Algidol 650 mg/10 mg/500 mg granules for oral solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Algidol 650 mg/ 10 mg/ 500 mg

effervescent granules for oral solution

paracetamol / codeine phosphate hemihydrate / ascorbic acid

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What Algidol is and what it is used for

Algidol contains the active substances paracetamol, codeine, and ascorbic acid, and belongs to a group of medicines called analgesics and antipyretics (for the treatment of pain and fever).

Algidol is indicated for the symptomatic treatment of mild to moderate pain, as well as febrile conditions.

This product contains codeine. Codeine belongs to a group of medicines called opioid analgesics, which work by relieving pain. It can be used alone or in combination with other analgesics such as paracetamol.

You should consult a doctor if pain or fever worsens or does not improve after 3 days.

2. What you need to know before taking Algidol

Do not take Algidol

• If you are allergic to the active substances or to any of the other components of this medicine (listed in section 6).
  • To relieve pain in children and adolescents (0–18 years of age) following tonsil or adenoid removal due to obstructive sleep apnea syndrome.
  • If you are known to metabolize codeine rapidly into morphine.
  • 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 stated in section 3.

During treatment with Algidol, inform your doctor:

• If you have serious medical 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 under these conditions 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, feeling unwell (nausea), and vomiting.
• If you have anemia (reduced red blood cells), heart disease, lung disease, kidney disease, hypothyroidism (a thyroid disorder), or an adrenal gland disorder; if you are elderly or debilitated; if you have suffered a head injury; or if you have an enlarged prostate. In these cases, avoid prolonged treatment, as the medicine contains paracetamol.
• If you have asthma and are also sensitive or allergic to acetylsalicylic acid, since taking paracetamol may trigger asthma attacks. Avoid high doses.
• Prolonged treatment should also be avoided in liver diseases, with or without hepatic insufficiency (including viral hepatitis). The maximum dose in case of hepatic insufficiency is 2 g/day of paracetamol (one Algidol sachet every 8 hours).
• If you are taking other medicines containing paracetamol, as this may increase the risk of liver toxicity. As a general rule, take care not to exceed 4 g/day of paracetamol.
• Consumption of alcoholic beverages (three or more alcoholic drinks per day) may cause paracetamol to cause liver damage. In alcoholic patients, take care not to exceed 2 g/day of paracetamol (equivalent to a maximum dose of one Algidol sachet every 8 hours).
• If you have sustained a head injury (head trauma) or have increased intracranial pressure, or if you have respiratory depression (breathing difficulties), as these conditions may worsen due to codeine.
• If you experience severe abdominal pain, possibly radiating to the back, nausea, vomiting, or fever, as these may be symptoms of inflammation of the pancreas (pancreatitis) or of the biliary system.
• If you experience pain or increased sensitivity to pain (hyperalgesia) that does not respond to an increased dose of the medicine.
• Sleep-related breathing disorders

Algidol may cause sleep-related breathing disorders, such as sleep apnea (pauses in breathing during sleep) and sleep-related hypoxemia (low blood oxygen levels during sleep). Symptoms may include pauses in breathing during sleep, waking up at night due to shortness of breath, difficulty maintaining sleep, or excessive daytime sleepiness. If you or someone else notices these symptoms, contact your doctor immediately. Your doctor may consider reducing the dose.

• If you have a history of kidney stones (renal calculi) 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 into morphine in the liver by an enzyme. Morphine is the substance responsible for pain relief. Some people have a genetic variation in this enzyme, which may affect individuals differently. In some people, little or no morphine is produced, resulting in inadequate pain relief. In others, a very high amount of morphine may be produced, increasing the risk of serious adverse reactions. If you experience any of the following adverse effects, stop taking this medicine immediately and seek medical help: slow or shallow breathing, confusion, drowsiness, constricted pupils, nausea or vomiting, constipation, or loss of appetite.

Consult your doctor, even if any of the above-mentioned circumstances have occurred only once in the past.

Tolerance, dependence, and addiction

Repeated use of opioids may reduce the effectiveness of the drug (the body becomes accustomed to it; this is called tolerance). Repeated use of Algidol may also lead to dependence, abuse, and addiction, which in turn may result in potentially fatal overdose. The risk of these adverse effects may increase with higher doses and longer duration of use.

Dependence or addiction may make you feel that you have lost control over how much medication you need to take or how often you need to take it.

The risk of developing dependence or addiction varies from person to person. You may have a higher risk of dependence or addiction to Algidol if:

• You or a family member have abused or been dependent on alcohol, prescription medications, or drugs ("addiction").
• You smoke.
• You have had mood-related problems (depression, anxiety, or personality disorders) or have been treated by a psychiatrist for other psychiatric disorders.

