Diarfin 2 mg hard capsules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Diarfin 2 mg hard capsules

loperamide hydrochloride

Read this entire leaflet carefully before you start taking this medicine because it contains important information for you.

Follow exactly the instructions for use provided in this leaflet or those given 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 adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
• You should consult a doctor if your condition worsens or if there is no improvement after 2 days of treatment.

Contents of this leaflet

1. What Diarfin is and what it is used for
2. What you need to know before taking Diarfin
3. How to take Diarfin
4. Possible side effects
5. How to store Diarfin
6. Contents of the pack and other information

1. What Diarfin is and what it is used for

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 of age.

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

2. What you need to know before taking Diarfin

Do not take Diarfin

• If you are allergic to loperamide hydrochloride or to any of the other ingredients of this medicine (listed in section 6).
• Do not administer to children under 2 years of age.
• If you notice blood in your stools or have a 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) following antibiotic treatment.
• If your diarrhea is due to an infection caused by organisms such as Salmonella, Shigella, or Campylobacter.

Warnings and precautions

Talk to 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 distension or paralytic ileus (absence of intestinal movements) occur, stop treatment and consult your doctor.
• If you have severe diarrhea, your body loses more fluids, sugars, and salts than normal, so you will need to replace fluids by drinking more than usual. Dehydration is characterized by dry mouth, excessive thirst, reduced urine output, wrinkled skin, dizziness, and lightheadedness. Preventing dehydration is especially important in children and elderly patients.
• Patients with AIDS should discontinue treatment at the first signs of abdominal distension.
• If you have liver or kidney disease or blood disorders, consult your doctor before taking this medicine.
• Since treatment of diarrhea with Diarfin is only symptomatic, the underlying cause of the diarrhea should be treated whenever possible.
• Do not use this medicine for purposes other than those indicated (see section 1), and never take more than the recommended dose (see section 3). Serious heart problems (including symptoms such as rapid or irregular heartbeat) have been reported in patients who have taken excessive amounts of loperamide, the active ingredient in 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

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

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 lower 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 severe pain), as they may increase the risk of severe constipation and central nervous system depression (e.g., drowsiness or decreased consciousness).
• Broad-spectrum antibiotics, as they may worsen antibiotic-associated diarrhea.

Diarfin may enhance the effects of similar medicines.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

The safety of this medicine during pregnancy has not been established; therefore, 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 may pass into breast milk.

Driving and use of machines

Fatigue, dizziness, or drowsiness may occur during treatment with Diarfin for diarrhea. Therefore, it is advisable not to operate machinery or drive vehicles.

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

Diarfin contains the colouring agent Sunset Yellow FCF (E-110). This medicine may cause allergic reactions because it contains Sunset Yellow FCF (E-110). It may provoke asthma, especially in patients allergic to acetylsalicylic acid.

3. How to take Diarfin

Follow exactly the instructions for administering this medicine provided in this leaflet or those given by your doctor or pharmacist. If in 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 daily dose for adults is 8 capsules (16 mg of loperamide hydrochloride).

Children over 12 years

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 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 feel that the effect of Diarfin 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 for assistance. Symptoms may include: increased heart rate, irregular heartbeat, disturbances in cardiac rhythm (these symptoms may have potentially serious and life-threatening consequences), muscle stiffness, uncoordinated movements, drowsiness, difficulty urinating, or weak breathing.

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number (91) 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Diarfin

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

If any of the following adverse effects occur, stop treatment and consult your doctor immediately:

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

Other adverse effects that may occur include:

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

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

Uncommon adverse reactions (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 rash (exanthema).
• Drowsiness.

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

• Intestinal paralysis (lack of intestinal movements or paralytic ileus).
• Abdominal swelling (distension).
• Dilatation of the large intestine (megacolon).
• Loss or decrease in level of consciousness.
• Stupor (generalized unconsciousness).
• Excessive increase in muscle tone (hypertonia).
• Abnormal coordination.
• Blisters on the skin (bullous eruptions, including Stevens-Johnson syndrome, erythema multiforme, and toxic epidermal necrolysis).
• Skin disorder causing lesions and intense itching (urticaria).
• Decreased urine output (urinary retention).
• Fatigue.
• Constriction of the pupils (miosis).
• Itching (pruritus).

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

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

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse 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 any special storage conditions.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the package and other information

Composition of Diarfin

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

• The other components are:

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

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

Appearance of the product and contents of the package

Diarfin is available as hard gelatin capsules with an orange cap and orange body.

It is supplied in PVC-PVDC/ALU blisters. Each Diarfin pack 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 most recent revision of this leaflet: July 2022

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/