PARACETAMOL TECNIGEN 1 g TABLETS

Introduction

Package Leaflet: Information for the User

Paracetamol Tecnigen 1 g Tablets EFG

Paracetamol

Contents of the Package Leaflet

1. What Paracetamol Tecnigen 1 g Tablets are and what they are used for.
2. What you need to know before you take Paracetamol Tecnigen 1 g Tablets.
3. How to take Paracetamol Tecnigen 1 g Tablets.
4. Possible side effects.
5. Storage of Paracetamol Tecnigen 1 g Tablets.
6. Contents of the pack and other information.

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

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 pain of any origin, such as postoperative and postpartum pain, rheumatic pain (osteoarthritis and rheumatoid arthritis), lumbago, torticollis, sciatica, neuralgia, back pain, muscle pain, menstrual pain, headache, and toothache. Also, for febrile states and discomforts accompanying colds and flu.

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

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

Do not takeParacetamol Tecnigen 1 g Tablets

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

Warnings and Precautions

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

During treatment with Paracetamol Tecnigen, inform your doctor immediately:

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 suffer from malnutrition, chronic alcoholism, or if you 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 may include: severe breathing difficulties with deep and rapid breathing, drowsiness, feeling of discomfort (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 must be reduced (see section 3. "How to take Paracetamol Tecnigen").

If you are taking other medicines that contain paracetamol, 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 can cause serious liver damage (see section 3. "How to take Paracetamol Tecnigen").

Long-term treatment, high doses, or incorrect use of analgesics may lead to headache that should not be treated with higher doses of this medicine.

In general, the habitual intake of analgesics, particularly combinations of several analgesic substances, can lead to permanent kidney damage with the risk of kidney failure (analgesic nephropathy).

Abrupt interruption after long-term treatment, high doses, or incorrect use of analgesics can lead to headache, fatigue, muscle pain, nervousness, and symptoms of the autonomic nervous system. These withdrawal symptoms disappear within a few days. Until this happens, you should avoid taking more analgesics and not start taking them again without medical advice.

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

Taking Paracetamol Tecnigen with other medicines:

Tell your doctor or pharmacist that you are taking, have recently taken, or might take any other medicines.

Medicines that may affect the effect of paracetamol are:

• probenecid(a medicine for gout)
• medicines that may cause possible liver damage, for example phenobarbital(sleeping medicines), phenytoin, carbamazepine, primidone(medicines used to treat epilepsy) and rifampicin(medicines used to treat tuberculosis): The simultaneous use of these medicines and paracetamol may cause liver damage.
• isoniazid(a medicine used to treat tuberculosis) and salicylamide(pain medicine) may lead to higher concentrations of paracetamol in your body.
• metoclopramideand domperidone(medicines used to treat nausea): These may increase the absorption and onset of the effect of paracetamol.
• medicines that decrease stomach emptying: These may delay the absorption and onset of the effect of paracetamol.
• cholestyramine(a medicine to reduce increased lipid levels in serum): These may decrease the absorption and onset of the effect of paracetamol. Therefore, cholestyramine should not be taken during the hour following the administration of paracetamol.
• medicines for blood coagulation (oral anticoagulants, particularly warfarin): The repeated intake of paracetamol for more than one week increases the tendency to bleed. Therefore, long-term administration of paracetamol should only take place under medical supervision. The occasional intake of paracetamol has no significant effects on the tendency to bleed.

Medicines that may be affected by Paracetamol are:

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

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

Effects of paracetamol on laboratory tests

Taking paracetamol may affect uric acid tests using acid and glucose analysis.

Taking Paracetamol Tecnigen 1 g Tablets with food and drinks

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

The tablets can be taken with or without food.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

No effects on newborns are known.

In case of need, Paracetamol can be used during pregnancy. However, consult your doctor before using paracetamol for a prolonged period if you are pregnant.

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

Driving and Using Machines

No effects have been described that modify the ability to drive and use machines.

3. How to Take Paracetamol Tecnigen 1 g Tablets

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

The dose of paracetamol 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).

