CODINEX 1 mg/mL + 1 mg/mL + 6.67 mg/mL SYRUP

2. What you need to know before taking Codinex

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 very rapid metabolizer of codeine.
• If you suffer from any of the following disorders or diseases:

• Respiratory problems such as chronic obstructive pulmonary disease (COPD), acute asthma attacks, or respiratory depression.
• Intestinal obstruction (paralytic ileus) or are at risk of having it.
• Diarrhea associated with pseudomembranous colitis (inflammation of the colon) caused by antibiotic medications 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 (narrow-angle glaucoma).
• Severe heart disease, severe circulation disorders, or high blood pressure (hypertension).

• If you are or have been treated with any monoamine oxidase inhibitor (MAOI) medication during the last two weeks. See the "Taking Codinex with other medications" section.
• 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) in the urethra.
• If you have underactive adrenal glands (Addison's disease).
• If you have reduced thyroid gland 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 decreased respiratory capacity.
• If you have low blood pressure or shock.
• If you have any inflammatory bowel disease (acute colitis, pseudomembranous colitis), or diverticulitis.
• If you have had sudden involuntary muscle movements (seizures).
• If you have a history of drug abuse or dependence (including alcoholism).
• If you have undergone stomach, intestine, or urinary tract surgery.
• 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 (narrow-angle glaucoma).

It is not recommended to take this medication for more than three days.

Prolonged and excessive administration of this medication can 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 can affect them differently. In some people (a small part of the population), morphine is not produced or is produced in very low amounts, and it will not have an effect on their cough symptoms. In other people (a small proportion of the European population), a very high amount of morphine can be produced, and they are therefore more prone to adverse reactions. If you experience any of the following effects, you should 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 break down codeine quickly or in large amounts (extensive or ultra-rapid metabolizers). See the "Other adverse effects in children and adolescents" section.

The use of this medication is not recommended in adolescents (12 to 18 years old), especially if they have respiratory problems. See the "Other adverse effects in children and adolescents" section.

Taking Codinex with Other Medications

Tell your doctor or pharmacist if you are taking, have recently taken, 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:

• MAOI medications: antidepressant medications such as tranylcypromine and moclobemide, Parkinson's disease medications such as selegiline, anticancer medications such as procarbazine, or anti-infective medications such as linezolid, as they can cause a severe increase in blood pressure, very high fever, and headache. See the "Do not take Codinex" section. Administration should be separated by a minimum of 15 days.

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

• Other medications from the ephedrine family, such as phenylpropanolamine, pseudoephedrine, phenylephrine, methylphenidate, as they can cause a severe increase in blood pressure, very high fever, and headache. See the "Do not take Codinex" section.
• Other medications that bind to the same receptors as codeine, such as buprenorphine or nalbuphine, pentazocine, or naltrexone, can modify the effects of codeine and produce withdrawal symptoms.
• Medications used for depression, such as tricyclic antidepressants, as they can have an increased effect.
• Medications used for the treatment of heart rhythm disorders (arrhythmias), such as mexiletine or quinidine.
• Anticholinergic medications or other medications with anticholinergic activity used for the relief of stomach, intestine, and bladder spasms or contractions can increase urinary retention and constipation, producing intestinal obstruction (paralytic ileus).
• Cimetidine (for stomach acidity), ciprofloxacin, or ritonavir (anti-infectives) can increase the effects of codeine.
• Medications used to treat vomiting (metoclopramide and domperidone) can produce the opposite effect due to the codeine content of this medication.
• Medications that produce depression of the central nervous system (CNS) used for insomnia, allergy, or anxiety (such as anxiolytics, hypnotics, antipsychotics, sedating antihistamines), can increase the CNS depressant effect and produce respiratory depression.
• Medications that modify urine acidity (such as ammonium chloride or sodium bicarbonate) can alter the effect of ephedrine.
• Inhaled anesthetics, as they can increase the risk of heart rhythm problems (arrhythmias) and produce an increase in blood pressure after surgery.
• Medications for migraine (such as ergotamine or methysergide) can cause an increase in blood pressure and gangrene.
• Certain medications for lowering blood pressure, such as alpha-blockers, methyldopa, reserpine, and some diuretics, can decrease the effectiveness of ephedrine.
• Beta-blocker medications, as their use with ephedrine can produce an increase in blood pressure and a slowing of the heart rate.
• Levodopa, used in the treatment of Parkinson's disease, can increase the risk of arrhythmias.
• Oxytocin, used to increase uterine contractions, can increase blood pressure.
• Theophylline, used to treat asthma, can increase the adverse effects (nausea, nervousness, and insomnia) of both medications.
• Cardiac glycosides used for the treatment of heart problems can produce alterations in heart rhythm.
• Dexamethasone, used as an anti-inflammatory, can have an increased effect in asthmatic patients.

