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IBUSTAR BĒRNIEM 100MG5ML SUSP 100ML

Attention: Information on this site is provided for informational purposes and is not meant to substitute for the advice provided by your own physician or other medical professional. You should not use the information contained herein for treating a health problem or disease, or prescribing any medication. iDrugs24.com is not responsible for any damage to your health as the result of self treatment.

# On 2024-Mar-29
IBUSTAR-KIDS-drug/medicine aproximate price on "IBUSTAR BĒRNIEM 100MG5ML SUSP 100ML" in Riga city, Latvia is:
  • 4.97€  5.37$  4.25£  574Rub  57.3SEK  21PLN  19.78₪ 

IBUSTAR, 20 mg/ml, geriamoji suspensija, vaikams, 100 ml, N1


Maximum allowed state defined price ( from ZVA webpage) Euro:State defined maximum allowed price indicated on the picture on drug/medicine  IBUSTAR BĒRNIEM 100MG5ML SUSP 100ML     Recheck

ATC codeM01AE01 

Active substances: Ibuprofenum

 


Vendor, principal: Berlin-Chemie Ag
No prescription needed/Patient care products, dressings, gloves, medical devices,...

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IBUSTAR 20 mg/ml geriamoji suspensija 100 ml

 .

IBUSTAR 100MG/5ML 100ML

Package leaflet: Information for the user

Ibustar 20 mg/ml oral suspension

Ibuprofen
For children from 5 kg (6 months) to 29 kg (9 years)

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.
-   Ask your pharmacist if you need more information or advice.
-   If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
-   You must contact a doctor if symptoms worsen or do not improve after 3 days.

What is in this leaflet:

1.   What Ibustar is and what it is used for
2.   What you need to know before you use Ibustar
3.   How to use Ibustar
4.   Possible side effects
5.   How to store Ibustar
6.   Contents of the pack and other information

1. What Ibustar is and what it is used for

Ibustar is an anti-inflammatory and pain-relieving medicine (non-steroidal anti-inflammatory drug, NSAID) with fever-lowering (antipyretic) properties.
Ibustar is used for the short-term symptomatic treatment of:
-   Fever
-   Mild to moderate pain
Ibustar is for use in children from 5 kg body weight (6 months) to 29 kg body weight (9 years).

2. What you need to know before you use Ibustar Do not administer Ibustar:

-   If your child is allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6);
-   In allergic reactions after taking acetylsalicylic acid (ASA) or other non-steroidal anti-inflammatories in the past, like:
-   Bronchospasm
-   Asthma attacks
-   Swelling of the mucous membrane of the nose
-   Skin reactions (e.g. reddening,    swelling, hives or similar)
-   In unclarified blood-formation    disturbances
-   In active or history of recurrent stomach/duodenal ulcers (peptic ulcers) or bleeding (two or more distinct episodes of proven ulceration or bleeding)
-   In a history of gastro-intestinal bleeding or perforation, related to previous NSAIDs therapy
-   In bleeding of the brain (cerebrovascular bleeding) or other active bleeding
-   In severe kidney- or liver-function disturbances
-   In severe heart failure
-   In severe dehydration (caused by vomiting, diarrhoea or insufficient fluid intake)
In the last 3 months of pregnancy

