Leaflet: information for the user

Diarfin 2 mg hard capsules

loperamide hydrochloride

Read this leaflet carefully before you start to take this medicine, because it contains important information for you.

Follow exactly the administration instructions of the medicine contained in this leaflet or those indicated by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if you get worse or do not improve after 2 days of treatment.

Diarfin is an antidiarrheal that reduces intestinal movements and secretions, resulting in a decrease in liquid stools.

Diarfin is used for the symptomatic treatment of acute nonspecific diarrhea in adults and children over 12 years old.

You should consult a doctor if it worsens or does not improve after 2 days.

Do not take Diarfin

• If you are allergic to loperamide hydrochloride or any of the other components of this medication (listed in section 6).
• Do not administer to children under 2 years old.
• If blood appears in the stool or high fever (above 38 °C) occurs.
• If you have been diagnosed with acute ulcerative colitis (inflammation of the intestine).
• If you suffer from severe diarrhea (pseudomembranous colitis) after taking antibiotics.
• If you suffer from diarrhea caused by an infection caused by organisms such asSalmonella,ShigellaorCampylobacter.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Diarfin.

• If no improvement is observed in 48 hours or fever, constipation, or other symptoms such as abdominal distension or paralytic ileus (absence of intestinal movements) appear, discontinue treatment and consult your doctor.
• If you suffer from severe diarrhea, your body loses more fluids, sugars, and salts than normal, so you will need to replenish the fluids by drinking more than usual. Dehydration manifests as dry mouth, excessive thirst, decreased urine output, wrinkled skin, dizziness, and drowsiness. It is very important to prevent dehydration in children and elderly patients.
• Patients with AIDS should discontinue treatment when the first symptoms of abdominal distension appear.
• If you have liver or kidney disease or blood disorders, consult your doctor before taking this medication.
• Since the treatment of diarrhea with Diarfin is only symptomatic, the diarrhea should be treated from its cause, when possible.
• Do not take this medication for a use other than the indicated (see section 1) and never take more than the recommended amount (see section 3). Severe heart problems (whose symptoms include rapid or irregular heartbeats) have been reported in patients who have taken an excessive amount of loperamide, the active ingredient in Diarfin.

Children and adolescents

This medication should not be administered to children under 12 years old without consulting a doctor.

Other medications and Diarfin

Inform your doctor or pharmacist if you are taking, have taken recently, or may have to take any other medication.

Particularly, inform your doctor or pharmacist if you are taking any of the following medications:

• Ritonavir, saquinavir (used to treat HIV).
• Quinidine (used to treat arrhythmias).
• Desmopressin (used to treat central diabetes insipidus and nocturnal enuresis in children).
• Itraconazole or ketoconazole (used to treat fungal infections).
• Gemfibrozil (used to reduce cholesterol).
• St. John's Wort (used to improve mood and treat mild depressions).
• Valerian (used to treat mild states of nervousness and anxiety).
• Opioid analgesics (used to treat very intense pain) as it may increase the risk of severe constipation and central nervous system depression (e.g., drowsiness or decreased consciousness).
• Broad-spectrum antibiotics as it may worsen diarrhea caused by antibiotics.

Diarfin may potentiate the action of similar medications.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

The safety of use of this medication during pregnancy has not been established, so pregnant women should not take this medication unless prescribed by a doctor.

Breastfeeding

Women who are breastfeeding should not use this medication without consulting their doctor as small amounts of it may pass into breast milk.

Driving and operating machinery

You may experience fatigue, dizziness, or drowsiness during treatment of diarrhea with Diarfin, so it is recommended not to operate machinery or drive vehicles.

Diarfin contains lactose.If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medication.

Diarfin contains Yellow Orange S (E-110).This medication may cause allergic reactions because it contains Yellow Orange S (E-110). It may cause asthma, especially in patients allergic to acetylsalicylic acid.

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

The recommended dose is:

Adults

2 capsules (4 mg of loperamide hydrochloride) as the initial dose, followed by 1 capsule (2 mg of loperamide hydrochloride) after each diarrheal stool.

The maximum dose for adults is 8 capsules (16 mg of loperamide hydrochloride) per day.

Children over 12 years old

1 capsule (2 mg of loperamide hydrochloride) as the initial dose, followed by 1 capsule (2 mg of loperamide hydrochloride) after each diarrheal stool.

In children, the maximum daily dose should be related to body weight:

Patients with liver disease

They should consult their doctor before taking this medication.

Administration form

This medication is taken orally. Swallow the capsules with a glass of water.

Do not exceed the recommended dose.

If you estimate that Diarfin's action is too strong or too weak, inform your doctor or pharmacist.

If you take more Diarfin than you should

If you have taken too much Diarfin, contact a doctor or hospital as soon as possible to seek help. Symptoms may include: increased heart rate, irregular heartbeats, heart rhythm disturbances (these symptoms may have potentially serious and life-threatening consequences), muscle stiffness, uncoordinated movements, drowsiness, difficulty urinating, or weak breathing.

Children react more severely to high amounts of Diarfin than adults. If a child takes an excessive amount or exhibits any of the above symptoms, call a doctor immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone (91) 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Diarfin

Do not take a double dose to compensate for the missed dose.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

If any of the following side effects occur, discontinue treatment and consult your doctor:

• Allergic reactions such as skin rash, facial swelling, tongue or throat swelling that may cause difficulty swallowing or breathing (angioedema).
• Severe allergic reactions including anaphylactic shock.
• Intense abdominal pain.
• Significant blisters or peeling of the skin.
• Loss or decrease in level of consciousness.

Other side effects that may occur are:

Frequent adverse reactions (may affect up to 1 in 10 people):

• Headache (cephalgia).
• Dizziness.
• Constipation.
• Nausea.
• Gas (flatulence).

Less frequent adverse reactions (may affect up to 1 in 100 people):

• Vomiting.
• Discomfort or pain in the upper-middle part of the stomach (dyspepsia).
• Dry mouth.
• Abdominal pain or discomfort.
• Skin discoloration (exanthema).
• Drowsiness.

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

• Intestinal paralysis (absence of intestinal movements or paralytic ileus).
• Abdominal distension.
• Colon dilation (megacolon).
• Loss or decrease in level of consciousness.
• Stupor (general unconsciousness).
• Exaggerated muscle tone (hypertonia).
• Abnormal coordination.
• Blisters on the skin (bullous eruptions, including Stevens-Johnson syndrome, erythema multiforme, and toxic epidermal necrolysis).
• Skin alteration that causes intense lesions and itching (urticaria).
• Decreased urine output (urinary retention).
• Fatigue.
• Pupil constriction (miosis).
• Itching (pruritus).

Adverse reactions of unknown frequency (cannot be estimated from available data):

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

This medication does not require special storage conditions.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Diarfin

• The active ingredient of Diarfin is loperamide hydrochloride. Each capsule contains 2 mg of loperamide hydrochloride.

• The other components are:

Contents of the capsule:pregelatinized cornstarch, lactose monohydrate, anhydrous colloidal silica, and magnesium stearate.

Durable capsule:gelatin, yellow-orange S (E-110), and titanium dioxide (E-171).

Appearance of the product and contents of the packaging

Diarfin is presented in the form of hard gelatin capsules with an orange cap and orange body.

It is presented in PVC-PVDC/ALU blisters. Each package of Diarfin contains 10 or 20 capsules.

Holder of the marketing authorization and responsible for manufacturing

Cinfa Laboratories, S.A.

Olaz-Chipi, 10. Areta Industrial Estate

31620 Huarte (Navarra) – Spain

Last review date of this leaflet:July 2022

The detailed and updated information of this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/