Active ingredients: Paracetamol, Codeine (Codeine phosphate)
CODAMOL 500 mg + 30 mg effervescent tablets
CODAMOL 500 mg + 30 mg film-coated tablets
Indications Why is Codamol used? What is it for?
Codamol contains two active ingredients: paracetamol and codeine.
Codamol is indicated in adults and adolescents 12 to 18 years of age for the treatment of symptoms of moderate to severe pain that does not respond to treatment with other pain relieving medicines - such as paracetamol or ibuprofen used alone.
Contraindications When Codamol should not be used
Do not take Codamol
If she / the teenager:
- you are allergic to paracetamol, proparacetamol (precursor of paracetamol), codeine or any of the other ingredients of this medicine (listed in section 6),
- suffer from lung disease (respiratory failure), as codeine can make your disease worse,
- is under 12 years old,
- are 12 to 18 years old and have had tonsil and / or adenoid removal surgery because of a disorder called obstructive sleep apnea syndrome,
- you are breastfeeding (see section 2. "Pregnancy and breastfeeding"),
- your body converts codeine to morphine (a powerful pain reliever) faster than normal.
Also do not take Codamol effervescent tablets if you / your adolescent:
- has a "fructose intolerance (see paragraph 2. Codamol effervescent tablets contain sodium, sorbitol and aspartame),
- you suffer from phenylketonuria, ie your body is unable to metabolize a substance called phenylalanine, contained for example in sweeteners based on aspartame (see paragraph 2. Codamol effervescent tablets contain sodium, sorbitol and aspartame).
Precautions for use What you need to know before taking Codamol
Talk to your doctor or pharmacist before taking Codamol.
Paracetamol should be administered with caution under certain conditions, so consult your doctor if you / your adolescent:
- suffer from liver disease, including severe liver disease (mild to moderate liver failure, including Gilbert's syndrome; severe liver failure (child-Pugh9), acute hepatitis),
- are taking medicines that change the way the liver works,
- suffer from a deficiency of an enzyme called glucose-6-phosphate dehydrogenase,
- suffer from a disease caused by the destruction of certain blood cells, red blood cells (haemolytic anemia),
- suffer from kidney disease (kidney failure),
- suffer from chronic alcoholism or consume large amounts of alcohol, such as 3 or more alcoholic drinks per day (see section 2. Codamol with alcohol),
- have an eating disorder where you eat too much or too little (bulimia or anorexia),
- suffer from severe wasting (cachexia),
- eat little and badly (chronic malnutrition),
- you have lost a lot of fluids (dehydration),
- suffer from a decrease in the volume of circulating blood (hypovolaemia).
Codeine is transformed into morphine by an enzyme in the liver. Morphine is the substance that relieves pain. Some people have a variation of this enzyme and this can affect the response to this medicine. In fact, in some people, morphine is either not produced or is produced in very small quantities that are not enough to relieve pain. Conversely, other people can produce a high amount of morphine and are therefore more likely to have serious side effects, including confusion, sleepiness, shallow breathing, narrowing of the pupil, nausea, vomiting, constipation and lack of appetite. In severe cases. you may have symptoms of respiratory and circulatory depression, which can be life-threatening and very rarely fatal.
Due to the presence of codeine, Codamol should be administered with caution if:
- the gallbladder has been removed, an organ where bile, a substance useful for digestive processes, is stored,
- have a cough that produces phlegm.
Prolonged use or excessive doses of this medicine can cause liver disease, kidney or blood problems, even severe (due to the presence of paracetamol) or addictive (due to the presence of codeine).
Children and adolescents
Do not give Codamol to children under 12 years of age. In these patients the conversion of codeine to morphine is variable and unpredictable and there is a risk of acute opioid toxicity.
Use in children over 12 years after surgery
For the presence of codeine do not use Codamol to relieve pain in children and adolescents after removal of the tonsils and / or adenoids for obstructive sleep apnea syndrome, as they can develop serious adverse events.
