Package leaflet: Information for the patient

Paracetamol and Codeine Mylan Pharma 500 mg/30 mg tablets

paracetamol + codeine phosphate hemihydrate
equivalent medicine
Read all of 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 give it to others, even if they have the same symptoms as yours, because it could be harmful.
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Paracetamol and Codeine Mylan Pharma is and what it is used for
What you need to know before taking Paracetamol and Codeine Mylan Pharma
How to take Paracetamol and Codeine Mylan Pharma
Possible side effects
How to store Paracetamol and Codeine Mylan Pharma
Contents of the pack and other information

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

Paracetamolo e Codeina Mylan Pharma contains two different analgesics (painkillers) called paracetamol and codeine (as codeine phosphate hemihydrate). Codeine belongs to a group of medicines called opioid analgesics, which act 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 12 years of age for 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 your symptoms worsen after 3 days.

2. What you need to know before taking Paracetamol and Codeine Mylan Pharma

Do not take Paracetamol and Codeine 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 oxibutynin sodium;
if you are a child under 12 years of age;
to relieve pain in children and adolescents (0–18 years of age) after removal of tonsils or adenoids due to obstructive sleep apnoea syndrome;
if you have severe liver disease;
if you have asthma;
if you have respiratory failure;
if you know you metabolize codeine rapidly into morphine;
if you are breastfeeding.

If in doubt, it is essential to consult your doctor or pharmacist.
Warnings and precautions
Paracetamol and Codeine Mylan Pharma contains paracetamol and codeine.
Check that you are not taking 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 Paracetamol and Codeine Mylan Pharma”.
Consult your doctor or pharmacist before taking Paracetamol and Codeine Mylan Pharma:

if you are an adult weighing 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 prescription);
if you have liver or kidney disease;
if you have Gilbert’s syndrome (familial non-haemolytic 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 may lead to haemolytic anaemia);
if you have nutritional problems (malnutrition – low hepatic glutathione reserves), anorexia, bulimia, or cachexia (significant weight loss);
if you have dehydration or hypovolaemia (significant loss of body water);
if you have a respiratory disease (including asthma);
in case of bronchial congestion (cough with sputum);
after gallbladder surgery;
in case of intracranial hypertension. This medicine may increase the severity of hypertension;
if you are or have been dependent on opioids, alcohol, prescription medicines, or illegal substances;
if you have a mental illness (e.g. major depression);
if you have biliary tract disease or pancreatitis (inflammation of the pancreas, causing severe abdominal and back pain).

