Tachiverde

Package leaflet: Information for the user

TACHIVERDE 1000 mg tablets, 1000 mg effervescent tablets

Paracetamol
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. 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. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

1. What Tachiverde is and what it is used for
2. What you need to know before taking Tachiverde
3. How to take Tachiverde
4. Possible side effects
5. How to store Tachiverde
6. Contents of the pack and other information

1. What Tachiverde is and what it is used for

Tachiverde contains the active substance paracetamol, which belongs to a group of medicines called
"analgesics and antipyretics",
which work by relieving pain and reducing fever.
Tachiverde is used in adults and adolescents over 15 years of age for all types of pain (for example, headache, joint pain, neck stiffness, backache, toothache, menstrual pain, minor surgical procedures).
Consult your doctor if you do not feel better or if you feel worse.

2. What you need to know before taking Tachiverde

Do not take Tachiverde

• if you are allergic to paracetamol or to any of the other ingredients of this medicine (listed in section 6)
• if the person taking the medicine is under 15 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before taking Tachiverde.
In particular, inform your doctor:

• -if you chronically consume alcohol or use it excessively (3 or more alcoholic drinks per day)
• if you suffer from anorexia (an eating disorder characterized by lack or reduction of appetite)
• if you suffer from bulimia (an eating disorder in which a person ingests an excessive amount of food and then resorts to various methods to eliminate it)
• if you suffer from cachexia (a condition characterized by extreme thinness, reduced muscle mass, and thinning of the skin due to chronic illness)
• if you have long-term inadequate nutrition (chronic malnutrition)
• if you suffer from dehydration (severe loss of water/fluids from the body)
• if you suffer from hypovolemia (reduced blood volume in circulation)
• if you have glucose-6-phosphate dehydrogenase deficiency (a substance normally present in the human body, deficiency of which may cause a blood disorder)
• if you suffer from haemolytic anaemia (a disease caused by destruction of certain blood cells, red blood cells)
• if you suffer from liver diseases that reduce liver function (severe hepatic insufficiency, Gilbert's syndrome, mild to moderate hepatocellular insufficiency, acute hepatitis) or if you are concurrently being treated with medicines that affect liver function.
• if you suffer from reduced kidney function (mild to moderate renal insufficiency)
• if you are concurrently being treated with any other medicine (see "Other medicines and Tachiverde").

During treatment with TACHIVERDE, inform your doctor immediately if:

• You suffer from serious illnesses, including severe kidney impairment or sepsis (when bacteria and their toxins circulate in the blood causing organ damage), malnutrition, chronic alcoholism, or if you are also taking flucloxacillin (an antibiotic). In patients with these conditions, a serious condition called metabolic acidosis (an abnormality in blood and body fluids) has been reported when paracetamol is used at regular doses for prolonged periods or when paracetamol is taken in combination with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties with deep, rapid breathing, drowsiness, nausea, and vomiting.

Use of high doses and/or for prolonged periods
The use of high doses and/or prolonged use of this medicine may cause liver disorders (hepatopathy) and even serious adverse effects on the kidneys and blood. Before taking this medicine, inform your doctor if the person taking the medicine suffers from kidney or liver disease.

In these cases, Tachiverde will be prescribed only if strictly necessary and under direct medical supervision.

Children and adolescents
Do not give Tachiverde to children and adolescents under 15 years of age (see section "Do not take Tachiverde").

Other medicines and Tachiverde
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor if you are taking:

• medicines containing paracetamol. During treatment with paracetamol, check before taking any other medicine to ensure it does not contain paracetamol, as serious adverse effects may occur if paracetamol is taken in high doses;
• medicines that slow gastric emptying (e.g. anticholinergics, opioids), as these medicines delay the effect of Tachiverde;
• medicines that accelerate gastric emptying (e.g. prokinetics), as these medicines accelerate the effect of Tachiverde;
• cholestyramine (a medicine used to reduce cholesterol levels in the blood), as it reduces the effect of paracetamol;
• chloramphenicol (an antibiotic), as it may increase the risk of adverse effects;
• rifampicin (an antibiotic);
• cimetidine (a medicine used in the treatment of stomach ulcers);
• antiepileptics (medicines used to treat epilepsy), such as glutethimide, phenobarbital, carbamazepine;
• zidovudine (a medicine for the treatment of HIV);
• oral anticoagulants, which are medicines used to make the blood less likely to clot. In this case, especially for prolonged treatment and high doses of paracetamol (4 g daily for at least 4 days), take Tachiverde only under strict medical supervision;
• flucloxacillin (an antibiotic), due to a serious risk of blood and fluid disturbances (called high anion gap metabolic acidosis) that must be treated urgently.

Interference with blood tests
If the person taking the medicine needs to undergo blood tests, keep in mind that administration of paracetamol may interfere with the measurement of uric acid and blood glucose levels.

Tachiverde and alcohol
Take Tachiverde with caution if you chronically consume alcohol or use it excessively (3 or more alcoholic drinks per day), as there is a risk of poisoning (see sections "Warnings and precautions" and "If you take more Tachiverde than you should").

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
If necessary, Tachiverde may be used during pregnancy. It is advisable to use the lowest possible dose that reduces pain and/or fever, and to take it for the shortest possible time. Contact your doctor if pain and/or fever do not improve or if you need to take the medicine more frequently.

Driving and using machines
Tachiverde does not affect the ability to drive or use machinery.

Tachiverde 1000 mg effervescent tablets contain sodium and sorbitol
Sodium: This medicine contains 499 mg of sodium (the main component of table salt) per tablet. This corresponds to 25% of the maximum recommended daily dietary intake for an adult.
Talk to your doctor or pharmacist if you need to take 1 or more Tachiverde 1000 mg effervescent tablets per day for a prolonged period, especially if you have been advised to follow a low-sodium diet.

