PARACETAMOLO 1000 mg Tablets

Зміст інструкції

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

PARACETAMOLO PENSA PHARMA 1000 mg
tablets
Paracetamol
Generic medicine

Read this leaflet carefully before taking 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 you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What is Paracetamolo Pensa Pharma and what is it used for?

Paracetamolo is a medicine that works by relieving pain and reducing fever (analgesic and
antipyretic).
Paracetamolo Pensa Pharma is used in adults to reduce mild to moderate pain and/or fever.

2. What you need to know before you take

Do not take Paracetamolo Pensa Pharma

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

Warnings and precautions
Talk to your doctor or pharmacist before taking Paracetamolo Pensa Pharma:
if you suffer from kidney problems.
if you suffer from heart or lung problems.
if you suffer from liver disease or if you are being treated concurrently with medicines that alter
liver function.
if you suffer from anemia (a condition due to 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 pay particular
attention to not taking more than 2 g of paracetamol every 24 hours.
if you are taking a medicine for the treatment of epilepsy, consult your doctor before taking
this medicine, because if used at the same time, the effectiveness is reduced and the hepatotoxicity of
paracetamol is increased, especially in treatments with high doses of paracetamol.
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 or for prolonged periods of time, because prolonged or frequent use of this medicine can cause liver disorders. Talk to your doctor or pharmacist if
you intend to take paracetamol for a prolonged period.
Do not use Paracetamolo Pensa Pharma without talking to a doctor if you have alcohol problems or if your liver
is damaged. Do not use Paracetamolo Pensa Pharma with alcohol. The effect of alcohol is not increased with
the intake of Paracetamolo Pensa Pharma.
a higher dose does not increase the effectiveness on 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.

Children and adolescents
Do not use in children or adolescents under 18 years of age.

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

Do nottake any other medicine containing paracetamol.
Paracetamolo Pensa Pharma can influence or be influenced by other medicines. In particular, tell
your doctor or pharmacist if you are taking:
metoclopramide or domperidone (to treat nausea (feeling sick) and vomiting (feeling sick));

• colestyramine (a medicine used to reduce cholesterol levels in the blood). Paracetamol must be taken one hour before or four hours after this medicine.
• warfarin and other medicines used to thin the blood, in case 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 can 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 can occur in particular 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 Pensa Pharma can interfere with some laboratory tests, such as the determination of
uricemia and glycemia.

Paracetamolo Pensa Pharma with food and alcohol
The use of Paracetamolo Pensa Pharma in patients who regularly consume alcohol (three or more
alcoholic beverages a 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 or breastfeeding, if you suspect or are planning a
pregnancy, ask your doctor or pharmacist for advice before taking this medicine.
If necessary, Paracetamolo Pensa Pharma 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 breastfed infants. Paracetamol at recommended doses can be used
during breastfeeding.

Driving and using machines
Paracetamolo Pensa Pharma has no or slight influence on the ability to drive vehicles or use
machines.

Paracetamolo Pensa Pharma 1000 mg tablets 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 Pensa Pharma

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
doubts, consult your doctor or pharmacist.
The recommended dose is:

Adults
Take 1 tablet every 6-8 hours, as needed. Do not exceed the maximum daily dose of 3 tablets
(3000 mg).
Patients with impaired renal or hepatic function
In patients with impaired renal or hepatic function, the dose must be reduced or the interval between doses must be
increased. In patients with severely impaired renal function, the interval between doses of Paracetamolo Pensa Pharma
must be at least 8 hours. Ask your doctor or pharmacist for advice.
The tablet can be divided into equal doses. Treatment should be started with the lowest effective dose.
Do not use in combination with other medicines containing paracetamol.
Do not exceed the indicated dosage.
Do not use paracetamol frequently for a long period of time, as prolonged or frequent use
may cause liver problems. Discuss with your doctor or pharmacist if you intend to take paracetamol for
a longer period of time.
The administration of this medicine is subject to the onset of pain or fever. As soon as the pain or
fever subsides, treatment should be discontinued.
If the pain lasts for more than 5 days, the fever lasts more than 3 days, or the pain or fever worsens or
other symptoms appear, you must stop treatment and consult your doctor.
Consult your doctor or pharmacist if you think this medicine is too strong or too weak.

If you take more Paracetamolo Pensa Pharma than you should
In case of accidental intake of an excessive dose of Paracetamolo Pensa Pharma, notify
immediately your doctor or pharmacist.
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 may include: nausea (feeling unwell), vomiting (feeling unwell), anorexia (loss of
appetite), sweating and malaise, yellowing of the skin and eyes (jaundice) and abdominal pain. In
this case, the patient should go to the 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 Pensa Pharma
Do not take a double dose to make up for a missed dose.
If you have any further questions 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.
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 severe
skin reactions.
Paracetamol may cause liver damage if taken at high doses or for prolonged treatments.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform 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 Pensa Pharma

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 blister and on the box after Scad.
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 eliminate medicines that you no longer use. This will help to protect the environment.

6. Package Contents and Other Information

What Paracetamolo Pensa Pharma Contains
the active ingredient is: paracetamol
the other ingredients are :sodium starch glycolate (Type A), purified water, pregelatinized starch,
povidone K30 (E1201), stearic acid (E570), crospovidone (E1202).

Description of the Appearance of Paracetamolo Pensa Pharma and Package Contents
Paracetamolo Pensa Pharma presents as white, biconvex, oval-shaped tablets with a fracture line
impressed on one side and PC on the other side, having a length of 21.0 ± 0.5 mm.
The tablets can be divided into equal doses.
Paracetamolo Pensa Pharma is available in blisters containing 16, 18, 20 and 40 tablets.
These packs are available only on medical prescription.
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 with the following
names:
Spain: Paracetamol pensa pharma 1 g comprimidos EFG
Portugal: Paracetamol Lumec