DIARFIN FLAS 2 mg ORAL LYOPHILIZED

Introduction

Package Leaflet: Information for the User

Diarfin Flas 2mg Oral Lyophilisate

Loperamide Hydrochloride

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

Follow exactly the administration instructions of the medicine contained in this leaflet or as 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 side effects, consult your doctor or pharmacist, even if it is a side effect not listed in this leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve after 2 days.

Contents of the Package Leaflet

1. What is Diarfin Flas and what is it used for
2. What you need to know before taking Diarfin Flas
3. How to take Diarfin Flas
4. Possible side effects
5. Storage of Diarfin Flas
6. Package Contents and Additional Information

1. What is Diarfin Flas and what is it used for

This medicine contains loperamide hydrochloride, which helps to stop diarrhea by solidifying the stools and reducing the frequency of bowel movements. It is used to treat sudden, short-term (acute) diarrhea in adults and adolescents over 12 years of age. This medicine should not be used for more than 2 days without medical assistance and supervision.

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

2. What you need to know before taking Diarfin Flas

Do not takeDiarfin Flas

• if you are allergic to loperamide hydrochloride or any of the other ingredients of this medicine (listed in section 6)
• in children under 2 years of age
• if you have acute dysentery, characterized by blood in the stool and elevated body temperature
• if you have ulcerative colitis
• if you suffer from bacterial enterocolitis caused by invasive microorganisms, including Salmonella, Shigella, and Campylobacter
• if you suffer from pseudomembranous colitis associated with the use of broad-spectrum antibiotics
• in all cases where bowel movements should not be inhibited. The administration of the medicine should be suspended immediately in case of constipation or abdominal inflammation.

Consult your doctor or pharmacist before taking loperamide hydrochloride if you are in any of the above circumstances.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Diarfin Flas:

• if you have AIDS and your stomach swells, stop taking the oral lyophilisates immediately and see a doctor right away
• if you have liver disease
• if you have diarrhea that lasts more than 48 hours, stop taking the medicine and consult your doctor
• if you have severe diarrhea, you will lose a lot of fluids (dehydration). Along with these fluids, other important substances are also lost. Dehydration symptoms can include dry mouth and dizziness. Vomiting can cause dehydration; this risk is especially high in young children and the elderly. Therefore, the first measures to tackle diarrhea should be to provide fluids and retain them in the body. This means drinking a lot and taking a supplementary intake of salt and sugar. At the pharmacy, you can purchase a special mixture of salt and sugar (oral rehydration solution) that should be dissolved in water. Consult your doctor or pharmacist for advice.

Other Medicines and Diarfin Flas

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

If you are taking any of these specific medicines:

• ritonavir (for HIV treatment)
• quinidine (for treating heart rhythm disorders or malaria)
• oral desmopressin (for treating excessive urination)
• itraconazole or ketoconazole (for treating fungal infections)
• gemfibrozil (for treating high cholesterol)

If you are not sure about any of the medicines you are taking, show the bottle or package to your pharmacist. If you are taking or have taken any of the above medicines, inform your doctor or pharmacist.

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.

Diarfin Flas should not be used during pregnancy, especially during the first trimester.

Small amounts of the medicine may be excreted in breast milk. Consult your doctor about the appropriate treatment.

Driving and Using Machines

During diarrhea, you may feel dizzy, tired, or drowsy. If you are affected, do not drive, use machinery, or engage in activities that may put you or others at risk.

Diarfin Flas Contains Sodium

This medicine contains less than 1 mmol of sodium (23 mg) per oral lyophilisate; it is essentially "sodium-free".

Diarfin Flas Contains Aspartame

This medicine contains 1.0 mg of aspartame in each oral lyophilisate. Aspartame is a source of phenylalanine, which may be harmful in cases of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot eliminate it properly.

3. How to Take Diarfin Flas

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.

Consult the following table to know the dose of medicine you should take.

