Blokmax rapid film tablets 10x400mg

The distribution of this drug over the Internet is strictly prohibited and regulated by the laws of the Republic of Serbia, while its presentation on the Internet is allowed, solely for the purpose of informing the general and professional public about its purpose and better familiarization with the basic characteristics of the drug itself.

YOU CAN VIEW THE REGULATION ON THE METHOD OF ADVERTISING MEDICINE, REGARDING MEDICINE ("Sl. Gl. RS", no. 79/2010) HERE.

Read this instruction carefully before you start taking this medicine, because it contains information that is important to you.
Always take this medicine exactly as stated in this leaflet or as explained to you by your doctor or pharmacist.

• Save the instructions. You may need to read it again.
• If you have additional questions or need advice, contact your pharmacist.
• If you experience any side effects, contact your doctor or pharmacist. This includes any side effects not listed in this guide. See section 4.
• If the symptoms of increased body temperature and pain last longer than 3 days or do not go away after 5 days of using the drug, you must contact your doctor.

In this guide you will read:

1. What is BlokMAX Rapid and what is it for?
2. What you need to know before taking BlokMAX Rapid
3. How to take the drug BlokMAX Rapid
4. Possible side effects
5. How to store BlokMAX Rapid medicine
6. Package contents and other information

1. What is BlokMAX Rapid and what is it for?

The active substance of BlokMAX Rapid is ibuprofen-lysine, a salt of ibuprofen. It belongs to a group of drugs called non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs work to relieve pain, swelling and high fever.

The drug BlokMAX Rapid is indicated for short-term symptomatic treatment of mild to moderate pain such as headache, migraine, toothache, dysmenorrhea, muscle pain, back pain, rheumatic pain, fevers and symptoms such as elevated body temperature and pain in the common cold and flu.

The drug BlokMAX Rapid is indicated for use in adults, adolescents over 12 years of age and body weight ≥ 40 kg.

If you do not feel better or feel worse after 3 days, you must contact your doctor.

2. What you need to know before taking BlokMAX Rapid

BlokMAX Rapid should not be taken:

• if you are allergic (hypersensitive) to ibuprofen, to aspirin (acetylsalicylic acid), other painkillers or to any of the auxiliary substances of this medicine (listed in section 6)
• if you have had shortness of breath, asthma, runny nose, swelling or hives when you have previously taken aspirin (acetylsalicylic acid) or similar pain relievers (NSAIDs);
• if you have or have had two or more episodes of stomach/duodenal ulcers or bleeding;
• if you have active bleeding (including bleeding in the brain);
• if you have had gastrointestinal bleeding or perforation (break through the wall) when you have previously taken NSAIDs (non-steroidal anti-inflammatory drugs);
• if you have serious heart, liver or kidney disease;
• if you have unclear blood formation disorders, severe dehydration (caused by vomiting, diarrhea or insufficient fluid intake);
• if you are in the third trimester of pregnancy;
• if you are an adolescent weighing less than 40 kg or you are younger than 12 years old.

Warnings and precautions

Talk to your doctor or pharmacist before taking BlokMAX Rapid if:

• you have or have had asthma or an allergic reaction with shortness of breath (difficulty breathing);
• you have hay fever, nasal polyps or chronic obstructive pulmonary disease, as the risk of allergic reactions is increased. Allergic reactions can occur in the form of asthma attacks (analgesic asthma), Quincke's edema or hives;
• you have problems with your kidneys, heart, liver or intestines;
• you have previously had gastrointestinal diseases (such as ulcerative colitis, Crohn's disease);
• you have congenital disorders of blood formation (eg acute intermittent porphyria);
• you suffer from systemic lupus erythematosus (SLE) or mixed connective tissue disease (a condition of the immune system that causes joint pain, skin changes and other organ disorders);
• you have chicken pox (chicken pox), it is advised to avoid the use of BlokMAX Rapid because your condition may worsen;
• you recently had a major surgical intervention;
• you are dehydrated;
• you are taking other NSAIDs. Concomitant use with other NSAIDs, including selective inhibitors of cyclooxygenase-2 should be avoided;
• you are pregnant (in the first 6 months of pregnancy).

Other warnings:

- Anti-inflammatory/pain relievers such as ibuprofen may be associated with a small increased risk of heart attack or stroke, especially when used in high doses. Do not exceed the recommended dose or length of treatment.

- Talk to your doctor or pharmacist about your treatment before taking BlokMAX Rapid, 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 feet due to narrow or blocked arteries) or any form of stroke (including "mini -stroke" or transient ischemic attack"TIA");
• you have high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or are a smoker.

