Dolomedil 500 mg/10 mg tablets
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: Information for the user
Dolomedil 500 mg/10 mg tablets
Paracetamol/codeine phosphate hemihydrate
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 you should not give it 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 these are effects not listed in this leaflet. See section 4.
Contents of the leaflet:
- What Dolomedil is and what it is used for
- What you need to know before taking Dolomedil
- How to take Dolomedil
- Possible side effects
- How to store Dolomedil
- Contents of the pack and other information
1. What Dolomedil is and what it is used for
Dolomedil contains paracetamol and codeine phosphate as active substances. 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 acute pain in patients over 12 years of age for whom the use of ibuprofen or paracetamol alone as an analgesic is not considered appropriate.
2. What you need to know before taking Dolomedil
Do not take Dolomedil
- If you are allergic to paracetamol, codeine, or any of the other ingredients of Dolomedil (listed in section 6)
- If you have acute respiratory depression, acute asthma, or chronic obstructive pulmonary disease (COPD)
- In children and adolescents (under 18 years of age) who have undergone tonsillectomy or adenoidectomy and suffer from obstructive sleep apnea
- If you are an extensive or ultra-rapid metabolizer in the conversion of codeine to morphine
- If you are breastfeeding.
Warnings and precautions
It is important to use the smallest dose that relieves your pain and not exceed the recommended doses in section 3 – "How to take Dolomedil". To achieve this, avoid taking other medicines containing paracetamol or codeine (used, for example, to treat colds, pain, and fever).
Tolerance, dependence, and addiction
This medicine contains codeine, which is an opioid. It may cause dependence and/or addiction.
Repeated use of opioids may lead to reduced effectiveness of the medicine (becoming accustomed to it, known as tolerance). Repeated use of Dolomedil may also lead to dependence, abuse, and addiction, which could result in a potentially fatal overdose. The risk of these adverse effects may be higher with higher doses and prolonged use.
Dependence or addiction may cause a feeling of lack of control over the amount of medicine you need to take or how often you need to take it.
The risk of dependence or addiction varies from person to person. You may be at higher risk of dependence or addiction to Dolomedil if:
- You or any member of your family have abused alcohol or experienced dependence on alcohol, prescription medicines, or illegal drugs ("addiction").
- You smoke.
- You have ever had mood disorders (depression, anxiety, or a personality disorder) or have received psychiatric treatment for other mental illnesses.
If you notice any of the following symptoms while taking Dolomedil, it could be a sign of dependence or addiction:
- You need to take the medicine for longer than recommended by your doctor
- You need to take a higher dose than recommended
- You feel the need to keep taking the medicine, even when it does not help relieve pain
- You are using the medicine for reasons other than prescribed, for example, "to stay calm" or "to help you sleep"
- You have made repeated unsuccessful attempts to stop using the medicine or control its use
- You feel unwell when you stop using the medicine, and feel better once 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 taking Dolomedil").
Consult your doctor, pharmacist, or nurse before starting to take Dolomedil:
- If you have any heart or lung disease, or if you have anemia (reduced hemoglobin levels in the blood, due or not to a reduction in red blood cells), or low levels of an enzyme in the blood called glucose-6-phosphate dehydrogenase, you should consult your doctor before taking this medicine.
- If you have liver problems (including Gilbert's syndrome) or kidney problems, or suffer from chronic malnutrition or dehydration, you may require a reduced dose of this medicine.
- If you have any condition affecting your ability to breathe, intracranial lesions (e.g., due to head contusion), asthma or a history of asthma, and/or are sensitive to acetylsalicylic acid.
- If you have any thyroid disease, prostate problems, or urethral narrowing (both associated with difficulty urinating), adrenal insufficiency (Addison's disease), or intestinal or gallbladder disorders.
- If you are elderly or feel weakened.
- If you suffer from chronic constipation, the use of this medicine may worsen symptoms.
- Codeine is converted into morphine by an enzyme in the liver. Morphine is the active substance responsible for pain relief. Some people may have variable activity of this enzyme, affecting them differently. In some, morphine is not produced or is produced in very small amounts, resulting in reduced analgesic effect. In contrast, those who produce large amounts of morphine may be more likely to experience serious adverse reactions. If you notice any of the following adverse effects, you must stop taking this medicine and seek immediate medical help: slow or shallow breathing, confusion, drowsiness, pinpoint pupils, nausea and vomiting, constipation, loss of appetite.
- If you consume alcoholic beverages, this may cause paracetamol to cause liver damage.
- Prolonged or frequent use of analgesics to treat headaches may worsen symptoms, which should not be treated with higher doses of the medicine.
- With repeated administration of this medicine, physical dependence and tolerance may develop. Treatment should be gradually discontinued after prolonged use.
- If you need to take this medicine for a prolonged period, treatment should be periodically re-evaluated by your doctor.
