PARACETAMOLO 500 mg/30 mg Coated Tablet

Зміст інструкції

1. Paracetamolo e Codeina Mylan Pharma 500 mg/30 mg tablets
   1. What is Paracetamolo e Codeina Mylan Pharma and what is it used for
   2. What you need to know before taking Paracetamolo e Codeina Mylan Pharma
   3. How to take Paracetamolo and Codeina Mylan Pharma
   4. Possible side effects
   5. How to store Paracetamolo e Codeina Mylan Pharma
   6. Contents of the pack and other information

Paracetamolo e Codeina Mylan Pharma 500 mg/30 mg tablets

paracetamol + codeine phosphate hemihydrate

generic medicine

Read this leaflet carefully before taking this medicine because 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 may 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 is Paracetamolo e Codeina Mylan Pharma and what it is used for
• 2. What you need to know before you take Paracetamolo e Codeina Mylan Pharma
• 3. How to take Paracetamolo e Codeina Mylan Pharma
• 4. Possible side effects
• 5. How to store Paracetamolo e Codeina Mylan Pharma
• 6. Contents of the pack and other information

1. What is Paracetamolo e Codeina Mylan Pharma and what is it used for

Paracetamolo e Codeina Mylan Pharma contains two different painkillers (analgesics) called
paracetamol and codeine (as codeine phosphate hemihydrate). Codeine belongs to a group of
medicines called opioid analgesics that work to relieve pain. It can be used alone
or in combination with other analgesics, such as paracetamol.
Paracetamolo e Codeina Mylan Pharma can be used in patients over the age of 12, in the
short-term treatment of moderate pain that is not relieved by other painkillers such as
paracetamol or ibuprofen alone. Consult your doctor if you do not notice any improvement or if you notice a
worsening of symptoms after 3 days.

2. What you need to know before taking Paracetamolo e Codeina Mylan Pharma

Do not take Paracetamolo e Codeina Mylan Pharma:

• if you are allergic to codeine, paracetamol or any of the other ingredients of this medicine (listed in section 6);
• if you are taking sodium oxybate;
• if you are a child under 12 years of age;
• to relieve pain in children and adolescents (0-18 years of age) after tonsillectomy or adenoidectomy due to obstructive sleep apnea syndrome;
• if you have severe liver disease;
• if you have asthma;
• if you have respiratory failure;
• if you know you metabolize codeine into morphine very quickly;
• if you are breastfeeding.

If in doubt, it is essential that you ask your doctor or pharmacist for advice.

Warnings and precautions
Paracetamolo e Codeina Mylan Pharma contains paracetamol and codeine.
Checkthat you are not taking any other medicines containing paracetamol and/or codeine, including
medicines obtained without a prescription.
To avoid exceeding the recommended daily dose, do not combine these medicines. See
section 3, “How to take Paracetamolo e Codeina Mylan Pharma”.
Talk to your doctor or pharmacist before taking Paracetamolo e Codeina Mylan Pharma:

• if you are an adult and weigh less than 50 kg;
• if you are taking other medicines containing paracetamol, codeine or any other medicine that may cause respiratory depression (medicines obtained with or without a prescription);
• if you have liver or kidney disease;
• if you have Gilbert's syndrome (familial non-hemolytic jaundice);
• or in case of alcohol abuse [excessive alcohol consumption (3 or more alcoholic drinks per day)];
• if you suffer from glucose-6-phosphate dehydrogenase (G6PD) deficiency (which can lead to hemolytic anemia);
• if you have nutritional problems (malnutrition - low liver reserves of glutathione), anorexia, bulimia or cachexia (significant weight loss);
• if you have problems with dehydration or hypovolemia (significant loss of body water);
• if you have a respiratory condition (including asthma);
• in case of bronchial congestion (cough with expectoration);
• in case of surgery to the gallbladder;
• in case of increased intracranial pressure. This medicine may increase the severity of hypertension;
• if you are or have been addicted to opioids, alcohol, prescription drugs or illegal substances;
• if you have a mental illness (e.g. major depression);
• if you have a disease of the bile ducts and pancreatitis (inflammation of the pancreas, which causes severe pain in the abdomen and back).

