Dolviran 400 mg/9.6 mg/50 mg tablets

Patient Information Leaflet

Introduction

Patient Information Leaflet

Dolvirán 400 mg/ 9.6 mg/ 50 mg tablets

Acetylsalicylic acid / Codeine phosphate hemihydrate / Caffeine

Package leaflet contents:

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

1. What Dolvirán is and what it is used for

Dolvirán is used in adults and adolescents over 16 years of age for the symptomatic relief of mild to moderate occasional pain, such as headaches, toothaches, menstrual pain, muscle pain (muscle spasms), or back pain (lumbago).

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 such as paracetamol.

2. What you need to know before taking Dolvirán

Do not take Dolvirán

• If you are allergic to acetylsalicylic acid, codeine, or any of the other components of this medicine (listed in section 6)
• If you have active, chronic, or recurrent gastroduodenal ulcer
• If you have asthma
• If you have or have had coagulation disorders, particularly haemophilia or hypoprothrombinaemia
• If you have severe renal or hepatic insufficiency
• If you are being treated with oral anticoagulants
• If you have nasal polyps associated with asthma induced or exacerbated by acetylsalicylic acid
• Do not administer to children under 16 years of age with fever, flu, or chickenpox, as in these cases the use of acetylsalicylic acid has been associated with the development of Reye's syndrome
• For pain relief in children and adolescents (0–18 years of age) following tonsil or adenoid removal due to obstructive sleep apnoea syndrome
• If you have hypersensitivity to codeine or conditions in which respiratory centre depression must be avoided
• If you are known to be a rapid metaboliser of codeine to morphine
• Should not be taken over prolonged periods in cases of chronic constipation
• If you have chronic cardiorespiratory insufficiency or cardiac conditions
• If you have biliary disorders, as codeine, like all morphine derivatives, may cause spasm of the sphincter of Oddi
• If you are in the third trimester of pregnancy
• If you are breastfeeding

If you believe you are affected by any of these conditions, consult your doctor before taking this medicine.

Warnings and precautions

Consult your doctor if pain persists for more than 5 days, fever for more than 3 days, or if pain or fever worsen or new symptoms appear.

• Caution is recommended in debilitated and elderly patients, and in those with intracranial lesions, hypothyroidism, adrenal insufficiency, or prostate hypertrophy
• Administration of acetylsalicylic acid should be avoided in patients before or after dental extraction or surgical intervention. This medicine should be discontinued one week prior to surgical procedures
• Do not administer systematically as preventive treatment for discomfort associated with vaccinations
• Do not take sedatives during treatment with this medicine
• As with all medicines containing codeine, dependence may develop after prolonged administration of high doses, with withdrawal syndrome if treatment is abruptly discontinued
• Do not exceed the recommended dose (see section 3. "How to take Dolvirán"), as serious adverse effects may occur (see section 4. "Possible side effects")
• If you have heart disease such as sinus tachycardia/extrasystoles, hepatic insufficiency, hyperthyroidism, or an anxiety syndrome, you should take reduced doses of caffeine (no more than 100 mg, equivalent to two tablets of Dolvirán) or preferably under medical supervision
• You experience pain or increased sensitivity to pain (hyperalgesia) that does not respond to higher doses of your medicine

Treatment with non-steroidal anti-inflammatory drugs is associated with gastrointestinal bleeding, ulceration, and perforation of the upper digestive tract. If melena, haematemesis, marked asthenia, or any other sign or symptom suggestive of gastrointestinal bleeding occurs, treatment must be discontinued immediately.

Contact your doctor if you experience severe upper abdominal pain that may radiate to the back, nausea, vomiting, or fever, as these could be symptoms associated with inflammation of the pancreas (pancreatitis) or biliary tract.

This medicine should be administered under strict medical supervision in cases of hypersensitivity to other anti-inflammatory/antirheumatic drugs, glucose-6-phosphate dehydrogenase deficiency, urticaria, rhinitis, or arterial hypertension.

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 may 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.

