Exidol

Active Ingredients

Each caplet contains:

• Acetylsalicylic acid       250 mg
• Paracetamol                 250 mg
• Caffeine anhydrous      65 mg

Indications

Therapeutic group:

Acetylsalicylic acid - Non-steroidal anti-inflammatory drug (NSAID).

Paracetamol - Analgesic and antipyretic.

Caffeine - Xanthine alkaloid, central nervous system stimulant.

Exidol caplets are intended for temporary relief of headaches, mild to moderate headaches associated with migraines, menstrual pains and pain accompanied by fever.

Instructions

Swallow the medicine whole with a full glass of water.

Take the medicine after a meal.

Do not halve or crush the tablet. There is no information about halving/crushing/chewing.

The usual recommended dosage is:

For treatment of migraine-related headache:

Adults: Two caplets.

If the medicine was taken for migraine and there has been no improvement or it became worse after the first dose, consult the doctor.

Children under the age of 18: you should consult the doctor.

Do not take the medicine for more than 48 hours.

For headaches, menstrual pain and pain accompanied by fever:

Adults and children over 12 years of age: 2 caplets every 6 hours.

Pain relief may be felt within 15 minutes of taking the dose.

Do not take more than 8 caplets in 24 hours.

Do not exceed the recommended dose.

Do not use the preparation for more than 5 days for pain or 3 days for pain accompanied by fever without consulting the doctor.

Do not lie down for 15-30 minutes after taking the medicine.

Exidol caplets contain acetylsalicylic acid (aspirin), paracetamol and caffeine. Do not take more than the recommended dosage and do not take other medicines that may contain these ingredients or other ingredients that are used for the treatment of pain, inflammation or high fever (nonsteroidal anti-inflammatory drugs) while using Exidol.

If you forgot to take Exidol take the medicine as soon as you remember but do not take a double dose to compensate for a forgotten dose.

Refer to the doctor if signs of ailment (symptoms) worsen or do not improve after 5 days of treatment for pain or after 3 days of treatment for pain accompanied by fever.

Exidol can be used for 9 months after first opening, but not later than the expiry date.

Warnings

Do not use Exidol if you are hypersensitive (allergic) to the active ingredients or to any of the additional ingredients this medicine contains. Symptoms of an allergic reaction may include: asthma, wheezing or shortness of breath, a skin rash or hives, swelling of the face or tongue, runny nose.

Do not use this medicine if:

• You are in the last three months of pregnancy
• You had an allergic reaction in the past to other medicines used to treat pain, inflammation or fever, such as diclofenac or ibuprofen
• You suffer from a gastric or intestinal ulcer or if you have a history of digestive (peptic) ulcers, you noticed blood in your stools or black stools (symptoms of bleeding or perforations in the digestive system)
• You suffer from hemophilia or other blood disorders
• You suffer from serious heart, liver or kidney problems
• You are taking more than 15 mg of methotrexate per week

Before treatment with Exidol tell the doctor if:

• You suffer from a migraine so acute that it necessitates bed rest, or if you have a headache that is different from your usual migraines, or if you suffer from vomiting together with the migraine headaches
• You began to suffer from headaches after or due to a head injury, exertion, cough or bending over
• You have chronic headaches (fifteen days or more in one month for more than three months), or if you experienced your first headache after the age of 50.
• You suffer from a fever and a stiff neck
• You have not been previously diagnosed as suffering from migraines, since potentially serious conditions that are related to the brain or nervous system should be ruled out prior to treatment
• You suffer from a hereditary condition called G6PD enzyme deficiency (glucose-6-phosphate dehydrogenase) which affects the red blood cells and may cause anemia, jaundice or spleen enlargement upon exposure to certain foods and medicines such as certain anti-inflammatory drugs [e.g. acetylsalicylic acid (aspirin)] , or cause other illnesses
• You have suffered in the past from problems in the digestive system such as a gastric ulcer, bleeding or black stools. If you have had abdominal discomfort or heartburn after taking analgesics or anti-inflammatory drugs
• You suffer from bleeding disorders or abnormal vaginal bleeding unlike menstruation (such as unusually prolonged and heavy menstruation)
• You recently had surgery (including minor surgery such as dental surgery) or you are about to have surgery in the next seven days
• You suffer from adult asthma, hay fever (allergic rhinitis), nasal polyps, a chronic respiratory disease or you develop allergic symptoms (e.g., skin reactions, itching, hives)
• You suffer from gout, diabetes, hyperthyroidism, irregular heartbeat, uncontrolled hypertension, impaired kidneys or liver function
• You suffer from alcohol addiction
• You are taking other medicines that contain acetylsalicylic acid (aspirin) or paracetamol, or other medicines, as certain medicines may interfere with Exidol and cause side effects
• You are in danger of dehydration (e.g., vomiting, diarrhea, or before or after major surgery)
• You are less than 18 years old. There is a possible association between acetylsalicylic acid (aspirin) and Reye’s Syndrome when it is given to children and adolescents. Reye’s syndrome is a rare syndrome that affects the brain and liver and can be fatal. For this reason, do not use Exidol in adolescents and children under 18 years old without an explicit instruction from the doctor.