Use in children over 12 with respiratory problems
Due to the presence of codeine do not give Codamol to children with respiratory problems, as the symptoms of morphine toxicity may be worse in these children.
Interactions Which drugs or foods can modify the effect of Codamol
Other medicines and Codamol
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Paracetamol may increase the chance of side effects if given at the same time as other medicines. In particular, tell your doctor if you are taking it. taking on:
- medicines that contain paracetamol, as serious side effects can occur if taken in high doses
- medicines to thin the blood taken by mouth (oral anticoagulants), as doses may need to be reduced
- probenecid, a medicine to treat high levels of uric acid in the blood,
- medicines that induce hepatic monooxygenases (enzymes found in the liver) such as: rifampicin, a medicine used to treat infections (antibiotic); cimetidine, a medicine to treat ulcers; medicines to treat uncontrolled body movements (antiepileptics such as glutethymide, phenobarbital, carbamazepine, phenytoin and barbiturates)
- medicines such as tranquilizers and sedatives,
- medicines to treat allergies, such as antihistamines
- pain relievers such as alfentanil, dextromoramide, dextropropoxyphene, fentanyl, dihydrocodeine, hydromorphone, morphine, oxycodone, pethidine, phenoperidine, remifentanil, sufentanil, tramadol,
- medicines to treat cough such as dextromethorphan, noscapine, pholcodine, codeine, etymorphine,
- neuroleptics, medicines to treat mental illness,
- benzodiazepines, medicines to treat depression or anxiety,
- methadone, a medicine to treat heroin addiction,
- Meprobramate or other medicines to treat anxiety other than benzodiazepines,
- hypnotics, medicines to treat insomnia
- medicines to treat depression (amitriptyline, doxepin, mirtazapine, mianserin, trimipramine),
- H1 antihistamines with sedative action, medicines to treat disorders caused by movement on means of transport (car, ship, etc.),
- centrally acting antihypertensives, medicines to treat high blood pressure
- baclofen, a medicine to reduce and relieve the excessive tension in the muscles (spasms) that occurs in various diseases
- thalidomide, a medicine to treat a disease of the immune system, the body's defense system (multiple myeloma)
Do not take Codamol if you are taking:
- powerful painkillers (buprenorphine, nalbuphine, pentazocine),
- naltrexone, a medicine to treat addiction to opioid drugs (similar to morphine),
- alcohol (see paragraph 2. Codamol and alcohol).
Laboratory tests and Codamol
The administration of paracetamol can interfere with the determination of certain blood values such as blood sugar and blood sugar. Therefore, please inform the testing center that you are being treated with Codamol before having blood tests.
Codamol and alcohol
Do not take Codamol if you usually have large amounts of alcohol (3 or more alcoholic drinks per day) or if you suffer from alcohol dependence (alcoholism).
It is advisable, due to the presence of codeine, not to take alcoholic beverages: alcohol increases the sedative effect of morphine analgesics; furthermore, codeine can cause increased pressure inside the head (intracranial hypertension).
Warnings It is important to know that:
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Take Codamol only when clearly needed and under the direct supervision of your doctor.
Feeding time
Do not take Codamol if you are breastfeeding. Codeine and morphine pass into breast milk.
Driving and using machines
Codamol can cause drowsiness and therefore be careful if you drive or use machines.
Codamol effervescent tablets contain sodium, sorbitol and aspartame
This medicinal product contains 348 mg (15 mEq) of sodium per effervescent tablet. To be taken into consideration in people with reduced kidney function or who follow a low sodium diet.
This medicine contains aspartame, a source of phenylalanine: therefore it can be harmful to those with phenylketonuria.
This medicine contains sorbitol. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Dosage and method of use How to use Codamol: Dosage
Always take this medicine exactly as your doctor or pharmacist has told you. If in doubt, consult your doctor or pharmacist.
The duration of treatment should be limited to 3 days and if you do not get effective pain relief, contact your doctor.
