Prospect: information for the user

Paracetamol Tecnigen 1 g tablets EFG

Paracetamol

1.What is Paracetamol Tecnigen 1 g tablets and what is it used for.

2.What you need to know before starting to take Paracetamol Tecnigen 1 g tablets

3.How to take Paracetamol Tecnigen 1 g tablets

4.Possible adverse effects.

5.Storage of Paracetamol Tecnigen 1 g tablets.

6.Contents of the package and additional information

Paracetamol Tecnigen 1 g tablets belong to a group of medicines called analgesics and antipyretics.

Paracetamol Tecnigen 1 g tablets are indicated for the symptomatic treatment of moderate intensity pain of any cause,such as: postoperative pain and postpartum pain, rheumatic pain (osteoarthritis and rheumatoid arthritis), lumbago, torticollis, sciatica, neuralgias, back pain, muscle pain, menstrual pain, headache, and toothache .Fever and the discomfort that accompanies the common cold and flu.

Paracetamol 1 g is suitable for adults and adolescents from 16 years of age (from 50 kg).

Do not takeParacetamol Tecnigen 1 g tablets

• If you are allergic to paracetamol, propacetamol, or any of the other components of this medication (listed in section 6).

Warnings and precautions

• If you have a chronic disease related to alcohol,
• If you have liver function abnormalities (hepatitis, Gilbert's syndrome),
• If you have severe kidney failure,
• If you have chronic dehydration and malnutrition,
• If you are asthmatic and sensitive to aspirin,
• If you have a deficiency of the glucose-6-phosphate dehydrogenase enzyme (enzyme deficiency),
• If you have hemolytic anemia (abnormal destruction of red blood cells).

Inform your doctor immediately during treatment with Paracetamol Tecnigen:

If you have severe diseases, such as severe kidney failure 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 severe disease called metabolic acidosis (a blood and fluid anomaly) has been reported in patients in these situations when using paracetamol at regular doses for a prolonged period or when taking paracetamol with flucloxacillin. Symptoms of metabolic acidosis may include: severe difficulty breathing with deep and rapid breathing, drowsiness, feeling unwell (nausea) and vomiting.

Do not take paracetamol unless your doctor prescribes it if you have had problems with alcohol or liver damage. In these patients, the dose should be reduced (see section 3. "How to take Paracetamol Tecnigen").

If you are taking other medications that contain paracetamol at the same time, do not take Paracetamol Tecnigen without consulting your doctor or pharmacist first.

Never take more Paracetamol Tecnigen than recommended. Higher doses do not increase pain relief and may cause severe liver damage (see section 3. "How to take Paracetamol Tecnigen").

Prolonged treatment, high doses, or incorrect use of analgesics may cause headaches that should not be treated with higher doses of this medication.

Regular use of analgesics, particularly combinations of several analgesic substances, may lead to permanent kidney damage with the risk of kidney failure (analgesic nephropathy).

A sudden interruption after long-term treatment, high doses, or incorrect use of analgesics may cause headaches, fatigue, muscle pain, nervousness, and autonomic nervous system symptoms. These withdrawal symptoms disappear within a few days. Until then, avoid taking more analgesics and do not start taking them again without consulting your doctor.

Consult your doctor or pharmacist before starting to take Paracetamol Tecnigen 1 g tablets.

Paracetamol Tecnigen 1 g tablets with other medications:

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

Medications that may affect the effect of paracetamol are:

• probenecid(a medication for treating gout)
• Medications that may cause possible liver damage, for examplefenobarbital(sleeping pills),phenytoin, carbamazepine, primidone(medications used to treat epilepsy) andrifampicin(medications used to treat tuberculosis): The simultaneous use of these medications and paracetamol may cause liver damage.
• isoniazid(a medication used to treat tuberculosis) andsalicylamide(pain medication) may lead to higher paracetamol concentrations in your body.
• metoclopramideanddomperidone(medications used to treat nausea): These may increase the absorption and onset of paracetamol effect.
• Medications that decrease stomach emptying: These may delay the absorption and onset of paracetamol effect.
• colestiramine(a medication to reduce serum lipid levels): These may decrease the absorption and onset of paracetamol effect. Therefore, do not take colestiramine during the hour after administering paracetamol.
• Medications for blood coagulation (oral anticoagulants, particularlywarfarin): The repeated use of paracetamol for more than a week increases the tendency to bleeding. Therefore, long-term administration of paracetamol should only be carried out under medical supervision. Occasional use of paracetamol has no significant effects on bleeding tendency.

Medications that may be affected by Paracetamol are:

• lamotrigine(a medication for epilepsy) may decrease its effect when taken with paracetamol.
• The simultaneous use of paracetamol and AZT (zidovudine, a medication used to treat HIV infections) increases the risk of liver damage and reduces white blood cell count (neutropenia). This may affect the immune system and increase the risk of infections. Paracetamol should therefore be used simultaneously with zidovudine only under medical advice.

• flucloxacillin (antibiotic), due to a severe risk of fluid and blood anomaly alteration (denominated metabolic acidosis) that requires urgent treatment (see section 2).

Effects of paracetamol on laboratory tests

Paracetamol may affect uric acid tests using acid and glucose analysis.

Paracetamol Tecnigen 1 g tablets with food and beverages

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

The tablets can be taken with or without food.

Pregnancy and lactation

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

No effects on newborns are known.

Paracetamol may be used during pregnancy if necessary. However, consult your doctor before using paracetamol for a prolonged period if you are pregnant.

Paracetamol passes in small amounts into breast milk. Since no negative effects on infants are known, paracetamol may be used during breastfeeding. However, consult your doctor before using paracetamol for a prolonged period if you are breastfeeding.

