PARACETAMOL MYLAN GENERICS

Package leaflet: Information for the user

Paracetamolo Mylan Generics 120 mg/5 ml oral solution

paracetamol
Generic medicine
Please read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you to.

• Keep this leaflet. You may need to read it again.
• If you need more advice or information, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice improvement or if you notice worsening of symptoms after 3 days.

Contents of this leaflet

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

1. What Paracetamolo Mylan Generics is and what it is used for

This medicinal product contains the active substance paracetamol, which works by relieving pain (analgesic effect)
and reducing body temperature in cases of fever (antipyretic effect).
Paracetamolo Mylan Generics is used in adults, adolescents, and children weighing at least 7 kg for:

• the treatment of fever
• the treatment of moderate pain of various origins (headache, nerve pain, muscle pain).

Consult your doctor if you or your child does not feel better or feels worse after 3 days of treatment.

2. What you need to know before using Paracetamol Mylan Generics

Do not use Paracetamol Mylan Generics

• if you are allergic to paracetamol or to any of the other ingredients of this medicine (listed in section 6)
• if you suffer from a severe blood disorder (haemolytic anaemia)
• if you suffer from severe liver disease (hepatic insufficiency).

Warnings and precautions
Talk to your doctor or pharmacist before using Paracetamol Mylan Generics.
If you experience allergic reactions after using this medicine, stop treatment with Paracetamol Mylan Generics and consult your doctor.
Consult your doctor before using Paracetamol Mylan Generics, particularly:

• if the person taking the medicine is a chronic or excessive alcohol user (3 or more alcoholic drinks per day)
• if the person taking the medicine suffers from anorexia (an eating disorder characterised by lack or reduction of appetite)
• if the person taking the medicine suffers from bulimia (an eating disorder in which a person consumes excessive amounts of food and then uses various methods to eliminate it)
• if the person taking the medicine suffers from cachexia (a condition characterised by extreme thinness, reduced muscle mass and thinning of the skin due to chronic illness)
• if the person taking the medicine has long-term inadequate nutrition (chronic malnutrition)
• if the person taking the medicine suffers from dehydration (severe loss of water/fluids from the body)
• if the person taking the medicine suffers from hypovolaemia (reduced blood volume in circulation)
• if the person taking the medicine has low levels of glucose-6-phosphate dehydrogenase
• if you are taking other medicines (see section “Other medicines and Paracetamol Mylan Generics”): make sure that none of the other medicines you are taking contain paracetamol, as administration of high doses of paracetamol may cause serious adverse effects
• if the person taking the medicine has liver problems (liver insufficiency, hepatitis, Gilbert's syndrome (a condition in which the liver produces more bilirubin than normal))
• if the person taking the medicine suffers from haemolytic anaemia (destruction of red blood cells).

During treatment with Paracetamol Mylan Generics, 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 fluid balance) has been reported when paracetamol is used at regular doses for prolonged periods or when paracetamol is taken concomitantly with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties with deep, rapid breathing, drowsiness, nausea and vomiting.
Use of high doses and/or for prolonged periods
Taking high doses of Paracetamol Mylan Generics for long periods may cause serious damage to the liver, kidneys and blood. In such cases, your doctor will periodically monitor, through appropriate tests, liver and kidney function and blood composition. Before using this medicine, inform your doctor if the person taking the medicine suffers from kidney or liver disease.
Other medicines and Paracetamol Mylan Generics
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicine.
Use this medicine with caution and inform your doctor if you are taking:

• medicines containing paracetamol. During treatment with paracetamol, check that any other medicine you take or give to a child does not contain paracetamol, as serious adverse effects may occur if paracetamol is taken in high doses
• medicines that slow down stomach emptying (e.g. anticholinergic medicines, opioids) or speed it up (prokinetic medicines), as these medicines may delay or accelerate the effect of Paracetamol Mylan Generics
• colestyramine, a medicine used to reduce cholesterol levels in the blood
• chloramphenicol, a medicine used to treat bacterial infections
• medicines used to prevent blood clots (oral anticoagulants). If taken together with these medicines, periodic blood tests are required to monitor blood clotting, both during and after the combined treatment
• flucloxacillin (an antibiotic), due to a serious risk of blood and fluid abnormalities (called metabolic acidosis) that require urgent treatment (see section 2).

The following medicines require close medical monitoring when used with Paracetamol Mylan Generics:

• rifampicin, used to treat bacterial infections (antibiotic)
• cimetidine, used to treat stomach ulcers
• glutethimide, phenobarbital, carbamazepine, used to treat epilepsy
• zidovudine, used to treat HIV infections
• if you consume alcohol chronically (e.g. alcoholism).

Laboratory tests
Taking this medicine may alter the results of certain laboratory tests, such as measurements of uric acid or blood sugar levels.
If you need to undergo these blood tests, inform your doctor or laboratory staff that you are taking Paracetamol Mylan Generics.
Paracetamol Mylan Generics and alcohol
Use this medicine 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 use more Paracetamol Mylan Generics than you should”).
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Pregnancy
Paracetamol Mylan Generics may be used during pregnancy if necessary. Use the lowest possible dose that effectively reduces pain and/or fever, and use the medicine for the shortest possible time. Consult your doctor or midwife if pain or fever persist or if you need to take the medicine more frequently.
Breastfeeding
If you are breastfeeding, use this medicine only if clearly needed and always under the direct supervision of your doctor.
Driving and using machines
This medicine does not affect or has a negligible effect on the ability to drive or use machinery.
Paracetamol Mylan Generics contains sucrose, parahydroxybenzoates and sodium
This medicine contains 7 g of sucrose (sugar) per 20 ml of oral solution. This should be taken into consideration in patients with diabetes mellitus. If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.
This medicine contains 27.4 mg of sodium (the main component of table salt) per 20 ml of oral solution. This corresponds to 1.37% of the maximum daily recommended dietary intake for an adult.
This medicine contains parahydroxybenzoates which may cause allergic reactions (including delayed reactions).

