PARACETAMOLO 500 mg/30 mg Tabletka Powlekana

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

Paracetamolo e Codeina Accord 500 mg/30 mg tablets

Paracetamol and codeine phosphate hemihydrate

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

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

Paracetamolo e Codeina Accord belongs to a group of medicines called analgesics (pain relievers) and is
used in adult patients (aged 18 years or older) to relieve severe pain. It can be used in
patients aged 12 years or older for the short-term treatment of moderate pain that is not relieved
by other pain relievers such as paracetamol or ibuprofen taken alone.
This product contains paracetamol and codeine.
Paracetamol is a pain reliever that can be used to relieve pain.
Codeine belongs to a group of medicines called opioid analgesics that work to relieve pain.

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

Do not take Paracetamolo e Codeina Accord

• To relieve pain in children and adolescents (0-18 years of age) after they have undergone surgery to remove the tonsils or adenoids due to obstructive sleep apnea syndrome
• If you are known to metabolize codeine very quickly into morphine
• In case of imminent childbirth or in case of risk of premature delivery
• If you are breastfeeding
• If you are allergic to codeine, paracetamol or any of the other ingredients of this medicine (listed in section 6)
• If you suffer from acute asthma or serious breathing problems
• If you have a head injury
• If you have recently undergone surgery on the gallbladder or a similar operation
• If you have increased pressure inside the brain
• If you are taking monoamine oxidase inhibitors (used to treat depression) or have taken them in the last 14 days
• If you are a chronic alcoholic
• If you are being treated with sodium oxybate.

Warnings and precautions
Codeine is converted into morphine in the liver by an enzyme. Morphine is the substance that produces
pain relief. Some people have a variation of this enzyme and this can affect them in different ways.
In some people, morphine is not produced or produced in very limited quantities that do not
provide sufficient pain relief.
Other people are more likely to have serious side effects because a very high amount of morphine is produced.
If you notice any of the following side effects, you should stop taking
this medicine and consult a doctor immediately: slow or shallow breathing, confusion,
drowsiness, small pupils, feeling unwell, constipation, loss of appetite.
Do not take this medicine with other products containing paracetamol.
Consult your doctor or pharmacist before taking Paracetamolo e Codeina Accord

• If you have problems with the prostate (e.g. difficulty passing water)
• If you have bowel problems
• If you have problems with the kidneys or liver, including alcoholic liver disease
• If you have low blood pressure (hypotension)
• If you have multiple sclerosis
• If you have a history of drug or alcohol abuse
• If you suffer from a condition known as glucose-6-phosphate dehydrogenase (G6PD) deficiency due to the risk of a particular form of anemia (low red blood cell count)
• If you have a glutathione deficiency
• If you have Gilbert's syndrome (familial non-hemolytic jaundice)
• If you suffer from chronic malnutrition or dehydration
• If you weigh less than 50 kg
• If you are elderly
• If you are taking other medicines containing paracetamol

Prolonged regular use, except under medical supervision, can lead to physical and psychological dependence
(addiction) and cause withdrawal symptoms such as restlessness and irritability, once you stop
taking the drug. If you feel you need to use this product for a long time, it is important
to consult your doctor.

Other medicines and Paracetamolo e Codeina Accord
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines, including medicines that can be taken without a prescription and herbal medicines.
This is because Paracetamolo e Codeina Accord can affect how some medicines work.
Also, some medicines can affect how Paracetamolo e Codeina Accord works.
Check with your doctor if you are taking any of the following medicines:

• Metoclopramide (used to treat nausea and vomiting)
• Domperidone
• Buprenorphine
• Nalbuphine
• Pentazocine
• Naltrexone
• Quinidine, used to treat irregular heartbeat
• Fluoxetine, paroxetine, bupropion, used to treat depression
• Cinacalcet, used to treat hyperparathyroidism
• Cholestyramine (used to treat high levels of cholesterol (fats) in the blood)
• Chloramphenicol, flucloxacillin, rifampicin, antibiotics used to treat infections
• Benzodiazepines, used to treat anxiety, due to an increased risk of sedation, breathing difficulties or even coma, when both are taken together.
• Morphine-based products, used to treat severe pain
• Methadone, used to treat opioid dependence and also severe pain
• Some cough medicines
• Oral contraceptives ("the pill")
• Medicines that cause drowsiness, including alcohol and barbiturates
• Medicines used to thin the blood (e.g. warfarin).
• Flucloxacillin (antibiotic), due to a serious risk of blood and fluid abnormalities (metabolic acidosis with high anion gap) requiring urgent treatment and which may occur particularly in case of severe renal 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 you are unsure whether any of the above conditions apply to you, talk to your doctor or pharmacist before taking this medicine.