If you notice any of the following signs while taking Algidol, it could indicate that you have developed dependence or addiction:

• You need to take the medication for longer than recommended by your doctor.
• You need to take a higher dose than recommended.
• You feel you need to keep taking the medication, even though it no longer helps relieve your pain.
• You take the medication for reasons other than those for which it was prescribed, for example, to "feel calm" or "help you sleep."
• You have tried several times to stop or control your use of the medication without success.
• You feel unwell when you stop taking the medication and feel better when you take it again ("withdrawal effects").

If you notice any of these signs, speak with your doctor to determine the best treatment approach for you, when to stop treatment, and how to do so (see section 3, If you stop treatment with Algidol).

Interference with diagnostic tests:

If you are undergoing any diagnostic tests (including blood or urine tests), inform your doctor that you are taking this medication, as it may alter test results.

This medicine may interfere with the following diagnostic tests:

• Uric acid
• Blood glucose
• Urine glucose
• Fecal occult blood
• Urine paracetamol measurements

Children and adolescents

This medicine must not be used in children under 12 years of age or in adolescents weighing less than 43 kg.

Use in children and adolescents after surgery:

Codeine must 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:

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

Other medicines and Algidol

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

Paracetamol may interact with the following medicines:

• Oral anticoagulants (used to thin the blood), such as acenocoumarol and warfarin, as paracetamol doses exceeding 2 g/day may increase the anticoagulant effect of these medicines.
• Anticholinergics (used to relieve spasms or contractions of the stomach, intestines, and bladder), 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.
• Antiepileptic drugs (used to treat epileptic seizures), 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 medicine.
• Antiviral drugs used to treat HIV infections, such as zidovudine. Paracetamol may reduce the effects of this medicine.
• 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.
• Loop diuretics, such as furosemide or others (used to increase urine elimination), as paracetamol may reduce the effect of these medicines.
• Antituberculosis drugs (used to treat tuberculosis), such as isoniazid and rifampicin, as they may enhance the action and toxicity of paracetamol.
• Antiemetics (used to prevent nausea and vomiting), such as metoclopramide and domperidone, as these medicines may increase the absorption of paracetamol.
• Flucloxacillin (antibiotic), due to a serious risk of blood and fluid disturbances (called metabolic acidosis with high anion gap) that must be treated urgently (see section 2).
• Medicines used to treat gout, such as probenecid and sulfinpyrazone, as the former may increase the action of paracetamol and the latter may decrease it.
• Ion-exchange resins (used to lower blood cholesterol levels), such as colestyramine, as they may reduce the amount of paracetamol in the blood.

Codeine may interact with the following medicines:

• 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 medicines.
• Anxiolytics (used to treat anxiety), antidepressants (used to treat depression), sedating antihistamines (used to treat allergies), medicines used to treat hypertension and migraine, such as clonidine, neuroleptic hypnotics (used to treat insomnia), sedatives (used to treat depression, anxiety), and the medicine thalidomide (used to treat certain types of cancer). Codeine may increase the effects of these medicines on the central nervous system, reducing alertness.
• Other morphine-like analgesics, barbiturates, benzodiazepines (used to treat pain), gabapentin or pregabalin (used to treat epilepsy or nerve injury-related pain [neuropathic pain]) together with codeine increase the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening. Therefore, concomitant use should only be considered when no other treatment options are available.

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

Inform your doctor about all sedative medicines you are taking and closely follow your doctor's dosage recommendations. It may be helpful to inform friends or family members who are aware of the signs and symptoms mentioned above. Contact your doctor if you experience such symptoms.

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

• Oral anticoagulants (used to thin the blood), as high doses of ascorbic acid (more than 2 g/day) may impair the absorption of these medicines.
• Antacids containing aluminum (used to relieve stomach acidity), as ascorbic acid may increase aluminum absorption and cause toxicity.
• Oral contraceptives (used to prevent pregnancy), such as ethinylestradiol, as high doses of ascorbic acid may impair their absorption. It is advisable to use additional contraceptive methods (e.g., barrier methods).
• Antiviral drugs with indinavir (used to treat people infected with HIV), as ascorbic acid may reduce the effectiveness of these medicines.
• Medicines or dietary supplements containing cyanocobalamin (vitamin B12), as ascorbic acid may reduce their effect.
• Other medicines containing ascorbic acid (vitamin C), as they may increase the occurrence of adverse effects due to ascorbic acid.
• Medicines or dietary supplements containing amygdalin (vitamin B17), as they may increase its toxicity.
• Iron-chelating preparations (used to reduce iron and aluminum levels in the body), such as deferoxamine, as they may cause heart problems.

Do not use with other analgesics (medicines that reduce pain) without consulting your doctor. As a general rule for any medicine, it is advisable to systematically inform your doctor or pharmacist if you are taking any other medicine. In the case of treatment with oral anticoagulants, paracetamol may occasionally be administered as the analgesic of choice.

