Fervex d
Poland
Table of Contents
Patient Information Leaflet
Caution! Keep this leaflet. Information on the immediate packaging is in a foreign language.
FERVEX D (FERVEX be cukraus)
500 mg + 200 mg + 25 mg
effervescent granules for oral solution
Paracetamol + Acidum ascorbicum + Pheniramine maleate
FERVEX D and FERVEX be cukraus are different trade names for the same medicine.
Please read this leaflet carefully 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
physician, pharmacist, or nurse.
- Keep this leaflet for future reference.
- If advice or additional information is needed, consult a pharmacist.
- If any adverse reactions occur, including any not listed in this leaflet, inform a physician, pharmacist, or nurse. See section 4.
- If there is no improvement after 5 days, or if symptoms worsen, or if fever persists beyond 3 days, contact a physician.
Table of contents of the leaflet:
- What FERVEX D is and what it is used for
- Important information before taking FERVEX D
- How to take FERVEX D
- Possible side effects
- How to store FERVEX D
- Contents of the package and other information
1. What FERVEX D is and what it is used for
FERVEX D is a combination medicine.
Paracetamol has analgesic and antipyretic effects.
Pheniramine maleate reduces congestion and swelling of mucous membranes, thereby clearing nasal passages, suppressing sneezing reflex and eye tearing.
Ascorbic acid replenishes vitamin C deficiency in the body.
Indications
FERVEX D is indicated for short-term relief of flu, cold, and flu-like symptoms (headache, fever, inflammation of nasal and throat mucosa) in adults and adolescents over 15 years of age.
It may be used by diabetic patients.
In case of bacterial infection, antibiotic treatment may be necessary.
If there is no improvement after 5 days or if the patient feels worse, consult a physician.
2. Important information before using FERVEX D
When not to use 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 benign 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.
Warnings and precautions
Before starting to use FERVEX D, consult a doctor, pharmacist, or nurse.
If symptoms persist for more than 5 days or fever lasts longer than 3 days, the patient should consult a doctor. Do not use for longer than 5 days without medical advice.
The risk of dependence, mainly psychological, is mainly observed when higher than recommended doses are used or during prolonged treatment.
This medicine contains paracetamol. To avoid the risk of overdose, check whether other medicines being taken also contain paracetamol. In adults with 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 glucose-6-phosphate dehydrogenase (G6PD) deficiency.
Children and adolescents
This medicine may be used in adolescents over 15 years of age.
Fervex D and other medicines
Inform your doctor or pharmacist about all medicines currently used, recently taken, or planned to be taken.
Due to the presence of pheniramine
Unrecommended combinations
Alcohol intensifies the sedative effect of most antihistamines – H receptor antagonists. Impaired attention may affect the ability to drive or operate machinery.
Avoid consuming alcoholic beverages or taking medicines containing alcohol.
Combinations requiring caution
Other medicines with sedative effects: morphine derivatives (analgesics, antitussives), neuroleptics, barbiturates, benzodiazepines, non-benzodiazepine anxiolytics (e.g. meprobamate), hypnotics, antidepressants with sedative properties (amitriptyline, doxepin, mianserin, mirtazapine, trimipramine), sedative H-receptor blocking antihistamines, centrally-acting antihypertensives, baclofen, and thalidomide.
Increased central nervous system depression and impaired attention may affect the ability to drive or operate machinery.
Other medicines with anticholinergic (atropine-like) effects: tricyclic antidepressants (e.g. imipramine-like compounds), most H-receptor blocking antihistamines, anticholinergic antiparkinsonian drugs, antispasmodic drugs with atropine-like action, disopyramide, phenothiazine-derived neuroleptics, clozapine.
Additive anticholinergic adverse effects such as urinary retention, constipation, and dry mouth may occur.
Due to the presence of paracetamol
Salicylamide prolongs the elimination time of paracetamol.
Rifampicin, antiepileptic drugs, hypnotics from the barbiturate group, and other drugs inducing microsomal enzymes, when used concomitantly with paracetamol, increase the risk of liver damage.
Caffeine enhances the analgesic and antipyretic effects of paracetamol.
Concomitant use of high doses of paracetamol and nonsteroidal anti-inflammatory drugs (NSAIDs) may increase the risk of kidney function disorders.
Paracetamol enhances the effect of oral anticoagulants of the coumarin group.
Paracetamol used together with MAO inhibitors may cause excitation and high fever.
Effect on laboratory test results
Paracetamol may interfere with the determination of serum uric acid levels by the phosphotungstic acid method, as well as with the determination of glucose levels by the glucose oxidase-peroxidase method.
Due to the presence of ascorbic acid
Ascorbic acid may reduce the effectiveness of warfarin and decrease plasma levels of fluphenazine. It also lowers urine pH, which may affect the excretion of other concurrently administered drugs.
Use of FERVEX D with food and drink
No contraindications.
Use of FERVEX D with alcohol
Consuming alcoholic beverages or taking sedatives (especially barbiturates) intensifies the sedative effect of antihistamines; therefore, simultaneous use should be avoided.
Particular risk of liver damage exists in patients who are fasting and regularly consume alcohol.
