Leaflet: information for the user

Yendol granulated for oral suspension

paracetamol / salicylamide / chlorphenamine maleate / caffeine anhydride

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

Follow exactly the administration instructions for 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 adverse 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 worsen or do not improve after 5 days of treatment or if fever persists for more than 3 days.

This medication achieves its effects through the association of different active principles: paracetamol and salicylamide (reduce pain and fever), chlorphenamine (relieves nasal secretion) and caffeine (counteracts lethargy).

Yendol is used in adults and adolescents over 16 years old for the relief of symptoms in catarrhal and flu-like states that are accompanied by fever, mild or moderate pain, headache, and nasal secretion.

You should consult a doctor if symptoms worsen or do not improve after 5 days of treatment or if fever persists for more than 3 days.

Do not take Yendol

• If you are allergic to paracetamol, salicylamide, chlorphenamine, caffeine or any of the other components of this medication (listed in section 6).
• If you have had allergic reactions when taking acetylsalicylic acid, xanthines (such as aminophylline, theophylline, etc.), any non-steroidal anti-inflammatory (medications used to relieve inflammation, pain and reduce fever) or a dye called tartrazine.
• If you are under 16 years old, as the use of salicylates (such as salicylamide) has been associated with Reye's Syndrome, a rare but serious disease.
• If you have chronic or recurrent ulcers in the upper part of the intestine (duodenal ulcer) or stomach (gastric ulcer).
• If you have a history of bleeding (blood loss) or gastric perforation after treatment with acetylsalicylic acid, salicylamide or other non-steroidal anti-inflammatory medications.
• If you have asthma or nasal polyps associated with asthma that are induced or exacerbated by acetylsalicylic acid.
• If you have bleeding disorders such as hemophilia (blood clotting defect) or hypoprothrombinemia (abnormal decrease in prothrombin levels in the blood, predisposing to bleeding), among others.
• If you have severe kidney and/or liver problems (severe renal and/or hepatic insufficiency).
• If you have any liver disease (with or without liver insufficiency) or viral hepatitis, as it increases the risk of paracetamol hepatotoxicity.
• If you are taking medications to prevent blood clotting (oral anticoagulants).
• If you are in the third trimester of pregnancy.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Yendol.It is especially important to consult your doctor if you:

• Suffer from certain respiratory diseases such as emphysema (a disorder that affects the lungs and causes difficulty breathing), chronic bronchitis, bronchial asthma or when cough is accompanied by excessive secretion, or in cases where symptoms are due to the presence of rhinitis (inflammation and swelling of the nasal mucosa that is characterized by nasal secretion and congestion).
• Suffer from glaucoma of narrow angle (sudden and episodic increases in intraocular pressure),duodenal pyloric obstruction(in the muscular valve that is located between the stomach and the small intestine),vesical neck obstructionorprostatic hypertrophy(difficulty urinating or prostate disease), as your symptoms may worsen.
• Areallergicto some medications calledantihistamines(medications that treat the symptoms of allergic rhinitis and/or urticaria).
• Havecardiac arrhythmias, presenthyperthyroidism,suffer from episodes ofanxiety.
• Are taking anti-inflammatory or other types of medications(antiplatelet agents, corticosteroids, certain antidepressants), as they may interact with Yendol and increase the risk of adverse effects (see the section “Other medications and Yendol”).
• Are an elderly patient (over 65 years old), as you have a higher risk of experiencing adverse effects.
• Have kidney or liver disease, as you may need to adjust the dose.
• Have a deficiency of glucose-6-phosphate dehydrogenase (6GDP) (may cause hemolytic anemia).

Inform your doctor immediately if you have severe diseases, such as severe renal insufficiency or sepsis (when bacteria and their toxins circulate in the blood, causing damage to organs), or if you have malnutrition, chronic alcoholism or if you are also taking flucloxacillin (an antibiotic). A serious disease called metabolic acidosis (a blood and fluid anomaly) has been reported in patients in these situations when using paracetamol at regular doses for a prolonged period or when taking paracetamol with flucloxacillin. Symptoms of metabolic acidosis may include: severe respiratory distress with deep and rapid breathing, drowsiness, feeling unwell (nausea) and vomiting.

Stop taking this medication and see your doctor if you detectblood in stool or vomit, or if you feelexcessive fatigue, as they may be symptoms of gastric bleeding.

Avoid using this medicationif you have recently undergone or will undergo anysurgical intervention or dental extractionwithin the next 7 days.

This medication should not be used regularly to prevent possible discomfort caused byvacinations.

Do not take more medication than recommended in section 3 “How to take Yendol”.

