CODAMOL 500 mg/30 mg Effervescent Tablet

Зміст інструкції

1. CODAMOL 500 mg + 30 mg effervescent tablets, 500 mg + 30 mg film-coated tablets
   1. What is Codamol and what is it used for
   2. What you need to know before taking Codamol
   3. How to take Codamol
   4. Possible side effects
   5. How to store Codamol
   6. Contents of the pack and other information

CODAMOL 500 mg + 30 mg effervescent tablets, 500 mg + 30 mg film-coated tablets

paracetamol + codeine phosphate

Generic medicine
Read this leaflet carefully before taking this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Codamol is and what it is used for
• 2. What you need to know before you take Codamol
• 3. How to take Codamol
• 4. Possible side effects
• 5. How to store Codamol
• 6. Contents of the pack and other information

1. What is Codamol and what is it used for

Codamol contains two active ingredients: paracetamol and codeine.
Codamol is indicated in adults and adolescents from 12 to 18 years of agefor the
treatment of symptoms of moderate to severe pain, which does not respond to treatment with
other pain relievers - such as paracetamol or ibuprofen used alone.

2. What you need to know before taking Codamol

Do not take Codamol
If you/the adolescent:

• are allergic to paracetamol, to proparacetamol (a precursor of paracetamol), to codeine or to any of the other ingredients of this medicine (listed in section 6),
• suffer from a lung disease (respiratory failure), as codeine may worsen your condition,
• are under 12 years of age,
• are between 12 and 18 years of age and have undergone surgery to remove tonsils and/or adenoids because you suffered from a condition called obstructive sleep apnea syndrome,
• have a liver enzyme that allows your body to convert codeine into a high amount of morphine (detected through urine testing) with a high probability of having serious side effects
• are breastfeeding (see section 2. “Pregnancy and breastfeeding”).

Also do not take Codamol effervescent tabletsif you/the adolescent:

• have a fructose intolerance (see section 2. Codamol effervescent tablets contains sodium, sorbitol and aspartame),

Warnings and precautions
Talk to your doctor or pharmacist before taking Codamol.
Paracetamol must be administered with caution in certain conditions, therefore
consult your doctor if you/the adolescent:

• suffer from mild/moderate impaired liver function (including Gilbert's syndrome, a disease characterized by excessive production of bilirubin, a substance that causes a yellowish color of the skin and eyes)
• suffer from severe liver problems
• suffer from acute hepatitis (acute liver inflammation)
• suffer from a deficiency of an enzyme called glucose-6-phosphate dehydrogenase (a substance normally present in the human body, the deficiency of which can cause hemolytic anemia),
• suffer from a disease due to the destruction of some blood cells, red blood cells (hemolytic anemia),
• suffer from kidney disease (renal failure),
• suffer from chronic alcoholism or consume large amounts of alcohol, such as 3 or more alcoholic beverages per day (see section 2. Codamol with alcohol),
• have an eating disorder in which you eat too much or too little (bulimia or anorexia),
• suffer from severe wasting characterized by extreme thinness, reduced muscle mass and thinning of the skin due to chronic diseases (cachexia),
• eat little and poorly (chronic malnutrition),
• have lost a lot of fluids (dehydration),
• suffer from a decrease in blood volume (hypovolemia),
• have a cough and produce phlegm. Paracetamol can cause severe skin reactions that can be fatal. The use of CODAMOL must be discontinued at the first appearance of skin rash or any other sign of hypersensitivity (allergic reaction).

Opioid therapy can cause:

• respiratory depression (reduced respiratory function) and sedation
• lowering of the convulsive threshold (i.e. increased excitability of the nervous system, as in the case of epilepsy)
• hyperalgesia (increased sensitivity to pain) constipation (difficult or infrequent bowel movements)
• nausea and vomiting
• masking of the symptoms of acute abdominal conditions (conditions characterized by pain
• severe and signs of irritation of the abdomen)
• obstruction of the outflow of bile and pancreatic juice, as in the case of some diseases of the biliary tract, for example pancreatitis (inflammation of the pancreas) and cholelithiasis (presence of gallstones in the gallbladder)
• increased release of histamine, as in the case of asthma (bronchial obstruction)
• itching
• reduction of hormone levels
• inhibition of immunological function (i.e. the function of the body's defense system)
• muscle rigidity and myoclonus (rapid involuntary muscle twitch)
• urinary retention (difficulty emptying the bladder) particularly in patients with narrowing of the urethra (the last tract of the urinary tract) or with enlargement of the prostate.

