ANALGIPLUS 500 mg/30 mg FILM-COATED TABLETS

2. What you need to know before taking AnalgiPlus

Do not take AnalgiPlus

• if you are allergic (hypersensitive) to paracetamol or propacetamol (paracetamol precursor), codeine, or any of the other components of this medication listed in section 6.
• if you have respiratory depression.

• to relieve pain in children and adolescents (0-18 years) after tonsil or adenoid removal 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 AnalgiPlus

• if you have any liver, kidney, heart, or lung disease, or if you have anemia (reduced hemoglobin levels in the blood due to or not due to a reduction in red blood cells). In this case, you should consult your doctor before taking this medication.
• if you have any thyroid disease, prostate disorders (prostatic hypertrophy), intracranial lesions, as well as acute asthma attacks, consult your doctor before taking this medication.
• if you have anemia, chronic cardiopulmonary insufficiency, or any pulmonary condition, as this medication should be administered with caution, avoiding prolonged treatments.
• if you are asthmatic or have a history of asthma and are also sensitive to acetylsalicylic acid, you should consult your doctor before taking this medication.
• in elderly patients, it is recommended that they consult their doctor before taking this medication.
• if you have a history of cholecystectomy. Consult a doctor before using this medication, as it may cause acute pancreatitis in some patients.

During treatment with AnalgiPlus, immediately inform your doctor if you have severe diseases, such as severe renal insufficiency or sepsis (when bacteria and their toxins circulate in the blood, causing damage to organs), or if you have malnutrition, chronic alcoholism, or if you are also taking flucloxacillin (an antibiotic). A serious 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 may include: severe breathing difficulties with deep and rapid breathing, drowsiness, feeling unwell (nausea) and vomiting.

Do not take more than the recommended dose.

Consuming alcoholic beverages (three or more alcoholic drinks per day) may cause paracetamol to damage the liver.

In chronic alcoholics, it should be taken with caution not to take more than 2 g/day of paracetamol.

Codeine is converted to morphine in the liver by an enzyme. Morphine is the substance that produces pain relief. Some people have a variation of this enzyme that can affect people in different ways. In some people, morphine is not produced or is produced in very low quantities, and it will not provide sufficient pain relief. Other people are more likely to suffer from 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, constricted pupils, nausea or vomiting, constipation, loss of appetite.

If the pain persists for more than 3 days, or worsens, or other symptoms appear, you should discontinue treatment and consult your doctor.

In children under 15 years of age, consult your doctor or pharmacist, as the use of this medication is not recommended in this group of patients.

Prolonged and excessive administration of codeine can cause dependence and/or tolerance, especially in people with a tendency to abuse and addiction. After prolonged treatments, you should gradually discontinue the administration as indicated by your doctor.

Children and Adolescents

Use in children and adolescents after surgery

Codeine should not be used for pain relief in children and adolescents after tonsil or adenoid removal due to obstructive sleep apnea syndrome.

Use in children with respiratory problems

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

Other Medications and AnalgiPlus

Inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medication, including those purchased without a prescription.

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, flucloxacillin).
• 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).

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

Inform your doctor or pharmacist if you are taking flucloxacillin (an antibiotic), due to a serious risk of blood and fluid alteration (called metabolic acidosis) that requires urgent treatment (see section 2).

As a general rule for any medication, it is recommended to systematically inform your doctor or pharmacist if you are being treated with another medication.

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 H1 (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 analytical tests: if you are going to undergo any analytical test (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 AnalgiPlus with Food and Drinks

The use of paracetamol in patients who regularly consume alcohol (three or more alcoholic drinks per day: beer, wine, liquor) may cause liver damage.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

AnalgiPlus is not recommended during pregnancy.

In case it is necessary, AnalgiPlus can be used during pregnancy. You should use the lowest possible dose that reduces pain or fever and use it for the shortest possible time, always under the supervision of your doctor, who will assess the potential risks and benefits of treatment.

Never exceed the recommended dose.

Contact your doctor if the pain or fever does not decrease or if you need to take the medication more frequently.

Breastfeeding

Small amounts of paracetamol may appear in breast milk.

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

Driving and Using Machines

This medication may affect your ability to drive vehicles or operate machinery that requires special attention.

Therefore, do not drive or use machinery until you have checked how you tolerate this medication. Alcohol can enhance this effect, so you should not consume alcoholic beverages during treatment.