You should be especially careful when taking this medication with other medications that contain any of its active ingredients.

Avoid taking this medication with other medications that contain paracetamol, as high doses may cause liver damage. If you take another medication that contains paracetamol, do not exceed the maximum dose of 3 g per 24 hours (maximum dose in chronic alcoholics is 2 g/day), taking into account the content of all medications you are taking that contain paracetamol.

If you consume alcoholic beverages or are taking sedatives or tranquilizers, be careful when taking this medication, as they may increase its adverse effects.

Children and adolescents

Do not use in children or adolescents under 16 years old(see section “Do not take Yendol”).

Other medications and Yendol

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

Certain medications may interact with Yendol; in these cases, you may need to adjust the dose or discontinue treatment with one of the medications, so do not combine their use without consulting your doctor first.

This is especially important in the case of:

• Other pain-relieving or anti-inflammatory medications (analgesics or anti-inflammatory agents), such as non-steroidal anti-inflammatory drugs and corticosteroids, as they may potentiate the risk of gastrointestinal bleeding or ulceration.
• Blood clotting medications (oral anticoagulants, heparin). See section “Do not take Yendol”.
• Thrombolytics and antiplatelet agents used for the elimination and prevention of blood clots.
• Medications used to lower blood sugar levels (oral antidiabetics, insulin).
• Sedatives or tranquilizers, to treat sleep disturbances, anxiety, etc.
• Medications used to reduce or inhibit stomach acid (antacids) such as cimetidine and ranitidine.
• Antiepileptic medications (phenytoin, barbiturates such as phenobarbital and metharbital, valproic acid, carbamazepine, lamotrigine, primidone).
• Oral contraceptives (medication taken orally to prevent pregnancy or other disorders related to female hormone levels).
• Medications used to increase urine elimination (diuretics) such as loop diuretics.
• Medications used to treat depression (lithium, tricyclic antidepressants, maprotiline, monoamine oxidase inhibitors, selective serotonin reuptake inhibitors).
• Medications used in the treatment of hypertension or heart disease (digoxin, mexiletine,?-blockers, angiotensin-converting enzyme inhibitors (ACEIs) or angiotensin II receptor antagonists).
• Medications used to treat asthma (bronchodilators and theophylline).
• Methotrexate (used to treat cancer and autoimmune diseases such as rheumatoid arthritis).
• Antibiotics such as sulfonamides, isoniazid, chloramphenicol, flucloxacillin; quinolones such as oxolinite acid, ciprofloxacin; erythromycin, vancomycin.
• Medications used to treat gout (probencid, benzobromarone).
• Zidovudine (used to treat HIV infections).
• Medications used to prevent rejection in transplants (ciclosporin).
• Medications used to relieve spasms or contractions of the stomach, intestine and bladder (anticholinergics).
• Medications used to treat nausea and vomiting (such as domperidone, metoclopramide, tropisetron, granisetron, 5HT3 antagonists).
• Ion exchange resins such as cholestyramine (used to prevent cholesterol increase).
• Disulfiram, medication used to treat chronic alcoholism.
• Sympathomimetics (medications used to treat asthma, or medications to accelerate heart rate).
• Thyroxine, medication used to treat thyroid diseases.
• Ephedrine, medication used as a cardiac stimulant.
• Iron supplements for the treatment of anemia.
• Antihistamines, used to treat the symptoms of allergic rhinitis and/or urticaria.
• Medications that are metabolized by cytochrome P450 1A2 (e.g.: theophylline propranolol)
• Medications ototoxic (that can damage the ear).
• Medications photosensitizing (that can cause allergic skin reactions upon contact with sunlight).

Inform your doctor or pharmacist if you are taking flucloxacillin (antibiotic), as there is a serious risk of blood and fluid alteration (metabolic acidosis) that requires urgent treatment (see section 2).

Yendol with food, drinks and alcohol

The simultaneous intake of this medication with beverages containing caffeine may cause nervousness, irritability or insomnia.

Do not consume alcoholic beverages during treatment with this medication. The simultaneous consumption of alcohol during treatment with this medication may potentiate the appearance of adverse effects, both gastrointestinal and on the central nervous system. If you habitually consume alcohol (three or more alcoholic beverages - beer, wine, liquor - per day), taking Yendol may cause gastric bleeding.

Pregnancy and lactation

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

The use of this medication during pregnancy or lactation may be hazardous to the embryo, fetus or infant andshould bemonitored by the doctor.