Sleep-related breathing disorders

Dolvirán may cause sleep-related breathing disorders such as sleep apnoea (breathing pauses during sleep) and sleep-related hypoxemia (low blood oxygen levels). Symptoms may include breathing pauses during sleep, nocturnal awakening due to dyspnoea, difficulty maintaining sleep, or excessive daytime sleepiness. If you or someone else observes these symptoms, contact your doctor. Your doctor may consider reducing the dose.

Tolerance, dependence, and addiction

This medicine contains codeine, which is an opioid. It may lead to dependence and/or addiction.

Repeated use of opioids may lead to reduced effectiveness of the medicine (becoming accustomed to it, known as tolerance). Repeated use of Dolvirán may also lead to dependence, abuse, and addiction, which could potentially result in a fatal overdose. The risk of these adverse effects may be higher with higher doses and prolonged use.

Dependence or addiction may lead to a feeling of lack of control over the amount of medicine used or the frequency of use.

The risk of dependence or addiction varies from person to person. You may have a higher risk of dependence or addiction to Dolvirán if:

• You or any member of your family has abused alcohol or been dependent on it, prescription medicines, or illegal drugs ("addiction")
• You smoke
• You have ever had mood disorders (depression, anxiety, or personality disorder) or have received psychiatric treatment for other mental illnesses

If you notice any of the following symptoms while taking Dolvirán, it could be a sign of dependence or addiction:

• You need to take the medicine for longer than recommended by your doctor
• You need to take a higher dose than recommended
• You may feel the need to continue taking the medicine even when it does not help relieve pain
• You are using the medicine for reasons other than prescribed, e.g., "to stay calm" or "to help you sleep"
• You have made repeated unsuccessful attempts to stop or control its use
• You feel unwell when you stop using the medicine, and feel better once you resume taking it ("withdrawal effects")

If you experience any of these symptoms, consult your doctor to determine the best course of treatment, when it is appropriate to discontinue the medicine, and how to do so safely.

Use in elderly patients

Elderly individuals should not take this medicine without consulting their doctor, as they are more likely to experience adverse effects.

Other medicines and Dolvirán

Certain medicines may interact with Dolvirán. In such cases, it may be necessary to adjust the dose or discontinue treatment with one of the medicines; therefore, they should not be used without consulting a doctor.

Concomitant use of this medicine with sedative medicines such as benzodiazepines or related drugs increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be fatal. Therefore, concomitant use should only be considered when no other treatment options are available.

However, if your doctor prescribes this medicine together with sedative medicines, the dose and duration of concomitant treatment must be limited by your doctor.

Inform your doctor about all sedative medicines you are taking and follow your doctor's recommendations regarding dosage carefully. It may be helpful to inform friends or family members so they are aware of the aforementioned signs and symptoms. Contact your doctor if you experience such symptoms.

Acetylsalicylic acid interacts with ethanol, cimetidine, ranitidine, anticoagulants, non-steroidal anti-inflammatory drugs, corticosteroids, phenytoin, oral hypoglycaemics or insulin, methotrexate, uricosuric agents, vancomycin, zidovudine, valproic acid, sulfonamides, digoxin, barbiturates, and lithium.

When administered concomitantly, metamizole (a substance used to relieve pain and fever) may reduce the effect of acetylsalicylic acid on platelet aggregation (blood cells clumping together to form a blood clot). Therefore, this combination should be used with caution in patients taking low-dose acetylsalicylic acid for cardioprotection.

Caffeine may interfere with disulfiram, sedatives, antihistamines, sympathomimetics, adrenergic bronchodilators, mexiletine, benzodiazepines, oral contraceptives, cimetidine, theophylline, and gyrase inhibitors.

Codeine may interact with central nervous system depressants, alcohol, and morphine agonist-antagonists.

Inform your doctor or pharmacist if you are currently using, or have recently used, any other medicines, including those obtained without a prescription.

• Gabapentin or pregabalin for the treatment of epilepsy or nerve-related pain (neuropathic pain)

If you are undergoing any diagnostic tests (including blood or urine tests), inform your doctor that you are taking this medicine, as it may alter test results.

Taking Dolvirán with food, drinks, and alcohol

Take this medicine after meals or with food.

Do not consume alcoholic beverages during treatment.

