Yendol granules for oral suspension

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Yendol granules for oral suspension

paracetamol / salicylamide / chlorpheniramine maleate / anhydrous caffeine

Read all of this 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 side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 5 days of treatment, or if fever persists for more than 3 days.

Contents of the leaflet

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

1. What Yendol is and what it is used for

This medicine achieves its effects through the combination of different active substances: paracetamol and salicylamide (reduce pain and fever), chlorpheniramine (relieves nasal discharge), and caffeine (counteracts feelings of fatigue).

Yendol is used in adults and adolescents over 16 years of age for the relief of symptoms in cold and flu-like conditions associated with fever, mild to moderate pain, headache, and nasal discharge.

You should consult a doctor if your condition worsens or does not improve after 5 days of treatment, or if fever persists for more than 3 days.

2. What you need to know before taking Yendol

Do not take Yendol

• If you are allergic to paracetamol, salicylamide, chlorpheniramine, caffeine, or any of the other components of this medicine (listed in section 6).
• If you have previously experienced allergic reactions when taking acetylsalicylic acid, xanthines (such as aminophylline, theophylline, etc.), any non-steroidal anti-inflammatory drugs (medicines used to relieve inflammation, pain, and reduce fever), or a dye called tartrazine.
• If you are under 16 years of age, as the use of salicylates (such as salicylamide) has been associated with Reye's syndrome, a rare but serious illness.
• If you have chronic or recurrent ulcers in the upper part of the intestine (duodenal ulcer) or in the stomach (gastric ulcer).
• If you have a history of gastrointestinal bleeding or perforation following treatment with acetylsalicylic acid, salicylamide, or other non-steroidal anti-inflammatory drugs.
• If you suffer from asthma or nasal polyps associated with asthma that are induced or worsened by acetylsalicylic acid.
• If you have blood coagulation disorders such as haemophilia (a blood clotting defect) or hypoprothrombinemia (abnormally low levels of prothrombin in the blood, which predisposes 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 hepatic insufficiency) or viral hepatitis, as this increases the risk of paracetamol hepatotoxicity.
• If you are being treated with medicines 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 lung disorder causing difficulty breathing), chronic bronchitis, bronchial asthma, or when cough is accompanied by excessive secretions, or in cases where your symptoms are due to rhinitis (inflammation and swelling of the nasal mucosa, characterized by nasal discharge and congestion).
• Suffer from narrow-angle glaucoma (sudden, episodic increases in intraocular pressure), pyloroduodenal obstruction (blockage at the muscular valve between the stomach and the small intestine), vesical neck obstruction or prostatic hypertrophy (difficulty urinating or prostate disease), as your symptoms may worsen.
• Are allergic to medicines called antihistamines (medicines used to treat symptoms of allergic rhinitis and/or urticaria).
• Have cardiac arrhythmias, hyperthyroidism (overactive thyroid gland), or suffer from anxiety.
• Are being treated with anti-inflammatory drugs or other types of medicines (antiplatelet agents, corticosteroids, certain antidepressants), as they may interact with Yendol and increase the risk of adverse effects (see section “Other medicines and Yendol”).
• Are an elderly patient (over 65 years of age), as you are at higher risk of experiencing adverse effects.
• Have kidney or liver disease, as dose adjustment may be necessary.
• Have glucose-6-phosphate dehydrogenase deficiency (6GPD) (which may cause haemolytic anaemia).

During treatment with Yendol, inform your doctor immediately if you develop serious conditions such as severe renal failure or sepsis (when bacteria and their toxins circulate in the blood, causing organ damage), or if you suffer from malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic). A serious condition called metabolic acidosis (an abnormality in blood and body fluids) has been reported in patients in these situations when paracetamol is used regularly over a prolonged period or when paracetamol is taken together with flucloxacillin. Symptoms of metabolic acidosis may include: severe difficulty breathing with deep and rapid breathing, drowsiness, malaise (nausea), and vomiting.

Stop taking this medicine and see your doctor immediately if you notice blood in your stools or vomit, or experience severe fatigue, as these may be symptoms of stomach bleeding.

Avoid using this medicine if you have recently undergone or are scheduled to undergo any surgical procedure or dental extraction within the next 7 days.