Paracetamolo e Codeina Accord with food and drink
Do not drink alcohol while taking Paracetamolo e Codeina Accord. This is because there is an increased
risk of sedation, breathing difficulties or even coma, when both are taken together.

Use in children and adolescents

Use in children and adolescents after surgery
Paracetamolo e Codeina Accord should not be used to relieve pain in children and adolescents
after surgery to remove the tonsils or adenoids due to obstructive sleep apnea
syndrome.

Use in children and adolescents with breathing problems
Paracetamolo e Codeina Accord is not recommended in children with breathing problems, as the symptoms
of morphine toxicity may be worse in these children.
Children between the ages of 12 and 18 who have breathing problems, including breathing problems during
sleep or other lung problems, should not take this medicine.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, ask your doctor or
pharmacist for advice before taking this medicine.
Do not take Paracetamolo e Codeina Accord while breastfeeding. Codeine and morphine pass into
breast milk and are dangerous for the baby.

Driving and using machines
While taking Paracetamolo e Codeina Accord you may feel dizzy or drowsy. You may also have
problems with your vision. If this happens, do not drive or use tools or machines.

Paracetamolo e Codeina Accord contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, that is to say essentially “sodium-free”.

3. How to take Paracetamolo e Codeina Accord

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts
consult your doctor or pharmacist. Your doctor will tell you how much Paracetamolo e Codeina Accord you should take.
Adults (18 years and over):
One to two tablets every 6 hours up to a maximum of four doses in 24 hours. Do not take more than 8 tablets
in 24 hours. Elderly patients may be prescribed a lower dose.
Adolescents aged 16 to 18 years:
The dose must be established on an individual basis according to body weight. The doctor will prescribe the medicine accordingly.
One to two tablets every 6 hours up to a maximum of four doses in 24 hours. Do not take more than 8 tablets
in 24 hours.
Adolescents aged 12 to 15 years:
The dose must be established on an individual basis according to body weight. The doctor will prescribe the medicine accordingly.
One tablet every 6 hours up to a maximum of four doses in 24 hours. Do not take more than 4 tablets in 24
hours.
Children under 12 years of age:
Paracetamolo e Codeina Accord should not be taken due to the risk of serious breathing problems.
Kidney problems:
Both the dosage and the interval between each dose may be adjusted. Always take the medicine as
directed by your doctor.
Do not take more than 4 tablets in 24 hours if:

• You weigh less than 50 kg
• You suffer from mild to moderate liver or kidney disease
• You suffer from Gilbert's syndrome (a mild condition in which the liver does not process bilirubin correctly) (familial non-hemolytic jaundice)
• You suffer from chronic alcoholism, malnutrition or dehydration

How to take the medicine
Swallow the tablet.
This medicine should not be taken for more than 3 days. If the pain does not improve within 3 days, consult
your doctor for advice.
If you suffer from kidney failure, wait at least 6-8 hours between doses.
While taking Paracetamolo e Codeina Accord, do not take other medicines that contain
paracetamol.
Do not exceed the indicated dose. Do not take the medicine for longer than recommended by your doctor.

If you take more Paracetamolo e Codeina Accord than you should
In case of overdose, even if you feel well, you should immediately consult a doctor due to the
risk of irreversible liver damage. Symptoms of liver damage usually appear after a few days. It is therefore
important that you contact a doctor immediately if you have taken a too high dose, even if you feel well.

If you forget to take Paracetamolo e Codeina Accord
If you forget to take a dose at the scheduled time, take it as soon as you remember. However, if it is almost time for
the next dose, skip the missed dose. Do not take two doses at the same time or almost. Remember to leave
at least 6 hours between doses.

