Package Leaflet: Information for the user

Dolomedil 500 mg/10 mg tablets

Paracetamol/codeine phosphate hemihydrate

Read this 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. Do not give it to others even if they have similar symptoms to you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Dolomedil contains paracetamol and codeine phosphate as active ingredients. Paracetamol belongs to a group of medicines called analgesics and antipyretics, and codeine is an opioid analgesic.

Dolomedil is indicated for the symptomatic treatment of moderate intensity acute pain in patients over 12 years old for whom the use of ibuprofen or paracetamol as a single analgesic is not considered appropriate.

Do not take Dolomedil

• If you are allergic to paracetamol, codeine, or any of the other components of Dolomedil (listed in section 6)
• If you have acute respiratory depression, acute asthma, or chronic obstructive pulmonary disease
• In children and adolescents (under 18 years) who have undergone tonsillectomy or adenoidectomy and suffer from obstructive sleep apnea
• If you are an extensive or ultra-rapid metabolizer of codeine to morphine
• If you are breastfeeding

Warnings and precautions

It is essential to use the smallest dose that relieves pain and not to exceed the recommended doses in Section 3 – “How to take Dolomedil.” To do this, avoid taking other medications that contain paracetamol or codeine (used, for example, to treat colds, pain, and fever).

Consult your doctor, pharmacist, or nurse before starting to take Dolomedil:

• If you have any heart or lung disease and in patients with anemia (decrease in hemoglobin levels in the blood, due or not due to a decrease in red blood cells), or with low levels of a blood enzyme called glucose-6-phosphate dehydrogenase, you must consult with your doctor before taking the medication.
• If you have liver (including Gilbert's syndrome) or kidney problems or suffer from chronic malnutrition or dehydration, you may require a reduction in the dose of this medication.
• If you have any disease that affects the ability to breathe, have intracranial injuries, for example, due to a head contusion, are asthmatic or have a history of asthma, and/or are sensitive to acetylsalicylic acid.
• If you have any thyroid, prostate, or urethral stricture disease (both accompanied by difficulty urinating), adrenal insufficiency (Addison's disease), or intestinal or biliary tract diseases.
• If you are an elderly person or feel weakened.
• If you have chronic constipation, the use of this medication may worsen the symptoms.
• The codeine is converted to morphine through an enzyme in the liver. Morphine is the active substance responsible for pain relief. Some people may have variability in the activity of this enzyme, affecting them differently. In some, morphine is not produced or is produced in very small quantities, obtaining a lesser analgesic effect. While those who produce large amounts of morphine will have a greater chance of presenting severe adverse reactions. If you notice any of the following adverse effects, stop taking this medication and seek medical help immediately: slow or shallow breathing, confusion, drowsiness, small pupils, nausea, and vomiting, constipation, loss of appetite.
• If you consume alcoholic beverages, it may cause paracetamol to damage the liver.
• The prolonged or frequent use of analgesics to treat headaches may worsen the symptoms, which should not be treated with higher doses of the medication.
• With repeated administration of this medication, physical dependence and tolerance may appear. Administration should be suspended gradually after prolonged treatments.
• If you need to take this medication for a prolonged period, the treatment should be reevaluated periodically by your doctor.

If the pain persists for more than 3 days (2 days for throat pain), worsens, or other symptoms appear, you should interrupt treatment and consult your doctor.

During treatment with Dolomedil, immediately inform your doctor 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 suffer from malnutrition, chronic alcoholism, or if you are also taking flucloxacillin (an antibiotic). A severe disease called metabolic acidosis (a blood and fluid anomaly) 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 respiratory difficulty with deep and rapid breathing, drowsiness, feeling unwell (nausea), and vomiting.

Interference with analytical tests

If you are to undergo any analytical test (including blood, urine, skin tests using allergens, etc.) inform your doctor that you are taking this medication, as it may alter the results of these tests.

Use of Dolomedil with other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, even those purchased without a prescription.

In particular, if you are using medications that contain any of the following active principles, it may be necessary to modify the dose or interrupt the treatment of any of them.

Paracetamol may interact with the following medications:

• Oral anticoagulants (acenocoumarol, warfarin)
• Antiepileptics (lamotrigine, phenytoin, or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine)
• Barbiturates (used as sleep inducers, sedatives, and anticonvulsants)
• Antituberculars (isoniazid, rifampicin)
• Medications used to treat gout (probencid and sulfinpyrazone)
• Propranolol (used to treat high blood pressure and cardiac arrhythmias)
• Anticholinergics (medications used to relieve spasms or cramps of the stomach, intestines, and bladder)
• Metoclopramide and domperidone (used to prevent nausea and vomiting)
• Zidovudine (used to treat patients infected with the human immunodeficiency virus, causing AIDS)
• Colestiramine (used to reduce blood cholesterol levels)
• Flucloxacillin (antibiotic), due to a severe risk of blood and fluid anomaly (metabolic acidosis) that must receive urgent treatment.

On the other hand, codeine may interact with the following medications:

• Narcotic analgesics (used to treat pain) such as nalbuphine, buprenorphine, pentazocine
• Antidepressants (used to treat depression)
• Sedatives (used to treat depression, anxiety)
• H1 antihistamines (used to treat allergies)
• Anxiolytics (used to treat anxiety)
• Hypnotic neuroleptics (used to treat insomnia)
• Clonidine and related (used to treat hypertension and migraine)
• Talidomide (used to treat certain types of cancer)
• Benzodiazepines
• Medications used to relieve spasms or cramps of the stomach, intestines, and bladder (anticholinergics).

Do not use with other analgesics (pain-relieving medications) without consulting your doctor.