Regular, long-term use of codeine (one of the active substances in this medicine) may lead
to dependence and misuse, potentially resulting in overdose that can be fatal. Prolonged use may also
cause headaches as a consequence of overdose. Do not take this medicine for longer than necessary.
Do not give this medicine to anyone else.
Consult your doctor if you suffer from acute viral hepatitis or if you discover you have acute viral
hepatitis during treatment with Paracetamol and Codeine Mylan Pharma. Treatment may be
discontinued by the 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 instructed by your doctor, especially if
symptoms persist beyond 3 days and/or if new symptoms appear after taking this medicine.
Do not exceed the prescribed dose and consult your doctor immediately in case of accidental
overdose.
Codeine is converted into morphine in the liver by an enzyme. Morphine is the substance responsible
for the effects of codeine. Some people have a variation in this enzyme, which may affect individuals
differently. In some people, morphine is not produced or is produced in very small amounts, which may
be insufficient to relieve pain. Other people produce high amounts of morphine and are at increased risk
of serious adverse effects. If you notice any of the following adverse effects, you must stop treatment and
contact a doctor immediately: slow or shallow breathing, confusion, drowsiness, pinpoint pupils, nausea
or vomiting, constipation, loss of appetite.
Children and adolescents
This medicine must not be given to children under 12 years of age. Consult your doctor or pharmacist.
Do not repeat this treatment for your child without further medical advice. Your child should be
monitored during treatment; if you think your child is excessively drowsy, do not give a higher dose.
Use in children and adolescents after surgery
Codeine must not be used to relieve pain in children and adolescents after removal of tonsils or
adenoids due to obstructive sleep apnoea syndrome.
Use in children with respiratory problems
Codeine is not recommended in children with respiratory problems, as symptoms of morphine toxicity
may be worse in these children.
If in doubt, consult your doctor or pharmacist.
Other medicines and Paracetamol and Codeine Mylan Pharma
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
Effects associated with paracetamol
You should contact your doctor if you are taking a medicine that slows blood clotting
(oral anticoagulants). At high doses, Paracetamol and Codeine Mylan Pharma may increase the effect
of the anticoagulant. If necessary, your doctor will adjust the dose of the anticoagulant.
You should contact your doctor if you are taking flucloxacillin (an antibiotic), due to a serious risk
of blood and fluid disturbances (metabolic acidosis with high anion gap) that requires urgent treatment
and may occur particularly in cases of severe renal impairment, sepsis (when bacteria and their toxins
circulate in the blood causing organ damage), malnutrition, chronic alcoholism, and when maximum
daily doses of paracetamol are used.
If your doctor prescribes tests to measure uric acid or blood sugar levels for you or your child, inform
the doctor that you or your child is taking this medicine.
Effects associated with codeine
Never take Paracetamol and Codeine Mylan Pharma together with oxibutynin sodium.
This medicine must not be used in combination with:
bupropion
cinacalcet
duloxetine
fluoxetine
some analgesics (morphine agonist-antagonist, partial morphine antagonists)
paroxetine
quinidine (a medicine for irregular heartbeat)
terbinafine
The use of Paracetamol and Codeine Mylan Pharma in combination with the following medicines must
be done with caution:
medicines that cause drowsiness or sleep (CNS depressants) such as sleeping pills, medicines for
treatment of anxiety (benzodiazepines and related medicines), anaesthetics (morphine-based analgesics or other morphine agonist analgesics), some antitussive medicines (morphine-like or morphine-based antitussives), or other sedatives
barbiturates (e.g. phenobarbital)
medicines containing atropine
methadone
Paracetamol and Codeine Mylan Pharma with alcohol
Alcohol consumption is not recommended during treatment.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding,
consult your doctor or pharmacist before taking this medicine.
If necessary, Paracetamol and Codeine Mylan Pharma may be used during pregnancy at the doses
recommended by your doctor. If used, the medicine should be taken at the lowest possible dose to
relieve pain and/or fever and for the shortest possible duration. Contact your doctor if pain and/or
fever do not improve or if you need to take the medicine more frequently.
In the later stages of pregnancy, taking codeine may 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 or operate machinery 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 helpful to
start this treatment in the evening. This effect is further worsened by consumption of alcoholic drinks.
Paracetamol and Codeine Mylan Pharma contains lactose.
If your doctor has told you that you have an intolerance to certain sugars, consult your doctor before
taking this medicine.

3. How to take Paracetamolo e Codeina Mylan Pharma

Take this medicine exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
Dosage
For adults and children over 12 years of age only.
This medicine must not be taken for more than 3 days. If pain does not improve after
3 days, consult your doctor.
To prevent the risk of overdose, check that any other medicines you may be taking,
including those obtained without a prescription, do not contain codeine and/or paracetamol.
Always wait at least 6 hours between doses.
The dose will be determined by the doctor, according to the intensity of pain; in general,
the lowest effective dose for the shortest possible duration should be used.
Please note that the usual dose depends on the patient's age and weight (see the table below):

| Weight (age) | Dose per administration | Minimum interval between doses | Maximum daily dose | |------------------|-----------------------------|-----------------------------------|------------------------| | 31-50 kg
(12-15 years of age) | 1 tablet
500 mg paracetamol + 30 mg codeine | 6 hours | 4 tablets per day
or
2 g paracetamol + 120 mg codeine | | Over 50 kg
(15-18 years of age) | 1 (or 2) tablet(s)
from 500 mg to 1 g paracetamol + 30-60 mg codeine | 6 hours | 6 tablets per day
or
3 g paracetamol + 180 mg codeine | | Adults
(unless otherwise indicated by the doctor) | 1 or 2 tablets | 6 hours | 6 tablets per day
or
3 g paracetamol + 180 mg codeine |

In adults, if necessary, take 2 tablets for severe pain, but do not exceed 6 tablets per day (unless otherwise directed by the doctor).

