ALGIDOL 650 mg / 10 mg / 500 mg ORAL SOLUTION GRANULES

2. What you need to know before taking Algidol

Do not take Algidol

• If you are allergic to the active ingredients or to any of the other components of this medication (listed in section 6).
  • To relieve pain in children and adolescents (0-18 years old) after tonsillectomy or adenoidectomy due to obstructive sleep apnea syndrome.
  • If you know you metabolize codeine to morphine very quickly.
  • If you are breastfeeding.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Algidol. Do not take more than the recommended dose in section 3.

During treatment with Algidol, inform your doctor:

• If you have serious illnesses, such as severe kidney failure or sepsis (when bacteria and their toxins circulate in the blood, causing damage to organs), or if you have malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic). A serious disease called metabolic acidosis (an anomaly in the blood and fluids) has been reported in patients in these situations when paracetamol is used at regular doses for a prolonged period or when paracetamol is taken with flucloxacillin. The symptoms of metabolic acidosis may include: severe breathing difficulties with deep and rapid breathing, drowsiness, feeling of discomfort (nausea) and vomiting.

• In case of anemia (decrease in red blood cells), any heart disease, lung disease, kidney disease, a thyroid disease called hypothyroidism, or a gland called the adrenal gland, if you are elderly or weak, if you have had a head injury, or if you have an enlarged prostate. In these cases, avoid prolonged treatments, as the medication contains paracetamol.
• If you are asthmatic and also have sensitivity or allergy to acetylsalicylic acid, as taking paracetamol may cause asthma. Avoid taking high doses.
• Also, prolonged treatments should be avoided in liver diseases, with or without liver failure (including viral hepatitis). The maximum dose in case of liver failure is 2 g/day of paracetamol (one sachet of Algidol every 8 hours).
• If you are taking other medications that contain paracetamol, as this may increase its toxicity in the liver. As a general rule, you should not take more than 4 g/day of paracetamol.
• Consuming alcoholic beverages (three or more alcoholic beverages per day) may cause paracetamol to damage the liver. In alcoholic patients, you should not take more than 2 g/day of paracetamol (which is equivalent to a maximum dose of one sachet of Algidol every 8 hours).
• If you have had a head injury and have high intracranial pressure, or if you have respiratory depression (breathing problems), as codeine may worsen your symptoms.
• Avoid prolonged and excessive administration of the preparation, as codeine can cause psychological dependence, physical dependence, and tolerance with withdrawal symptoms after stopping the medication. Therefore, after prolonged treatments, its administration should be gradually interrupted.
• If you have had kidney stones or gout, if you have excess iron in the blood, or if you are diabetic, as ascorbic acid may worsen these conditions.

Codeine is converted to morphine in the liver by an enzyme. Morphine is the substance that produces pain relief. Some people have a variation of this enzyme that can affect people in different ways. In some people, morphine is not produced or is produced in very small quantities, and it will not provide sufficient pain relief. Other people are more likely to suffer from serious adverse reactions because they produce a very high amount of morphine. If you experience any of the following side effects, you should stop taking this medication and seek medical help immediately: slow or shallow breathing, confusion, drowsiness, constricted pupils, nausea or vomiting, constipation, loss of appetite.

Consult your doctor, even if any of the above circumstances have occurred to you in the past.

Interference with Laboratory Tests: If you are going to have any diagnostic tests (including blood or urine tests), inform your doctor that you are taking this medication, as it may alter the results.

This medication may interfere with the following diagnostic tests:

• Uric Acid
• Blood Glucose
• Urine Glucose
• Stool Blood
• Paracetamol Determinations in Urine

Children and Adolescents

This medication should not be used in children under 12 years old or in adolescents weighing less than 43 kg.

Use in children and adolescents after surgery:

Codeine should not be used for pain relief in children and adolescents after tonsillectomy or adenoidectomy due to obstructive sleep apnea syndrome.

Use in children with respiratory problems:

Codeine is not recommended for use in children with respiratory problems, as the symptoms of morphine toxicity may be worse in these children.

Other Medications and Algidol

Inform your doctor or pharmacist that you are using, have recently used, or may need to use any other medication.

Paracetamol may interact with the following medications:

