Package leaflet: Information for the patient

PARACETAMOLO ALTER 1000 mg effervescent granules

Paracetamol
Generic medicine
Please read all of this leaflet carefully before you take 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 they have the same symptoms 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:

What PARACETAMOLO ALTER is and what it is used for
What you need to know before taking PARACETAMOLO ALTER
How to take PARACETAMOLO ALTER
Possible side effects
How to store PARACETAMOLO ALTER
Contents of the pack and other information

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

PARACETAMOLO ALTER contains the active substance paracetamol, which belongs to a group of medicines known as analgesics and antipyretics, as they work by relieving pain and inflammation (analgesic and anti-inflammatory action) and reducing body temperature in case of fever (antipyretic action).
PARACETAMOLO ALTER is used to reduce fever and to provide relief from mild to moderate pain in adults.
This medicine is also used to provide relief from joint pain (arthritic pain) in adults.

2. What you should know before taking PARACETAMOLO ALTER

Do not take PARACETAMOLO ALTER:

if you are allergic (hypersensitive) to paracetamol, propacetamol hydrochloride (a precursor of paracetamol), or to any of the other ingredients of this medicine (listed in section 6);
if the person taking this medicine is a child under 15 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before taking PARACETAMOLO ALTER.
Never exceed the recommended dose.
Take this medicine with caution:

if you have liver problems such as hepatic insufficiency, Gilbert's syndrome (an inherited condition causing yellowing of the skin), or acute hepatitis, or if you are taking other medicines that affect liver function;
if you have haemolytic anaemia, characterised by a low number of red blood cells in the blood;
if you are an alcohol abuser; in this case the dose should be reduced;
if you have severe kidney problems (renal insufficiency);
if you have a rare inherited disorder characterised by low levels of an enzyme known as glucose-6-phosphate dehydrogenase;
if you have eating disorders (anorexia, bulimia, cachexia);
if you suffer from chronic malnutrition (low hepatic glutathione reserves) and dehydration;
if you have reduced blood volume (hypovolemia);
if you are taking this medicine for a prolonged period. In this case, your doctor may decide to monitor liver and kidney function and blood composition.

During treatment with PARACETAMOLO ALTER, inform your doctor immediately:

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 have 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 at regular doses for a prolonged period 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.

Stop treatment if you experience allergic reactions.
If you are taking other medicines, inform your doctor. (See section “Other medicines and PARACETAMOLO ALTER”).
Avoid prolonged (more than 3 consecutive days) or frequent use of the medicine without first consulting your doctor, and do not take other products containing paracetamol at the same time, as this may cause serious adverse effects.
Do not take higher doses than recommended, because a higher dose will not increase pain relief but may instead cause serious liver, kidney and blood damage. For this reason, contact your doctor or go to the nearest hospital as soon as possible if you have taken more PARACETAMOLO ALTER than recommended in this leaflet.
Taking this medicine may alter the results of certain laboratory tests, such as measurements of uric acid levels (uricemia) or blood sugar (glycemia).

Children and adolescents
This medicine must not be taken by children under 15 years of age.

Other medicines and PARACETAMOLO ALTER
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Take this medicine with caution and inform your doctor if you are taking the following medicines:

probenecid (a medicine used to treat gout);
rifampicin, a medicine used to treat tuberculosis;
medicines used to treat epilepsy (glutethimide, carbamazepine, phenytoin, phenobarbital);
zidovudine, a medicine used to treat AIDS;
cimetidine, a medicine used to treat ulcers;
medicines that slow down stomach emptying (e.g. anticholinergics);
chloramphenicol, a medicine used to treat bacterial infections;
salicylamide, a medicine used as a sedative and for bone and joint pain;
medicines used to thin the blood (anticoagulants);
flucloxacillin (antibiotic), due to a serious risk of blood and fluid imbalances (called metabolic acidosis) which require urgent treatment (see section 2).

PARACETAMOLO ALTER and alcohol
You must not consume alcohol during treatment with PARACETAMOLO ALTER.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning a pregnancy, or breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
PARACETAMOLO ALTER may be used during pregnancy if necessary. 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 improve, or if you need to take the medicine more frequently.

Breastfeeding
Take this medicine with caution and only after consulting your doctor if you are breastfeeding, because paracetamol passes into breast milk in small amounts and may cause skin irritations (rash) in your baby.

Driving and using machines
The use of PARACETAMOLO ALTER does not affect the ability to drive or operate machinery.

PARACETAMOLO ALTER contains sodium and sorbitol
This medicine contains approximately 16.8 mmol (386.14 mg) of sodium per sachet. This is equivalent to 19% of the maximum daily recommended dietary intake for an adult. This should be taken into account in patients with impaired kidney function or those on a low-sodium diet.
This medicine contains 400 mg of sorbitol per sachet. If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

3. How to take PARACETAMOLO ALTER

Take this medicine exactly as directed by your doctor or pharmacist.
If in doubt, consult your doctor or pharmacist.
Instructions for use: Pour the contents of one sachet into half a glass of water.
Use in adults over 15 years of age
The recommended dose is 1 sachet, 1-2 times a day.
This dose may be increased to 3 sachets per day in more severe cases.
The interval between doses should not be less than 4 hours.
If you take more PARACETAMOLO ALTER than you should
In case of overdose with PARACETAMOLO ALTER, inform your doctor or go to the emergency room immediately.
Overdose has very serious consequences and may even lead to death. Immediate treatment is essential due to the risk of severe liver damage, which may be delayed.
Symptoms may be limited to nausea, vomiting, loss of appetite, pallor, and abdominal pain, and may not reflect the severity of the overdose or the risk of organ damage.
If you forget to take PARACETAMOLO ALTER
Do not take a double dose to make up for the missed dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur:
Frequency not known (cannot be estimated from the available data):

reduction in platelets (thrombocytopenia), white blood cells (leucopenia, neutropenia, agranulocytosis), and red blood cells (anaemia);
diarrhoea, abdominal pain;
increased liver enzymes;
severe allergic reactions (anaphylactic shock, Quincke's oedema, hypersensitivity reactions);
laboratory test abnormalities: increased or decreased bleeding time (INR values);
skin irritations (urticaria, erythema, rash);
reduction in blood pressure (hypotension, as a symptom of anaphylaxis);
severe skin reactions (including epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme);
swelling of face, tongue and throat (angioedema), swelling of the throat (laryngeal oedema);
liver problems (liver function abnormalities and hepatitis);
kidney problems (acute kidney failure, interstitial nephritis), presence of blood in urine (haematuria), absence of urine production (anuria);
stomach and intestinal reactions (gastrointestinal reactions) and dizziness;
severe condition that may make the blood more acidic (called metabolic acidosis), in patients with a serious illness using paracetamol (see section 2).

Reporting of side effects
If you get any side effects, including ones 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 .
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store PARACETAMOLO ALTER

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp.".
The expiry date refers to the last day of that month.
Store protected from heat and moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What PARACETAMOLO ALTER contains

The active substance is paracetamol. Each sachet contains 1000 mg of paracetamol.
The other components are: citric acid, sodium bicarbonate, sorbitol, sodium docusate, povidone, sodium saccharin, sodium citrate, mannitol, sodium carbonate.

Description of the appearance of PARACETAMOLO ALTER and contents of the pack
Pack containing 16 or 20 sachets.
Marketing Authorization Holder
Laboratori Alter S.r.l. - Via Egadi, 7 - 20144 Milan, Italy
Manufacturer
Laboratorios Alter S.A. - C/ Mateo Inurria, 30 - 28036 Madrid, Spain