Paracetamol Pensapharma

Package leaflet: Information for the user

PARACETAMOL PENSA PHARMA 1000 mg

tablets
Paracetamol
Please read all of 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 they have the same symptoms as yours, because it may be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

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

Paracetamol 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 taking it

Do not take Paracetamol 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 Paracetamol Pensa Pharma:
if you have kidney problems.
if you have heart or lung disorders.
if you have liver disease or are receiving concomitant treatment with medicines that affect liver function.
if you have anaemia (a condition caused by a reduction in red blood cells, which may make your skin look pale and yellowish and cause weakness or shortness of breath).
if you regularly consume large amounts of alcohol. Chronic alcoholics should pay particular attention not to exceed 2 g of paracetamol every 24 hours.
if you are taking a medicine for epilepsy, consult your doctor before taking this medicine, as its effectiveness may be reduced and the hepatotoxicity of paracetamol may be increased, especially when high doses of paracetamol are used.
if you are taking other medicines containing paracetamol, as they may seriously damage the liver.
if you are asthmatic and sensitive to acetylsalicylic acid (aspirin).
During treatment with Paracetamol Pensa Pharma, 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 (an abnormality in blood and body fluids) has been reported when paracetamol is used regularly for prolonged periods or when paracetamol is taken together with flucloxacillin. Symptoms of metabolic acidosis may include severe breathing difficulties with deep, rapid breathing, drowsiness, nausea, and vomiting.
You must not take paracetamol frequently or for prolonged periods, because prolonged or frequent use of this medicine may cause liver problems. Speak with your doctor or pharmacist if you intend to take paracetamol for a prolonged period.
Do not use Paracetamol Pensa Pharma without speaking to a doctor if you have alcohol-related problems or if you have liver damage. Do not use Paracetamol Pensa Pharma with alcohol. The effect of alcohol is not increased by taking Paracetamol Pensa Pharma.
Do not take more paracetamol than recommended in section 3 of this leaflet. A higher dose does not increase pain relief but may cause severe 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 Paracetamol Pensa Pharma
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not take any other medicine containing paracetamol.
Paracetamol Pensa Pharma may affect or be affected by other medicines. In particular, inform your doctor or pharmacist if you are taking:
metoclopramide or domperidone (for treating nausea (feeling unwell) and vomiting (sickness));
cholestyramine (a medicine used to reduce cholesterol levels in the blood). Paracetamol should be taken one hour before or four hours after taking this medicine;
warfarin and other medicines used to thin the blood, if you need to take a painkiller daily for a long period;
medicines used to increase urine output (loop diuretics such as those belonging to the furosemide group);
probenecid (used for the treatment of gout);
substances that induce liver enzymes, e.g. rifampicin (used to treat infections) and medicines for 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 (antibiotic), due to a serious risk of blood and fluid abnormalities (called metabolic acidosis) that require urgent treatment (see section 2).

Paracetamol Pensa Pharma may interfere with certain laboratory tests, such as the measurement of uric acid and blood glucose levels.

Paracetamol Pensa Pharma with food and alcohol
Taking Paracetamol Pensa Pharma in patients who regularly consume alcohol (three or more alcoholic drinks per day – beer, wine, spirits – daily) may 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 you may be pregnant, or if you are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
If necessary, Paracetamol Pensa Pharma can 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 often.
Although paracetamol is excreted in breast milk in small amounts, no adverse effects have been reported in breastfed infants. Paracetamol at the recommended doses can be used during breastfeeding.

Driving and using machines
Paracetamol Pensa Pharma has no or negligible influence on the ability to drive or use machines.

Paracetamol Pensa Pharma 1000 mg tablets contain sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

3. How to take Paracetamol Pensa Pharma

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any 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 should be reduced or the dosing interval increased. In patients with severely impaired renal function, the dosing interval for Paracetamol Pensa Pharma should be at least 8 hours. Ask your doctor or pharmacist for advice.
The tablet may be divided into equal doses. Treatment should be initiated with the lowest effective dose.
Do not use in combination with other medicines containing paracetamol.
Do not exceed the recommended dosage.
Do not use paracetamol frequently for long periods, 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.
This medicine should be administered only when pain or fever occurs. As soon as pain or fever subsides, treatment should be discontinued.
If pain lasts more than 5 days, fever lasts more than 3 days, or if pain or fever worsens or new symptoms appear, treatment must be stopped and a doctor should be consulted.
Consult your doctor or pharmacist if you think this medicine is too strong or too weak.
If you take more Paracetamol Pensa Pharma than you should
In case of accidental overdose of Paracetamol Pensa Pharma, inform your doctor or pharmacist immediately.
Even if you feel well, you may be at risk of liver damage. To prevent liver damage, it is important that treatment is started as soon as possible (preferably within 10–12 hours after overdose).
Symptoms may include: nausea (feeling unwell), vomiting, anoressia (loss of appetite), sweating and malaise, yellowing of the skin and eyes (jaundice), and abdominal pain. In such cases, the patient must 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 Paracetamol Pensa Pharma
Do not take a double dose to make up for the missed dose.
If you have any further 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.
This medicine may cause the following side effects:
Rare (may affect up to 1 in 1,000 people): discomfort, drop in blood pressure (hypotension), and increased blood transaminase levels.
Very rare (may affect up to 1 in 10,000 people): kidney disorders, cloudy urine, allergic dermatitis (skin rash), jaundice (yellowing of the skin), blood disorders (agranulocytosis, leucopenia, neutropenia, haemolytic anaemia), and hypoglycaemia (low blood sugar). There have been very rare cases of severe skin reactions.
Frequency not known (cannot be estimated from the available data): a serious condition that may make the blood more acidic (called metabolic acidosis) in patients with a severe illness who use paracetamol (see section 2).
Paracetamol may cause liver damage if taken in high doses or for prolonged treatment periods.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via 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 stated on the blister and carton after Exp.
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
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. Package contents and other information

What Paracetamolo Pensa Pharma contains
The active substance is: paracetamol.
The other components 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 pack contents
Paracetamolo Pensa Pharma is presented as white, biconvex, oval tablets, with a break line marked on one side and "PC" on the other side, measuring 21.0 ± 0.5 mm in length.
The tablets may be divided into equal doses.
Paracetamolo Pensa Pharma is available in blister packs containing 16, 18, 20 and 40 tablets.
These packs are available only by medical prescription.
It is possible that not all pack sizes are marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Towa Pharmaceutical S.p.A.
Via Enrico Tazzoli 6
20154 Milan
Italy

Manufacturer
Galenicum Health, S.L.U.
Sant Gabriel, 50
Esplugues de Llobregat
08950 Barcelona
Spain
or
SAG Manufacturing S.L.U.
Crta. N-I, Km 36,
San Agustín de Guadalix,
28750 Madrid
Spain

This medicinal product is authorized in the European Economic Area countries under the following names:
Spain: Paracetamol pensa pharma 1 g comprimidos EFG
Portugal: Paracetamol toLife