An interval of at least 6 hours should be maintained between taking the tablets, meaning 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 should be taken without chewing with a sufficient amount of liquid.

Special Patient Groups

Patient with renal insufficiency

In patients with renal insufficiency, the dose should 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.

Patient with chronic alcoholism or hepatic insufficiency

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

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

Patient of advanced age

No dose adjustment is required in patients of advanced age.

Use in Children and Adolescents

This medicine should not be used in children and adolescents under 16 years of age with a weight below 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 medicine is too strong or too 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 overdosing can be serious and in rare cases may even lead to death.

If you take more paracetamol than recommended, you should seek medical attention immediately, even if you feel well. There is a risk that liver damage may occur delayed. To avoid possible liver damage, it is important 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 Toxicology Information Service, telephone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Paracetamol Tecnigen 1 g Tablets

Do not take a double dose to make up for the forgotten dose.

If you forget to take your corresponding dose, take it as soon as you remember. However, if the time of the next dose is near, skip the forgotten dose and take the next dose at the usual time.

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

4. Possible Side Effects

Like all medicines, Paracetamol Tecnigen 1 g Tablets can cause side effects, although not everybody gets them.

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

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

Rare(Affects 1 to 10 in every 10,000 patients):

• hypersensitivity reactions, such as skin rash or urticaria
• in sensitive patients, bronchospasm with respiratory insufficiency and symptoms similar to asthma (analgesic asthma) may occur
• blood disorders, coagulation disorders
• abdominal pain, bleeding, diarrhea, nausea, vomiting, dizziness, fever, sweating, sedation
• tremor, headache, abnormal vision
• depression, confusion, hallucinations
• overdose and poisoning
• abnormal liver function, renal insufficiency, jaundice, slight increase in certain liver enzymes (serum transaminases)

Very Rare(Affects less than 1 in every 10,000 patients)

• hepatotoxicity (liver damage caused by chemicals)
• hypersensitivity reactions requiring treatment interruption (severe allergic reaction)
• reduced platelet count, decreased white blood cells, abnormal destruction of red blood cells (hemolytic anemia)
• decreased blood sugar levels
• cloudy urine and kidney disorders
• Very rare cases of severe skin reactions have been reported

Unknown(Frequency cannot be estimated from the available data):

• necrolysis (skin disorder that can potentially affect life), erythema multiforme (allergic reaction or skin infection), Stevens-Johnson syndrome (skin disorder that can potentially and severely affect life)
• kidney inflammation (interstitial nephritis) after prolonged use at high doses.
• Cases of angioedema and anaphylactic shock have been reported. In case of anaphylactic shock, you should immediately call a doctor.
• A serious disease that can make the blood more acidic (called metabolic acidosis) in patients with severe disease using paracetamol (see section 2).

Paracetamol may cause a reduction in the number of white blood cells, which can 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/mouth irritation or urinary problems, you should go to the doctor immediately. A blood test will be necessary to check for a possible decrease in white blood cells (agranulocytosis). It is important that you inform your doctor about your medication.

If you experience side effects, talk to your doctor or pharmacist, even if it is a side effect not listed in this leaflet.

5. Storage of Paracetamol Tecnigen 1 g Tablets

This medicine does not require special storage conditions.

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

Do not use this medicine after the expiry date which is stated on the packaging after EXP. The expiry date is the last day of the month indicated.

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

6. Contents of the Pack and Other Information

Composition of Paracetamol Tecnigen 1 g Tablets

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

• The other ingredients are: pregelatinized corn starch (gluten-free), stearic acid, povidone, crospovidone, microcrystalline cellulose, and vegetable magnesium stearate.

Appearance of the Product and Contents of the Pack

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

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

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Tecnimede España Industria Farmacéutica, S.A.

Avda. Bruselas, 13

28108 Alcobendas (Madrid)

Manufacturer:

SAG Manufacturing SLU

Crta N-I, Km 36

28750 San Agustin de Guadalix, Madrid

Spain

Date of the Last Revision of this Leaflet:January 2025

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