Package Insert: Information for the User

Toseina 2 mg/ml Oral Solution

Codeine Phosphate Hemihydrate

Read this entire 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 refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, 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.

6. Contents of the pack and additional informationl

Toseína contains codeine phosphate hemihydrate.

This medication is used for the symptomatic treatment of dry cough (not accompanied by mucus) in adults and adolescents aged 12 years and older.

Do not take Toseina:

• If you are allergic to codeine or any of the other components of this medication (listed in section 6).
• If you have respiratory problems such as chronic obstructive pulmonary disease (COPD), respiratory depression (slow or insufficient breathing), or acute asthma attacks.
• If you have paralytic ileus (intestinal obstruction) or are at risk of having it,
• If you have diarrhea associated with pseudomembranous colitis (colon inflammation) caused by antibiotic medications (such as cephalosporins, lincomycins, or penicillins) or diarrhea caused by poisoning.
• If you are under 12 years of age.
• If you know that you metabolize codeine very quickly to morphine.
• If you are pregnant or breastfeeding.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Toseina:

• If you have heart, lung, liver, gallbladder, or kidney problems, as well as cases of prostate enlargement (prostatic hypertrophy), urethral stricture (urethral stenosis), obstructive or inflammatory intestinal disorders, chronic ulcerative colitis, acute pancreatitis, hypothyroidism, multiple sclerosis.
• Older people or those who are weakened are more sensitive to the effects and adverse reactions of this medication, especially respiratory depression.
• In case of a severe head injury (cranial trauma) and increased intracranial pressure, codeine may increase cerebrospinal fluid pressure, potentially increasing the depressive effect on breathing (slow or insufficient breathing).
• Like other opioids, codeine can inhibit intestinal movement, worsening chronic constipation in patients.
• Abuse and dependence:Long-term administration and excessive codeine use can cause dependence and/or tolerance, especially in people with a tendency to abuse and addiction. After prolonged treatment, you should discontinue administration gradually as advised by your doctor.
• This medication should not be taken for more than three days. If you do not experience relief from coughing after three days, you should consult your doctor.

Codeine is transformed into morphine in the liver by an enzyme. Morphine is a substance that produces the effect of codeine. Some people have a variant of this enzyme that can affect them differently. In some people, morphine is not produced or is produced in very small quantities, and it will not affect your cough symptoms. Others are more prone to severe adverse reactions because they produce a very high amount of morphine. If you experience any of the following adverse effects, stop taking this medication and seek medical help immediately: slow or shallow breathing, confusion, drowsiness, constricted pupils, discomfort or feeling of discomfort, constipation, loss of appetite.

Children and adolescents

Adolescents over 12 years of age: codeine is not recommended for use in adolescents with respiratory problems for the treatment of cough.

Other medications and Toseina

Inform your doctor or pharmacist if you are using or have used recently or may need to use any other medication.

Particularly, if you are using any of the following medications, it may be necessary to modify the dose of one of them or discontinue treatment:

• Opioid analgesics (for pain), antipsychotics (tranquilizers), anxiolytics (for anxiety), neuromuscular blockers (medication used to facilitate mechanical ventilation), and other central nervous system depressants (including alcohol); Avoid consuming medications containing alcohol during treatment;
• Buprenorphine (pain medication) and naltrexone (medication used in the treatment of acute codeine, morphine, heroin, and alcohol poisoning);
• Anticholinergics (medications to reduce the effects of acetylcholine);
• MAO inhibitors (medications used to treat depression or Parkinson's disease) or tricyclic antidepressants;
• Hydroxyzine (medications to treat allergies);
• Some phenothiazines (medications to treat nervous, mental, and emotional disorders, also used to control severe nausea and vomiting);
• Antidiarrheal medications that inhibit intestinal movement.

Taking Toseina with food, drinks, and alcohol

Avoid consuming alcoholic beverages, as alcohol potentiates the depressive effect of codeine on the central nervous system.

Pregnancy, breastfeeding, and fertility

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

Pregnancy:

Do not take Toseina during pregnancy.

Breastfeeding:

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

Driving and using machines

Codeine can cause drowsiness, affecting mental and/or physical ability. If you experience these effects, avoid driving vehicles or using machines.

