Package Insert: Information for the Patient

Dolmen 500 mg/250 mg/10 mg Effervescent Tablets

Acetylsalicylic Acid, Ascorbic Acid, Codeine Phosphate Hemihydrate

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

1.What is Dolmen and for what it is used

2.What you need to know before starting to take Dolmen

3.How to take Dolmen

4.Possible adverse effects

5.Storage of Dolmen

6.Contents of the package and additional information

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

Codeine belongs to a group of medications called opioid analgesics that act by relieving pain. Codeine can be used in adolescents over 16 years old for short-term treatment of moderate pain that is not relieved by other analgesics such as paracetamol or ibuprofen alone.

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

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

It is also indicated for febrile states.

Do not take Dolmen:

• If you are allergic to the active ingredients or any of the other components of this medication (listed in section 6).
• If you have a stomach ulcer, duodenal ulcer, or recurring stomach pain.
• If you have had an allergic reaction of the asthmatic type (difficulty breathing, choking, bronchospasm, and in some cases, coughing or wheezing) when taking anti-inflammatory medications, acetylsalicylic acid, other analgesics, as well as tartrazine dye.
• If you have or have had asthma, rhinitis, or urticaria.
• If you have hemophilia or other blood clotting disorders.
• If you are taking medications for blood clotting (oral anticoagulants).
• If you have kidney or liver disease (renal or hepatic insufficiency).
• If you have kidney stones accompanied by oxaluria or aciduria or normal urine pH.
• If you have hematological disorders such as glucose-6-phosphate dehydrogenase deficiency, hemochromatosis, sideroblastic anemia, and thalassemia.
• If you have respiratory insufficiency.
• If you are under 16 years old, unless a doctor's explicit indication, as the use of acetylsalicylic acid has been linked to Reye's syndrome, a rare but serious disease.
• To relieve pain in children and adolescents (0-18 years old) after tonsillectomy or adenoidectomy due to obstructive sleep apnea syndrome.
• If you have biliary disorders.
• If you are in your third trimester of pregnancy.
• If you are breastfeeding.
• If you know that you metabolize codeine very quickly to morphine.

Warnings and precautions

If you have reduced kidney, heart, or liver function, head injuries, hypothyroidism, prostate hypertrophy, adrenal insufficiency, or are taking anticoagulants, consult your doctor before taking this medication.

If you are taking anti-inflammatory medications or other types of medications, as certain medications may interact with Dolmen and produce undesirable effects (see "Other medications and Dolmen").

If you have or have had rhinitis or urticaria.

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

If you are diabetic, due to the content of this medication in ascorbic acid, there is a possibility that it may produce erroneous results in urine glucose tests, including those using test strips.

In cases of elevated intracranial pressure and head trauma, as codeine may increase cerebrospinal fluid pressure.

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 differently. In some people, morphine is not produced or is produced in very small quantities, and it will not provide sufficient pain relief. In others, it is more likely that they will experience severe adverse reactions because they produce a very high amount of morphine. If you experience any of the following adverse effects, stop taking this medication and seek medical help immediately: slow or shallow breathing, confusion, drowsiness, small pupils, nausea or vomiting, constipation, loss of appetite.

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

If your doctor requests a blood test, urine test, or other diagnostic test, inform them that you are taking this medication, as the values of the determinations may be altered.

You must inform your doctor or dentist before any surgical interventions.

Do not administer systematically as a preventive measure for possible discomfort caused by vaccinations.

Due to its codeine content, it should be administered with caution to patients with a tendency to abuse and addiction, as its prolonged administration may cause dependence.

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

Children and adolescents

Do not administer to children or adolescents under 16 years old.

Use in children and adolescents after surgery

Do not use codeine for pain relief in children and adolescents after tonsillectomy or adenoidectomy due to obstructive sleep apnea syndrome.

Use in children with respiratory problems

Codeine should not be used in children with respiratory problems, as the symptoms of morphine toxicity may be worse in these children.

Use in the elderly

People of advanced age should not take this medication without consulting their doctor, as they are more prone to experiencing its adverse effects.

Interference with diagnostic tests

If you are to undergo any diagnostic test (including blood tests, urine tests, etc.), inform your doctor that you are taking this medication, as it may alter the results, including those using test strips.

