Tachicaf

Package leaflet: Information for the user

TACHICAF 1000 mg/130 mg effervescent granules for oral solution

Paracetamol/Caffeine
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 other people, even if their symptoms are the same as yours, because it could be dangerous.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

1. What Tachicaf is and what it is used for

Tachicaf contains two active substances: paracetamol and caffeine.
Paracetamol acts to relieve pain, and caffeine enhances the effect of paracetamol.
Tachicaf is used in adults and adolescents over 15 years of age for all types of pain (for example, headache, joint, bone and muscle pain, toothache, menstrual pain, post-surgical pain).
Consult a doctor if you do not feel better or if you feel worse.

2. What you should know before taking Tachicaf

Do not take Tachicaf

• if you are allergic to paracetamol, caffeine, or any of the other ingredients of this medicine (listed in section 6)
• if the person taking the medicine is under 15 years of age
• if you suffer from severe haemolytic anaemia (a disease caused by the destruction of certain blood cells, red blood cells)
• if you suffer from severe liver disease (severe hepatic insufficiency)
• if you have phenylketonuria, as Tachicaf contains a sweetener (aspartame) which is a source of phenylalanine, a substance that cannot be metabolized by people with this condition (see section “Tachicaf contains maltitol, sodium and aspartame”).

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

• if you suffer from glucose-6-phosphate dehydrogenase deficiency (a substance normally present in the human body, whose deficiency may cause a blood disorder)
• if you suffer from liver diseases that reduce liver function (mild/moderate hepatic insufficiency, Gilbert's syndrome)
• if you suffer from reduced kidney function (mild/moderate renal insufficiency)
• if you are concurrently being treated with any other medicine (see “Other medicines and Tachicaf”).

During treatment with Tachicaf, inform your doctor immediately if:
You suffer from serious conditions, including severe kidney impairment or sepsis (when bacteria and their toxins circulate in the blood causing organ damage), or if you suffer from malnutrition, chronic alcoholism, or 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 regularly for prolonged periods or when paracetamol is taken in combination with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties with rapid, deep breathing, drowsiness, nausea and vomiting.
Use of high doses and/or prolonged use
Taking high doses and/or prolonged use of this medicine may cause liver disorders (hepatopathy) and serious changes affecting the kidneys and blood. In such cases, your doctor will periodically monitor, through appropriate tests, liver and kidney function and blood composition. In addition, your doctor will check for any symptoms related to excessive levels of caffeine in the blood (see sections “If you take more Tachicaf than you should” and “Possible side effects”).
Before taking this medicine, inform your doctor if the person taking the medicine suffers from kidney or liver disease.
Children and adolescents
Do not give Tachicaf to children and adolescents under 15 years of age (see section “Do not take Tachicaf”).
Other medicines and Tachicaf
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
In particular, inform your doctor if you are taking:

• medicines containing paracetamol. During treatment with paracetamol, check before taking any other medicine whether it contains paracetamol, as taking paracetamol in high doses may lead to serious adverse effects;
• medicines that slow down stomach emptying (e.g. anticholinergics, opioids), as these medicines delay the effect of Tachicaf;
• medicines that speed up stomach emptying (e.g. prokinetics), as these medicines accelerate the effect of Tachicaf;
• 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 used to treat HIV);
• oral anticoagulants, which are medicines used to make the blood less likely to clot. In this case, especially during prolonged treatment and high-dose paracetamol use (4 g daily for at least 4 days), take Tachicaf only under strict medical supervision;
• clozapine (a medicine used to treat mental disorders), as it may increase the risk of adverse effects;
• lithium (a medicine used to treat mental disorders), as it may reduce the effect of lithium;
• flucloxacillin (an antibiotic), due to a serious risk of blood and fluid abnormalities (called high anion gap metabolic acidosis) which requires urgent treatment.

