BlokMax Duo film tablet, 500mg+200mg, 20 tablets.

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BlokMAX® Duo, 500 mg/200 mg, film tablets
paracetamol/ibuprofen
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
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.
- You should not take this product for more than 3 days.
- If you do not feel better or feel worse after 3 days, you must contact your doctor.
In this guide you will read:
1. What is BlokMAX Duo and what is it for?
2. What you need to know before taking BlokMAX Duo
3. How to take BlokMAX Duo
4. Possible side effects
5. How to store BlokMAX Duo medicine
6. Contents of the package and other information
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1. What is BlokMAX Duo and what is it for?
BlokMAX Duo contains two active substances: paracetamol and ibuprofen.
Ibuprofen belongs to a group of drugs called non-steroidal anti-inflammatory drugs (NSAIDs).
NSAIDs work by relieving pain, reducing swelling and lowering high body temperature.
Paracetamol is an analgesic that has a different mechanism of action than ibuprofen for relief
pain and lowering of elevated body temperature.
The drug BlokMAX Duo is used for short-term therapy of mild to moderate pain associated with:
headache, back pain, menstrual pain, toothache, rheumatic and muscle pain,
cold and flu symptoms such as fever and sore throat.
This drug is particularly suitable in the treatment of pain that requires stronger analgesia than ibuprofen alone or
Paracetamol.
You must contact your doctor if you do not feel better or if you feel worse after 3 days.
2. What you need to know before taking BlokMAX Duo
BlokMAX Duo should not be taken if:
- you are allergic (hypersensitive) to paracetamol, ibuprofen or any of the auxiliary substances
of this medicine (listed in section 6);
- you have previously had an allergic reaction, such as shortness of breath, asthma attacks, swelling
nasal mucosa, rash and swelling (angioedema) of the face, lips, tongue or throat or skin reactions after
taking acetylsalicylic acid or other NSAIDs;
- you have previously had gastrointestinal bleeding (bleeding in the stomach or intestines) or perforation
(breakthrough of the stomach or intestinal wall) caused by taking NSAIDs;
- you have or have ever had an ulcer or bleeding in the stomach or duodenum (at least two
separate episodes of confirmed bleeding or ulcers);
– you have a blood clotting disorder (coagulation);
- you have liver, kidney or heart weakness (including so-called ischemic heart disease);
- you are taking any other pain reliever, including ibuprofen, high dose acetylsalicylic acid
acid (more than 75 mg per day) or another non-steroidal anti-inflammatory drug (NSAIL)
including selective inhibitors of cyclooxygenase type 2 (COX-2);
- you are already taking any other medicine containing paracetamol;
- you are in the last 3 months of pregnancy.
Warnings and precautions
Talk to your doctor or pharmacist before taking BlokMAX Duo if:
- you have an infection - see the "Infections" section;
- you are older;
- you have or have previously had asthma;
- you have damage to the heart, liver, kidneys or intestinal disorders;
- you have SLE (systemic lupus erythematosus) - a disorder of the immune system that affects the connective tissue,
it leads to pain in the joints, changes in the skin and disorders of other organs or others
mixed connective tissue diseases;
- you have diseases of the gastrointestinal tract or chronic intestinal inflammation (ulcerative colitis,
Crohn's disease);
- you are pregnant (in the first 6 months of pregnancy) or breastfeeding;
– you are planning a pregnancy.
Anti-inflammatory/pain relievers such as ibuprofen may be associated
with a small increased risk of heart attack or stroke (stroke), especially when
used in high doses. Do not exceed the recommended dose or duration of treatment.
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Talk to your doctor or pharmacist before taking BlokMAX Duo if:
- you have heart problems, including heart failure (failure), chest pain (angina) or
if you have had a heart attack, bypass surgery, peripheral artery disease (poor circulation
in the legs due to narrow or blocked arteries) or any form of stroke (incl
"mini-stroke" or transient ischemic attack "TIA");
- you have high blood pressure, diabetes, high cholesterol, you have a family history
a history of heart disease or stroke, or if you are a smoker.
