Dampirina

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE PATIENT

DAMPIRYNA, 400 mg + 50 mg, tablets
Acidum acetylsalicylicum + Coffeinum

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in the patient leaflet or as directed by the doctor.

• Keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist.
• If after 3 days there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet:

• 1. What is Dampiryna and what is it used for
• 2. Important information before taking Dampiryna
• 3. How to take Dampiryna
• 4. Possible side effects
• 5. How to store Dampiryna
• 6. Contents of the pack and other information
• What is Dampiryna and what is it used for

The medicine contains two active substances: acetylsalicylic acid with analgesic, antipyretic, and anti-inflammatory effects, and caffeine, which, by acting directly on cerebral blood vessels, enhances the effect of acetylsalicylic acid in headaches.
The medicine is used for mild to moderate pain, such as headache, muscle pain, menstrual pain, and fever.

• Important information before taking Dampiryna

When not to take Dampiryna:

• if the patient is allergic to the active substances or any of the other ingredients of this medicine (listed in section 6),
• in case of hypersensitivity to salicylates or other nonsteroidal anti-inflammatory drugs,
• if the patient has a bleeding disorder,
• if the patient has severe heart failure or severe liver or kidney failure,
• if the patient has gout,
• if the patient has stomach or duodenal ulcer disease,
• if the patient has severe cardiovascular disease or uncontrolled hypertension that cannot be controlled with antihypertensive drugs,
• if the patient has a history of asthma attacks triggered by the administration of salicylates or substances with similar effects, especially nonsteroidal anti-inflammatory drugs,
• if the patient is taking methotrexate (used in cancer diseases) at doses of 15 mg per week or higher,
• in children under 12 years of age during viral infections due to the risk of Reye's syndrome - a rare but serious disease that causes liver and brain damage,
• if the patient is in the third trimester of pregnancy or breastfeeding.

Warnings and precautions:

When to exercise special caution when taking Dampiryna:

• if the patient is hypersensitive to anti-rheumatic drugs or other allergenic substances,
• in the first and second trimester of pregnancy,
• if the patient is taking anticoagulant drugs, such as coumarin derivatives, heparins,
• if the patient has impaired liver or kidney function,
• if the patient has hyperthyroidism,
• if the patient has a history of stomach ulcers or gastrointestinal bleeding,
• if the patient has a genetic disorder involving a deficiency of the enzyme - glucose-6-phosphate dehydrogenase.

Acetylsalicylic acid may cause bronchospasm and trigger asthma attacks or other hypersensitivity reactions.
Patients with asthma, chronic respiratory diseases, hay fever, nasal polyps, and those with allergic reactions to other substances (e.g., skin reactions, itching, hives) are particularly at risk.
Patients undergoing surgical procedures (including minor procedures, e.g., tooth extraction) should inform their doctor about taking Dampiryna.
Acetylsalicylic acid, even in small doses, reduces the excretion of uric acid from the body.
In patients with a tendency to reduced uric acid excretion, the medicine may cause a gout attack.
This medicine belongs to a group of medicines that may adversely affect female fertility (see "Warning and precautions").

Children and adolescents

Do not use in children under 12 years of age due to the content of caffeine and the risk of Reye's syndrome.

Dampiryna and other medicines

Tell your doctor about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
Exercise special caution when taking Dampiryna with the following medicines, as acetylsalicylic acid enhances:

• the toxic effect of methotrexate (a medicine used mainly in cancer diseases) on the bone marrow; do not take acetylsalicylic acid at the same time as methotrexate at doses of 15 mg per week or higher; taking methotrexate at doses less than 15 mg per week requires special caution;
• the effect of anticoagulant medicines (e.g., coumarin derivatives, heparin), thrombolytic medicines (dissolving blood clots, e.g., streptokinase, urokinase), and platelet aggregation inhibitors (e.g., ticlopidine), which may increase the risk of prolonged bleeding time and bleeding;
• the risk of stomach ulcers and gastrointestinal bleeding when taken simultaneously with corticosteroids, other nonsteroidal anti-inflammatory drugs, including other salicylates in high doses, or when alcohol is consumed during treatment; after stopping systemic glucocorticoids (except for hydrocortisone used as replacement therapy in Addison's disease), the risk of salicylate overdose increases;
• the effect of digoxin (a medicine used in heart diseases), as it increases its concentration in the blood;
• the effect of antidiabetic medicines, e.g., insulin, sulfonylurea derivatives;
• the toxic effect of valproic acid (a medicine used, among others, in epilepsy), which in turn enhances the anti-aggregatory effect of acetylsalicylic acid;
• the effect of selective serotonin reuptake inhibitors (SSRIs) (medicines used in the treatment of, among others, depression), which may increase the risk of gastrointestinal bleeding.

