FERVEX 150 mg Suppositories

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. Fervex pain and fever baby, 150 mg, rectal suppositories
   1. Read the leaflet carefully before taking 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 revision of the leaflet:

Leaflet attached to the packaging: patient information

Fervex pain and fever baby, 150 mg, rectal suppositories

Paracetamol

Read the leaflet carefully before taking 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 advised by a doctor, pharmacist, or nurse.

• The leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any 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 the patient feels worse, they should contact a 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 of the other ingredients 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 (a group of medicines used in depression) and for 14 days after stopping 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 treatment with Fervex pain and fever baby, the patient should discuss it with their doctor, pharmacist, or nurse.
Fervex pain and fever baby contains paracetamol. To avoid overdose, the patient should check if other medicines (including prescription and over-the-counter medicines) they are taking contain paracetamol. Overdose can lead to severe liver damage and death.
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.
If a child is taking a paracetamol dose of 60 mg/kg body weight per day, other antipyretic medicines should only be considered if the effect is insufficient.
Higher doses than recommended should not be used. Using higher doses of paracetamol than recommended carries the risk of 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.
The patient should inform their doctor about any skin reactions.
The patient should consult their doctor before taking Fervex pain and fever baby if they have any of the following conditions:

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

During treatment with Fervex pain and fever baby, the patient should immediately inform their doctor if they experience severe diseases, 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 they are 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).
The patient should inform their doctor about taking 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

Alcohol should not be consumed due to the risk of toxic liver damage.

Pregnancy, breastfeeding, and fertility

This medicine is not intended for adults (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 effective dose should be used for the shortest possible time.
If the pain is not relieved or the fever does not subside, or if it is necessary to increase the frequency of taking the medicine, the patient should consult their doctor.
This medicine can be used during breastfeeding only with the doctor's consent and in individual cases.
There is no sufficient data to determine whether paracetamol affects fertility.

Driving and using machines

The medicine does not affect psychomotor performance. There are no contraindications to driving or 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 advised by a doctor, pharmacist, or nurse. In case of doubt, the patient should consult their doctor, pharmacist, or nurse.
In children, the dosage should be based on body weight; therefore, rectal suppositories of the appropriate strength should be chosen. The approximate age corresponding to a given body weight is provided only as a guide.
The recommended single dose of paracetamol for children 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, 150 mg, is intended for children with a body weight of 10 kg to 15 kg (approximately 24 months to 3 years).
The recommended single dose is 1 suppository (150 mg of paracetamol). If necessary, the dose can be repeated, but not more often than every 6 hours. No more than 4 suppositories should be used per day (the maximum daily dose of paracetamol is 600 mg).
Patients with kidney function disorders
In patients with kidney function disorders, the minimum interval between doses should be modified, and the maximum daily dose should be 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 function disorders
In patients with liver function 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 per day (should not exceed 2 g/day):
in adults with a body weight below 50 kg,
chronic or 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 for the prevention of 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, the medicine should not be used for more than 3 days.

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

In case of using a higher dose than recommended, the patient should immediately contact their 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 liver disease, liver disease, or are taking medicines that induce liver enzymes, as these patients 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

A double dose should not be used to make up for a missed dose.
If the patient has any further doubts about the use of this medicine, they should consult their 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, or urticaria, purpura, 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 disease taking paracetamol (see section 2).
*Very rare, treatment-requiring cases of hypersensitivity reactions (dyspnea, bronchospasm, excessive sweating) have been reported.
Reporting side effects
If any side effects occur, including those not listed in this leaflet, the patient should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Fervex pain and fever baby

The medicine should be stored out of sight and reach of children.
It should not be stored at a temperature above 30°C.
The medicine should not be used 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. The patient should ask their 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 150 mg of paracetamol.
The other ingredients are: solid fat with additives, including soybean lecithin.

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

Rectal suppository.
Packaging: 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, the patient 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 revision of the leaflet: