2 mg hard capsules
loperamide hydrochloride
What Loperamide Mylan is and what it is used for
Loperamide Mylan is used for temporary ( acute ) diarrhea. Can also be prescribed by a doctor for other uses such as prolonged ( chronic ) diarrhea and in the “bag on the stomach” ( stoma ) after certain gastrointestinal surgeries or in the event of inability to hold the stool (feces incontinence).
The capsules contain loperamide hydrochloride which reduces diarrhea by normalizing the excessive bowel movements and which also facilitates the absorption of water and salts from the intestine.
If you buy Loperamide Mylan without a prescription, you must talk to a doctor if you do not feel better or if you feel worse after 2 days.
What you need to know before you use Loperamide Mylan
Do not use Loperamide Mylan
- if you are allergic to loperamide hydrochloride or any of the other ingredients of this medicine (listed in section 6).
- to children under 12 years.
- if the stool contains blood or if you have diarrhea with a high fever.
- if you have inflammation of the colon ( ulcerative colitis or pseudomembranous colitis ) after taking antibiotics .
- if you have inflammation in the intestine caused by so-called invasive organisms (eg Salmonella , Shigella or Campylobacter ).
- if the passage of food through the intestine is already slow, for example if you are constipated or bothered by a tense stomach.
Warnings and cautions
- Loperamide Mylan only treats the symptoms of diarrhea. In some cases, the cause of your diarrhea may require treatment. If symptoms persist or worsen, consult your doctor. If you have severe diarrhea, your body loses more fluid, sugar and salts than normal. You need to compensate for the fluid loss by drinking more than you normally do. Ask the pharmacy staff about preparations that replace sugar and salts.
- If temporary diarrhea has not stopped after two days of treatment, stop treatment and consult a doctor.
- In case of signs of constipation or other signs of impaired bowel passage, stop treatment and consult a doctor.
- If you have liver disease, you should consult a doctor before starting treatment with the tablets. Some of the side effects can be more troublesome.
- If you have AIDS and your stomach swells, stop taking the tablets immediately and contact a doctor.
- Do not take this medicine for anything other than its intended use (see section 1) and never take more than the recommended dose (see section 3). Severe heart problems (with symptoms such as rapid or irregular heartbeat) have been reported in patients who have taken too much loperamide, the active substance in Loperamide Mylan.
Children
Loperamide Mylan should not be given to children under 12 years of age.
Other medicines and Loperamide Mylan
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Some medicines may affect or be affected by treatment with Loperamide Mylan if taken at the same time. Examples of such drugs are:
- cholestyramine and gemifibrozil (used to treat high cholesterol )
- quinidine (used to treat heart rhythm disorders and malaria )
- ritonavir (used to treat HIV – infection and AIDS )
- cyclosporine (inhibits the immune system)
- verapamil (used to treat high blood pressure )
- erythromycin and clarithromycin ( antibiotics )
- itraconazole and ketoconazole (used to treat fungal infections)
- desmopressin taken by mouth (used for eg nocturnal urination and to control thirst and urine production in patients with central diabetes insipidus)
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
Experience with use during pregnancy is limited. Ask your doctor for advice before taking Loperamide Mylan if you are pregnant or think you may be pregnant.
Breast-feeding
Do not take Loperamide Mylan if you are breastfeeding. Small amounts of the drug may pass into breast milk.
Driving and using machines
This medicine may make you feel dizzy, tired, or drowsy. If you experience these symptoms, do not drive or use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Loperamide Mylan contains lactose
Loperamide Mylan capsules contain lactose monohydrates. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
How to use Loperamide Mylan
Always use this medicine exactly as your doctor has told you if it was prescribed for you personally or exactly as described in this leaflet if you bought it without a prescription. Ask your doctor or pharmacist if you are unsure.
