PARACETAMOLO 500 mg Coated Tablet

Зміст інструкції

1. What is Paracetamolo Pensavital and what is it used for
2. What you need to know before you take Paracetamolo Pensavital
3. How to take Paracetamolo Pensavital
4. Possible side effects
5. How to store Paracetamolo Pensavital
6. Package Contents and Other Information

Paracetamolo Pensavital 500 mg tablets
paracetamol
Generic medicine

Read this leaflet carefully before taking this medicine as it contains important
information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or
pharmacist has told you.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• Talk to your doctor if you do not feel better or if your symptoms worsen after 3 days.

Contents of this leaflet:

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

1. What is Paracetamolo Pensavital and what is it used for

Paracetamol is a medicine that works by relieving pain and reducing fever (analgesic and
antipyretic).
Paracetamolo Pensavital is used to reduce mild to moderate pain and/or fever in adults and in
children aged 10 years and over ( or weighing more than 33 kg).

2. What you need to know before you take Paracetamolo Pensavital

Do not take Paracetamolo Pensavital

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

Warnings and precautions
Talk to your doctor or pharmacist before taking Paracetamolo Pensavital:
if you suffer from kidney problems
if you suffer from heart or lung diseases
if you suffer from liver disease or if you are taking medicines that alter liver function
if you suffer from anemia (a reduction in red blood cells that can make the skin pale yellow and
cause weakness or shortness of breath)
if you regularly consume large amounts of alcohol. Chronic alcoholics should be careful not to
take more than 2 g of paracetamol every 24 hours.
if you are taking other medicines containing paracetamol, as they can seriously damage the
liver
if you are asthmatic and sensitive to acetylsalicylic acid (aspirin).
Do not take paracetamol frequently for prolonged periods, as prolonged or frequent use can cause liver problems. Talk to your doctor or pharmacist if you intend to
take paracetamol for a longer period.
Do not use Paracetamolo Pensavital without talking to a doctor if you have alcohol problems or if your liver
is damaged. Do not use Paracetamolo Pensavital with alcohol. The effect of alcohol does not increase with
taking Paracetamolo Pensavital.
higher is not increase the effectiveness for pain, instead it can cause serious liver damage. Symptoms of liver damage usually appear after a couple of days. Therefore, it is very important that you contact your doctor
as soon as possible if you have taken a higher dose than recommended.
In case of high fever or signs of infection after more than 3 days of treatment or if the pain persists after
more than 5 days of treatment, you should contact your doctor.

Children
Do not use in children under 10 years of age. For children under 10 years of age, consult your
doctor or pharmacist as there are other presentations with doses more suitable for this group of patients.

Other medicines and Paracetamolo Pensavital
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.

Do nottake any other medicine containing paracetamol.
Paracetamolo Pensavital can affect or be affected by other medicines. Tell your doctor or
pharmacist if you are taking:
metoclopramide or domperidone (used to treat nausea (feeling sick) or vomiting (feeling sick));

• cholestyramine (used to reduce cholesterol levels in the blood). This medicine should be taken at least one hour before or after paracetamol.
• warfarin and other medicines used to thin the blood, if you need to take a pain reliever every day for a long period
• medicines used to increase urine output (loop diuretics such as those belonging to the furosemide group)
• probenecid (used to treat gout)
• substances that induce liver enzymes e.g. rifampicin (used to treat infections) and medicines for the treatment of epilepsy such as barbiturates, phenytoin, carbamazepine, primidone
• lamotrigine (for the treatment of epilepsy), as paracetamol may reduce its effects
• propranolol (used to treat high blood pressure and heart rhythm disorders)
• flucloxacillin (an antibiotic), due to a serious risk of alterations in blood and fluids (metabolic acidosis with high anion gap) which must be treated urgently and which may occur particularly in case of severe renal impairment, sepsis (when bacteria and their toxins circulate in the blood causing organ damage), malnutrition, chronic alcoholism and if you take the maximum daily dose of paracetamol.

Paracetamolo Pensavital can interfere with some laboratory tests, such as the determination of uric acid
and blood glucose.

Paracetamolo Pensavital with food and alcohol
The use of paracetamol in patients who regularly consume alcohol (3 or more alcoholic drinks per
day – beer, wine, spirits… daily) can cause liver damage.
Taking this medicine with food does not alter its effectiveness.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
If necessary, paracetamol can be used during pregnancy. It is advisable to use the lowest possible dose
that reduces pain and/or fever and take it for the shortest possible time. Contact your doctor if the pain
and/or fever does not decrease or if you need to take the medicine more often.
Although paracetamol is excreted in breast milk in small amounts, no adverse effects have been
reported in infants. Paracetamol at recommended doses can be used briefly during
breastfeeding.