Use of high doses and/or for prolonged periods
The use of high doses or prolonged use of paracetamol can cause a liver disease
(hepatopathy)
and alterations also serious to the kidney and blood.
Prolonged use of pain relievers, including opioids, increases the risk of headache
from drug abuse. In addition, in elderly people, prolonged use may worsen a
pre-existing condition.
With prolonged use of opioids, a reduction in analgesic efficacy may occur
(tolerance).
Prolonged administration of codeine or at doses higher than therapeutic doses can give
physical and psychological dependence (habituation) and withdrawal syndrome following
abrupt
discontinuation of administration which can be observed in both patients and newborns
born from
mothers dependent on codeine. CODAMOL should be used with caution in patients with
dependence or
with a history of opioid dependence, and alternative analgesic therapies should be considered.

Elderly
Elderly patients may be at greater risk of side effects associated
with the use of
opioids, such as respiratory depression and constipation.

Children and adolescents
Donot give codeine to relieve pain in children and adolescents after removal
of the
tonsils or adenoids for obstructive sleep apnea syndrome.
Children and adolescents should be carefully monitored for signs of depression
of the central nervous system associated with codeine, such as extreme drowsiness and respiratory
depression.
Codeine is not recommended in children and adolescents with respiratory problems, as
symptoms of morphine toxicity may be worse.

Other medicines and Codamol
Tell your doctor or pharmacist if you/the adolescent are taking, have recently
taken or might take any other medicines.
In particular, tell your doctor if you are taking :
other medicines that contain paracetamol, as if paracetamol is
taken in high doses, serious side effects may occur

other medicines that contain opioids or other substances that depress the
central nervous system, to avoid the risk of overdose or serious
side effects

coumarin anticoagulants including warfarin(medicines that delay
blood clotting): the doctor will carry out more rigorous monitoring of INR values (time taken for blood to clot)

medicines or substances that stimulate liver enzymes (increasing the way
the liver works), for example:
rifampicin (an antibiotic)
cimetidine (a medicine used in the treatment of stomach ulcers)
antiepileptics (medicines used to treat epilepsy), such as glutethimide,
phenobarbital, carbamazepine and phenytoin. If treated with phenytoin, do not
take high doses or prolonged doses of paracetamol.
The use of these medicines with CODAMOL requires extreme caution and must be
carried out only under strict medical supervision.

probenecid, a medicine used for the treatment of hyperuricemia (high
concentration of uric acid in the blood) and gout (inflammation of the
joints due to uric acid deposits): the doctor will advise you to reduce the doses of
CODAMOL

salicylamide(a pain reliever and fever reducer)

flucloxacillin(antibiotic), due to a serious risk of alterations in the blood and
fluids (metabolic acidosis with high anion gap) which must be treated
urgently and which may occur particularly in cases of severe renal impairment, sepsis (when bacteria and their toxins circulate in the blood leading to damage
to organs), malnutrition, chronic alcoholism and if the maximum daily doses of paracetamol are used. .
chloramphenicol(an antibiotic): may increase the risk of possible side effects

medicines that slow down gastric emptying, such as
anticholinergics: these medicines delay the effect of CODAMOL.

