Effernalcaps

Package leaflet: Information for the user

EFFERALCAPS 1000 mg, hard capsules

paracetamol
Please read this leaflet carefully before using 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, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What EFFERALCAPS is and what it is used for

Pharmacotherapeutic category: OTHER ANALGESICS AND ANTIPYRETICS, ANILIDES, ATC code:
N02BE01
EFFERALCAPS contains the active substance paracetamol and is indicated in adults and adolescents weighing 50 kg or more (aged 15 years or older) for the relief of mild to moderate pain and for reducing fever.
For children weighing less than 50 kg or aged under 15 years, other medicines are available: please consult your doctor or pharmacist.
It is recommended to always follow the doctor's instructions. Consult your doctor if pain persists for more than 5 days, fever for more than 3 days, or if pain or fever worsen or new symptoms occur.

2. What you need to know before using EFFERALCAPS

Do not use EFFERALCAPS:

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

Warnings and precautions
Talk to your doctor or pharmacist before using EFFERALCAPS. EFFERALCAPS is not suitable for
children weighing less than 50 kg or under 15 years of age.
During treatment with EFFERALCAPS, inform your doctor immediately if you suffer from serious
illnesses, including severe renal 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 (a blood and fluid imbalance) has been reported when paracetamol is used regularly over a prolonged period or when paracetamol is taken concomitantly with
flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties 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 paracetamol.
Check that you are not taking other medicines containing paracetamol, including those obtained
without a prescription.
Do not combine these medicines to avoid exceeding the recommended daily dose. If you need to take other
medicines containing these substances, you must first consult your doctor or pharmacist. (See
section 3 "How to use EFFERALCAPS")
Prolonged, incorrect, and/or high-dose use of this medicine in patients with chronic headache
may increase and/or worsen headache. In such 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:

• weigh less than 50 kg,
• have mild to moderate hepatocellular insufficiency (liver disease),
• have Gilbert's syndrome (familial non-haemolytic jaundice),
• have renal impairment (kidney disease),
• have glucose-6-phosphate dehydrogenase deficiency,
• have chronic alcoholism, or have recently stopped consuming alcohol,
• have anorexia, bulimia, cachexia (a state of severe physical weakness), or chronic malnutrition (low hepatic glutathione reserves),
• are dehydrated or hypovolemic (reduced total blood volume),
• are receiving concomitant treatment with medicines affecting liver function (e.g. potentially hepatotoxic medicines or medicines inducing cytochrome P450 enzymes such as phenobarbital, phenytoin, carbamazepine, topiramate, rifampicin),
• are elderly,
• have acute viral hepatitis. If you are diagnosed with acute viral hepatitis during treatment with EFFERALCAPS, consult your doctor. Your doctor may discontinue treatment.

Alcohol consumption during treatment is not recommended.
Paracetamol may cause serious skin reactions. If you develop a skin rash or other signs of
allergy, stop treatment and contact your doctor immediately.
Children and adolescents
In children and adolescents treated with paracetamol, combining it with another antipyretic is not
justified, except in cases of inefficacy. In such cases, consult your doctor.
Other medicines and EFFERALCAPS
Inform your doctor or pharmacist if you are taking, have recently taken, or might take
any other medicine.
Medicines that may affect the effects of EFFERALCAPS:

• probenecid (a medicine used to treat gout). A reduction in the dose of EFFERALCAPS 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). Simultaneous use of these medicines or other potentially toxic medicines with paracetamol may cause liver damage.
• zidovudine (AZT, a medicine used to treat HIV infections). Concurrent use of paracetamol and AZT increases the tendency to reduced white blood cells (neutropenia). Therefore, EFFERALCAPS should be used concurrently 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 EFFERALCAPS.
• medicines that slow down stomach emptying may delay the absorption and onset of effect of EFFERALCAPS.
• colestyramine (a medicine used to reduce elevated serum lipid levels) may reduce the absorption and onset of effect of EFFERALCAPS. Therefore, do not take colestyramine within one hour of paracetamol administration.
• oral anticoagulants, particularly warfarin (medicines that thin the blood). Repeated use of paracetamol for more than one week increases the tendency to bleeding. Therefore, long-term administration of paracetamol should only occur under medical supervision. Occasional use of paracetamol has no significant effect on bleeding tendency.
• acetylsalicylic acid and salicylamide (medicines for the treatment of pain and fever). A reduction in the dosage of acetylsalicylic acid or salicylamide may be necessary, as advised by the doctor.
• chloramphenicol (an antibiotic agent). A reduction in the dosage of chloramphenicol may be necessary, as advised by the doctor.
• medicines used to increase urine elimination (loop diuretics such as those belonging to the furosemide group).
• propranolol (used to treat high blood pressure and heart rhythm disorders).
• flucloxacillin (an antibiotic), due to a serious risk of blood and fluid abnormalities (called metabolic acidosis), which require urgent treatment (see section 2).