If any of the above applies to you, consult your doctor before taking
the drug BlokMAX Duo.
Infections
BlokMAX Duo can mask symptoms or signs of infection such as high blood pressure
temperature and pain. Therefore, it is possible that BlokMAX Duo can delay appropriate treatment
infection, which can lead to an increased risk of complications. This has been observed in inflammation
lungs caused by bacteria and in bacterial skin infections associated with chickenpox. If you take
this medicine while you have an infection, and the symptoms of the infection continue or worsen, without delay
consult a doctor.
Skin reactions
Serious skin reactions associated with ibuprofen treatment have been reported. Stop taking the medicine
BlokMAX Duo and seek medical help immediately if any skin rash, damage occurs
mucous membranes, blisters or other signs of allergy, because these can be the first signs of a very serious reaction to
the skin. See section 4.
Elderly patients
Elderly patients have an increased risk of side effects when taking them
NSAIDs, especially those related to the stomach and intestines.
Patients who previously had poisoning in the gastrointestinal tract (stomach and intestines), especially
elderly, should report any unusual stomach symptoms (especially gastrointestinal
bleeding), especially at the beginning of treatment.
Children and adolescents
This medicine is not intended for use in children and adolescents under 18 years of age.
Other medicines and BlokMAX Duo medicine
Tell your doctor or pharmacist if you are taking, have recently taken or might take
take any other medicines.
You should not take BlokMAX Duo with:
- other medicines containing paracetamol (see the section You must not take BlokMAX Duo medicine
if:);
- other drugs containing ibuprofen or other NSAIDs or with acetylsalicylic acid
(see the section BlokMAX Duo should not be taken if:).
The drug BlokMAX Duo can affect or be affected by some other drugs, such as, for example:
- corticosteroids, which are used to relieve inflammation in the affected parts of the body
(eg cortisone, prednisone);
– antibiotics (chloramphenicol, quinolones);
- anti-nausea drugs (metoclopramide, domperidone);
- anticoagulants (medicines to thin the blood/prevent the formation of clots, e.g. acetylsalicylic acid).
acid, warfarin, ticlopidine);
- drugs for heart stimulation (cardiotonic glycosides);
- drugs used in the treatment of high cholesterol (cholestyramine);
- diuretics (medicines that facilitate the elimination of excess fluid);
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- drugs used in the treatment of high blood pressure (ACE inhibitors such as
captopril, beta-blockers such as atenolol, angiotensin II receptor antagonists such as
losartan);
- drugs for suppressing the immune system (methotrexate, ciclosporin, tacrolimus);
- drugs used in depression therapy (selective reuptake inhibitors
serotonin (SSRI));
– drugs for mania and bipolar disorder (eg lithium);
– mifepristone (pregnancy termination drug);
- drugs for the treatment of HIV (zidovudine).
Some other drugs can also affect or be affected by BlokMAX Duo.
Therefore, always seek the advice of your doctor or pharmacist before you start taking the medicine
BlokMAX Duo with other drugs.
Taking BlokMAX Duo with drinks
Do not drink alcohol during therapy, due to a possible increase in the risk of liver damage.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you are pregnant or are planning to become pregnant, contact your doctor
doctor or pharmacist for advice before taking this medicine.
Do not take this medicine in the last 3 months of pregnancy, as it may harm the unborn child. Not
take this medicine in the first 6 months of pregnancy unless your doctor advises you otherwise. The drug BlokMAX
Duo can make conception difficult. Ibuprofen belongs to a group of drugs that can adversely affect
female fertility. This is reversible after stopping the drug.
Tell your doctor if you are planning to become pregnant or if you are having problems becoming pregnant.