As with any type of headache analgesics, taking Exidol too often (i.e., more than ten days per month for this medicine) when there are chronic headaches (fifteen days or more per month), for more than three months, may worsen your headache or migraine. If you think that this may be the case, refer to your doctor for advice. It may be necessary to stop taking Exidol in order to resolve the problem.

Exidol may reduce the symptoms of infection (e.g., headache, high fever) and therefore may make it harder to detect the infection. If you do not feel well and you need to refer to the doctor, remember to tell him that you are taking Exidol.

Exidol is not intended for children under the age of 12.

If you are taking, or have recently taken other medicines, including non-prescription drugs and nutrition supplements, tell the doctor or pharmacist. Especially if you are taking:

• Any other preparation that contains paracetamol, acetylsalicylic acid (aspirin), or any other analgesic/antipyretic
• Anticoagulants such as oral anticoagulants (e.g., warfarin), heparin, thrombolytics (e.g., streptokinase), or other antiplatelets (ticlopidine, clopidogrel, cilostazol)
• Sulfonylurea and insulin (for the treatment of diabetes)
• Medicines for the treatment of gout
• Oral contraceptives
• Medicines for the treatment of epilepsy
• Barbiturates and benzodiazepines (for the treatment of anxiety and insomnia), preparations that stimulate the production of enzymes in the liver (e.g., rifampicin, barbiturates)
• Metoclopramide ( for the treatment of nausea and vomiting)
• Certain medicines for the treatment of an infection (such as rifampicin, isoniazid, chloramphenicol, ciprofloxacin, or pipemidic acid)
• Levothyroxine (for the treatment of hypothyroidism)
• Cholestyramine (for the treatment of high cholesterol levels)

• Zidovudine [for the treatment of human immunodeficiency virus (HIV)
• Medicines for the treatment of hypertension and heart failure
• Lithium, selective serotonin reuptake inhibitors (SSRIs) or fluvoxamine (for the treatment of depression)
• Theophylline (for the treatment of asthma)
• Diuretics (to increase urine production and reduce excessive fluids)
• Methotrexate (for the treatment of certain types of cancer, arthritis or psoriasis).
• Corticosteroids (used to relieve inflammation)
• Medicines for the treatment of slow gastric emptying (e.g., propantheline)
• Clozapine (for the treatment of schizophrenia)
• Sympathomimetic medicines (to raise blood pressure or for the treatment of nasal congestion)
• Anti-allergy medicines (for the treatment or relief of allergies)
• Terbinafine (for the treatment of fungal infections)
• Cimetidine (for the treatment of heartburn and peptic ulcer)
• Disulfiram ( for the treatment of alcohol dependency)
• Nicotine (for cessation of smoking)

The recommended dose of this preparation contains a quantity of caffeine similar to that in a cup of coffee. While using the preparation, limit the intake of medicines, foods and drinks that contain caffeine as too much caffeine may cause irritability, restlessness, insomnia, and occasionally a rapid heartbeat.

Avoid alcohol consumption while using the medicine. If you consume three or more alcoholic drinks every day, ask your doctor if you should take this medicine or other analgesics/antipyretics. Paracetamol and acetylsalicylic acid (aspirin) may cause damage to the liver and stomach bleeding.

If you are pregnant, think you may be pregnant or are planning to become pregnant, tell your doctor and do not take Exidol. It is especially important not to take Exidol during the last three months of pregnancy, as it may harm the fetus or cause problems during labor.

Exidol is not recommended during breastfeeding.

Exidol belongs to a group of medicines (NSAIDs) that may impair fertility in women. This effect is reversible when stopping use of the medicine.

Please do not consider this information as an alternative to consulting your physician or pharmacist.

For further information on instructions for use, risks and side effects, please read the patient package insert and consult your doctor or pharmacist.
Read the patient package insert carefully before starting to take any medication.