Leaflet: information for the user

Codeisan 1.26 mg/ml syrup

codeine phosphate hemihydrate

Read this leaflet carefully before you start taking this medicine, because 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 should not be given to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Codeine phosphate is a water-soluble salt of codeine. Codeine calms oralleviatescough (antitussive).

This medication is used:

?For the symptomatic treatment of unproductive cough (cough without secretions).

Do not take Codeisan

• if you are allergic to codeine or any of the other components of this medication (listed in section 6),
• if you have respiratory problems (chronic obstructive pulmonary disease, acute asthma attacks, or respiratory depression),
• if you have paralytic ileus (intestinal obstruction) or are at risk of developing it,
• if you have diarrhea associated with pseudomembranous colitis or diarrhea caused by intoxication,
• if you are a patient under 18 years old undergoing tonsillectomy or adenoidectomy,
• if you are under 12 years old.
• 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 this medication.

• if you have heart, lung, liver, gallbladder, or kidney problems, as well as cases of prostate enlargement (prostatic hypertrophy), urethral stricture (urethral stenosis), adrenal insufficiency (Addison's disease), obstructive or inflammatory intestinal disorders, chronic ulcerative colitis, acute pancreatitis, hypothyroidism, multiple sclerosis.
• Codeine is transformed into morphine in the liver by an enzyme. Morphine is the 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 produce an effect on your cough symptoms. Other people are more prone to severe adverse reactions because they produce a very high amount of morphine. If you experience any of the following 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.
• Older or weakened people are usually more sensitive to the effects and adverse reactions of this medication, especially respiratory depression.
• In the case of a severe head injury (cranial trauma) and elevated intracranial pressure, codeine can increase cerebrospinal fluid pressure, potentially increasing the depressive effect on respiration (slow or insufficient breathing).

• Like other opioids, codeine can inhibit intestinal movement, worsening chronic constipation in patients.

• Abuse and dependence: Prolonged and excessive administration of codeine can cause dependence and/or tolerance, especially in people with a tendency to abuse and addiction. Codeine should be used with caution in patients with a history of drug abuse or dependence. After prolonged treatment, you should gradually discontinue administration 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.

Children and Adolescents

• Codeine is not recommended for use in children who may have respiratory problems, such as neuromuscular disorders, severe respiratory or heart disease, pulmonary infections, or upper airway infections, multiple trauma, or children who have undergone extensive surgical procedures.

• Children under 12 years old are at a higher risk of experiencing adverse reactions after taking codeine; these reactions can be very severe in children who metabolize codeine extensively or quickly (extensive or ultra-rapid metabolizers).

• Adolescents over 12 years old

Codeine is not recommended for use in adolescents with respiratory problems for the treatment of cough.

Use of Codeisan with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

- Depressants of the central nervous system (CNS): The administration of codeine with other CNS depressants (such as narcotic analgesics, anxiolytics, antipsychotics, neuromuscular blockers, antidepressants, antihistamines H1, neuroleptics, adrenergic blockers) may cause additive CNS depression, so the dose should be reduced.

- The concomitant use of codeine and sedatives such as benzodiazepines or related medications increases the risk of drowsiness, difficulty breathing (respiratory depression), coma, and can be potentially fatal. Therefore, concomitant use should only be considered when other treatment options are not possible.

However, if your doctor prescribes codeine with sedatives, your doctor should limit the dose and duration of concomitant treatment.

Inform your doctor about all sedatives you are taking and follow your doctor's dose recommendation closely. It may be helpful to inform friends or family members who are aware of the signs and symptoms mentioned above. Contact your doctor when you experience these symptoms.

- The concomitant use with opioid agonists such as buprenorphine may increase the effects of codeine. The concomitant use with opioid antagonists such as naltrexone may delay the effects of codeine.

- The simultaneous administration with anticholinergics may cause paralytic ileus and/or urinary retention.

- The use of antidepressants such as monoamine oxidase inhibitors (MAOIs) or tricyclic antidepressants may potentiate the effects of codeine or antidepressants.

- The administration of antihistamines such as hydroxyzine may produce sedation.

Use of Codeisan with alcohol

Consuming alcohol may increase drowsiness by potentiating the depressive effect of codeine on the central nervous system.

