Paramig fast

Patient Information Leaflet

PARAMIG Fast, 500 mg, granules in sachet
Paracetamolum
Please read the entire leaflet carefully before using this medicine, as it contains important information for the patient.

• Always take this medicine exactly as described in this patient leaflet or as directed by your doctor or pharmacist. Keep this leaflet for future reference.
• If you need advice or further information, consult your doctor or pharmacist.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 3 days, or if your condition worsens, consult your doctor.

Table of contents:

1. What PARAMIG Fast is and what it is used for
2. Important information before taking PARAMIG Fast
3. How to take PARAMIG Fast
4. Possible side effects
5. How to store PARAMIG Fast
6. Contents of the pack and other information

1. What PARAMIG Fast is and what it is used for

PARAMIG Fast contains paracetamol as the active substance.
Paracetamol belongs to the pharmacotherapeutic group of analgesics (pain-relieving medicines), which also exert antipyretic (fever-reducing) effects with weak anti-inflammatory activity.
PARAMIG Fast is indicated for symptomatic treatment of mild to moderate pain and fever.
Do not use PARAMIG Fast for longer than three days without medical advice.

2. Important information before taking Paramig Fast

When not to take Paramig Fast:

• if the patient is allergic (hypersensitive) to paracetamol or any of the other ingredients of this medicine (listed in section 6),
• if the patient has severe liver failure,
• if the patient has acute hepatitis,
• if the patient has severe kidney failure,
• if the patient is taking this medicine simultaneously with drugs that have adverse effects on liver function,
• if the patient has severe haemolytic anaemia,
• if the patient is taking monoamine oxidase inhibitors (MAO inhibitors) or within 2 weeks after discontinuation of such treatment.

Warnings and precautions
Before starting to take Paramig Fast, consult a doctor or pharmacist if the patient has:

• liver function disorders, including Gilbert's syndrome (familial hyperbilirubinaemia),
• severe kidney or liver dysfunction,
• alcohol-related disease,
• anorexia, bulimia or cachexia, prolonged malnutrition,
• low hepatic glutathione reserves, e.g. appetite disorders, cystic fibrosis, HIV infection, starvation or wasting, sepsis,
• dehydration,
• hypovolaemia.

Do not exceed the recommended dose of the medicine.
Long-term or frequent use of the medicine is not recommended. Do not take other medicines containing paracetamol at the same time. Taking multiple times the daily dose at once may cause severe liver damage. In such cases, loss of consciousness does not occur, but immediate medical attention is required. Prolonged use of the medicine without medical supervision may be harmful. In children treated with paracetamol at a daily dose of 60 mg/kg, there is no justification for simultaneously administering another antipyretic unless paracetamol alone is ineffective.

The risk of overdose is higher in individuals with alcohol-induced liver damage without signs of cirrhosis. Caution is advised in cases of chronic alcoholism. In such cases, the total daily dose should not exceed 2 grams.
If the patient is alcohol-dependent or has liver damage, do not use paracetamol unless prescribed by a doctor. Alcohol should not be consumed during treatment with paracetamol. Paracetamol does not enhance the effects of alcohol.

If high fever or signs of secondary infection occur, or if symptoms persist beyond 3 days, the treatment should be re-evaluated.
If symptoms worsen or do not improve after 3 days, or if high fever develops, consult a doctor.

If the patient has severe illnesses, including severe kidney dysfunction or sepsis (when bacteria and their toxins circulate in the blood, leading to organ damage) or malnutrition, chronic alcoholism, or is also taking flucloxacillin (an antibiotic), caution is advised. In these situations, patients have been reported to develop a serious condition called metabolic acidosis (an abnormality in blood and body fluids) when taking paracetamol regularly over a prolonged period or when taking paracetamol together with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, nausea and vomiting.

The total dose of paracetamol should not exceed 3 g per day in adults and children weighing at least 50 kg. If the patient is simultaneously taking other painkillers containing paracetamol, do not take Paramig Fast without prior consultation with a doctor or pharmacist.

Never take Paramig Fast in a dose higher than recommended. Higher doses do not provide stronger pain relief but may cause severe liver damage.
The first signs of liver damage may appear after several days. Therefore, it is very important to contact a doctor immediately if Paramig Fast has been taken in a dose higher than recommended in this leaflet.

Prolonged or improper use of painkillers, or taking them in high doses, may lead to headaches that should not be treated with higher doses of this medicine.

Generally, habitual use of painkillers, especially combinations of several analgesic substances, may lead to permanent kidney damage with risk of kidney failure (analgesic nephropathy).

Sudden discontinuation of the medicine after prolonged, improper use in high doses may cause headaches, weakness, muscle pain, restlessness and autonomic symptoms. These withdrawal symptoms resolve within a few days. During this time, further use of painkillers should be avoided, and their re-initiation should not occur without consulting a doctor.

