PARACETAMOL/CODEINE PENSA 500 mg/30 mg TABLETS

Introduction

Patient Information Leaflet

Paracetamol/Codeine500 mg/30 mg tablets EFG

Paracetamol/Codeine phosphate hemihydrate

Read the entire leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the Leaflet

1. What Paracetamol/Codeine is and what it is used for
2. What you need to know before taking Paracetamol/Codeine
3. How to take Paracetamol/Codeine
4. Possible side effects
5. Storage of Paracetamol/Codeine
6. Package contents and additional information

1. What Paracetamol/Codeine is and what it is used for

Paracetamol/Codeine is an association of paracetamol and codeine. Paracetamol is a proven analgesic and antipyretic medication (pain relief and fever reduction), whose effects are enhanced by the action of codeine, a central analgesic.

This medication is indicated for adults and children over 12 years of age for the short-term treatment of moderate pain that is not relieved by other analgesics such as paracetamol or ibuprofen alone.

This product contains codeine. Codeine belongs to a group of medications called opioid analgesics that act by relieving pain. It can be used alone or in combination with other analgesics such as paracetamol.

2. What you need to know before taking Paracetamol/Codeine

Do not take Paracetamol/Codeine:

• if you are allergic to paracetamol or propacetamol (a precursor to paracetamol), codeine, or any of the other components of this medication (listed in section 6).
• if you have respiratory depression, acute asthma, or chronic obstructive pulmonary disease.
• If you have or are at risk of paralytic ileus.
• To relieve pain in children and adolescents (0-18 years old) after tonsillectomy or adenoidectomy due to obstructive sleep apnea syndrome.
• if you know you metabolize codeine to morphine very quickly.
• If you are breastfeeding.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medication.

• Do not take more than the recommended dose in Section 3 - "How to take Paracetamol/Codeine" and check that you are not using other medications that contain paracetamol or codeine at the same time.
• Taking more than one medication that contains paracetamol at the same time can lead to overdose.
• If you have any liver, kidney, heart, or lung disease, or have anemia (reduced hemoglobin levels in the blood), you should consult your doctor before taking this medication.
• If you have any disease that affects your ability to breathe, have intracranial injuries (e.g., due to a head injury), are asthmatic, or have a history of asthma, and are sensitive to acetylsalicylic acid, you should consult your doctor before taking this medication.
• If you have any thyroid disease, prostate or urethra problems (which can cause difficulty urinating), adrenal insufficiency (Addison's disease), or intestinal or gallbladder problems, you should consult your doctor before taking this medication.
• Paracetamol should be administered with caution in patients with chronic malnutrition or dehydration.
• Consuming alcoholic beverages (three or more alcoholic drinks per day) can cause paracetamol to damage the liver.
• In chronic alcoholics, paracetamol should not be taken in doses exceeding 2 g/day.
• Children: Paracetamol/Codeine is not recommended for children over 12 years old who have compromised respiratory function. It should be used with caution in children over 12 years old who have undergone extensive surgery. See the "Children and Adolescents" section.
• If you are weak or elderly, you should consult your doctor before taking this medication.
• Codeine is converted to morphine through an enzyme in the liver. Morphine is the active substance responsible for pain relief. Some people may have a variation of this enzyme that can affect people differently. In some people, morphine is not produced or is produced in very small quantities, and it will not provide sufficient pain relief. Others are more likely to experience severe adverse reactions because they produce a very high amount of morphine. If you experience any of the following side effects, you should stop taking this medication and seek medical help immediately: slow or shallow breathing, confusion, drowsiness, small pupils, nausea, and vomiting, constipation, loss of appetite.
• Codeine can inhibit peristalsis, worsening constipation in patients with chronic constipation.
• It is essential to use the smallest dose that relieves/control pain and for the shortest possible period to relieve pain. Prolonged or excessive administration of codeine can cause dependence and/or tolerance, especially in people with a tendency to abuse and addiction. After prolonged treatments, the administration should be gradually interrupted as indicated by your doctor.
• Prolonged or frequent use of analgesics to treat headaches can worsen symptoms, which should not be treated with higher doses of the medication.
• The benefit/risk balance during continued use should be periodically reevaluated by the doctor.
• If the pain persists for more than 3 days, or worsens, or other symptoms appear, treatment should be discontinued, and a doctor consulted.

