Paracetamol ratiopharm: detailed information

Package leaflet: Information for the patient

Paracetamol ratiopharm 1000 mg effervescent tablets

Equivalent medicine
Please read 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 doubts, consult 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, as it could be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Paracetamolo ratiopharm contains the active substance paracetamol, a compound that helps relieve
pain (analgesic) and reduce fever (antipyretic).
This medicine is therefore indicated in adults and adolescents over the age of 15 for:

the treatment of symptoms of painful conditions such as headache, neuralgia (painful nerve inflammation), toothache, menstrual pain, joint pain (arthritic pain);
the treatment of symptoms associated with fever.

Consult your doctor if you do not feel better or feel worse after 3 days.

2. What you should know before taking Paracetamol ratiopharm

Do not take Paracetamol ratiopharm

if you are allergic to paracetamol or propacetamol hydrochloride (a precursor of paracetamol) or to any of the other ingredients of this medicine (listed in section 6);
to treat a child or adolescent under 15 years of age;
together with other analgesics, antipyretics, or non-steroidal anti-inflammatory drugs (NSAIDs) (see also section “Other medicines and Paracetamol ratiopharm”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Paracetamol ratiopharm.
DO NOT take Paracetamol ratiopharm for more than 3 consecutive days unless otherwise directed by your doctor.
DO NOT take other medicines containing paracetamol during treatment with this medicine, as this may increase the risk of adverse reactions.
Be especially careful and consult your doctor before taking Paracetamol ratiopharm if:

you are elderly;
you are a chronic or excessive alcohol user (3 or more alcoholic drinks per day);
you suffer from anorexia (an eating disorder characterized by lack or reduction of appetite);
you suffer from bulimia (an eating disorder in which a person consumes excessive amounts of food and then uses various methods to eliminate it);
you suffer from cachexia (a condition characterized by extreme thinness, reduced muscle mass, and thinning skin due to chronic illness);
you have long-term inadequate nutrition (chronic malnutrition);
you suffer from dehydration (severe loss of water/fluids from the body);
you suffer from hypovolemia (reduced blood volume in circulation);
your liver function is impaired (mild to severe liver insufficiency, including Gilbert’s syndrome (a condition characterized by excessive bilirubin production, causing yellowish skin and eyes), acute hepatitis);
you have a deficiency of glutathione (a substance with antioxidant properties) or of the enzyme glucose-6-phosphate dehydrogenase (a substance normally present in the human body, deficiency of which may cause blood disorders);
you have a specific form of anemia called “hemolytic anemia” (destruction of red blood cells);
your kidney function is impaired (renal insufficiency);
you are concurrently being treated with medicines that affect liver function (see “Other medicines and Paracetamol ratiopharm”).

During treatment with Paracetamol ratiopharm, 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 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 over 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.

In addition, you must stop treatment and contact your doctor immediately if you develop skin rashes, itching, difficulty breathing (bronchospasm) or swallowing, swelling of the face, hands and feet, eyes, lips and/or tongue (angioedema). These may be signs of allergic reactions, even severe ones (anaphylactic shock). See also section 4 (“Possible side effects”).
Paracetamol may cause serious skin reactions which can be fatal. The use of Paracetamol ratiopharm must be discontinued at the first sign of skin rash or any other sign of hypersensitivity/allergy.
Use of high doses and/or prolonged use
Taking high doses or using paracetamol for long periods may indeed cause serious adverse reactions such as: liver function abnormalities (hepatopathies) or serious kidney and blood disorders. In such cases, your doctor will monitor liver and kidney function and blood composition through appropriate tests.
Prolonged use of analgesics (for more than 3 months) in patients with chronic headache, especially if frequent and recurrent, may increase or worsen headache. In such cases, medical advice should be sought.
Children and adolescents under 15 years of age
The use of Paracetamol ratiopharm 1000 mg in children and adolescents under 15 years of age is contraindicated due to the high paracetamol content per tablet (see section “Do not take Paracetamol ratiopharm”).
Other medicines and Paracetamol ratiopharm
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.
In particular, inform your doctor if the person taking the medicine is also taking:

other medicines containing paracetamol , as serious side effects may occur if paracetamol is taken in high doses;
oral anticoagulant coumarins, including warfarin (medicines used to prevent blood clots): in this case, your doctor will perform more frequent monitoring of blood coagulation times (INR);
medicines or substances capable of stimulating certain liver enzymes called monooxygenases, for example:
rifampicin (an antibiotic);
cimetidine (an antihistamine used in the treatment of stomach ulcers);
antiepileptics such as phenobarbital, carbamazepine, and phenytoin (medicines used to treat epilepsy), or sedatives such as glutethimide. In case of treatment with phenytoin, do not take high or prolonged doses of paracetamol.

