DIARFIN 2 mg HARD CAPSULES

2. What you need to know before taking Diarfin

Do not take Diarfin

• If you are allergic to loperamide hydrochloride or any of the other components of this medicine (listed in section 6).
• Do not administer to children under 2 years of age.
• If blood appears in the stool or high fever (above 38 °C).
• 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 due to an infection caused by organisms such as Salmonella, Shigellaor Campylobacter.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Diarfin.

• If there is no improvement within 48 hours or if fever, constipation, or other symptoms such as abdominal swelling 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 usual, so you will need to replenish fluids by drinking more than usual. Dehydration is characterized by dry mouth, excessive thirst, decreased urine output, wrinkled skin, dizziness, and drowsiness. It is very important to prevent dehydration in children and elderly patients.
• Patient with AIDS should discontinue treatment when the first symptoms of abdominal swelling appear.
• If you have any liver or kidney disease or blood disorders, consult your doctor before taking this medicine.
• Since the treatment of diarrhea with Diarfin is only symptomatic, diarrhea should be treated from its cause, when possible.
• Do not take this medicine for a use other than indicated (see section 1) and never take more than the recommended amount (see section 3). Serious 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 of Diarfin.

Children and adolescents

This medicine should not be administered to children under 12 years of age without consulting a doctor.

Other medicines and Diarfin

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.

In particular, inform your doctor or pharmacist if you are taking any of the following medicines:

• Ritonavir, saquinavir (used to treat HIV).
• Quinidine (used to treat heart rhythm disorders).
• Desmopressin (used to treat central diabetes insipidus and nocturnal urinary incontinence 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 depression).
• Valerian (used to treat mild nervousness and anxiety).
• Opioid analgesics (used to treat 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 antibiotic-associated diarrhea.

Diarfin may enhance the effect of similar medicines.

Pregnancy and breastfeeding

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

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

Breastfeeding

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

Driving and using machines

Drowsiness, dizziness, or drowsiness may occur during treatment with Diarfin, so it is advised not to use machinery or drive vehicles.

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

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

3. How to take Diarfin

Follow exactly the administration instructions of the medicine contained in this leaflet or as 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 an 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 of age

1 capsule (2 mg of loperamide hydrochloride) as an 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:

Patient with liver disease

They should consult their doctor before taking this medicine.

Method of administration

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

Do not exceed the recommended dose.

If you think the effect of Diarfin is too strong or too weak, tell 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 for advice. The symptoms may include: increased heart rate, irregular heartbeats, cardiac arrhythmias (these symptoms can 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 presents 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 Toxicology Information Service, phone (91) 562 04 20, indicating the medicine and the amount taken.

If you forget to take Diarfin

Do not take a double dose to make up for the forgotten dose.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

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

Other side effects that may occur are:

Common side effects (may affect up to 1 in 10 people):

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

Uncommon side effects (may affect up to 1 in 100 people):

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

Rare side effects (may affect up to 1 in 1,000 people):

• Intestinal paralysis (absence of intestinal movements or paralytic ileus).
• Abdominal swelling (distension).
• Dilation of the large intestine (megacolon).
• Loss or decrease in level of consciousness.
• Stupor (general unconsciousness).
• Muscle hypertonia.
• Abnormal coordination.
• Blisters on the skin (bullous eruptions, including Stevens-Johnson syndrome, erythema multiforme, and toxic epidermal necrolysis).
• Skin disorder that produces lesions and intense itching (urticaria).
• Decreased urine output (urinary retention).
• Fatigue.
• Pupillary constriction (miosis).
• Itching (pruritus).

Side effects of unknown frequency (cannot be estimated from the available data):

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

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency (AEMPS) https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Diarfin

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

This medicine does not require special storage conditions.

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

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of Diarfin

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

• The other ingredients are:

Capsule content:pregelatinized corn starch, lactose monohydrate, anhydrous colloidal silica, and magnesium stearate.

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

Appearance of the product and pack contents

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 pack of Diarfin contains 10 or 20 capsules.

Marketing authorization holder and manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Date of the last revision of this leaflet:July 2022

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/