zidovudine(a medicine for the treatment of HIV)

potent painkillers(buprenorphine, butorphanol, nalbuphine, nalorphine, pentazocine)

naltrexone(a medicine to treat drug addiction)

antihistamines(medicines to treat allergies)

analgesics(alfentanil, destromoramide, destropropoxyphene, fentanyl,
dihydrocodeine, hydromorphone, morphine, oxycodone, pethidine, phenoperidine,
remifentanil, sufentanil, tramadol)

medicines to treat cough(dextromethorphan, noscapine, folcodine, codeine,
etimorphine)

medicines to treat psychiatric disorders(chlorpromazine, haloperidol,
levomepromazine, thioridazine)

methadone(a medicine to treat drug addiction)

meprobamate(a medicine to treat anxiety)

benzodiazepines and barbiturates(medicines to treat insomnia and anxiety)

medicines to treat depression(paroxetine, fluoxetine, bupropion,
sertraline, imipramine, clomipramine, amitriptyline, nortriptyline, doxepin,
mirtazapine, mianserin, trimipramine and monoamine oxidase inhibitors)

antihypertensives(medicines to treat high blood pressure)

baclofen, a medicine to reduce and relieve muscle spasms (excessive
tension in the muscles that occurs in various diseases)

thalidomide, a medicine to treat multiple myeloma (a disease of the
immune system, the body's defense system)

celecoxib(a medicine that relieves inflammation)

quinidine(a medicine to treat irregular heartbeat)

dexamethasone(a medicine to treat various disorders such as inflammation and allergies)

anticholinergics(medicines to treat various conditions such as bladder problems,
allergies and depression).
The concomitant use of Codamol and sedative medicines such as benzodiazepines or related drugs increases the risk of drowsiness, difficulty breathing (respiratory
depression), coma and may be life-threatening. For this reason, concomitant use should be considered only when other
treatment options are not possible.
However, if the doctor prescribes Codamol together with sedative medicines, the dose and duration of
treatment should be limited by the doctor.
Tell your doctor about all the sedative medicines you are taking and carefully follow the
recommendations on dosage given by the doctor. It may be helpful to inform friends or
family that you are aware of the above signs and symptoms. See your doctor
when these symptoms occur.

Laboratory tests and Codamol
The administration of paracetamol may interfere with the determination of some values
in the blood such as uricemia (the amount of uric acid in the blood) and glycemia (the amount
of sugar in the blood).
Therefore, inform the analysis center that you are being treated with Codamol before undergoing
blood tests.

Codamol and alcohol
Do not take Codamol if you usually consume large amounts of alcohol (3 or more alcoholic
drinks
per day) or suffer from alcohol dependence (alcoholism).
It is advisable, due to the presence of codeine, not to consume alcoholic beverages: alcohol increases
the sedative effect of opioid analgesics.;

Pregnancy and breastfeeding
If you are pregnant, suspect or are planning a pregnancy, ask your
doctor or pharmacist before taking this medicine.

TakeCodamol only when absolutely necessary and under direct medical supervision. It is
advisable to use the lowest possible dose that reduces pain and take it for the shortest
possible time. Contact your doctor if the pain does not decrease or if you have to take
the
medicine more often.

Pregnancy
Paracetamol
Clinical experience with the use of paracetamol during pregnancy is limited.
Codeine
Available data are insufficient to exclude an association between malformations and
use of codeine in pregnancy.
Maternal use of codeine at any stage of pregnancy may be associated with scheduled cesarean delivery. Use in the third trimester may be associated with an increased
risk of urgent cesarean delivery, postpartum hemorrhage and the possible onset of
neonatal opioid withdrawal symptoms including restlessness, excessive crying,
tremors, increased muscle tone (hypertonia), increased respiratory rate
(tachypnea), fever (pyrexia), vomiting and diarrhea.

Breastfeeding

Donot take Codamol if you are breastfeeding. Codeine and morphine pass into
breast milk.

Driving and using machines
Codamol can affect your ability to drive vehicles or use machinery as it can
cause side effects such as drowsiness and cognitive impairment, such as altered
attention.