• Remove the cap and pour the oral lyophilisate to remove it. Do not press the oral lyophilisate against the foil to extract it.
• Place the correct amount of oral lyophilisates on the tongue. They dissolve quickly in the mouth, so you do not need water to swallow them. Do not chew them. Oral use only.
• Do not use a dose higher than those indicated in the tables.
• The oral lyophilisates should not be taken as prolonged treatment.

Short-term Diarrhea

Elderly Patients

No dose adjustment is necessary in elderly patients.

Patients with Renal Impairment

No dose adjustment is necessary in patients with renal impairment.

Patients with Hepatic Impairment

If you have hepatic impairment, you should consult your doctor or pharmacist before taking this medicine.

Duration of Treatment with Diarfin Flas for Short-term Diarrhea

You can use this medicine for a maximum of 48 hours.

If diarrhea lasts more than 48 hours, if you have repeated diarrhea episodes, or if symptoms change, stop taking loperamide hydrochloride and consult your doctor.

If You Take More Diarfin Flas Than You Should

If you take more loperamide hydrochloride than you should, contact your doctor or hospital immediately for assistance. Symptoms may include increased heart rate, irregular heartbeat, changes in heartbeat (these symptoms can have serious and potentially fatal consequences), muscle stiffness, movement coordination disorders, drowsiness, difficulty urinating, or weak breathing.

Children react more intensely to high doses of loperamide hydrochloride than adults. If a child takes too much or shows any of the above symptoms, call a doctor immediately.

If You Forget to Take Diarfin Flas

You should only take this medicine when you need it, following the administration instructions of the doses indicated above.

If you forget to take a dose, take it after the next soft stool (bowel movement). Do not take a double dose to make up for forgotten doses.

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them; most are usually mild.

Seek medical attention immediately.

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

• Nausea, constipation, or gas
• Headache

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

• Itching or hives
• Stomach pain or swelling
• Dizziness or drowsiness
• Vomiting, indigestion
• Dry mouth

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

• Allergic reactions including unexplained wheezing, difficulty breathing, fainting, or swelling of the face and throat
• Severe skin reactions that can be intense and include blistering or peeling of the skin
• Loss of consciousness or reduced level of consciousness (fainting, feeling of fainting, or decreased alertness), movement coordination disorders
• Difficulty urinating
• Severe constipation
• Feeling of tingling or pinching on the tongue
• Miosis (pupil constriction)
• Fatigue

Frequency Not Known(cannot be estimated from the available data)

• Upper abdominal pain
• Abdominal pain radiating to the back
• Abdominal tenderness
• Fever
• Rapid pulse
• Nausea
• Vomiting
• Which can be symptoms of acute pancreatitis

If you experience any of these side effects, stop taking the medicine and seek medical attention immediately. Consult a doctor as soon as possible.

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 Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Diarfin Flas

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 shown on the box and blister after "EXP". The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Diarfin Flas

The active ingredient is loperamide hydrochloride.

Each oral lyophilisate contains 2 mg of loperamide hydrochloride.

The other ingredients are pullulan, mannitol (E-421), sodium hydrogen carbonate, aspartame (E-951), polysorbate 80, peppermint flavor (corn maltodextrin, flavoring ingredients, and modified corn starch).

Appearance of the Product and Package Contents

Oral lyophilisate.

White or almost white round tablets with the inscription "T" engraved on one side.

Blister packs in packs of 6 or 12 oral lyophilisates.

The blister is composed of a PVC/polyamide/aluminum/PVC blister with a removable paper/PET/aluminum lidding foil.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

S.C. SANTA S.A.

Str. Panselelor nr.25, nr.27, si nr.29,

Brasov, Jud. Brasov - 500419

Romania

Fairmed Health Care GmbH

Maria-Goeppert-Strasse 3

23562 Lubeck, Germany

Date of Last Revision of this Leaflet:May 2022

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