FERVEX 80 mg Suppositories

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. Fervex pain and fever baby, 80 mg, rectal suppositories
   1. You should carefully read the contents of the leaflet before using the medicine, as it contains
   2. Table of contents of the leaflet
3. What is Fervex pain and fever baby and what is it used for
4. Important information before taking Fervex pain and fever baby
   1. When not to take Fervex pain and fever baby
   2. Warnings and precautions
   3. Using Fervex pain and fever baby with food, drink, and alcohol
   4. Pregnancy, breastfeeding, and fertility
   5. Driving and using machines
5. How to take Fervex pain and fever baby
   1. Using a higher dose of Fervex pain and fever baby than recommended
   2. Missing a dose of Fervex pain and fever baby
6. Possible side effects
7. How to store Fervex pain and fever baby
8. Package contents and other information
   1. What Fervex pain and fever baby contains
   2. What Fervex pain and fever baby looks like and what the package contains
   3. Marketing authorization holder
   4. Manufacturer
   5. Date of last update of the leaflet:

Leaflet attached to the packaging: patient information

Fervex pain and fever baby, 80 mg, rectal suppositories

Paracetamol

You should carefully read the contents of the leaflet before using the medicine, as it contains

important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor, pharmacist, or nurse.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.
• If there is no improvement after 3 days or if the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

• 1. What is Fervex pain and fever baby and what is it used for
• 2. Important information before taking Fervex pain and fever baby
• 3. How to take Fervex pain and fever baby
• 4. Possible side effects
• 5. How to store Fervex pain and fever baby
• 6. Package contents and other information

1. What is Fervex pain and fever baby and what is it used for

Fervex pain and fever baby is a medicine with analgesic and antipyretic effects. It reduces elevated body temperature that occurs during illness, without lowering normal temperature.
Indications for use:

• fever,
• symptomatic treatment of flu-like conditions and colds,
• pains of various origins.

2. Important information before taking Fervex pain and fever baby

When not to take Fervex pain and fever baby

• if the patient is allergic to paracetamol, propacetamol hydrochloride (a precursor to paracetamol), or any other component of this medicine (listed in section 6),
• if the patient has severe liver failure or active, uncontrolled liver disease,
• if the patient has a deficiency of glucose-6-phosphate dehydrogenase (G6PD), which may lead to hemolytic anemia,
• if the patient is being treated with MAO inhibitors (medicines used, among other things, in depression) and for 14 days after the end of treatment,
• in patients who have recently had proctitis, proctocolitis, or rectal bleeding.

The medicine contains soybean oil. It should not be used in case of known hypersensitivity to peanuts or soy.

Warnings and precautions

Before starting to take Fervex pain and fever baby, you should discuss it with your doctor, pharmacist, or nurse.
Fervex pain and fever baby contains paracetamol. To avoid overdose, you should check if other medicines (including prescription and over-the-counter medicines) taken by the patient do not contain paracetamol. Overdose can lead to severe liver damage and death.
The medicine can be used in children under 2 years of age only on a doctor's prescription. If a child is taking a dose of paracetamol of 60 mg/kg body weight/day, other antipyretic medicines can be considered only if the effect is insufficient.
When using suppositories, there is a risk of local irritation, the frequency and severity of which increase with the duration of treatment, frequency of use, and dose of the medicine.
Do not take higher doses than recommended. Taking higher doses of paracetamol than recommended carries the risk of very severe liver damage.
Paracetamol can cause severe skin reactions, such as acute generalized exanthematous pustulosis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, which can be fatal.
You should inform your doctor about any skin reactions.
You should consult your doctor before taking Fervex pain and fever baby if the patient has any of the following conditions:

• liver failure, including Gilbert's syndrome (familial hyperbilirubinemia),
• severe kidney failure,
• alcoholic disease,
• chronic malnutrition (low glutathione reserves in the liver), anorexia, bulimia, emaciation, or starvation,
• dehydration,
• reduced blood volume.

During the use of Fervex pain and fever baby, you should immediately inform your doctor if the patient experiences severe illnesses, including severe kidney disorders or sepsis (when bacteria and their toxins are present in the blood, leading to organ damage) or malnutrition, chronic alcoholism, or if the patient is also taking flucloxacillin (an antibiotic). In these situations, patients have been reported to develop a severe condition called metabolic acidosis (a blood and body fluid disorder), which requires emergency treatment (see section 2).
You should inform your doctor about the use of this medicine if the doctor orders a test for uric acid or blood sugar.

Using Fervex pain and fever baby with food, drink, and alcohol

You should not drink alcohol due to the risk of toxic liver damage.

Pregnancy, breastfeeding, and fertility

This medicine is intended for children (see section 3).
If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before taking this medicine.
Other medicines containing paracetamol as the active substance, intended for adults, have been approved.
Paracetamol can be given to pregnant women if necessary. The lowest possible dose should be used to relieve pain or reduce fever, and the medicine should be taken for the shortest possible time.
If the pain is not relieved or the fever does not decrease, or if it is necessary to increase the frequency of taking the medicine, you should consult a doctor.
This medicine can be used during breastfeeding only with the doctor's consent and in individual cases.
There is no sufficient data available to indicate whether paracetamol affects fertility.

Driving and using machines

The medicine does not affect psychomotor performance. There are no contraindications to driving vehicles and operating machinery.