Use in Athletes

Be especially careful with AnalgiPlus if you are an athlete, as this medication contains a component, codeine, which can result in a positive doping test.

3. How to Take AnalgiPlus

Follow your doctor's instructions for taking AnalgiPlus exactly. Consult your doctor or pharmacist if you have any doubts.

Your doctor will indicate the amount of medication to take and the duration of treatment based on the intensity and characteristics of the pain.

The recommended dose is:

Adults and children over 15 years

1 tablet every 6 hours. The maximum dose per intake will be 2 tablets and the maximum daily dose will be 8 tablets.

Never exceed the recommended dose.

AnalgiPlus should be taken orally. The ingestion of the tablets can be helped with a sip of water or another non-alcoholic liquid.

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

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

Use in Children and Adolescents

Children under 15 years

Consult your doctor, as the administration of this medication is not recommended in this population group.

Children under 12 years

Children under 12 years should not take AnalgiPlus due to the risk of severe respiratory problems.

Patients with Liver Disease

Consult your doctor before taking this medication.

You should take the amount of medication prescribed by your doctor with a minimum interval of 8 hours between each intake. Do not take more than 2 grams of paracetamol in 24 hours, divided into several intakes.

Patients with Kidney Disease

Consult your doctor before taking this medication.

Depending on your disease, your doctor will indicate whether you should take your medication with a minimum interval of 6 or 8 hours. Do not take more than 2 grams of paracetamol in 24 hours, divided into several intakes, never exceeding 500 milligrams per intake.

Elderly Patients

Consult your doctor before taking this medication.

If you think the effect of AnalgiPlus is too strong or too weak, inform your doctor or pharmacist.

If You Take More AnalgiPlus Than You Should

If you have taken more AnalgiPlus 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 after taking the medication.

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

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

The symptoms of codeine overdose may be: initial excitement, anxiety, inability to fall asleep (insomnia), and later in some cases, drowsiness (somnolence), headache (cephalalgia), changes in blood pressure, arrhythmias, dry mouth, skin rashes, tachycardia, convulsions, gastrointestinal disorders, nausea, vomiting, and respiratory depression.

If You Forget to Take AnalgiPlus

Do not take a double dose to make up for missed doses. Take the missed dose as soon as you remember and if your next dose is near in time, skip the missed dose and continue taking the medication at the usual schedule. In case of 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, AnalgiPlus can cause side effects, although not everyone will experience them.

The side effects observed are described below according to their frequency of occurrence: very common (may affect more than 1 in 10 patients), common (may affect up to 1 in 10 patients), uncommon (may affect up to 1 in 100 patients), rare (may affect up to 1 in 1,000 patients), very rare (may affect up to 1 in 10,000 patients), and unknown frequency (cannot be estimated from available data).

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), severe skin reactions, 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.

Unknown Frequency:a serious disease that can make the blood more acidic (called metabolic acidosis) in patients with severe disease who use paracetamol (see section 2).

The following side effects have also been described with codeine:

Rare:discomfort, drowsiness (somnolence), 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 alterations.

Unknown Frequency:acute pancreatitis in patients with a history of cholecystectomy.

Reporting Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this package leaflet. You can also report them directly through the Spanish Medication Monitoring System for Human Use: https://www.notificaram.es/. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of AnalgiPlus

Keep this medication out of sight and reach of children.

Do not use AnalgiPlus after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

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

6. Package Contents and Additional Information

Composition of AnalgiPlus 500 mg/ 30 mg film-coated tablets

• 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: glycerol palmitostearate, magnesium stearate, sodium croscarmellose, gluten-free corn starch, stearic acid, povidone, hypromellose, microcrystalline cellulose, polyoxyethylene-40 stearate, titanium dioxide (E-171).

Appearance of the Product and Package Contents

Each package contains 20 film-coated tablets. The medication is presented in a blister pack (aluminum/PVC) that individualizes and protects each pharmaceutical form.

Marketing Authorization Holder

Faes Farma, S.A.

Autonomia Etorbidea, 10

48940 Leioa (Bizkaia)

Spain

Manufacturer

Faes Farma, S.A.

Maximo Agirre Kalea, 14

48940 Leioa (Bizkaia)

Spain

Or

Faes Farma, S.A.

Bizkaia Science and Technology Park

Ibaizabal Bidea, Building 901

48160 Derio (Bizkaia)

Spain

Date of the Last Revision of this Leaflet:January 2025

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