DOLODENS 100 mg/15 mg/10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Dolodens 100 mg/15 mg/10 mg Coated Tablets

Propyphenazone / Hydroxyzine Hydrochloride / 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 questions, ask 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 side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

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

1. What is Dolodens and what is it used for

Dolodens contains propyphenazone, hydroxyzine, and codeine. This medication belongs to the group of analgesics and is indicated for adult patients for the relief of moderate acute pain (e.g., in toothaches, maxillary neuralgia, periodontitis, and postoperative pain in dentistry) that is not relieved by other analgesics such as paracetamol or ibuprofen alone.

This medication contains codeine. Codeine belongs to a group of medications called opioid analgesics that act by relieving pain. It can be used alone or in combination with other analgesics.

2. What you need to know before taking Dolodens

Do not take Dolodens:

• If you are allergic (hypersensitive) to propyphenazone, hydroxyzine, codeine, or other pyrazolone derivatives (such as metamizole or phenylbutazone) or to any of the other components of this medication (listed in section 6).
• If you have had hypersensitivity (rhinitis, asthma, angioedema, or urticaria) to salicylic acid or other non-steroidal anti-inflammatory drugs.
• If you have respiratory problems (chronic obstructive pulmonary disease, acute asthma attacks, or respiratory depression).
• If you have anemia (decrease in hemoglobin levels in the blood, due to or not due to a decrease in red blood cells).
• If you have severe kidney, liver, or heart disease (renal, hepatic, or cardiac insufficiency).
• If you have any metabolic disease such as porphyria (a rare, usually hereditary disorder in which large amounts of porphyrin are eliminated in feces and urine) or congenital glucose-6-phosphate dehydrogenase deficiency.
• If you know you metabolize codeine to morphine very quickly.
• If you are pregnant or breastfeeding.
• If your ECG (electrocardiogram) shows a heart rhythm problem called "prolonged QT interval".
• If you have or have had a cardiovascular disease or if your heart rate is very low.
• If you have low levels of salts in your body (e.g., low potassium or magnesium levels).
• If you are taking certain medications for heart rhythm problems or medications that can affect heart rhythm (see "Using Dolodens with other medications").
• If a close relative has died suddenly from heart problems.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medication. It is essential to use the smallest dose that relieves the pain. Do not take more doses than recommended by your doctor or as stated in section 3 of this package leaflet "How to take Dolodens".

Prolonged or frequent use of this medication is not recommended.

Be particularly careful with Dolodens:

• If you have any liver or kidney disease.
• If you have hypertension or heart disease worsened by fluid retention and edema.
• If you have suffered from bone marrow function disorders (e.g., after receiving chemotherapy) or if you have had blood diseases (blood dyscrasias).

If you have a history of stomach or intestinal disease or gastrointestinal ulcers.

• If you have glaucoma, bladder flow obstruction, decreased gastrointestinal motility, biliary colic, myasthenia gravis, or dementia.
• If you have any thyroid gland disease (hypothyroidism), prostate gland disease (prostatic hypertrophy), or adrenal gland disease (adrenal insufficiency).
• If you have multiple sclerosis.
• If you have diseases that cause decreased respiratory capacity.
• If you have a history of strokes or think you may be at risk of suffering from these conditions (e.g., you have high blood pressure, suffer from diabetes, have high cholesterol, or are a smoker), you should consult your doctor or pharmacist about this treatment.
• If you notice redness on the skin, rash, blisters, or peeling, discontinue treatment and consult your doctor.
• During treatment with non-steroidal anti-inflammatory drugs (NSAIDs), gastrointestinal bleeding, ulcers, and perforations (potentially fatal) have been reported. If you have a history of gastrointestinal toxicity, and especially in elderly patients, you should immediately inform your doctor of any unusual abdominal symptoms (especially gastrointestinal bleeding) during treatment and especially at the start of treatment.
• If gastrointestinal bleeding or ulcers occur during treatment with this medication, you should discontinue treatment immediately.
• Use the medication with caution if you have a history of ulcerative colitis or Crohn's disease.
• 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, no morphine is produced or it is produced in very low quantities and will not provide sufficient pain relief. Other people are more likely to suffer from severe 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 medical help immediately: slow or shallow breathing, confusion, drowsiness, constricted pupils, nausea or vomiting, constipation, loss of appetite.
• If you have a high risk of seizures.
• Dolodens may be associated with an increased risk of cardiac rhythm disorders that can be life-threatening. Therefore, inform your doctor if you have any heart problems or if you are taking any other medication, including those purchased without a prescription.