Warnings and precautions

Talk to your doctor or pharmacist before taking Ibustar
Side effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms.
Safety in the gastro-intestinal tract
The use of Ibustar at the same time as NSAIDs, including so-called COX-2 inhibitors (cyclooxygenase-2 selective inhibitors) should be avoided.
Elderly:
The elderly have an increased frequency of adverse reactions to NSAIDs especially gastro-intestinal bleeding and perforation which may be fatal. Particularly careful monitoring by a doctor is therefore required in elderly patients.
Gastro-intestinal bleeding, ulceration or perforation, which can be fatal, has been reported with all NSAIDs at any time during treatment, with or without warning symptoms or a previous history of serious gastro-intestinal events.
The risk of gastro-intestinal bleeding, ulceration or perforation is higher with increasing NSAID doses, in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation (see Section 2: "Do not take Ibustar"), and in the elderly. These patients should commence treatment on the lowest dose available. Combination therapy with protective agents (e.g. misoprostol or proton-pump inhibitors) should be considered for these patients, and also for patients requiring an accompanying therapy with low-dose acetylsalicylic acid (ASA) or other drugs likely to increase gastro-intestinal risk.
If your child has a history of gastro-intestinal side effects you should report any unusual abdominal symptoms (especially gastro-intestinal bleeding) particularly in the initial stages of treatment.
Caution should be advised if your child is receiving at the same time medications which could increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulant medicines such as warfarin, selective serotonin-reuptake inhibitors, which are used amongst other things for the treatment of depressive mood, or anti-platelet medicines such as ASA (see Section 2: "Taking other medicines").
If your child experiences bleeding or ulcers in the stomach or intestines during treatment, stop administering Ibustar. Inform your doctor immediately if your child has any unusual abdominal symptoms.
NSAIDs should be given with care to patients with a history of a gastro-intestinal disease (ulcerative colitis, Crohn's disease), as these conditions may get worse (see Section 4 "Possible side effects").
Effects on the cardiovascular and cerebrovascular system
Anti-inflammatory/pain-killer medicines like ibuprofen may be associated with a small increased risk of heart attack or stroke, particularly when used at high doses. Do not exceed the recommended dose or duration of treatment.
You should discuss your treatment with your doctor or pharmacist before taking [Ibustar] if you:
-   have heart problems including heart failure, angina (chest pain), or if you have had a heart attack, bypass surgery, peripheral artery disease (poor circulation in the legs of feet due to narrow or blocked arteries), or any kind of stroke (including ‘mini-stroke’ or transient ischaemic attack “TIA”).
-   have high blood pressure, diabetes, high cholesterol, have a family history of heart disease or stroke, or if you are a smoker.
Skin reactions
Serious skin reactions with reddening and blistering, some of them fatal, (exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis/Lyell's syndrome) have been reported very rarely in association with the use of NSAIDs (see Section 4 "Possible side effects").
Patients appear to be at highest risk of these reactions early in the course of therapy: the onset of the reaction occurring in the majority of cases within the first month of treatment.
Ibustar should be discontinued and a doctor consulted at once at the first appearance of skin rash, mucous-membrane lesions, or any other signs of hypersensitivity.
During chickenpox (varicella) it is advisable to avoid the use of Ibustar.
Other notes
Ibustar should only be used with strict assessment of the benefit/risk ratio if your child:
-   Has certain auto-immune diseases (systemic lupus erythematosus and mixed connective-tissue disease); there is an increased risk of developing symptoms of a non-infectious inflammation of the brain lining (aseptic meningitis) (see Section 4 "Possible side effects").
-   Has certain hereditary blood-formation disturbances (e.g. acute intermittent porphyria)
-   Particularly careful monitoring by a doctor is required:
-   In impaired kidney or liver function
-   Directly after major surgical procedures
-   In allergies (e.g. skin reactions to other medicines, asthma, hayfever), chronic swelling of the mucous membrane of the nose or chronic airway disorders that narrow the airways
-   In dehydration (there is a risk of renal impairment in dehydrated children and adolescents);
-   Severe acute hypersensitivity reactions (for example anaphylactic shock) are observed very rarely. At the first sign of a severe hypersensitivity reaction after taking Ibustar, you must stop administering it immediately and go to a doctor.
-   Ibuprofen, the active substance of Ibustar, may temporarily inhibit the blood-platelet function (thrombocyte aggregation). Patients with blood-coagulation disturbances should therefore be monitored carefully.
-   In prolonged administration of Ibustar, regular checking of the liver values, the kidney function, as well as of the blood count, is required.
-   The doctor or dentist is to be asked or informed if Ibustar is administered before surgical procedures.
-   Prolonged use of any type of painkiller for headaches can make them worse. If this situation is experienced or suspected, medical advice should be obtained and treatment should be discontinued. The diagnosis of medication overuse headache (MOH) should be suspected in patients who have frequent or daily headaches despite (or because of) the regular use of headache medications
-   In general terms, habitually taking painkillers, particularly on combination of several pain-relieving active substances, may lead to permanent kidney damage with the risk of kidney failure (analgesic nephropathy).
-   NSAIDs such as ibuprofen may mask the symptoms of infection and fever.