Pregnancy

Do not take Yendol if you are in the last 3 months of pregnancy, as it may harm the fetus or cause problems during delivery. It may cause renal and cardiac problems in your fetus. It may affect your tendency and that of your baby to bleed and delay or prolong delivery more than expected. Do not take Yendol during the first 6 months of pregnancy unless it is clearly necessary and as your doctor indicates. If you need treatment during this period of time or while trying to become pregnant, you should take the minimum dose for the shortest time possible. From week 20 of pregnancy, salicylamide may cause renal problems in your fetus if taken for more than a few days, which may cause low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If you need treatment for a period longer than a few days, your doctor may recommend additional controls.

Lactation

Do not take this medicationduring lactation withoutconsulting your doctor first. Yendol is excreted in breast milk.

Driving and operating machines

Do not drive or operate tools or machines if you feel drowsiness or decreased reaction capacity until you check that your ability to perform these activities is not affected by taking this medication.

Yendol contains saccharose

This medication contains 6.56 g of saccharose per dose. Patients with hereditary fructose intolerance (IHF), glucose absorption problems or galactose insufficiency, or saccharase-isomaltase insufficiency should not take this medication.

Patients with diabetes mellitus should be aware that this medication contains 6.56 g of saccharose per dose.

Interference with diagnostic tests

If you are to undergo any diagnostic test (including blood, urine, etc.), inform your doctor that you are taking this medication, as it may alter the results.

Athletes

Inform athletes that this medication contains some components that may give a positive result in the doping control analysis.

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

Always use the lowest effective dose. The administration of the medication depends on whether you have painful or feverish symptoms. As these symptoms disappear, discontinue this medication.

The recommended doses are:

• Adults and adolescents over 16 years:

1 tablet every 8 hours. Do not exceed 5 tablets per 24 hours.

Do not take more than 3 grams of paracetamol per 24 hours (see section “Warnings and precautions”).

• Patients with reduced liver, kidney, or heart function:

Do not take this medication without consulting your doctor first, as the dose should be reduced according to the patient's situation.

• Patients with hyperthyroidism or anxiety

Do not take this medication without consulting your doctor first, as the dose should be reduced.

• Patients over 65 years old

Do not take this medication without consulting your doctor first, as they are more prone to experiencing adverse effects.

This medication is administered only orally.

Empty the contents of the packet into a half glass of water, milk, or juice and shake. Take the medication with meals or food, especially if digestive discomfort is noted.

Use in children and adolescents

Children under 16 years old should not take this medication.

If you take more Yendol than you should

There is a greater risk of overdose in elderly patients, patients with liver disease (liver disease), chronic alcoholics, patients with chronic malnutrition, and patients taking certain medications.

The main symptoms of overdose are: headache, dizziness, ringing in the ears, blurred vision, drowsiness, excessive sweating, nausea, vomiting, and occasionally diarrhea. Icterus (yellow discoloration of the skin and eyes) may also occur, loss of appetite, or abdominal pain.

Regarding paracetamol, overdose can also cause coagulation disorders (blood clots and bleeding).

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or go to a medical center immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Yendol

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

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

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

The following are the side effects associated with each active ingredient of the medicine.

Side effects associated with chlorphenamine:

Very common side effects (may affect more than 1 in 10 patients):

• drowsiness (feeling of sleep), dizziness and muscle weakness, facial dyskinesia (presence of abnormal and involuntary movements in the facial muscles), motor discoordination, tremor, paresthesias (sensation of pins and needles in the skin),
• blurred vision, diplopia (double vision),
• dryness of the nose and throat, thickening of mucosities,
• dry mouth, loss of appetite, alterations in taste or smell, gastrointestinal discomfort (nausea, vomiting, diarrhea, constipation, epigastric pain) that can be reduced by taking the medicine with food,
• increased sweating,
• urinary retention or difficulty urinating.

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

• blood disorders (blood alterations) that may appear with symptoms of hemorrhage (bleeding), throat pain or fatigue,
• hypersensitivity reactions, anaphylactic or acute allergic reaction (cough, difficulty swallowing, palpitations, itching, swelling of eyelids or around the eyes, face, tongue, shortness of breath, fatigue), photosensitivity,
• paradoxical excitement (characterized by restlessness, insomnia, tremors, nervousness, delirium, palpitations, and even convulsions), especially at high doses and in children or the elderly,
• ringing in the ears (tinnitus), acute labyrinthitis (inflammation of the inner ear),
• irregular heartbeats (arrhythmias, palpitations, tachycardia), usually with overdose,
• hypotension, hypertension, edema (swelling),
• sensation of chest oppression, wheezing (high-pitched sounds, like whistling, that occur during breathing when the airways are partially blocked),
• bile duct obstruction (detention of bile in its exit to the duodenum), hepatitis or other liver function disorders (with abdominal pain or dark urine, etc.),
• impotence, early menstruation.

