Codeisan 28.7 mg tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Codeisan 28.7 mg tablets

codeine phosphate hemihydrate

Read the entire 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 it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects 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 suppresses cough (antitussive), therefore it is used in the symptomatic treatment of non-productive cough (cough without secretions).

Codeine may also be used in children over 12 years of age for the short-term treatment of moderate pain that is not relieved by other analgesics such as paracetamol or ibuprofen alone.

This medicine contains codeine. Codeine belongs to a group of medicines called opioid analgesics, which work by relieving pain. It can be used alone or in combination with other analgesics such as paracetamol.

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 suffer from diarrhea associated with pseudomembranous colitis or diarrhea caused by intoxication,
• to relieve pain in children or adolescents (0–18 years of age) after tonsillectomy or adenoidectomy due to obstructive sleep apnea syndrome,
• if you are under 12 years of age,
• if you know that you metabolize codeine very rapidly into morphine,
• if you are breastfeeding.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medicine.

• If you have heart, lung, liver, gallbladder, or kidney problems, or conditions such as prostate disorders (prostatic hypertrophy), urethral narrowing (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 higher doses of your medication.

• Codeine is converted into morphine in the liver by an enzyme. Morphine is the substance responsible for codeine’s effects in relieving pain and cough symptoms. Some people have a genetic variation of this enzyme that affects how they respond. In some individuals, little or no morphine is produced, resulting in inadequate pain or cough relief. Others produce very high levels of morphine and are at greater risk of serious adverse reactions. If you experience any of the following adverse effects, stop taking this medicine immediately and seek medical help: slow or shallow breathing, confusion, drowsiness, constricted pupils, discomfort or feeling unwell, constipation, 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) and increased pressure inside the brain (intracranial pressure), codeine may increase cerebrospinal fluid pressure and enhance respiratory depression (slow or insufficient breathing).

• Like other opioids, codeine may inhibit 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 associated with inflammation of the pancreas (pancreatitis) or bile ducts.

• Sleep-related breathing disorders

Codeisan may cause sleep-related breathing disorders, such as sleep apnea (pauses in breathing 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 loss of control over the amount or frequency of medicine use.

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 been dependent 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 treatment from a psychiatrist 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 for 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 cough.
• You are using the medicine for reasons other than prescribed, e.g., "to stay calm" or "to help you sleep."
• You have made repeated but unsuccessful attempts to stop or control your use of the medicine.
• 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 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 pain does not improve after three days, consult your doctor.

Children and adolescents

• 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

The use of codeine is not recommended in children with respiratory problems, as symptoms of morphine toxicity may be more severe in these children.

• Adolescents over 12 years of age

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

• The use of codeine is not recommended in children who may have respiratory 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 experiencing serious adverse reactions after taking codeine; these reactions may be particularly severe in children who metabolize codeine rapidly or in large amounts (extensive or ultrarapid metabolizers).

Taking Codeisan with other medicines

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

• Central nervous system (CNS) depressants: Administering 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; therefore, 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. For this reason, 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 about the signs and symptoms listed above. Contact your doctor if you experience such symptoms.

• Concomitant 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 increase analgesia and sedation.

Some phenothiazines (used for nervous, mental, and emotional disorders) increase codeine-induced analgesia, while others reduce it.

Alcohol consumption

Drinking alcohol may increase drowsiness by enhancing the central nervous system depressant effect of codeine.

Pregnancy, breastfeeding, and fertility

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

Pregnancy

The use of 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, impairing the 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 component that may result in a positive analytical test for opioids.

Codeisan contains sodium

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

3. How to take Codeisan

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

Before starting treatment and periodically during treatment, your doctor will explain what you can expect from using Codeisan, when and for how long you need to use it, when to contact your doctor, and when you should stop taking it (see also the section "If you stop taking Codeisan").

Dosages must be individualized for each patient. Codeine should be used at the lowest effective dose for the shortest possible duration. This dose may be taken up to 4 times daily, at intervals of no less than 6 hours. The lowest effective dose should be used to control symptoms.

The administration of the medicine depends on the presence of symptoms, and the dosage may be reduced as symptoms gradually disappear.

This medicine should not be used for longer than 3 days. If pain does not improve after 3 days, consult your doctor. Codeisan should be used for the shortest time necessary to relieve symptoms.

Adults

Analgesic:

The recommended dose is 1 tablet every 6 hours.

If the desired analgesic effect is not achieved, the dose may be increased to 2 tablets per dose, up to a maximum of 6 tablets in 24 hours.

Antitussive:

The recommended dose is 1 tablet every 6 hours.

Use in children and adolescents

This medicine is contraindicated in children under 12 years of age.

Children aged 12 years and older

Analgesic:

Children aged 12 years or older should take 1 tablet every 6 hours, when necessary. If the desired analgesic effect is not achieved, the dose may be increased to 2 tablets per dose, up to a maximum of 6 tablets in 24 hours.

Children under 12 years of age must not take Codeisan due to the risk of serious breathing problems.

Elderly population

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

The score line on the tablet is only intended to facilitate breaking the tablet if you have difficulty swallowing it whole.

If you take more Codeisan than you should:

The following signs and symptoms may occur in codeine poisoning:

• Respiratory depression
• Drowsiness 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 poisoning:

• 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 in 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 may cause adverse effects, although not everyone experiences 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.
• Pruritus.
• Dizziness.
• Biliary spasms.
• Urinary retention.
• Symptoms associated with inflammation of the pancreas (pancreatitis) and of the biliary system (a condition affecting a digestive tract valve, 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 Medicines: 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 container 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, protected place inaccessible to others. This medicine may cause serious harm or even be fatal to 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 the 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 (28.7 mg). Each tablet contains
28.7 mg of codeine phosphate, equivalent to 21.4 mg of codeine.

The other components are: talc (E-553b), dibasic calcium phosphate, microcrystalline cellulose (E-460i), magnesium stearate (E-470b), colloidal silicon dioxide (E-551), and sodium carboxymethylstarch type A (from potato).

Appearance of the medicine and contents of the pack

Codeisan are round, flat, bevel-edged white tablets, with one side marked with a "C" and the other side scored.

Codeisan is available in packs containing 10 and 20 tablets.

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

Manufacturer

Teva Pharma S.L.U.
Polígono Malpica, C/ C, 4
50016 Zaragoza

Date of the most recent revision of this leaflet: January 2026

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