Paracetamol and codeine Accord Healthcare

Patient Information Leaflet

Paracetamol and Codeine Accord Healthcare 500 mg/30 mg effervescent tablets

Paracetamol and codeine phosphate hemihydrate
Equivalent medicine
Please 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 others, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

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

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

Paracetamolo e Codeina Accord Healthcare belongs to a group of medicines called analgesics (painkillers) and is used in adult patients (aged 18 years and older) to relieve intense pain.
Paracetamolo e Codeina Accord Healthcare may be used in patients over 12 years of age for the treatment of acute and moderate pain that is 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 work by acting on the central nervous system to relieve pain.

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

Do not take Paracetamol and Codeine Accord Healthcare

• If you are allergic to codeine, paracetamol, or any of the other ingredients of this medicine (listed in section 6.1)
• If you have acute asthma or severe breathing problems
• If you have recently had a head injury
• If you have recently undergone gallbladder surgery or a similar procedure
• If you have increased pressure inside the brain
• If you are an alcoholic or have recently consumed large amounts of alcohol
• 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 are taking monoamine oxidase inhibitors (used to treat depression) or have taken them within the last 14 days
• If you know you metabolize codeine into morphine very rapidly
• If you are breastfeeding

Do not take this medicine if any of the above conditions apply to you.

Warnings and precautions
Codeine is converted into morphine in the liver by an enzyme. Morphine is the substance that provides pain relief. Some individuals have a variation in this enzyme, which may affect them in different ways. In some people, morphine is not produced or is produced only in very small amounts, which may not provide adequate 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, stop taking this medicine immediately and consult a doctor without delay: slow or shallow breathing, confusion, drowsiness, pinpoint pupils, feeling unwell, nausea, constipation, loss of appetite.
Do not take this medicine together with other products containing paracetamol.

Talk to your doctor before taking Paracetamol and Codeine Accord Healthcare

• 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 specific 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

During treatment with Paracetamol and Codeine Accord Healthcare, inform your doctor immediately if:

• You suffer from serious illnesses, including severe renal impairment or sepsis (when bacteria and their toxins circulate in the blood causing organ damage), or malnutrition, chronic alcoholism, or if you are also taking flucloxacillin (an antibiotic). A serious condition called metabolic acidosis (an abnormality in blood and body fluids) has been reported in patients with these conditions when paracetamol is used regularly over a prolonged period or when paracetamol is taken concomitantly with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties with deep, rapid breathing, drowsiness, nausea, and vomiting.

Prolonged regular use, except under medical supervision, may lead to physical and psychological dependence (addiction) and may 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.

Children and adolescents
Do not administer this medicine to children under 12 years of age, as it is unlikely to be safe.

Use in children and adolescents after surgery
Paracetamol and Codeine Accord Healthcare 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
Paracetamol and Codeine Accord Healthcare 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 with respiratory problems must not take this product. This includes breathing problems during sleep or other lung conditions.

Other medicines and Paracetamol and Codeine Accord Healthcare
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those available without a prescription and herbal remedies. This is because this medicine may affect how some other medicines work. Also, some medicines may affect how this medicine works.

Tell your doctor if you are taking any of the following medicines:

• Metoclopramide, domperidone (used to treat nausea and vomiting)
• Buprenorphine, nalbuphine, pentazocine, naltrexone (used to reduce analgesic effect due to competitive receptor blockade)
• Quinidine (used to treat irregular heartbeat)
• Fluoxetine, paroxetine, bupropion, amitriptyline, sertraline (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
• Flucloxacillin (antibiotic), due to a serious risk of blood and fluid abnormalities (called metabolic acidosis) requiring urgent treatment (see section 2)
• Medicines that prevent blood clotting (anticoagulants such as warfarin)
• Medicines used to treat epilepsy (e.g. phenytoin, phenobarbital, carbamazepine)
• The blood pressure-lowering effects of antihypertensive agents, including diuretics, may be enhanced by codeine
• MAOIs (monoamine oxidase inhibitors) used to treat depression, taken within the last 14 days
• Medicines used to dry up secretions in the mouth and lungs, known as anticholinergics

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 Healthcare and alcohol
You must not drink alcohol while taking these effervescent tablets. This is because there is an increased risk of sedation, breathing difficulties, or even coma when both are taken together.

