ACETISAL PH8 FILM TABLETE

The sale of this medicine is prohibited on the Internet by the law of the Republic of Serbia, while advertising the same on the Internet is allowed only  as a reminder and has the purpose of informing.

REGULATION ON LEAF METHODS, RELATED MEDICAL FIELD FIG. Gl. RS ", No.79 / 2010 YOU CAN SEE OVDE.

What is acetylsalpha 8 and what is it for?
ACETISAL pH 8 is intended for use in adults and children over 16 years of age. ACETISAL pH 8 contains acetylsalicylic acid, which belongs to the group of non-steroidal antiinflammatory (anti-inflammatory) drugs, and is intended to treat mild to moderate pain and lower the elevated temperature.

ACETISAL pH 8 film tablets are used in:

• Mild and moderate pain of different etiology (headaches, toothache, rheumatic diseases, muscle pain, joints, nerve pain and painful periods).
• Increased body temperature during illness such as colds and flu.

Be sure to consult your doctor before you first use this medicine!

What should you know before you take acetylsalpha 8?
Warn your doctor if you are taking other medicines, you have some chronic illness, some metabolic disorder, you are hypersensitive to medicines, or you have had allergic reactions to some of them.
 
You should not use Lek ACETISAL pH 8:
If you are allergic to the active substance or to any of the other ingredients.

Acetylsalicylic acid is contraindicated in the code:

• patients with hypersensitivity or if you have previously had hypersensitivity reactions: bronchospasm, musculature, urticaria, angioedema (sudden swelling of the face, tongue, lips, dyspnea and other parts of the body, especially the hand), rhinitis (inflammation of the nasal mucous membrane) or other evidence of hypersensitivity to salicylates or other non-steroidal antiinflammatory drugs;
• bronchial asthma patients;
• diseases of the upper digestive tract, such as gastritis and stomach or twin-pancreas;
• tendencies to bleeding (haemophilia or other blood coagulation);
• severe heart, kidney and liver disease;
• gout;
• patients receiving a methotrexate dose of 15 mg / week or more.

Acetylsalicylic acid is contraindicated in the last trimester of pregnancy. The use of ACETISAL pH 8 is contraindicated in children under 16 years of age, except in specific indications such as Kawasaki's disease and thrombosis prevention in cardiac surgery.

When taking the medicine ACETISAL pH 8, take special care:

• if you are hypersensitive (allergic) to other painkillers, inflammation (antiinflammatory agents) or other allergens;
• if you have had gastrointestinal bleeding and / or gastric ulcer or duodenal ulcer before;
• if you receive anticoagulant medication (see "Using other medicines");
• if you have kidney function damage;
• if you have impaired liver function;
• ibuprofen may interfere with the useful properties of acetylsalicylic acid. Consult your doctor if you are taking ACETISAL pH 8 and use ibuprofen for pain.

If the pain lasts for more than 10 days, fever for more than 3 days, and worsening for more than 2 days, consult your doctor.
Before taking this medicine, tell your doctor if you have impaired liver or kidney function, bronchial asthma, uncontrolled hypertension, haemophilia or other blood coagulation or if you have dehydrated. Acetylsalicylic acid can cause bronchospasm (respiratory muscle spasms) and asthma attacks or some other hypersensitivity reaction (allergic reaction). Risk factors are already existing asthma, pollen allergy, nose polyp or chronic respiratory disease. This also applies to patients who exhibit allergic reactions (eg reactions to the skin, itching, hives) to other substances. Special attention is needed in patients with the island of the mucous membrane of the nose (nasal polyps).
Lek should be avoided a few days before the surgery due to a possible increased tendency to bleed. Due to its inhibiting effect on platelet accumulation, which lasts several days after taking, acetylsalicylic acid
Acid may cause a tendency to increased bleeding during and after surgery (including minor surgeries, such as tooth extraction). In low doses, acetylsalicylic acid reduces the release of uric acid. This can cause gout attacks in patients with predisposition. Caution should be exercised when administering medication to patients with mild to moderately severe heart failure. Acetylsalicylic acid should not be given to children and adolescents in case of viral infections with or without temperature if you do not seek doctor advice before. In certain types of diseases, particularly type A influenza, type B and varicella flu, there is a risk of Reye's syndrome, very rare diseases that cause life-threatening brain and liver damage and require urgent medical intervention. The risk may be higher if acetylsalicylic acid is given as a propagating therapy; however, no cause-and-effect relationship has been demonstrated. If sustained vomiting occurs, this may be a sign of the Reagent Syndrome. Caution is essential if you are anemic or you have a deficiency of glucose-6-phosphate dehydrogenase enzyme.
Long-term use of the medicine should be avoided in the elderly due to the increased risk of bleeding from the digestive system.

