Codeisan 1.26 mg/ml syrup

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Codeisan 1.26 mg/ml syrup

codeine phosphate hemihydrate

Read all of 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if such effects are not listed in this leaflet. See section 4.

Contents of the leaflet:

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

1. What Codeisan is and what it is used for

Codeine phosphate is a water-soluble salt of codeine. Codeine relieves or suppresses cough (antitussive).

This medicine is used for:

• The symptomatic treatment of dry cough (non-productive cough, i.e., cough without secretions).

2. What you need to know before taking Codeisan

Do not take Codeisan

• if you are allergic to codeine or any of the other ingredients of this medicine (listed in section 6),
• if you have breathing 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 poisoning,
• in patients under 18 years of age who are undergoing tonsil or adenoid surgery (tonsillectomy/adenoidectomy),
• if you are under 12 years of age,
• if you know that you metabolize codeine very rapidly into morphine,
• if you are pregnant or breastfeeding.

Warnings and precautions

Talk to your doctor or pharmacist before taking this medicine.

• If you have heart, lung, liver, gallbladder, or kidney problems, or conditions such as prostate disorders (prostatic hypertrophy), narrowing of the urethra (urethral stenosis), adrenal insufficiency (Addison's disease), obstructive or inflammatory intestinal disorders, chronic ulcerative colitis, acute pancreatitis, hypothyroidism, or multiple sclerosis.

• If you experience pain or increased sensitivity to pain (hyperalgesia) that does not respond to a higher dose of your medicine.

• Codeine is converted into morphine in the liver by an enzyme. Morphine is the substance responsible for codeine's effects. Some people have a genetic variation in this enzyme that affects how they respond. In some individuals, little or no morphine is produced, so the medicine will not relieve cough symptoms. In others, very high levels of morphine are produced, increasing the risk of serious adverse reactions. If you experience any of the following symptoms, stop taking this medicine immediately and seek medical help: slow or shallow breathing, confusion, drowsiness, pinpoint pupils, discomfort or feeling unwell, constipation, or loss of appetite.

• Elderly or weakened individuals are usually more sensitive to the effects and adverse reactions of this medicine, especially respiratory depression.

• In cases of severe head injury (cranial trauma) or increased pressure inside the brain (intracranial pressure), codeine may increase cerebrospinal fluid pressure and worsen respiratory depression (slow or inadequate breathing).

• Like other opioids, codeine may reduce intestinal motility, worsening constipation in patients with chronic constipation.

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

• Sleep-related breathing disorders

Codeisan may cause sleep-related breathing disorders, such as sleep apnea (breathing pauses during sleep) and sleep-related hypoxemia (low blood oxygen levels). Symptoms may include breathing pauses during sleep, waking up at night due to shortness of breath, difficulty maintaining sleep, or excessive daytime sleepiness. If you or someone else notices these symptoms, contact your doctor. Your doctor may consider reducing the dose.

• Tolerance, dependence, and addiction

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

Dependence or addiction may cause a feeling of losing control over how much medicine you take or how often you take it.

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

• You or any family member have abused alcohol or experienced dependence on alcohol, prescription medicines, or illegal drugs ("addiction").
• You smoke.
• You have ever had mood disorders (depression, anxiety, or a personality disorder) or have received psychiatric treatment for other mental illnesses.

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

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

If you notice any of these symptoms, consult your doctor to determine the best course of treatment, when it is appropriate to stop taking the medicine, and how to do so safely (see section 3 "If you stop taking Codeisan").

• This medicine should not be taken for more than three days. If your cough has not improved after three days, you should consult your doctor.

Children and adolescents

• The use of codeine is not recommended in children who may have breathing problems, such as those with neuromuscular disorders, severe respiratory or heart disease, lung or upper airway infections, multiple trauma, or those who have undergone extensive surgical procedures.

• Children under 12 years of age have a higher risk of serious adverse reactions after taking codeine; these reactions can be very severe in children who metabolize codeine rapidly or in large amounts (extensive or ultra-rapid metabolizers).

• Adolescents over 12 years of age

The use of codeine is not recommended in adolescents with breathing problems for the treatment of cough.

Taking Codeisan with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

• Central nervous system (CNS) depressants: Taking codeine together with other CNS depressants (such as narcotic analgesics, anxiolytics, antipsychotics, neuromuscular blockers, antidepressants, H1 antihistamines, neuroleptics, adrenergic blockers) may cause additive CNS depression, so the dose should be reduced.