Adults and Teenagers (12-18 years)
The recommended dose is 1-2 tablets depending on the intensity of the pain, 1-3 times a day at intervals of not less than 4 hours.
Senior citizens
The starting dose should be halved compared to the recommended adult dose and may be subsequently increased.
Patients with kidney disease
If you suffer from severe kidney disease, the interval between two administrations should be at least 8 hours.
Method of administration of the effervescent tablets
Dissolve the effervescent tablet in a glass of water and drink the resulting solution immediately.
Overdose What to do if you have taken an overdose of Codamol
If you take more Codamol than you should
If you have taken or swallowed an overdose of this medicine, notify your doctor immediately or go to the nearest hospital.
If you suffer from liver disease, chronic alcoholism, chronic malnutrition or are on enzyme inducers, overdose can be fatal.
Symptoms of paracetamol overdose that usually appear within 24 hours, and can reach a maximum of 3-4 days are:
- nausea
- He retched
- lack of appetite
- pallor
- belly pain
- malaise
- sweating
- changes detectable by blood tests (AST, ALT, LDH, lactic dehydrogenase, bilirubin, prothrombin)
Paracetamol in very high doses can cause liver cell death, increased acid in the blood (metabolic acidosis) and an altered mental state (encephalopathy) caused by liver malfunction, which can lead to profound loss of consciousness (coma) and death; at the same time, changes detectable by blood tests (AST, ALT, LDH, lactic dehydrogenase, bilirubin, prothrombin) are observed which can occur 12 to 48 hours after taking. Therefore, if you suspect that you have accidentally taken high doses of the drug, go to hospital.
Symptoms of codeine overdose are:
- skin that turns blue from lack of oxygen (cyanosis)
- reduced respiratory function,
- drowsiness,
- skin rash (rash),
- itch,
- He retched,
- difficulty moving (ataxia),
- accumulation of fluid around the lungs (pulmonary edema)
If an overdose of Codamol is accidentally taken by a child, they may experience:
- difficulty in breathing, even severe (reduced respiratory function, respiratory arrest),
- narrowing of the pupils (miosis)
- uncontrolled body movements (seizures),
- facial redness and swelling,
- urticaria,
- collapse,
- inability to empty the bladder (urinary retention).
The recommended treatment, in addition to common practices (gastric lavage), consists in the timely administration of antidotes (substances capable of counteracting the toxic effect of the drug) such as acetylcysteine and naloxone and in assisted breathing. The doctor will subject you to blood tests for check your health In very severe cases a liver transplant may be required.
If you forget to take Codamol
Do not take a double dose to make up for a forgotten dose.
If you stop taking Codamol
If you have any further questions on the use of this medicine, ask your doctor or pharmacist. If you take Codamol at higher than therapeutic doses you run the risk of developing an addiction and experiencing a withdrawal syndrome following a sudden discontinuation of the drug. Such effects may also be seen in a newborn if the mother was codeine-dependent when she was pregnant.
Side Effects What are the side effects of Codamol
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If during treatment you / your adolescent experience any of the following side effects:
- allergic reactions,
- slow or shallow breathing,
- confusion,
- drowsiness,
- reduced pupils,
- nausea or vomiting,
- constipation (constipation),
- lack of appetite
STOP treatment and contact your doctor immediately.