• Oral Anticoagulants (used to thin the blood) such as acenocoumarol and warfarin, as doses greater than 2 g/day of paracetamol may increase the anticoagulant effect of these medications.
• Anticholinergics (used to relieve stomach, intestine, and bladder spasms or contractions), as they may delay or reduce the action of paracetamol.
• Oral Contraceptives (used to prevent pregnancy) and estrogen treatments, as they may reduce the effect of paracetamol.
• Antiepileptics (used to treat epilepsy), such as phenytoin or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine, as they may delay or reduce the effect of paracetamol. In the case of lamotrigine, paracetamol may reduce the effect of this medication.
• Antivirals used to treat HIV infections, such as zidovudine. Paracetamol may reduce the effects of this medication.
• Beta-blockers (used to treat hypertension and tachycardia) such as propranolol, as they may increase the action of paracetamol.
• The antibiotic chloramphenicol (used to treat infections), as paracetamol may increase its toxicity.
• Diuretics, such as furosemide, as paracetamol may reduce the effect of these medications.
• Antitubercular medications (used to treat tuberculosis), such as isoniazid and rifampicin, as they may increase the action and toxicity of paracetamol.
• Anti-emetics (used to prevent nausea and vomiting), such as metoclopramide and domperidone, as these medications may increase the absorption of paracetamol.
• Flucloxacillin (an antibiotic), due to a serious risk of alteration of blood and fluids (called metabolic acidosis with high anion gap) that should be treated urgently (see section 2).
• Medications used to treat gout, such as probenecid and sulfinpyrazone, as the first may increase the action of paracetamol and the second may decrease it.
• Ion exchange resins (used to decrease cholesterol levels in the blood), such as cholestyramine, as they may reduce the amount of paracetamol in the blood.

Codeine may interact with the following medications:

• Narcotic analgesics (used to treat pain), such as nalbuphine, buprenorphine, and pentazocine. Do not take Algidol if you are taking narcotic analgesics, as codeine may reduce the effect of these medications.
• Anxiolytics (used to treat anxiety), antidepressants (used to treat depression), sedating antihistamines (used to treat allergies), medications used to treat hypertension and migraines, such as clonidine, hypnotics, and neuroleptics (used to treat insomnia), sedatives (used to treat depression and anxiety), and the medication thalidomide (used to treat certain types of cancer). Codeine may increase the effects of these medications on the nervous system, reducing alertness.
• Other opioid analgesics, barbiturates, benzodiazepines (used to treat pain), along with codeine, increase the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening. Due to this, concomitant use should only be considered when other treatment options are not possible.

However, if your doctor prescribes Algidol along with sedative medications, your doctor should limit the dose and duration of concomitant treatment.

Inform your doctor about all sedative medications you are taking and closely follow the recommended dose from your doctor. It may be useful to inform friends or family members who are aware of the signs and symptoms indicated above. Contact your doctor when you experience these symptoms.

On the other hand, ascorbic acid may interact with the following medications:

• Oral Anticoagulants (used to thin the blood), as high amounts of ascorbic acid (more than 2 g/day) may hinder the absorption of these medications.
• Antacids containing aluminum (used to relieve stomach acidity), as ascorbic acid may increase the absorption of aluminum and cause toxicity.
• Oral Contraceptives (used to prevent pregnancy), such as ethinylestradiol, as high doses of ascorbic acid may hinder their absorption. It is recommended to use additional contraceptive methods (e.g., barrier methods).
• Antivirals with indinavir (used to treat HIV-infected individuals), as ascorbic acid may reduce the efficacy of these medications.
• Medications or dietary supplements containing cyanocobalamin (vitamin B12), as ascorbic acid may reduce its effect.
• Other medications that contain ascorbic acid (vitamin C), as this may increase the occurrence of adverse effects due to ascorbic acid.
• Medications or dietary supplements containing amygdalin (vitamin B17), as they may increase their toxicity.
• Chelating agents for iron (used to reduce the amount of iron and aluminum in the body), such as deferoxamine, as they may cause heart problems.

Do not use with other analgesics (medications that reduce pain) without consulting your doctor. As a general rule for any medication, it is recommended to systematically inform your doctor or pharmacist if you are being treated with another medication. In the case of treatment with oral anticoagulants, it can be administered occasionally as the analgesic of choice.

Taking Algidol with Food, Beverages, and Alcohol

Alcoholic beverages should not be consumed while being treated with Algidol. If you regularly consume alcohol, inform your doctor or pharmacist, as it may increase the risk of paracetamol's toxic effects on the liver and increase the alteration that codeine produces on alertness.

Pregnancy, Breastfeeding, and Fertility

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

Do not take codeine if you are breastfeeding. Codeine and morphine pass into breast milk.

Driving and Using Machines

Be especially careful when driving vehicles, handling hazardous machinery, and, in general, in activities where lack of concentration and skill may pose a risk, as this medication may cause drowsiness.

Algidol Contains Sucrose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

This medication may cause allergic reactions because it contains the yellow-orange colorant S (E-110). It may cause asthma, especially in patients allergic to acetylsalicylic acid.

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

3. How to Take Algidol

Follow the administration instructions of this medication exactly as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

This medication should not be taken for more than 3 days. If the pain does not improve after 3 days, ask your doctor for advice.

Dosage:

The dose of Algidol should be as indicated by your doctor according to your individual needs.

Adults:

The recommended dose in adults is 1 sachet every 4/6 hours, not exceeding 6 sachets every 24 hours.

Pediatric Population:

The dose will be as prescribed by the doctor and adjusted according to the severity of the process and the patient's response. The recommended doses are:

Adolescents from 15 years old: 1 sachet every 4-6 hours, as needed, not exceeding 6 sachets every 24 hours.