Driving vehicles and operating machines
In some patients, the drug BlokMAX Duo can cause dizziness, drowsiness, fatigue and
vision disorders. This should be taken into account in cases where high vigilance is required, e.g. during
driving. Be careful while driving or operating machinery until you see how the medicine works
BlokMAX Duo works on you.
3. How to take BlokMAX Duo
Always take this medicine exactly as stated in this leaflet or as explained to you by your doctor
doctor or pharmacist. If you are not sure, check with your doctor or pharmacist.
The drug is intended for oral use and short-term treatment.
To relieve symptoms, it is necessary to use the lowest effective dose for the shortest possible time.
If you have an infection and symptoms (such as fever and pain) continue
or get worse, see your doctor without delay (see section 2).
You should not take BlokMAX Duo for more than 3 days. If symptoms worsen or persist,
consult your doctor.
Adults
Take one tablet with food or water, up to 3 times a day. The interval between doses must be at least
six o'clock.
If one tablet cannot help you, you can take a maximum of two tablets, up to three times a day.
Do not take more than six tablets in a 24-hour period (equivalent to 3000 mg of paracetamol, 1200
mg of ibuprofen per day).
If you have liver or kidney damage or are elderly, your doctor will determine the exact dose for you
you should take, and that will be the lowest possible dose.
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Application in children and adolescents
The drug BlokMAX Duo is not intended for children and adolescents under 18 years of age.
If you have taken more BlokMAX Duo than you should
If you have taken more BlokMAX Duo than you should or if children have accidentally taken this medicine, always
contact your doctor or nearest hospital for an opinion on the risk and advice on what
you should take action.
Symptoms that may occur are nausea, stomach pain, vomiting (may also be with the appearance of blood),
headache, ringing in the ears, confusion and involuntary eye movements. In high doses, they have been reported
drowsiness, chest pain, palpitations, loss of consciousness, convulsions (mainly in children),
weakness and dizziness, blood in the urine, feeling cold and breathing problems.
If you have taken more BlokMAX Duo than you should, contact your doctor immediately, even if
you feel good. This is because too much paracetamol can cause delayed serious damage
liver.
If you forgot to take BlokMAX Duo
Do not take a double dose to make up for a missed dose. If you forget to take a dose
medicine, take it as soon as you remember, then take your next dose at least 6 hours later.
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 they may not occur
of all patients taking this medicine.
Stop using BlokMAX Duo and seek immediate medical attention if
Get in touch with:
- heartburn, digestive problems (often);
- signs of intestinal bleeding (severe pain in the stomach, vomiting blood or vomiting a mass containing dark
coffee-like particles, presence of blood in the stool, black, tar-colored stool) (occasionally);
- signs of inflammation of the meninges such as stiff neck, headache, nausea, high
body temperature or feeling of disorientation (very rare);
- signs of severe allergic reactions (swelling of the face, tongue or throat, difficulty breathing, aggravation
asthma) (very rare);
- serious skin reactions with the appearance of blisters such as erythema multiforme, Stevens-Johnson's
syndrome and toxic epidermal necrolysis (very rare);
– a serious skin reaction known as DRESS syndrome. Symptoms of DRESS include a skin rash,
increased body temperature, swelling of lymph nodes and increase in eosinophils (a type of white
blood cells) (frequency not known).
– a red, scaly, widespread rash with bumps under the skin and blisters that are mostly
localized on skin folds, trunk and upper extremities, accompanied by elevated body temperature
temperature at the beginning of treatment (acute generalized exanthematous pustulosis) (very rare).
If the above symptoms appear, stop using BlokMAX Duo immediately
seek medical attention. See section 2.
Other side effects
Common side effects (may occur in up to 1 in 10 patients taking the medicine):
- pain or discomfort in the stomach, feeling sick, diarrhea;
- elevated values of some liver enzymes (ALT, GGT), blood creatinine and urea (shown in
blood tests).
