Fervex d
Poland
Table of Contents
Patient Information Leaflet
Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Fervex D ( Fervex be cukraus ), 500 mg + 200 mg + 25 mg
Granules for oral solution
Paracetamolum + Acidum ascorbicum + Pheniramini maleas
Fervex D and Fervex be cukraus are different trade names for the same medicine.
Please read the entire leaflet carefully before using this 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
your doctor, pharmacist, or nurse.
- Keep this leaflet, so you can read it again if needed.
- If you need advice or further information, please consult your pharmacist.
- If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
- If there is no improvement after 5 days, or if your condition worsens, or if fever persists beyond 3 days, consult your doctor.
Table of contents:
- 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 pack 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 the sneezing reflex, and reducing eye tearing.
Ascorbic acid replenishes vitamin C deficiency in the body.
Indications
Fervex D is indicated for short-term relief of symptoms of influenza, colds, and flu-like conditions (headache, fever, inflammation of nasal and throat mucosa) in adults and adolescents over 15 years of age.
It may be used by patients with diabetes.
In case of bacterial infection, antibiotic treatment may be necessary.
If there is no improvement after 5 days or if symptoms worsen, consult your doctor.
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 treatment with 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 doses higher than recommended are used or during long-term treatment.
The medicine contains paracetamol. To avoid the risk of overdose, check whether other medicines currently taken also contain paracetamol. In adults with body weight above 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
The medicine may be used in adolescents above 15 years of age.
Fervex D and other medicines
Tell your doctor or pharmacist about any other medicines you are currently taking, have recently taken or plan to take.
Due to the presence of pheniramine
Unrecommended combinations
Alcohol intensifies the sedative effect of most antihistamines – H receptor antagonists. Changes in concentration ability may impair the ability to drive vehicles and 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 associated impairment in concentration ability may affect the ability to drive vehicles and operate machinery.
Other drugs with anticholinergic (atropine-like) effects: tricyclic antidepressants (structurally similar to imipramine), most H -receptor blocking antihistamines, anticholinergic antiparkinsonian drugs, antispasmodic drugs with atropine-like action, disopyramide, phenothiazine derivatives, clozapine.
Additive anticholinergic side 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 may increase the risk of kidney function disorders.
Paracetamol enhances the effect of oral anticoagulants from the coumarin group.
Paracetamol used together with MAO inhibitors may cause a state of excitation and high fever.
Effect on laboratory test results
Paracetamol may interfere with blood uric acid measurement by the phosphotungstic acid method, as well as with blood glucose measurement by the oxidase-peroxidase method.
Due to the presence of ascorbic acid
Ascorbic acid may reduce the effectiveness of warfarin and lower plasma levels of fluphenazine. It also decreases urine pH, which may affect the excretion of other concurrently administered drugs.
Taking Fervex D with food and drink
There are no contraindications.
Taking 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 in those who regularly consume alcohol.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, 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 psychomotor performance of persons 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 corresponds 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 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 impaired renal and/or hepatic function
Caution is advised when administering the medicine to patients with impaired renal function.
In cases of renal impairment (creatinine clearance below 10 ml/min), intervals between doses should be
at least 8 hours.
Method of administration
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 fever lasts longer than 3 days, the patient should
consult a doctor.
If you feel the medicine’s effect is too strong or too weak, consult your doctor or
pharmacist.
Use of a higher than recommended dose of Fervex D
Symptoms of overdose
Related to pheniramine
Pheniramine overdose may cause: seizures (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 higher than recommended or accidental poisoning); such poisonings
may lead to death.
Overdose of the product may cause symptoms such as: nausea, vomiting, excessive
sweating, drowsiness, and general weakness, followed the next day by abdominal distension, recurrence of nausea, and jaundice.
Management
If a higher than recommended dose has been taken, 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.
Discontinuation of Fervex D
If you have any further questions concerning the use of this medicine, consult your
doctor or pharmacist.
4. Possible adverse reactions
Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Related to pheniramine
Adverse reactions 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 frequent 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 edema (swelling of lips, tongue or larynx),
- Anaphylactic shock (a type of immediate systemic allergic reaction with circulatory and respiratory disturbances).
Blood system disorders:
- Leukopenia (reduced number of white blood cells), neutropenia (reduced number of granulocytes),
- Thrombocytopenia (reduced number of blood platelets),
- Hemolytic anemia.
Related to paracetamol
Rare cases of hypersensitivity reactions have been reported, such as: anaphylactic shock, Quincke's edema, erythema, urticaria and skin rash. If any of these symptoms occur, administration of this medicine and of medicines with similar composition should be immediately discontinued.
Exceptionally rare cases of thrombocytopenia (reduced number of blood platelets), leukopenia and neutropenia have been observed.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor, pharmacist or nurse. Adverse reactions can also 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.
By reporting adverse reactions, more information on the safety of the medicine can be collected.
5. How to store Fervex D
Keep the medicine out of sight and reach of children.
Do not store above 25°C.
Do not use this 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 required. Such measures help protect the environment.
6. Contents of the packaging and other information
What the medicine 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, p-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
Aluminium/paper/polyethylene sachets containing granules for oral solution, packed in a cardboard box.
Cardboard box containing 8 sachets.
For more detailed information, please contact the Marketing Authorisation Holder 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
304, avenue du Docteur Jean Bru
47000 Agen, France
UPSA SAS
979, Avenue des Pyrénées
47520 Le Passage, France
Parallel Importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw, Poland
Repackaged by:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw, Poland
Marketing Authorisation Number in Lithuania, country of export: LT/1/97/3290/002
Parallel Import Authorisation Number: 210/23