Leaflet: information for the user

Codeisan 28.7 mg tablets

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 others, even if they have the same symptoms, 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.

1. What Codeisan is and what it is used for

2. What you need to know before you start taking Codeisan

3. How to take Codeisan

4. Possible side effects

5. Storage of Codeisan

6. Contents of the pack and additional information

Codeine phosphate is a water-soluble salt of codeine. Codeine calms cough (antitussive), so it is used in the symptomatic treatment of unproductive cough (cough without secretions).

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

This medication contains codeine. Codeine belongs to a group of medications called opioid analgesics that act by relieving pain. It can be used alone or in combination with other analgesics such as paracetamol.

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,
• to relieve pain in children or adolescents (0-18 years old) after tonsillectomy or adenoidectomy due to obstructive sleep apnea syndrome,
• if you are under 12 years old.
• if you know that you metabolize codeine very quickly to morphine.
• if you are 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 and relieves pain and cough symptoms. 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 amounts, and it will not provide sufficient pain relief or cough relief. 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, nausea, or feeling unwell, constipation, loss of appetite.

• Older people or those who are debilitated are 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:Long-term 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, discontinue administration gradually as advised by your doctor.

• This medication should not be taken for more than three days. If the 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 to relieve pain in children and adolescents after tonsillectomy or adenoidectomy due to obstructive sleep apnea syndrome.

• Use in children with respiratory problems

Codeine is not recommended for use in children with respiratory problems, as the symptoms of morphine toxicity can be worse in these children.

• Adolescents over 12 years old

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

• Codeine is not recommended for use in children who may have respiratory problems, such as neuromuscular disorders, severe respiratory or heart disease, upper respiratory tract infections, or multiple trauma, or those 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 rapidly metabolize codeine (extensive or ultra-rapid metabolizers).

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.

- Central nervous system depressants (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 somnolence, 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 recommended dose 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 use of opioid agonists such as buprenorphine may increase the effects of codeine. The use of 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 increased analgesia and sedation.

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

Use of Codeisan with alcohol

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

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 medication.

Pregnancy

Codeine is not recommended during pregnancy.Su use puede causar dependencia física en el feto, lo que lleva a síntomas de abstinencia en el recién nacido.

Lactancia

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 sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet; it 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 must be individualized for each patient. Codeine should be used at the most effective dose for the shortest time possible. This dose can be taken up to 4 times a day, at intervals of no less than 6 hours. The most effective dose should be used to control symptoms.

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

This medication should not be used for more than 3 days. If the pain does not improve after 3 days, ask your doctor for advice.

Adults

Pain reliever:

The recommended dose is 1 tablet every 6 hours.

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

Cough suppressant:

The recommended dose is 1 tablet every 6 hours.

Use in children and adolescents

This medication is contraindicated in children under 12 years old.

Children 12 years and older

Pain reliever:

Children 12 years of age or older should take 1 tablet every 6 hours, as needed. If the desired analgesic effect is not obtained, the dose can be increased to 2 tablets per dose, up to a maximum of 6 tablets in 24 hours.

Children under 12 years of age should not take Codeisan, due to the risk of severe respiratory problems.

Geriatric population

Due to the fact that these patients may eliminate codeine more slowly, it may be necessary to adjust the dosage. The maximum daily dose should be reduced and the administration interval increased. The dose should be individualized for each patient.

The groove is only for breaking the tablet if it is difficult to swallow whole.

If you take more Codeisan than you should:

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

- Respiratory depression

- Somnolence that progresses to stupor or coma

- Flaccid musculoskeletal

- Cold and sticky skin

- Bradycardia (decreased heart rate)

- Hypotension (decreased blood pressure)

- Miosis (pupil constriction)

And in severe poisoning:

- 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 the non-absorbed drug and should be followed by the administration of activated charcoal.

Naloxone (which counteracts the effect of codeine) is the antidote for respiratory depression and should be administered intravenously at 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's time.

If you interrupt treatment with Codeisan

You may experience physical dependence and tolerance with repeated administration of this medication.

Administration should be discontinued gradually after prolonged use.

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 may experience them.

Adverse effects are generally mild. Please be aware that many of the effects may be symptoms of your illness and will therefore improve when you start 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 possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: 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.

Keep in the original packaging perfectly closed.

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

Codeisan Composition

The active ingredient is hemihydrate codeine phosphate (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), calcium dihydrogen phosphate, microcrystalline cellulose (E-460i), magnesium stearate (E-470b), colloidal silicon dioxide (E-551), and sodium carboxymethylcellulose type A (from potato).

Product appearance and packaging content

Codeisan are round, flat, and bisected white tablets, with one face engraved with C and the other face scored.

Codeisan is presented in packaging of 10 and 20 tablets.

Only some packaging sizes may be commercially marketed.

Marketing Authorization Holder

Teva Pharma S.L.U.

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

28108 Alcobendas- Madrid

Responsible for Manufacturing

Teva Pharma S.L.U.

Polígono Malpica, C/ C, 4.

50016 Zaragoza

Last review date of this leaflet: June 2018

The detailed and updated information on this medication is available on the website

of the Spanish Agency for Medicines and Medical Devices (AEMPS)

http://www.aemps.gob.es/