This medicine should not be used regularly to prevent discomfort associated with vaccinations.

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

Special care should be taken when using this medicine together with other medicines containing any of its active ingredients.

Concurrent use of this medicine with other medicines containing paracetamol should be avoided, as high doses may cause liver damage. If another medicine containing paracetamol is administered, the maximum daily dose of paracetamol should not exceed 3 g every 24 hours (the maximum dose in chronic alcoholics is 2 g/day), taking into account the paracetamol content in all medicines you are using.

If you consume alcoholic beverages or are taking sedatives or tranquilizers, you should exercise special caution when taking this medicine, as they may increase its adverse effects.

Children and adolescents

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

Other medicines and Yendol

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicine.

Certain medicines may interact with Yendol; in such cases, it may be necessary to adjust the dose or discontinue treatment with one of the medicines. Therefore, do not combine its use without first consulting your doctor.

This is especially important in the case of:

• Other pain or inflammation relief medicines (analgesics or anti-inflammatory drugs), such as non-steroidal anti-inflammatory drugs and corticosteroids, as they may increase the risk of gastrointestinal bleeding or ulceration.
• Medicines for blood clotting (oral anticoagulants, heparin). See section “Do not take Yendol”.
• Thrombolytics and antiplatelet agents used to dissolve and prevent blood clots.
• Medicines to lower blood sugar levels (oral antidiabetics, insulin).
• Sedatives or tranquilizers used to treat sleep disorders, anxiety, etc.
• Medicines used to reduce or inhibit stomach acid (antacids) such as cimetidine and ranitidine.
• Antiepileptics (phenytoin, barbiturates such as phenobarbital and methylphenobarbital, valproic acid, carbamazepine, lamotrigine, primidone).
• Oral contraceptives (medicines taken orally to prevent pregnancy or treat hormone-related disorders).
• Medicines used to increase urine elimination (diuretics) such as loop diuretics.
• Medicines used to treat depression (lithium, tricyclic antidepressants, maprotiline, monoamine oxidase inhibitors, selective serotonin reuptake inhibitors).
• Medicines used in the treatment of hypertension or heart diseases (digoxin, mexiletine, β-blockers, angiotensin-converting enzyme inhibitors (ACE inhibitors), or angiotensin II receptor antagonists).
• Medicines used to treat asthma (adrenergic bronchodilators and theophylline).
• Methotrexate (used in the treatment of cancer and autoimmune diseases such as rheumatoid arthritis).
• Antibiotics such as sulfonamides, isoniazid, chloramphenicol, flucloxacillin; quinolones such as oxolinic acid, ciprofloxacin; erythromycin, vancomycin.
• Medicines used in the treatment of gout (probenecid, benzbromarone).
• Zidovudine (used in the treatment of HIV infections).
• Medicines used to prevent transplant rejection (cyclosporine).
• Medicines used to relieve spasms or contractions of the stomach, intestines, and bladder (anticholinergics).
• Medicines 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, a medicine used in the treatment of chronic alcoholism.
• Sympathomimetics (medicines used to treat asthma, or medicines to increase heart rate).
• Thyroxine, a medicine used in the treatment of thyroid disorders.
• Ephedrine, a medicine used as a cardiac stimulant.
• Iron supplements used to treat anaemias.
• Antihistamines, used to treat symptoms of allergic rhinitis and/or urticaria.
• Drugs metabolized by cytochrome P450 1A2 (e.g., theophylline, propranolol).
• Ototoxic medicines (which may damage the ear).
• Photosensitizing medicines (which may cause allergic skin reactions upon exposure to sunlight).

Inform your doctor or pharmacist if you are taking flucloxacillin (an antibiotic), due to a serious risk of blood and fluid imbalance (called metabolic acidosis) that requires urgent treatment (see section 2).

Taking Yendol with food, drinks, and alcohol

Taking this medicine simultaneously with beverages containing caffeine may cause nervousness, irritability, or insomnia.

Do not consume alcoholic beverages during treatment with this medicine. Consuming alcohol simultaneously with this medicine may increase the risk of adverse effects, both gastrointestinal and on the central nervous system. If you regularly consume alcohol (three or more alcoholic drinks—beer, wine, spirits—per day), taking Yendol may cause stomach bleeding.