Effect of taking EFFERALCAPS on laboratory tests:
If your doctor prescribes blood tests for uric acid or blood sugar levels for you or the child, inform them that you or the child is taking this medicine.
EFFERALCAPS with food, drinks, and alcohol
Avoid consuming alcoholic beverages during the treatment period.
Pregnancy, breastfeeding, and fertility
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before using this medicine.
Pregnancy
If necessary, EFFERALCAPS 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 duration. Contact your doctor if pain and/or fever do not subside or if you need to take the medicine more frequently.
Breastfeeding
Paracetamol passes into breast milk in small amounts. Skin rash has been reported in breastfed infants. However, administration of paracetamol is considered compatible with breastfeeding. Nevertheless, paracetamol should be used with caution in breastfeeding women.
Fertility
Paracetamol may possibly alter female fertility, reversible upon discontinuation of treatment.
Driving and using machines
Paracetamol does not affect or affects negligibly the ability to drive and use machines.
EFFERALCAPS contains sodium and azorubine/carmoisine (E122).
This medicine contains an azo dye (E122 azorubine/carmoisine) 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 EFFERALCAPS

Take this medicine exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
This medicine is intended for adults and adolescents weighing 50 kg or more and aged 15 years or older.
WARNING: this formulation contains 1000 mg of paracetamol (1 g) in each hard capsule: do not take 2 hard capsules simultaneously.
The lowest effective dose should be used for the shortest possible duration.

Age
Dose per Dosing Maximum daily
administration interval dose
Adults 1 hard capsule 3 hard capsules
(minimum 4 hours) (3000 mg)
The maximum daily dose of paracetamol must not exceed 3000 mg 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 feel that the effect of EFFERALCAPS is too strong or too weak, consult your doctor or pharmacist.
Check that you are not taking other medicines containing paracetamol, including those obtained without a prescription.
Do not combine these medicines to avoid exceeding the recommended daily dose. If you need to take other medicines containing paracetamol, consult your doctor or pharmacist first.
DO NOT TAKE MORE THAN 4 GRAMS OF PARACETAMOL PER DAY (taking into account all other medicines containing paracetamol in their composition).

Children and adolescents
For children weighing 50 kg or more (aged 15 years or older): refer to the dosing instructions below.

Age and weight
Dose per Dosing Maximum daily
administration interval dose
1 hard capsule 3 hard capsules
Adolescents ≥ 50 kg (≥15 years) (1000 mg) minimum 4 hours (3000 mg)
For children weighing less than 50 kg (or aged under 15 years): paracetamol medicines with lower dosages should be used; consult your doctor or pharmacist.

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

Hepatic impairment, chronic alcoholism, Gilbert's syndrome (familial non-haemolytic jaundice)
In case of hepatic impairment, and particularly in adults weighing less than 50 kg, chronic alcoholism, malnutrition (low hepatic glutathione stores), dehydration, or Gilbert's syndrome (familial non-haemolytic jaundice), do not exceed 2000 mg of paracetamol per day (2 hard capsules). If in doubt, consult your doctor or pharmacist.

Renal impairment
In case of renal impairment (kidney disease), consult your doctor, who will adjust the dosage and dosing intervals. The minimum interval between doses should be adjusted according to creatinine clearance (a parameter defining the severity of renal impairment):

Creatinine clearance (cl) Dosing interval Maximum daily dose
cl 10–50 ml/min 6 hours 3000 mg (3 g)/day
cl <10 ml/min 8 hours 2000 mg (2 g)/day

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

If you take more EFFERALCAPS than you should
Stop treatment immediately and consult your doctor immediately or go as quickly as possible to an Emergency Room.
An overdose can be fatal.
Within the first 24 hours, the main symptoms of poisoning are: nausea, vomiting, anorexia, pallor, malaise, sweating, and abdominal pain.
Paracetamol overdose can cause liver damage, brain damage, coma, and even death, particularly in vulnerable populations such as young children, the elderly, and in certain conditions (liver or kidney disease, chronic alcoholism, chronic malnutrition, fasting, recent weight loss, Gilbert's syndrome, and in patients receiving concomitant treatment with certain drugs). Rare cases of pancreatic damage have also been reported.

If you forget to take EFFERALCAPS
Do not take a double dose to make up for the forgotten capsule.

If you stop taking EFFERALCAPS
Not applicable.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

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

• Skin redness, skin rash, urticaria. Treatment must be stopped immediately.
• Blood spots on the skin. Treatment must be stopped immediately.
• Diarrhoea, abdominal pain.
• Malaise.
• Drop in 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 certain white blood cells or of certain blood components such as platelets, which may cause nosebleeds or bleeding gums.
• Severe skin reactions. Treatment must be stopped immediately.
• Blood and fluid abnormalities (metabolic acidosis with high anion gap) occurring when plasma acidity increases, when paracetamol is used concomitantly with flucloxacillin, usually in the presence of risk factors (see section 2).
• Kidney disease.
• Cloudy urine.
• Yellowing of the skin (jaundice).
• Decrease in blood sugar (hypoglycaemia).

Frequency not known: frequency cannot be estimated from 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 must be stopped immediately.
• Excessive (and prolonged) contraction of the airway muscles causing breathing difficulty (bronchospasm).
• Reddish-purple skin patch recurring in the same body area.
• Increase in liver enzymes.
• Severe condition that may make the blood more acidic (called metabolic acidosis).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . Reporting side effects can help provide more information on the safety of this medicine.

5. How to store EFFERALCAPS

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
Do not store above 30°C.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What EFFERALCAPS contains

• The active substance is: paracetamol 1000 mg per hard capsule
• The other components are: hydroxypropylcellulose, sodium croscarmellose*, glycerol dibehenate, magnesium stearate, colloidal anhydrous silica, film-coating agent. *See section 2.

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

Description of the appearance of EFFERALCAPS and contents of the pack
This medicine is a red hard capsule. Packs of 8, 16, 24, 32, 40 capsules.
Not all pack sizes may be marketed.

Marketing Authorization Holder
UPSA S.A.S. - 3, rue Joseph Monier, Rueil Malmaison (France)
represented in Italy by
UPSA ITALY S.R.L. - Viale Luca Gaurico 91/93 – 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