Read all of this leaflet carefully because it contains important information for you.
This medicine can be obtained without prescription for the treatment of minor diseases without the intervention of your doctor.
However, you must use carefully diarfin 2 mg hard capsules to obtain the best results.
– Keep this leaflet. You may need to read it again.
– Ask your pharmacist if you need more information or advice.
– If the symptoms worsen or if they persist after 2 days, you must talk to your doctor.
In this patient leaflet, you will find out:
1. What diarfin 2 mg hard capsules is and what it is used for.
2. Before you take diarfin 2 mg hard capsules.
3. How to take diarfin 2 mg hard capsules.
4. Possible side effects.
5. Storing diarfin 2 mg hard capsules.
diarfin 2 mg hard capsules
Each capsule contains as active ingredient:
Loperamide hydrochloride: 2 mg
The other components (excipients) are: gluten-free pregelatinised maize starch, lactose monohydrate, colloidal anhydrous silica,
magnesium stearate. The ingredients of the capsule are: gelatin,
yellow-orange dye S (E-110) and titanium dioxide (E-171).
1. WHAT diarfin 2 mg hard capsules IS AND WHAT
IT IS USED FOR
It is supplied in packages containing 10 or 20 hard capsules.
Loperamide is an antidiarrhoeal which reduces intestinal movements and secretions, causing a reduction of liquid stools.
diarfin 2 mg hard capsules is used in the symptomatic treatment of occasional diarrhoea.
2. BEFORE YOU TAKE diarfin 2 mg hard capsules.
Do not take diarfin 2 mg hard capsules:
– If you are allergic to loperamide or to any of the components of the medicine.
The treatment of diarrhoea with this medicine is only symptomatic and must not be used in case of:
– Presence of blood in stools and high fever (over 38º C).
– Patients diagnosed with acute ulcerative colitis or pseudomembranous colitis associated to treatment with broad-spectrum antibiotics.
– If sudden constipation and/or abdominal distention occur.
Its use is not recommended in children under 12 years of age without prior medical consultation.
Take special care with diarfin 2 mg hard capsules:
If no clinical improvement is seen in 48 hours or if fever, constipation or other symptoms occur, stop the treatment and ask
Patients with diarrhoea should drink plenty of liquids to prevent
dehydration evidenced as: dry mouth, excessive thirst, reduced
urine output, wrinkled skin, light-headedness, confusion. This
is particularly important in children and the elderly.
Since the treatment of diarrhoea with loperamide is symptomatic,
diarrhoea must be treated from its cause when such treatment
Medicines prolonging bowel transit can induce the development
of toxic megacolon (complication of other intestinal diseases
characterised by: dilated colon, abdominal distention and sometimes
fever, increased heart rate, abdominal pain and dehydration).
Patients with liver disorders must ask their doctors before taking
Pregnancy: Ask your doctor or pharmacist for advice before
taking any medicine.
The safety of this medicine for use in pregnancy has not been
IMPORTANT FOR WOMEN
If you are pregnant or think you may be, ask your doctor
before taking this medicine.
The use of medicines during pregnancy can be dangerous for
the embryo or foetus and must be monitored by your doctor.
Lactation: Ask your doctor or pharmacist for advice before taking any medicine.
The use of loperamide is not recommended in nursing women.
Driving and using machines: Although no effects of this type are expected, if tiredness, lightheadedness or drowsiness occur, do not drive or use machines.
Important information about some of the ingredients in diarfin 2 mg hard capsules: This medicine contains lactose. If your doctor has informed you that you suffer intolerance to some sugars, ask him/her before taking this medicine.
Due to its orange dye S (E 110) contents, it can cause allergic reactions. It can cause asthma, particularly in patients who are allergic to aspirin.
Notify your doctor or pharmacist if you are using or have recently used any other medicine, even those available over-the-counter, homeopathics, medicinal herbs and health-related products, since it may be necessary to stop the medicine or adjust the dosage of some of them.
If you are taking any antibiotic or narcotic-type analgesic, ask your doctor or pharmacist before taking this medicine, since it can interact with them.
Concomitant use with other opiate analgesics can increase the risk of severe constipation and central nervous system depression.
Loperamide can worsen or prolong the diarrhoea caused by broad-spectrum antibiotics.
3. HOW TO TAKE diarfin 2 mg hard capsules.
Follow these instructions unless your doctor has given you other instructions.
If you have the impression that the effect of diarfin 2 mg hard capsules is too strong or too weak, talk to your doctor or pharmacist.
This medicine is for oral use.
Adults and children over 12 years of age:
The starting dose is two capsules (4 mg of loperamide) in a single dose. Then take one capsule (2 mg of loperamide) after
each episode of diarrhoeal stools.
Do not take more than eight capsules (16 mg of loperamide) a day.
Do not take this medicine for more than 2 days.
Instructions for adequate administration of the preparation
Swallow the capsules whole, without biting or chewing, with a glass of water.
If you take more diarfin 2 mg hard capsules than you should: If you have taken more diarfin 2 mg hard capsules
than you should, immediately consult your doctor or pharmacist, or contact the Toxicology Information Service, phone number 915620420, indicating the medicine and amount taken.
Carry this leaflet with you.
In case of overdose or accidental ingestion, stupor, coordination problems, drowsiness, muscle hypertonia, respiratory depression, dry mouth, abdominal discomfort, nausea, vomiting and constipation can occur.
If you forget to take diarfin 2 mg hard capsules:
Do not take a double dose to make up for forgotten doses.
4. POSSIBLE SIDE EFFECTS
Like all medicines, diarfin 2 mg hard capsules can have side effects.
The side effects described are:
• Infrequent (less than 1 per 100 cases but more than 1 per 1000): hypersensitivity reactions (skin rash), urinary retention.
• Very rare (less than 1 per 10,000): toxic megacolon (constipation, abdominal distention, nausea and vomiting) paralytic ileus
(persistent constipation), particularly when the established recommendations have not been followed.
Also disorders usually difficult to distinguish from symptoms of diarrhoea such as: abdominal pain and/or distention, nausea and vomiting, tiredness, drowsiness or dizziness and dry mouth.
If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.
5. STORING diarfin 2 mg hard capsules
Keep all medicines out of the reach and sight of children.
There are no special storage instructions.
Do not dispose of medicines in wastewater or trash. Ask your pharmacist about the disposal of medicines you do not need.
In this way you will help protect the environment.
Laboratorios Cinfa, S.A.
C/ Olaz-Chipi, 10 - Poligono Industrial Areta., 31620 Huarte-Pamplona (Navarra). España.