Codamol effervescent tablets contain sodium, sorbitol and aspartame
This medicine contains 348 mg (15 mEq) of sodiumper each effervescent tablet.
This is equivalent to approximately 17% of the maximum daily intake recommended with the diet of an adult. Talk to your doctor or pharmacist if you need
one or more doses per day for a prolonged period, especially if you have been advised to
follow a low-sodium diet.
This medicine contains 30 mg of aspartameper tablet. Aspartame is a source of
phenylalanine: therefore it may be harmful for those affected by phenylketonuria, a rare
genetic disease that causes the accumulation of phenylalanine because the body cannot eliminate it
correctly.
This medicine contains 252 mg of sorbitol.Sorbitol is a source of fructose. If your
doctor has told you that you (or the child) are intolerant to some sugars, or if you have a
diagnosis of hereditary fructose intolerance, a rare genetic disease in which patients
cannot transform fructose, talk to your doctor before you (or the child) take
this medicine.

3. How to take Codamol

Take this medicine following the instructions of your doctor or pharmacist exactly. If you have doubts, consult your doctor or pharmacist.
The duration of treatment should be limited to 3 days and if you do not obtain effective pain relief, contact your doctor.
To avoid the risk of overdose, check that other medicines you are taking (with or without a prescription) do not contain paracetamol or codeine.
Accidental intake of an excessive dose of paracetamol can cause serious liver damage
and death (see section If you use more CODAMOL than you should).

Adults and adolescents aged 12 years and over and weighing more than 60 kg
The recommended dose is 1 or 2 tablets, depending on the intensity of the pain, to be taken 1 to 3 times a day at intervals of at least 6 hours.

Adolescents aged 12 years and over and weighing less than 60 kg
The dosage must be determined based on weight.
The recommended dosage is 1 tablet per administration, up to a maximum of 4 tablets per day, at intervals of at least 6 hours.

Children under 12 years of age

Donot give Co-Efferalgan to children under 12 years of age.

Elderly
The initial dose should be halved compared to the recommended dosage for adults and may subsequently be increased.

Patients with kidney disease
If you suffer from severe kidney disease, the interval between two administrations must be at least 8 hours.

Patients with liver disease
If you suffer from impaired liver function, the dose must be reduced or the interval between two administrations prolonged.

Method of administration

Film-coated tablets
Oral use. Swallow the film-coated tablet with a glass of water. Do not chew.

Effervescent tablets
Oral use. Let the effervescent tablet dissolve in a glass of water and drink the resulting solution immediately.
The CODAMOOL tablets can be divided into equal parts.

If you take more Codamol than you should
In case of taking or ingesting an excessive dose of this medicine, immediately inform your doctor or go to the nearest hospital.

Paracetamol
Taking an excessive dose of paracetamol increases the risk of poisoning and can lead to
death, especially if:

• you suffer from liver disease
• you abuse alcohol
• you suffer from chronic malnutrition
• you are taking medicines or substances that stimulate liver enzymes (increasing the way the liver works). In case of taking very high doses of paracetamol, the symptoms that may appear within the first 24 hours include
• nausea
• vomiting
• anorexia (loss or reduction of appetite)
• pallor
• malaise
• diaphoresis (profuse sweating). If 7.5 g or more of paracetamol is ingested in adults and 140 mg per kg of body weight in children, serious liver damage may occur with resulting alteration of some blood tests (AST, ALT, lactic dehydrogenase, bilirubin, prothrombin), coma (deep unconsciousness) or death. Symptoms of liver damage reach their peak after 3-4 days.

Codeine
The maximum dose of opioids varies from individual to individual.
Taking an excessive dose of codeine or other opioids can primarily lead to:

• respiratory depression ranging from decreased respiratory rate to apnea (cessation of breathing)
• extreme sedation ranging from drowsiness to coma
• miosis (constriction of the pupils). Other symptoms related to effects on the central nervous system may also occur, including:
• headache
• vomiting
• urinary retention (difficulty emptying the bladder)
• decreased intestinal motility (peristalsis)
• bradycardia (decreased heart rate)
• hypotension (lowering of blood pressure).

The recommended treatment, in addition to common practices (gastric lavage), consists of the timely administration of antidotes (substances capable of counteracting the toxic effect of the drug) such as acetylcysteine ​​and naloxone and assisted breathing.
The doctor will subject you to blood tests to check your health status. In very severe cases, a liver transplant may be necessary.

If you forget to take Codamol
Do not take/give the adolescent a double dose to make up for a missed dose.

