FERVEX COLD AND FLU 500mg/4mg x 16 tabl
Fervex
FERVEX COLD AND FLU tablets * 16
Leaflet: user information
Fervex Cold and Flu 500 mg/4 mg film-coated tablets
Paracetamol / Chlorphenamine Maleate
Fervex cold and flu 500 mg/ 4 mg film-coated tablets
Paracetamol / Chlorphenamine maleate
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
- Keep this leaflet. You may need to read it again.
- If you need further information or advice, ask your pharmacist.
- If you get any side effects, tell your doctor or pharmacist. This also includes any possible side effects not described in this leaflet. See point 4.
- If after 5 days you do not feel better or your condition worsens, you should seek medical help.
What this leaflet contains
1. What Fervex cold and flu is and what it is used for
2. What you need to know before you take Fervex cold and flu
3. How to take Fervex cold and flu
4. Possible side effects
5. How to store Fervex cold and flu
6. Contents of the package and additional information
1. What Fervex cold and flu is and what it is used for
Pharmacotherapeutic group - antipyretic, analgesic, H1 receptor antihistamine inhibitor - ATS code: R05X.
This medicine contains 2 active substances:
paracetamol, which relieves pain and reduces high fever;
chlorphenamine maleate, which reduces nasal discharge, tearing and sneezing.
This medicine is used to treat colds, rhinitis, nasopharyngitis and flu-like conditions in adults and children over 15 years of age:
- clear discharge from the nose and tearing from the eyes;
- sneezing;
- headache and/or high fever.
There are other suitable medicines for children under 15: talk to your doctor or pharmacist.
If after 5 days you do not feel better or your condition worsens, you should seek medical attention.
Fervex
2. What you need to know before you take Fervex cold and flu
Do not use Fervex cold and flu:
- if you are allergic to the active substances or to any of the other ingredients of this medicine (listed in point 6);
- for children under 15 years of age;
- if you have serious liver disease;
- at risk of glaucoma (increased intraocular pressure);
- if you have difficulty urinating, due to problems with the prostate or other causes.
Warnings and precautions
Talk to your doctor or pharmacist before taking Fervex cold and flu.
Consult a doctor immediately in case of overdose or accidentally taking too high a dose.
This medicine contains paracetamol and chlorphenamine. Other medicines also contain these substances.
Check that you are not taking any other medicines containing paracetamol and/or chlorphenamine, including over-the-counter medicines.
Do not combine them so as not to exceed the recommended daily dose. Consult your doctor or pharmacist first if you need to take other medicines containing these substances.
(See "Dosage" and "Symptoms and instructions in case of overdose").
Consult your doctor in case of discharge of purulent secretions from the nose, if the fever or pain persists for more than 3 days or if there is no improvement of symptoms after 5 days from the start of treatment.
The dosage, duration of treatment of 5 days and contraindications must be strictly observed.
You should inform your doctor or pharmacist before taking this medicine in the following cases:
- weight below 50 kg;
- mild to moderate liver failure (liver disease);
- kidney failure (kidney disease);
- glucose-6-phosphate dehydrogenase deficiency;
- chronic alcoholism, excessive alcohol intake (3 or more alcoholic drinks per day);
- anorexia, bulimia, cachexia (severe loss of body weight), chronic malnutrition;
- dehydration and hypovolemia (reduction in total blood volume).
Paracetamol can cause severe skin reactions. Stop treatment and contact your doctor immediately if you have a rash or other signs of allergy.
This medicine contains azo dye (E122, carmoisine), which may cause allergic reactions.
Attention should be paid to patients with prostate problems (especially the elderly), patients prone to chronic constipation, vertigo or dizziness.
Children and adolescents
Not applicable.
Other medicines and Fervex cold and flu
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Associated with the presence of paracetamol:
You should contact your doctor if you are taking oral anticoagulants, medicines that slow blood clotting (anti-vitamin K). Fervex cold and flu in high doses may increase the effect of your anticoagulant. Your doctor may change the dosage of the anticoagulant if necessary.
Tell your doctor if you or your child are taking this medicine and a blood urea or blood sugar test is ordered.
Associated with the presence of chlorphenamine maleate
During treatment, the use of sodium oxybate, alcoholic beverages, sedative drugs or those containing alcohol should be avoided.
Fervex cold and flu with food, drink and alcohol
This drug may cause increased dizziness when combined with alcohol:
it is better to start the treatment in the evening;
refrain from the use of alcoholic beverages, sedative drugs or those containing alcohol during treatment.
Pregnancy, lactation and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
Subject to the recommended dose and normal conditions of use, this medicine can be used during pregnancy, if it is for a short period (a few days). However, at the end of pregnancy, excessive intake of this drug can cause neurological effects on the newborn. For this reason, always consult your doctor before taking this medicine and never exceed the recommended doses.
Breastfeeding
This drug is very likely to pass into breast milk. Due to the sedative effect it may have on your child (lethargy, decreased tone) or the opposite, stimulating effect (insomnia), this medicine is not recommended to be taken during breastfeeding.
Fertility
It is possible that paracetamol may have an effect on female fertility, and this effect is reversible upon discontinuation of therapy.
Driving and using machines
Be very careful while driving or operating machinery, as this medicine may lead to a risk of drowsiness, especially at the beginning of treatment. If you have any other questions, ask your doctor or pharmacist.
This effect is enhanced by taking alcohol or drugs containing alcohol or sedative drugs. It is recommended to start the treatment in the evening.
Fervex cold and flu contains carmoisine (E122), which can cause allergic reactions.
3. How to take Fervex cold and flu
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
This medicine is intended for adults and children over 15 years of age.
Weight (age) Single dose Dose Interval between doses Maximum daily dose
Adults and children >50 kg (>15 years) 1 tablet (500 mg paracetamol 4 mg chlorphenamine) 4 hours 4 tablets (2000 mg paracetamol 16 mg chlorphenamine)
The maximum daily dose of paracetamol should not exceed 3,000 mg per day.
The maximum daily dose of chlorphenamine maleate should not exceed 16 mg per day, i.e. 4 tablets daily.
Check that you are not taking any other medicines containing paracetamol and/or chlorphenamine, including over-the-counter medicines.
Do not combine them so as not to exceed the recommended daily dose. Consult your doctor or pharmacist first if you need to take other medicines containing these substances.
Application method
Oral administration.
Tablets should be swallowed whole with liquid (eg water, milk, fruit juice).
It is preferable to start the treatment in the evening, due to the sedative effect of this medicine.
Frequency of application
After a minimum of 4 hours, if necessary, take another tablet, not exceeding 4 tablets per day.
Duration of treatment
If pain or fever persists for more than 3 days, or symptoms do not improve after 5 days of treatment, treatment should be reevaluated.
Kidney failure
In case of renal insufficiency (kidney disease), consult your doctor, who will adjust the doses and intervals between doses. The minimum interval between 2 doses should be changed according to the value of creatinine clearance (a value that indicates the severity of renal failure):
Creatinine clearance (cl) Interval between administrations
cl >50 ml/min 4 hours
cl 10-50 ml/min 6 hours
cl < 10 ml/min 8 hours
If you have taken more than the required dose of Fervex cold and flu
Stop treatment and consult your doctor or emergency medical help immediately.
Overdose can be fatal.
In the first 24 hours, the main symptoms of poisoning are: vomiting, abdominal pain and pallor.
If you forget to take Fervex cold and flu
Do not take a double dose to make up for a missed tablet.
If you have any further questions related to the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
ASSOCIATED WITH PARACETAMOL
In some rare cases, the appearance of a skin rash, redness or an allergic reaction in the form of sudden swelling of the face or neck, or sudden malaise is possible. Treatment should be stopped immediately, a doctor should be consulted and medicines containing paracetamol should never be taken again;
Some rare cases of severe skin reactions have been reported. Treatment should be stopped immediately, a doctor should be consulted and medicines containing paracetamol should never be taken again;
Cases requiring blood transfusion have been observed extremely rarely: disorders of liver function, abnormally low levels of certain blood cells (platelets and white blood cells), such as nosebleeds or bleeding gums. In such a case, consult a doctor;
Diarrhea, abdominal pain, elevated liver enzymes, and impaired blood clotting have been reported.
RELATED TO CHLORPHENAMINE MALEATE
Other side effects may occur:
drowsiness, reduced attention, more pronounced at the beginning of treatment;
a drop in blood pressure when standing upright, which may be accompanied by dizziness;
dry mouth, visual disturbances, urinary retention, constipation, palpitations;
memory or concentration disorders, confusion, dizziness, hallucinations;
difficulty coordinating movements, tremors.
