PARACETAMOLO 1000 mg Hard Capsules

Зміст інструкції

1. PARACETAMOLO SKILLPHARMA 1000 mg, hard capsules
   1. What is PARACETAMOLO SKILLPHARMA and what is it used for
   2. What you need to know before using PARACETAMOLO SKILLPHARMA
   3. How to use PARACETAMOLO SKILLPHARMA
   4. Possible side effects
   5. How to store PARACETAMOLO SKILLPHARMA
   6. Contents of the pack and other information

PARACETAMOLO SKILLPHARMA 1000 mg, hard capsules

paracetamol

Read this leaflet carefully before using this medicine as 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What is PARACETAMOLO SKILLPHARMA and what is it used for

Pharmacotherapeutic category: OTHER ANALGESICS AND ANTIPYRETICS, ANILIDES, ATC code:
N02BE01
PARACETAMOLO SKILLPHARMA contains the active ingredient paracetamol, it is indicated in
adults and adolescents weighing 50 kg or more (aged 15 years or older), for
relieving mild to moderate pain and for reducing fever.
For children weighing less than 50 kg or under 15 years of age, other medicines are available:
ask your doctor or pharmacist for advice.
It is recommended to always follow your doctor's prescription. Consult your doctor if the pain persists
for more than 5 days, the fever for more than 3 days, or the pain or fever worsens or other symptoms appear.

2. What you need to know before using PARACETAMOLO SKILLPHARMA

Do not use PARACETAMOLO SKILLPHARMA:

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

Warnings and precautions
Consult your doctor or pharmacist before using PARACETAMOLO SKILLPHARMA.
PARACETAMOLO SKILLPHARMA is not suitable for children weighing less than 50 kg or under the age of 15.
During treatment with PARACETAMOLO SKILLPHARMA, immediately inform your doctor if you suffer from serious illnesses, including severe kidney impairment or sepsis (when bacteria and their toxins circulate in the blood causing organ damage) or if you are malnourished, a chronic alcoholic, or if you are also taking flucloxacillin (an antibiotic). In patients in these situations, a serious condition called metabolic acidosis (an abnormality of the blood and fluids) has been reported when paracetamol is used at regular doses for a prolonged period or when paracetamol is taken in association with flucloxacillin. The symptoms of metabolic acidosis may include: severe difficulty breathing with rapid, deep breathing, drowsiness, nausea and vomiting.
In case of overdose or if you have accidentally taken an excessive dose, consult your doctor immediately.

This medicine contains paracetamol. Other medicines also contain it.
Checkthat you are not taking other medicines containing paracetamol, including those obtained without a prescription.
Do not combinethese medicines in order not to exceed the recommended daily dose. If you need to take other medicines containing these substances, you should first ask your doctor or pharmacist for advice.

(See section 3 "How to use PARACETAMOLO SKILLPHARMA")
Prolonged, incorrect and/or high-dose use of this drug in patients with chronic headaches may increase and/or worsen the headache. In these cases, do not increase the dose of painkillers and consult your doctor.

Before using this medicine, you must inform your doctor or pharmacist if you have:

• a body weight of less than 50 kg,
• mild to moderate hepatic insufficiency (liver disease),
• Gilbert's syndrome (non-hemolytic familial jaundice),
• kidney impairment (kidney disease),
• glucose-6-phosphate dehydrogenase deficiency,
• chronic alcoholism, or if you have recently stopped drinking alcohol,
• anorexia, bulimia, cachexia (state of severe weakening of the body) or chronic malnutrition (low hepatic glutathione reserves),
• dehydration and hypovolemia (reduction in total blood volume),
• concomitant treatment with medicines that affect liver function (e.g. potentially hepatotoxic medicines or medicines that induce cytochrome P450 enzymes such as phenobarbital, phenytoin, carbamazepine, topiramate, rifampicin),
• are elderly,
• acute viral hepatitis. If you are diagnosed with acute viral hepatitis during treatment with PARACETAMOLO SKILLPHARMA, consult your doctor. The doctor may discontinue treatment.

Consumption of alcohol during treatment is not recommended.
Paracetamol may cause serious skin reactions. If you develop a rash or other signs of allergy, stop treatment and contact your doctor immediately.

Children and adolescents
In children and adolescents treated with paracetamol, the association with another antipyretic is not justified, unless in case of ineffectiveness. In this case, ask your doctor for advice.