Other medicines and Ibustar

Tell your doctor or pharmacist if you are administering or if you have recently administered or might administer any other medicines, including medicines obtained without a prescription.
Ibustar may affect or be affected by some other medicines. For example:
-   medicines that are anti-coagulants (i.e. thin blood/prevent clotting e.g. aspirin/acetylsalicylic acid, warfarin, ticlopidine)
-   medicines that reduce high blood pressure (ACE-inhibitors such as captopril, beta-blockers such as atenolol medicines, angiotensin-II receptor antagonists such as losartan)
Some other medicines may also affect or be affected by the treatment of Ibustar. You should therefore always
seek the advice of your doctor or pharmacist before you use Ibustar with other medicines.
The effect of the medicinal substances or preparation groups stated below may be influenced in treatment with
Ibustar at the same time.
Increase in the effect and/or side effects:
-   If the following medicines are taken at the same time, the blood concentrations of these medicines may increase:
-   Digoxin (medicine for strengthening the output of the heart)
-   Phenytoin (medicine for treating seizures)
-   Lithium (medicine for treating psychiatric disorders)
A check of serum-lithium levels, serum-digoxin and serum-phenytoin levels is not required as a rule if used correctly (over a maximum 3 days).
-   Anti-clotting medicines such as warfarin;
-   Methotrexate (medicine for treating cancer or certain rheumatic disorders): Do not take Ibustar within 24 hours before or after administration of methotrexate. This may lead to raised concentrations of methotrexate and to an increase in its side effects.
-   Acetylsalicylic acid and other anti-inflammatory painkillers (non-steroidal anti-inflammatory drugs), as well as glucocorticoids (medicines containing cortisone or cortisone-like substances): An increased risk of ulcers and bleeding in the gastro-intestinal tract exists;
-   Anti-platelet agents and selective serotonin-reuptake inhibitors (medicines for treating depressive mood): An increased risk of bleeding in the gastro-intestinal tract exists.
-   Medicines that contain probenecid or sulfinpyrazone (for treating gout): These may delay the excretion of ibuprofen. There may be accumulation of ibuprofen in the body with an increase in its side effects through this.
Weakening of the effect:
-   Medicines for increasing fluid excretion (diuretics) and medicines for too high blood pressure (antihypertensives) and there could be a possible increased risk for the kidneys.
-   ACE inhibitors (medicines for treating heart failure and high blood pressure): Risk of a kidney-function disturbance occurring is increased.
-   Acetylsalicylic acid in a low dose: The effect of low-dose acetylsalicylic acid on the coagulation-promoting blood platelets may be impaired.
Other possible interactions:
-   Zidovudine (medicine for treating AIDS): An increased risk exists of bleeding of the joints and bruises in haemophiliacs with HIV infection.
-   Ciclosporin (medicine for suppressing the immune response, after a transplant for example, and for treating rheumatism): The risk exists of your kidneys being damaged.
-   Tacrolimus: The risk exists of your kidneys being damaged.
-   Potassium-sparing water-removing agents (certain diuretics): If taken at the same time, there may be an increase in potassium levels.
-   Sulphonylureas (medicines for lowering blood sugar): Although interactions between ibuprofen and sulphonylureas, unlike other NSAIDs, have not yet been described, your blood-sugar values should be checked as a precaution if taken at the same time.
-   Quinolone antibiotics: There may be an increased risk of convulsions.
-   Concomitant administration of ibuprofen with CYP2C9 inhibitors may increase the exposure to ibuprofen (CYP2C9 substrate). In a study with voriconazole and fluconazole (CYP2C9 inhibitors), an increased S(+)-ibuprofen exposure by approximately 80 to 100% has been shown. Reduction of the ibuprofen dose should be considered when potent CYP2C9 inhibitors are administered concomitantly, particularly when high-dose ibuprofen is administered with either voriconazole or fluconazole.

Taking Ibustar with alcohol

If possible, you should not drink alcohol during use of Ibustar, as side effects, particularly those that affect the
gastro-intestinal tract or the central nervous system, may be increased

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

If a pregnancy is established during use of Ibustar, then the doctor is to be notified.
You may only use ibuprofen in the first 6 months of pregnancy after consulting your doctor.
Because of an increased risk of complications for mother and child, Ibustar must not be used in the last 3 months of pregnancy.

Fertility

Ibustar belongs to a group of medicines (non-steroidal anti-inflammatory drugs) that may impair the fertility of women. This effect is reversible after withdrawal of the medicine.

Breast-feeding

The active substance ibuprofen and its breakdown products only cross into breast milk in small quantities. As negative consequences for the infant have not yet become known, an interruption to breast-feeding is not required as a rule on short-term use. However, if prolonged use or taking higher doses is prescribed, early weaning should be considered.