Toseina contains aspartame (E-951)

This medication contains 2 mg of aspartame (E-951) per ml, equivalent to 10 mg/5 ml and 20 mg/10 ml. Aspartame (E-951) contains a source of phenylalanine that can be harmful in cases of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it correctly.

Toseina contains sorbitol (E-420)

This medication contains 175 mg of sorbitol (E-420) per ml, equivalent to 875 mg/5 ml and 1,750 mg/10 ml. Sorbitol (E-420) is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to certain sugars or have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which the patient cannot break down fructose, consult your doctor before taking this medication.

Toseina contains sodium benzoate (E-211)

This medication contains 2 mg of sodium benzoate (E-211) per ml, equivalent to 10 mg/5 ml and 20 mg/10 ml.

Toseina contains azorubine (E-122)

This medication may cause allergic reactions because it contains azorubine (carmoisine) (E-122). It can cause asthma, especially in patients allergic to acetylsalicylic acid.

Toseina contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per ml; it is essentially "sodium-free."

Use in athletes

This medication contains codeine, which can produce a positive result in doping control tests.

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

The doses should be individualized for each patient. The effective dose should be used to control symptoms. The dose may be divided into up to 4 daily doses administered at intervals of not less than 6 hours.

The administration of the medication is subject to the appearance of symptoms, and the dosage may be reduced as the symptoms subside.

The duration of treatment should be limited to 3 days.

Adults and adolescents over 12 years old: 10 to 20 mg of codeine (5 to 10 ml) at intervals of at least 6 hours.

Pediatric population:This medication is contraindicated in children under 12 years of age.

Geriatric population: The dosage will be established by the doctor, as lower doses or longer dosing intervals may be necessary. See Adverse Reactions and Precautions sections.

Administration form

To open the bottle, remove the measuring cup, press the cap down and turn it in the direction indicated by the arrows, as shown in the diagram on the top of the cap. The bottle should be closed after each use.

If you take more Toseina than you should

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

Accidental ingestion of very high doses may produce initial excitement, anxiety, insomnia, and subsequently in certain cases somnolence that progresses to stupor or coma, headache, miosis, blood pressure alterations, arrhythmias, dry mouth, hypersensitivity reactions, cold and sticky skin, tachycardia, convulsions, gastrointestinal disturbances, nausea, vomiting, and respiratory depression. In severe intoxication, apnea, circulatory collapse, cardiac arrest, and death may appear.

Generally, treatment of symptoms will be performed:

Restore an adequate respiratory exchange by means of a patent airway and assisted ventilation.

Administration of activated charcoal.

Aspiration and gastric lavage may be useful to eliminate the non-absorbed drug. They should be followed by the administration of activated charcoal.

The opioid antagonist clorhidrato of naloxone is an antidote against respiratory depression and should be administered intravenously at appropriate doses.

If you forgot to take Toseina

Do not take a double dose to compensate for the missed doses.

If you interrupt the treatment with Toseina

Your doctor will indicate the duration of treatment. Administration should be gradually discontinued after prolonged treatments.

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

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Be aware that many of the effects may be symptoms of your illness and will therefore improve when you start to feel better.

Although the frequency of adverse effects is unknown, as it cannot be estimated from the available data, these are: constipation, nausea, vomiting, dizziness, and drowsiness.

Convulsions, mental confusion, mood alteration (happiness or sadness), and itching have also been described. Skin eruptions may appear in allergic patients.

At high doses and over a long period, it may cause respiratory depression (slow or insufficient breathing).

Reporting Adverse Effects

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

Store in the original packaging to protect it from light.

Keep this medication out of sight and reach of children.

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

Medications should not be disposed of through drains or trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition of Toseina

The active principle is codeine phosphate hemihydrate. Each ml of oral solution contains 2 mg of codeine phosphate hemihydrate.

The other components (excipients) are: sodium benzoate (E-211), citric acid monohydrate, hydroxyethylcellulose, sodium saccharin, aspartame (E-951), sorbitol (E-420), strawberry flavor, raspberry essence, azorubine (E-122) and purified water.

Appearance of the product and contents of the packaging

This medicine is a red-colored solution that is presented in 100 and 250 ml bottles accompanied by a measuring cup.

Holder of the marketing authorization and responsible for manufacturing:

ITALFARMACO S.A.

C/ San Rafael, 3, 28108 - Alcobendas (Madrid)

Tel.: 916572323

Last review date of this leaflet: August 2021

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