Patient Information Leaflet

Paracetamol Cipla 1g Effervescent Tablets EFG

Read this leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as 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, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2. What you need to know before taking Paracetamol Cipla

3. How to take Paracetamol Cipla

4. Possible side effects

5. Storage of Paracetamol Cipla

6. Contents of the pack and additional information

This medication contains paracetamol, which belongs to the group of analgesic and antipyretic medications, that relieve mild to moderate pain and fever.

It can be taken to relieve headache, migraine, neuralgia, toothache, menstrual pain, rheumatic pain, throat pain and symptoms of the common cold and flu.

You should consult your doctor if you do not feel better or if you get worse after three days.

Do not take Paracetamol Cipla effervescent tablets

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

Take special care with Paracetamol Cipla

Inform your doctor or pharmacist before taking this medicine if:

• you have kidney problems?
• you have liver problems, including those caused by excessive alcohol consumption.
• you have Gilbert's syndrome (mild jaundice).
• you have haemolytic anaemia (abnormal decrease in red blood cells).
• you are asthmatic and sensitive to aspirin (acetylsalicylic acid).
• you suffer from chronic dehydration and malnutrition.
• you are taking other medicines that contain paracetamol.
• if you still have a fever after treatment with paracetamol.
• if you have a deficiency of glucose-6-phosphate dehydrogenase (enzyme deficiency).

Inform your doctor immediately during treatment with Paracetamol Cipla effervescent tablets if:

Other important information

Do not drink alcohol while taking this medicine (for example: wine, beer, or spirits).

This medicine should not be used in patients weighing less than 50kg.

If you suffer from alcohol addiction, or liver damage, do not take paracetamol unless your doctor prescribes it. If this affects you, do not take these tablets with alcohol. If you are using another pain medication that contains paracetamol, do not take these tablets without consulting your doctor or pharmacist first.

Never take more Paracetamol tablets than recommended. A higher dose will not relieve pain more, but may cause serious liver damage. Liver damage symptoms appear after a few days. It is essential to see your doctor immediately if you have taken more paracetamol tablets than recommended in this leaflet.

Children and adolescents

This medicine should not be used in children, adolescents under 16 years, or weighing less than 50 Kg.

Use of other medicines

Inform your doctor or pharmacist if you are using or have recently used other medicines, even those purchased without a prescription.

Inform your doctor before taking Paracetamol Cipla if you are taking:

• blood-thinning medicines (anticoagulants, e.g. warfarin, other coumarins)

• medicines to relieve nausea (e.g. metoclopramide, domperidone)

• medicines to treat high cholesterol (cholestyramine)

• probenecid (medicines to treat high levels of uric acid in the blood (gout))

• medicines to treat fever or mild pain (acetylsalicylic acid, salicylamide)

• medicines like rifampicin (to treat infections), antiepileptics (such as carbamazepine) or medicines to treat seizures (such as phenytoin, phenobarbital, and primidone).

• medicines to treat epilepsy (lamotrigine)

• medicines to treat tuberculosis (isoniazid)

• flucloxacillin (antibiotic), due to a serious risk of blood and fluid disorder (metabolic acidosis) that must be treated urgently (see section 2).

Paracetamol may prolong the action of chloramphenicol.

Interference with analytical tests

May affect blood uric acid and sugar tests.

Paracetamol Cipla with food and drinks

Taking this medicine with food does not affect its absorption.

Pregnancy and breastfeeding

If necessary, Paracetamol Cipla effervescent tablets can be used during pregnancy. Take the minimum dose possible to reduce pain or fever and use it for the shortest time possible. Talk to your doctor if the pain does not decrease or if you have to take the medicine more frequently.

Paracetamol passes into breast milk. Women in lactation can take paracetamol at the doses indicated in this leaflet.

Driving and operating machines

Paracetamol does not affect the ability to drive and operate machines.

Paracetamol Cipla contains sodium and aspartame

This medicine contains 533.51mg of sodium (main component of table salt) in each effervescent tablet. This is equivalent to 26.68% of the maximum daily recommended intake for an adult.

This medicine contains 10mg of aspartame in each effervescent tablet. Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria, a rare genetic disorder in which phenylalanine accumulates because the body cannot eliminate it correctly.

This medication is only for adults and adolescents 16 years of age and older.

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

Paracetamol Cipla is administered orally and can be taken with or without food.

Place the tablet in a full glass of water. Let it dissolve completely and drink the solution immediately afterwards.

If you have any doubt about the correct dose of this medication, consult your doctor.

Adults and adolescents (16 years of age and older) weighing more than 50 kg:

Take 1 Paracetamol Cipla tablet (1000 mg of paracetamol) every 6 hours, up to a maximum of 4 tablets (4000 mg of paracetamol) in 24 hours.

Paracetamol 1g tablets are not suitable for:

• children and adolescents under 16 years of age.
• adults or adolescents 16 to 18 years of age weighing less than 50 kg.

If the pain persists for more than 5 days or the fever for more than 3 days, or worsens or other symptoms appear, discontinue treatment and see a doctor.

Do not take this medication for more than 10 days without consulting your doctor.

If the pain persists or worsens, seek medical help. Do not exceed the indicated dose.

Renal problems:

In case of moderate renal problems, the usual dose is 500 mg every 6 hours.