Adolescents from 13 years old:

• Weight between 43 and 54 kg: 1 sachet every 6 hours, as needed, not exceeding 4 sachets every 24 hours (2,600 g of paracetamol).
• Weight over 54 kg: up to 1 sachet every 4-6 hours, as needed, not exceeding 5 sachets every 24 hours (3,250 g of paracetamol).

Algidol should not be administered to children under 12 years old or to adolescents weighing less than 43 kg.

Children under 12 years old should not take Algidol due to the risk of serious respiratory problems.

Elderly Patients: the recommended dose is 1 sachet every 8 hours.

Patients with Liver Disease: before taking this medication, you must consult your doctor. You should take the prescribed amount of medication with a minimum interval of 8 hours between each dose. Do not take more than 2 grams of paracetamol in 24 hours.

Patients with Kidney Disease: before taking this medication, you must consult your doctor.

Due to the dose, the medication is not indicated for this group of patients.

Method of Administration:

For administration, the contents of the sachet should be dissolved in half a glass of water. Algidol can be taken before, during, or after meals.

If you think the effect of Algidol is too strong or too weak, inform your doctor or pharmacist.

If You Take More Algidol Than You Should

If you take more Algidol than indicated, consult your doctor immediately or contact the Toxicology Information Service, Telephone 915 620 420.

If You Forget to Take Algidol

Do not take a double dose to make up for forgotten doses, simply take the forgotten dose when you remember, and take the next doses with the indicated interval between doses (at least 4 hours).

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

4. Possible Adverse Effects

Like all medicines, Algidol can produce adverse effects, although not all people suffer from them.

The observed adverse effects are described below according to their frequency of presentation:

Uncommon (may affect up to 1 in 100 patients), rare (may affect up to 1 in 1,000 patients), and very rare (may affect up to 1 in 10,000 patients).

The following adverse effects have been observed and are produced by paracetamol:

Rare: Discomfort, increased levels of liver transaminases (liver enzymes), and hypotension (decrease in blood pressure).

Very rare: Severe skin reactions, allergic reactions (hypersensitivity) ranging from a simple skin rash (redness or inflammation of the skin) or urticaria (hives) to anaphylactic shock (a type of severe allergic reaction), hepatotoxicity (liver toxicity), and jaundice (yellowish color of skin and mucous membranes), hypoglycemia (reduced glucose levels in the blood), thrombocytopenia (reduction of platelets in the blood), agranulocytosis, leucopenia, neutropenia (decrease in white blood cells in the blood), hemolytic anemia (decrease in red blood cells in the blood), sterile pyuria (cloudy urine), and adverse renal effects.

Frequency not known (cannot be estimated from the available data): A severe disease that can make the blood more acidic (called metabolic acidosis) in patients with severe illness using paracetamol (see section 2).

The following adverse effects have been described and are produced by codeine:

Rare: Discomfort, drowsiness (feeling of sleep), constipation, nausea, and vertigo, bronchospasm (spasms in the bronchi that make breathing difficult), and respiratory depression (slow breathing).

Very rare: Allergic reactions (hypersensitivity) ranging from a simple skin rash or urticaria to anaphylactic shock, fever, jaundice (yellowish color of the skin and eyes), hypoglycemia (reduced glucose levels in the blood), thrombocytopenia, agranulocytosis, leucopenia, neutropenia, hemolytic anemia.

The following adverse effects have been described and are produced by ascorbic acid:

Very rare: Hyperglycemia (elevated glucose levels in the blood).

Adverse effects of unknown frequency: Formation of kidney stones (renal calculi), acute gout attacks (in predisposed individuals), diarrhea, nausea, vomiting, abdominal pain, allergic reactions (hypersensitivity), allergic asthma syndrome (which presents with rashes, urticaria, edema, pruritus, and more rarely anaphylactic shock).

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Algidol

It does not require special storage conditions.

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

Do not use this medicine after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be thrown away through the sewage system or in the trash. Deposit the packaging and medicines you no longer need at the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Packaging Content and Additional Information

Composition of Algidol

The active ingredients are paracetamol, codeine, and ascorbic acid.

Each sachet of Algidol contains: 650 mg of paracetamol, 10 mg of codeine phosphate hemihydrate, and 500 mg of ascorbic acid.

The other components are sucrose, sodium saccharin, colloidal silica, povidone, maltose, microcrystalline cellulose, orange flavor, and yellow-orange colorant S (E-110).

Appearance of the Product and Packaging Content

Algidol is presented in the form of single-dose sachets with granules for oral solution. Each package contains 12 or 20 aluminum and low-density polyethylene sachets.

Marketing Authorization Holder

Laboratorios ERN, S.A.

C/Perú, 228

08020 Barcelona, Spain

Manufacturer

Industrias Farmacéuticas Almirall, S.A.

Ctra. de Martorell, 41-61, 08740 Sant Andreu de la Barca - Barcelona (Spain).

Date of the Last Revision of this Prospectus:January 2025

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