If pain persists for more than 3 days (2 days for sore throat), worsens, or new symptoms appear, you should stop treatment and consult your doctor.
During treatment with Dolomedil, inform your doctor immediately if:
-
You have 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 fluids) has been reported in patients in these situations when paracetamol is used at regular doses over a prolonged period or when paracetamol is taken together with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulty with deep and rapid breathing, drowsiness, feeling unwell (nausea), and vomiting.
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You experience pain or increased sensitivity to pain (hyperalgesia) that does not respond to an increased dose of the medicine.
Contact your doctor if you have 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 tract system.
Sleep-related breathing disorders
Dolomedil may cause sleep-related breathing disorders, such as sleep apnea (breathing pauses during sleep) and sleep-related hypoxemia (low blood oxygen levels). Symptoms may include breathing pauses during sleep, waking up at night due to breathlessness, difficulty maintaining sleep, or excessive daytime sleepiness. If you or someone else observes these symptoms, contact your doctor. Your doctor may consider reducing the dose.
Interference with laboratory tests
If you are due to have any laboratory tests (including blood and urine tests, skin tests using allergens, etc.), inform your doctor that you are taking this medicine, as it may alter the results of these tests.
Use of Dolomedil with other medicines
Inform your doctor or pharmacist if you are using or have recently used other medicines, including those obtained without a prescription.
In particular, if you are using medicines containing any of the following active substances, it may be necessary to modify the dose or discontinue treatment with any of them.
Paracetamol may interact with the following medicines:
- Oral anticoagulants (acenocoumarol, warfarin)
- Antiepileptics (lamotrigine, phenytoin or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine)
- Barbiturates (used as sleep inducers, sedatives, and anticonvulsants)
- Antituberculosis medicines (isoniazid, rifampicin)
- Medicines used to treat gout (probenecid and sulfinpyrazone)
- Propranolol (used to treat high blood pressure (hypertension) and heart rhythm disorders (cardiac arrhythmias))
- Anticholinergics (medicines used to relieve stomach, intestinal, and bladder spasms or cramps)
- Metoclopramide and domperidone (used to prevent nausea and vomiting)
- Zidovudine (used to treat patients infected with the human immunodeficiency virus, the cause of AIDS)
- Cholestyramine (used to lower blood cholesterol levels)
- Flucloxacillin (antibiotic), due to a serious risk of blood and fluid abnormalities (called metabolic acidosis) that requires urgent treatment.
Codeine, in turn, may interact with the following medicines:
- Narcotic analgesics (used to treat pain) such as nalbuphine, buprenorphine, pentazocine
- Antidepressants (used to treat depression)
- Sedatives (used to treat depression, anxiety)
- Sedating H1 antihistamines (used to treat allergies)
- Anxiolytics (used to treat anxiety)
- Neuroleptic hypnotics (used to treat insomnia)
- Clonidine and related substances (used to treat hypertension and migraine)
- Thalidomide (used to treat certain types of cancer)
- Benzodiazepines
- Medicines used to relieve stomach, intestinal, and bladder spasms or cramps (anticholinergics)
- Gabapentin or pregabalin to treat epilepsy or pain caused by nervous system injuries (neuropathic pain).
Do not use with other analgesics (medicines that reduce pain) without consulting your doctor.
Concomitant use of codeine and sedative medicines such as benzodiazepines or related medicines increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be fatal. Therefore, concomitant use should only be considered when no other treatment options are possible.
However, if your doctor prescribes codeine together with sedative medicines, the dose and duration of concomitant treatment must be limited by your doctor.
Inform your doctor about all sedative medicines you are taking and follow your doctor's recommendations regarding dosage carefully. It may be helpful to inform friends or family members so they are aware of the aforementioned signs and symptoms. Contact your doctor if you experience such symptoms.
Taking Dolomedil with food, drinks, and alcohol
Using paracetamol in patients who habitually consume alcohol (three or more alcoholic drinks per day) may damage the liver. In addition, alcohol may enhance the depressant effect of codeine. Therefore, alcohol should not be consumed during treatment with this medicine.
Pregnancy, breastfeeding, and fertility
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.
Do not take this medicine during breastfeeding. Codeine and morphine pass into breast milk.
Driving and using machines
Dolomedil contains codeine, which may cause drowsiness and impair mental and/or physical abilities.
If you experience these effects, avoid driving vehicles or operating machinery.
Dolomedil contains hydrogenated castor oil
This medicine may cause stomach discomfort and diarrhea because it contains hydrogenated castor oil.
Use in athletes: This medicine contains codeine. As a result of its metabolism, certain compounds are produced that may lead to a positive result in doping control tests.
3. How to take Dolomedil
Follow exactly the instructions for the administration of Dolomedil provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Before starting treatment and regularly during treatment, your doctor will explain what you can expect from using Dolomedil, when and for how long you should use it, when you should contact your doctor, and when you should interrupt treatment (see also “If you stop treatment with Dolomedil”).