Driving and using machines
Paracetamol does not alter or negligibly alters the ability to drive vehicles or use machines.

Paracetamolo Pensavital contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

3. How to take Paracetamolo Pensavital

Take this medicine following exactly as indicated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Treatment should be started with the lowest effective dose.
The recommended dose is:
Adults and adolescents aged 15 years or over:
Take one or two tablets every 4-6 hours (3-4 times a day) but do not exceed the maximum daily dose of 6 tablets (3000 mg).
Children aged 12 years or over (or weighing over 40 kg):
Take one 500 mg tablet up to 6 times a day.
The maximum daily dose should not exceed 6 tablets (3000 mg).
Children aged between 10 and 12 years (or weighing between 33 kg and 40 kg):
Take one 500 mg tablet up to 4 times a day.
The maximum daily dose should not exceed 4 tablets (2000 mg).
Oral use. The tablets should be taken with a glass of liquid, preferably water.
This medicine is not recommended for use by children under 10 years of age.
At least 4 hours should elapse between two administrations.
Do not use in combination with other products containing paracetamol.
Do not exceed the indicated dosage.
Patients with impaired renal or hepatic function
In patients with impaired renal or hepatic function, the dose should be reduced or the interval between administrations should be increased. In patients with severely impaired renal function, the interval between administrations of Paracetamolo Pensavital should be at least 8 hours. Ask your doctor or pharmacist for advice.
Follow the instructions given here, unless your doctor has given you other advice.
Consult your doctor or pharmacist if you think this medicine is too strong or too weak.

If you take more Paracetamolo Pensavital than you should
In case of taking an excessive dose of paracetamol, contact your doctor or pharmacist immediately. Even if you feel well, you may risk liver damage.
To prevent liver damage, it is important that the doctor can start treatment as soon as possible (preferably within 10-12 hours of the overdose).
Symptoms of overdose may include: nausea (feeling unwell), vomiting (feeling unwell), anorexia (loss of appetite), yellowing of the skin and eyes (jaundice), abdominal pain and risk of kidney or liver damage. In this case, the patient should go to hospital immediately.
Patients undergoing treatment with barbiturates or chronic alcoholics may be more susceptible to the toxicity of a paracetamol overdose.

If you forget to take Paracetamolo Pensavital
Do not take a double dose to make up for a missed dose.
If you have any further questions on 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.
This medicine may cause the following side effects:
Rare (may affect up to 1 in 1,000 people): discomfort, low blood pressure (hypotension) and
increased levels of transaminases in the blood.
Very rare (may affect up to 1 in 10,000 people): kidney diseases, cloudy urine, allergic dermatitis
(skin rash), jaundice (yellowing of the skin), blood disorders (agranulocytosis, leukopenia,
neutropenia, hemolytic anemia) and hypoglycemia (low blood sugar). There have been very rare cases of
serious skin reactions.
Paracetamol may cause liver damage if taken at high doses or for prolonged treatments.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your
doctor or pharmacist. 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 Pensavital

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 after Exp. The expiry date
refers to the last day of that month.
This medicine does not require any particular storage conditions
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. Package Contents and Other Information

What Paracetamolo Pensavital Contains
The active ingredient is paracetamol.
The other ingredients are sodium carboxymethylcellulose (Type A), purified water, pregelatinized starch,
povidone K30 (E1201), stearic acid (E570), crospovidone (E1202).

Description of the Appearance of Paracetamolo Pensavital and Package Contents
Paracetamolo Pensavital presents as white, biconvex, round tablets, with PA imprinted on one
side, having a diameter of 11.0 ± 0.5 mm.
Paracetamolo Pensavital is available in blisters of 20 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Towa Pharmaceutical S.p.A.
Via Enrico Tazzoli, 6
20154 Milano
Italy

Manufacturer
Galenicum Health, S.L.
Avda. Cornell á 144, 7 º -1 ª , Edificio Lekla
Esplugues de Llobregat
08950 Barcelona
Spain
or
SAG Manufacturing S.L.U
Crta. N-I, Km 36,
San Agust í n de Guadalix,
28750 Madrid
Spain

This medicinal product is authorised in the Member States of the European Economic Area under the following
names:

• Portugal: Paracetamol Amperlem 500 mg Comprimidos
• Italy: Paracetamolo Pensavital

Detailed and updated information on this product is available by scanning the QR
Code on the outer packaging with a smartphone. The same information is also available
at the following URL:

https://www.pensapharma.it/paracetamolo-pensavital-500mgcompresse/