Reporting adverse reactions
If you get any side effects, tell your doctor or pharmacist. This includes all possible side effects not described in this leaflet. You can also report side effects directly (see details below). By reporting side effects, you can contribute to getting more information about the safety of this medicine.
Executive Medicines Agency,
Sofia 1303, Damyan Gruev St. 8,
Tel.: +35 928903417,
website: www.bda.bg.
5. How to store Fervex cold and flu
Keep out of the reach of children.
Do not use this medicine after the expiry date which is stated on the carton. The expiration date corresponds to the last day of the specified month.
This medicinal product does not require special storage conditions.
Do not dispose of medicines down the drain or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.
6. Contents of the package and additional information
What Fervex cold and flu contains
- The active substances are: Paracetamol 500 mg, Chlorphenamine maleate 4 mg - for one film-coated tablet
- The other ingredients are: croscarmellose sodium, hypromellose, microcrystalline cellulose, povidone K90, glyceryl behenate, magnesium stearate, coating*, polishing coating**.
*Coating agent: Hypromellose (E464), propylene glycol (E1520), titanium dioxide (E171), carmoisine (E122), indigo carmine (E132).
** Polishing agent: Purified water, beeswax (E901), carnauba wax (E903), polysorbate 20 (E432), sorbic acid (E200).
What Fervex cold and flu looks like and what it contains
This medicine is in the form of an oblong purple film-coated tablet.
Box with 4, 8, 12, 16, 20, 24, 28 or 32 tablets.
Not all types of packaging can be put on sale.
Marketing Authorization Holder and Manufacturer:
Marketing Authorization Holder:
UPSA SAS, France.
Manufacturer:
UPSA SAS, France.
Leaflet last revised date 02/2019.
Other sources of information
Detailed information about this medicine is provided on the website of the Bulgarian Medicines Agency (www.bda.bg).
Health Tips:
WHAT TO DO WITH A CLOGGED OR RUNNING NOSE:
This medicine is used to treat nasal congestion and headache and/or high fever in the case of a cold in adults and children over 15 years of age.
A cold is a very common and acute but mild infection that affects the lining of the nose (the inside of the nose). This mucous membrane secretes a liquid that moistens the inhaled air and fights the pathogens. When the mucous membrane is irritated, it swells and increases fluid secretion, resulting in a "runny" nose.
To avoid the appearance of such symptoms, observe the following hygiene rules as much as possible:
wash your hands regularly, especially before eating or preparing food;
cover your mouth when you sneeze or cough;
blow your nose regularly with disposable tissues (so as not to re-infect yourself), throw them away immediately after use and wash your hands;
when using nasal drops, avoid the use of the same tip by all family members;
avoid contact with women who have recently given birth and their newborns, the elderly and people taking drugs that suppress the immune system (corticosteroids, drugs for blood disorders, cancer, etc.). In such cases, it is recommended to wear a face mask.
To relieve the condition:
take enough fluids;
moisten the nasal mucosa with appropriate solutions (saline, sea or thermal water spray). Avoid the use of the same tip by the whole family;
avoid smoking or passive smoking;
sleep with a higher pillow to improve breathing through blocked nostrils and your sleep;
if necessary, protect the upper lip and nostrils by smearing them with cream, as frequent nose blowing can irritate the skin;
avoid air conditioners that dry out the air and, accordingly, the nasal mucosa, the optimal room temperature should be around 18-20°C;
regularly ventilate the rooms.
WHAT TO DO FOR A FEVER:
Normal body temperature is different for different people and is between 36.5°C and 37.5°C. An elevated temperature above 38°C can be considered a high temperature.
If the high temperature causes you discomfort, you can use this medicine containing paracetamol, following the recommended intake.
To avoid the risk of dehydration, remember to drink fluids often.
With this medicine, the high temperature should go down quickly. However:
if other unusual symptoms occur,
if you have a high temperature for more than 3 days or if your condition worsens,
if your headache becomes severe, or if you are vomiting,
CONSULT YOUR DOCTOR IMMEDIATELY.
WHAT TO DO IN CASE OF PAIN:
The feeling of the strength of pain and the ability to endure pain are different for different people.
if there is no improvement after 5 days of treatment,
if the pain is severe, unexpected or occurs suddenly (especially with severe chest pain) and/or conversely if the pain occurs regularly,
if it is accompanied by other signs, such as general malaise, fever, unusual swelling in the area of pain, weakness in the limbs,
if you wake up at night in pain,