This medicine should not be taken for more than 3 days. If pain does not subside within 3 days, you must consult your doctor. Dolomedil should be used for the shortest duration necessary to relieve symptoms. If effective pain relief is not achieved during treatment with this medicine, you should consult a 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. Doses should be spaced at least 4 hours apart. Treatment is recommended to start with 2 tablets.
Use in children and adolescents
Adolescents aged 12 to 18 years: 1 tablet 4 to 5 times daily, as needed, up to a maximum of 5 tablets per day.
Do not use in patients under 12 years of age due to the risk of serious respiratory problems.
Recommended maximum doses
In adults, the maximum dose corresponds to 8 tablets per day, and 5 tablets per day for adolescents aged 12 to 18 years.
Patients with kidney and/or liver disease
If you have kidney and/or liver disease, your doctor may prescribe a lower than usual dose. If so, take exactly the dose prescribed by your doctor.
Elderly patients
Elderly individuals are generally more susceptible to adverse effects, so dose reduction may be necessary. Consult your doctor.
Instructions for correct administration
Dolomedil is administered orally.
The tablets should be taken with a glass of liquid, preferably water or another non-alcoholic drink.
If you take more Dolomedil than you should
If you have taken more Dolomedil than you should, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount taken. It is recommended to bring the medicine’s packaging and leaflet to the healthcare professional.
Symptoms of overdose due to paracetamol may include: dizziness, vomiting, loss of appetite, yellowing of the skin and eyes (jaundice), and abdominal pain.
Patients undergoing treatment with barbiturates or those with chronic alcoholism may be more susceptible to paracetamol overdose.
Symptoms characteristic of codeine overdose include: drowsiness, progressing even to stupor or coma, cold skin, miosis, muscle flaccidity, and occasionally bradycardia, hypotension, and respiratory depression.
If you forget to take Dolomedil
Do not take a double dose to make up for missed doses.
If you have forgotten a dose, take it as soon as possible and continue with your new schedule, maintaining the minimum interval between doses. However, if the time for the next dose is approaching, skip the missed dose and take the next dose at its scheduled time.
If you stop treatment with Dolomedil
Your doctor will inform you about the duration of treatment with Dolomedil and when and how you should discontinue it. Do not stop treatment prematurely, as you will not achieve the expected effect.
There is a risk of possible withdrawal-related effects upon discontinuation of treatment. Therefore, in prolonged treatments, doses should be gradually reduced (see section 2).
If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
The adverse effects observed are described below according to their frequency of occurrence:
Rare (may affect up to 1 in 1,000 patients) and very rare (may affect up to 1 in 10,000 patients).
The adverse effects of paracetamol are:
Rare: Malaise, increased levels of hepatic transaminases (liver enzymes), and hypotension (reduction in 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 severe type of allergic reaction), hepatotoxicity (liver toxicity), jaundice (yellowing of the skin and mucous membranes), hypoglycemia (reduced glucose levels in blood), thrombocytopenia (reduction in platelets in blood), agranulocytosis, leucopenia, neutropenia (decrease in white blood cells in blood), haemolytic anaemia (decrease in red blood cells in blood), sterile pyuria (cloudy urine), and adverse renal effects.
Very rare cases of serious skin reactions have been reported.
Frequency not known (cannot be estimated from the 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).
The adverse effects of codeine are:
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 glucose levels in blood), thrombocytopenia, agranulocytosis, leucopenia, neutropenia, haemolytic anaemia.
Frequency not known (cannot be estimated from the available data): Symptoms associated with inflammation of the pancreas (pancreatitis) and of the biliary tract system (a condition affecting a digestive tract valve, known as Oddi sphincter dysfunction), such as severe upper abdominal pain that may radiate to the back, nausea, vomiting, or fever.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if these adverse effects are not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Dolomedil
Keep out of sight and reach of children.
Store this medicine in a secure place inaccessible to others. It may cause serious harm or be fatal to individuals for whom it has not been prescribed.
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 should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at a SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.
6. Contents of the pack and other information
Composition of Dolomedil
- The active substances 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), corn starch, tricalcium phosphate (E341), stearic acid (E570), hydrogenated castor oil, and magnesium stearate (E470b).
Appearance of the product and contents of the pack
Dolomedil tablets are white, biconvex, oblong, and scored on both sides. The tablets are packed in PVC/Alu blisters. Each pack contains 20 tablets.
The score line is intended to facilitate breaking the tablet and swallowing, but not for dividing the tablet into equal doses.
Marketing Authorization Holder and Manufacturer
Kern Pharma, S.L.
Venus, 72 – Pol. Ind. Colón II
08228 Terrassa - Barcelona
Spain
Date of the most recent revision of this leaflet: January 2026
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/