During treatment with Paracetamol/Codeine, inform your doctor immediately if:

If you have severe diseases, such as severe renal insufficiency or sepsis (when bacteria and their toxins circulate in the blood, causing organ damage), or if you have malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic). A severe disease called metabolic acidosis (an anomaly in the blood and fluids) has been reported in patients in these situations when paracetamol is used at regular doses for a prolonged period or when paracetamol is taken with flucloxacillin. The symptoms of metabolic acidosis can include: severe breathing difficulties with deep and rapid breathing, drowsiness, feeling unwell (nausea) and vomiting.

Children and Adolescents

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 respiratory problems

Codeine is not recommended for children with respiratory problems, as the symptoms of morphine toxicity can be worse in these children.

Other medications and Paracetamol/Codeine

Tell your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.

In particular, if you are using medications that contain any of the following active ingredients, it may be necessary to modify the dose or interrupt treatment of either of them:

Paracetamol may interact with the following medications:

• Antibiotics (chloramphenicol)
• Anticoagulants (used to treat thromboembolic diseases)
• Oral contraceptives and estrogen treatments.
• Antiepileptics (used to treat epileptic seizures)
• Metoclopramide and domperidone (used to prevent nausea and vomiting).
• Activated charcoal, used for diarrhea or gas treatment
• Diuretics (used to increase urine elimination)
• Isoniazid (used to treat tuberculosis)
• Lamotrigine (used to treat epilepsy)
• Probenecid (used to treat gout)
• Propranolol (used to treat hypertension, cardiac arrhythmias)
• Rifampicin (used to treat tuberculosis)
• Anticholinergics (used to relieve stomach, intestine, and bladder spasms or contractions).
• Zidovudine (used to treat HIV infections).
• Colestyramine (used to reduce blood cholesterol levels).
• Flucloxacillin (an antibiotic), due to a serious risk of blood and fluid anomalies (called metabolic acidosis) that require urgent treatment (see section 2).

Do not use with other analgesics (pain-relieving medications) without consulting your doctor.

On the other hand, codeine may interact with the following medications:

• Nalbuphine, buprenorphine, pentazocine (used to treat pain).
• Antidepressants (used to treat depression).
• Sedatives (used to treat depression, anxiety).
• Sedating antihistamines (used to treat allergies).
• Anxiolytics (used to treat anxiety).
• Hypnotic neuroleptics (used to treat insomnia).
• Clonidine and related medications (used to treat hypertension and migraine)
• Other morphinic analgesics, barbiturates, benzodiazepines (used to treat pain).

Interference with laboratory tests

If you are going to have any laboratory tests (including blood tests, urine tests, skin tests using allergens, etc.), inform your doctor that you are taking this medication, as it may alter the results of these tests.

Taking Paracetamol/Codeine with food, drinks, and alcohol

Using paracetamol in patients who regularly consume alcohol (three or more alcoholic drinks per day: beer, wine, liquor...) can cause liver damage. Additionally, alcohol can enhance the depressant effect of codeine.

Pregnancy and breastfeeding

Pregnancy

Paracetamol/Codeine should not be taken during pregnancy, and if used, it should be under the supervision of your doctor, who will assess the potential risks and benefits of treatment. Never exceed the recommended dose.

Breastfeeding

Do not take codeine if you are breastfeeding. Codeine and morphine pass into breast milk.

Driving and using machines

This medication contains codeine, which can cause drowsiness, affecting mental and/or physical ability. If you notice these effects, avoid driving vehicles or using machines.

Alcohol can enhance this effect, so you should not consume alcoholic beverages during treatment.

3. How to take Paracetamol/Codeine

Follow your doctor's or pharmacist's instructions for taking this medication exactly. If in doubt, consult your doctor or pharmacist again.

Your doctor will indicate the amount of medication to take and the duration of treatment based on the intensity and characteristics of the pain. If necessary, the dosage can be adjusted to half a tablet per dose.

The recommended dose is:

Adults and adolescents over 15 years old:1 tablet every 6 hours. The maximum dose per intake will be 2 tablets, and the maximum daily dose will be 8 tablets.

Adolescents (over 12 years old) and weighing over 50 kg:1 tablet every 6 hours. The maximum dose per intake will be 1 tablet, and the maximum daily dose will be 4 tablets.

Adolescents (over 12 years old) and weighing over 40 kg:half (1/2) a tablet every 4-6 hours. The maximum dose per intake will be 1 tablet, and the maximum daily dose will be 3 tablets.

Never exceed the maximum recommended dose.

This medication should not be taken for more than 3 days. If the pain does not improve after 3 days, consult your doctor.

Children under 12 years old should not take Paracetamol/Codeine due to the risk of severe respiratory problems.

Paracetamol/Codeine should be taken orally. Swallowing the tablets can be helped with a sip of water or another non-alcoholic liquid.