Driving and using machines

As central nervous side effects like tiredness and dizziness may occur if Ibustar is used at higher dosage, reactions may be changed and the ability to take part actively in road traffic and to operate machines may be impaired in isolated cases. This applies to an increased extent in combination with alcohol. You are then no longer able to react fast and purposely enough to unexpected and sudden events. Do not drive cars or other vehicles in this case! Do not operate tools or machines! Do not work without a secure foothold!
Ibustar contains liquid maltitol
If you have been told by your doctor that your child has an intolerance to some sugars, contact your doctor before administering this medicinal product.
Ibustar contains sodium
This medicinal product contains 3.7 mg sodium per ml. To be taken into consideration by patients on a controlled sodium diet.

3. How to use Ibustar

Always administer this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Unless prescribed otherwise by your doctor, the recommended dose of IbustarIbustar 20 mg/ml is:
Body weight (Age)
Single dose
Max. daily dose
5 - 6 kg
(Infants 6 - 8 months)
50 mg
(equivalent to 2.5 ml of suspension)
150 mg
(equivalent to 7.5 ml of suspension per day)
7 - 9 kg
(Infants 9 - 12 months)
50 mg
(equivalent to 2.5 ml of suspension)
200 mg
(equivalent to 10 ml of suspension per day)
10 - 15 kg
(Infants/Children 1 - 3 years)
100 mg
(equivalent to 5 ml of suspension)
300 mg
(equivalent to 15 ml of suspension per day)
16 - 20 kg
(Children 4 - 6 years)
150 mg
(equivalent to 7.5 ml of suspension)
450 mg
(equivalent to 22.5 ml of suspension per day)
21 - 29 kg
200 mg
600 mg
(Children 7 - 9 years)
(equivalent to 10 ml of
(equivalent to 30 ml of

suspension)
suspension per day)

The interval between the doses should be at least 6 hours.
Do not exceed the recommended dose or length of treatment (maximum 3 days).
Impaired kidney or liver function:
No dose reduction is required in mild to moderate impairment to kidney or liver function.
Ibustar is not recommended for use in infants under 6 months or under 5 kg.

Method and route of administration

For oral use in children
For exact dosing, an oral syringe is enclosed with the packing (graduated in half millilitre steps up to 5 ml).
1.   Shake the bottle before use.
2.   To open the bottle, press the cap down and turn it in the direction indicated by the arrows.
3.   Insert the oral syringe into the opening.
4.   Turn the bottle upside down, hold the syringe in place and pull the piston carefully to the required mark.
5.   Put the bottle back in an upright position and release the syringe by carefully turning.
6.   To administer the syrup, insert the end of the syringe into the mouth of your child and press the piston slowly back into the cylinder. Please adapt the speed to the swallowing of your child.
After use, replace the cap. Remove the piston from the cylinder, wash both in warm water and allow to dry. Store the oral syringe out of the reach of children.
A small number of patients may experience mild indigestion with Ibustar. If this happens to your child, it may help if you administer the medicine during meals.
Please speak to your doctor if you think that the effect of Ibustar is too strong or too weak.

Duration of treatment

For short-term use only.
If this medicine is required for more than 3 days, or if symptoms worsen a doctor should be consulted.
Do not administer Ibustar for more than 3 days without the advice of a doctor or dentist.

