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IBUMAX 400 TBL 400MG N10

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-28
IBUMAX-drug/medicine -tablets aproximate price on "IBUMAX 400 TBL 400MG N10" in Riga city, Latvia is:
  • 1.30€  1.41$  1.11£  150Rub  15SEK  6PLN  5.15₪ 

IBUMAX, 400 mg, plėvele dengtos tabletės, N10


Maximum allowed state defined price ( from ZVA webpage) Euro:State defined maximum allowed price indicated on the picture on drug/medicine -tablets  IBUMAX 400 TBL 400MG N10     Recheck

Reģ. Nr.: 97-0118

ATC codeM01AE01 

Active substances: Ibuprofenum

 


Vendor, principal: Vitabalans Oy
No prescription needed/Patient care products, dressings, gloves, medical devices,...

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IBUMAX 400MG tabletes N10

 .

IBUMAX 400MG N10

Package leaflet: Information for the user

IBUMAX 200 mg film-coated tablets IBUMAX 400 mg film-coated tablets

Ibuprofen

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

Always use this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse 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 a doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
•   You must talk to a doctor if you do not feel better or if you feel worse after 3 days.

What is in this leaflet

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

1. What IBUMAX is and what it is used for

IBUMAX is a medicine with an analgesic and inflammatory effect. IBUMAX reduces pain and redness, swelling and fever.
IBUMAX is used in case of mild to moderate pain, fever and painful menstruation. Your doctor may also prescribe IBUMAX for other indications.

2. What you need to know before you use IBUMAX

Do not use IBUMAX

o if you are allergic to the active substance ibuprofen or any of the other ingredients of this medicine (listed in section 6) or to other non-steroidal anti-inflammatory drugs (e.g. indometacin, diclofenac sodium etc.) or acetylsalicylic acid, i.e. if you have previously had allergic or other unpleasant reactions (asthma, bronchospasm, runny nose or hives) when using these medicines;
o if you have cirrhosis of the liver, severe heart failure or severe kidney disease;
o if you have a stomach or duodenal ulcer;
o if you have suffered from a gastrointestinal haemorrhage or perforation as a result of using nonsteroidal anti-inflammatory drugs in the past;
o if you have had a severe or recurring gastrointestinal ulcer/haemorrhage (two or more distinct ulceration or bleeding events);
o if you have inflammation of the optic nerve;
o if you are more than 20 weeks pregnant.

Warnings and precautions

Talk to your doctor before using IBUMAX if you have liver or kidney failure.
In patients with asthma, chronic obstructive (constructive) pulmonary disease, hay fever, chronic swelling of the nasal mucosa (nasal polyps) or chronic respiratory infection (with concomitant hay fever-like symptoms), the active ingredient ibuprofen may induce an asthma attack (e.g. analgesic intolerance / analgesic asthma), swelling of the soft tissues (tongue, face, neck and throat) or hives.
If you have kidney or liver failure or if you are concomitantly using diuretics, monitoring fluid retention and renal function is necessary, as ibuprofen can inhibit renal function.
Avoid taking other non-steroidal anti-inflammatory drugs (NSAIDs) during the use of IBUMAX.
Anti-inflammatory/analgesic medicines, such as ibuprofen, may be associated with a slightly increased risk of infarction or stroke, especially when used in large doses. Do not exceed the recommended dose or duration of treatment.
Talk to your doctor or pharmacist before taking IBUMAX, if:
-   if you have heart problems, such as heart failure or angina (chest pain), or if you have had a heart attack, bypass, peripheral arterial disease (poor blood supply in legs or feet due to narrowed or clogged arteries) or any type of stroke (incl. mini-stroke or transient ischemic attack (TIA));
-   if you have high blood pressure, diabetes or high cholesterol, if heart disease or stroke has occurred in your family history or if you smoke.
It is advisable to avoid the use of IBUMAX during a chicken pox infection, as it can cause serious skin damage.
You are at a higher risk of gastrointestinal haemorrhage, ulceration and perforation (hole in the gut wall), if your dose of NSAIDs has been increased or if you have had a gastrointestinal ulcer in the past, especially if the ulcer occurred with a complicated bleeding or perforation, as well as if you are elderly. You must start treatment with the lowest dose, if possible.
Tell your doctor about any unusual gastrointestinal symptoms (such as gastrointestinal haemorrhage), especially if these occur at the beginning of treatment.
If a gastrointestinal haemorrhage or ulcer occurs during treatment with ibuprofen, the treatment must be stopped immediately.
Patients with a history of gastrointestinal diseases (ulcerative colitis or Crohn’s disease) should take NSAIDs with special care and under a doctor’s supervision.
Take special care if you are concomitantly using medicines that increase the risk of a gastrointestinal ulcer and haemorrhage, such as oral corticosteroids, medicines that reduce blood clotting (anticoagulants, e.g. warfarin), selective serotonin reuptake inhibitors (certain antidepressants) or platelet aggregation inhibitors, such as acetylsalicylic acid.
In very rare cases, the use of NSAIDs has caused severe skin disorders, some of which are potentially lethal (incl. exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis). The risk of skin reactions is the highest at the beginning of treatment (especially in the first month of treatment). If you get a skin rash, mucosal lesion or another symptom of hypersensitivity, discontinue using IBUMAX immediately and talk to your doctor.
There is some evidence that anti-inflammatory and analgesic medicines (incl. ibuprofen) may cause decreased fertility in women. The disorder is reversible and passes after the discontinuation of the medicine.
Take special care in case of systemic connective tissue disease (lupus erythematosus).
Children and adolescents suffering from dehydration are at risk of renal failure.