Very rarely, potentially life-threatening skin rashes (exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis) associated with NSAID use have been reported. Patients are at greatest risk for developing these reactions during the first month of therapy.
Stop taking BlokMAX Rapid and contact your doctor or pharmacist if you notice a skin rash, mucosal lesions or any other sign of an allergic reaction.

Adverse reactions can be minimized by using the lowest effective dose in the shortest possible time. Elderly patients have an increased risk of side effects.

Ibuprofen can temporarily inhibit platelet function (platelet aggregation). Therefore, the condition of patients with blood clotting disorders should be carefully monitored. A doctor or dentist should be advised or informed if BlokMAX Rapid is administered before surgical procedures.

Regular use of (several types of) analgesics can lead to permanent serious kidney problems and the risk of kidney failure. This risk may be increased under physical exertion associated with salt loss and dehydration. Therefore, regular use of analgesics should be avoided.

Prolonged use of painkillers for headache can lead to its worsening. If this happens or there is any doubt, you should consult a doctor and stop the therapy. Headache caused by excessive use of drugs can be suspected in patients who have frequent or daily headaches in addition to (or because of) regular use of headache medication.

With long-term use of the drug BlokMAX Rapid, it is necessary to regularly check the values of liver parameters, kidney function, as well as regular blood tests.
NSAIDs can mask the symptoms of infection and fever.

Children and adolescents
This medicine is not intended for adolescents weighing less than 40 kg and children under 12 years of age.
There is a risk of kidney damage in dehydrated adolescents.

Other drugs and the drug BlokMAX Rapid
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Avoid taking this medicine with the following medicines:

• anticoagulants (medicines to thin the blood/prevent blood clotting, eg aspirin (acetylsalicylic acid), warfarin, ticlopidine);
• ACE inhibitors such as captopril; beta-blockers such as atenolol; angiotensin-II receptor antagonists such as losartan (to reduce high blood pressure);
• aspirin (acetylsalicylic acid) or other NSAIDs due to increased risk of gastrointestinal ulceration or bleeding;
• with digoxin (a medicine used in the treatment of heart failure) due to the possible strengthening of the effect of digoxin;
• glucocorticoids (medicines containing cortisone or substances similar to it) due to a possible increase in the risk of gastrointestinal ulcers or bleeding;
• antiplatelet drugs because they increase the risk of gastrointestinal bleeding;
• with phenytoin (a medicine used in the treatment of epilepsy) because the effect of phenytoin can be increased;
• potassium-sparing diuretics (medications to expel excess fluid from the body) because an increased concentration of potassium in the blood may occur);
• with methotrexate (medicine used in the treatment of cancer or rheumatism), because the effect of methotrexate can be increased;
• ciclosporin, tacrolimus (for temporary suppression of the immune system) because kidney damage may occur;
• selective serotonin reuptake inhibitors (a drug used in the treatment of depression) because they increase the risk of gastrointestinal bleeding;
• lithium (a medicine used to treat mania or depression) because the effect of lithium can be increased;
• probenecid and sulfinpyrazone (medicines used to treat gout) as they may delay the excretion of ibuprofen;
• mifepristone (for termination of pregnancy) - because the effect of mifepristone can be reduced;
• zidovudine (to treat HIV/AIDS) because ibuprofen may increase the risk of joint bleeding or bleeding leading to swelling in HIV(+) hemophiliacs;
• sulfonylurea derivatives (medicine used in the treatment of diabetes) because interactions are possible;
• quinolone antibiotics because the risk of convulsions is increased;
• drugs that inhibit the CYP2C9 enzyme, such as the antifungal drugs voriconazole or fluconazole, as exposure to ibuprofen may be increased;
• herbal medicines such as ginkgo biloba - there is a possibility that you will bleed more easily if you take ibuprofen and ginkgo biloba at the same time;
• do not take this medicine if you are taking acetylsalicylic acid in a dose higher than 75 mg per day. If you are on low doses of acetylsalicylic acid (up to 75 mg per day), consult your doctor or pharmacist before taking BlokMAX Rapid.

Some other drugs can also affect or BlokMAX Rapid therapy can affect the effect of other drugs. Therefore, you must always seek the advice of your doctor or pharmacist before you start using BlokMAX Rapid with other medicines.

Taking BlokMAX Rapid with food and drinks
Some side effects, such as those affecting the gastrointestinal and central nervous systems, may be more likely to occur if alcohol is taken at the same time as BlokMAX Rapid.

Pregnancy, breastfeeding 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 taking this medicine.

Do not take this medicine in the last 3 months of pregnancy or if you are breast-feeding.
Avoid using this medicine during the first 6 months of pregnancy unless otherwise advised by your doctor.

