Label: information for the user

Dolvirán 400 mg/ 9.6 mg / 50 mg suppositories

Acid acetysalicylic/ Codeine phosphate hemihydrate/ Caffeine

Contents of the package and additional information

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

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 such as paracetamol.

No use Dolvirán

• If you are allergic to acetylsalicylic acid, codeine, or any of the other components of this medication (listed in section 6).
• If you have an active, chronic, or recurrent gastric ulcer.
• If you have asthma.
• If you have bleeding disorders, primarily hemophilia or hypoprothrombinemia.
• If you have severe renal or hepatic insufficiency.
• If you are being treated with oral anticoagulants.
• If you have nasal polyps associated with asthma that are induced or exacerbated by acetylsalicylic acid.
• Do not administer to children under 16 years old with fever, flu, or chickenpox, as 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 old) after tonsillectomy or adenoidectomy due to obstructive sleep apnea syndrome.
• If you have hypersensitivity to codeine and in conditions where respiratory depression should be avoided.
• If you know that you metabolize codeine very quickly to morphine.
• Do not take for prolonged periods with chronic constipation.
• If you have chronic cardiac or respiratory insufficiency or heart disease.
• If you have biliary disorders, as codeine, like all morphine derivatives, can cause spasms of the Oddi sphincter.
• If you are in the third trimester of pregnancy.
• If you are breastfeeding.

If you think you are affected by any of these cases, consult your doctor before using this medication.

Warnings and Precautions

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

• Use with caution in debilitated patients and the elderly, with intracranial injuries, hypothyroidism, adrenal insufficiency, and prostatic hypertrophy.
• Avoid administering acetylsalicylic acid to patients before or after dental extraction or surgical intervention. Discontinue administration of this medication one week before surgical interventions.
• Do not administer systematically as a preventive measure for possible discomfort caused by vaccinations.
• Do not take sedatives during treatment with this medication.
• As with all medications containing codeine, dependence may develop after prolonged administration of high doses of Dolvirán, with withdrawal syndrome if treatment is stopped abruptly.
• Do not exceed the recommended dose (see section 3. "How to take Dolvirán"), as severe adverse effects may occur (see section 4. "Possible adverse effects").
• If you have any heart disease, such as sinus tachycardia/ extrasystoles, liver insufficiency, hyperthyroidism, or any anxiety syndrome, take caffeine in reduced doses (not more than 100 mg, equivalent to two Dolvirán suppositories) or preferably under medical supervision.

The treatment with nonsteroidal anti-inflammatory drugs is associated with the development of gastrointestinal bleeding, ulceration, and perforation. In case of melena, hematemesis, marked asthenia, or any other sign or symptom suggestive of gastric hemorrhage, treatment should be discontinued immediately.

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

Codeine is transformed into 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 quantities, and it will not provide sufficient pain relief. In other people, it is more likely that they will experience severe adverse reactions because they produce a very high amount of morphine. If you experience any of the following adverse effects, stop using this medication and seek medical help immediately: slow or shallow breathing, confusion, drowsiness, constricted pupils, nausea or vomiting, constipation, loss of appetite.

Use in elderly patients

Elderly patients should not take this medication without consulting their doctor, as they are more prone to experiencing adverse effects.

Other medications and Dolvirán

Certain medications may interact with Dolvirán. In these cases, it may be necessary to change the dose or discontinue treatment with one of the medications, so they should not be used without consulting a doctor.

The concomitant use of this medication and sedatives such as benzodiazepines or related medications increases the risk of somnolence, respiratory difficulties (respiratory depression), coma, and can be fatal. Therefore, concomitant use should only be considered when other treatment options are not possible.

However, if your doctor prescribes this medication along with sedatives, the dose and duration of concomitant treatment should be limited by your doctor.

Inform your doctor or pharmacist about all other medications you are taking, including those acquired without a prescription.

If you are to undergo any diagnostic tests (including blood and urine analyses, etc.), inform your doctor that you are taking this medication, as it may affect the results.

Use of Dolvirán with food, drinks, and alcohol

Do not consume alcoholic beverages during treatment.

The simultaneous use of this medication with the consumption of caffeine-containing beverages may cause excessive stimulation of the nervous system and produce nervousness, irritability, or insomnia.

Pregnancy, lactation, 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 medication.

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

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

Do not take this medication if you are breastfeeding, as its components pass into the 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 old.

Use in children and adolescents after surgery

Codeine should not be used for pain relief in children and adolescents after tonsillectomy or adenoidectomy due to obstructive sleep apnea syndrome.

Use in children with respiratory problems

Codeine should not be used in children with respiratory problems, as the symptoms of morphine toxicity may be worse in these children.

Driving and operating machinery

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

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Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

After removing the suppository from the packaging, insert it deeply into the rectum. You must use the entire suppository. Do not break the suppositories before administration.

Suppress defecation as much as possible so that the medication can exert its action.

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

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

The recommended dose is:

Adults and adolescents over 16 years:1 suppository 1 to 3 times a day. The maximum daily dose is 3 suppositories and there should be a minimum of 8 hours between each dose.

