Fervex D

Leaflet attached to the packaging: patient information

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

Fervex D(Fervex without sugar)

500 mg + 200 mg + 25 mg, granules for oral solution

Paracetamol + Ascorbic Acid + Pheniramine Maleate
Fervex D and Fervex without sugar are different trade names for the same drug.

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

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

• You should keep this leaflet so that 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 5 days or the patient feels worse, or if the fever does not subside after 3 days, they should contact their doctor.

Table of contents of the leaflet:

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

1. What is Fervex D and what is it used for

Fervex D is a combination drug.
Paracetamol acts as an analgesic and antipyretic.
Pheniramine maleate reduces congestion and swelling of mucous membranes, thereby clearing nasal passages, inhibiting the sneezing reflex, and reducing eye tearing.
Ascorbic acid supplements vitamin C deficiencies in the body.

Indications for use

Fervex D is indicated for use in adults and adolescents over 15 years of age for the temporary relief of symptoms of influenza, colds, and flu-like conditions (headache, fever, nasal congestion and sore throat).
It can be used by patients with diabetes.
In the event of a bacterial infection, antibiotic treatment may be necessary.
If there is no improvement after 5 days or the patient feels worse, they should consult their doctor.

2. Important information before taking Fervex D

When not to take Fervex D:

• if the patient is allergic to paracetamol, ascorbic acid, pheniramine maleate, or any of the other ingredients of this medicine (listed in section 6),
• if the patient has severe liver or kidney failure,
• if the patient has narrow-angle glaucoma,
• if the patient has prostatic hyperplasia with accompanying urinary retention,
• in children and adolescents under 15 years of age,
• in patients with phenylketonuria, due to the presence of aspartame (E 951).

Warnings and precautions

Before starting to take Fervex D, you should consult a doctor, pharmacist, or nurse.
In the event of symptoms persisting for more than 5 days or fever lasting more than 3 days, the patient should consult a doctor. Without a doctor's recommendation, do not take for more than 5 days.
The risk of dependence, mainly psychological, is observed mainly in the case of taking higher doses than recommended and in the case of long-term treatment.
The medicine contains paracetamol. To avoid the risk of overdose, you should check if other medicines being taken contain paracetamol. In adults with a body weight over 50 kg, the TOTAL DAILY DOSE OF PARACETAMOL MUST NOT EXCEED 4 GRAMS.
Paracetamol should be used with caution in patients with a deficiency of glucose-6-phosphate dehydrogenase (G6PD).

Children and adolescents

The medicine can be used in adolescents over 15 years of age.

Fervex D and other medicines:

You should tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as any medicines you plan to take.

Due to the presence of pheniramine

Contraindicated combinations
Alcohol enhances the sedative effect of most antihistamine drugs - H receptor antagonists. Changes in attention may impair the ability to drive vehicles and operate machinery.
You should avoid taking alcoholic beverages or medicines containing alcohol.
Combinations that should be used with caution
Other sedative medicines: morphine derivatives (painkillers, antitussives), neuroleptics, barbiturates, benzodiazepines, anxiolytics other than benzodiazepines (e.g. meprobamate), sleeping pills, antidepressants with a sedative effect (amitriptyline, doxepin, mianserin, mirtazapine, trimipramine), antihistamines blocking the H receptor with a sedative effect, antihypertensive drugs with a central effect, baclofen, and thalidomide.
Increased inhibition of the central nervous system and associated changes in attention may impair the ability to drive vehicles and operate machinery in motion.
Other medicines with an atropine-like effect: antidepressants with a structure similar to imipramine, most antihistamines blocking the H receptor with anticholinergic effects, antiparkinsonian medicines, atropine-like medicines with an antispasmodic effect, dyzopiramid, neuroleptics from the phenothiazine group, clozapine.
Summation of atropine-like side effects such as urinary retention, constipation, and dry mouth.

Due to the presence of paracetamol

Salicylamide prolongs the elimination time of paracetamol.
Rifampicin, antiepileptic drugs, barbiturate sleeping pills, and other microsomal enzyme-inducing drugs used in combination with paracetamol increase the risk of liver damage.
Caffeine enhances the analgesic and antipyretic effect of paracetamol.
Concomitant use of high doses of paracetamol and non-steroidal anti-inflammatory drugs may increase the risk of kidney function disorders.
Paracetamol enhances the effect of oral anticoagulant drugs from the coumarin group.
Paracetamol used with MAO inhibitors can cause excitement and high fever.
Effect on laboratory test results
Paracetamol may affect the determination of uric acid levels in the blood by the phosphotungstic method, as well as the determination of glucose levels by the oxidase-peroxidase method.

Due to the presence of ascorbic acid

Ascorbic acid may reduce the effectiveness of warfarin and the concentration of flufenazine in serum, as well as reduce the pH of urine, which may affect the excretion of other medicines taken at the same time.

Taking Fervex D with food and drink

There are no contraindications.

Taking Fervex D with alcohol

Drinking alcoholic beverages or taking sedatives (especially barbiturates) enhances the sedative effect of antihistamines, so you should avoid taking them at the same time.
A special risk of liver damage exists in patients who are fasting and regularly drink alcohol.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before taking this medicine.
Pregnancy
It is not recommended to take the medicine during pregnancy.
Breastfeeding
It is not recommended to take the medicine during breastfeeding.