Regular, long-term use of codeine (one of the active ingredients of this medicine) can lead to
dependence and misuse, resulting in overdose which can be fatal. Prolonged use can also cause
headache as a result of overdose. Do not take this medicine for longer than necessary. Do not give this
medicine to anyone else.
See your doctor if you suffer from acute viral hepatitis or if you discover you have acute viral
hepatitis during treatment with Paracetamolo e Codeina Mylan Pharma. Treatment may be
suspended by your doctor.
In case of overdose or if you accidentally take too high a dose, contact your doctor immediately.
Do not use the medicine for prolonged periods unless directed by your doctor, especially if the
symptoms persist after 3 days and/or if other symptoms appear after taking this
medicine.
Do not exceed the dose prescribed by your doctor and contact your doctor immediately in case of
accidental overdose.
Codeine is converted into morphine in the liver by an enzyme. Morphine is the substance that
produces the effects of codeine. Some people have a variation of this enzyme and this can
affect people in different ways. In some people, morphine is not produced or is produced in
small quantities and will not be enough to relieve pain. Other people produce a
high amount of morphine and are likely to have serious side effects. If you notice the
appearance of any of the following side effects, you should stop treatment and
contact your doctor immediately: slow or shallow breathing, confusion, drowsiness,
pinpoint pupils, nausea or vomiting, constipation, loss of appetite.

Children and adolescents
This medicine should not be given to children under 12 years of age. Ask your
doctor or pharmacist.
Do not repeat this treatment for your child without further medical advice. Your child should be
monitored during this treatment; if you think your child is becoming excessively
drowsy, do not give them an increased dose.
Use in children and adolescents after surgery
Codeine should not be used to relieve pain in children and adolescents after
tonsillectomy or adenoidectomy due to obstructive sleep apnea syndrome.
Use in children with breathing problems
Codeine is not recommended in children with breathing problems, as the symptoms of morphine toxicity
may be worse in these children.
If in doubt, ask your doctor or pharmacist for advice.

Other medicines and Paracetamolo e Codeina Mylan Pharma
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Effects associated with paracetamol
You should contact your doctor if you are taking a medicine that slows blood clotting
(oral anticoagulants). At high doses, Paracetamolo e Codeina Mylan Pharma may increase the action
of the anticoagulant. If necessary, your doctor will adjust the dose of the anticoagulant.
You should contact your doctor if you are taking flucloxacillin (antibiotic), due to a serious risk
of alterations in blood and fluids (metabolic acidosis with high anion gap) which must be
treated urgently and which may occur particularly in case of severe kidney impairment,
sepsis (when bacteria and their toxins circulate in the blood leading to organ damage),
malnutrition, chronic alcoholism and if the maximum daily doses of paracetamol are used.
If your doctor prescribes you or your child tests to measure uric acid or sugar levels in
the blood, tell your doctor that you or your child are taking this medicine.
Effects associated with codeine
Never take Paracetamolo e Codeina Mylan Pharma at the same time as sodium oxybate.
This medicine should not be used in combination with:
bupropion
cinacalcet
duloxetine
fluoxetine
some analgesics (morphine agonist-antagonists, partial morphine antagonists)
paroxetine
quinidine (a medicine for irregular heartbeat)
terbinafine
The use of Paracetamolo e Codeina Mylan Pharma in combination with the following medicines must
be carried out with caution:
medicines that induce drowsiness or sleep (depressants of the CNS) such as sleeping pills, medicines for the
treatment of anxiety (benzodiazepines and related medicines), anesthetics (morphine-based analgesics or other opioid analgesics), some cough medicines (cough medicines
similar to morphine or based on morphine) or other sedatives
barbiturates (e.g. phenobarbital)
medicines containing atropine
methadone