If you administer more Ibustar than you should

Administer Ibustar according to the instructions of the doctor or the dosage guide stated in the package leaflet. If you have the feeling that your child is not experiencing adequate pain relief, then do NOT increase the dose on your own, but ask a doctor.
If you have administered more Ibustar than you should, or if children have taken this medicine by accident
always contact a doctor or nearest hospital to get an opinion of the risk and advice on action to be taken.
Possible symptoms of an overdose are:
-   The symptoms can include nausea, stomach pain, vomiting (may be blood streaked), headache, ringing in the ears, confusion and shaky eye movement. At high doses, drowsiness, chest pain, palpitations, loss of consciousness, convulsion (mainly in children), weakness and dizziness, blood in urine, cold body feeling, and breathing problems have been reported.
-   Central nervous disturbances like headache, dizziness, light-headedness and unconsciousness (also seizures in children)
-   Gastro-intestinal disturbances like stomach ache, nausea and vomiting, bleeding in the gastro-intestinal tract
-   Function disturbances of the liver and kidneys
-   Drop in blood pressure
-   Lessened breathing (respiratory depression)
-   Blue-red coloration of skin and mucous membranes (cyanosis)
There is no specific antidote.
If an overdose with Ibustar is suspected, notify a doctor at once. According to the severity of the poisoning, they
can decide about the measures that might be required.
If you forget to administer Ibustar
Do not administer a double dose to make up for a forgotten dose.
If you have any further questions on 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. If you notice that your child has the following side effects, please discuss this with your doctor, who will then decide how to proceed further.
STOP TAKING this medicine and seek immediate medical help if your child develops:
•   signs of intestinal bleeding such as: relatively severe pain in the abdomen, black tarry stools, vomiting blood or dark particles that look like coffee grounds.
•   signs of rare but serious allergic reaction such as worsening of asthma, unexplained wheezing or shortness of breath, swelling of the face, tongue or throat, difficulty breathing, racing heart, drop in blood pressure leading to shock. These can happen even on first use of this medicine. If any of these symptoms occur, call a doctor at once.
•   severe skin reactions such as rashes covering the whole body, peeling, blistering or flaking skin. Possible side effects
The list of the following undesirable effects comprises all side effects that have become known under treatment with ibuprofen, also those under high-dose long-term therapy in rheumatism patients. The stated frequencies, which extend beyond very rare reports, refer to the short-term use of daily doses up to a maximum of 1200 mg ibuprofen for oral dosage forms and a maximum of 1800 mg for suppositories.
It must be accounted for that the following adverse drug reactions are predominantly dose-dependant and vary from patient to patient.
The most commonly observed side effects are gastro-intestinal in nature.
Stomach/duodenal ulcers (peptic ulcers), perforation or gastro-intestinal bleeding, sometimes fatal, particularly in the elderly, may occur (see Section 2: "Take special care with Ibustar ").
Nausea, vomiting, diarrhoea, flatulence, constipation, digestive complaints, abdominal pain, tarry stool, vomiting blood, ulcerative stomatitis (inflammation of the mucous membrane of the mouth with ulceration), worsening of the intestinal disorders colitis and Crohn's disease (see Section 2: "Take special care with Ibustar") have been reported following use.
Less frequently, inflammation of the mucous membrane of the stomach (gastritis) has been observed. The risk of gastro-intestinal bleeding in particular occurring depends on the dose range and the length of use.
Oedema, high blood pressure and heart failure have been reported in association with NSAID treatment.
Medicines such as Ibustar may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke.
Common (may affect up to 1 in 10 people)
Stomach and digestive system: Gastro-intestinal complaints like heartburn, stomachache, nausea, vomiting, flatulence, diarrhoea, constipation and slight gastro-intestinal blood losses that may cause a lack of red blood cells (anaemia) in exceptional cases
Uncommon (may affect up to 1 in 100 people)
Immune system: Hypersensitivity reactions with skin rashes and skin itching, as well as asthma attacks (possibly with drop in blood pressure)
A doctor is to be informed at once in this case, and Ibustar must no longer be taken.
Nervous system: Central nervous disturbances like headache, dizziness, sleeplessness, agitation, irritability or tiredness
Eyes: Visual disturbances
A doctor is to be informed at once in this case, and Ibustar must not longer be taken.
Stomach and digestive system: Stomach/duodenal ulcers (peptic ulcers), potentially with bleeding and perforation, inflammation of the lining of the mouth with ulceration (ulcerative stomatitis), increase of ulcerative colitis or Crohn's disease, inflammation of the lining of the stomach (gastritis)
Skin and hair: Various skin rashes
Rare (may affect up to 1 in 1,000 people)
Ears: Ear noises (tinnitus)
Kidneys and urinary system: Kidney-tissue damage (papillary necrosis), particularly in long-term therapy, and raised uric acid concentrations in the blood may also occur.
Very rare (may affect up to 1 in 10,000 people)