If you stop taking Codamol
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.
If you take Codamol at doses higher than those recommended, you run the risk of developing a dependence and experiencing withdrawal syndrome following sudden discontinuation of the drug. These effects may also be visible in a newborn if the mother was codeine-dependent during pregnancy.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you/the adolescent develops the following side effectsSTOP treatment with this medicine and contactyour doctor immediately:
skin reactions that may manifest with:
itching,
urticaria (appearance of hives on the skin accompanied by itching),
skin rash
erythema (redness of the skin)
erythema multiforme (appearance of red spots on the skin with a "bull's-eye" appearance associated with itching)
Stevens-Johnson syndrome (a severe skin disease with the appearance of
rashes and exfoliation)
toxic epidermal necrolysis (a severe skin disease characterized by redness,
blistering lesions with areas of detachment and skin death)
acute generalized exanthematous pustulosis (eruption of hundreds of superficial pustules
spread all over the body)
allergic reactions that may manifest with:
laryngeal edema (swelling of the throat)
angioedema (swelling of hands, feet, ankles, face, lips, tongue and/or throat)
hypotension (low blood pressure)
anaphylactic shock (severe allergic reaction)
hypersensitivity
respiratory depression (reduction of breathing activity)

Furthermore, the following side effects may occur for which there are not
sufficient data to establish the frequency:
anemia (reduction of hemoglobin in the blood, a substance that carries oxygen in the
blood)
thrombocytopenia (reduction in the number of platelets in the blood)
leukopenia/agranulocytosis/neutropenia (reduction in the number of white blood cells in the
blood)
abnormal liver function
hepatitis (inflammation of the liver)
biliary colic (severe pain in the upper abdomen)
dizziness
drowsiness
vertigo
myoclonus (rapid involuntary muscle twitch)
paresthesia (tingling)
syncope (temporary loss of consciousness)
tremor
sedation
confusional state
drug abuse
drug dependence
hallucination
euphoria (excitement)
dysphoria (depressed mood with irritability and nervousness)
acute renal failure (reduction of kidney function)
interstitial nephritis (inflammation of the kidneys)
hematuria (blood in the urine)
anuria (cessation or reduction of urine production by the kidney)
urinary retention (inability of the bladder to empty completely)
diarrhea
abdominal pain
nausea
vomiting
constipation
reactions to the stomach and intestines
pancreatitis (inflammation of the pancreas)
dyspnea (difficulty breathing)
increased liver enzymes
decrease or increase of INR (value used to express the time it takes for the
blood to coagulate)
rhabdomyolysis (severe muscle damage)
asthenia (weakness)
malaise
miosis (constriction of the pupils)
edema (swelling due to fluid accumulation)

Reporting of side effects
If you/the adolescent experiences any side effects, including those not listed
in this leaflet, please inform your doctor or pharmacist. You can also report side
effects directly through the national reporting system at
http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse ..
By reporting side effects you can help provide more information on
the safety of this medicine.

5. How to store Codamol

Codamol film-coated tablets
This medicine does not require any special storage conditions.

Codamol effervescent tablets
Do not store at a temperature 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 pack after EXP.
The expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

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, sodiumbicarbonate , sodiumcarbonate, sorbitol (E 420), aspartame (E 951), orange aroma, lemon aroma, docusate sodium, simeticone (see section 2. Codamol effervescent tablets contains sodium, aspartame and sorbitol).

Description of the appearance of Codamol and contents of the pack

Codamol film-coated tablets
CODAMOL is available as divisible tablets.
It is available in packs of 16 tablets.

Codamol effervescent tablets
Codamol is available as divisible effervescent tablets.
It is available in packs of 16 tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
ABIOGEN PHARMA S.p.A.
Via Meucci, 36
Ospedaletto - PISA

Manufacturer

Film-coated tablets
ABIOGEN PHARMA S.p.A.
Via Meucci, 36
Loc. Ospedaletto - Pisa

Effervescent tablets
E-Pharma Trento S.p.A.
Frazione Ravina
Via Provina, 2
38123 Trento (TN).