Sorbitol: Sorbitol is a source of fructose. If your doctor has told you that you are intolerant to certain sugars, or if you have been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which patients cannot metabolize fructose, talk to your doctor before taking this medicine.

Tachiverde 1000 mg tablets contain less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially "sodium-free".

3. How to take Tachiverde

Take this medicine exactly as directed by your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
Adults and adolescents over 15 years of age
The recommended dose is 1 tablet or 1 effervescent tablet, up to a maximum of 3 times daily.
The interval between doses must not be less than four hours.
Dissolve effervescent tablets in a glass of water.
If you suffer from severe renal impairment (severe reduction in kidney function)
If your doctor has diagnosed severe renal impairment, the interval between doses must be at least 8 hours.
If you take more Tachiverde than you should
In case of accidental overdose of Tachiverde, contact your doctor immediately or go to the nearest hospital.
In case of accidental ingestion of very high doses of paracetamol, symptoms that may generally appear within the first 12–48 hours include:

• anorexia (loss or reduced appetite), nausea and vomiting followed by a severe deterioration in general condition
• changes in blood laboratory values (increased blood bilirubin, lactic dehydrogenase, liver transaminase levels, reduced blood prothrombin levels)
• liver damage that may lead to coma and death. Taking an excessive dose of paracetamol increases the risk of poisoning and can be fatal, especially in the following cases:
  • if the person taking the medicine has liver disease
  • chronic alcoholism
  • if the person taking the medicine has long-term poor nutrition (chronic malnutrition)
  • if the person taking the medicine is taking other medicines or substances that increase liver activity.

Treatment
The doctor will provide appropriate supportive therapy based on the nature and severity of symptoms.
Note for healthcare professionals: the specific antidote in case of paracetamol poisoning is N-acetylcysteine administered intravenously: the dosage is 150 mg/kg IV in glucose solution over 15 minutes, followed by 50 mg/kg over the next 4 hours and 100 mg/kg over the following 16 hours, for a total of 300 mg/kg over 20 hours.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the following side effects, STOP taking this medicine and contact your doctor immediately:

• allergic reactions such as:
  • skin rashes with skin irritation (erythema) and redness of the skin accompanied by itching (urticaria)
  • swelling of the throat (laryngeal edema)
  • swelling of hands, feet, ankles, face, lips, tongue and/or throat (angioedema)
  • severe allergic reaction (anaphylactic shock).

Additionally, patients taking this medicine may experience the following side effects, for which sufficient data are not available to determine their frequency.
Effects related to the blood

• decrease in the number of platelets in the blood (thrombocytopenia)
• decrease in the number of white blood cells in the blood (leucopenia/agranulocytosis)
• decrease in haemoglobin in the blood, the substance that carries oxygen in the blood (anaemia).

Effects related to the nervous system

• dizziness.

Effects related to the stomach and intestines

• stomach and intestinal disturbances such as vomiting, diarrhoea and abdominal pain.

Effects related to the liver

• abnormal liver function
• inflammation of the liver (hepatitis).

Effects related to the skin and subcutaneous tissue

• red spots, blistering lesions with areas of skin detachment, blisters, skin rashes (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis). Very rare cases of serious skin reactions have been reported.

Effects related to the kidneys and urinary tract

• reduced kidney function (acute renal failure)
• inflammation of the kidneys (interstitial nephritis)
• blood in the urine (haematuria)
• cessation or reduction in urine production (anuria).

Frequency not known (cannot be estimated from the available data): severe condition that may make the blood more acidic (called metabolic acidosis), in patients with severe illness using paracetamol (see section 2).
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Tachiverde

Keep this medicine out of the sight and reach of children.
Tablets: this medicine requires no special storage conditions.
Effervescent tablets: store in the original packaging to protect the medicine from light and moisture.
Do not use this medicine after the expiry date stated on the carton after "Exp". The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Tachiverde contains
Tachiverde 1000 mg tablets

• The active substance is: paracetamol (each tablet contains 1000 mg of paracetamol)
• The other components are: microcrystalline cellulose, croscarmellose sodium, povidone, pregelatinized starch, stearic acid.

Tachiverde 1000 mg effervescent tablets

• The active substance is: paracetamol (each effervescent tablet contains 1000 mg of paracetamol)
• The other components are: citric acid, sodium carbonate, sodium bicarbonate, sodium benzoate, sodium docusate, sorbitol (see section “Tachiverde 1000 mg effervescent tablets contain sodium and sorbitol”), orange flavour, acesulfame K, simeticone emulsion.

Description of the appearance of Tachiverde and the contents of the pack
Tachiverde 1000 mg tablets
White, elongated tablets with a score line on both sides. The tablets are divisible and packed in blisters within a carton pack containing 8 tablets (1 blister) or 16 tablets (2 blisters of 8 tablets each).
Tachiverde 1000 mg effervescent tablets
White to off-white, round effervescent tablets. The effervescent tablets are packed in blisters within a carton pack containing 12 tablets (4 blisters of 3 tablets each).
Not all pack sizes may be marketed.

Marketing Authorization Holder
Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. S.p.A.
Viale Amelia, 70 - 00181 Rome, Italy.

Manufacturer
Tablets
A.C.R.A.F. S.p.A. – Via Vecchia del Pinocchio, 22 - 60131 Ancona
or
Fine Foods N.T.M. S.p.A. - Via Berlino, 39 - 24040 Verdellino (Bergamo), Italy.

Effervescent tablets
A.C.R.A.F. S.p.A. - Via Vecchia del Pinocchio, 22 - 60131 Ancona
or
E-Pharma Trento S.p.A. - Frazione Ravina - Via Provina, 2 - 38123 Trento (TN), Italy.