Package Insert: Information for the Patient

Dolodens 100 mg/15 mg/ 10 mg Coated Tablets

Propifenazona / Hydroxyzine hydrochloride / 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 read it again.
  If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you alone, 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 Dolodens and for what it is used

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

3. How to take Dolodens

4. Possible adverse effects

5. Storage of Dolodens

6. Contents of the package and additional information

Dolodens contains propifenazona, hidroxizina and codeine. This medication belongs to the group of analgesics and is indicated in adult patients for the relief of moderate acute pain (for example in toothaches, maxillary neuralgias, periodontitis and postoperative dental pain) 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 may be used alone or in combination with other analgesics.

Do not take Dolodens:

- If you are allergic (hypersensitive) to propifenazona, hidroxizina, codeína, or other pyrazolone derivatives (such as metamizol or fenilbutazona) or to any of the other components of this medication (listed in section 6).

- If you have had hypersensitivity (rinitis, asma, angioedema, or urticaria) to salicylic acid or to other nonsteroidal 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 or not to a decrease in red blood cells).

- If you have severe kidney, liver, or heart disease (renal, hepatic, or cardiac insufficiency).

- If you have a metabolic disease such as porphyria (a rare, usually inherited disorder in which a large amount of porphyrin is eliminated in feces and urine) or congenital glucose-6-phosphate dehydrogenase deficiency.

- If you know that you metabolize codeína very quickly to morphine.

- If you are pregnant or breastfeeding.

- If your ECG (electrocardiogram) shows a heart rhythm problem called "prolongation of the QT interval."

- If you have or have had cardiovascular disease or if your heart rate is very low.

- If you have low levels of electrolytes in your body (for example, low potassium or magnesium levels).

- If you are taking certain medications for heart rhythm problems or medications that can affect heart rhythm (see "Dolodens use with other medications").

- If a close relative has died suddenly from heart problems.

Warnings and precautions

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

Do not recommend prolonged or frequent use of this medication.

Be especially careful with Dolodens:

- If you have liver or kidney disease.

- If you have hypertension or heart disease exacerbated by fluid retention and edema.

- If you have had bone marrow function alterations (for example, after chemotherapy) or if you have had blood diseases (blood disorders).

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

- If you have glaucoma, urinary tract obstruction, decreased gastrointestinal motility, biliary tract problems, myasthenia gravis, or dementia.

- If you have 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 seizures or think you may be at risk of them (for example, you have high blood pressure, diabetes, high cholesterol, or are a smoker) consult this treatment with your doctor or pharmacist.

- If you notice redness of the skin, rash, blisters, or peeling, discontinue treatment and consult your doctor.

- During treatment with nonsteroidal anti-inflammatory drugs (NSAIDs), gastrointestinal bleeding, ulcers, and perforations (potentially fatal) have been reported. If you have a history of gastrointestinal toxicity, especially in elderly patients, inform your doctor immediately of any unusual abdominal symptoms (especially gastrointestinal bleeding) during treatment and particularly at the start of treatment.

- If a gastrointestinal hemorrhage or ulcer occurs during treatment with this medication, discontinue treatment immediately.

- Use the medication with caution if you have a history of ulcerative colitis or Crohn's disease.

- Codeína is metabolized 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 amounts and will not provide sufficient pain relief. Other people are more likely to experience severe adverse reactions because they produce a very high amount of morphine. If you experience any of the following adverse effects, discontinue 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 life-threatening heart rhythm disorders. Therefore, inform your doctor if you have any heart problems or if you are taking any other medications, including those obtained without a prescription.

Seek medical attention immediately if, while taking Dolodens, you experience heart problems such as palpitations, difficulty breathing, or loss of consciousness. Hydroxyzine treatment should be discontinued.

Abuse and dependence:

Although it seems unlikely that misuse of the medication will occur, prolonged and excessive administration of codeína, like other major opioid analgesics, can cause psychological dependence, physical dependence, and tolerance with subsequent withdrawal symptoms after sudden cessation of the drug. Administration should be discontinued gradually after prolonged treatment as advised by your doctor.

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

Interference with diagnostic tests:

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

The treatment should be discontinued at least 5 days before undergoing an allergy test or a bronchial provocation test with metacolina to avoid effects on the results.

Use in athletes:

This medication contains codeína. As a result of its metabolism, some compounds are produced that can produce a positive result in doping control tests.

Children and adolescents.

This medication is not recommended for use in children or adolescents (under 18 years old).

Use after surgery:

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

Use in children with respiratory problems:

Codeína is not recommended for use 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 taken recently, or may need to take any other medication. This includes any medication obtained 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 like aspirin. You should also inform your doctor about the use of other medications that may increase the risk of bleeding, such as corticosteroids and selective serotonin reuptake inhibitors.

- Other anti-inflammatory medications.

- Other opioid analgesics, barbiturates, benzodiazepines.