Pregnancy and breastfeeding

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

The use of this medicine during pregnancy or breastfeeding may be harmful to the embryo, fetus, or infant and should be monitored by your doctor.

Pregnancy

Do not take Yendol during the last 3 months of pregnancy, as it may harm the fetus or cause complications during delivery. It may cause kidney and heart problems in your fetus. It may affect your tendency and your baby's tendency to bleed and may delay or prolong labour beyond expected duration. Do not take Yendol during the first 6 months of pregnancy unless clearly necessary and as directed by your doctor. If treatment is needed during this period or while trying to conceive, you should take the lowest effective dose for the shortest possible time. From week 20 of pregnancy, salicylamide may cause kidney problems in your fetus if taken for more than a few days, leading to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If treatment is needed for longer than a few days, your doctor may recommend additional monitoring.

Lactation

It is not recommended to take this medicine during breastfeeding without first consulting your doctor. Yendol is excreted in breast milk.

Driving and using machines

Do not drive or operate tools or machinery if you experience drowsiness or reduced reaction capacity until you determine that your ability to perform these activities is not affected by taking this medicine.

Yendol contains sucrose

This medicine contains 6.56 g of sucrose per dose. Patients with hereditary fructose intolerance (HFI), glucose-galactose malabsorption, or saccharase-isomaltase deficiency should not take this medicine.

Patients with diabetes mellitus should be aware that this medicine contains 6.56 g of sucrose per sachet.

Interference with diagnostic tests

If you are scheduled for any diagnostic tests (including blood and urine tests), inform your doctor that you are taking this medicine, as it may alter test results.

Athletes

Athletes should be informed that this medicine contains components that may lead to a positive result in doping control tests.

3. How to take Yendol

Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Always use the lowest effective dose. The administration of the medicine depends on whether you are experiencing painful or febrile symptoms. As these symptoms subside, this medication should be discontinued.

The recommended doses are:

• Adults and adolescents over 16 years of age:

1 sachet every 8 hours. Do not exceed 5 sachets in any 24-hour period.

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

• Patients with reduced organ function (liver, kidney, or heart impairment):

Do not take this medicine without first consulting your doctor, as the dose should be adjusted according to the patient's condition.

• Patients with hyperthyroidism or anxiety:

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

• Elderly patients (over 65 years of age):

Do not take this medicine without first consulting your doctor, as they are more likely to experience adverse effects.

This medicine is for oral use only.

Empty the contents of the sachet into a half glass of water, milk, or juice and stir. Take the medicine with food or meals, especially if gastrointestinal discomfort occurs.

Use in children and adolescents

This medicine must not be taken by children under 16 years of age.

If you take more Yendol than you should

There is an increased risk of overdose in elderly individuals, patients with liver disease (hepatic disease), chronic alcoholics, chronically malnourished patients, and patients taking certain medications.

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

With regard to paracetamol, overdose may also cause coagulation disorders (blood clots and bleeding).

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, go to a medical center immediately, or call the Toxicology Information Service at: 91 562 04 20, stating the name of the medicine and the amount ingested.

If you forget to take Yendol

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

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 will experience them.

Below are the adverse effects associated with each active substance in the medicine.

Adverse effects associated with chlorpheniramine:

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

• drowsiness (feeling sleepy), dizziness and muscle weakness, facial dyskinesia (presence of abnormal, involuntary movements in the facial muscles), motor incoordination, tremor, paresthesia (tingling sensation in the skin),
• blurred vision, diplopia (double vision),
• dryness of nose and throat, thickening of mucus secretions,
• dry mouth, loss of appetite, disturbances in taste or smell, gastrointestinal discomfort (nausea, vomiting, diarrhea, constipation, epigastric pain) which may be reduced by taking the medicine with food,
• increased sweating,
• urinary retention or difficulty urinating.

