CODEISAN 1.26 mg/ml SYRUP

2. What you need to know before you take 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 respiratory problems (chronic obstructive pulmonary disease, acute asthma attacks or respiratory depression),
• if you have paralytic ileus (intestinal obstruction) or are at risk of having it,
• if you suffer from diarrhea associated with pseudomembranous colitis or diarrhea caused by poisoning,
• if you are patients under 18 years of age who are going to undergo tonsil or adenoid surgery (tonsillectomy/adenoidectomy),
• if you are under 12 years of age.
• if you know you metabolize codeine very quickly into morphine,
• if you are pregnant or 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, as well as in cases of prostate disorders (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 converted 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 low quantities, 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 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.
• Elderly or debilitated patients are usually more sensitive to the effects and adverse reactions of this medicine, especially respiratory depression.
• In the event of a severe head injury (cranial trauma) and increased pressure inside the brain (intracranial), codeine may increase the pressure of the cerebrospinal fluid, potentially increasing 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 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 treatments, the administration should be gradually interrupted as indicated by your doctor.

• This medicine should not be taken for more than three days. If after three days you do not have relief from cough, you should consult your doctor.

Children and adolescents

• The use of codeine is not recommended in children who may have respiratory problems such as 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 are at a higher risk of suffering from adverse reactions after administration of codeine; these reactions can be very serious in children who break down codeine in large quantities or quickly (extensive or ultra-rapid metabolizers).

• Adolescents over 12 years of age

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

Using Codeisan with other medicines

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

• Central nervous system depressants (CNS): The administration of codeine together with other CNS depressant drugs (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 sedative medicines such as benzodiazepines or related medicines increases the risk of drowsiness, difficulty breathing (respiratory depression), coma, and can be potentially fatal. Due to this, concomitant use should only be considered when other treatment options are not possible.

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

Tell your doctor about all sedative medicines you are taking and closely follow your doctor's dose recommendation. It may be useful to inform friends or family members who are aware of the signs and symptoms indicated above. Contact your doctor when you experience such 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.

• Concomitant 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.

Using Codeisan with alcohol

Consuming alcohol may increase drowsiness by potentiating 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 are planning to have a baby, ask your doctor or pharmacist for advice before taking 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, altering the mental and/or physical ability required for the performance of potentially hazardous activities, such as driving vehicles or operating machinery. Avoid driving vehicles or using machines during treatment.

Use in athletes

This medicine contains a component that may result in a positive opioid control test.

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 note that this medicine contains 9.75 g of sucrose per dose (15 ml).

This medicine contains 9.6 mg of alcohol (ethanol) in each dose of 15 ml. 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) in each dose (15 ml).

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

3. How to take Codeisan

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

The doses should be individualized for each patient. The effective dose should be used to control the symptoms. The dose may be divided into up to 4 daily doses administered at intervals of not less than 6 hours.

The administration of the medicine 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 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

Because these patients may eliminate codeine more slowly, 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 poisoning, the following signs and symptoms may appear:

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

And in severe poisoning:

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

Treatment

• Reestablish 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 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 in adequate doses.

In case of overdose or accidental ingestion, consult the Toxicology Information Service. Phone 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 normal dose when it is due.

If you stop taking Codeisan

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

If you have any further questions on 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 everybody gets them.

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

Frequency not known (cannot be estimated from the 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 of side effects:

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Health Products Agency (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 Codeisan

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

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.

No special storage conditions are required. Keep in the original package, tightly closed.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Codeisan

The active substance 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 ingredients are: sodium benzoate (E-211), sucrose, lemon flavor (contains ethanol), hydrochloric acid, and purified water.

A

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 certain pack sizes may be marketed.

Marketing authorization holder

Teva Pharma S.L.U.

C/ Anabel Segura 11, Edificio Albatros B, 1ª planta

28108 Alcobendas- Madrid

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 last revision of this leaflet: June 2018

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/