Other medicines and IBUMAX

Tell your doctor if you are taking, have recently taken or might take any other medicines.
Ibumax may influence the effect of other medicines and vice versa. These medicines include, for example:
-   anticoagulants (which thin the blood and prevent the formation of blood clots, e.g. aspirin or acetylsalicylic acid, warfarin, ticlopidine);
-   medicines for the treatment of hypertension (ACE inhibitors, such as captopril; beta-blockers, such as atenolol; angiotensin II receptor antagonists, such as losartan).
Ibuprofen can also decrease the blood pressure-reducing effect of diuretics.
Ibuprofen can increase the effects of digoxine, phenytoin and lithium.
Some other medicines can influence treatment with Ibumax and vice versa. Therefore, always talk to your doctor or pharmacist before taking Ibumax with other medicines.

IBUMAX with food, drink, and alcohol

It is recommended to take this medicine with food or milk.

Pregnancy, breast-feeding and fertility

Ibuprofen, like all other non-steroidal anti-inflammatory drugs, is not recommended until the 20th week of pregnancy, as harmful effects on the pregnancy and/or foetus/infant have been reported. Ibuprofen is contraindicated starting from the 20th week of pregnancy.
Ibuprofen is absorbed into breast milk, but the occurrence of harmful effects in the infant is unlikely in case of therapeutic doses. Breast-feeding should be discontinued in case of a need for prolonged treatment.
Tell your doctor if you are pregnant, think you may be pregnant or if you are breast-feeding.

Driving and using machines

IBUMAX may cause dizziness or other central nervous system disorders (e.g. drowsiness, nervousness). If you get any of these symptoms, avoid driving and using machines.

3. How to use IBUMAX

Always use this medicine exactly as described in this leaflet or as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
The maximum daily dose for mild to moderate pain and fever should not exceed 1200 mg.
Transient pain and fever: 400 mg three times per day.
Dysmenorrhea (painful menstruation): 400 mg (every 4 hours).

Use in children

The standard dose is 20-40 mg/kg per day divided into 3...4 doses.
For children weighing over 20 kg, administer 200 mg 3 times per day.
For children weighing over 30 kg, administer 200...400 mg 3 times per day.
For children weighing over 40 kg, administer 400 mg 3 times per day.
Talk to a doctor if children or adolescents need more than 3 days of treatment with this medicine or if the symptoms are exacerbated.
The tablets are taken with a copious amount of liquid, preferably after a meal. Long-term use is permitted only under a doctor’s prescription.
The doctor may also prescribe IBUMAX in other doses, in which case follow the doctor’s prescription.
If you feel that the effect of IBUMAX is too strong or too weak, talk to your doctor or pharmacist.

If you take more IBUMAX than you should

If you have taken more IBUMAX than recommended or if children have accidentally taken this medicine, contact your doctor or nearest hospital immediately to get information on possible risks and necessary treatment options.
Symptoms of overdose include: headache, as well as stomach pain, nausea and vomiting (may be blood-mixed), ringing in the ears, confusion and flickering eye movements. At particularly high doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness and dizziness, blood in the urine, chills in the body and respiratory problems may occur.
If overdose symptoms occur or if overdose is suspected, talk to your doctor immediately. Take the pack with you to the doctor.

If you forget to take IBUMAX

Do not take 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.
The most frequent side effects are gastrointestinal disorders (nausea, vomiting, constipation, bloating, abdominal discomfort, diarrhoea, stomach pain) or eczema.
Other possible effects are gastrointestinal ulcers, perforation or gastrointestinal haemorrhage (manifested as melaena or haematemesis) that can be fatal, especially in elderly patients. In case the excrement is black or bloody, discontinue the treatment and talk to your doctor immediately.
Rarer symptoms include allergy, hives, runny nose, gastritis (gastric inflammation).
Hypersensitivity reactions that can be manifested as respiratory symptoms (bronchospasm, dyspnoea, asthma attack) or skin reactions.
Uncommon symptoms can include headache, dizziness, drowsiness, agitation and impaired hearing. Rare symptoms include liver function disorders, circulatory system disorders, kidney function disorders.
In very rare cases, symptoms can include severe blistering skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis.
A severe skin reaction called DRESS may occur. The symptoms of DRESS are skin rash, fever, swelling of the lymph nodes and an increase in the number of eosinophils (a type of white blood cells).
IBUMAX can be connected to an elevated risk of myocardial infarction or a stroke.

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 IBUMAX

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package.
The expiry date refers to the last day of that month.
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 IBUMAX contains

The active substance is ibuprofen. One tablet contains 200 or 400 mg of ibuprofen.
The other ingredients are:
Tablet core: pregelatinised corn starch, hypromellose, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, stearic acid, anhydrous colloidal silica.
Tablet coating: macrogol 4000, polydextrose, hypromellose and colouring agent (titanium dioxide E171).

What IBUMAX looks like and contents of the pack

IBUMAX 200 mg is a round white film-coated tablet with a score line and a diameter of 11 mm. IBUMAX 400 mg is a capsule-shaped white film-coated tablet with a score line and which measures 7.5 mm in diameter and 18.0 mm in length.
200 mg: 10, 20, 30, 50, or 100 tablets in blister packs (Al/PVC/PVdC, Al/PVdC).
400 mg 10, 20, or 30 tablets in blister packs (Al/PVC).
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Vitabalans Oy Varastokatu 8,
13500 Hämeenlinna,
Finland
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Vitabalans Pharma OÜ,
Höbekuuse 26 12111 Tallinn Phone +372 6230018

This leaflet was last revised in September 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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