Interference with blood tests
If the person taking the medicine needs to undergo blood tests, be aware that administration of paracetamol may interfere with the measurement of uric acid and blood glucose levels.
Tachicaf with food, drinks and alcohol
During treatment with Tachicaf, avoid consuming excessive amounts of coffee, tea, or other substances containing caffeine.
In addition, take Tachicaf with caution and only under strict medical supervision if you are an alcohol abuser.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
If necessary, Tachicaf may be used during pregnancy. It is advisable to use the lowest possible dose that relieves pain and/or fever, and to take it for the shortest possible time.
Contact your doctor if pain and/or fever do not decrease or if you need to take the medicine more frequently.
Driving and using machines
Tachicaf does not normally affect the ability to drive or operate machinery. However, bear in mind that dizziness may occur.
Tachicaf contains maltitol, sodium and aspartame
Maltitol: if your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.
Sodium: this medicine contains 15 mmol (or 345 mg) of sodium per sachet. This should be taken into account in individuals with reduced kidney function or those following a low-sodium diet.
Aspartame: this medicine contains a source of phenylalanine. It may be harmful if you have phenylketonuria.

3. How to take Tachicaf

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 sachet, to be dissolved in water, 1–2 times daily; in more severe cases, the dose may be increased up to 3 sachets per day.
The interval between doses must not be less than four hours.

If you take more Tachicaf than you should
If you accidentally take an excessive dose of Tachicaf, 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:

• loss or reduction of appetite (anorexia)
• nausea
• vomiting
• profound deterioration in general condition
• yellowish coloration of the skin and eyes (elevated blood bilirubin levels)
• alterations in blood laboratory values (reduced blood prothrombin levels, increased liver transaminases, lactate dehydrogenase enzyme, and bilirubinemia)
• severe liver disease (which may lead to serious conditions: hepatocellular failure, metabolic acidosis, and encephalopathy), eventually resulting in coma and death.

Additionally, you may experience the following adverse effects due to excessive levels of caffeine in the blood:

• anxiety, restlessness, insomnia, which usually disappear shortly after discontinuation of treatment
• disturbances in heart rate and rhythm (tachycardia, arrhythmia)
• increased urine production
• gastrointestinal disturbances.

Treatment
Depending on the nature and severity of symptoms, the doctor will provide appropriate supportive therapy.

Note for healthcare professionals: The specific antidote in case of paracetamol poisoning is intravenous N-acetylcysteine: dosage is 150 mg/kg intravenously in glucose solution over 15 minutes, followed by 50 mg/kg over the next 4 hours, and then 100 mg/kg over the subsequent 16 hours, for a total dose of 300 mg/kg over 20 hours. In case of caffeine poisoning, early gastric decontamination is recommended, along with supportive therapy.

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 immediately and contact your doctor without delay:

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

In addition, very rare cases of serious skin reactions have been reported.
Patients taking this medicine may experience the following side effects, for which insufficient data are available to determine frequency.

Effects related to 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 intestine

• 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 available data): severe condition causing the blood to become more acidic (called metabolic acidosis), in patients with severe illness using paracetamol (see section 2).

In addition, you may experience the following side effects, the occurrence of which may be avoided by reducing your daily intake of coffee, tea, or other caffeine-containing substances during treatment with Tachicaf.

Effects related to the mind

• insomnia
• restlessness
• excitement.

Effects related to the heart

• increased heart rate (tachycardia)
• irregular heart rhythm, i.e. changes in the number of heartbeats per minute (arrhythmia).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website:
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 Tachicaf

Keep this medicine out of the sight and reach of children.
Store below 30°C.
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 you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Tachicaf contains

• The active substances are: paracetamol and caffeine (each sachet contains 1000 mg of paracetamol and 130 mg of caffeine).
• The other components are: maltitol, sodium bicarbonate, sodium docusate, aspartame (see section “Tachicaf contains maltitol, sodium and aspartame”), mannitol, anhydrous citric acid, citrus flavour, simeticone emulsion.

Description of the appearance of Tachicaf and contents of the pack
Tachicaf is an effervescent granulate for oral use, white to slightly yellow in colour.
The granulate is contained in sachets packed in cartons containing 10, 12, 16 or 20 sachets.
Not all pack sizes may be marketed.

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

Manufacturer
A.C.R.A.F. S.p.A. – Via Vecchia del Pinocchio, 22 - 60131 Ancona, Italy
FINE FOODS & PHARMACEUTICALS N.T.M. S.P.A.
Via Grignano, 43 - 24041 Brembate (BG), Italy