Label: Information for the Patient

Codinex 1 mg/ml + 1 mg/ml + 6.67 mg/ml Syrup

Codeine Phosphate Hemihydrate / Ephedrine Hydrochloride / Potassium Sulfoguaiacolate

Read this label carefully before taking this medicine, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you should not give it to others who 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 label. See section 4.

Codinexis a codeine phosphate association, an antitussive for the relief of cough, chlorpheniramine, which alleviates nasal congestion, and potassium sulfoguaiacolate, which facilitates the elimination of respiratory secretions

Codinexis indicated in adults for the symptomatic treatment of respiratory conditions accompanied by cough, especially dry cough (not accompanied by mucus), and nasal congestion.

Do not take Codinex:

• If you are allergic to codeine phosphate, ephedrine hydrochloride, potassium sulfoguaiacolate or any of the other components of this medication (listed in section 6).
• If you are under 12 years of age.
• If you are pregnant or breastfeeding.
• If you know you are a fast metabolizer of codeine.
• If you have any of the following conditions or diseases:

• Respiratory problems such as chronic obstructive pulmonary disease (COPD), acute asthma attacks or depression of breathing.
• Intestinal obstruction (paralytic ileus) or are at risk of having it.
• Diarrea associated with pseudomembranous colitis (inflammation of the colon) caused by antibiotics or diarrhea caused by poisoning.

• Thyroid problems or other diseases that produce an excess of thyroid hormones (hyperthyroidism or thyrotoxicosis).
• Enlarged prostate (prostatic hypertrophy).
• High eye pressure (closed-angle glaucoma).
• Severe heart disease, severe circulation disorders or high blood pressure (hypertension).

• If you are or have been taking a monoamine oxidase inhibitor (MAOI) in the last two weeks. See the section "Taking Codinex with other medications".
• If you are taking other medications from the ephedrine family such as phenylpropanolamine, pseudoephedrine, methylphenidate or phenylephrine.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Codinex.

Codinex should be used with caution in the following conditions:

• If you are an elderly person, as you may be more sensitive to the effects and adverse reactions of this medication, both due to its codeine content (especially respiratory depression) and ephedrine content (cardiovascular effects).
• If you have any kidney or liver disease.
• If you have urinary retention or a narrowing (stenosis) of the urethra.
• If you have adrenal gland insufficiency (Addison's disease).
• If you have reduced thyroid function (hypothyroidism).
• If you have muscle weakness or fatigue (multiple sclerosis or myasthenia gravis).
• If you have chronic ulcerative colitis.
• If you have gallbladder problems.
• If you have any lung disease with reduced respiratory capacity.
• If you have low blood pressure or shock.
• If you have any inflammatory bowel disease (acute colitis, pseudomembranous colitis), or diverticula.
• If you have had convulsions.
• If you have a history of drug abuse or dependence (including alcoholism).
• If you have had surgery on the stomach, intestines or urinary tract.
• If you have a tumor in the adrenal gland such as pheochromocytoma.
• If you are diabetic.
• If you have a history of increased eye pressure (closed-angle glaucoma).

Do not take this medication for more than three days.

Prolonged and excessive use of this medication may cause dependence and/or tolerance.

Codeine is converted to morphine in the liver by an enzyme. Some people have a variant of this enzyme that may affect them differently. In some people (a small proportion of the population), morphine is not produced or is produced in very small amounts, and will not produce an effect on their cough symptoms. In other people (a small proportion of the European population), a large amount of morphine may be produced and are therefore more prone to adverse reactions. 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, nausea, vomiting, constipation or loss of appetite.

Children and adolescents

Children under 12 years of age should not take this medication as they are at a higher risk of experiencing adverse reactions after taking codeine. These reactions can be very serious in children who degrade codeine in large amounts or quickly (extensive or ultra-rapid metabolizers).See the section "Other adverse effects in children and adolescents".

This medication is not recommended for use in adolescents aged 12 to 18 years, especially if they have respiratory problems.See the section "Other adverse effects in children and adolescents".

Taking Codinex with other medications

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

This information is especially important with the following medications, as it may be necessary to modify the dose of one of them or interrupt treatment:

-MAOIs: depression medications such as tranilcipromina and moclobemida, Parkinson's disease medications such as selegilina, anticancer medications such as procarbazina or anti-infectious medications such as linezolida, as they may cause a severe increase in blood pressure, high fever and headache. See the section "Do not take Codinex". A minimum of 15 days should be separated from the administration.