Pregnancy and breastfeeding
Pregnancy
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 this medicine during labour, as it may affect the baby and cause breathing problems at birth.

Breastfeeding
Do not take this medicine while breastfeeding, as it passes into breast milk and may be harmful to the baby.

Driving and using machines
While taking this medicine, you may feel dizzy or drowsy. You may also experience vision problems. If this occurs, do not drive or operate tools or machinery.

Paracetamol and Codeine Accord Healthcare contains sodium and sorbitol

• Sorbitol: this medicine contains 100 mg of sorbitol in each effervescent tablet. Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to certain sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic condition in which a person cannot break down fructose, speak with your doctor before you (or your child) take or receive this medicine.
• Sodium: this medicine contains 419 mg of sodium (a main component of table salt) per effervescent tablet. This is equivalent to 21% of the maximum daily dietary intake of sodium recommended for an adult. Consult your pharmacist or doctor if you need to take this medicine daily for a prolonged period, especially if you have been advised to follow a low-salt diet.

3. How to take Paracetamol and Codeine Accord Healthcare

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.

Adults (from 18 years of age and older):
Take one or two tablets every 6 hours.
Do not take more than 8 tablets in 24 hours.

Adolescents aged 16 to 18 years:
Take one or two tablets every 6 hours, up to a maximum of three doses in any 24-hour period. Do not exceed 6 tablets in 24 hours.

Adolescents aged 12 to 15 years:
Take one tablet every 6 hours. Do not take more than 4 tablets in 24 hours.

Children under 12 years of age:
This medicine must not be taken by children under 12 years of age due to the risk of serious breathing problems.

Elderly:
A lower dose may be prescribed for elderly patients.

Renal impairment:
Both the dosage and the interval between doses may need to be adjusted. Always take the medicine as directed by your doctor.

Hepatic impairment:
In patients with impaired liver function or Gilbert's syndrome, the dose should be reduced or the dosing interval prolonged.

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 (familial non-haemolytic jaundice)
• You suffer from chronic alcoholism, malnutrition, or dehydration

How to take the medicine:
Dissolve the effervescent tablets in at least half a glass of water (approximately 100–125 ml of water).

This medicine must not be taken for longer than 3 days. If pain does not improve within 3 days, consult your doctor for advice.

While taking this medicine, do not take any other medicines containing paracetamol.
Do not exceed the recommended dose. Do not take the medicine for longer than advised by your doctor.

If you take more Paracetamol and Codeine Accord Healthcare than you should:
In case of overdose, even if you feel well, you must seek immediate medical advice because of the risk of irreversible liver damage.

If you forget to take Paracetamol and Codeine Accord Healthcare:
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 your next dose, skip the missed dose. Do not take two doses at the same time or close together. Remember to leave at least 6 hours between doses.
Do not take a double dose to make up for a forgotten dose.

If you stop treatment with Paracetamol and Codeine Accord Healthcare:
Long-term use of this medicine may lead to tolerance and dependence. If you have been taking regular daily doses of this medicine for a prolonged period, do not increase the dose or stop treatment abruptly without speaking to your doctor.

If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. If you experience any unwanted side effects, you should seek advice from your doctor, pharmacist or other healthcare professional.

Important side effects you should be aware of with Paracetamol and Codeine Accord:

• Taking a painkiller for headache too often or for too long can make the headache worse.
• Regular use of codeine over a long period can lead to dependence, which may cause you to feel restless and irritable when you stop taking the tablets.

Stop taking Paracetamol and Codeine Accord Healthcare and consult a doctor or go
immediately to hospital if:

• You develop a rash, swelling or itching, have difficulty breathing, or feel dizzy. These symptoms could be signs of an allergic reaction.
• You develop blisters or bleeding on the skin around the lips, eyes, mouth, nose and genitals. Also flu-like symptoms and fever. This could be something called “Stevens-Johnson syndrome”.
• You have a severe skin rash with blisters where layers of skin may peel off, leaving large areas of exposed and raw skin. Also, a general feeling of being unwell, fever, chills and muscle pain. This could be something called “toxic epidermal necrolysis”. Very rare cases of serious skin reactions have been reported.

Seek immediate medical advice if you notice the following serious side effects:

• Stomach pain that may spread to your back. This could be a sign of inflammation of the pancreas (pancreatitis). This is a very rare side effect.