3. How to take Fervex pain and fever baby

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor, pharmacist, or nurse. If in doubt, you should consult a doctor, pharmacist, or nurse.
In children, the dosage should be observed in relation to body weight, and therefore suppositories of the appropriate strength should be chosen. The approximate age corresponding to a given body weight is provided only as a guide.
In children, the recommended single dose of paracetamol is approximately 15 mg/kg body weight. If necessary, it can be given up to 4 times a day, but not more often than every 6 hours. The recommended maximum daily dose of paracetamol is approximately 60 mg/kg body weight.
Fervex pain and fever baby, rectal suppositories, 80 mg, is intended for infants and children weighing from 5 kg to 10 kg (approximately 2 to 24 months) only on a doctor's prescription.
The recommended single dose is 1 suppository (80 mg of paracetamol). If necessary, the dose can be repeated, but not more often than every 6 hours. Do not take more than 4 suppositories per day (the maximum daily dose of paracetamol is 320 mg).
Patients with kidney disorders
In patients with kidney disorders, the minimum interval between doses should be modified and the maximum daily dose reduced, according to the following scheme:
Creatinine clearance
Interval between doses
Maximum daily dose
CrCl 10-50 ml/min
6 hours
3000 mg (3 g)
CrCl <10 ml min
8 hours
2000 mg (2 g)
Patients with liver disorders
In patients with liver disorders, the dose of the medicine should be reduced or the intervals between doses prolonged. In the following situations, the maximum daily dose should not exceed 60 mg/kg body weight/day (should not exceed 2 g/day):
in adults with a body weight below 50 kg,
chronic or controlled active liver disease, mild to moderate liver failure,
Gilbert's syndrome (familial non-hemolytic hyperbilirubinemia),
chronic alcoholic disease,
chronic malnutrition (low glutathione reserves in the liver),
dehydration.
Method of administration
Rectal administration. It is not recommended to use suppositories in children with diarrhea.
Frequency of use
Due to the possibility of local irritating effects, it is not recommended to use suppositories more often than 4 times a day.
Regular use of the medicine allows you to prevent periodic exacerbations of pain or fever.
In children, equal 6-hour intervals should be maintained between doses, both during the day and at night.
Duration of treatment
The duration of suppository use should be as short as possible. Without consulting a doctor, do not use this medicine for more than 3 days.

Using a higher dose of Fervex pain and fever baby than recommended

In case of taking a higher dose than recommended, you should immediately contact a doctor, even if no symptoms have occurred, as it may lead to life-threatening liver damage.
Overdose is particularly dangerous in the elderly, small children, patients who are chronically malnourished, have alcoholic disease, liver disease, and patients taking medicines that induce liver enzymes, as these individuals have an increased risk of liver damage.
Overdose of the medicine may cause symptoms such as nausea, vomiting, loss of appetite, pallor, excessive sweating, drowsiness, and general weakness within a few to several hours. These symptoms may resolve the next day, despite the fact that liver damage is developing, manifested by abdominal distension, return of nausea, and jaundice.
After paracetamol overdose, the following events have been observed:

• acute kidney failure,
• disseminated intravascular coagulation,
• rare cases of acute pancreatitis.

Missing a dose of Fervex pain and fever baby

You should not take a double dose to make up for a missed dose.
If you have any further doubts about the use of this medicine, you should consult a doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The frequency of side effects listed below is unknown - it cannot be estimated from the available data.
Unknown: increased liver enzyme activity, anaphylactic reaction (including hypotension), anaphylactic shock, hypersensitivity reactions*, angioedema (swelling of the deep layers of the skin and subcutaneous tissue), diarrhea, abdominal pain; thrombocytopenia (reduced platelet count), leukopenia (reduced white blood cell count), neutropenia (reduced neutrophil count); skin redness, rash, erythema, urticaria, papular, acute generalized exanthematous pustulosis, toxic epidermal necrolysis, Stevens-Johnson syndrome, bronchospasm, fixed drug eruption; a serious condition that can cause acidification of the blood (so-called metabolic acidosis), in patients with severe illness taking paracetamol (see section 2).
*Very rare, treatment-requiring cases of hypersensitivity reactions (dyspnea, bronchospasm, excessive sweating) have been reported.
Reporting side effects
If you experience any side effects, including any side effects not listed in this leaflet, you should inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products,
Jerozolimskie Avenue 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309,
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Fervex pain and fever baby

The medicine should be stored out of sight and reach of children.
Do not store above 30°C.
Do not use this medicine after the expiry date stated on the carton after EXP.
The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Fervex pain and fever baby contains

The active substance of the medicine is paracetamol. Each suppository contains 80 mg of paracetamol.
Other ingredients: solid fat with additives, including lecithin derived from soybean oil.

What Fervex pain and fever baby looks like and what the package contains

Rectal suppository.
Package: 2 blisters of PVC/polyurethane (as an adhesive layer)/LDPE, in a cardboard box, containing 5 suppositories each.

Marketing authorization holder

UPSA SAS
3 rue Joseph Monier
92500 Rueil-Malmaison, France

Manufacturer

UPSA SAS
304, Avenue du Dr Jean Bru
47000 Agen, France
UPSA SAS
979, Avenue des Pyrénées
47520 Le Passage, France
To obtain more detailed information about this medicine, you should contact the local representative of the marketing authorization holder:
MagnaPharm Poland sp. z o.o.
Inflancka Street 4
00-189 Warsaw
tel: +48 22 570 27 00

Date of last update of the leaflet: