Dolmen 500 mg/250 mg/10 mg effervescent tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Dolmen 500 mg/250 mg/10 mg effervescent tablets

Acetylsalicylic acid, Ascorbic acid, 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, 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 such effects are not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Dolmen is and what it is used for

Acetylsalicylic acid belongs to a group of analgesic, antipyretic, and non-steroidal anti-inflammatory drugs, and ascorbic acid is vitamin C. This medicine also contains codeine phosphate.

Codeine belongs to a group of medicines called opioid analgesics, which work by relieving pain. Codeine may be used in adolescents over 16 years of age for the short-term treatment of moderate pain not relieved by other analgesics such as paracetamol or ibuprofen alone.

Dolmen is indicated for the symptomatic relief of mild to moderate occasional pain, such as headaches, dental pain, menstrual pain, and back pain.

It is also indicated for the treatment of non-rheumatic inflammation and for the treatment of rheumatoid arthritis, juvenile arthritis, osteoarthritis, and rheumatic fever.

It is also indicated for febrile conditions.

2. What you need to know before taking Dolmen

Do not take Dolmen:

• If you are allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6).
• If you have gastric or duodenal ulcer, or recurrent gastric discomfort.
• If you have experienced asthma-type allergic reactions (difficulty breathing, suffocation, bronchospasms, and in some cases coughing or wheezing) when taking anti-inflammatory medicines, acetylsalicylic acid, other analgesics, or the tartrazine dye.
• If you have asthma, rhinitis, or urticaria, or have had them in the past.
• If you have hemophilia or other blood coagulation disorders.
• If you are being treated with blood-thinning medicines (oral anticoagulants).
• If you have kidney and/or liver problems (renal and/or hepatic insufficiency).
• If you have renal lithiasis accompanied by oxaluria or aciduria, or normal urinary pH.
• If you have blood disorders such as glucose-6-phosphate dehydrogenase deficiency, hemochromatosis, sideroblastic anemia, or thalassemia.
• If you have respiratory insufficiency.
• If you are under 16 years of age, unless specifically instructed by a doctor, as the use of acetylsalicylic acid has been associated with Reye's syndrome, a rare but serious illness.
• 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 have biliary disorders.
• If you are in the third trimester of pregnancy.
• If you are breastfeeding.
• If you know you metabolize codeine rapidly into morphine.

Warnings and precautions

If you have reduced kidney, heart, or liver function, cranial injuries, hypothyroidism, prostate hypertrophy, adrenal insufficiency, blood coagulation disorders, or are being treated with anticoagulants, you should consult your doctor before taking this medicine.

If you are taking anti-inflammatory or other types of medicines, as certain medicines may interact with Dolmen and cause undesirable effects (see “Other medicines and Dolmen”).

If you have asthma, rhinitis, or urticaria, or have had them in the past.

Patients with a history of kidney stone formation or gout should consult their doctor before taking this medicine.

If you are diabetic, due to the presence of ascorbic acid in this medicine, urine glucose tests—including reactive strip tests—may yield inaccurate results.

In cases of increased intracranial pressure or head trauma, as codeine may increase cerebrospinal fluid pressure.

Codeine is converted into morphine in the liver by an enzyme. Morphine is the substance responsible for pain relief. Some individuals have genetic variations in this enzyme that may affect them 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, pinpoint pupils, nausea or vomiting, constipation, or loss of appetite.

If you regularly consume alcohol (three or more alcoholic drinks per day), as this may cause liver damage and increase the risk of gastrointestinal bleeding.

If your doctor orders a blood test, urine test, or other diagnostic procedure, inform them that you are taking this medicine, as test results may be altered.

You should inform your doctor or dentist if you are scheduled for any surgical procedures.

Do not administer systematically as a preventive measure for discomfort associated with vaccinations.

During treatment with Dolmen, inform your doctor immediately if:

• You experience severe abdominal pain, possibly radiating to the back, along with nausea, vomiting, or fever, as these may be symptoms of pancreatitis or biliary tract inflammation.
• You experience pain or increased sensitivity to pain (hyperalgesia) that does not respond to increased doses of the medicine.
• You experience sleep-related breathing disorders.

Sleep-related breathing disorders

Dolmen 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 breathing pauses during sleep, waking up at night due to breathlessness, difficulty maintaining sleep, or excessive daytime drowsiness. If you or someone else notices these symptoms, contact your doctor. Your doctor may consider reducing the dose.

Tolerance, dependence, and addiction

Repeated use of opioids may reduce the drug's effectiveness (the body becomes accustomed to it; this is known as tolerance). Repeated use of Dolmen 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 Dolmen 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 Dolmen, 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 that you need to continue taking the medication, even though it is not helping relieve your pain.
• You take the medication for reasons other than the one for which it was prescribed, for example, to "feel calm" or "help you sleep."
• You have tried several times to stop taking the medication or control its use 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 and how to discontinue treatment (see section 3, If you stop taking Dolmen).

Children and adolescents

Do not administer to children or adolescents under 16 years of age.

Use in children and adolescents after surgery

Codeine must not be used for pain relief in children and adolescents after tonsil or adenoid removal due to obstructive sleep apnea syndrome.

Use in children with respiratory problems

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

Use in elderly

Elderly individuals should not take this medication without consulting their doctor, as they are more likely to experience adverse effects.

Interference with diagnostic tests

If you are scheduled for any diagnostic tests (including blood or urine tests, etc.), inform your doctor that you are taking this medication, as it may alter the results, including those of dipstick tests.

Other medicines and Dolmen

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medication.

This is especially important in the case of:

• Medications used to prevent transplant rejection (cyclosporine and tacrolimus).
• High blood pressure (diuretics and ACE inhibitors).
• Cancer, rheumatoid arthritis (methotrexate).
• Other analgesics or non-steroidal anti-inflammatory drugs (medications used to treat pain and/or muscle inflammation).
• Anticoagulants (medications used to "thin" the blood and prevent blood clots) such as warfarin.
• Medications used to treat gout (probenecid).
• Medications to lower blood sugar levels (oral antidiabetics).
• Barbiturates (medications used as sedatives, anticonvulsants, and for sleep disorders).
• Corticosteroids, as they may increase the risk of gastrointestinal bleeding.
• Cimetidine and ranitidine (used for stomach acidity).
• Digoxin (a heart medication).
• Phenytoin and valproic acid (antiepileptics).
• Lithium (used for depression).
• The antibiotic vancomycin and sulfonamides (used for infections).
• Zidovudine (used in the treatment of HIV infections).
• Anticholinergics and codeine, as they may cause intestinal obstruction.
• Anxiolytics and antipsychotics, as they may enhance their sedative effect.
• Gabapentin or pregabalin for treating epilepsy or pain caused by nerve system injuries (neuropathic pain).
• Tricyclic antidepressants or monoamine oxidase inhibitors.
• Hormonal contraceptives.

Taking Dolmen with food, drinks, and alcohol

Take this medication after meals or with food.

If you regularly consume alcohol (three or more alcoholic drinks—beer, wine, liquor—per day), taking Dolmen may cause stomach bleeding.

Pregnancy and breastfeeding

Pregnancy

Consult your doctor or pharmacist before taking any medication.

If you are pregnant or think you might be pregnant, consult your doctor before taking this medication. Taking this medication during the first and second trimesters of pregnancy may be harmful to the embryo or fetus and must be monitored by your doctor. You should not take this medication during the third trimester of pregnancy.

Breastfeeding

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

Driving and use of machines

Dolmen may make you feel drowsy; therefore, caution is advised when driving, operating dangerous machinery, or performing any activity where lack of concentration could pose a risk.

Dolmen contains sodium benzoate (E-211) and sodium (as sodium benzoate, sodium bicarbonate, anhydrous monosodium citrate, and sodium saccharin):

This medicine contains 102 mg of sodium benzoate (E-211) per tablet.

This medicine contains 384 mg of sodium (the main component of table/cooking salt) per tablet. This corresponds to 19% of the maximum recommended daily sodium intake for an adult.

Consult your doctor or pharmacist if you need to take one or more tablets daily for a prolonged period, especially if you have been advised to follow a low-salt (sodium) diet.

Use in athletes

This medicine contains codeine, which may result in a positive finding in doping control tests.

