BENALGIN RAPID x 10 bags
BENALGIN RAPID sachet * 10 ACTAVIS
Leaflet: patient information
Benalgin Rapid 500 mg/50 mg/37.61 mg powder for oral solution
Benalgin Rapid 500 mg/50 mg/37.61 mg powder for oral solution
metamizole sodium monohydrate / caffeine / thiamine nitrate
metamizole sodium monohydrate / caffeine / thiamine nitrate
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or 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 3-5 days you do not feel better or your condition worsens, you should seek medical help.
What this leaflet contains
1. What Benalgin Rapid is and what it is used for
2. What you need to know before using Benalgin
3. How to use Benalgin Rapid
4. Possible side effects
5. How to store Benalgin Rapid
6. Contents of the package and additional information
1. What Benalgin Rapid is and what it is used for
Benalgin Rapid is a combined medicinal product that contains metamizole, caffeine and thiamine (vitamin B1). Metamizole quickly and effectively controls pain of various origins and lowers high fever. Caffeine supports the analgesic effect of metamizole and facilitates its penetration into the brain. Vitamin B1 improves metabolism and facilitates the conduction of nerve impulses. It also has a certain analgesic effect.
Benalgin Rapid is used for the short-term treatment of pain in the following cases:
• headache, incl. migraine and tension headache;
• joint and muscle pains in inflammatory and degenerative diseases of the musculoskeletal system;
• after surgical operations;
• diseases of the peripheral nervous system such as radiculitis, plexitis, neuritis, etc.;
• with painful menstruation.
If after 3-5 days you do not feel better or your condition worsens, you should seek medical help.
2. What you need to know before you take Benalgin Rapid
Do not take Benalgin Rapid:
• if you are allergic to metamizole, caffeine, thiamine or any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to other drugs from the group of pyrazolones or pyrazolidines (phenazone, propifenazone, phenylbutazone, oxyphenazone);
• if you have recently been treated or are currently being treated with cytostatics;
• if, after taking other pain-relieving or temperature-lowering drugs, you have experienced difficulty breathing with wheezing, rashes, itching;
• if you have blood disorders or suppressed bone marrow function, especially leukopenia (reduced number of white blood cells), agranulocytosis (lack of white blood cells), hemolytic anemia (destruction of red blood cells), aplastic anemia (reduced number of all types of blood cells due to impaired bone marrow function);
• if you suffer from porphyria (a rare hereditary disease related to disorders in the formation of hemoglobin);
• if you have a hereditary disease associated with a deficiency of the enzyme glucose-6-phosphate dehydrogenase, in which there is an increased tendency to destroy red blood cells;
• if you suffer from severe liver and kidney diseases;
• if you have an active ulcer or have had stomach or intestinal bleeding;
• if you are in the last three months of pregnancy.
Warnings and precautions
Talk to your doctor or pharmacist before taking Benalgin Rapid.
In some cases, although rare, metamizole can lead to the development of severe and life-threatening allergic reactions, manifested by difficulty breathing and dizziness.
In these cases, you should immediately stop taking this medicine and contact your doctor.
It is also necessary to know that if you have had similar incidents after taking drugs containing metamizole or other painkillers and antipyretics, the risk of such manifestations also exists with:
• intake of other drugs from the group of pyrazolones and pyrazolidines.
• persons with asthma (attacks of shortness of breath, difficulty breathing with wheezing), allergic rhinitis, polyps in the nose, chronic urticaria (hives).
• allergy or intolerance to preservatives (benzoates) or dyes (tartrazine).
• intolerance to alcohol (tears, sneezing and intense reddening of the face when consuming even small amounts of alcohol).
• fever (high body temperature with chills).
It is known that metamizole, although rarely, can cause a severe decrease in the number of white blood cells, which increases the likelihood of infection. This condition is known as agranulocytosis. Note that if you have a high temperature that does not go down despite taking this medicine, or feel that you have a new significant rise in temperature and a serious worsening of your general condition with the appearance of painful sores in the throat, mouth or nose, genitals or anus, you should immediately contact your doctor and stop taking the medicine. These may be signs of agranulocytosis. These manifestations may be mild if you are currently taking antibiotics.