Only small amounts of ibuprofen and its breakdown products pass into breast milk. This medicine can be taken during breastfeeding if it is used in the recommended dose and for the shortest possible period.

The drug BlokMAX Rapid belongs to the group of drugs that can reduce fertility in women. This effect is reversible upon discontinuation of the drug.

3. How to take BlokMAX Rapid

Always take this medicine exactly as stated in this leaflet or as explained to you by your doctor or pharmacist. If you are not sure, check with your doctor or pharmacist.

This medicine is for short-term use only.
You should take the lowest dose for the shortest time necessary to relieve symptoms.

Adults and adolescents with body weight ≥ 40 kg (12 years and older)
The recommended single dose is 1 tablet to be taken with water, up to three times a day as needed.
The interval between two doses should not be shorter than 6 hours.
Do not take more than 3 tablets (1200 mg ibuprofen) in a 24-hour period.

Children and adolescents:
BlokMAX Rapid is not intended for children under 12 years of age or adolescents weighing less than 40 kg.

Lek BlokMAX Rapid film tablets have a dividing line on one side. The dividing line serves only to facilitate breaking for ease of swallowing and not to divide the medicine into equal doses.

Length of therapy
In children and adolescents aged 12 to 18 years, if the symptoms worsen or continue after 3 days, the therapy must not be continued without consulting a doctor.
In adults, if the drug needs to be taken for more than 3 days in case of migraine or elevated body temperature, i.e. for more than 5 days for pain therapy, or if the symptoms continue or worsen, a doctor should be consulted.

If you have taken more BlokMAX Rapid than you should
If you take more of this medicine than you should, or if children accidentally take this medicine, always contact a doctor or the nearest hospital to get an opinion about the risk or what measures to take.

Nausea, abdominal pain, diarrhea, ringing in the ears, headache, vomiting (may be blood-tinged), blood in the stool, confusion, or involuntary eye movements may occur. When using higher doses, drowsiness, excitement, disorientation, chest pain, palpitations, low blood pressure, kidney weakness, liver weakness, blue coloration of the skin and mucous membranes (cyanosis), loss of consciousness, coma, convulsions (mainly in children) may occur. increased tendency to bleed, weakness and fainting, blood in the urine, cold feeling in the body and problems with breathing. Asthmatics may experience worsening of asthma.

If you forget to take BlokMAX Rapid
Do not take a double dose to make up for a missed tablet.
If you have any further questions about 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.

Some side effects can be minimized by taking the lowest dose for the shortest time necessary to relieve symptoms. Elderly patients are at increased risk for developing these side effects.
If any side effect becomes serious or you notice any side effect not listed in this guide, inform your doctor or pharmacist.
Medicines such as BlokMAX Rapid may be associated with a small increase in the risk of heart attack (myocardial infarction) or stroke (see section 2 Other warnings).

Stop taking the medicine and seek emergency medical help if you notice:

• Occasional (may occur in up to 1 in 100 patients taking the drug) bleeding in the intestines such as: stomach pain, bright red stool, black tar-like stool, vomiting blood or dark particles that look like coffee beans.
• Very rare (may occur in up to 1 in 10,000 patients taking the drug) but serious allergic reactions such as: difficulty breathing, swelling of the face, tongue or throat, faster heartbeat, drop in blood pressure leading to shock. This can also happen when taking the medicine for the first time.
• Occasional (may occur in up to 1 in 100 patients taking the drug) but a serious allergic reaction such as an asthma attack (possibly with a drop in blood pressure), worsening asthma, unexplained wheezing or shortness of breath.
• Serious very rare forms of skin reaction (may affect up to 1 in 10,000 patients taking the medicine) such as skin rash all over the body, peeling skin, blistering or peeling skin (eg Stevens-Johnson syndrome, toxic epidermal necrolysis). Serious skin reactions known as DRESS syndrome (frequency cannot be estimated from the available data).
  Symptoms that include DRESS syndrome: skin rash, fever, swollen lymph nodes, and an increase in the number of eosinophils (a type of white blood cell).
• Inflammation of the pancreas with severe pain in the upper part of the stomach, often with nausea and vomiting may occur very rarely (in up to 1 in 10,000 patients taking the drug).
• Problems with making blood cells (the first signs are fever, sore throat, superficial ulcers in the mouth, flu-like symptoms, severe exhaustion, bleeding from the nose and skin) may occur very rarely (in up to 1 in 10,000 patients taking the medicine).
• Very rare (may occur in up to 1 in 10,000 patients taking the drug) aseptic meningitis (inflammation of the lining of the brain with symptoms that include a stiff neck, headache, nausea, vomiting, fever, or disorientation). Patients with autoimmune disorders (lupus, mixed connective tissue disease) are likely to be at risk.