Simultaneous consumption of this medicine with drinks containing caffeine may cause excessive stimulation of the nervous system, leading to nervousness, irritability, or insomnia.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

This medicine should not be used during the third trimester of pregnancy.

Additionally, it should not be taken during the rest of pregnancy unless your doctor considers it strictly necessary.

Do not take this medicine if you are breastfeeding, as its components pass into breast milk and may affect the infant. Codeine and morphine pass into breast milk.

Use in children and adolescents

Do not administer to children under 16 years of age.

Use in children and adolescents after surgery

Codeine should not be used for pain relief in children and adolescents following tonsil or adenoid removal due to obstructive sleep apnoea 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.

Driving and using machines

Codeine may cause drowsiness, impairing the mental and/or physical abilities required for potentially dangerous activities such as driving or operating machinery. Avoid driving or operating machinery during treatment.

3. How to take Dolvirán

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

Before starting treatment and periodically during treatment, your doctor will explain to you what to expect from using Dolvirán, when and for how long you need to use it, when to contact your doctor, and when you should stop taking it.

The tablets should be taken after meals, swallowed with a little water or dissolved in half a glass of water.

Do not exceed the recommended dose. Always use the lowest effective dose.

This medicine should not be taken for longer than 3 days. If pain does not improve after 3 days, consult your doctor again. Dolvirán should be used for the shortest time necessary to relieve symptoms.

The recommended dose is:

Adults and adolescents over 16 years of age: 1 or 2 tablets every 8 or 12 hours (2 to 3 times daily). The maximum daily dose is 6 tablets, maintaining a minimum interval of 8 hours between doses.

Patients with renal or hepatic impairment: your doctor will determine the appropriate dose.

Elderly patients: your doctor will determine the appropriate dose.

Use in children and adolescents under 16 years of age:

Do not administer to children and adolescents under 16 years of age:

• Do not administer to children under 16 years of age with fever-related conditions, influenza, or varicella, as in these cases the use of acetylsalicylic acid has been associated with the development of Reye's syndrome.
• Children under 12 years of age should not take codeine due to the risk of serious respiratory problems.

If you take more Dolvirán than you should

This may lead to an overdose, and therefore the effects related to acetylsalicylic acid, codeine, and caffeine should be considered.

In case of overdose, characteristic symptoms of acetylsalicylic acid poisoning may occur, such as nausea, vomiting, tinnitus, deafness, sweating, vasodilation, hyperventilation, headache, blurred vision, and occasionally diarrhea as signs of overdose. Neurological disorders such as confusion, delirium, seizures, and coma are signs of acute intoxication.

Symptoms characteristic of codeine overdose may also occur (drowsiness, skin flushing, miosis, vomiting, pruritus, ataxia, headache, skin swelling, urinary and fecal retention, and respiratory depression that may lead to respiratory arrest) or symptoms due to caffeine overdose from excessive central nervous system stimulation (insomnia, restlessness, vomiting, seizures, and excitatory symptoms) and gastrointestinal irritation (nausea, vomiting, diarrhea, abdominal pain).

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, go to a medical center immediately, or call the Toxicology Information Service at telephone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Dolvirán

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

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

4. Possible adverse effects

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

Adverse reactions due to acetylsalicylic acid may include:

Frequent (may affect up to 1 in 10 people):

• Gastrointestinal disturbances such as heartburn, nausea, vomiting, abdominal pain, and diarrhea.
• Increased tendency to bleed.
• Minor blood loss from the gastrointestinal tract (micro-bleeding).
• Bleeding such as nosebleeds, bleeding gums, skin bleeding, or bleeding from the urinary tract and genital organs, possibly with prolonged bleeding time. This effect may last from 4 to 8 days after ingestion.

Uncommon (may affect up to 1 in 100 people):

• Bleeding from the stomach or intestines. After long-term use of acetylsalicylic acid, anemia (iron-deficiency anemia) may occur due to occult blood loss from the stomach or intestines.
• Intracranial bleeding, blood in the urine.
• Gastric or intestinal ulcers, which very rarely may lead to perforation.
• Gastrointestinal inflammation.
• Skin reactions such as urticaria.
• Runny nose.