Infections and infestations: A worsening of infection-related inflammations (e.g. development of necrotising fasciitis) coinciding with the use of certain anti-inflammatory medicines (non-steroidal anti-inflammatory drugs, to which Ibustar also belongs) has been described.
Symptoms of an inflammation of the brain lining (aseptic meningitis), like severe headache, nausea, vomiting, fever, neck stiffness or consciousness clouding have been observed. An increased risk appears to exist for patients who are already suffering from certain auto-immune disorders (systemic lupus erythematosus, mixed connective-tissue disease).
If signs of an infection (e.g. reddening, swelling, overheating, pain, fever) occur or get worse during use of Ibustar, ask a doctor for advice without delay.
Blood and lymph system: Disturbances to blood formation (anaemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis)
The first signs may be fever, sore throat, superficial wounds in the mouth, influenza-like complaints, severe fatigue, nosebleeds and skin bleeding.
In these cases, stop taking the medicine immediately and go to a doctor. Do NOT attempt any kind of selftreatment with pain- or fever-lowering medicines.
Immune system: Severe general allergic reactions
They may emerge as water accumulation in the face (oedema), swelling of the tongue, internal swelling of the larynx with narrowing of the airways, breathlessness, racing heart, drop in blood pressure up to life-threatening shock.
If one of these symptoms occurs, which can happen even on first use, the immediate assistance of a doctor is required.
Psychiatric disorders: Psychotic reactions, depression
Heart and vessels: Pounding heart (palpitations), heart failure, heart attack ("myocardial infarction"), high blood pressure (arterial hypertension)
Respiratory, thoracic and mediastinal disorders:_asthma, broncospasm, dyspnoea and wheezing
Stomach and digestive system: Inflammation of the gullet (oesophagitis) and of the pancreas (pancreatitis), formation of membrane-like narrowing in the small and large intestines (intestinal, diaphragm-like strictures)
Liver and gall bladder:
Liver-function disturbances, liver damage, particularly in long-term therapy, liver failure, acute inflammation of the liver (hepatitis)
On prolonged administration, the liver values should be checked regularly.
Skin and hair:
Severe skin reactions like skin rash with reddening and blistering (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis/Lyell's syndrome), hair loss (alopecia)
In exceptional cases, severe skin infections and soft-tissue complications may occur during a chickenpox (varicella) infection (see also "Infections and infestations").
Kidneys and urinary system: Lessening of urine excretion and increased water retention in the tissue (oedemas), particularly in patients with high blood pressure or impaired kidney function, nephrotic syndrome (water accumulation in the body [oedemas] and pronounced protein excretion in the urine), inflammatory kidney disorder (interstitial nephritis), which may be accompanied by acute kidney-function disturbance
Lessening of urine excretion, accumulation of water in the body (oedemas), as well as generally feeling unwell, may be a sign of a kidney disorder up to kidney failure. If the stated symptoms occur or get worse, then you must stop taking Ibustar and go to a doctor immediately.
Not known (cannot be estimated from the available data)
A severe skin reaction known as DRESS syndrome can occur. Symptoms of DRESS include: skin rash, fever, swelling of lymph nodes and an increase of eosinophils (a type of white blood cells).
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via www.ravimiamet.ee. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Ibustar
Keep this medicine out of the sight and reach of children..
Do not administer this medicine after the expiry date which is stated on the bottle and folding box after "EXP". The expiry date refers to the last day of that month.
Stability after opening of the bottle: 6 months, if stored below 25 °C No special storage conditions are required for this medicine.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Ibustar contains
The active substance is ibuprofen.
Each ml of suspension contains 20 mg ibuprofen.
The other excipients are:
Sodium benzoate; citric acid, anhydrous; sodium citrate; saccharin sodium; sodium chloride; hypromellose; xanthan gum; liquid maltitol; glycerol; purified water; strawberry flavouring (containing substances identical to natural flavourings, natural flavouring preparations, propylene glycol).
What Ibustar looks like and contents of the pack
Ibustar is a white or off-white viscous oral suspension .
Ibustar comes in a bottle with 100 ml or 200 ml of oral suspension.
An oral syringe (graduated in half millilitre steps up to 5 ml) is enclosed.
Marketing Authorisation Holder
Berlin-Chemie AG (Menarini Group)
Glienicker Weg 125 12489 Berlin Germany
Manufacturers
Laboratorios Alcala Farma, S.L.
Avenida de Madrid, 82
28802 Alcala de Henares - Madrid
Spain
or
Farmasierra Manufacturing, S.L.
Ctra. Irun, Km 26,200
28700 San Sebastian de los Reyes- Madrid
Spain
or
Berlin-Chemie AG Glienicker Weg 125 12489 Berlin Germany
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
OÜ Berlin-Chemie Menarini Eesti Paldiski mnt 29 10612 Tallinn Estonia
Phone:+372 667 5001
This leaflet was last revised in February 2018.





  Instruction, annotation source for medicine: State Agency of Medicines, Estonia





• Medicaments images are for illustrative purposes only and may differ from the actual product.


[*1]

DDD. Information source: WHO Collaborating Centre for Drug Statistics Methodology. Norwegian Institute of Public Health


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