Tell your doctor if you have any of the following side effects:

Common side effects (may occur in up to 1 in 10 patients taking the drug):

• gastrointestinal complaints such as heartburn, stomach pain, feeling sick, weakness, gas (flatulence), diarrhoea, constipation and small blood losses in the stomach and/or intestines which can cause anemia in exceptional cases.

Occasional side effects (may occur in up to 1 in 100 patients taking the drug):

• stomach and intestinal ulcers, sometimes with bleeding and perforations,
• inflammation of the mucous membrane of the mouth with ulceration (ulcerative stomatitis), inflammation of the stomach (gastritis), exacerbation of colitis and Crohn's disease;
• central nervous system disorders such as headache, dizziness, insomnia, agitation, irritability or fatigue;
• visual impairment;
• various types of skin rashes;
• allergic reactions, such as skin rash (hives) or itching.

Rare side effects (may occur in up to 1 in 1000 patients taking the drug):

• ringing in the ears (tinnitus);
• impairment of kidney function (papillary necrosis) and increased concentration of uric acid in the blood.

Very rare side effects (may occur in up to 1 in 10,000 patients taking the drug):

• inflammation of the esophagus, narrowing of the intestine;
• serious skin infections with soft tissue complications can occur if you have chicken pox (chicken pox);
• accumulation of fluid in the tissues, especially in patients with high blood pressure or kidney problems, swelling and foamy urine (nephrotic syndrome), inflammatory kidney disease (interstitial nephritis) which can lead to sudden weakening of the kidneys;
• psychotic reactions, depression;
• exacerbation of inflammation caused by infection (development of necrotizing fasciitis) may occur with the use of certain NSAIDs. If signs of infection appear or if they worsen while using ibuprofen, you must see a doctor without delay. It should be investigated whether there is an indication for the use of anti-infective/antibiotic therapy;
• high blood pressure, inflammation of blood vessels, palpitations, heart failure, myocardial infarction;
• liver problems, impairment of liver function (especially after long-term use), liver weakness, acute inflammation of the liver (hepatitis);
• hair loss.

Reporting adverse reactions
If you experience any unwanted reaction, you should inform your doctor or pharmacist. This includes any possible side effects that are not listed in this guide.
By reporting side effects, you can help evaluate the safety of this medicine. You can report suspected adverse reactions to the Agency for Medicines and Medical Devices of Serbia (ALIMS):

Agency for Medicines and Medical Devices of Serbia
National Center for Pharmacovigilance
Vojvode Stepe 458, 11221 Belgrade
Republic of Serbia
website: www.alims.gov.rs
e-mail: nezeljene.reakcije@alims.gov.rs

5. How to store BlokMAX Rapid medicine

Keep the medicine out of the sight and reach of children.
You must not use the drug BlokMAX Rapid after the expiration date indicated on the outer packaging ("Expiry Until"). The term of use expires on the last day of the specified month.
Store at a temperature of up to 30°C.
Unusable medicines are handed over to the pharmacy, which has a notice that the pharmacy collects unusable medicines from citizens. Unusable medicines must not be thrown into the sewer or together with municipal waste. These measures will help protect the environment.

6. Contents of the package and other information

• What does BlokMAX Rapid contain?
  The active substance is ibuprofen-lysine.
  One film-coated tablet contains 400 mg of ibuprofen (in the form of ibuprofen-lysine 684 mg).
• Auxiliary substances are:
  Tablet Core: cellulose, microcrystalline, siliconized; copovidone; sodium starch glycolate type A; magnesium stearate.
  Tablet coating: Opadry II White (hypromellose; titanium dioxide (E 171); polydextrose; talc; maltodextrin; triglycerides, medium chain length).

What BlokMAX Rapid looks like and the contents of the package
The drug BlokMAX Rapid are elongated, biconvex, film-coated tablets of white to creamy white color with a dividing line on one side. The dividing line serves only to facilitate breaking the medicine to make it easier to swallow, not to divide the dose into equal doses.

Inner packaging: White PVC/PVDC blister with aluminum foil containing 10 film-coated tablets.

Outer packaging: Collapsible cardboard box containing 10 film tablets (1 blister) and

Instructions for the drug.

License holder and manufacturer

License holder
ALKALOID DOO BELGRADE
Prahovska 3, Belgrade

Manufacturer
ALKALOID AD Skopje
Bulevar Aleksandar Makedonski 12,
Skopje, Republic of Macedonia

Mode of administration of the drug:
The drug is issued without a doctor's prescription

License number and date:
515-01-05372-17-001 from 07.06.2019.

Before use, study the instructions in detail. Consult your doctor or pharmacist about indications, precautions and adverse drug reactions.

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