In case of severe renal problems, the usual dose is 500 mg every 8 hours.

Liver problems:

In case of liver problems, consult your doctor. Your doctor may decide to reduce the dose.

In case of chronic alcoholism, the dose should not exceed 2 g per day.

Do not divide the 1 g tablet to obtain equal parts with half the dose. There are available effervescent tablets of paracetamol with a lower dose.

Do not exceed the indicated dose. Do not administer to children or adolescents under 16 years of age.

If you take more Paracetamol Cipla than you should:

The symptoms of paracetamol overdose in the first 24 hours may include, pallor, nausea, vomiting, loss of appetite, and stomach pain. If you or someone you know accidentally takes more than the indicated dose (overdose), you must contact your doctor immediately, even if you feel well, as there is a risk of severe liver damage delayed.

In case of overdose or accidental ingestion, go immediately to a medical center or call the Toxicological Information Service (phone 91 5620420), indicating the medication and the amount ingested.

If you forgot to take Paracetamol Cipla:

If you forget to take a dose, take another as soon as you remember, unless the time for the next dose is near, in which case you should wait until then. The minimum interval between two doses should be between 4 and 6 hours. Do not take a double dose to compensate for the missed doses.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

You should stop taking Paracetamol Cipla and consult your doctor if you experience any of the following symptoms:

• Severe skin reactions that cause redness, peeling, blisters, or ulcers (Stevens-Johnson Syndrome).
• Skin reactions with redness, peeling, and blisters (necrolisis epidérmica).
• Generalized skin rash with blisters and fever (exanthema pustulosum generalizado).
• Generalized rash (may appear as round or oval patches of redness and swelling of the skin).
• Swelling of the face, tongue, or throat, difficulty swallowing, red and itchy skin, or difficulty breathing.
• Stomach ulcers and bleeding (gastrointestinal effects).

Other side effects include:

Rare (may affect 1 in 1,000 patients):

• Bleeding or clotting disorders (platelet abnormalities), decreased blood cell formation, decreased white blood cell count that may cause severe infections (agranulocytosis), frequent infections due to impaired white blood cell function or decreased white blood cell count (leucopenia), decreased platelet count that increases the risk of bleeding or bruising (thrombocytopenia), abnormal destruction of red blood cells that may cause weakness or paleness (hemolytic anemia), decreased blood cell count, decreased neutrophil count in the blood (neutropenia).

• Allergies (excluding facial, oral, or hand swelling)

• Depression, confusion, hallucinations

• Tremor, headache

• Abnormal vision

• Abnormal accumulation of fluid under the skin (edema)

• Abdominal pain, diarrhea, nausea, vomiting, bleeding (hemorrhage)

• Abnormal liver function, liver insufficiency, liver cell death (hepatic necrosis), jaundice

• Dizziness, general discomfort, fever, sedation, interaction with other medications

• Overdose and intoxication

Very rare (may affect fewer than 1 in 10,000 patients):

• Liver damage (hepatotoxicity)

• Severe immediate allergic reaction (hypersensitivity reaction requiring discontinuation of treatment)

• Low blood sugar (hypoglycemia)

• Cloudy urine and kidney disorders

•

• Skin allergy (erythema multiforme).

• Accumulation of fluid in the larynx

• • Decreased red blood cells (anemia)

• Severe kidney damage (interstitial nephritis)

• Kidney damage

• Blood in the urine (hematuria)

• Inability to urinate (anuresis)

• Restlessness

Unknown frequency (cannot be estimated from available data):

A severe disease that may make the blood more acidic (designated as metabolic acidosis) in patients with severe disease using paracetamol (see section 2).

Reporting of adverse reactions:
If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is an adverse reaction that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting adverse reactions, you can contribute to providing more information on the safety of this medicine.

• Keep this medication out of the reach and sight of children.
• Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.
• This medication does not require special temperature storage conditions.
• Store in the original packaging to protect it from light and moisture.
• The solution is stable for up to 8 hours at a temperature below 25°C after dissolving the tablet, so the solution must be consumed within 8 hours at most.
• Do not use the tablets if you observe visible signs of deterioration, such as black or brown spots on the tablets, swelling, or discoloration of the tablets.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

Composition of Paracetamol Cipla 1 g effervescent tablets EFG

The active ingredient is paracetamol. Each effervescent tablet contains 1 g of paracetamol.

The other components are: anhydrous citric acid (E330), povidone, sodium bicarbonate (E500), sodium saccharin (E954), anhydrous sodium carbonate (E500), simethicone (E900), polysorbate 80 (E443), aspartame (E951).

Appearance of the product and contents of the packaging

They are effervescent tablets of white or almost white color, round, flat, with beveled edges and smooth on both sides. Diameter: 25.2 mm.

The laminated aluminum strips are packaged in a cardboard box.

The packaging sizes for the strips are: 8, 10, 12, 16, 20, 32, 40, 50, 60, 100 tablets.

Not all packaging sizes may be marketed.

Holder of the marketing authorization and responsible manufacturer

Cipla Europe NV

De Keyserlei 58-60 Box-19,

2018 Antwerp, Belgium

Local representative

Cipla Europe NV subsidiary in Spain

C/Guzmán el Bueno, 133 Edif Britannia

28003 Madrid, Spain

This medicine is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet:February 2025

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