Leaflet: information for the user

Diarfin Flas 2mg lyophilized oral

hydrochloride of loperamide

Read 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 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 it worsens or does not improve after 2 days.

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

2.What you need to know before starting to take Diarfin Flas

3.How to take Diarfin Flas

4.Possible side effects

5.Storage of Diarfin Flas

6.Contents of the package and additional information

This medication contains hydrochloride of loperamide, which allows stopping diarrhea by solidifying the feces and reducing the frequency of bowel movements.It is used to treat sudden, short-term (acute) episodes of diarrhea in adults and adolescents over 12 years old.This medication 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.

Do not takeDiarrheal Flas

• if you are allergic to hydrochloride of loperamide or to any of the other components of this medication (listed in section 6)
• in the case of children under 2 years old
• if you have acute diarrhea, 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, includingSalmonella,ShigellaandCampylobacter
• if you suffer from pseudomembranous colitis associated with the use of broad-spectrum antibiotics
• in all cases where bowel movements should not be inhibited. Discontinue the medication immediately in case of constipation or abdominal inflammation.

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

Warnings and precautions

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

• if you suffer from AIDS and your stomach swells, stop taking the oral lyophilizates immediately and see your doctor right away
• if you have liver disease
• if you have diarrhea that lasts more than 48 hours, stop taking the medication and consult your doctor
• if you have intense diarrhea, you will lose many liquids (dehydration). With these liquids, other important substances are also lost. Dehydration symptoms may include dry mouth and dizziness. Vomiting can cause dehydration; this risk is especially present in young children and the elderly. Therefore, the first measures to combat diarrhea should be to provide liquids and retain them in the body. This means you should drink a lot and take a supplementary intake of salt and sugar. You can buy a special mixture of salt and sugar (oral rehydration solution) at the pharmacy that should be dissolved in water. Consult your doctor or pharmacist for advice.

Other medications and Diarrheal Flas

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

If you are taking any of the following medications in particular:

• ritonavir (to treat HIV)
• quinidine (to treat heart rhythm abnormalities or malaria)
• desmopressin oral (to treat excessive urination)
• itraconazole or ketoconazole (to treat fungal infections)
• gemfibrozil (to treat high cholesterol)

If you are unsure about any of the medications you are taking, show the bottle or packaging to your pharmacist. If you are taking or have taken any of the above medications, inform your doctor or pharmacist.

Pregnancy and breastfeeding

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

This medication should not be used during pregnancy, especially during the first trimester.

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

Driving and operating machinery

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

Diarheal Flas contains sodium

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

Diarheal Flas contains aspartameThis medication contains 1.0 mg of aspartame in each oral lyophilizate. Aspartame contains a source of phenylalanine that may be harmful in the case of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it correctly.

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.

Consult the following table to know the medication dose you should take.

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

Short-term diarrhea

Older patients

No dose adjustment is necessary for older patients.

Patients with renal insufficiency

No dose adjustment is necessary for patients with renal insufficiency.

Patients with liver insufficiency

If you have liver insufficiency, consult your doctor or pharmacist before taking this medication.

Treatment duration with Diarfin Flas for short-term diarrhea

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

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

If you take moreDiarfin Flasthan you should

If you take more hydrochloride of loperamide than you should, contact your doctor or a hospital immediately to receive assistance. Symptoms may include the following: increased heart rate, irregular heartbeats, heart rhythm disturbances (these symptoms may have potentially severe and fatal consequences), muscle stiffness, movement coordination difficulties, drowsiness, difficulty urinating or weak breathing.

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

If you forgot to takeDiarfin Flas

You should only take this medication when needed, following the administration instructions for the doses indicated above.

If you forget to take a dose, take it after the next loose stool (intestinal evacuation). Do not take a double dose to compensate for the missed doses.

Like all medicines, this medicine may cause side effects, although not everyone will experience them; most are usually mild.

Seek immediate medical assistance.

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

• Nausea, constipation, or gas
• Headache

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

• Itching or urticaria
• Abdominal pain or swelling
• Dizziness or drowsiness
• Vomiting, indigestion
• Dry mouth

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

• Allergic reactions including unexplained wheezing, difficulty breathing, fainting, or swelling of the face and throat
• Intense skin eruptions that may be accompanied by blistering or peeling of the skin
• Loss of consciousness or reduction in level of consciousness (fainting, feeling faint, or decreased alertness), movement coordination difficulties
• Urination difficulties
• Severe constipation
• Burning or prickling sensation on the tongue
• Miosis (pupil constriction of the eye)
• Fatigue

Frequency unknown(cannot be estimated from available data)

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

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

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist,even if it is a possible side effect not listed 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 side 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 box and the blister pack 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 the containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition ofDiarfin Flas

The active ingredient is hydrochloride of loperamide.

Each lyophilized oral contains 2mg of hydrochloride of loperamide.

The other components are pullulan, mannitol (E-421), sodium hydrogen carbonate, aspartame (E-951), polisorbate80, peppermint flavor (cornstarch, flavoring ingredients, and modified cornstarch).

Appearance of the product and content of the container

Lyophilized oral.

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

Blister packs in containers of 6 or 12lyophilized oral.

The blister pack is composed of a PVC/polyamide/aluminum/PVC blister with a removable sealing layer of paper/PET/aluminum.

Only some sizes of containers may be commercially marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Laboratorios Cinfa, S.A

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra) – Spain

Responsible manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Industrial Estate 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

Last review date of this leaflet:May 2022

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