Taking Algidol with food, drinks, and alcohol

Do not consume alcoholic beverages while being treated with Algidol. If you regularly consume alcohol, inform your doctor or pharmacist, as this may increase the risk of paracetamol-induced liver toxicity and increase the impairment caused by codeine 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 medicine.

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

Driving and operating machinery

Exercise particular caution when driving vehicles, operating dangerous machinery, and in general, in any activity where lack of concentration or coordination may pose a risk, as this medicine may cause drowsiness.

Algidol contains sucrose. If your doctor has informed you of an intolerance to certain sugars, consult with him before taking this medicine.

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

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

3. How to take Algidol

Follow exactly the instructions for using this medicine as given by your doctor. If in doubt, please consult your doctor or pharmacist again.

Before starting treatment and regularly during treatment, your doctor will explain to you what to expect from using Algidol, when and for how long you should use it, when you should contact your doctor, and when you should stop treatment (see also If you stop taking Algidol).

This medicine should not be taken for more than 3 days. If pain does not improve after 3 days, seek advice from your doctor.

Algidol should be used for the shortest duration necessary to relieve symptoms. If adequate pain relief is not achieved during treatment with the medicine, you should consult a doctor.

Dosage:

The dose of Algidol should be the one prescribed by your doctor according to your individual needs.

Adults:

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

Paediatric population:

Dosage must be as prescribed by a physician and adjusted according to the severity of the condition and the patient's response. The recommended doses are:

Adolescents from 15 years of age: 1 sachet every 4 to 6 hours as needed, not exceeding 6 sachets in 24 hours.

Adolescents from 13 years of age:

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

Algidol must not be administered to children under 12 years of age or to adolescents weighing less than 43 kg.

Children under 12 years of age must not take Algidol due to the risk of serious breathing problems.

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

Patients with liver disease: you must consult your doctor before taking this medicine. You should take the amount prescribed by your doctor, with a minimum interval of 8 hours between doses. You must not take more than 2 grams of paracetamol in 24 hours.

Patients with kidney disease: you must consult your doctor before taking this medicine.

Due to the dosage, this medicine is not indicated for this patient group.

Method of administration:

To administer, the contents of the sachet should be dissolved in half a glass of water. Algidol may be taken before, during, or after meals.

If you feel that 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 prescribed, 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 a missed dose. Simply take the missed dose when you remember, and take the following doses at the recommended intervals (at least 4 hours apart).

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

If you stop taking Algidol

Your doctor will advise you on the duration of treatment with Algidol and when and how you should stop it. Do not stop treatment prematurely, as you will not achieve the intended effect.

There is a risk of possible withdrawal-related effects when stopping treatment. Therefore, in prolonged treatments, doses should be gradually reduced (see section 2).

4. Possible adverse effects

Like all medicines, Algidol may cause adverse effects, although not everyone experiences them.

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

Uncommon (may affect up to 1 in 100 patients), rare (may affect up to 1 in 1,000 patients), very rare (may affect up to 1 in 10,000 patients), and frequency not known (cannot be estimated from available data).

The following adverse effects have been observed with paracetamol:

Rare: Malaise, increased levels of hepatic transaminases (liver enzymes), and hypotension (reduction 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), jaundice (yellowing of the skin and mucous membranes), hypoglycemia (reduced blood glucose levels), thrombocytopenia (reduced platelet count in blood), agranulocytosis, leucopenia, neutropenia (reduced white blood cell count), hemolytic anemia (reduced red blood cells), sterile pyuria (cloudy urine), and adverse renal effects.

Frequency not known: A serious condition that may cause the blood to become more acidic (called metabolic acidosis) in patients with severe illness who use paracetamol (see section 2).

The following adverse effects have been reported with codeine:

Rare: Malaise, somnolence (drowsiness), constipation, nausea and dizziness, bronchospasm (spasms in the bronchi causing breathing difficulty), and respiratory depression (slow breathing).

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

Frequency not known: A problem affecting a valve in the intestine (Oddi sphincter dysfunction).

The following adverse effects have been reported with ascorbic acid:

Very rare: Hyperglycemia (elevated blood glucose levels).

Adverse effects with frequency not established: Kidney stone formation (renal calculi), acute gout attacks (in predisposed individuals), diarrhea, nausea, vomiting, abdominal pain, allergic reactions (hypersensitivity), and allergic asthma syndrome (manifesting as 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 they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Algidol

Keep this medicine out of sight and reach of children.

No special storage conditions are required.

Store this medicine in a safe place inaccessible to other people. It may cause serious harm and can be fatal to individuals for whom it has not been prescribed.

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 drains or household waste. Return empty containers and any unused medicines to the SIGRE point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Algidol

The active substances 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 flavour and orange-yellow S colour (E–110).

Nature of the product and contents of the pack

Algidol is presented in single-dose sachets containing granules for oral solution. Each pack contains 12 or 20 aluminium 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 most recent review of this leaflet: February 2026.

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