The use of these medicines together with Paracetamol ratiopharm requires extreme caution and should only be done under strict medical supervision:

probenecid , a medicine used to treat hyperuricemia (high blood uric acid levels) and gout (joint inflammation due to uric acid deposits): in this case, your doctor may advise reducing the dose of Paracetamol ratiopharm;
salicylamide (a pain-relieving and fever-reducing medicine);
flucloxacillin (an antibiotic), due to a serious risk of blood and fluid abnormalities (called metabolic acidosis) requiring urgent treatment (see section 2 “Warnings and precautions”);
chloramphenicol (an antibiotic), as taking it together with paracetamol may increase its side effects;
medicines that slow down or increase gastric emptying (such as anticholinergic drugs , opioids or prokinetics ), as they may interfere with the onset of paracetamol’s therapeutic effect;
zidovudine (a medicine used to treat HIV);
cholestyramine (a medicine used to reduce blood cholesterol levels), as it reduces the effect of paracetamol.

Laboratory tests
The paracetamol contained in this medicine may interfere with the measurement of uric acid levels (uricemia) or blood glucose levels (glycemia).
Paracetamol ratiopharm and alcohol
Take Paracetamol ratiopharm with caution if you are a chronic or excessive alcohol user (3 or more alcoholic drinks per day), as there is a risk of poisoning (see sections “Warnings and precautions” and “If you take more Paracetamol ratiopharm than you should”).
Alcohol consumption during treatment is not recommended.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Paracetamol ratiopharm 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
Paracetamol passes into breast milk in small amounts. Skin rashes have been reported in breastfed infants. However, paracetamol administration is considered compatible with breastfeeding. Nevertheless, paracetamol should be used with caution in breastfeeding women.
Driving and using machines
Paracetamol ratiopharm does not affect or has a negligible effect on the ability to drive and use machines.
Paracetamol ratiopharm contains

550 mg of sorbitol per effervescent tablet. Sorbitol is a source of fructose. If your doctor has told you that you have an intolerance to certain sugars, or if you have been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which patients cannot metabolize fructose, talk to your doctor before taking this medicine;
50 mg of sodium benzoate per effervescent tablet;
499 mg of sodium (the main component of table salt) per effervescent tablet. This corresponds to approximately 25% of the maximum recommended daily dietary intake for an adult. Talk to your doctor or pharmacist, especially if you have been advised to follow a low-sodium diet.

3. How to take Paracetamol ratiopharm

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
To avoid the risk of overdose, check that other medicines you are taking (with or without prescription) do not contain paracetamol. Accidental intake of an excessive dose of paracetamol may cause severe liver damage and death (see section “If you take more Paracetamol ratiopharm than you should”).

Adults and adolescents over 15 years of age
The recommended dose is 1 tablet of 1000 mg per administration, repeated if necessary, respecting an interval of at least 6–8 hours between doses, without exceeding 3 doses per day (equivalent to 3 g of paracetamol per day). Always maintain an interval of at least 4 hours between doses.

Do not take Paracetamol ratiopharm for more than 3 consecutive days without consulting your doctor, who must assess whether a longer treatment is necessary.

Maximum recommended dosage
The maximum dose is 3 g of paracetamol per day.

Elderly patients
If you are elderly, your doctor will prescribe the most appropriate dose for your condition, possibly considering a reduction of the doses indicated above.

Patients with severely reduced kidney function
If you suffer from kidney disease (severe renal insufficiency), you must wait at least 8 hours before taking another paracetamol tablet. Do not exceed 3 g of paracetamol per day (equivalent to 3 tablets).

Patients with liver disease
If the person taking the medicine suffers from reduced liver function, the dose should be reduced or the interval between doses prolonged.
The maximum dose must not exceed 2 tablets per day in the following cases: adult patients weighing less than 50 kg, liver disease (hepatopathy), Gilbert's syndrome, chronic alcoholism, chronic malnutrition, or dehydration.

Method of administration
This medicine should be taken with food.
Dissolve the tablet in a glass of water, stirring if necessary with a teaspoon. The resulting solution can be drunk directly from the glass. Do not chew or swallow the tablet whole.

If you take more Paracetamol ratiopharm than you should
In case of accidental ingestion/overdose of this medicine, contact your doctor immediately or go to the nearest hospital.
Taking an excessive dose of paracetamol increases the risk of poisoning and can be fatal, especially if the person taking the medicine:

suffers from liver disease;
abuses alcohol;
suffers from chronic malnutrition;
is taking medicines or substances that stimulate liver enzymes (increase the activity of the liver).