Rare (may affect up to 1 in 1,000 people):

• Hypersensitivity reactions affecting the skin, respiratory tract, gastrointestinal system, and cardiovascular system, especially in asthmatic patients. The following disease manifestations may occur: drop in blood pressure, attacks of dyspnea, inflammation of the nasal mucosa, nasal congestion, allergic shock, swelling of the face, tongue, and larynx (Quincke's edema).
• Severe skin reactions such as rash known as erythema multiforme, and life-threatening forms including Stevens-Johnson syndrome and Lyell's syndrome.
• Severe bleeding, such as cerebral hemorrhage, especially in patients with uncontrolled high blood pressure and/or concomitant treatment with anticoagulants (blood-thinning medicines), which may endanger life in individual cases.
• Confusion.
• Headache, dizziness.
• Hearing impairment or ringing in the ears (tinnitus), especially in children and elderly patients, which may be signs of overdose (see also “If you take more Dolvirán tablets than you should”).
• Abnormally heavy or prolonged menstrual periods.

Very rare (may affect up to 1 in 10,000 people):

• Abnormal liver function tests.
• Kidney dysfunction and acute renal failure.
• Decreased blood sugar (hypoglycemia).
• Acetylsalicylic acid reduces uric acid excretion at low doses. This may trigger an attack of gout in patients at risk.
• Febrile rashes with mucous membrane involvement (multiform exudative erythema).

Frequency not known (frequency cannot be estimated from available data):

• Accelerated breakdown or destruction of red blood cells and a certain form of anemia in patients with severe glucose-6-phosphate dehydrogenase deficiency.
• Dizziness.

Treatment must be stopped immediately if the patient experiences any type of hearing loss, tinnitus, or dizziness. In patients with a history of hypersensitivity to acetylsalicylic acid and other non-steroidal anti-inflammatory drugs, anaphylactic or anaphylactoid reactions may occur. This may also happen in patients who have not previously shown hypersensitivity to these drugs.

Adverse reactions due to codeine may include:

Rare (may affect up to 1 in 1,000 people):

• Gastrointestinal disorders (constipation, nausea).
• General disorders (malaise, somnolence).

Very rare (may affect up to 1 in 10,000 people):

• Blood and lymphatic system disorders (thrombocytopenia, agranulocytosis, leukopenia, neutropenia, hemolytic anemia).
• Metabolic disorders (hypoglycemia).
• Gastrointestinal disorders (jaundice).
• General disorders (hypersensitivity reactions ranging from simple skin rash or urticaria to anaphylactic shock, fever).

Frequency not known (cannot be estimated from available data):

• Symptoms associated with inflammation of the pancreas (pancreatitis) and of the biliary tract system (a condition affecting a digestive tract valve, known as Oddi sphincter dysfunction), for example, severe upper abdominal pain radiating to the back, nausea, vomiting, or fever.

The following adverse effects caused by caffeine have been observed, although their frequency cannot be precisely determined:

• Nervousness.
• Restlessness.
• Stomach or intestinal irritation.
• Tachycardia.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can 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 Dolvirán

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging and on the blister after EXP. The expiry date refers to the last day of the month indicated.

Keep in the original packaging, tightly closed.

Store this medicine in a secure and protected place inaccessible to others. This medicine may cause serious harm or be fatal to individuals who take it without having been prescribed it.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and their containers should be returned to the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Dolvirán

The active substances are acetylsalicylic acid, codeine phosphate hemihydrate, and caffeine.

Each tablet contains 400 mg of acetylsalicylic acid, 9.6 mg of codeine phosphate hemihydrate (equivalent to 7.34 mg of codeine), and 50 mg of caffeine.

The other components are: corn starch, microcrystalline cellulose, and magnesium stearate.

Appearance of Dolvirán and contents of the pack

White, round tablets.

Presented in packs of 20 tablets in PVC/PVDC/Al blisters.

Marketing Authorization Holder and Manufacturer

Kern Pharma, S.L.
Venus, 72 - Pol. Ind. Colón II
08228 Terrassa - Barcelona
Spain

Date of the most recent review of this leaflet: January 2026

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/