Metamizole can cause a significant decrease in blood pressure, therefore its intake should be avoided in patients with low blood pressure, unstable blood supply and circulation, significant fluid loss, combined with very high fever. In patients in whom lowering of blood pressure must be absolutely avoided (eg, severe coronary artery disease, cerebral vasoconstriction), this drug should be administered only under strict control of cardiac function.
This medicine is used in patients with impaired kidney and liver function, as well as in certain diseases of the stomach and intestines, myasthenia gravis, bronchial asthma and other diseases of the respiratory system, and glaucoma after a doctor's assessment. Your doctor will assess the benefit-risk ratio for you of taking this medicine.
If you find that a progressive rash, often accompanied by blisters or damage to the mucous membranes, appears during or after taking this medicine, you should immediately stop taking the medicine and consult a doctor. These may be manifestations of a severe skin disease.
In elderly people, the elimination of metamizole from the body can be delayed.
In case of a need for longer administration of this drug, it is necessary to monitor the parameters of the peripheral blood and the functional state of the liver.
When metamizole is taken in high doses, the urine can be colored red.
The caffeine contained in this medicine can cause tension, anxiety, hand tremors, insomnia and increased blood pressure, so it is not suitable for people with such complaints. Consumption of caffeine-containing foods and beverages should be limited during treatment. Treatment should be discontinued if palpitations (feeling of the heartbeat) or rapid heartbeat occur.
Other medicines and Benalgin Rapid
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
The risk of allergies is higher when taken simultaneously with other antipyretic, analgesic and anti-inflammatory drugs.
Possible interactions of metamizole with captopril (used to treat high blood pressure), lithium (used to treat certain mental illnesses), methotrexate (used to treat rheumatism or some cancers) and triamterene (a drainage medicine) may occur change in their effect.
There is a risk of impaired formation of white blood cells when taken simultaneously with drugs that suppress bone marrow function, e.g. gold-containing drugs and anti-cancer products.
Metamizole reduces the blood level of cyclosporine (a drug that suppresses the rejection reaction after organ transplantation), so the blood levels of the latter should be monitored.
Metamizole reduces the activity of coumarin anticoagulants (anticoagulants).
Concomitant use with chlorpromazine (psychotropic product) may lead to a risk of severe hypothermia (significant decrease in body temperature).
Tricyclic antidepressants, oral contraceptives and allopurinol increase the toxicity of metamizole.
Caffeine can reduce the effect of barbiturates and benzodiazepines (hypnotics and sedatives).
With simultaneous use with certain types of antibacterial agents (quinolones), the elimination of caffeine and its metabolite paraxanthine can be delayed. Oral contraceptives reduce the emission of caffeine.
Simultaneous use with CNS stimulants, MAO-inhibitors and drugs or drinks containing caffeine or methylxanthines is not recommended.
In case you are going to have laboratory tests, it is necessary to inform the doctor that you are taking this medicine. Caffeine can change the results of some tests.
Benalgin Rapid with food, drink and alcohol
The consumption of caffeine-containing foods and drinks while taking this medicine should be avoided. It is undesirable to drink alcohol while using the medication.
Pregnancy, lactation and fertility
Pregnancy
The available data on the use of metamizole during the first three months of pregnancy are limited, but do not indicate harmful effects on the embryo. In certain cases, when there are no other treatment options, it is possible to accept the administration of single doses of metamizole during the first and second trimesters after consultation with a doctor or pharmacist and after careful consideration of the benefits and risks of its use. In general, however, the use of metamizole is not recommended during the first and second trimesters.
In the last three months of pregnancy, you should not take Benalgin Rapid due to an increased risk of complications for the mother and the child (bleeding, premature closure of an important blood vessel - the so-called ductus Botali in the unborn, which closes naturally only after birth).
Breastfeeding
Metamizole degradation products pass into breast milk in significant quantities and a risk to the infant cannot be ruled out. Therefore, repeated use of metamizole during breastfeeding should be avoided. In the case of a single dose of metamizole, mothers are advised to collect and discard the breast milk within 48 hours after taking the dose.