Seek medical attention immediately if, while being treated with Dolodens, you experience heart problems such as palpitations, difficulty breathing, or loss of consciousness. Treatment with hydroxyzine should be discontinued.

Abuse and dependence:

Although it seems unlikely that the medication will be misused, prolonged and excessive administration of codeine, like other major opioid analgesics, can cause psychological dependence, physical dependence, and tolerance with consecutive withdrawal symptoms after sudden discontinuation of the medication. Administration should be gradually discontinued after prolonged treatments as indicated by your doctor.

If you need to take this medication for an extended period, the treatment should be periodically reevaluated by your doctor.

Interference with laboratory tests:

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

Treatment should be discontinued at least 5 days before performing an allergy test or a bronchial provocation test with methacholine to avoid effects on the results.

Use in athletes:

This medication contains codeine. As a result of its metabolism, some compounds are produced that can result in a positive test result in doping controls.

Children and adolescents.

The use of this medication is not recommended in children or adolescents (under 18 years of age).

Use after surgery:

Codeine should not be used for pain relief in children or adolescents (0-18 years of age) after tonsillectomy or adenoidectomy due to obstructive sleep apnea syndrome.

Use in children with respiratory problems:

The use of codeine is not recommended in children with respiratory problems, as the symptoms of morphine toxicity can be worse in these children.

Taking Dolodens with other medications

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication. This includes any medication purchased without a prescription. Dolodens may affect or be affected by other medications.

• If you take medications that alter blood coagulation, such as oral anticoagulants or antiplatelet agents of the aspirin type. You should also comment on the use of other medications that could increase the risk of such bleeding, such as corticosteroids and selective serotonin reuptake inhibitor antidepressants.
• Other anti-inflammatory medications.
• Other morphine-like analgesics, barbiturates, benzodiazepines.
• Morphine agonist-antagonists (nalbuphine, buprenorphine, pentazocine)
• Patients undergoing treatment with central nervous system depressant medications in conjunction with Dolodens may present with additional central nervous system depression. These medications include those used to combat sleep disorders, pain, and epileptic seizures.

Do not take Dolodens if you are taking medications to treat:

• Bacterial infections (e.g., antibiotics such as erythromycin, moxifloxacin, levofloxacin)
• Fungal infections (e.g., pentamidine)
• Heart problems or high blood pressure (e.g., amiodarone, quinidine, disopyramide, sotalol)
• Psychosis (e.g., haloperidol)
• Depression (e.g., citalopram, escitalopram)
• Gastrointestinal disorders (e.g., prucalopride)
• Allergies
• Malaria (e.g., mefloquine)
• Cancer (e.g., toremifene, vandetanib)
• Drug abuse or severe pain (methadone)

Taking Dolodens with food, drinks, and alcohol

Alcohol may enhance the effects of Dolodens, so it is recommended not to consume alcoholic beverages during treatment. The simultaneous administration of hydroxyzine, codeine, and alcohol may produce an additive depressant effect on the central nervous system.

Pregnancy, breastfeeding, and fertility

The use of this medication is contraindicated during pregnancy and breastfeeding.

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

Driving and using machines

This medication contains codeine, which can cause drowsiness, altering mental and/or physical ability. If you notice these effects, avoid driving vehicles or using machines. Hydroxyzine can cause drowsiness, decrease your attention, or decrease your reaction capacity.

Dolodens contains sucrose and lactose

This medication contains sucrose (185.66 mg). Patients with hereditary fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase insufficiency should not take this medication. It also contains lactose (50 mg); patients with lactase deficiency should not use this medication.

3. How to take Dolodens

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.

The smallest effective dose of Dolodens should be administered and for the shortest possible duration.

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.

The recommended dose is:

Adults

2 tablets at the time of acute pain. Maximum 4 tablets per day.

Children and adolescents

The use of the medication is not recommended in children under 18 years of age.

Elderly patients

Maximum 3 tablets per day.

In elderly patients, the maximum daily dose of hydroxyzine is 50 mg/day.

Dolodens is administered orally.

Take the tablets with the help of a glass of water.

If you take more Dolodens than you should

If you have taken too much Dolodens, consult your doctor or pharmacist immediately or go to the nearest hospital, especially if it is a child who has taken too much. Gastric lavage is advised, and symptomatic treatment should be initiated. Electrocardiographic monitoring (ECG) may be performed due to the possibility of a heart rhythm problem, such as prolonged QT interval or Torsade de Pointes.

In case of overdose or accidental ingestion, consult the Toxicology Information Service. Telephone 91 562 04 20.