Administration of the preparation is subject to the appearance of painful or febrile symptoms. As these symptoms disappear, this medication should be discontinued.

Patient with liver disease:before taking this medication, they must consult their doctor.

They should take the prescribed amount of medication with a minimum interval of 8 hours between each dose. They should not take more than 2 grams of paracetamol in 24 hours (4 tablets), divided into several doses.

Patient with kidney disease:before taking this medication, they must consult their doctor.

According to their disease, their doctor will indicate whether they should take the medication with a minimum interval of 6 or 8 hours. They should not take more than 2 grams in 24 hours (4 tablets) divided into several doses, never exceeding 500 milligrams per dose.

Elderly patients:before taking this medication, they must consult their doctor.

If they think the effect of Paracetamol/Codeine is too strong or too weak, they should inform their doctor or pharmacist.

If you take more Paracetamol/Codeine than you should

If you have taken more Paracetamol/Codeine than you should, consult your doctor or pharmacist immediately, or call the Toxicology Information Service, phone 915 620 420, indicating the medication and the amount ingested.

If you have taken an overdose, you should go to a medical center immediately, even if you do not have symptoms, as they often do not appear until 3 days after taking the overdose, even in cases of severe poisoning.

Treatment of the overdose is more effective if started within 4 hours of taking the medication.

Paracetamol overdose is considered to be a single dose of more than 6 g in adults (12 Paracetamol/Codeine tablets) and more than 100 mg/kg body weight in children (for a 20 kg child, 4 tablets in a single dose).

The symptoms of paracetamol overdose can be: dizziness, vomiting, loss of appetite, yellowing of the skin and eyes (jaundice), abdominal pain.

The symptoms of codeine overdose can be: initial excitement, anxiety, insomnia, and later, in some cases, drowsiness, headache, changes in blood pressure, arrhythmias, dry mouth, skin rashes, tachycardia, convulsions, gastrointestinal disorders, nausea, vomiting, and respiratory depression.

If you forget to take Paracetamol/Codeine

Do not take a double dose to make up for forgotten doses. Take the missed dose as soon as you remember, and if your next dose is near, skip the missed dose and continue taking the medication at the usual time. If in doubt, consult your doctor or pharmacist.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

The observed side effects are described below according to their frequency:

Very common (may affect more than 1 in 10 people), common (may affect up to 1 in 10 people), uncommon (may affect up to 1 in 100 people), rare (may affect up to 1 in 1,000 people), and very rare (may affect up to 1 in 10,000 people).

The following side effects have been observed with paracetamol:

Rare:discomfort, increased liver transaminase levels (liver enzymes), hypotension (low blood pressure),

Very rare:allergic reactions (hypersensitivity) ranging from a simple skin rash (redness or inflammation of the skin) or urticaria (hives) to anaphylactic shock (a type of severe allergic reaction), hepatotoxicity (liver toxicity) and jaundice (yellowing of the skin and mucous membranes), hypoglycemia (low blood sugar levels), thrombocytopenia (reduced platelet count), agranulocytosis, leucopenia, neutropenia (reduced white blood cell count), hemolytic anemia (reduced red blood cell count), sterile pyuria (cloudy urine), adverse renal effects. Very rare cases of severe skin reactions have been reported.

The following side effects have also been described with codeine:

Rare: discomfort, drowsiness, constipation, and nausea.

Very rare:allergic reactions (hypersensitivity) ranging from a simple skin rash (redness or inflammation of the skin) or urticaria (hives) to anaphylactic shock (a type of severe allergic reaction), fever, yellowing of the skin and eyes (jaundice), low blood sugar levels (hypoglycemia), blood disorders.

Frequency not known (cannot be estimated from available data): a severe disease that can make the blood more acidic (called metabolic acidosis) in patients with severe disease who use paracetamol (see section 2).

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the national reporting system at www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Paracetamol/Codeine Pensa

No special storage conditions are required.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Paracetamol/Codeine Pensa

• 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 components (excipients) are: pregelatinized corn starch, stearic acid, povidone, crospovidone, microcrystalline cellulose, and vegetable magnesium stearate.

Appearance of the Product and Package Contents

Each package contains 20 tablets. The medicine is presented in PVC/PVDC-white opaque/Al blisters.

Marketing Authorization Holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturer

FARMALIDER, S.A.

C/ Aragoneses 2

28108 – Alcobendas (Madrid)

or

TOLL MANUFACTURING SERVICES S.L.

C/ Aragoneses 2

28108 – Alcobendas (Madrid)

Date of the Last Revision of this Leaflet:February 2025

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/