3. How to use Paracetamol Mylan Generics

Use this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Adults
The recommended dose is 20 ml at a time (equivalent to 480 mg), to be repeated if necessary after 4 hours, without exceeding 6 doses per day.
The maximum recommended dose is 3,000 mg per day (see section “If you use more Paracetamol Mylan Generics than you should”).

Use in children and adolescents
In children, it is essential to follow the recommended dose according to body weight. Approximate age ranges corresponding to body weight are provided for informational purposes only.
For children under three months of age, the single dose must be reduced if jaundice is present (characterized by yellowing of the skin and whites of the eyes).

The package contains a dosing cup with markings indicating levels corresponding to 2.5 ml, 5 ml, 7.5 ml and 10 ml:

To help calculate the dose according to body weight, use the dosing syringe provided
inside the package.
If you or your child suffer from severe renal impairment (severe reduction in kidney function)
If the doctor has diagnosed severe renal impairment, the interval between doses must be
at least 8 hours.
Duration of treatment
Do not use Paracetamolo Mylan Generics for more than 3 consecutive days without consulting your doctor. Your doctor
must assess the need for treatment beyond 3 consecutive days.
If you take more Paracetamolo Mylan Generics than you should
In case of accidental ingestion of an excessive dose of this medicine, inform your doctor immediately
or go to the Emergency Room of the nearest hospital.
Take this leaflet, the bottle and its container with you to the hospital or doctor so that they know
which medicine has been taken.
Symptoms
If you or your child accidentally take a very high dose of this medicine, symptoms that may generally appear
within the first 24–48 hours include:

• loss or reduction of appetite (anorexia), nausea and vomiting followed by a marked worsening of general condition
• changes in blood levels of various substances (increased hepatic transaminases, lactic dehydrogenase, and bilirubin levels, and decreased prothrombin levels)
• liver damage which may severely worsen and lead to coma and death.

Taking an excessive dose of paracetamol increases the risk of poisoning and may lead to
death, especially in the following cases:

• if the person taking the medicine suffers from liver disease
• chronic alcoholism (alcohol dependence)
• if the person taking the medicine has long-term inadequate nutrition (chronic malnutrition)
• if the person taking the medicine is taking other medicines or substances that increase liver activity.

Treatment
The doctor will carry out appropriate supportive therapy based on the nature and severity of symptoms.
If you forget to use Paracetamolo Mylan Generics
If you forget to take a dose, take it as soon as you remember, unless it is almost time for the next dose.
Do not take a double dose to make up for the missed dose.
If you have any doubts 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 will experience them.
STOP using this medicine and contact your doctor immediately if you or your child experience any of the following side effects:

• allergic reactions with skin rash, redness of the skin or hives
• swelling of the larynx
• swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing (angioedema)
• severe, potentially life-threatening allergic reaction (anaphylactic shock)

In addition, people taking this medicine may experience the following side effects, for which sufficient data are not available to determine frequency:

• red skin lesions which may affect the mouth and other areas of the body (erythema multiforme)
• rare, serious skin condition with blistering and severe bleeding of the lips, eyes, mouth, nose and genitals (Stevens-Johnson syndrome)
• severe skin disease (toxic epidermal necrolysis)
• reduced number of platelets in the blood (thrombocytopenia)
• reduced number of white blood cells in the blood (leucopenia, agranulocytosis)
• reduced number of red blood cells (anaemia)
• liver problems (hepatitis, reduced liver function)
• kidney problems (reduced kidney function, interstitial nephritis, presence of blood in urine, reduced or no urine production)
• blood in the urine (haematuria)
• cessation or reduction of urine production (anuria)
• stomach and intestinal problems
• dizziness

Frequency not known (cannot be estimated from available data): severe condition that may increase blood acidity (called metabolic acidosis) in patients with severe illness taking paracetamol (see section 2).
Very rare cases of serious skin reactions have been reported.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You may also report side effects directly via the adverse reaction reporting website 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 Paracetamol Mylan Generics

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.
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 Mylan Generics contains

• The active substance is paracetamol. 100 ml of oral solution contain 2.4 g of paracetamol.
• The other components are: sucrose, macrogol 6000, sodium citrate, anhydrous citric acid, sodium saccharin, methyl parahydroxybenzoate, propyl parahydroxybenzoate, strawberry/mandarin flavour, purified water.

Description of the appearance of Paracetamolo Mylan Generics and contents of the pack
120 ml bottle of oral solution with dosing spoon.
Marketing Authorization Holder and Manufacturer
Mylan S.p.A.
Via Vittor Pisani 20,
20124 Milano - Italy
Manufacturer
ABC Farmaceutici S.p.A.
via Canton Moretti 29, 10015 S. Bernardo d'Ivrea (TO)