The following side effects have been reported during treatment with paracetamol:
Allergic reactions, including severe ones such as:
- swelling of the face, lips, eyelids, tongue and / or throat, hands, feet, ankles (angioedema)
- swelling of the larynx
- anaphylactic shock
- lowering of blood pressure
Effects affecting the skin, of various types and severities, including:
- condition characterized by the appearance of red spots on the skin with a "bull's eye" appearance associated with itching (erythema multiforme)
- severe skin lesions characterized by erythema, bullous lesions with areas of peeling of the skin (Stevens Johnson syndrome)
- severe skin disease characterized by red, bullous lesions with areas of peeling and dying of the skin (epidermal necrolysis)
- rash (hives, rash)
- redness of the skin (erythema)
Effects affecting the blood:
- reduction in the number of platelets in the blood (thrombocytopenia)
- reduction in the number of white blood cells (leukopenia, neutropenia)
- reduction of hemoglobin, a substance that carries oxygen in the blood (anemia)
- reduction in the number of blood granulocytes, a type of white blood cell (agranulocytosis)
Effects affecting the liver
- changes in liver function
- inflammation of the liver (hepatitis)
- increased liver enzymes
- destruction of liver cells which can lead to liver death (see section 3. "If you take more Codamol than you should".
Effects affecting the kidneys:
- kidney disease (acute kidney failure)
- inflammation of the kidneys (interstitial nephritis)
- presence of blood in the urine (haematuria)
- failure to produce urine (anuria)
Effects affecting the stomach and intestines:
- reactions to the stomach and intestines
- diarrhea
- bellyache
Effects that affect the whole organism:
- dizziness
Laboratory tests
- decrease in INR values (international normalized ratio, blood coagulation index)
- increase in the values of the INR (international normalized ratio)
The following side effects have been reported during treatment with codeine:
Effects affecting the nervous system
- sedation,
- excitement (euphoria),
- depressed mood with agitation, irritability, nervousness (dysphoria)
Effects affecting the eyes
- narrowing of the pupil (miosis)
Allergic reactions
- allergic reactions (itching, hives, rash)
Effects affecting the kidneys:
- inability of the bladder to empty completely (urinary retention)
Effects affecting the stomach and intestines:
- constipation, nausea, vomiting
- acute abdominal pain (probably due to spasm of the sphincter of Oddi, which occurs particularly in patients who have had their gallbladder removed)
Effects that affect the whole organism:
- dizziness
- drowsiness
Effects affecting the lungs
- difficulty in breathing (bronchospasm),
- decreased respiratory activity (respiratory depression)
The risk of inflammation of the pancreas, a gland involved in the digestion of food (pancreatitis), has been highlighted with medicines containing the combination of paracetamol and codeine.
Reporting of side effects
If you / your adolescent get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system at https: // www. .aifa.gov.it / content / reports-adverse-reactions. By reporting side effects you can help provide more information on the safety of this medicine.
Expiry and Retention
Codamol film-coated tablets
This medicinal product does not require any special storage conditions.
Codamol effervescent tablets
Do not store above 25 ° C.
Store in the original package to protect the medicine from moisture.
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.
Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
Composition and pharmaceutical form
What Codamol contains
Codamol film-coated tablets
- The active ingredients are paracetamol and codeine phosphate. Each tablet contains 500 mg of paracetamol and 30 mg of codeine phosphate.
- The other ingredients are core: Low-substituted hydroxypropylcellulose, microcrystalline cellulose (E 460), povidone (E 1201), hydroxypropylcellulose (E 463), magnesium stearate (E 572), stearic acid (E 570), anhydrous colloidal silica (E 551 ). Coating: polyvinyl alcohol (E 1203), titanium dioxide (E 171), macrogol 3350 (E 1521), talc (E 553b).
Codamol effervescent tablets
- The active ingredients are paracetamol and codeine phosphate. Each tablet contains 500 mg of paracetamol and 30 mg of codeine phosphate.
- The other ingredients are citric acid, sodium bicarbonate, sodium carbonate, sorbitol (E 420), aspartame (E 951), orange flavor, lemon flavor, docusate sodium, simethicone (see paragraph 2. Codamol effervescent tablets contain sodium, aspartame and sorbitol) .
What Codamol looks like and contents of the pack
Codamol film-coated tablets
CODAMOL comes in the form of tablets.
It is available in packs of 16 tablets.
Codamol effervescent tablets
Codamol comes in the form of divisible effervescent tablets.
It is available in packs of 16 tablets.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