Taking Codinex with Alcohol

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

Pregnancy and Breastfeeding

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

Pregnancy

Do not take Codinex during pregnancy. Its use can cause physical dependence and changes in the fetus's heartbeat. In the newborn, it can produce withdrawal syndrome and respiratory depression.

Breastfeeding

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

Driving and Using Machines

Codinex can cause drowsiness, altering mental and/or physical ability. Avoid driving vehicles or using machines if you notice these effects.

Athletes

This medication contains components that can induce positive results in doping tests.

Codinex Contains Sodium Benzoate (E-211)

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

Sodium benzoate can increase the risk of jaundice (yellowing of the skin and eyes) in newborns (up to 4 weeks old).

Codinex Contains Ethanol

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

Codinex Contains Sucrose

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

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

Codinex Contains Red Colorant Ponceau 4R (E-124)

This medication can cause allergic reactions because it contains the red colorant Ponceau 4R (E-124). It can 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".

3. How to Take Codinex

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist again.

The lowest effective dose should be used. The treatment will be as short as possible.

If you do not experience relief from symptoms after three days, you should consult your doctor. See the "Warnings and Precautions" section.

The recommended dose is usually:

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

Elderly patients:

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

Patients with renal and/or hepatic insufficiency:

Your doctor may recommend lower 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 More Codinex Than You Should

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

It can also cause nausea and vomiting, changes in blood pressure and heart rate, fever, restlessness, and convulsions. Alterations in perception, such as delirium or hallucinations, can 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 Take Codinex

Do not take a double dose to make up for forgotten doses.

If You Stop Taking Codinex

In case of prolonged use of this medication (see the "Warnings and Precautions" section), administration should be gradually suspended.

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

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

The following side effects have been observed, whose frequency has not been established with precision (frequency not known)

Adverse Reactions Due to Codeine

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

*Prolonged regular use of this medication can produce tolerance, and treatment interruption should be gradual to avoid withdrawal syndrome. (See the "Warnings and Precautions" section). Restlessness and irritability may appear when treatment is stopped.

Adverse Reactions Due to Ephedrine

• Headache, tremor, dependence.
• Anxiety, restlessness, and insomnia.
• Changes in heart rhythm (tachycardia and arrhythmias), myocardial infarction.
• Increased blood pressure (hypertension), changes in 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 or urinary tract stones.

Other Adverse Effects in Children and Adolescents

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

In children, taking this medication can have a stimulating effect with nighttime urinary incontinence and cause insomnia, although it can also have a sedative effect in some children.

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

Reporting Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Codinex

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

Do not use this medication after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medications at the SIGRE collection point in the pharmacy. If you have any doubts, ask your pharmacist how to dispose of the packaging and any unused medications. This will help protect the environment.

6. Container Content and Additional Information

Composition ofCodinex

• The active ingredients are: codeine phosphate hemihydrate, ephedrine hydrochloride, and potassium guaicol sulfate. Each ml of syrup contains 1 mg of codeine phosphate hemihydrate, 1 mg of ephedrine hydrochloride, and 6.67 mg of potassium guaicol sulfate.
• 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], carmine indigo [E-132], and sodium chloride), sodium citrate (E-331), anhydrous citric acid (E-330), ethanol, and purified water.

Appearance of the Product and Container Content

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

The medication is presented in:

• A topaz-colored glass bottle, with a syrup content of 125 ml and a child-resistant cap.
• Topaz-colored polyethylene terephthalate bottles, with a syrup content of 125 ml and a child-resistant cap.

Each container is provided with a dosing spoon.

Marketing Authorization Holder and Manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta.

31620 Huarte (Navarra) - Spain

Date of the last revision of this prospectus: September2020

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/