Paracetamolo e Codeina Mylan Pharma with alcohol
The use of alcohol is not recommended during treatment.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.
If necessary, Paracetamolo e Codeina Mylan Pharma can be used during pregnancy at the
recommended doses by your doctor. If used, the medicine should be taken at the lowest possible dose
to reduce pain and/or fever and for the shortest possible time. Contact your doctor if the
pain and/or fever does not decrease or if you need to take the medicine more often.
In the later stages of pregnancy, taking codeine can cause toxicity in the newborn.
Always consult your doctor before taking this medicine and never exceed the recommended
dose.
Do not take codeine while breastfeeding. Codeine and morphine pass into breast milk.
Paracetamol may affect fertility in women, reversibly upon discontinuation of
treatment.

Driving and using machines
People who drive and use machines should be informed of the risk of drowsiness due to the presence
of codeine in this medicine. This effect diminishes after several doses, so it may be
useful to start this treatment in the evening. This effect is further aggravated by the consumption of
alcoholic beverages.

Paracetamolo e Codeina Mylan Pharma contains lactose.
If your doctor has told you that you are intolerant to some sugars, contact your doctor before taking
this medicine.

3. How to take Paracetamolo and Codeina Mylan Pharma

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
Dosage
Only for adults and children over 12 years of age.
This medicine should not be taken for more than 3 days. If the pain does not improve after
3 days, ask your doctor for advice.
To prevent the risk of overdose, check that other medicines you may be taking,
including those obtained without a prescription, do not contain codeine and/or paracetamol.
Always wait an interval of 6 hours between doses.

The dose will be determined by the doctor, depending on the intensity of the pain; in general, the
lowest effective dose should be used for the shortest possible duration.
Please note that the usual dose depends on the patient's age and weight (see the table below):

Weight(age) Doseper
administration

Minimum intervalDose maximum
daily

31-50 kg
(12-15 years of age)
between doses

1 tablet6 hours4 tablets per day
or
2 g of paracetamol
+ 120 mg of codeine

over 50 kg
(15-18 years of age)
or
500 mg of paracetamol
+ 30 mg of codeine

1(or 2) tablet(s)6 hours6 tablets per day
or
from 500 mg to 1 g of
or
3 g of paracetamol
paracetamol + 180 mg of codeine
+ 30-60 mg of codeine

Adults1 or 2 tablets6 hours6 tablets per day
(unless otherwise
indicated by the
doctor)
or
3 g of paracetamol
+ 180 mg of codeine
In adults, if necessary, take 2 tablets for severe pain, but do not exceed
6 tablets per day(unless otherwise indicated by the doctor).

Use in children and adolescents
Children under 12 years of age
Due to the risk of serious breathing problems, Paracetamolo and Codeina Mylan Parma should not
be taken by children under 12 years of age.
Children over 12 years of age
Strictly follow the dose prescribed by the doctor.
Regular doses help prevent the return of pain.

It is essential to take the correct dose, which depends on the child's weight. In the table above,
ages are given for information only. The dose will be decided by the doctor based on body
weight and pain intensity.

Elderly
The initial dose is generally halved compared to the recommended dose for adults. The
doctor may increase the dose based on your tolerance and needs.

Kidney disease
In case of kidney disease (renal insufficiency), there is a risk of accumulation of codeine and
paracetamol. Consequently, the doctor may reduce the dose. The minimum interval between doses
must be 8 hours.
Careful monitoring is required for children with kidney disease. If you notice unusual symptoms (e.g.
drowsiness or difficulty breathing), consult your doctor.

Recommended maximum doses
To avoid the risk of overdose:
check that other medicines you may be taking, including those obtained without
prescription, do not contain codeine and/or paracetamol;

never exceed the recommended maximum doses(unless otherwise indicated by the doctor),
taking into account all medicines whose formula contains paracetamol.