Using other medicines:
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those that can be obtained without a prescription.
The interactions between acetylsalicylic acid and the following drugs should be considered:
Increased effect increases the risk of side effects:

• Thyroid coagulants (blood coagulation drugs), thrombolytics / other drugs that prevent the accumulation of blood platelets (platelets): acetylsalicylic acid may increase the risk of bleeding when taken before thrombolytic therapy;
• Systemic glucocorticosteroids, other than hydrocortisone, used as substitution therapy in Adison's disease or alcohol use: increased risk of gastrointestinal ulcers and bleeding;
• Non-steroidal anti-inflammatory drugs with salicylates used in higher doses: an increased risk of gastrointestinal ulcers and bleeding;
• Anxiety, eg, insulin, sulfonylurea: the blood glucose level may be reduced;
• Orthogonal (heartburn boost);
• Methotrexate (lek used to treat cancer and certain rheumatic diseases);
• Valproic acid (lek used for epilepsy).

Easing effect:

• Diuretics (drugs that increase urine secretion);
• Certain medicines for lowering blood pressure (especially ACE inhibitors);
• Glues that are used in gout (swelling) and which accelerate the secretion of urine.

With the simultaneous administration of acetylsalicylic acid, as with other NSAIDs, ACE inhibitors have increased the risk of acute renal failure. Also, the simultaneous use of acetylsalicylic acid and cyclosporin, or tacrolimus, increases the risk of toxic kidney damage. Tell your doctor and pharmacist if you are taking or have recently taken any other medicines, including those that can be obtained without a prescription.

Taking ACETISAL pH 8 with food or drink :
It is not recommended to use ACETISAL pH 8 with alcohol because of the increased risk of damage to the mucous membrane of the gastric mucous membrane and bleeding from the gastrointestinal tract.

Administration of ACETISAL pH 8 in the period of pregnancy and lactation:
Talk to your doctor or pharmacist before taking any medicine.
The use of the drug is not recommended during pregnancy and lactation. The use of ACETISAL pH 8 is contraindicated in the last trimester of pregnancy.

The effect of ACETISAL pH 8 on the management of motor vehicles and machine handling:
Lek does not affect the psychophysical abilities of driving a motor vehicle and handling machines.

Important information about some of the ingredients of ACETISAL pH 8:
There are no known adverse reactions to the excipients contained in the product.

How to use acetisal ph 8?
Lek Acetisal pH 8 should be taken exactly as your doctor told you. If you are not sure, check with your doctor or pharmacist.
If you think ACETISAL pH 8 is too weak or very active for your body, contact your doctor or pharmacist.
The drug is administered orally.
The tablet should be taken during or after a meal, with a glass of water. Tablets should not be divided or broken in any way.
Adults and children older than 16 years: 500 mg every 4-6 hours.
Up to 4 tablets a day can be taken, but the dose interval should not be shorter than 4 hours.
For antireumatic, i.e. antiinflammatory action should be taken with high doses: 1 g (2 tablets) 3-4 times a day; The maximum dose is 4 g / day.
Elderly: No need to reduce the dose.
Lek does not apply to children younger than 16 years of age, unless indicated (for example, Kawasaki's disease).

If you take more ACETISAL pH 8 than you should:
If you take more ACETISAL pH 8 than you should, talk to your doctor or pharmacist immediately!
Common symptoms include vomiting, dehydration, buzzing in the ears, dizziness, deafness, sweating, warm extremities, pulsation in the extremities, and hyperventilation (rapid and deep breathing). There may still be nausea, vomiting, headache, sweating, and all symptoms can be controlled by reducing the dose. In most cases, there is a degree of disturbance of the acid-base balance. Symptoms related to the central nervous system involving confusion, disorientation, coma and convulsions are more common in children than in adults.
In case of acute poisoning, the stomach should be rinsed and caused vomiting, maintain fluid and electrolyte balance, and apply other supportive measures.

If you forget to take a medicine ACETISAL pH 8:
Do not take a double dose to make up for a skipped dose.

If you suddenly stop taking the medicine ACETISAL pH 8:
Your doctor will decide to stop treatment with ACETISAL pH 8. If you have any further questions on the use of this medicine, contact your doctor or pharmacist.