Do not take Paramig Fast for a prolonged period or in high doses without consulting a doctor or dentist.

Paramig Fast and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, including those available without a prescription.

Medicines that may interfere with the action of Paramig Fast:

• probenecid, a medicine used in the treatment of gout (podagra);
• medicines potentially harmful to the liver, e.g. phenobarbital (sleeping tablets), phenytoin, carbamazepine, primidone (antiepileptic drugs) and rifampicin (used in the treatment of tuberculosis). Concurrent use of these medicines with paracetamol may cause liver damage;
• metoclopramide and domperidone (used to treat nausea). These medicines may accelerate the absorption and onset of action of paracetamol;
• medicines that delay gastric emptying. These medicines may delay the absorption and onset of action of paracetamol;
• cholestyramine (used to reduce elevated serum lipid levels) may reduce absorption and delay the onset of action of paracetamol. Therefore, cholestyramine should not be taken within the first hour after administration of paracetamol;
• medicines that reduce blood clotting (oral anticoagulants, especially warfarin).

Inform your doctor or pharmacist if the patient is taking:

• flucloxacillin (an antibiotic), due to the serious risk of blood and body fluid disorders (called metabolic acidosis), which require urgent treatment (see section 2).

Concomitant administration of paracetamol and AZT (zidovudine, a medicine used in HIV infections) increases the tendency for a decrease in white blood cells (neutropenia), which may impair immune system function and increase the risk of infections. Therefore, Paramig Fast may be taken together with zidovudine only on a doctor's recommendation.

Repeated use of paracetamol for more than one week increases the tendency for bleeding. Therefore, long-term use of paracetamol should only occur under medical supervision. Occasional use of paracetamol has no significant effect on bleeding tendency.

Effect of paracetamol on laboratory test results
Paracetamol may affect the measurement of uric acid and blood glucose levels.

Paramig Fast with food and drink
Do not consume alcohol during treatment with paracetamol. Do not take the medicinal product Paramig Fast after a meal.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor before using this medicine.

Pregnancy
Paramig Fast may be administered to pregnant women if necessary. Use the lowest effective dose sufficient to relieve pain or reduce fever, and take the medicine for as short a time as possible.

Breastfeeding
The medicine passes into breast milk. Therapeutic doses of this medicine may be used during breastfeeding.

Driving and operating machinery
Paramig Fast has no effect on the ability to drive or operate machinery.

Warnings regarding excipients
Paramig Fast contains in one sachet:

• 1.28 mg of sucrose. Patients with rare hereditary disorders related to fructose intolerance, glucose-galactose malabsorption syndrome or sucrase-isomaltase deficiency should not take this medicine;
• trace amounts of glucose. Patients with glucose-galactose malabsorption syndrome should not take this medicinal product;
• 15.35 mg of aspartame (E 951), a source of phenylalanine, which may be harmful to people with phenylketonuria. This is a rare genetic disorder in which phenylalanine accumulates in the body due to improper excretion;
• 40.50 mg of glycerol (E 422). The medicine may cause headache, gastrointestinal disturbances and diarrhoea;
• 115 mg of sodium, equivalent to 5.8% of the WHO recommended maximum daily sodium intake of 2 g for adults. This should be taken into account in patients on a sodium-controlled diet.

3. How to take PARAMIG Fast

PARAMIG Fast should always be taken exactly as described in this leaflet. If in doubt, consult your doctor or pharmacist.

Dosage in children depends on age and body weight. The single dose is 10 mg/kg body weight (b.w.) every 4 hours or 15 mg/kg b.w. every 6 hours. The maximum daily dose is 60 mg/kg body weight. The interval between individual doses should not be less than 4 hours.

Do not use PARAMIG Fast for longer than three days without medical advice.

Dosage is determined based on the information provided in the table below.

500 mg sachet

| Body weight (b.w.) | Single dose | Maximum daily dose | |--------------------|-------------|---------------------| | (Age) | | | | 26–40 kg | 500 mg paracetamol | 1500 mg paracetamol | | (8–12 years) | (1 sachet) | (3 sachets) | | > 40 kg | 500–1000 mg paracetamol | 3000 mg paracetamol | | (adolescents over 12 years and adults) | (1–2 sachets) | (6 sachets) |

Adults and adolescents over 12 years of age (b.w. > 40 kg):
500–1000 mg (1–2 sachets) every 4–6 hours as needed. Do not exceed the maximum daily dose of 3000 mg paracetamol (i.e. 6 sachets). At least a 4-hour interval must be maintained between doses.

Children aged 8 to 12 years (b.w. 26–40 kg):
500 mg (1 sachet) every 4–6 hours as needed. Do not exceed the maximum daily dose of 1500 mg paracetamol (i.e. 3 sachets). At least a 4-hour interval must be maintained between doses.

Method of administration

For oral use only.