• Gabapentin or pregabalin used to treat epilepsy or nerve-related pain (neuropathic pain).

• Concomitant use of codeine and sedative medicines such as benzodiazepines or related medicines increases the risk of drowsiness, difficulty breathing (respiratory depression), coma, and may be potentially fatal. Because of this, concomitant use should only be considered when no other treatment options are available.

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

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

• Use with opioid agonists such as buprenorphine may increase the effects of codeine. Use with opioid antagonists such as naltrexone may delay the effects of codeine.

• Simultaneous administration with anticholinergics may cause paralytic ileus and/or urinary retention.

• Use of antidepressants such as monoamine oxidase inhibitors (MAOIs) or tricyclic antidepressants may enhance the effects of codeine or the antidepressants.

• Administration of antihistamines such as hydroxyzine may cause sedation.

Alcohol consumption with Codeisan

Drinking alcohol may increase drowsiness by enhancing the CNS depressant effect of codeine.

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.

Pregnancy

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

Breastfeeding

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

Driving and using machines

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

Use in athletes

This medicine contains a substance that may lead to a positive analytical test result for opioids.

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

This medicine contains sucrose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

Patients with diabetes mellitus should be aware that this medicine contains 9.75 g of sucrose per dose (15 ml).

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

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

This medicine contains less than 1 mmol of sodium (23 mg) per 15 ml; therefore, it is essentially "sodium-free."

3. How to take Codeisan

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

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

Administration of the medicine depends on the occurrence of symptoms, and the dosage may be reduced as symptoms gradually disappear.

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

Codeisan should be used for the shortest time necessary to relieve symptoms.

Adults and adolescents over 12 years of age

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 of age.

Elderly population

Since these patients may eliminate codeine more slowly, dosage adjustment may be necessary. The maximum daily dose should be reduced and the administration interval increased. The dose must be individualized for each patient.

If you take more Codeisan than you should:

The following signs and symptoms may occur in codeine intoxication:

• Respiratory depression
• Somnolence progressing to stupor or coma
• Musculoskeletal flaccidity
• Cold and clammy skin
• Bradycardia (decreased heart rate)
• Hypotension (decreased blood pressure)
• Miosis (pupil constriction)

And in severe intoxication:

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

Treatment

• Restore adequate respiratory exchange by ensuring a patent airway and providing assisted ventilation.
• Administration of activated charcoal.
• Aspiration and gastric lavage may be useful to remove 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 at appropriate doses.

In case of overdose or accidental ingestion, contact the Toxicology Information Service. Telephone: 91 562 04 20.

If you forget to take Codeisan

Do not take a double dose to make up for forgotten doses. Continue taking your next dose at the usual time.

If you stop taking Codeisan

Physical dependence and tolerance may occur with repeated administration of this medicine. Treatment should be discontinued gradually after prolonged use.

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

4. Possible adverse effects

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

Adverse effects are generally mild. Please be aware that many of these effects may be symptoms of your illness and will therefore improve as you start to feel better.

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

• Mood changes
• Headache, drowsiness
• Tachycardia, bradycardia, and palpitations
• Hypotension
• Respiratory depression
• Constipation, nausea, vomiting, dry mouth, pancreatitis
• Itching (pruritus)
• Dizziness
• Biliary spasms
• Urinary retention
• Symptoms associated with inflammation of the pancreas (pancreatitis) and of the biliary system (a condition affecting a valve in the digestive tract, known as Oddi sphincter dysfunction), for example, severe upper abdominal pain that may radiate to the back, nausea, vomiting, or fever.

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may 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 Codeisan

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

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

No special storage conditions are required. 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 even death in individuals who take it without having been prescribed it.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at a SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Codeisan

The active substance is codeine phosphate hemihydrate. Each millilitre 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 flavour (contains ethanol), hydrochloric acid, and purified water.

Product appearance and contents of the pack

Codeisan is a clear or slightly opalescent solution.

Codeisan is available in glass bottles with child-resistant closure containing 125 millilitres and 250 millilitres of syrup.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Teva Pharma S.L.U.
C/ Anabel Segura 11, Edificio Albatros B, 1st floor
28108 Alcobendas, Madrid
Spain

Manufacturer

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
Czech Republic

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 of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/