Other medicines and PARACETAMOLO SKILLPHARMA
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
Medicines that can affect the effects of PARACETAMOLO SKILLPHARMA:

• probenecid (a medicine used to treat gout). A reduction in the dose of PARACETAMOLO SKILLPHARMA may be necessary as probenecid increases serum levels of paracetamol.
• phenobarbital, phenytoin, carbamazepine, primidone (medicines used to treat epilepsy) and rifampicin (a medicine used to treat tuberculosis). The simultaneous use of these medicines or other potentially toxic medicines with paracetamol can cause liver damage.
• zidovudine (AZT, a medicine used to treat HIV infections). The concomitant use of paracetamol and AZT increases the tendency to reduce white blood cells (neutropenia). PARACETAMOLO SKILLPHARMA should therefore be used simultaneously with zidovudine only on medical advice.
• metoclopramide (a medicine used to treat nausea) and other medicines that accelerate gastric emptying, may increase the absorption and onset of effect of PARACETAMOLO SKILLPHARMA.
• medicines that slow down gastric emptying, may delay the absorption and onset of effect of PARACETAMOLO SKILLPHARMA.
• cholestyramine (a medicine used to reduce high levels of serum lipids), may decrease the absorption and onset of effect of PARACETAMOLO SKILLPHARMA. Therefore, you should not take cholestyramine within one hour of administering paracetamol.
• oral anticoagulants, in particular warfarin (blood-thinning medicines). Repeated intake of paracetamol for more than one week increases the tendency to bleed. Therefore, long-term administration of paracetamol should only occur under medical control. Occasional intake of paracetamol has no significant effects on the tendency to bleed.
• acetylsalicylic acid and salicylamide (medicines for the treatment of pain and fever). A reduction in the dosage of acetylsalicylic acid, salicylamide may be necessary by the doctor.
• chloramphenicol (an antibiotic agent). A reduction in the dosage of chloramphenicol may be necessary by the doctor.
• medicines used to increase urine excretion (loop diuretics such as those belonging to the furosemide group).
• propranolol (used to treat high blood pressure and heart rhythm disorders).
• flucloxacillin (antibiotic), due to a serious risk of blood and fluid abnormality (called metabolic acidosis) (which must be treated urgently (see section 2).

Effect of taking PARACETAMOLO SKILLPHARMA on laboratory tests:
If your doctor prescribes a measurement of uric acid or sugar levels in your blood, inform them that you or the child are taking this medicine.

PARACETAMOLO SKILLPHARMA with food, drinks and alcohol
Abstain from drinking alcoholic beverages during the treatment period.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
If necessary, PARACETAMOLO SKILLPHARMA can be used in pregnancy. It is advisable to use the lowest possible dose that relieves pain and/or fever and take it for the shortest possible time.
Contact your doctor if the pain and/or fever does not subside or if you need to take the medicine more often.
Breastfeeding
Paracetamol passes in small amounts into breast milk. Skin rash has been reported in children breastfed by mothers taking paracetamol. However, the administration of paracetamol is considered compatible with breastfeeding. Paracetamol in breastfeeding women should still be used with caution.
Fertility
Paracetamol may alter female fertility, reversible with discontinuation of treatment.

Driving and operating machinery
Paracetamol does not impair or negligibly impairs the ability to drive vehicles and operate machinery.

PARACETAMOLO SKILLPHARMA contains sodium and azo dye/carmine (E122).
This medicine contains an azo dye (E122 azo rubine/carmine) and may cause allergic reactions.
This medicine contains less than 1 mmol of sodium (23 mg) per capsule, i.e. essentially “sodium-free”.

3. How to use PARACETAMOLO SKILLPHARMA

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, ask your doctor or pharmacist.
This medicine is reserved for adults and adolescents starting from 50 kg, aged 15 years or
over.

WARNING: this formulation contains 1000 mg of paracetamol (1 g) in each hard
capsule: do not take 2 hard capsules at the same time.
The lowest effective dose should be used, for the shortest possible duration.

Age
Dose per
administration
Interval of
administration
Maximum daily
dose
Adults1 hard capsule
(1000 mg)
minimum 4 hours

3 hard capsules
(3000 mg)
The maximum daily dose of paracetamol should not exceed 3000mg per day, i.e. 3 hard
capsules per day or the dose prescribed by your doctor: in cases of more intense pain, your doctor may
increase the prescribed dose to 4 hard capsules per day (maximum dose).
If you think that the effect of PARACETAMOLO SKILLPHARMA is too strong or too weak, ask
your doctor or pharmacist.

Checksthat you are not taking any other medicines containing paracetamol, including those obtained
without a prescription.

Do not combinethese medicines in order not to exceed the recommended daily dose. If you need to take
other medicines containing paracetamol, you should first ask your doctor or pharmacist for advice.
DO NOT TAKE MORE THAN 4 GRAMS OF PARACETAMOL PER DAY (considering all
other medicines containing paracetamol in their composition).

Children and adolescents
In the case of children weighing 50 kg or more (aged 15 years or over): refer to the
dosage indicated below.

Age and weight
Dose per
administration
Interval of
administration
Maximum daily
dose
1 hard capsule 3 hard capsules

Adolescents ≥ 50 kg (≥15 years)(1000 mg) minimum 4 hours (3000 mg)
In the case of children weighing less than 50 kg (or under 15 years of age): medicines based on
paracetamol at lower dosages should be used; ask your doctor or pharmacist.