Additionally, the simultaneous use of MAOIs with this medication may potentiate the adverse effects of ephedrine and codeine as well as those of these medications.

-Other ephedrine family medications such as phenylpropanolamine, pseudoephedrine, phenylephrine, methylphenidate, as they may cause a severe increase in blood pressure, high fever and headache. See the section "Do not take Codinex".

-Other medications that bind to the same receptors as codeine such as buprenorphine or nalbuphine, pentazocine or naltrexone, may modify the effects of codeine and produce withdrawal symptoms.

-Depression medications such as tricyclic antidepressants, as they may have an increased effect.

-Medications used to treat heart rhythm disorders (arrhythmias) such as mexiletina or quinidina.

-Anticholinergic medications or other medications with anticholinergic activity used to relieve spasms or contractions of the stomach, intestines and bladder, may increase urinary retention and constipation, causing intestinal obstruction (paralytic ileus).

-Cimetidine (for stomach acid), ciprofloxacin or ritonavir (anti-infectious) may increase the effects of codeine.

-Medications used to treat vomiting (metoclopramide and domperidone) may produce the opposite effect due to the codeine content of this medication.

-Medications that depress the Central Nervous System (CNS) used to treat insomnia, allergy or anxiety (such as anxiolytics, hypnotics, antipsychotics, antihistamines H1 sedatives), may increase the CNS depressant effect and produce respiratory depression.

-Medications that modify the acidity of the urine (such as ammonium chloride or sodium bicarbonate) as they may alter the effect of ephedrine.

-Inhaled anesthetics, as they may increase the risk of heart rhythm disorders (arrhythmias) and produce increased blood pressure after surgery.

-Migraine medications (such as ergotamine or metisergida) may cause increased blood pressure and gangrene.

-Some medications used to lower blood pressure such as alpha-blockers, metildopa, reserpine and some diuretics, may reduce the effectiveness of ephedrine.

-Beta-blockers, as their use with ephedrine may produce increased blood pressure and slowed heart rate.

-Levodopa, used to treat Parkinson's disease, may increase the risk of arrhythmias.

-Oxytocin, used to increase uterine contractions, may increase blood pressure.

-Theophylline, used to treat asthma, may increase the adverse effects (nausea, nervousness and insomnia) of both medications.

-Cardiac glycosides used to treat heart problems, may cause alterations in heart rhythm.

-Dexamethasone, used as an anti-inflammatory, may have an increased effect in asthmatic patients.

Taking Codinex with alcohol

Do not take alcoholic beverages while taking this medication as it may cause hypotension and severe respiratory depression, as well as symptoms of overdose.

Pregnancy and lactation

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

Pregnancy

Do not take Codinex during pregnancy. Its use may cause physical dependence and changes in fetal heart rate. In the newborn, it may produce withdrawal syndrome and respiratory depression.

Lactation

Do not take this medication if you are breastfeeding. Some components of this medication and its metabolites pass into breast milk and may be harmful to the infant.

Driving and operating machines

Codinex may cause drowsiness, altering mental and/or physical ability. Avoid driving vehicles or operating machines if you experience these effects.

Athletes

This medication contains components that may induce positive results in antidoping controls.

Codinex contains benzoate of sodium (E-211)

This medication contains 2 mg of benzoate of sodium per ml of syrup.

Benzoate of sodium may increase the risk of jaundice (yellowing of the skin and eyes) in newborns (up to 4 weeks of age).

Codinex contains ethanol

This medication contains 0.17% mg of ethanol (alcohol), which corresponds to 25.5 mg per 15 ml.

Codinex contains saccharose

If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medication.

Patients with diabetes mellitus should note that this medication contains 11.5 g of saccharose per 15 ml.

Codinex contains red Ponceau 4R (E-124) colorant

This medication may cause allergic reactions because it contains red Ponceau 4R (E-124) colorant. It may cause asthma, especially in patients allergic to acetylsalicylic acid.

Codinex contains sodium

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

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The lowest effective dose should be used to control symptoms. Treatment should be continued for the shortest time possible.

If there is no relief of symptoms after three days, you should consult your doctor. See the "Warnings and Precautions" section.