- Swallow the right number of capsules whole along with liquid
- Do not use more than the indicated dose one
In case of temporary diarrhea:
The usual dose for adults and adolescents from 12 years of age: Start with 2 capsules. If diarrhea has not stopped within 2-3 hours, take 1 capsule at a time after each loose stool. Take a maximum of 8 capsules per day. Take Loperamide Mylan for a maximum of 2 days straight. Doctors may prescribe another dosage.
In case of chronic diarrhea: Dose one is determined by the doctor who adjusts it individually for you.
The usual dose for adults and adolescents from 12 years: 1-8 capsules per day. Take a maximum of 8 capsules per day.
Do not give Loperamide Mylan capsules to children under 12 years of age.
If you take more Loperamide Mylan than you should
If you take more Loperamide Mylan than you should contact your doctor or hospital immediately for advice. Symptoms may include increased heart rate, irregular heartbeat, changes in a heartbeat (these symptoms can potentially have serious, life-threatening consequences), muscle stiffness, uncoordinated movements, drowsiness, difficulty urinating, or poor breathing.
Children react more strongly than adults to large amounts of Loperamide Mylan. Contact a doctor immediately if a child has ingested too much of the medicine or has any of the above symptoms.
Too many capsules can cause drowsiness, make it difficult to think clearly or perform normal activities. Your muscles may feel stiff or you may find it difficult to breathe. You may become dry in the mouth or have reduced pupils. You may have a stomach ache, feel sick or vomit, become constipated, or have difficulty throwing water.
If you forget to take Loperamide Mylan
Take one capsule after the next loose stool (bowel movement). Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Loperamide Mylan and contact your doctor immediately if you get any of the following rare symptoms:
- swelling of the face, tongue or throat, difficulty swallowing or hives and difficulty breathing. This is a sign of angioedema .
- extreme fatigue, coordination problems and unconsciousness or decreased level of consciousness.
- severe abdominal pain and / or swollen stomach which may be a sign of blocked or enlarged bowel.
- Lyellas syndrome ( toxic epidermal necrolysis ): Severe widespread skin damage (skin peeling of the epidermis and superficial mucous membranes).
- Stevens-Johnson syndrome: An extremely severe allergic reaction with skin rash usually in the form of blisters or sores in the oral cavity and eyes as well as other mucous membranes such as genitals.
The following side effects have been reported:
Common (affects more than 1 user in 100):
- constipation
- nausea
- gases
- headache
- dizziness.
Uncommon (affects less than 1 user in 100):
- somnolence
- pain or discomfort in the stomach
- dry mouth
- vomiting
- indigestion
- rash.
Rare (affects less than 1 user in 1,000):
- hypersensitivity reaction such as anaphylactic shock
- muscle stiffness
- small pupils are
- itching
- hives
- difficulty urinating
How to store Loperamide Mylan
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.” or “Exp.”.
The expiration date is the last day of the specified month.
The medicine 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 to protect the environment.
Contents of the pack and other information
Content declaration
- The active substance is loperamide hydrochloride. Each capsule contains 2 mg of loperamide hydrochloride.
- The other ingredients are lactose monohydrate 100 mg, maize starch, magnesium stearate, gelatin, titanium dioxide (dye E171), black iron oxide (dye E172), erythrosine (dye E127), quinoline yellow (dye E104), indigo carmine (dye E132).
- Marking inks: Ammonium hydroxide (E527), povidone, shellac, simethicone, sodium hydroxide, titanium dioxide (E171).
What the medicine looks like and contents of the pack
The capsules are hard, dark green/purple, marked “LOPERA-MIDE 2”.
Pack sizes:
16 pcs (print packaging) without a prescription
16×1 pcs (print packaging, single dose)
40 pcs (print packaging)
40×1 pcs (print packaging, single dose)
100 pcs (print packaging)
100×1 pcs (print packaging, single dose)
250 pcs (plastic jar)
Marketing Authorization Holder and Manufacturer
Mylan AB, Box 23033, 104 35 Stockholm.