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 or pharmacist before using this medicine.
Pregnancy
Use of this medicine during pregnancy is not recommended.
Breastfeeding
Use of this medicine during breastfeeding is not recommended.
Driving and operating machinery
Drowsiness may occur during treatment, which may affect the psycho-physical performance of individuals driving vehicles or operating machinery.
Warnings regarding excipients with known effects
Fervex D contains 50 mg of aspartame (E 951) per sachet.
Aspartame 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 impaired excretion.
Fervex D contains 3.5 g of mannitol (E 421) per sachet.
Fervex D contains 3 mg of alcohol (ethanol) per sachet. The amount of alcohol in one sachet is equivalent to a very small amount of beer or wine (trace amounts). This trace amount of alcohol in the medicine will not cause noticeable effects.
3. How to use FERVEX D
This medicine should always be taken exactly as described in this patient information leaflet or as directed by your doctor, pharmacist, or nurse. If in doubt, consult your doctor, pharmacist, or nurse.
Adults and adolescents over 15 years of age: 1 sachet 2 or 3 times daily (corresponding to 1500 mg paracetamol, 75 mg pheniramine maleate, and 600 mg vitamin C).
Intervals between doses should be at least 4 hours.
Elderly patients
No contraindications.
Patients with renal and/or hepatic impairment
Caution is advised when administering this medicine to patients with impaired kidney function.
In cases of renal impairment (creatinine clearance below 10 ml/min), intervals of at least 8 hours should be maintained between doses.
Method of administration
For oral use. The contents of the sachet should be dissolved in a glass of hot or cold water.
Duration of treatment
Do not use this medicine for longer than 5 days without consulting a doctor. If symptoms persist for more than 5 days or if fever lasts longer than 3 days, the patient should consult a doctor. If you feel the effect of the medicine is too strong or too weak, consult your doctor or pharmacist.
Use of more than the recommended dose of FERVEX D
Symptoms of overdose
Related to pheniramine
Pheniramine overdose may cause: convulsions (especially in children), disturbances of consciousness, coma.
Related to paracetamol
There is a particular risk of paracetamol poisoning in elderly individuals and young children (most commonly due to ingestion of doses exceeding the recommended amount or accidental poisoning); such poisonings may lead to death.
Overdose of this product may cause symptoms such as: nausea, vomiting, excessive sweating, drowsiness, and general weakness, followed the next day by abdominal distension, return of nausea, and jaundice.
What to do
In case of ingestion of a dose higher than recommended, seek immediate advice from a doctor or pharmacist.
Missed dose of FERVEX D
Do not take a double dose to make up for a missed dose.
Stopping treatment with FERVEX D
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Related to pheniramine
Adverse effects of varying severity, both dose-dependent and independent, may occur:
Neurovegetative effects:
- Sedation or drowsiness, more pronounced at the beginning of treatment,
- Anticholinergic symptoms such as dryness of mucous membranes, constipation, accommodation disturbances, pupil dilation, palpitations, risk of urinary retention,
- Orthostatic hypotension,
- Loss of balance, dizziness, memory or concentration disturbances, more frequently in elderly patients,
- Motor coordination disturbances, tremors,
- Confusion, hallucinations,
- Less frequently, symptoms of excitation: restlessness, nervousness, insomnia.
Hypersensitivity reactions (rare):
- Erythema, itching, rash, purpura, urticaria,
- Swelling, less frequently Quincke's oedema (angioedema of lips, tongue or larynx),
- Anaphylactic shock (a type of immediate systemic allergic reaction with circulatory and respiratory disturbances).
Blood dyscrasias:
- Leukopenia (reduced white blood cell count), neutropenia (reduced granulocyte count),
- Thrombocytopenia (reduced platelet count),
- Hemolytic anaemia.
Related to paracetamol
Rare cases of hypersensitivity reactions have been reported, such as: anaphylactic shock, Quincke's oedema, erythema, urticaria and skin rash. If any of these symptoms occur, administration of this medicine and of medicines with similar composition must be discontinued immediately.
Exceptionally rare cases of thrombocytopenia (reduced platelet count), leukopenia and neutropenia have been observed.
Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions at 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
Reporting adverse effects allows the collection of further information on the safety of using the medicine.
5. How to store FERVEX D
Store below 25°C.
Keep the medicine in a place invisible and out of reach of children.
Do not use the medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This helps protect the environment.
6. Contents of the package and other information
What FERVEX D contains
- The active substances are: paracetamol 500 mg, ascorbic acid 200 mg, pheniramine maleate 25 mg.
- Other ingredients are: mannitol (E 421), citric acid, povidone, magnesium citrate, aspartame (E 951), lemon flavour. Lemon flavour: flavouring components (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), gum arabic (E 414), ethanol.
What FERVEX D looks like and contents of the pack
Paper/aluminium/polyethylene sachets containing granules for oral solution, packed in a cardboard box.
Cardboard box containing 8 sachets.
For more detailed information, please contact the responsible party or the parallel importer.
Marketing Authorisation 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:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing Authorisation Number in Lithuania, country of export: LT/1/97/3290/002
Parallel Import Authorisation Number: 48/23