Possible side effects:
Lek ACETISAL pH 8 may have side effects, although it does not have to show up at all.
Blood and lymphatic system disorders:

• Krvarenje (iz nosa, desni ili kože), moguće sa produženim vremenom krvarenja. Ovaj efekat može potrajati 4 do 8 dana posle uzimanja leka. Ukoliko imate česta krvarenja iz nosa ili primetite lako nastajanje modrica (krvnih
• podliva) obratite se lekaru. Prijavljeni su i retki slučajevi ozbiljnog krvarenja, posebno kod pacijenata sa nelečenim niskim pritiskom/ili kod pacijenata koji istovremeno uzimaju lekove protiv zgrušavanja, što u pojedinim slučajevima može ugroziti život.
• Anemija (malokrvnost), promene u broju i tipu krvnih ćelija.
• Hemoliza kod urođenog nedostatka enzima glukozo-6-fosfat dehidrogenaze u eritrocitima.

Poremećaj nervnog sistema:

• Ukoliko uzimate visoke doze leka u dužem vremenskom periodu može doći do promena u nervnom sistemu i pojave simptoma salicilizma (trovanje salicilatima) koji uključuju ošamućenost, vrtoglavicu, zujanje u ušima, gluvoću, glavobolju, zbunjenost, znojenje, osećaj mučnine i hiperventilaciju (ubrzano i produbljeno disanje).
• Retko se mogu javiti poremećaji vida i sluha.

Želudačnocrevni poremećaji:
Najčešći neželjeni efekti su dispepsija (problemi sa varenjem), mučnina, gorušica i povraćanje. Moguća je pojava dijareje (proliv). Prijavljeni su i slučajevi želudačnocrevnog krvarenja, koji u nekim slučajevima mogu prouzrokovati anemiju. Može doći do razvoja želudačno-crevnog čira koji može voditi do krvarenja i perforacije. Ukoliko primetite crnu prebojenost stolice, ili povraćanje sa primesama krvi, potrebno je odmah prekinuti
terapiju i obratiti se lekaru.

Poremećaji bubrega i mokraćnog sistema:
Može doći do poremećaja funkcije bubrega.

Poremećaji imunog sistema:
U retkim slučajevima se mogu javiti reakcije preosetljivosti, kao što je oticanje kože i sluzokože, ospa, svrab, koprivnjača, grč disajnih mišića, pogoršanje astme, pad krvnog pritiska, angioedem (postepeno oticanje lica, usana, jezika, guše i drugih delova tela, tipično šaka ruku, očnih kapaka i teškoće pri disanju). Ukoliko primetite znake reakcije preosetljivosti, obratite se lekaru.

Poremećaji jetre i žuči:
Retko može doći do poremećaja funkcije jetre (porast transaminaza-parametara koji pokazuju funkciju jetre).
 
Ukoliko neko neželjeno dejstvo postane ozbiljno ili primetite neko neželjeno dejstvo koje nije navedeno u ovom uputstvu, molimo Vas da o tome obavestite svog lekara ili farmaceuta.

Kako čuvati lek acetisal ph 8?
Čuvati van domašaja i vidokruga dece.

Rok upotrebe:
2 godine.

• Nemojte koristiti lek Acetisal pH 8 posle isteka roka upotrebe naznačenog na spoljašnjem pakovanju .
• Rok upotrebe ističe poslednjeg dana navedenog meseca.
• Lek se ne sme koristiti posle isteka roka upotrebe označenog na pakovanju!

Čuvanje:

• Čuvati na temperaturi do 25ºC u originalnom pakovanju.
• Lekove ne treba bacati u kanalizaciju, niti kućni otpad.Pitajte svog farmaceuta kako da uklonite lekove koji Vam više nisu potrebni.Ove mere pomažu očuvanju životne sredine.
• Neupotrebljen lek se uništava u skladu sa važećim propisima.

Šta sadrži lek ACETISAL pH 8:
Sadržaj aktivne supstance:
1 film tableta sadrži 500 mg acetilsalicilne kiseline.
Sadržaj pomoćnih supstanci jezgra tablete su:
celuloza, mikrokristalna; skrob, kukuruzni; povidon K25; kremofor RH 40; silicijum-dioksid, koloidni; stearinska kiselina
Sadržaj pomoćnih supstanci filma tablete su:
makrogol 6000; titan-dioksid; talk; eudražit L 12,5; kremofor RH 40

Kako izgleda lek ACETISAL pH 8 i sadržaj pakovanja:
Izgled: okrugle, bikonveksne, filmom obložene tablete, skoro bele boje.

Nosilac dozvole za stavljanje leka u promet:
GALENIKA a.d., Batajnički drum b.b., 11 080 BEOGRAD, Republika Srbija

Proizvođač:
GALENIKA ad, Batajnicki drum bb, 11 080 BELGRADE, Republic of Serbia The
 
mode of drug delivery:
Lek can be issued without a doctor's prescription.

Packaging: 2 blisters (20 film tablets)

Before use, consult a guideline. Consult with your doctor or pharmacist about the indications, precautions and adverse reactions to the medicine or medical device.