Driving and operating machinery

No effects that modify the ability to drive and operate machinery have been described.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The paracetamol dose depends on body weight and age; the normal dose is 10 to 15 mg of paracetamol per Kg of body weight as a single dose, up to a maximum of 60 mg/Kg of body weight, not exceeding 3 tablets (equivalent to 3000 mg of paracetamol).

It is necessary to maintain an interval of at least 6 hours between taking, which means a maximum administration of 4 times a day. Be careful not to exceed the maximum daily dose.

If the pain persists for more than 5 days or the fever lasts more than 3 days, or worsens or other symptoms appear, you should interrupt the treatment and consult a doctor.

Method of administration

The tablets must be taken without chewing with a sufficient amount of liquid.

Special patient groups

Patients with renal insufficiency

In patients with renal insufficiency, the dose must be reduced.

In patients with renal or hepatic insufficiency, the dose should be reduced or the interval between doses prolonged. Consult your doctor or pharmacist.

Patients with chronic alcoholism or hepatic insufficiency

Being a chronic consumer of alcohol or having hepatic insufficiency may decrease the paracetamol toxicity threshold.

In these patients, the dose should be reduced or the interval between doses prolonged. Consult your doctor or pharmacist.

Older patients

No dose adjustment is required in older patients.

Use in children and adolescents

This medication should not be used in children and adolescents under 16 years of age with a body weight less than 50 Kg, as the dose is not suitable for this group of patients. For this group of patients, other formulations and doses are available.

If you consider that the effect of this medication is too strong or weak, please consult your doctor or pharmacist.

If you take more Paracetamol Tecnigen 1 g tablets than you should

The total daily dose of paracetamol should not exceed 60 mg/Kg/day and should not exceed 3000 mg (equivalent to 3 tablets).

The consequences of overdose can be severe and in rare cases may even lead to death.

If you take more paracetamol than recommended, you should seek medical attention as soon as possible, even if you feel well. There is a risk of delayed liver damage. To avoid possible liver damage, it is essential that an antidote be administered by a doctor as soon as possible.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to takeparacetamol Tecnigen 1 g tablets

Do not take a double dose to compensate for the missed dose.

If you forget to take your corresponding dose, take it as soon as you remember. However, if the time for the next dose is very close, skip the missed dose and take the next dose at your usual time.

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

Like all medicines, Paracetamol Tecnigen 1 g tablets may cause side effects, although not everyone will experience them.

You should stop taking paracetamol and see your doctor immediately if you experience symptoms of angioedema, such as

• inflammation of the face, tongue, or pharynx
• difficulty swallowing
• urticaria and difficulty breathing

Rare(Affects between 1 and 10 of every 10,000 patients):

• allergic reactions, such as skin rash or urticaria
• in sensitive patients, it may appear narrowing of the airways with respiratory insufficiency and symptoms similar to asthma (asthma caused by analgesics)
• blood formation disorders, coagulation disorders
• abdominal pain, bleeding, diarrhea, nausea, vomiting, dizziness, fever, sweating, sedation
• shaking, headache, abnormal vision
• depression, confusion, hallucinations
• overdose and poisoning
• abnormal liver function, renal insufficiency, jaundice, mild increase in certain liver enzymes (serum transaminases)

Very rare(Affects less than 1 of every 10,000 patients)

• hepatotoxicity (liver damage caused by chemical substances)
• allergic reactions requiring discontinuation of treatment (severe immediate allergic reaction)
• reduction in platelet count, decrease in certain white blood cells, abnormal destruction of red blood cells (hemolytic anemia)
• decrease in blood sugar levels
• cloudy urine and kidney alterations
• Very rarely, severe skin reactions have been reported.

Unknown(The frequency cannot be estimated from the available data):

• epidermal necrosis (skin alteration that may potentially be life-threatening), erythema multiforme (allergic or infectious skin reaction), Stevens-Johnson syndrome (skin alteration that may potentially and severely be life-threatening)
• interstitial nephritis (kidney inflammation) after prolonged use at high doses.
• Angioedema and anaphylactic shock have been reported. In case of anaphylactic shock, call a doctor immediately.
• A severe disease that may make the blood more acidic (denominated metabolic acidosis) in patients with severe disease using paracetamol (see section 2).

Paracetamol may cause a reduction in the number of white blood cells, so it may decrease resistance to infections. If you experience an infection with symptoms such as fever and a severe deterioration of your general condition, or fever with symptoms of local infection such as throat, pharynx, or mouth irritation or urinary problems, you should see your doctor immediately. A blood test will be necessary to check for a possible decrease in white blood cells (agranulocytosis). It is essential to inform your doctor about your medication.

If you experience side effects, consult your doctor or pharmacist, even if they are side effects that do not appear in this prospectus.

This medication does not require special storage conditions.

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

Do not use this medicationafter the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

“Medicines should not be thrown down the drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.”

Composition ofParacetamol Tecnigen 1 g tablets

• The active ingredient is paracetamol. Each tablet contains 1000 mg (= 1 g) of paracetamol.

• The other components are: pregelatinized cornstarch (gluten-free), stearic acid, povidone, crospovidone, microcrystalline cellulose, and plant-derived magnesium stearate.

Appearance of the product and contents of the packaging

Paracetamol Tecnigen 1 g tablets are presented in the form of oral tablets for administration, in packaging of 20 and 40 tablets.

The tablets are scored, which allows them to be split in half to facilitate swallowing.

Holder of the marketing authorization and responsible for manufacturing

Holder

Tecnimede España Industria Farmacéutica, S.A.

Avda. Bruselas, 13

28108 Alcobendas (Madrid)

Responsible for manufacturing:

SAG Manufacturing SLU

Crta N-I, Km 36

28750 San Agustin de Guadalix, Madrid

Spain

Last review date of this leaflet:January 2025

“Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/”