3. How to take Dolmen

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

Before starting treatment and regularly during treatment, your doctor will explain what you can expect from using Dolmen, 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 taking Dolmen).

This medicine is for oral use. The recommended dose is:

Adults and adolescents over 16 years of age: take 1 effervescent tablet every 4–6 hours, up to a maximum of 8 effervescent tablets per day, as needed.

Use in children and adolescents

Do not administer to children or adolescents under 16 years of age:

• Do not administer to adolescents under 16 years of age with fever-related conditions, influenza, or varicella, as in these cases the use of acetylsalicylic acid has been associated with the occurrence of Reye's syndrome.
• Children under 12 years of age must not take codeine due to the risk of serious respiratory problems.

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

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

Patients with reduced liver or kidney function: consult your doctor, as the dose should be reduced.

Administration of this medicine should be based on the presence of painful or fever-related symptoms. As these symptoms subside, the medication should be discontinued.

This medicine must not be taken for more than 3 days. If pain or fever persists for more than 3 days, worsens, or new symptoms appear, seek advice from your doctor.

Instructions for correct administration of the preparation:

To take Dolmen, dissolve the effervescent tablet in half a glass of water and wait until the bubbling or effervescence has stopped before drinking. This medicine should be taken after meals or with food.

If you take more Dolmen than you should

The main symptoms of overdose are: headache, dizziness, tinnitus, blurred vision, drowsiness, sweating, nausea, vomiting, and occasionally diarrhea.

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 telephone 915 620 420, indicating the medicine and the amount ingested.

If you forget to take Dolmen

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

4. Possible adverse effects

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

The most common adverse effects are gastrointestinal discomfort, skin rashes, breathing difficulties, drowsiness, and dizziness.

Frequent adverse effects:

• Gastrointestinal disorders, such as gastric ulcer, duodenal ulcer, gastrointestinal bleeding, abdominal pain, gastric discomfort, nausea, vomiting.

• Respiratory disorders, such as difficulty breathing, bronchospasm, rhinitis.

• Urticaria, skin rashes, angioedema.

• Hypoprothrombinemia (with high doses).

Uncommon adverse effects:

• Reye's syndrome in patients under 16 years of age with febrile conditions, influenza, or varicella.
• Hepatic disorders, especially in patients with juvenile arthritis.
• Occasionally, and at doses exceeding 600 mg/day of vitamin C (3 tablets/day): diarrhea, skin flushing, headache, nausea, vomiting, and stomach cramps.
• Risk of urinary tract stones or gout attacks in predisposed individuals.

Other possible adverse effects:

Frequency unknown (cannot be estimated from 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), for example, severe upper abdominal pain that may radiate to the back, nausea, vomiting, or fever.

Stop taking this medicine and consult your doctor immediately if you notice any of the following, as they may indicate the onset of side effects requiring urgent medical attention:

• Stomach discomfort or pain, gastric or intestinal bleeding, or black stools.
• Skin disorders, such as rashes or redness.
• Difficulty breathing.
• Unexpected changes in the amount or appearance of urine.
• Swelling of the face, feet, or legs.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, 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 Dolmen

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

Keep the tube tightly closed and store below 25 °C.

Store this medicine in a safe place inaccessible to other people. It may cause serious harm and could 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 or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, 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 Dolmen

The active substances are: 500 mg of acetylsalicylic acid, 250 mg of ascorbic acid and 10 mg of codeine phosphate.

The other components are: citric acid, sodium benzoate (E-211), sodium bicarbonate, anhydrous monosodium citrate, orange flavour, povidone K-30, sodium saccharin.

Appearance of the medicine and contents of the pack

Dolmen is available in packs of 10 and 20 effervescent tablets, in an aluminium tube. The tablets are round, white in colour and unmarked.

Marketing Authorisation Holder

Laboratorios ERN, S.A.

Perú, 228 - 08020 Barcelona, Spain

Manufacturer

• Uriach y Compañía, S.A.

Av. Camí Reial 51-57

08184 Palau-solità i Plegamans, Barcelona, Spain

or

Laboratorios ERN, S.A.

Polígono Industrial Can Salvatella

Gorchs Lladó, 188

08210 Barberá del Vallés, 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 Health Products (AEMPS) http://www.aemps.gob.es/.