory distress, or decreased alertness, narrowing of the pupil, bloating or constipation.
In this case, you must go to the hospital where an antidote (naloxone) may be administered to you. Hospital surveillance must then be maintained for at least 48 hours. Children react more strongly to large doses of LOPERAMIDE MYLAN PHARMA 2 mg capsule than adults. If a child takes too much or has any of the above symptoms, contact a doctor immediately.
If you forget to take LOPERAMIDE MYLAN PHARMA 2 mg capsule:
Do not take a double dose to make up for the dose you forgot to take.
If you stop taking LOPERAMIDE MYLAN PHARMA 2 mg capsule:
Not applicable.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist for more information.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most common side effects (more than 1 in 100 patients) are constipation, flatulence, headache and nausea.
The following side effects have also been reported with loperamide:
· Allergic reactions which may include breathing or swallowing difficulties, swelling of the face or skin reactions (rash, hives, itching).
· Vomiting, difficulty digesting, dry mouth, severe constipation, abdominal pain or swelling, abdominal discomfort, bowel obstruction, tongue pain.
· Sometimes severe rashes.
· Tired.
· Difficulty urinating.
· Dizziness, drowsiness, loss or decrease in consciousness, stupor, increased muscle tone, difficulty coordinating movements.
· Narrowing of the pupil (miosis).
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This also applies to any side effect that is not mentioned in this leaflet. You can also report side effects directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and network of Regional Pharmacovigilance Centers - Website: www.signalement-sante.gouv.fr .
By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE LOPERAMIDE MYLAN PHARMA 2 mg capsule?
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 box. The expiration date refers to the last day of this month.
No special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist to discard any medicines you no longer use. These measures will help protect the environment .
6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION
What LOPERAMIDE MYLAN PHARMA 2 mg contains, capsule
· The active substance is:
Loperamide hydrochloride ............................................... ............................................ 2.00 mg
Quantity corresponding to loperamide base ............................................. ........................ 1.86 mg
For one capsule
· The other components are:
Lactose monohydrate, rice starch, talc, magnesium stearate.
Composition of the capsule shell : gelatin, titanium dioxide.
What is LOPERAMIDE MYLAN PHARMA 2 mg, capsule and contents of the pack
This medication comes in capsule form. Box of 6 or 12.
Marketing authorization holder
MYLAN SAS
117 ALLEE DES PARCS
69800 SAINT PRIEST
Marketing authorization operator
MYLAN SAS
117 ALLEE DES PARCS
69800 SAINT PRIEST
Maker
MYLAN SAS
117 ALLEE DES PARCS
69 800 SAINT PRIEST
or
BTT LABORATORIES
KRAFFT INDUSTRIAL AREA
67 150 ERSTEIN
Names of the drug in the member states of the European Economic Area
Not applicable.
The last date on which this leaflet was revised is:
[to be completed later by the holder]
Other
Detailed information on this medicine is available on the ANSM website (France).
Health Education Council:
Diarrhea causes loss of fluids and mineral salts.
This medication treats the symptoms of acute diarrhea in adults, but does not dispense with rehydration, accompanied by dietary hygiene.
It is therefore necessary to drink plenty of sugary drinks (fruit juice) and salty broths to compensate for these losses. Avoid milk, green vegetables, raw vegetables, fruits, spices, until disappearance of diarrhea.