Side effects associated with salicylamide:

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

• paroxysmal bronchospasm (contraction of bronchial muscle), severe dyspnea (severe breathing difficulty), rhinitis (inflammation of the nasal mucosa characterized by nasal mucosities, sneezing, nasal congestion, and/or itching),
• gastric ulcer, duodenal ulcer, gastrointestinal hemorrhage (bleeding through the mouth and expulsion of blood through the rectum), dyspepsia (indigestion), nausea, vomiting,
• urticaria, exanthematous eruption (rash), angioedema (swelling of the skin and mucous membranes).

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

• hepatitis (inflammation of the liver), especially in people with juvenile arthritis (inflammation of the joints).

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

• confusion, dizziness, vertigo, headache,
• tinnitus (ringing in the ears), hearing loss,
• sweating,
• kidney problems such as renal insufficiency and acute interstitial nephritis (renal disorder that makes the kidney not function correctly),
• anaphylactic or anaphylactoid reactions (sudden, generalized, potentially severe allergic reactions).

Stop taking Yendol immediately if you experience any type of hearing loss (deafness),tinnitus(ringing in the ears), dizziness, or headache.

Side effects associated with paracetamol:

Side effectsare rare (may affect up to 1 in 1,000 people)

• elevated levels of liver transaminases (evaluate liver function).

Very rare side effects (may affect up to 1 in 10,000 people)

• blood disorders such as thrombocytopenia (decrease in the number of circulating platelets), agranulocytosis (blood disorder that occurs when the count of blood cells is low), leucopenia (low production of white blood cells), neutropenia (abnormally low number of neutrophils [a type of white blood cell] in the blood), hemolytic anemia (decrease in the number of red blood cells due to their rupture),
• hypoglycemia (low blood sugar level),
• hepatotoxicity (yellowing of the skin and the white part of the eyes),
• severe skin reactions,
• sterile pyuria (cloudy urine), renal function disorders,
• hypersensitivity reactions, skin rash (skin eruption), urticaria, or the appearance of anaphylactic shock (acute, generalized, potentially severe allergic reaction).

Stop taking Yendol if you experience anaphylactic shock(acute, generalized, potentially severe allergic reaction that can manifest with difficulty breathing, or decreased blood pressure).

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

• a severe disease that can make the blood more acidic (denominated metabolic acidosis) in patients with severe disease who use paracetamol (see section 2).

Side effects associated with caffeine:

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

• hypoglycemia or hyperglycemia (low or high blood sugar level),
• insomnia, agitation, excitement (nervousness), headache,tinnitus(ringing in the ears), disorientation, anxiety neurosis (at high doses),
• extrasystoles (premature heartbeat compared to the normal heart rate of the individual), palpitations, tachycardia, cardiac arrhythmia,
• tachypnea (increased breathing rate),
• polyuria (increased urine volume).

Other side effects in children and adolescents

Side effects associated with chlorphenamine:

Side effects of unknown frequency (cannot be estimated from available data): In children, it may cause a paradoxical reaction characterized by excitement, restlessness, irritability, and insomnia.

Side effects associated withsalicylamide:

Side effects are rare (up to 1 in 1,000 people): Reye's syndrome (a severe disease that causes intense vomiting, loss of consciousness, irritability, convulsions...) in children under 16 years old who recover from a viral disease such as flu or chickenpox. See the "Do not take Yendol" section.

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 that does not appear in this prospectus. You can also report them directly through the Spanish System for the 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.

Keepthis medicationout of the sight and reach of children.

No special storage conditions are required.

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

Do not dispose of medications through drains or trash. Dispose of packaging and unused medications at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Yendol

- The active principles are: paracetamol, salicylamide, chlorphenamine maleate, and anhydrous caffeine. Each sachet contains 200 mg of paracetamol, 500 mg of salicylamide, 3 mg of chlorphenamine maleate, and 30 mg of anhydrous caffeine.

- The other components are: citric acid monohydrate, sodium saccharin, sucrose, sodium lauryl sulfate, orange aroma, and yellow quinoline (E-104) dye.

Appearance of the product and content of the packaging

Yendol is a yellow-colored oral suspension granule with an orange odor. It is presented in packs of 10 sachets.

Holder of the marketing authorization

Faes Farma, S.A.

Autonomia Etorbidea, 10

48940 Leioa (Bizkaia)

Spain

Responsible for manufacturing

Faes Farma, S.A.

Maximo Agirre Kalea, 14

48940 Leioa (Bizkaia)

Spain

Last review date of this leaflet:July 2023

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