The usually recommended dose is:

Adults:15 ml every 6 hours or more (maximum of 4 doses per day).

Senior patients:

Your doctor may recommendlower doses or longer dosing intervals than younger patients. See the "Warnings and Precautions" section.

Patients with renal and/or hepatic insufficiency:

Your doctor may recommendlower doses than usual. See the "Warnings and Precautions" section.

Use in children and adolescents

See the "Children and Adolescents" section in section 2.

If you take moreCodinexthan you should

Taking high doses of this medication or taking it with sedatives or alcoholic beverages may cause drowsiness and slow breathing, which can be severe.

Other possible effects include nausea and vomiting, blood pressure and heart rate changes, fever, restlessness, and seizures. Alterations in perception, such as delirium or hallucinations, may also occur.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to takeCodinex

Do not take a double dose to make up for the missed dose.

If you interrupt treatment withCodinex

In case of prolonged use (see "Warnings and Precautions" section), administration should be gradually discontinued.

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

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

The following side effects have been observed, but their frequency is not established with precision (unknown frequency)

Adverse reactions due to codeine

• Skin rash, itching, difficulty breathing, increased sweating, facial flushing.
• Mood changes, hallucinations, symptoms of excitement, decreased alertness, nightmares.
• Confusion, drowsiness, dizziness, vertigo, involuntary muscle movements, headache, increased intracranial pressure, dependence (*).
• Pupil constriction, blurred vision or double vision.
• Alterations in heart rhythm, palpitations (sensation of altered heartbeat).
• Decreased blood pressure and decreased blood pressure upon standing.
• Slow breathing and difficulty breathing
• Constipation, abdominal pain, nausea, vomiting, dry mouth.
• Muscle stiffness.
• Lower back pain and genital pain, decreased urine production, difficulty urinating.
• Decreased libido and sexual potency.
• General discomfort, fatigue, decreased body temperature, tolerance (*).

*Prolonged regular use of this medicine may cause tolerance and treatment interruption should be done gradually to avoid withdrawal syndrome. (See "Warnings and Precautions"). Anxiety and irritability may appear when treatment is stopped.

Adverse reactions due to ephedrine

• Headache, tremor, dependence.
• Anxiety, restlessness, insomnia.
• Alteration of heart rhythm (tachycardia and arrhythmias), myocardial infarction.
• Increased blood pressure (hypertension), alteration of circulation in arms and legs.
• Nausea, dry mouth.
• Tolerance.

Adverse reactions due to potassium sulfoguaiacolate

• At very high doses, it is suspected to cause kidney stones or urinary tract stones.

Other side effects in children and adolescents

Children under 12 years of age are at a higher risk of experiencing adverse reactions after taking this medicine; these reactions can be very severe in children who metabolize codeine quickly.

This medicine may have a stimulating effect in children, causing nocturnal incontinence and insomnia, although it may also have a sedative effect in some children.

The symptoms of codeine toxicity may be more severe in adolescents (12 to less than 18 years) with respiratory problems, so its use is not recommended in this population.

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 that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

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.

Medications should not be disposed of through drains or in the trash. Dispose of 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 packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Codinex

• The active principles are: codeine phosphate hemihydrate, ephedrine hydrochloride, and potassium sulfoguaiacolate. Each milliliter of syrup contains 1 mg of codeine phosphate hemihydrate, 1 mg of ephedrine hydrochloride, and 6.67 mg of potassium sulfoguaiacolate.
• The other components (excipients) are: sodium benzoate (E-211), sucrose, menthol, vanillin, orange color (composed of: quinoline yellow [E-104], Ponceau 4R red dye [E-124], indigo carmine [E-132], and sodium chloride), sodium citrate (E-331), anhydrous citric acid (E-330), ethanol, and purified water.

Appearance of the product and contents of the packaging

Codinex is a transparent syrup of brown-orange color with a characteristic aroma.

The medicine is presented in:

• Glass bottle of topaz color, with a syrup content of 125 ml and a child-resistant cap.
• Polycarbonate bottles of topaz color, with a syrup content of 125 ml and a child-resistant cap.

Each package is provided with a dosing spoon.

Holder of the marketing authorization and responsible for manufacturing

Laboratorios Cinfa, S.A

Carretera Olaz-Chipi, 10. Industrial Park Areta.

31620 Huarte (Navarra) - Spain

Last review date of this leaflet: September 2020

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