Paracetamol Mylan Pharma

Patient Information Leaflet

Paracetamol Mylan Pharma

1000 mg effervescent tablets
Equivalent 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 other people, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

What is in this leaflet:

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

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

Paracetamolo Mylan Pharma contains the active substance paracetamol, which acts as an analgesic (relieves pain) and antipyretic (reduces fever).
Paracetamolo Mylan Pharma is indicated:

• for the relief of mild to moderate pain
• to reduce fever
• for the treatment of bone and joint pain.

2. What you need to know before taking Paracetamol Mylan Pharma

Do not take Paracetamol Mylan Pharma

• if you are allergic to paracetamol, propacetamol, or any of the other ingredients of this medicine (listed in section 6)
• if the patient is a child under 15 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before taking Paracetamol Mylan Pharma.
Be especially careful with Paracetamol Mylan Pharma:

• if you experience an allergic reaction: in this case, stop treatment and consult your doctor
• if you have liver disease (including Gilbert's syndrome and hepatitis)
• if you have kidney failure
• if you have been diagnosed with glucose-6-phosphate dehydrogenase deficiency
• if you have haemolytic anaemia
• if you suffer from chronic alcoholism or consume excessive amounts of alcohol (3 or more alcoholic drinks per day)
• if you have eating disorders (anorexia or bulimia)
• if you suffer from chronic malnutrition or have a severe form of wasting (cachexia)
• if you are dehydrated
• if you have reduced circulating blood volume (hypovolaemia)
• do not take other medicines containing paracetamol at the same time: if you take paracetamol at high doses or for a long time, you may experience serious liver, kidney, and blood damage. If you need to take the medicine for a prolonged period, your doctor may perform blood tests.
• before combining with any other medicine, contact your doctor (read the section “Other medicines and Paracetamol Mylan Pharma”).

Other medicines and Paracetamol Mylan Pharma
Tell your doctor or pharmacist if you are using, have recently used, or might use any other
medicines.
Paracetamol may increase the likelihood of adverse effects when taken
concomitantly with other medicines.
In particular, inform your doctor before taking Paracetamol Mylan Pharma if you are taking the following
medicines:

• medicines used to prevent blood clotting
• glutethimide, phenobarbital, carbamazepine, phenytoin (medicines used for the treatment of epilepsy)
• rifampicin (an antibiotic used to treat tuberculosis)
• cimetidine (a medicine used to treat gastric ulcer)
• medicines that slow gastric emptying (e.g. anticholinergics)
• chloramphenicol (a medicine used to treat infections)
• probenecid (a medicine used to lower blood uric acid levels)
• zidovudine
• salicylamide.

Paracetamol Mylan Pharma and alcohol
Be especially careful when using paracetamol if you suffer from chronic alcoholism or consume excessive amounts of alcohol (3 or more alcoholic drinks per day).
Paracetamol Mylan Pharma and laboratory tests
If you are due to have blood tests to check your glucose or uric acid levels, make sure to
inform your doctor that you are taking Paracetamol Mylan Pharma.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor before taking this medicine.
Pregnancy
If necessary, Paracetamol Mylan Pharma may 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 improve, or if you need to take the medicine more frequently.
Consult your doctor before taking this medicine. Your doctor will assess whether the benefits to you clearly outweigh the risks to the foetus. In pregnant patients, the doctor will carefully evaluate the dose and duration of treatment.
Breastfeeding
Paracetamol is excreted in small amounts in breast milk. Skin rashes have been reported in breastfed infants. However, paracetamol administration is considered compatible with breastfeeding. Nevertheless, consult your doctor before taking Paracetamol Mylan Pharma during breastfeeding.
Driving and using machines
Paracetamol Mylan Pharma does not impair the ability to drive or use machinery.
Paracetamol Mylan Pharma contains sorbitol and sodium
Paracetamol Mylan Pharma 1000 mg effervescent tablets contain:

• 550 mg of sorbitol per tablet, equivalent to 10 mg/kg. Sorbitol is a source of fructose. If your doctor has told you that you (or the child) have an intolerance to certain sugars, or if you have been diagnosed with hereditary fructose intolerance, a rare genetic condition in which patients cannot metabolize fructose, talk to your doctor before you (or the child) take this medicine.
• 499 mg of sodium (the main component of table salt) per tablet. This corresponds to 24.95% of the maximum daily recommended dietary intake for an adult.

3. How to take Paracetamolo Mylan Pharma

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Adults and adolescents over 15 years of age
The recommended dose is one tablet 1–2 times a day. In more severe cases, the daily dose may be increased to three tablets.
The interval between doses must not be less than 4 hours.
Dissolve the effervescent tablet in a glass of water and drink the solution immediately after preparation.

If you take more Paracetamolo Mylan Pharma than you should
If you accidentally take an excessive dose of Paracetamolo Mylan Pharma, contact your doctor immediately or go to the nearest hospital.
If you have taken more than the recommended dose, you may experience the following symptoms, which generally occur within the first 24 hours:

• nausea
• vomiting
• loss of appetite
• pallor
• malaise
• profuse sweating

Consult a doctor anyway, as there is a risk of serious and irreversible liver damage. The risk of toxicity is higher in patients with liver disease, chronic alcoholism, chronic malnutrition, and in patients receiving enzyme inducers. In these cases, taking an excessive dose may be fatal.

If you forget to take Paracetamolo Mylan Pharma
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.
Below are the side effects associated with paracetamol. There are insufficient data available to establish the frequency of the individual effects listed.

• Very rare cases of serious skin reactions (including cases of erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis)
• Allergic reactions such as skin rash with erythema or urticaria, or laryngeal edema, or sudden swelling of the skin and mucous membranes (angioedema, Quincke's edema), or anaphylactic shock, or drop in blood pressure (as a symptom of severe allergic reaction), or hypersensitivity reactions
• Reductions in blood cells: platelets and white or red blood cells
• Liver function abnormalities and hepatitis
• Increased liver enzymes
• Kidney-related disorders (acute kidney failure, interstitial nephritis, haematuria, anuria)
• Gastrointestinal reactions
• Diarrhoea
• Abdominal pain
• Increased or decreased bleeding time (INR values)
• Dizziness

If allergic reactions occur, stop treatment immediately.
In case of overdose, paracetamol may cause severe and irreversible liver damage.
Following the instructions provided in this leaflet reduces the risk of side effects.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may 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 Mylan 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 packaging after Exp.. The expiry date refers to the last day of that month.
Keep the tube tightly closed to protect the product from moisture.
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 Paracetamol Mylan Pharma contains

• The active substance is paracetamol. Each effervescent tablet contains 1000 mg of paracetamol.
• The other components are citric acid, sodium bicarbonate, sorbitol (E420), sodium carbonate, sodium benzoate, orange flavour, acesulfame potassium, simethicone emulsion, sodium docusate.

Description of the appearance of Paracetamol Mylan Pharma and package contents
Paracetamol Mylan Pharma 1000 mg is presented as effervescent tablets.
The pack contains 16 divisible tablets.
Marketing Authorisation Holder
Mylan S.p.A.
Via Vittor Pisani 20
20124 Milan
Manufacturer
E-Pharma Trento S.p.A. - Via Provina, 2 - 38123 Trento (TN)