Dolodens 100 mg/15 mg/10 mg film-coated tablets

Package leaflet: Information for the user

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 leaflet carefully before you start taking this medicine, as 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 other people, 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 they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Dolodens is and what it is used for

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

This medicine contains codeine. Codeine belongs to a group of medicines called opioid analgesics, which work by relieving pain. It may 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 other than propyphenazone (such as metamizole or phenylbutazone), or to any of the other ingredients of this medicine (listed in section 6).
• If you have previously experienced hypersensitivity (rhinitis, asthma, angioedema, or urticaria) to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs).
• If you have respiratory problems (chronic obstructive pulmonary disease, acute asthma attacks, or respiratory depression).
• If you have anemia (reduced hemoglobin levels in the blood, with or without a reduction in red blood cells).
• If you have severe kidney, liver, or heart disease (renal, hepatic, or cardiac insufficiency).
• If you have a metabolic disorder such as porphyria (a rare, usually hereditary condition characterized by excessive excretion of porphyrins in feces and urine) or congenital glucose-6-phosphate dehydrogenase deficiency.
• If you are known to metabolize codeine rapidly into morphine.
• If you are pregnant or breastfeeding.
• If your ECG (electrocardiogram) shows a heart rhythm problem called "QT interval prolongation".
• 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 disorders or medications that may affect heart rhythm (see "Use of Dolodens with other medicines").
• If a close family member has died suddenly from cardiac problems.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take this medicine. It is important to use the lowest dose that relieves your pain. Do not take more than the dose recommended by your doctor or the dose stated in section 3 of this leaflet, “How to take Dolodens”.

Prolonged or frequent use of this medicine is not recommended.

Take special care with Dolodens:

• If you have any liver or kidney disease.
• If you have hypertension or heart conditions worsened by fluid retention and edema.
• If you have previously experienced bone marrow function disorders (e.g., after chemotherapy) or blood disorders (blood dyscrasias).

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

• If you have glaucoma, bladder outflow obstruction, reduced gastrointestinal motility, gallbladder disease, myasthenia gravis, or dementia.
• If you have any disease of the thyroid gland (hypothyroidism), prostate gland (prostatic hypertrophy), or adrenal gland (adrenal insufficiency).
• If you have multiple sclerosis.
• If you have diseases associated with reduced respiratory capacity.
• If you have a history of stroke, or think you may be at risk of such conditions (e.g., high blood pressure, diabetes, high cholesterol, or if you are a smoker), you should discuss this treatment with your doctor or pharmacist.
• If you notice skin redness, rash, blisters, or peeling, stop treatment and consult your doctor.
• Gastrointestinal bleeding, ulcers, and perforations (potentially fatal) have been reported during treatment with non-steroidal anti-inflammatory drugs (NSAIDs). If you have a history of gastrointestinal toxicity, especially elderly patients, inform your doctor immediately of any unusual abdominal symptoms (particularly gastrointestinal bleeding) during treatment, especially at the beginning of treatment.
• If gastrointestinal bleeding or ulceration occurs during treatment with this medicine, treatment must be stopped immediately.
• Use the medicine 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 responsible for pain relief. Some people have a variation of this enzyme that can affect individuals differently. In some people, morphine is not produced or is produced in very low amounts, resulting in insufficient 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 and seek immediate medical help: slow or shallow breathing, confusion, drowsiness, pinpoint pupils, nausea or vomiting, constipation, or 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 medicines, including those obtained without a prescription.

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

Abuse and dependence:

Although inappropriate use of this medicine seems unlikely, prolonged and excessive administration of codeine, like other strong opioid analgesics, may lead to psychological dependence, physical dependence, and tolerance, with withdrawal symptoms occurring after abrupt discontinuation of the drug. After prolonged treatment, the medicine should be discontinued gradually as directed by your doctor.

If you need to take this medicine for a prolonged period, your treatment should be periodically re-evaluated by your doctor.

Interference with diagnostic tests:

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

Treatment should be discontinued at least 5 days before undergoing an allergy test or a bronchial provocation test with methacholine to avoid interference with test results.

Use in athletes:

This medicine contains codeine. As a result of its metabolism, certain compounds are produced that may lead to a positive result in doping control tests.

Children and adolescents

The use of this medicine 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 and adolescents (0–18 years of age) after tonsil or adenoid removal due to the risk of obstructive sleep apnea syndrome.

Use in children with respiratory problems:

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

Taking Dolodens with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This includes any medicines obtained without a prescription. Dolodens may affect or be affected by other medicines.

• If you are taking medications that affect blood coagulation, such as oral anticoagulants or platelet aggregation inhibitors like acetylsalicylic acid. You should also mention the use of other medicines that could increase the risk of such bleeding, such as corticosteroids and selective serotonin reuptake inhibitor (SSRI) antidepressants.
• Other anti-inflammatory drugs.
• Other opioid analgesics, barbiturates, benzodiazepines.
• Opioid agonist-antagonists (nalbuphine, buprenorphine, pentazocine).
• Patients receiving central nervous system (CNS) depressants together with Dolodens may experience additional CNS depression. These include medicines used to treat sleep disorders, pain, and epileptic seizures.

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

• Bacterial infections (e.g., the antibiotics 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)
• Medication abuse or severe pain (methadone)

Taking Dolodens with food, drinks, and alcohol

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

Pregnancy, breastfeeding, and fertility

The use of this medicine 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 medicine contains codeine, which may cause drowsiness and impair mental and/or physical abilities. If you experience these effects, avoid driving or operating machinery. Hydroxyzine may cause drowsiness, reduce attention, or impair reaction ability.

Dolodens contains sucrose and lactose

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

3. How to take Dolodens

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

The lowest effective dose of Dolodens for the shortest possible duration should be used.

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

The recommended dose is:

Adults

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

Children and adolescents

The use of this medicine is not recommended in individuals 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 a glass of water.

If you take more Dolodens than you should

If you have taken too much Dolodens, contact your doctor or pharmacist immediately or go to the nearest hospital, especially if an overdose has occurred in a child. Gastric lavage and symptomatic treatment are recommended. Electrocardiographic (ECG) monitoring may be performed due to the possibility of cardiac rhythm disturbances, such as QT interval prolongation or Torsade de Pointes.

In case of overdose or accidental ingestion, contact 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 missed doses. Continue taking your regular dose at the scheduled time.

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

4. Possible adverse effects

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

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

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

Propyphenazone

Gastrointestinal

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

Cardiovascular

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

Skin disorders

Very rare: Bullous reactions including Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis.

Hepatobiliary disorders

Rare: Hepatic injury.

Hydroxyzine

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.

Additional investigations

Rare: Abnormal liver function tests.

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

Nervous system disorders

Very common: Somnolence.

Common: Headache, sedation.

Uncommon: Dizziness, insomnia, tremor.

Rare: Seizures, 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, drug-induced fixed 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, leucopenia, neutropenia, hemolytic anemia.

Reporting of adverse effects

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

No special storage conditions are required.

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

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.

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

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 usual pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Dolodens

The active substances 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 copolymer E, talc, polyvinylpyrrolidone, gelatin, titanium dioxide, yellow wax and carnauba wax.

Appearance of the product and contents of the pack

Dolodens is presented as 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 most recent review of this leaflet: September 2021

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/