Other side effects
Codeine:
Very common (may affect more than 1 in 10 people)

• dizziness, drowsiness, headache
• feeling unwell (nausea), feeling unwell (vomiting)
• constipation, stomach pain
• skin rash or itching
• extreme feelings of joy and happiness (euphoria)
• extreme feelings of sadness and depression (dysphoria)

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

• confusion
• difficulty passing urine
• seizures
• dry mouth
• ringing in the ears (tinnitus)
• blurred vision due to reduced pupil size of the eye (miosis)
• You start breathing faster than normal and the skin around your mouth turns blue. These could be symptoms of respiratory depression.

Paracetamol:
Rare (may affect up to 1 in 1,000 people):

• abnormal vision,
• bleeding (haemorrhage), abdominal pain, diarrhoea, nausea, vomiting,
• dizziness, fever, reduced irritability or agitation (sedation)
• platelet disorders (problems with blood clotting), disorders of stem cells (problems with cells that form blood in the bone marrow),
• abnormal liver function, liver failure, liver necrosis (death of liver cells), jaundice,
• overdose and poisoning,
• tremor, headache,
• depression, confusion, hallucinations,
• sweating,
• feeling very unwell (malaise)

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

• hepatotoxicity (liver damage),
• thrombocytopenia (reduced platelets in the blood, increasing the risk of bleeding or bruising),
• leucopenia (frequent infections due to poorly functioning or reduced white blood cells),
• neutropenia (reduced number of neutrophils in the blood),
• agranulocytosis (severe reduction in white blood cells which can lead to serious infections),
• haemolytic anaemia (abnormal breakdown of red blood cells, which may cause weakness or paleness of the skin),
• hypoglycaemia (low blood glucose levels),
• cloudy urine and kidney disorders

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

• anaemia (reduction in red blood cells),

• gastrointestinal effects,

• vertigo,

• fluid accumulation in the larynx.

• difficulty breathing, wheezing, tightness in the chest (bronchospasm),

• loss of appetite, abdominal pain and general feeling of being unwell, and your skin and/or the whites of your eyes turn yellow. These could be symptoms of cytolytic hepatitis, a serious liver disease, or excess acid in the blood caused by excessive pyroglutamic acid due to low glutathione levels.

• A serious condition that may make the blood more acidic (called metabolic acidosis), in patients with severe illness taking paracetamol (see section 2).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the Italian Medicines Agency (Agenzia Italiana del Farmaco) 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 Healthcare

Keep this medicine out of the sight and reach of children and adolescents.
Do not use this medicine after the expiry date stated on the blister and carton after Exp. The expiry date refers to the last day of that month.
Store below 25 °C.
Keep in the original packaging to protect from moisture.
Ask your pharmacist how to dispose of medicines no longer required.
Do not dispose of any medicine via wastewater or household waste. This will help protect the environment.

6. Package contents and other information

What Paracetamolo e Codeina Accord Healthcare contains
The active substances in Paracetamolo e Codeina Accord Healthcare are codeine phosphate hemihydrate and paracetamol.
Each tablet contains 500 mg of paracetamol and 30 mg of codeine phosphate hemihydrate.
The other components are citric acid (E 330), sorbitol (E 420), sodium hydrogen carbonate (E 500 (II)),
povidone (E 1201), simethicone, sodium carbonate (E 500 (I)), sodium saccharin (E 954), polyethylene glycol (E
1521) and lemon flavour (containing maize maltodextrin, gum arabic (E 414), natural flavourings, flavouring preparations, flavouring substances, alpha-tocopherol (E 307)).
Description of the appearance of Paracetamolo e Codeina Accord Healthcare and contents of the
pack
Paracetamolo e Codeina Accord Healthcare are white to off-white, round, flat tablets with bevelled edges, smooth on both sides. The tablet diameter is approximately 26 mm.
Packs with Surlyn strips (laminated strip consisting of 4-layer plain paper with outer layer of 50 g/m² paper / 12 g/m² PE extrusion / 9 μ aluminium / 23 g/m² Surlyn inner layer) {Surlyn is a copolymer of ethylene and methacrylic acid used as packaging material}: containing: 4, 8, 10, 12, 14, 16, 20, 24, 28, 30, 32, 36, 40, 50, 60, 90 and 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
Manufacturers
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

Pharmadox Healthcare Limited
KW20A Kordin Industrial Park
PLA 3000 Paola
Malta