Pregnancy, lactation, and fertility

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

Pregnancy

Codeine is not recommended during pregnancy. Its use can cause physical dependence in the fetus, leading to withdrawal symptoms in the newborn.

Lactation

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

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.

Use in athletes

This medication contains a component that may result in a positive analytical result for opioid control.

Codeisan contains saccharose, sodium benzoate (E-211), ethanol, and sodium

This medication contains saccharose. If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

Patients with diabetes mellitus should note that this medication contains 9.75 g of saccharose per dose (15 ml).

This medication contains 9.6 mg of alcohol (ethanol) per dose of 15 ml. The amount in 15 ml of this medication is equivalent to less than 1 ml of beer or 1 ml of wine. The small amount of alcohol in this medication does not produce any noticeable effect.

This medication contains 45 mg of sodium benzoate (E-211) per dose (15 ml).

This medication contains less than 1 mmol of sodium (23 mg) per 15 ml; this is essentially "sodium-free".

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

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 no less than 6 hours.

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

The total duration of treatment should be limited to 3 days.

Adults and adolescents over 12 years old

The recommended dose is 15 milliliters (one tablespoon) every 6 hours, with a maximum of 4 doses per day.

Pediatric population

It is contraindicated in children under 12 years old.

Geriatric population

Due to the possibility of slower elimination of codeine in these patients, a dose adjustment may be necessary. The maximum daily dose should be reduced and the administration interval increased. The dose should be individualized for each patient.

If you take more Codeisan than you should:

In codeine overdose, the following signs and symptoms may appear:

• Respiratory depression
• Somnolence that progresses to stupor or coma
• Muscle-skeletal flaccidity
• Cold and viscid skin
• Bradycardia (decreased heart rate)
• Hypotension (decreased blood pressure)
• Miosis (pupil constriction)

And in severe overdose:

• Apnea (lack of breathing), circulatory collapse, cardiac arrest, and death.

Treatment

• Restore adequate respiratory exchange through a patent airway and assisted ventilation.
• Administration of activated charcoal.
• Gastric aspiration and lavage may be useful to eliminate unabsorbed drug and should be followed by administration of activated charcoal.

Naloxone (which counteracts the effect of codeine) is the antidote for respiratory depression and should be administered intravenously in adequate doses.

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

If you forget to take Codeisan

Do not take a double dose to compensate for the missed doses. Continue taking your normal dose when it is due.

If you interrupt treatment with Codeisan

Physical dependence and tolerance may appear with repeated administration of this drug. Administration should be gradually discontinued after prolonged use.

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

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

Although adverse effects are generally mild. Please be aware that many of the effects may be symptoms of your illness and will therefore improveas you begin to feel better.

Unknown frequency (cannot be estimated from available data):

• Mood changes
• Headache, drowsiness
• Tachycardia, bradycardia, and palpitations
• Hypotension
• Respiratory depression
• Constipation, nausea, vomiting, dry mouth, pancreatitis
• Pruritus
• Dizziness
• Biliary spasms
• Urinary retention

Reporting Adverse Effects:

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

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

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

No special storage conditions are required. Store in its original packaging perfectly closed.

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

Codeisan Composition

The active principle is codeine phosphate hemihydrate. Each milliliter of syrup contains 1.26 mg of codeine phosphate hemihydrate equivalent to 0.93 mg of codeine.

The other components are: sodium benzoate (E-211), sucrose, lemon essence (contains ethanol), hydrochloric acid, and purified water.

AProduct and Packaging

Codeisan is a clear or slightly opalescent solution.

Codeisan is presented in glass bottles with child-resistant closures containing 125 milliliters and 250 milliliters of syrup.

Only some sizes of packaging may be commercially available.

Marketing Authorization Holder

Teva Pharma S.L.U.

C/ Anabel Segura 11, Edificio Albatros B, 1st floor

28108 Alcobendas- Madrid

Responsible for Manufacturing

Teva Czech Industries, s.r.o.

Ostravska 29, c.p. 305 Building No 80 Small OSD and Building No 881 NOSD

747 70 Opava-Komarov

Republic of Czech

Last Review Date of this Leaflet: June 2018

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