Use in children and adolescents
Children under 12 years of age
Due to the risk of serious breathing problems, Paracetamolo e Codeina Mylan Pharma must 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 dosing helps prevent the recurrence of pain.
It is essential to take the correct dose, which depends on the child's weight. The ages listed in the table above are provided for information only. The doctor will determine the dose based on body weight and pain intensity.

Elderly
The initial dose is generally half the dose recommended for adults. The doctor may increase the dose depending on tolerance and individual needs.

Renal impairment
In case of kidney disease (renal insufficiency), there is a risk of accumulation of codeine and paracetamol. Therefore, the doctor may reduce the dose. The minimum interval between doses must be 8 hours.
Children with renal impairment require careful monitoring. 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 any other medicines you may be taking, including those obtained without a prescription, do not contain codeine and/or paracetamol;
never exceed the recommended maximum doses (unless otherwise directed by the doctor), taking into account all medicines containing paracetamol.

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

If you take more Paracetamolo e Codeina Mylan Pharma than you should
Paracetamol and codeine poisoning can be severe. In case of overdose or accidental poisoning, seek urgent medical advice.
The main symptoms of codeine overdose are drowsiness and breathing difficulties.
Contact your doctor or pharmacist immediately.

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

If you stop taking Paracetamolo e Codeina Mylan Pharma
If taken for a prolonged period, abruptly stopping this medicine may lead to withdrawal symptoms.

If you have any questions 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 gets them.
Side effects associated with codeine
drowsiness, euphoria, mood disturbance, hallucinations;
constricted pupils, muscle spasms, muscle cell breakdown, tingling,
numbness, fainting, tremors, difficulty urinating, kidney damage;
hypersensitivity (itching, hives, widespread skin rash);
constipation, nausea, vomiting;
drowsiness, dizziness;
difficulty breathing;
abdominal pain, particularly in patients who have undergone cholecystectomy (removal of the
gallbladder);
abuse, dependence with prolonged use;
withdrawal syndrome in case of abrupt discontinuation of treatment and in newborns of mothers
dependent on codeine during pregnancy;
inflammation of the pancreas (pancreatitis), causing severe pain in the abdomen and back
(frequency not known).
Side effects associated with paracetamol
In some rare cases, patients may develop a skin rash or redness of the skin or an allergic reaction which may present as sudden swelling of the face and neck or sudden feeling of illness, with a drop in blood pressure.
You must stop treatment immediately, inform your doctor straight away and never take medicines containing paracetamol again.
In rare cases, serious skin reactions have been reported. You must stop treatment immediately, inform your doctor straight away and never take medicines containing paracetamol again.
In exceptional cases, biological changes have been observed which require analysis of blood cell counts: abnormally low levels of certain white blood cells or certain blood cells such as platelets, which could cause nosebleeds or bleeding gums. In such cases, consult your doctor.
Cases of diarrhoea, 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, consult your doctor or pharmacist. You may also report side effects directly via 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 any special storage conditions.
Do not use this medicine after the expiry date which is stated on the label and on the carton after
“Exp.”. The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Paracetamolo e Codeina Mylan Pharma contains

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

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

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

This medicinal product is authorized in the European Economic Area countries under the
following names:
France Paracétamol/Codéine Viatris 500 mg/30 mg, comprimé
Italy Paracetamolo e Codeina Mylan Pharma