Patients with renal or hepatic insufficiency:Your doctor will indicate the appropriate dose.

Older adults:Your doctor will indicate the appropriate dose.

Use in children and adolescents under 16 years:

Do not administer to children and adolescents under 16 years:

• Do not administer to children under 16 years with feverish processes, flu, or chickenpox, as the use of acetylsalicylic acid has been associated with the appearance of Reye's Syndrome.
• Children under 12 years of age should not take codeine due to the risk of severe respiratory problems.

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If you use more Dolvirán than you should

This may lead to an overdose, so be aware of the effects due to acetylsalicylic acid, codeine, and caffeine.

In case of overdose, the characteristic symptoms of aspirin intoxication may appear, such as nausea, vomiting, tinnitus, deafness, sweating, vasodilation, and hyperventilation, headache, blurred vision, and occasionally diarrhea as signs of overdose. Acute intoxication symptoms include neurological disorders, such as confusion, delirium, seizures, and coma.

Also, the characteristic symptoms of codeine overdose (drowsiness, skin flushing, miosis, vomiting, pruritus, ataxia, headache, skin inflammation, urinary and fecal retention, and respiratory depression that may lead to respiratory arrest) or caffeine overdose (excessive stimulation of the central nervous system, insomnia, restlessness, vomiting, seizures, and gastrointestinal irritation symptoms, such as nausea, vomiting, diarrhea, and abdominal pain) may appear.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or go to a medical center immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to use Dolvirán

Do not use a double dose to compensate for the missed doses. If you have any other questions about the use of this product, ask your doctor or pharmacist.

Like all medications, this medication mayproduceadverse effects, although not all people will experience them.

Adverse reactions due toacetylsalicylic acidmay be:

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

• Gastrointestinal discomfort such as heartburn, nausea, vomiting, abdominal pain, and diarrhea.
• Increased tendency to bleed
• Minor blood loss from the gastrointestinal tract (microbleeding).
• Bleeding such as nasal hemorrhages, gum bleeding, skin bleeding, or bleeding from the urinary tract and genital organs with possible prolonged bleeding time. This effect may last from 4 to 8 days after ingestion.

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

• Stomach or intestinal bleeding. After long-term use of acetylsalicylic acid, anemia (iron deficiency anemia) may occur due to hidden blood loss from the stomach or intestines.
• Intracranial bleeding, blood in the urine.
• Stomach or intestinal ulcers, which very rarely may cause perforation.
• Gastrointestinal inflammation.
• Dermatological reactions such as urticaria
• Nasal discharge

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

• Skin hypersensitivity reactions, respiratory tract, gastrointestinal system, and cardiovascular system, especially in asthmatics. The following disease characteristics may occur: hypotension, dyspnea attacks, nasal mucosa inflammation, nasal congestion, anaphylactic shock, facial swelling, tongue, and laryngeal edema (Quincke's edema).
• Severe skin reactions such as a rash known as erythema multiforme, and life-threatening forms such as Stevens-Johnson syndrome and Lyell syndrome.
• Severe bleeding, such as cerebral hemorrhage, especially in patients with uncontrolled high blood pressure and/or concomitant treatment with anticoagulants (anticoagulant medications) that may put life at risk in individual cases.
• Confusion
• Headache, dizziness
• Impaired hearing or tinnitus, especially in children and the elderly, which may be signs of an overdose (see also "If you take more Dolviran than you should").
• Prolonged or excessively heavy menstrual bleeding.

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

• Liver function test abnormalities.
• Renal dysfunction and acute renal insufficiency.
• Low blood sugar (hypoglycemia).
• Acetylsalicylic acid reduces the excretion of uric acid at low doses. This may trigger a gout attack in patients at risk.
• Febrile eruptions with mucous membrane involvement (erythema exudativum multiforme).

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

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

The treatment should be discontinued 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 nonsteroidal anti-inflammatory drugs, anaphylactic or anaphylactoid reactions may occur. This may also occur in patients who have not previously shown hypersensitivity to these medications.

Adverse effects due tocodeinemay be:

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

• Gastrointestinal disturbances (constipation, nausea)
• General disturbances (discomfort, 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 a simple skin rash or urticaria to anaphylactic shock, fever)

The following adverse effects have been observed due tocaffeinewhose frequency cannot be established with precision:

• Nervousness
• Restlessness
• Stomach or intestinal irritation
• Tachycardia

Reporting of adverse effects

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

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

Do not store at a temperature above 25°C. Store in the original packaging.

Do not use this medication after the expiration date that appears on the packaging and on the blister pack after CAD. The expiration date is the last day of the month indicated.

Keep in the original packaging perfectly closed.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Dolvirán

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

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

The other components are: solid semisynthetic glycerides.

Appearance of Dolviránand contents of the packaging

White-yellowish suppositories. They are presented in PVC/PE laminated packaging of 10 suppositories.

Holder of the Marketing Authorization and responsible for manufacturing

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Last review date of this leaflet:July 2021

The detailed and updated information of this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/