DOLMEN 500 mg/250 mg/10 mg EFFERVSCENT TABLETS

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

• Keep this package leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed to you only, 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 side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Dolmen and what is it used for
2. What you need to know before taking Dolmen
3. How to take Dolmen
4. Possible side effects
5. Storage of Dolmen
6. Package Contents and Additional Information

1. What is Dolmen and what is it used for

Acetylsalicylic acid belongs to a group of analgesic, antipyretic, and non-steroidal anti-inflammatory medications, 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 the short-term treatment of moderate pain that is not relieved by other analgesics such as paracetamol or ibuprofen alone.

Dolmen is indicated for the symptomatic relief of occasional mild or moderate pain, such as headaches, toothaches, menstrual cramps, 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.

2. What you need to know before taking Dolmen

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 discomfort.
• If you have had allergic reactions of an asthmatic type (difficulty breathing, shortness of breath, bronchospasm, and in some cases cough or wheezing) when taking anti-inflammatory medications, acetylsalicylic acid, other analgesics, as well as the tartrazine dye.
• If you have asthma, rhinitis, or urticaria.
• If you have hemophilia or other blood coagulation problems.
• If you are being treated with medications for blood coagulation (oral anticoagulants).
• If you have kidney and/or liver problems (renal and/or hepatic insufficiency).
• If you have kidney stones accompanied by oxaluria or aciduria or normal urinary pH.
• If you have blood disorders such as glucose-6-phosphate dehydrogenase deficiency, hemochromatosis, sideroblastic anemia, and thalassemia.
• If you have respiratory failure.
• If you are under 16 years old, unless explicitly indicated by a doctor, 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 tonsil or adenoid removal 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 you metabolize codeine to morphine very quickly.

Warnings and Precautions

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

If you are taking anti-inflammatory medications or other types of medications, as certain medications can interact with Dolmen and produce unwanted 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 tests with reactive strips.

In the case of elevated intracranial pressure and head trauma, as codeine can 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 in different ways. In some people, morphine is not produced or is produced in very low quantities, and it will not provide sufficient pain relief. Other people are more likely to suffer from serious adverse reactions because they produce a very high amount of morphine. If you experience any of the following side effects, you should stop taking this medication and seek immediate medical attention: slow or shallow breathing, confusion, drowsiness, small pupils, nausea or vomiting, constipation, loss of appetite.

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

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

You should inform your doctor or dentist before any possible surgical interventions.

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

As it contains codeine, it should be administered with caution to patients with a tendency to abuse and addiction, as prolonged administration can cause dependence.

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

Children and Adolescents

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

Use in children and adolescents after surgery

Codeine should 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 for use in children with respiratory problems, as the symptoms of morphine toxicity can be worse in these children.

Use in the Elderly

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

Interference with Diagnostic Tests

If you are going to have any diagnostic tests (including blood tests, urine tests, etc.), inform your doctor that you are taking this medication, as it may alter the results, including tests with reactive strips.

Other Medications and Dolmen

Inform your doctor or pharmacist if you are taking, have recently taken, or may 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 medications (medications used to treat pain and/or muscle inflammation).
• Anticoagulants (medications used to "thin" the blood and prevent the formation of clots) such as warfarin.
• Medications used to treat gout (probenecid).
• Medications to lower blood sugar levels (oral antidiabetics).
• Barbiturates (medications used as sedatives, as anticonvulsants, and for sleep problems).
• Corticosteroids, as they can increase the risk of gastrointestinal bleeding.
• Cimetidine and ranitidine (used for stomach acid).
• Digoxin (medication for the heart).
• 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 can cause intestinal obstruction.
• Anxiolytics and antipsychotics, as they can potentiate their sedative effect.
• Tricyclic antidepressants or monoamine oxidase inhibitors.
• Hormonal contraceptives.

Taking Dolmen with Food, Drinks, and Alcohol

Take this medication after meals or with some food.

If you regularly consume alcohol (three or more alcoholic beverages - beer, wine, liquor - per day), taking Dolmen can cause stomach bleeding.

Pregnancy and Breastfeeding

Pregnancy

Consult your doctor or pharmacist before taking any medication.

If you are pregnant or think you may be pregnant, consult your doctor before taking this medication. The use of this medication during the first and second trimester of pregnancy may be hazardous to the embryo or fetus and should 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 Using Machines

Dolmen can make you feel drowsy, so it is recommended to exercise caution when driving, operating hazardous machinery, or performing activities where lack of concentration may pose a risk.

Dolmen contains Sodium Benzoate (E-211) and Sodium (as Sodium Benzoate, Sodium Bicarbonate, Anhydrous Sodium Citrate, and Sodium Saccharin):

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

This medication contains 384 mg of sodium (main component of table salt) per effervescent tablet. This is equivalent to 19% of the maximum recommended daily intake of sodium 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 recommended a low-salt diet (sodium).

Use in Athletes

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

3. How to Take Dolmen

Follow the administration instructions of this medication exactly as indicated by your doctor or pharmacist. In case of 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 febrile processes, flu, or chickenpox, as the use of acetylsalicylic acid has been associated with the appearance of Reye's Syndrome in these cases.
• Children under 12 years old should not take codeine due to the risk of serious respiratory problems.

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

The administration of this medication is subject to the appearance of painful or febrile symptoms. As these symptoms disappear, the medication should be suspended.

This medication should not be taken for more than 3 days. If the pain or fever persists for more than 3 days, or worsens, or other symptoms appear, ask your doctor for advice.

Instructions for the 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 some 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 Toxicology Information Service, phone 915 620 420, indicating the medication and the amount ingested.

If You Forget to Take Dolmen

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

4. Possible Side Effects

Like all medications, this medication can produce side effects, although not all people experience them.

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

Frequent Side Effects:

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

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

Uncommon Side Effects:

• Reye's Syndrome in children under 16 years old with febrile processes, flu, or chickenpox.
• Liver 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 stone formation 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 side effects that require urgent medical attention, if you observe the appearance of:

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

Reporting Side Effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that is not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Dolmen

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.

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Dolmen

The active ingredients 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 sodium citrate, orange flavor, povidone K-30, sodium saccharin.

Appearance of the Product and Package Contents

Dolmen is presented in packages of 10 and 20 effervescent tablets, in an aluminum tube. The tablets are round, white, and unmarked.

Marketing Authorization 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

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

Date of the Last Revision of this Package Leaflet: March 2021.

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http:www.aemps.gob.es/.