Adults weighing less than 50 kg and the elderly
In the case of adults weighing less than 50 kg and the elderly, the maximum daily dose of paracetamol should
not exceed 3000 mg per day, i.e. 3 hard capsules per day.

Hepatic insufficiency, chronic alcoholism, Gilbert's syndrome (non-hemolytic familial jaundice)
In case of hepatic insufficiency, and in particular, in the case of adults weighing less than 50 kg, chronic
alcoholism, malnutrition ( low hepatic glutathione reserves) or dehydration, Gilbert's syndrome ( familial

non-hemolytic jaundice) do not take more than 2000 mg of paracetamol per day (2 hard capsules). If
you are not sure, ask your doctor or pharmacist.

Renal impairment
In case of renal impairment ( kidney disease), consult your doctor who will adjust the doses and
intervals of administration. The minimum interval between two administrations must be modified
based on the value of creatinine clearance ( parameter that defines the severity of renal

insufficiency):

Creatinine clearanceInterval of
administration
Maximum daily
dose (cl)
cl 10-50 ml/min 6 hours
3000 mg (3g)/day
cl <10 ml/min 8 hours
2000 mg (2g)/day

Route of administration
Oral use.
The hard capsules must be swallowed whole with a drink (e.g. water, milk, fruit juice).

If you use more PARACETAMOLO SKILLPHARMA than you should
Stop treatment and consult immediatelyyour doctor or go to the nearest Emergency
Room as soon as possible.

An overdose can be fatal.
Within the first 24 hours, the main symptoms of intoxication are: nausea, vomiting, anorexia, pallor,
malaise, sweating, abdominal pain.
Paracetamol overdose can cause liver damage, brain damage, coma and even
death, in particularly vulnerable populations such as young children, the elderly and in certain
situations (liver or kidney disease, chronic alcoholism, chronic malnutrition, fasting, recent
weight loss, Gilbert's syndrome and in patients treated concurrently with certain drugs). Rare cases of
pancreas damage have also been reported.

If you forget to use PARACETAMOLO SKILLPHARMA
Do not use a double dose to make up for the forgotten hard capsule.

If you stop using PARACETAMOLO SKILLPHARMA
Not applicable.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Rare side effects:may affect up to 1 in 1,000 people

• skin redness, skin rashes, urticaria. Treatment should be stopped immediately.
• blood spots on the skin. Treatment should be stopped immediately.
• diarrhoea, abdominal pain.
• malaise.
• low blood pressure (hypotension).
• increased levels of transaminases in the blood.

Very rare side effects:may affect up to 1 in 10,000 people

• liver function disorders, abnormally low levels of some white blood cells or some blood components such as platelets, which can cause nosebleeds or bleeding gums.
• severe skin reactions. Treatment should be stopped immediately.
• alterations of blood and fluids (metabolic acidosis with elevated anion gap) that occur when there is an increase in plasma acidity, when paracetamol is used in combination with flucloxacillin, generally in the presence of risk factors (see section 2).
• kidney diseases.
• cloudy urine.
• yellowing of the skin (jaundice).
• low blood sugar (hypoglycemia).

Frequency not known:the frequency cannot be estimated on the basis of the available data

• severe allergic reactions with sudden swelling of the face and neck, or sudden malaise with a drop in blood pressure (anaphylactic shock). Treatment should be stopped immediately.
• excessive (and prolonged) contraction of the muscles of the airways causing difficulty breathing (bronchospasm).
• red-purple skin patch that recurs in the same place on the body.
• increased liver enzymes.
• severe condition that can make the blood more acidic (called metabolic acidosis).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. You can also report side effects directly through 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 PARACETAMOLO SKILLPHARMA

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 pack. The expiry date refers to the last day of that month.
Do not store at a temperature above 30°C.
Do not dispose of any medicine in waste water 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 the medicine containsPARACETAMOLO SKILLPHARMA

• The active ingredient is: paracetamol 1000 mg per hard capsule
• The other ingredients are: hydroxypropylcellulose, sodium croscarmellose*, dibeenate glycerol, magnesium stearate, hydrophobic colloidal silica, film-forming agent. *See paragraph 2.

Composition of the film-forming agent: hypromellose, hydroxypropylcellulose, polyethylene glycol.
Composition of the hard capsule: gelatin, azorubine/carmine (E122)*, yellow iron oxide and red iron oxide.
*See paragraph 2.

Description of the appearance of PARACETAMOLO SKILLPHARMA and contents of the pack
This medicine is presented in the form of a red hard capsule. Pack sizes of 8, 16, 24, 32,
40 capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Skillpharma S.r.l.
Via Umberto Saba 4, 00144, Rome

Manufacturer
UPSA S.A.S., 979, Avenue des Pyrénées, 47520 Le Passage, France
UPSA S.A.S., Avenue du Docteur Jean Bru 304, 47000 Agen, France