If you forget to take Dolodens

Do not take a double dose to make up for forgotten doses. Continue taking your normal dose when it is due.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

The assessment of the frequency of adverse reactions is based on the following criteria:

Very common side effects (may affect more than 1 in 10 patients). Common side effects (may affect up to 1 in 10 patients). Uncommon side effects (may affect up to 1 in 100 patients). Rare side effects (may affect up to 1 in 1,000 patients). Very rare side effects (may affect up to 1 in 10,000 patients). Side effects with unknown frequency (cannot be estimated from available data).

Propyphenazone

Gastrointestinal disorders

The most frequent adverse reactions in treatment with non-steroidal anti-inflammatory drugs are of a gastrointestinal nature. Peptic ulcers, perforation, or gastrointestinal bleeding, potentially fatal, may occur, especially in elderly patients. Nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, melena, hematemesis, stomatitis, ulceration, exacerbation of colitis, and Crohn's disease have also been reported. Less frequently, gastritis has been observed.

Cardiovascular disorders

Edema, arterial hypertension, and heart failure, as well as an increased risk of atherothrombotic events (e.g., myocardial infarction or stroke), have been reported in high doses and long-term treatment.

Skin disorders

Very rare: Bullous reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis.

Hepatobiliary disorders

Rare: Liver damage.

Hydroxyzine

Cardiac disorders

Rare: Tachycardia.

Unknown frequency: Stop taking this medication and seek medical attention immediately if you experience any heart rhythm problems, such as palpitations, difficulty breathing, or loss of consciousness.

Ocular disorders

Rare: Accommodation disorders, blurred vision.

Gastrointestinal disorders

Common: Dry mouth.

Uncommon: Nausea.

Rare: Vomiting.

General disorders and administration site conditions

Common: Fatigue.

Uncommon: Malaise, pyrexia.

Immune system disorders

Rare: Hypersensitivity.

Very rare: Anaphylactic shock.

Investigations

Rare: Abnormal liver function tests.

Unknown frequency: Weight gain.

Nervous system disorders

Very common: Drowsiness.

Common: Headache, sedation.

Uncommon: Dizziness, insomnia, tremor.

Rare: Convulsions, dyskinesia.

Psychiatric disorders

Uncommon: Agitation, confusion.

Rare: Disorientation, hallucinations.

Renal and urinary disorders

Rare: Urinary retention.

Respiratory, thoracic, and mediastinal disorders

Very rare: Bronchospasm.

Skin and subcutaneous tissue disorders

Rare: Pruritus, erythematous rash, maculopapular rash, urticaria, dermatitis.

Very rare: Angioneurotic edema, increased sweating, fixed drug eruption, acute generalized exanthematous pustulosis, erythema multiforme.

Vascular disorders

Rare: Hypotension.

Codeine

Gastrointestinal disorders

Rare: Constipation.

Hepatobiliary disorders

Very rare: Jaundice.

Metabolism and nutrition disorders

Very rare: Hypoglycemia.

Blood and lymphatic system disorders

Very rare: Thrombocytopenia, agranulocytosis, leukopenia, neutropenia, hemolytic anemia

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are side effects 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 Dolodens

No special storage conditions are required.

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

Do not use this medication after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not use this medication if you notice visible signs of deterioration.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE point in your usual 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. Packaging Content and Additional Information

Dolodens Composition

The active ingredients are Propyphenazone, Hydroxyzine hydrochloride, Codeine phosphate hemihydrate; each coated tablet contains 100 milligrams of propyphenazone,15 milligrams of hydroxyzine hydrochloride and 10 milligrams of codeine phosphate hemihydrate.

The other components (excipients) are:

• Core: lactose, microcrystalline cellulose, sodium croscarmellose, corn starch, polyvinylpyrrolidone, gelatin, and magnesium stearate.
• Coating: sucrose, erythrosine (E-127), calcium carbonate, methacrylic acid polymer, talc, polyvinylpyrrolidone, gelatin, titanium dioxide, yellow wax, and carnauba wax.

Product Appearance and Packaging Content

Dolodens is presented in the form of coated tablets for oral administration, in packs of 2 and 4 round pink tablets with a smooth surface and convex faces in aluminum/PVC blisters.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

FARMALIDER S.A.

C/ La Granja, 1

28108- Alcobendas- Madrid

Spain

Manufacturer

TOLL MANUFACTURING SERVICES, S.L.

Aragoneses, 2

28108 Alcobendas (Madrid) Spain

Date of the Last Revision of this Prospectus: September 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/