Driving and operating machinery

While taking the medicine, drowsiness may occur, affecting the psychophysical fitness of people driving vehicles and operating machinery.
Warnings regarding excipients with known effects
Fervex D contains 50 mg of aspartame (E 951) in each sachet.
Aspartame (E 951) is a source of phenylalanine. It may be harmful to patients with phenylketonuria.
This is a rare genetic disorder in which phenylalanine accumulates in the body due to its improper excretion.
Fervex D contains 3.5 g of mannitol (E 421) in each sachet.
Fervex D contains 3 mg of alcohol (ethanol) in each sachet. The amount of alcohol in a sachet of this medicine is equivalent to a small amount of beer or wine (trace amounts). A small amount of alcohol in this medicine will not cause noticeable effects.

3. How to take Fervex D

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor, pharmacist, or nurse. If you have any doubts, you should consult a doctor, pharmacist, or nurse.
Adults and adolescents over 15 years of age: 1 sachet 2 or 3 times a day (which corresponds to 1500 mg of paracetamol, 75 mg of pheniramine maleate, and 600 mg of vitamin C).
Intervals between consecutive doses should be at least 4 hours.
Elderly patients
There are no contraindications.
Patients with renal and/or hepatic impairment
Caution should be exercised when administering the medicine to patients with renal impairment. In the event of renal impairment (creatinine clearance below 10 ml/min), intervals of at least 8 hours should be maintained between doses.
Method of administration
Oral administration. The contents of the sachet should be dissolved in a glass of hot or cold water.
Duration of treatment
Without consulting a doctor, do not take this medicine for more than 5 days. If symptoms persist for more than 5 days or fever lasts more than 3 days, the patient should consult a doctor.
If you feel that the effect of the medicine is too strong or too weak, you should consult a doctor or pharmacist.

Taking a higher dose of Fervex D than recommended

Overdose symptoms

Related to pheniramine
Overdose of pheniramine may cause: seizures (especially in children), disorders of consciousness, coma.
Related to paracetamol
A special risk of paracetamol poisoning occurs in the elderly and small children (the most common causes are taking higher doses than recommended and accidental poisoning); these poisonings can lead to death.
Overdose of the product may cause symptoms such as: nausea, vomiting, excessive sweating, drowsiness, and general weakness, and the next day, abdominal distension, return of nausea, and jaundice.
Procedure
In the event of taking a higher dose of the medicine than recommended, you should immediately consult a doctor or pharmacist.

Missing a dose of Fervex D

You should not take a double dose to make up for a missed dose.

Stopping treatment with Fervex D

If you have any further doubts about taking this medicine, you should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Related to pheniramine

Side effects of varying severity may occur, depending on and independent of the dose:
Neurovegetative effects:

• sedation or drowsiness, more pronounced in the initial treatment period,
• anticholinergic symptoms such as dryness of mucous membranes, constipation, accommodation disorders, pupil dilation, palpitations, risk of urinary retention,
• orthostatic hypotension,
• balance disorders, dizziness, memory or attention disorders, more frequently in the elderly,
• coordination disorders, tremors,
• confusion, hallucinations,
• rarely, symptoms of excitement: restlessness, nervousness, insomnia.

Allergic reactions (rare):

• flushing, itching, rash, erythema, urticaria,
• edema, rarely Quincke's edema (edema of the lips, tongue, or larynx),
• anaphylactic shock (a type of systemic allergic reaction with circulatory and respiratory disorders).

Blood system disorders:

• leukopenia (reduced white blood cell count), neutropenia (reduced granulocyte count),
• thrombocytopenia (reduced platelet count),
• hemolytic anemia.

Related to paracetamol

Rare cases of allergic reactions have been reported, such as: anaphylactic shock, Quincke's edema, flushing, urticaria, and skin rash. If any of these symptoms occur, you should immediately stop taking this medicine and medicines with a similar composition.
Very rare cases of thrombocytopenia (reduced platelet count), leukopenia, and neutropenia have been observed.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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.
By reporting side effects, you can help gather more information on the safety of the medicine.

5. How to store Fervex D

The medicine should be stored out of sight and reach of children.
Do not store above 25°C.
Do not use the medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste containers. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Fervex D contains

• The active substances of the medicine are: paracetamol 500 mg, ascorbic acid 200 mg, pheniramine maleate 25 mg.
• The other ingredients are: mannitol (E 421), citric acid, povidone, magnesium citrate, aspartame (E 951), lemon flavor.

Lemon flavor: flavoring ingredients (alpha-pinene, beta-pinene, sabinene, myrcene, limonene, gamma-terpinene, para-cymene, linalool, neral, geranial, geranyl acetate, geraniol), triacetin (E 1518), modified corn starch (E 1450), arabic gum (E 414), ethanol.

What Fervex D looks like and what the packaging contains

Paper/Al/PE sachet containing granules for oral solution, in a cardboard box.
The cardboard box contains 8 sachets of 4.95 g each.
To obtain more detailed information, you should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Lithuania, country of export:

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

Manufacturer:

UPSA SAS
979, Avenue des Pyrénées
47520 Le Passage
France
UPSA SAS
304, avenue du Docteur Jean Bru
47000 Agen
France

Parallel importer:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing authorization number in Lithuania, country of export: LT/1/97/3290/002

Parallel import authorization number: 281/24

Date of leaflet approval: 09.07.2024

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