Method and route of administration
Oral route.
The tablet must be swallowed whole with a glass of water.

If you take more Paracetamolo and Codeina Mylan Pharma than you should
Paracetamol and codeine poisoning can be serious. In case of overdose or
accidental poisoning, urgently contact a doctor.
The main symptoms of codeine overdose are drowsiness and difficulty breathing.
Contact your doctor or pharmacist immediately.

If you forget to take Paracetamolo and Codeina Mylan Pharma
Do not take a double dose to make up for a missed dose. Continue treatment
as prescribed.
Do not increase the dose and respect the interval between doses.

If you stop taking Paracetamolo and Codeina Mylan Pharma
If taken for a prolonged period, abrupt discontinuation of this medicine
may lead to withdrawal syndrome.
If you have any doubts about the use of this medicine, consult your doctor, pharmacist or
nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Effects associated with codeine
feeling of drowsiness, euphoria, mood disturbance, hallucinations;
constricted pupils, muscle contraction, muscle cell destruction, tingling,
numbness, syncope, tremors, difficulty urinating, kidney damage;
hypersensitivity (itching, urticaria, widespread skin rash);
constipation, nausea, vomiting;
drowsiness, dizziness;
difficulty breathing;
abdominal pain, especially in patients who have undergone cholecystectomy (removal of the
gallbladder);
abuse, dependence in case of prolonged use;
withdrawal syndrome in case of abrupt discontinuation of treatment and in newborns of mothers
intoxicated by codeine during pregnancy;
inflammation of the pancreas (pancreatitis), which causes severe pain in the abdomen and back
(frequency not known).
Effects associated with paracetamol
In some rare cases, patients may experience a skin rash or redness
of the skin or an allergic reaction that may present as sudden swelling of the
face and neck or a sudden feeling of unwellness, with a drop in blood pressure.
You must immediately stop treatment, inform your doctor immediately and never
take any more medicines containing paracetamol.
In very rare cases, severe skin reactions have been reported. You must immediately stop
treatment, inform your doctor immediately and never take any more medicines containing
paracetamol.
In exceptional cases, biological changes have been observed that require analysis of the
quantity of blood cells: abnormally low levels of certain white blood cells or
certain blood cells, such as platelets, which may cause bleeding from the
nose or gums. In such cases, consult your doctor.
Cases of diarrhea, abdominal pain, increased liver enzymes and increased or decreased INR
(international normalized ratio) have been reported.

Reporting of side effects
If you experience any side effect, 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 Paracetamolo e Codeina Mylan Pharma

Keep this medicine out of the sight and reach of children.
This medicine does not require special storage conditions.
Do not use this medicine after the expiry date which is stated on the label and on the package after
“Exp.”. The expiry date refers to the last day of that month.
Do not dispose of any medicine in the 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 Paracetamolo e Codeina Mylan Pharma contains

• The active ingredients are paracetamol and codeine phosphate hemihydrate. Each tablet contains 500 mg of paracetamol and 30 mg of codeine phosphate hemihydrate.
• The other ingredients are pregelatinized corn starch, stearic acid, povidone, lactose monohydrate, powdered cellulose, talc and magnesium stearate.

Description of the appearance of Paracetamolo e Codeina Mylan Pharma and pack contents
The tablets are white to almost white in colour, uncoated, capsule-shaped, flat with
bevelled edges, with “PC2” imprinted on one side and a “score line” on the other side of the
tablet.
This medicine is available in blister packs of 8 or 16 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Mylan SpA, via Vittor Pisani 20 – 20124 Milano
Manufacturer
SANTA SA
Str. Panselelor nr. 25. 27, 29
Brasov, jud. Brasov, cod 500419
Romania

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
France Paracétamol/Codéine Viatris 500 mg/30 mg, comprimé
Italy Paracetamolo e Codeina Mylan Pharma