Other medications and Dolmen

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

This is especially important in the case of:

• Medications used to prevent transplant rejection (ciclosporin and tacrolimus).
• High blood pressure (diuretics and ACE inhibitors).
• Cancer, rheumatoid arthritis (methotrexate).
• Other analgesics or anti-inflammatory non-steroidal medications (medications used to treat muscle pain and/or inflammation).
• Anticoagulants (medications used to "thin" the blood and prevent the formation of blood clots) such as warfarin.
• Medications used to treat gout (probenecid).
• Oral antidiabetic medications.
• Barbiturates (medications used as sedatives, anticonvulsants, and for sleep problems).
• Corticosteroids, as it may increase the risk of gastrointestinal bleeding.
• Cimetidine and ranitidine (used for stomach acid).
• Digoxin (heart medication).
• Phenytoin and valproic acid (antiepileptic medications).
• Lithium (used for depression).
• Vancomycin (used to treat infections) and sulfonamides (used to treat infections).
• Zidovudine (used to treat HIV infections).
• Anticholinergics and codeine, as they may cause intestinal obstruction.
• Anxiolytics and antipsychotics, as they may potentiate their sedative effect.
• Tricyclic antidepressants or monoamine oxidase inhibitors.
• Oral contraceptives.

Taking Dolmen with food, drinks, and alcohol

Take this medication after meals or with some food.

If you habitually consume alcohol (three or more alcoholic beverages 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 believe you may be pregnant, consult your doctor before taking this medication. The consumption of this medication during the first and second trimesters of pregnancy may be hazardous to the embryo or fetus and should be monitored by your doctor. Do 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 operating machinery

Dolmen may cause drowsiness, so it is recommended to exercise caution when driving, operating hazardous machinery, or in general, performing activities where lack of concentration may pose a risk.

Dolmen contains benzoate of sodium(E-211) and sodium (asbenzoate of sodium,bicarbonate of sodium,citrate monosodium anhydrousand saccharin sodium):

This medication contains 102 mg of benzoate of sodium (E-211) in each tablet.

This medication contains 384 mg of sodium (main component of table salt/for cooking) in each tablet. This is equivalent to 19% of the recommended daily maximum sodium intake for an adult.

Consult your doctor or pharmacist if you need one or more tablets per day for a prolonged period, especially if you have been recommended a low-sodium diet.

Use in athletes

This medication contains codeine, which may produce a positive result in doping control tests.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

This medication should be taken orally. The recommended dose is:

Adults and adolescents over 16 years old: 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 old:

• Do not administer to adolescents under 16 years old with feverish, flu, or chickenpox processes, as the use of acetylsalicylic acid has been associated with the appearance of Reye's Syndrome.
• Children under 12 years old should not take codeine due to the risk of severe respiratory problems.

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

The administration of this medication is subject to the appearance of painful or feverish symptoms. As these symptoms disappear, discontinue this medication.

This medication should not be taken for more than 3 days. If pain or fever persists for more than 3 days, worsens, or new symptoms appear, consult your doctor.

Instructions for correct administration of the preparation:

To take Dolmen, dissolve the effervescent tablet in half a glass of water and wait for the bubbling or effervescence to disappear before drinking it. This medication should be taken after meals or with food.

If you take more Dolmen than you should

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or go to a medical center immediately or call the Toxicological Information Service, phone 915 620 420, indicating the medication and the amount ingested.

If you forgot to take Dolmen

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

Like all medications, this medication may produce adverse effects, although not all people will experience them.

The most common are gastrointestinal discomfort, skin rashes, respiratory difficulty, drowsiness, and dizziness.

Frequent Adverse Effects:

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

• Respiratory disorders, such as difficulty breathing, bronchial spasm, rhinitis.
• Urticaria, skin rashes, angioedema.
• Hypoprothrombinemia (with high doses).

Rare Adverse Effects:

• Reye's syndrome in individuals under 16 years old with feverish processes, flu, or chickenpox.
• Hepatic disorders, especially in patients with juvenile arthritis.
• Occasionally, and at doses above 600 mg/day of vitamin C (3 tablets/day): diarrhea, skin redness, headache, nausea, vomiting, and stomach cramps.
• There is a risk of forming stones in the urinary tract or gout attacks in predisposed individuals.

Stop taking the medication and consult your doctor immediately, as they may indicate the appearance of adverse effects that require urgent medical attention, if you notice the appearance of:

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

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

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

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 thrown down the drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Composition of Dolmen

The active principles 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 flavor, povidone K-30, sodium saccharin.

Appearance of the product and contents of the packaging

Dolmen is presented in packaging of 10 and 20 effervescent tablets, in an aluminum tube. The tablets are round, white in color, and do not bear any mark.

Holder of the marketing authorization

LABORATORIOS ERN, S.A.

Perú, 228 -08020 Barcelona, Spain

Responsible for manufacturing

J. Uriach and Company, S.A.

Av. Camí Reial 51-57

08184 Palau-solità i Plegamans, Barcelona. Spain

or

LABORATORIOS ERN, S.A.

Polígono Industrial Can Salvatella

Gorgs Lladó, 188 - 08210 Barberá del Vallés, Barcelona. Spain

Date of the last review of this leaflet: March 2021.

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