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

• blood dyscrasias (blood disorders) that may present with symptoms of bleeding (hemorrhage), sore throat, or fatigue,
• hypersensitivity reactions, anaphylactic or acute allergic reaction (cough, difficulty swallowing, palpitations, itching, swelling of eyelids or around the eyes, face, tongue, dyspnea, fatigue), photosensitivity,
• paradoxical excitation (characterized by restlessness, insomnia, tremors, nervousness, delirium, palpitations, and even seizures), especially at high doses and in children or elderly patients,
• tinnitus (perception of ringing or buzzing in the ear), acute labyrinthitis (inflammation of the inner ear),
• irregular heartbeat (cardiac arrhythmias, palpitations, tachycardia), usually with overdose,
• hypotension, hypertension, edema (swelling),
• sensation of chest tightness, wheezing (high-pitched, whistling sounds during breathing when airways are partially blocked),
• cholestasis (arrest of bile flow into the duodenum), hepatitis or other liver function disorders (with stomach or abdominal pain, dark urine, etc.),
• impotence, menstrual cycle disturbances.

Adverse effects associated with salicylamide:

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

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

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

• hepatitis (liver inflammation), especially in individuals with juvenile arthritis (joint inflammation).

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

• confusion, dizziness, vertigo, headache,
• tinnitus (perception of ringing or buzzing in the ear), deafness,
• sweating,
• kidney problems such as renal failure and acute interstitial nephritis (a kidney disorder causing impaired kidney function),
• anaphylactic or anaphylactoid reactions (sudden, generalized, potentially severe allergic reactions).

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

Adverse effects associated with paracetamol:

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

• elevated levels of hepatic transaminases (used to assess liver function).

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

• blood disorders such as thrombocytopenia (reduced number of circulating platelets in the bloodstream), agranulocytosis (a blood disease caused by low blood cell count), leucopenia (reduced production of leukocytes or white blood cells), neutropenia (abnormally low number of neutrophils [a type of white blood cell] in the blood), hemolytic anemia (reduction in red blood cells due to red blood cell rupture),
• hypoglycemia (low blood glucose or sugar levels),
• hepatotoxicity (yellowing of the skin and whites of the eyes),
• severe skin reactions,
• sterile pyuria (cloudy urine), kidney function disturbances,
• hypersensitivity reactions, skin rash, urticaria, or onset of anaphylactic shock (severe acute allergic reaction).

Stop taking Yendol if you experience anaphylactic shock (a severe acute allergic reaction that may present with difficulty breathing or decreased blood pressure).

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

• a serious condition that may cause the blood to become more acidic (called metabolic acidosis) in patients with severe illness who are using paracetamol (see section 2).

Adverse effects associated with caffeine:

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

• hypoglycemia or hyperglycemia (low or high blood glucose or sugar levels),
• insomnia, agitation, excitement (nervousness), headache, tinnitus (ringing or buzzing in the ear), disorientation, anxiety neurosis (at high doses),
• extrasystoles (premature heartbeat relative to the individual's normal heart rate), palpitations, tachycardia, cardiac arrhythmia,
• tachypnea (increased respiratory rate),
• polyuria (increased urine volume).

Other adverse effects in children and adolescents

Adverse effects associated with chlorpheniramine:

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

Adverse effects associated with salicylamide:

Rare adverse effects (up to 1 in 1,000 people): Reye's syndrome (a serious illness causing severe vomiting, loss of consciousness, irritability, seizures, etc.) in individuals under 16 years of age recovering from a viral illness such as influenza or chickenpox. See section "Do not take Yendol".

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 Medicinal Products: https://www.notificaRAM.es/. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Yendol

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

No special storage conditions are required.

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 in doubt, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Yendol

• The active substances are: paracetamol, salicylamide, maleate chlorphenamine and anhydrous caffeine. Each sachet contains 200 mg of paracetamol, 500 mg of salicylamide, 3 mg of maleate chlorphenamine and 30 mg of anhydrous caffeine.
• The other components are: citric acid monohydrate, sodium saccharin, sucrose, sodium lauryl sulfate, orange flavour and quinoline yellow colour (E-104).

Appearance of the product and contents of the pack

Yendol is a yellow granulate for oral suspension with an orange odour. It is supplied in packs of 10 sachets.

Marketing Authorisation Holder

Faes Farma, S.A.

Autonomia Etorbidea, 10

48940 Leioa (Bizkaia)

Spain

Manufacturer

Faes Farma, S.A.

Maximo Agirre Kalea, 14

48940 Leioa (Bizkaia)

Spain

Date of the most recent revision of this leaflet: July 2023

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