TOSEINA 2 mg/ml ORAL SOLUTION

2. What you need to know before taking Toseina

Do not take Toseina:

• If you are allergic to codeine or any of the other components of this medicine (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 (inflammation of the colon) caused by antibiotic medications (such as cephalosporins, lincosamides, or penicillins) or diarrhea caused by poisoning.
• If you are under 12 years of age.
• If you know you metabolize codeine to morphine very quickly.
• If you are pregnant or breastfeeding.

Warnings and precautions

Consult your doctor or pharmacist before taking Toseina:

• If you have heart, lung, liver, gallbladder, or kidney problems, as well as in cases of prostate disorders (prostatic hypertrophy), urethral stricture (urethral stenosis), intestinal obstructive or inflammatory disorders, chronic ulcerative colitis, acute pancreatitis, hypothyroidism, or multiple sclerosis.
• Elderly or debilitated people are usually more sensitive to the effects and adverse reactions of this medicine, especially respiratory depression.
• In case of severe head trauma and increased intracranial pressure, codeine may increase cerebrospinal fluid pressure, which can increase the depressant effect on respiration (slow or insufficient breathing).
• Like other opioids, codeine may inhibit intestinal movement, worsening constipation in patients with chronic constipation.
• Abuse and dependence:Prolonged and excessive administration of codeine may lead to dependence and/or tolerance, especially in people with a tendency to abuse and addiction. After prolonged treatment, you should gradually discontinue administration as indicated by your doctor.
• This medicine should not be taken for more than three days. If you do not have relief from cough after three days, you should consult your doctor.

Codeine is converted to 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 low amounts, and it will not have an effect on their cough symptoms. Other people are more likely to suffer from severe adverse reactions because they produce a very high amount of morphine. If you experience any of the following side effects, you should stop taking this medicine 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: the use of codeine is not recommended in adolescents with respiratory problems for the treatment of cough.

Other medicines and Toseina

Tell your doctor or pharmacist if you are taking or have recently taken or may take any other medicines.

In particular, if you are taking any of the following medicines, it may be necessary to modify the dose of one of them or discontinue treatment:

• Narcotic analgesics (for pain), antipsychotics (tranquilizers), anxiolytics (for anxiety), neuromuscular blockers (medicines used to facilitate mechanical ventilation), and other central nervous system depressants (including alcohol); You should avoid taking medicines that contain alcohol during treatment;
• Buprenorphine (analgesic medicine) and naltrexone (medicine used in the treatment of acute intoxication with codeine, morphine, heroin, and alcohol);
• Anticholinergics (drugs to reduce the effects of acetylcholine);
• MAO inhibitors (medicines used to treat depression or Parkinson's disease) or tricyclic antidepressants;
• Hydroxyzine (medicines to treat allergies);
• Certain phenothiazines (medicines to treat nervous, mental, and emotional disorders, also used to control severe nausea and vomiting);
• Antidiarrheal medicines that inhibit intestinal movement.

Taking Toseina with food, drinks, and alcohol

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

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 taking this medicine.

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 may cause drowsiness, altering mental and/or physical ability. If you notice these effects, avoid driving vehicles or using machines.

Toseina contains aspartame (E-951)

This medicine 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 may be harmful in case of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it properly.

Toseina contains sorbitol (E-420)

This medicine 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 (or your child) that you have an intolerance to certain sugars, or you 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 medicine.

Toseina contains sodium benzoate (E-211)

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

Use in athletes

This medicine contains codeine, which may produce a positive result in doping tests.

3. How to take Toseina

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

Doses should be individualized for each patient. The lowest effective dose should be used to control symptoms. The dose may be divided into up to 4 daily doses administered at intervals of no less than 6 hours.

Administration of the medicine is subject to the appearance of symptoms, and the dosage may be reduced as the symptoms disappear.

Treatment duration should be limited to 3 days.

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

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

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

Method of administration

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 drawing 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 Toxicology Information Service. Tel.: 91 562 04 20.

Accidental ingestion of very high doses may cause initial excitement, anxiety, insomnia, and later, in some cases, drowsiness that progresses to stupor or coma, headache, miosis, changes in blood pressure, arrhythmias, dry mouth, hypersensitivity reactions, cold and viscous skin, tachycardia, convulsions, gastrointestinal disorders, nausea, vomiting, and respiratory depression. In severe poisoning, apnea, circulatory collapse, cardiac arrest, and death may occur.

Generally, symptomatic treatment will be performed:

Restoring adequate respiratory exchange through a permeable airway and assisted ventilation.

Administration of activated charcoal.

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

The opioid antagonist naloxone hydrochloride is an antidote against respiratory depression and should be administered intravenously in appropriate doses.

If you forget to take Toseina

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

If you stop taking Toseina

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

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

Although the frequency of side effects is not known, as it cannot be estimated from the available data, they are: constipation, nausea, vomiting, dizziness, and drowsiness.

Convulsions, mental confusion, mood changes (euphoria or depression), and itching have also been reported. Skin rashes may occur in allergic patients.

At high doses and long-term, it may cause respiratory depression (slow or insufficient breathing).

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency's (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Toseina

Keep in the original packaging to protect it from light.

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

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

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medicines in the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package contents and additional information

Composition of Toseina

The active ingredient 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), blackcurrant flavor, raspberry essence, azorubine (E-122), and purified water.

Appearance of the product and package contents

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

Marketing authorization holder and manufacturer:

ITALFARMACO S.A.

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

Tel.: 916572323

Date of the last revision of this leaflet: August 2021

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http//www.aemps.gob.es/