The granules should be taken directly into the mouth (onto the tongue) and swallowed without water. The granules dissolve immediately in the oral cavity. Additionally, the mild effervescent effect of the medicinal product increases saliva production, facilitating swallowing.

Do not take PARAMIG Fast after a meal.

Special patient groups

Children
Do not use in children under 8 years of age or with body weight below 26 kg. Other paracetamol-containing products in different formulations and strengths are available for this age group.

Elderly patients
No dose adjustment is required in elderly patients.

Patients with renal or hepatic impairment
In patients with impaired kidney or liver function, the dose should be reduced or the dosing intervals extended. Consult your doctor or pharmacist.

Chronic alcoholism
Chronic alcohol consumption may lower the toxic threshold of paracetamol. In these patients, the interval between doses should be at least 8 hours. Do not exceed a daily dose of 2 g paracetamol.

Use of a higher than recommended dose of PARAMIG Fast

In case of overdose of PARAMIG Fast, contact your doctor or emergency department immediately. Overdose has very serious consequences and may even lead to death.

Immediate treatment is necessary, even if the patient feels well, due to the risk of delayed severe liver damage. Symptoms may be limited to nausea or vomiting and may not reflect the severity of the overdose or the risk of organ damage.

Missed dose of PARAMIG Fast

Do not take a double dose to make up for a missed dose.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, Paramig Fast may cause adverse reactions, although not everyone will experience them.
If any of the following symptoms occur, treatment must be discontinued immediately and you should contact your doctor without delay:

• Rare (may affect less than 1 in 1,000 people):
• itching, rash, sweating, purpura, angioedema (swelling of the face, lips, throat, breathing difficulties), urticaria, oedema,
• bleeding,
• abdominal pain, diarrhoea, nausea, vomiting, liver failure, hepatic necrosis, jaundice,
• acute and chronic pancreatitis (severe abdominal pain, vomiting, bloating, fever, muscle pain, diarrhoea, itching),
• Very rare (may affect less than 1 in 10,000 people):
• severe skin reactions (rash with blisters all over the body or erosions in the mouth, eyes, genital organs and skin, red spots on the body, often with blisters in the center, bursting blisters, large peeling skin sheets, weakness, fever and joint pain).
• Frequency not known (cannot be estimated from available data):
• a serious condition that may cause blood acidification (so-called metabolic acidosis) in patients with severe disease taking paracetamol (see section 2).

Other adverse reactions occurring rarely (may affect less than 1 in 1,000 people):

• anaemia,
• non-haemolytic anaemia and bone marrow suppression,
• thrombocytopenia (reduced platelet count, nose and gum bleeding, bruising),
• kidney disorders.

Paracetamol is a widely used medicine, and reports of adverse reactions are rare and usually associated with overdose.
Nephrotoxic effects are rare; no association has been observed with therapeutic doses except in cases of long-term use.
If any of the adverse symptoms worsen or if any adverse effect not listed in this leaflet occurs, inform your doctor or pharmacist.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
tel.: +48 22 49 21 301, fax: +48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store PARAMIG Fast

Do not use PARAMIG Fast after the expiry date stated on the sachet and
the cardboard box (marked as EXP). The expiry date refers to the last day of the specified month.
There are no special storage requirements for this medicinal product.
Keep the medicine in a place invisible and inaccessible to children.
Medicines must not be disposed of via wastewater or household waste. Ask your
pharmacist what to do with medicines no longer required. This will help protect
the environment.

6. Contents of the packaging and other information

What Paramig Fast contains
Each sachet contains 500 mg of paracetamol (Paracetamolum) as the active substance.
Other ingredients of the medicine:
ethylcellulose, hypromellose, macrogol 400, calcium carbonate, sodium bicarbonate, disodium
dihydrogen citrate, aspartame (E 951), glycerol distearate (E 422) type I, mannitol, sodium croscarmellose,
sodium carboxymethyl starch type A, amorphous silica; flavour- and odour-masking agent (501482 TP0424)
containing natural flavourings, flavourings identical to natural ones, maltodextrin, sucrose, aspartame (E 951)
and acesulfame potassium (E 950); lemon flavour (502336 TP0551) containing natural flavouring preparations,
synthetic flavourings, maltodextrin and alpha-tocopherol (E 307).

What Paramig Fast looks like and contents of the pack
Packaging in the form of a sachet: polyester/aluminium/polyethylene (LDPE).
White to yellowish-white granules with a lemon scent.
The outer package contains 12 or 24 sachets in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Synoptis Pharma Sp. z o.o.
ul. Krakowiaków 65
02-255 Warszawa
Tel.: 22 32 16 240

Manufacturer:
Zinereo Pharma, S.L.U.
A Relva s/n, O Porriño
36410 Pontevedra
Spain
Farmalider S.A.
C/Aragoneses, 2
28108 Alcobendas (Madrid)
Spain
Edefarm S.L.
Poligono Industrial Enchilagar del Rullo 117
46191 Vilamarxant
Spain