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Occasional side effects (may occur in up to 1 in 100 patients taking
medicine):
- headache and dizziness;
- flatulence (gas) and constipation;
- exacerbation of symptoms of colitis and Crohn's disease;
- problems with digestion, heartburn or feeling sick (gastritis);
- inflammation of the pancreas accompanied by severe pain in the upper part of the stomach that spreads towards the back and
vomiting (pancreatitis);
- skin rash, itching and facial swelling;
- higher values of liver enzymes (AST, ALP), and CPK (increased value in case of muscle damage)
(shown in blood tests),
- fatigue and dizziness due to the decrease in the number of red blood cells;
- increase in the number of blood platelets (thrombocytes).
Very rare side effects (may affect up to 1 in 10,000 patients taking
medicine):
- decrease in the number of blood cells (which leads to inflammation of the throat, ulcers in the mouth, similar symptoms
flu, severe exhaustion, unexplained bleeding, bruising and nosebleeds);
- visual disturbance, ringing in the ears, feeling of dizziness;
– confusion, depression, hallucinations;
- numbness, itching and tingling sensation on the skin, inflammation of the optic nerve and drowsiness;
- fatigue, general weakness;
– high blood pressure, water retention;
- problems with the liver (causes the appearance of yellow skin and white eyes);
- kidney problems (cause increased or decreased urination, leg swelling);
- weakness of the heart (leads to loss of breath, swelling);
- excessive sweating;
- purpura (red or purple spots on the skin due to subcutaneous bleeding, which do not disappear when
press);
- increased sensitivity of the skin to sunlight.
Medicines such as BlokMAX Duo may be associated with a small increased risk of heart attack
("myocardial infarction") or stroke (see section 2. Warnings and precautions).
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. Doubt
You can report 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 Duo medicine
Keep the medicine out of the sight and reach of children.
You must not use BlokMAX Duo after the expiration date indicated on the outside
packaging after "Valid until:". The expiration date refers to the last day of the above
of the month.
This medicine does not require special storage conditions.
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Unusable medicines are handed over to the pharmacy where the notice to that pharmacy is displayed
they collect unusable medicines from citizens. Unusable medicines must not be thrown away
sewage or together with municipal waste. These measures will help protect the environment.
6. Contents of the package and other information
What does BlokMAX Duo contain?
- The active substances are paracetamol and ibuprofen.
One film-coated tablet contains 500 mg of paracetamol and 200 mg of ibuprofen.
- Auxiliary substances are:
Tablet core: starch, corn; povidone K 30; croscarmellose sodium; cellulose,
microcrystalline; silica, colloidal, anhydrous; glycerol dibehenate.
Tablet coating: Opadry white (polyvinyl alcohol, partially hydrolyzed; talc; titanium dioxide;
glycerol-monocaprylocaprate; sodium lauryl sulfate).
What the BlokMAX Duo drug looks like and the contents of the package
The drug BlokMAX Duo are white to almost white, elongated, biconvex, film tablets with a double
circle on one side.
Inner packaging: Blister made of white PVC/PVDC/aluminum rigid foil. One blister
contains 10 film tablets.
Outer packaging: Collapsible cardboard box containing 10 film-coated tablets (1 blister) or 20
tablet film (2 blisters) and instructions for the drug.
License holder and manufacturer
License holder
ALKALOID D.O.O. WHITE CITY
Prahovska 3,
White City
Manufacturer
ALKALOID AD Skopje
Bulevar Aleksandar Makedonski 12,
Skopje, Republic of North Macedonia
This instruction was last approved
January, 2021.
Mode of administration of the drug:
The drug is issued without a doctor's prescription.
License number and date:
BlokMAX Duo 10 x 500 mg/200 mg
License number: 515-01-02366-19-001 from 01.20.2021.
BlokMAX Duo 20 x 500 mg/200 mg
License number: 515-01-02367-19-001 from 01.20.2021