Symptoms
Symptoms of overdose appearing within the first 24 hours after taking Paracetamol ratiopharm may include: pallor, nausea, malaise, vomiting, hyperhidrosis, diaphoresis (excessive sweating), loss of appetite (anorexia), and abdominal pain, followed by a marked deterioration in general health.
Cases of acute pancreatitis have been reported.
Taking a very high dose of paracetamol may lead to severe kidney damage (renal tubular necrosis) and blood disorders, destruction of liver cells (hepatic cytolysis), and may progress to irreversible loss of liver function (liver necrosis), sometimes resulting in death. These symptoms may appear 12 to 48 hours after ingestion of the excessive dose. Symptoms of liver damage peak after 3–4 days.

Treatment
Depending on the nature and severity of symptoms, the doctor will provide appropriate supportive therapy.

If you forget to take Paracetamol ratiopharm
Do not take a double dose to make up for the missed dose.

If you stop taking Paracetamol ratiopharm
If you have any doubts about using 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.
Stop taking the medicine and contact your doctor immediately if you experience:

hypersensitivity, for example skin rash, redness of the skin (erythema), appearance of itchy skin swellings (urticaria), appearance of purple-coloured skin patches of various sizes (purpura),
erythema multiforme (appearance of red spots on the skin with "target-like" appearance associated with itching),
Stevens-Johnson syndrome (a severe form of polymorphic erythema),
toxic epidermal necrolysis (a serious skin lesion characterized by redness, blistering lesions with areas of skin detachment and skin death),
acute generalized exanthematous pustulosis (widespread eruption of hundreds of superficial pustules over the entire body),
swelling of the face, hands and feet, eyes, lips and/or tongue (angioedema),
laryngeal edema (swelling of the throat),
anaphylactic reaction (severe allergic reaction), including low blood pressure (hypotension),
anaphylactic shock (severe and sudden allergic reaction).

In addition, the following side effects may occur:
Very rare (may affect up to 1 in 10,000 people)

severe skin reactions presenting with skin changes such as urticaria, formation of red papules or widespread blisters and peeling, particularly on legs, arms, hands and feet, which may extend to the face and lips, occasionally accompanied by fever. These may be symptoms of serious skin diseases such as Stevens-Johnson syndrome (a severe form of polymorphic erythema), toxic epidermal necrolysis (a severe skin lesion characterized by redness, blistering lesions with areas of skin detachment and skin death), acute generalized exanthematous pustulosis (AGEP), or erythema multiforme (appearance of red spots on the skin with "target-like" appearance associated with itching).

Frequency not known (cannot be estimated from the available data)

reduction in the number of blood cells called platelets (thrombocytopenia);
reduction, even severe, in the number of white blood cells in the blood (agranulocytosis, leucopenia, neutropenia);
excessive decrease in red blood cells (anaemia);
severe condition that may make the blood more acidic (called metabolic acidosis), in patients with a serious illness using paracetamol (see section 2);
altered liver function, liver damage, inflammation of the liver (hepatitis), liver failure, hepatic necrosis;
hypersensitivity, for example skin rash, redness of the skin (erythema), appearance of itchy skin swellings (urticaria), appearance of purple-coloured skin patches of various sizes (purpura);
swelling of the face, hands and feet, eyes, lips and/or tongue (angioedema);
laryngeal edema (swelling of the throat);
anaphylactic reaction (severe allergic reaction), including low blood pressure (hypotension);
anaphylactic shock (severe and sudden allergic reaction);
reduced kidney function (acute kidney injury), inflammation of the kidneys (tubulointerstitial nephritis);
blood in the urine (haematuria) and reduced urine output (anuria);
stomach or intestinal disorders (gastrointestinal disturbances), diarrhoea, abdominal pain;
dizziness;
headache;
decrease or increase in the international normalized ratio (INR), a value used to express the time taken for blood to clot;
increased liver enzymes.

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 ratiopharm

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Keep the container tightly closed to protect the medicine from moisture.
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.
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 ratiopharm Contains

The active substance is paracetamol. One effervescent tablet contains 1000 mg of paracetamol.
The other components are: citric acid, sodium bicarbonate, sorbitol, sodium carbonate, sodium benzoate, orange flavour, acesulfame potassium, simeticone emulsion, docusate sodium.

Description of the Appearance of Paracetamolo ratiopharm and Package Contents
Paracetamolo ratiopharm is presented in a box containing a bottle with 8 or 16 effervescent tablets.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
ratiopharm GmbH - Graf-Arco Strasse, 3 - 89079 Ulm (Germany)
Manufacturer
E-Pharma Trento S.p.A. - Via Provina, 2 - Ravina Fraction - 38123 Trento (TN)