- Agonist-antagonist opioids (nalbufina, buprenorfina, pentazocina)

- Patients undergoing treatment with central nervous system depressants in combination with Dolodens may experience additional depression of the central nervous system. These medications include those used to treat sleep disorders, pain, and seizures.

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

- Bacterial infections (e.g., eritromicina, moxifloxacino, levofloxacino)

- Fungal infections (e.g., pentamidina)

- Heart problems or high blood pressure (e.g., amiodarona, quinidina, disopiramida, sotalol)

- Psychosis (e.g., haloperidol)

- Depression (e.g., citalopram, escitalopram)

- Gastrointestinal disorders (e.g., prucaloprida)

- Allergy

- Malaria (e.g., mefloquina)

- Cancer (e.g., toremifeno, vandetanib)

- Medication abuse or intense pain (metadona)

Taking Dolodens with food, drinks, and alcohol

Alcohol can potentiate the effects of Dolodens, so it is recommended not to consume alcoholic beverages during treatment. Simultaneous administration of hydroxyzine, codeína, and alcohol can produce additive depressive effects on the central nervous system.

Pregnancy, lactation, and fertility

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

Do not take codeína if you are breastfeeding. Codeína and morphine pass into breast milk.

Driving and operating machinery

This medication contains codeína, which can cause drowsiness, impairing mental and/or physical ability. If you experience these effects, avoid driving vehicles or operating machinery. Hydroxyzine can cause drowsiness, decrease attention, or decrease reaction time.

Dolodens contains saccharose and lactose

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

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

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

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

The recommended dose is:

Adults

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

Children and adolescents

Use of the medication is not recommended in individuals under 18 years old.

Senior patients

Maximum 3 tablets per day.

In senior 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 a child has taken too much. Gastric lavage and symptomatic treatment are recommended. Electrocardiogram (ECG) monitoring may be performed due to the possibility of a cardiac rhythm problem, such as QT interval prolongation or Torsade de Pointes.

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

If you forgot to take Dolodens

Do not take a double dose to compensate for the missed doses. Continue taking your regular dose when it is due.

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

Like all medicines, this medicine 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 (may affect more than 1 in 10 patients). Common (may affect up to 1 in 10 patients). Uncommon (may affect up to 1 in 100 patients). Rare (may affect up to 1 in 1,000 patients). Very rare (may affect up to 1 in 10,000 patients). Frequency not known (cannot be estimated from available data).

Propifenazona

Gastrointestinal

The most common adverse reactions in the treatment with nonsteroidal anti-inflammatory drugs are of gastrointestinal type. They may cause peptic ulcers, gastrointestinal perforation or hemorrhage, potentially fatal, especially in elderly patients. Nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, melena, hematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease have also been reported. Less frequently, gastritis has been observed.

Cardiovascular

Edema, hypertension, heart failure, and 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.

Hidroxizina

Cardiac disorders

Rare: Tachycardia.

Frequency not known: Stop taking this medicine and seek immediate medical attention if you experience any heart rhythm problems such as palpitations, difficulty breathing, or loss of consciousness.

Eye 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.

Frequency not known (the frequency cannot be estimated from available data): Weight gain.

Nervous system disorders

Very common: Drowsiness.

Common: Headache, sedation.

Uncommon: Dizziness, insomnia, tremor.

Rare: Convulsions, dyskinesia.

Mental and behavioural 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 oedema, increased sweating, fixed drug eruption, acute generalised pustular psoriasis, erythema multiforme.

Vascular disorders

Rare: Hypotension.

Codeína

Gastrointestinal disorders

Rare: Constipation.

Hepatobiliary disorders

Very rare: Jaundice.

Metabolism and nutrition disorders

Very rare: Hypoglycaemia.

Haematological disorders

Very rare: Thrombocytopenia, agranulocytosis, leucopenia, neutropenia, haemolytic anaemia.

Reporting of side effects

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

No requires special conservation conditions.

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

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.

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

Medicines should not be thrown down the drain or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point of your usual pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

Composition of Dolodens

The active principles are Propifenazona, Hidroxizina hydrochloride, Codeína phosphate hemihydrate; each coated tablet contains 100 milligrams of propifenazona,15 milligrams of hidroxizina hydrochloride and 10 milligrams of codeína phosphate hemihydrate.

The other components (excipients) are:

- Core: lactose, microcrystalline cellulose, sodium croscarmellose, cornstarch, polyvinylpyrrolidone, gelatin and magnesium stearate.

- Coating: sucrose, erythrosine (E-127), calcium carbonate, methacrylic polymer E, talc, polyvinylpyrrolidone, gelatin, titanium dioxide, yellow wax and carnauba wax.

Appearance of the product and contents of the packaging

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

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

FARMALIDER S.A.

C/ La Granja, 1

28108- Alcobendas- Madrid

Spain

Responsible for manufacturing

TOLL MANUFACTURING SERVICES, S.L.

Aragoneses, 2

28108 Alcobendas (Madrid) Spain

Last review date of this leaflet: September 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/