Paracetamol and codeine Accord

Package leaflet: Information for the patient

Paracetamol and Codeine Accord 500 mg/30 mg tablets

Paracetamol and 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 give it to other people, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

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

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

Do not take Paracetamolo e Codeina Accord

• To relieve pain in children and adolescents (0–18 years of age) after surgery for removal of tonsils or adenoids due to obstructive sleep apnoea syndrome
• If you are known to be a rapid metaboliser of codeine to morphine
• If you are close to giving birth or are at 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 have acute asthma or severe breathing problems
• If you have a head injury
• If you have recently undergone gallbladder surgery or a similar operation
• If you have increased pressure inside the skull
• If you are taking monoamine oxidase inhibitors (used to treat depression) or have taken them within 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 provides pain relief. Some people have a variation in this enzyme, which can affect them in different ways. In some individuals, morphine is either not produced or produced in very limited amounts, resulting in insufficient pain relief.
Other individuals are more likely to experience serious side effects because a very high amount of morphine is produced. If you notice any of the following side effects, you must stop taking this medicine and contact a doctor immediately: slow or shallow breathing, confusion, drowsiness, pinpoint pupils, feeling unwell, constipation, loss of appetite.
Do not take this medicine with other products containing paracetamol.
Consult your doctor or pharmacist before taking Paracetamol and Codeine Accord

• If you have prostate problems (e.g. difficulty passing urine)
• If you have intestinal problems
• If you have kidney or liver problems, 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 have a condition known as glucose-6-phosphate dehydrogenase (G6PD) deficiency due to the risk of a particular type of anaemia (low red blood cell count)
• If you have glutathione deficiency
• If you have Gilbert's syndrome (familial non-haemolytic 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

Regular prolonged use, except under medical supervision, may lead to physical and psychological dependence (addiction) and cause withdrawal symptoms such as restlessness and irritability once the medicine is discontinued. If you think you need to use this product for a long time, it is important to consult your doctor.
Other medicines and Paracetamol and Codeine Accord
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines you can buy without a prescription and herbal medicines.
This is because Paracetamol and Codeine Accord may affect how some medicines work. In addition, some medicines may affect how Paracetamol and Codeine 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-containing 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, 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 maximum daily doses of paracetamol are used. If you are unsure whether any of the above conditions apply to you, speak with your doctor or pharmacist before taking this medicine.

Paracetamol and Codeine Accord with food and drinks
Do not drink alcohol while taking Paracetamol and Codeine 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
Paracetamol and Codeine Accord must not be used to relieve pain in children and adolescents after surgery for removal of tonsils or adenoids due to obstructive sleep apnoea syndrome.
Use in children and adolescents with respiratory problems
Paracetamol and Codeine Accord is not recommended in children with respiratory problems, as symptoms of morphine toxicity may be worse in these children.
Children aged 12 to 18 years who have respiratory problems, including breathing difficulties during sleep or other lung problems, must not take this medicine.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Do not take Paracetamol and Codeine Accord while breastfeeding. Codeine and morphine pass into breast milk and are dangerous for the infant.
Driving and using machines
While taking Paracetamol and Codeine Accord, you may feel dizzy or drowsy. You may also have vision problems. If this happens, do not drive or operate tools or machinery.
Paracetamol and Codeine Accord contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially "sodium-free".

3. How to take Paracetamol and Codeine Accord

Take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist. Your doctor will tell you how much Paracetamol and Codeine 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 should be determined individually based on body weight. Your 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 should be determined individually based on body weight. Your 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:
Paracetamol and Codeine Accord must not be taken due to the risk of serious breathing problems.

Kidney problems:
Both the dosage and the interval between doses may need to be adjusted. Always take the medicine exactly as your doctor has instructed.

Do not take more than 4 tablets in 24 hours if:

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

How to take the medicine
Swallow the tablet whole.
This medicine should not be taken for more than 3 days. If pain does not improve within 3 days, consult your doctor for advice.
If you have renal impairment, wait at least 6–8 hours between doses.
While taking Paracetamol and Codeine Accord, do not take any other medicines containing paracetamol.
Do not exceed the recommended dose. Do not take the medicine for longer than your doctor has advised.

If you take more Paracetamol and Codeine Accord than you should
In case of overdose, even if you feel well, you must seek immediate medical attention due to the risk of irreversible liver damage. Symptoms of liver damage usually appear a few days after overdose. It is therefore important that you contact a doctor immediately if you have taken too high a dose, even if you feel well.

If you forget to take Paracetamol and Codeine 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 nearly at the same time. Remember to leave at least 6 hours between doses.

If you stop taking Paracetamol and Codeine Accord
Long-term use of Paracetamol and Codeine Accord may lead to tolerance and dependence. If you have been taking regular daily doses of Paracetamol and Codeine Accord for a long time, do not increase the dose or 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 taking Paracetamol and Codeine Accord and contact your doctor immediately if you experience symptoms of serious side effects: angioedema, Stevens-Johnson syndrome, or toxic epidermal necrolysis (frequency not known, cannot be estimated from the available data).

Angioedema

• With symptoms such as: skin rash, swelling or itching, difficulty breathing, feeling dizzy. These symptoms could 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 in which layers of skin may peel off, leaving large areas of exposed raw skin over the body. Also, feeling generally unwell, fever, chills and muscle pain.

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

• You get infections or bruising more easily than usual. This could be due to a blood problem (such as leucopenia, neutropenia or thrombocytopenia).
• Stomach pain that may extend to your back. This could be a sign of inflammation of the pancreas (pancreatitis).

Not known (frequency cannot be estimated from the available data):

• constipation
• feeling sick (nausea) or being sick (vomiting)
• headache, dizziness, vertigo, drowsiness and confusion
• difficulty passing water (urine)
• seizure
• dry mouth
• itchy skin rash (pruritus)
• ringing in the ears (tinnitus)
• difficulty breathing, wheezing and tightness in the chest (bronchospasm)
• extreme feelings of joy and happiness (euphoria) or extreme feelings of sadness and depression (dysphoria)
• blurred vision due to shrinking of the pupil of the eye (miosis)
• breathing faster than normal and blue colouring of the skin around the mouth. These could be symptoms of respiratory depression.
• tiredness, yellowing of the skin and/or whites of the eyes. These could be symptoms of haemolytic anaemia.
• loss of appetite, stomach pain and general malaise, and yellowing of the skin and/or whites of the eyes. These could be symptoms of cytolytic hepatitis, a serious liver disease.

Reporting of side effects
If you get any side effects, including any not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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 Paracetamol and Codeine 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 via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
This medicine requires no special storage conditions.

6. Package contents and other information

What Paracetamolo e Codeina Accord 500 mg/30 mg Tablets 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 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 package contents
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 blister packs 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 under the following
names:
Codeine phosphate hemihydrate/Paracetamol Accord 30 mg/500 mg film-coated
LT :
tablets
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 : Paracetamol and Codeine Accord
IE : Paracetamol/Codeine phosphate hemihydrate Accord 500 mg/30 mg tablets