The concomitant use of codeine and sedatives such as benzodiazepines or related medications increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be fatal. Therefore, concomitant use should only be considered when other treatment options are not possible.

However, if your doctor prescribes codeine along with sedatives, the dose and duration of concomitant treatment should be limited by your doctor.

Inform your doctor about all sedatives you are taking and follow your doctor's recommendations carefully regarding the dose. It may be helpful to inform friends or family members to be aware of the mentioned signs and symptoms. Contact your doctor when you experience these symptoms.

Taking Dolomedil with food, drinks, and alcohol

The use of paracetamol in patients who regularly consume alcohol (three or more alcoholic beverages per day) may damage the liver. Additionally, alcohol may potentiate the depressant effect of codeine. Therefore, do not consume alcohol during treatment with this medication.

Pregnancy, breastfeeding, and fertility

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

Do not take this medication during breastfeeding. Codeine and morphine pass into breast milk.

Driving and operating machines

Dolomedil contains codeine, which may cause drowsiness, altering mental and/or physical ability.

If you experience these effects, avoid driving vehicles or operating machines.

Dolomedil contains hydrogenated ricin oil

This medication may cause stomach discomfort and diarrhea due to the presence of hydrogenated ricin oil.

Use in athletes:This medication contains codeine. As a result of its metabolism, some compounds are produced that may produce a positive result in doping control tests.

Follow exactly the administration instructions for Dolomedil indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist.

This medication should not be taken for more than 3 days. If the pain does not subside in 3 days, you should consult your doctor.

The recommended dose is:

Adults:

1 or 2 tablets every 4 or 6 hours depending on the severity of symptoms, up to a maximum of 8 tablets per day. Intervals between doses should be at least 4 hours. It is recommended to start treatment with 2 tablets.

Use in children and adolescents

Adolescents 12 to 18 years old: 1 tablet 4 or 5 times a day, as needed, and up to a maximum of 5 tablets per day.

Do not use in patients under 12 years old due to the risk of severe respiratory problems.

Maximum recommended doses

In adults, the maximum dose corresponds to 8 tablets per day, and 5 tablets for adolescents 12 to 18 years old.

Patients with kidney and/or liver diseases

If you have a kidney and/or liver disease, your doctor may prescribe a lower dose than usual. If so, take the exact dose prescribed by your doctor.

Older patients

Older people are more prone to adverse effects, so it may be necessary to reduce the dose. Consult your doctor.

Instructions for correct administration of the preparation

Dolomedil is administered orally.

The tablets should be taken with a glass of liquid, preferably water or another non-alcoholic liquid.

If you take more Dolomedil than you should

If you have taken more Dolomedil than you should, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount used. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

The symptoms of overdose due to paracetamol may be: dizziness, vomiting, loss of appetite, yellowing of the skin and eyes (jaundice), and abdominal pain.

In cases where the patient is being treated with barbiturates or has chronic alcoholism, they may be more susceptible to a paracetamol overdose.

The symptoms that characterize a codeine overdose are: drowsiness, even to the point of stupor or coma, cold skin, miosis, muscle flaccidity, and, in some cases, bradycardia, hypotension, and respiratory depression.

If you forget to take Dolomedil

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

If you have forgotten a dose, take it as soon as possible and continue with the new schedule, maintaining the minimum interval between doses. However, if the next dose is due soon, skip the missed dose and take the next dose at its usual time.

If you interrupt the treatment with Dolomedil

Your doctor will indicate the duration of treatment with Dolomedil and when and how you should interrupt it. Do not suspend treatment prematurely, as you will not achieve the expected effect.

There is a risk of possible effects derived from abstinence when suspending treatment. Therefore, in prolonged treatments, doses should be gradually reduced (see section 2).

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

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

The observed side effects are described below according to the frequency of presentation:

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

The side effects ofparacetamolare:

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

Very rare: 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 (yellow discoloration of the skin and mucous membranes), hypoglycemia (low blood glucose levels), thrombocytopenia (low platelet count), agranulocytosis, leukopenia, neutropenia (low white blood cell count), hemolytic anemia (low red blood cell count), sterile pyuria (cloudy urine), and adverse renal effects.

Very rarely, severe skin reactions have been reported.

Unknown frequency(cannot be estimated from available data): A serious disease that can make the blood more acidic (metabolic acidosis) in patients with severe disease who use paracetamol (see section 2).

The side effects ofcodeineare:

Rare: Discomfort, drowsiness (feeling of sleep), constipation, nausea, and dizziness, bronchospasm (bronchial spasms 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 (yellow discoloration of the skin and eyes), hypoglycemia, thrombocytopenia, agranulocytosis, leukopenia, neutropenia, and hemolytic anemia.

Reporting of side effects

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

Keep out of sight and reach of children.

No special storage conditions are required.

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

Composition of Dolomedil

• The active principles are paracetamol and codeine phosphate hemihydrate. Each tablet contains 500 mg of paracetamol and 10 mg of codeine phosphate hemihydrate.
• The other components are: povidone, sodium croscarmellose, talc (E553b), cornstarch, calcium phosphate (E341), stearic acid (E570), hydrogenated ricin oil and magnesium stearate (E470b).

Appearance of the product and contents of the packaging

Dolomedil tablets are white, biconvex, oblong, and scored on both faces. The tablets are packaged in PVC/Alu blisters. Each package contains 20 tablets.

The score serves to break and facilitate swallowing but not to divide into equal doses.

Holder of the marketing authorization and responsible for manufacturing

Kern Pharma, S.L.

Venus, 72 – Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Last review date of this leaflet: January 2025

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