If you stop taking Paracetamolo e Codeina Accord
Long-term use of Paracetamolo e Codeina Accord can lead to tolerance and dependence. If you have taken
regular daily doses of Paracetamolo e Codeina Accord for a long time, do not increase the dose and do not stop
treatment abruptly without talking to your doctor.

4. Possible side effects

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

Stop takingParacetamolo e Codeina Accord and contact your doctor immediately if you experience the
symptoms of serious side effects: angioedema, Stevens-Johnson syndrome or toxic epidermal necrolysis
(frequency not known, cannot be estimated based on available data).
Angioedema

• With symptoms such as: skin rash, swelling or itching, difficulty breathing, feeling dizzy. These symptoms may be signs of an allergic reaction. Stevens-Johnson syndrome
• With symptoms such as: blistering or bleeding of the skin around the lips, eyes, mouth, nose and genitals. Also, flu-like symptoms and fever. Toxic epidermal necrolysis
• With symptoms such as: a severe skin rash with blisters where layers of skin may peel off leaving large areas of exposed skin all over the body. Also, feeling generally unwell, fever, chills and muscle aches.

Other side effects
Very rare (may affect up to 1 in 10,000 people):

• You get infections or bruise more easily than usual. This may be due to a blood problem (such as leucopenia, neutropenia or thrombocytopenia)
• Stomach pain, which can reach the back. This may be a sign of inflammation of the pancreas (pancreatitis).

Not known (frequency cannot be estimated based on available data):

• constipation
• feeling sick (nausea) or being sick (vomiting)
• headache, dizziness, drowsiness and confusion
• difficulty passing water (urine)
• seizure
• dry mouth
• itchy skin rash (pruritus)
• ringing in the ears (tinnitus)
• difficulty breathing, wheezing and a feeling of tightness in the chest (bronchospasm)
• extreme feelings of joy and happiness (euphoria) or extreme feelings of sadness and depression (dysphoria)
• blurred vision due to the narrowing of the pupil of the eye (miosis)
• breathing faster than normal and bluish skin around the mouth. These may be symptoms of respiratory depression.
• fatigue, skin and/or whites of the eyes are yellowish. These may be symptoms of hemolytic anemia
• loss of appetite, abdominal pain and feeling generally unwell and skin and/or whites of the eyes are yellowish. These may be symptoms of cytolytic hepatitis, a serious liver disease.

Reporting of side effects
If you 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 through the national reporting system at
https://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 Accord

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging 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.
This medicine does not require any particular storage conditions.

6. Contents of the pack and other information

What Paracetamolo e Codeina Accord 500 mg/30 mg Tablets 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 anhydrous colloidal silica (E551), sodium croscarmellose (E468), copovidone, microcrystalline cellulose (E460), talc (E553b), magnesium stearate (E570) and povidone.

Description of the appearance of Paracetamolo e Codeina Accord and contents of the pack
Paracetamolo e Codeina Accord are white, oval (17 mm x 8.5 mm), biconvex tablets, marked
with "LK" on one side.
Paracetamolo e Codeina Accord is available in PVC//Alu/Paper blisters containing 10, 16, 20, 30, 50, 90 or
100 tablets.
Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer
Marketing authorisation holder
Accord Healthcare S.L.U.
World Trade Center,
Moll de Barcelona,
s/n, Edifici Est 6ª planta,
08039 Barcelona,
Spain
Manufacturer

Accord Healthcare Polska Sp. z.o.o.
Ul. Lutomierska 50, 95-200,
Pabianice, Poland

Laboratori Fundació Dau
C/ C, 12-14 Pol.
Ind. Zona Franca,
Barcelona, 08040, Spain

This medicinal product is authorised in the Member States of the European Economic Area with the following
names:
LT :
Codeine phosphate hemihydrate/Paracetamol Accord 30 mg/500 mg plėvele dengtos
tabletės
EE : Paracetamol/codeine Accord
LV : Paracetamol/codeine Accord
NO : Paracetamol/Codeine Accord
SE : Paracetamol/Codeine Accord
FR : PARACETAMOL/CODEINE ACCORD 500 mg/30 mg, comprimé
IT : Paracetamolo e Codeina Accord
IE : Paracetamol/Codeine phosphate hemihydrate Accord 500 mg/30 mg tablets