Driving and using machines
In the recommended doses, Benalgin Rapid usually does not affect the ability to drive and operate machinery.
Given some of the possible side effects (dizziness, drowsiness, headache), especially with longer intake, it is possible to reduce the ability to concentrate attention, therefore, in the event of such symptoms, it is necessary to stop driving and activities related to the management of machines.
Benalgin Rapid contains sucrose and sodium
The product contains 1.78 g of sucrose per dose. This should be considered in patients with diabetes mellitus. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
This medicine contains less than 1 mmol sodium (23 mg) per sachet, i.e. it can be said to be practically sodium-free.
3. How to take Benalgin Rapid
Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
The dose depends on the intensity of pain or fever and on individual sensitivity to Benalgin Rapid. The lowest dose needed to control pain and fever should be selected.
Adults and adolescents over 16 years of age
1 sachet as a single dose that can be taken 3-4 times a day at intervals of 6-8 hours. The maximum daily dose should not exceed 6 sachets.
Elderly and patients with impaired general health / with renal impairment
The dose should be reduced in elderly patients, in exhausted patients and in patients with reduced renal function, as the excretion of metamizole degradation products may be delayed.
Patients with impaired renal or hepatic function
Since the rate of elimination is reduced in patients with impaired renal or hepatic function, repeated high doses should be avoided. Dose reduction is not necessary for short-term use only. No experience of long-term use is available.
Method and duration of application
The medicine can be taken regardless of mealtime. The contents of one sachet are dissolved in a glass with a sufficient amount of water. It is mixed well until a homogeneous solution is obtained, which is taken orally.
The duration of administration depends on the type and severity of the disease. With long-term use, your doctor will assess whether monitoring of the blood count is necessary.
If this drug is not prescribed by a doctor, its application should not exceed 3-5 days.
If you have taken more than the required dose of Benalgin Rapid
Symptoms of overdose are: nausea, vomiting, agitation, insomnia, headache, dizziness, tinnitus, in some cases blood in the urine and feces. In more severe cases, it is possible to reduce to stopping the excretion of urine, seizures, anemia, a significant decrease in the number of white blood cells.
If you take more than the recommended dose, immediately seek help from a doctor. The treatment is carried out in a hospital setting.
If you think you have taken more than the recommended dose or have any of the symptoms described above, contact your doctor immediately.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
It is possible to observe the following adverse drug reactions, which are of unknown frequency (the frequency cannot be estimated from the available data): allergy - most often from the skin (rash, itching, redness), in rarer cases of breathing difficulties, allergic shock or other severe allergic reactions; insomnia, dizziness, increased excitability; accelerated heart activity, palpitations; transient decrease in the number of white blood cells and/or platelets, anemia, punctate skin hemorrhages; loss of appetite, nausea, vomiting, bile stasis, jaundice.
Reporting of suspected 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 by:
The Medicines Executive Agency,
Damyan Gruev St. No. 8,
1303 Sofia,
phone: +359 28 903 417,
website: www.bda.bg.
By reporting side effects, you can contribute to getting more information about the safety of this medicine.
5. How to store Benalgin Rapid
Keep out of the reach of children.
To be stored below 25 °C.
Do not use this medicine after the expiry date which is stated on the sachet. It corresponds to the last day of the specified month.
Do not use this medicine if you notice changes in its appearance.
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 Benalgin Rapid contains
- The active substances in 1 sachet are: metamizole sodium monohydrate 500 mg, caffeine 50 mg and thiamine nitrate 37.61 mg.
- The other ingredients (excipients) are: sucrose, poloxamer 188, sodium cyclamate, saccharin sodium, strawberry flavor (mixture of flavoring substances and glucose), colloidal, anhydrous silicon dioxide.
What Benalgin Rapid looks like and contents of the pack
A white or off-white powder with a strawberry smell.
Powder for oral solution 2.5 g in a paper / aluminum / polyethylene sachet.
One package contains 10 sachets.
Marketing Authorization Holder:
Actavis EAD, Bulgaria.
Manufacturer:
Adipharm EAD, Bulgaria.
Date of last revision of the leaflet: 09.2019.