Exercise special caution when taking Dampiryna with the following medicines, as acetylsalicylic acid weakens:

• the effect of uricosuric medicines used to treat gout, which increase uric acid excretion from the body (e.g., benzbromarone, probenecid), which may worsen gout symptoms;
• the effect of diuretics;
• the effect of some antihypertensive medicines (from the group of so-called angiotensin-converting enzyme inhibitors, e.g., captopril, enalapril).

Exercise special caution when taking Dampiryna with the following medicines:

• sedatives and hypnotics (e.g., barbituric acid derivatives or antihistamine medicines), as caffeine inhibits their effect;
• medicines that cause increased heart rate (e.g., thyroxine), as caffeine enhances their effect;
• theophylline (a medicine used in the treatment of asthma and allergic conditions), as caffeine inhibits its excretion;
• oral contraceptives, cimetidine, and disulfiram, as they inhibit caffeine metabolism in the liver;
• barbituric acid derivatives (sedative medicines), as they accelerate caffeine metabolism;
• certain antibiotics, as they may delay caffeine excretion and its metabolite.

Taking Dampiryna with food and drink

Do not take the medicine on an empty stomach, as it may cause stomach pain.
Take the medicine after a meal, and swallow the tablets with a large amount of water.

Pregnancy, breastfeeding, and fertility

The medicine can be used in the first 6 months of pregnancy (I and II trimester) only after consulting a doctor.
Taking the medicine in the last three months of pregnancy (III trimester) is contraindicated.
In case of pregnancy during long-term use of the medicine, inform your doctor.
Do not take the medicine during breastfeeding.
This medicine may adversely affect female fertility (see "Warning and precautions").

Driving and using machines

The product does not impair psychophysical fitness, the ability to drive vehicles, and operate machines.

• How to take Dampiryna

In case of pain, the recommended dose is:
Adults: single dose of 1 to 2 tablets (corresponding to 400 mg to 800 mg of acetylsalicylic acid and 50 mg to 100 mg of caffeine).
If necessary, the single dose may be repeated, but not more often than every 4 to 8 hours.
Do not take more than 6 tablets (i.e., 2400 mg of acetylsalicylic acid and 300 mg of caffeine) per day.
Adolescents over 12 years of age: single dose of ½ to 1 tablet (corresponding to 200 mg to 400 mg of acetylsalicylic acid and 25 mg to 50 mg of caffeine).
If necessary, the single dose may be repeated, but not more often than every 4 to 8 hours.
Do not take more than 3 tablets (i.e., 1200 mg of acetylsalicylic acid and 150 mg of caffeine) per day.
Take the tablets orally, after a meal, and swallow them with a large amount of water.
Do not take the medicine for more than 3 days without consulting a doctor.
Note: Alcohol may increase the risk of gastrointestinal side effects, such as stomach ulcers or bleeding.
Always take this medicine exactly as described in the patient leaflet or as directed by your doctor or pharmacist.
In case of doubt, consult your doctor or pharmacist.

Taking a higher dose of Dampiryna than recommended

Overdose of the active substance of Dampiryna can be caused by prolonged use of the medicine (mild overdose) or overdose (severe overdose), which can be life-threatening, e.g., after accidental ingestion by children or the elderly.
Symptoms of mild overdose are: dizziness (including vertigo), tinnitus, hearing loss, excessive sweating, nausea, and vomiting, headache, confusion (disorders of consciousness with disorientation, thinking and speech disorders, delusions, hallucinations, anxiety, and psychomotor agitation), rapid breathing, deep breathing, and symptoms of respiratory alkalosis (darkness before the eyes, fainting).
In case of severe overdose, the following may also occur: high fever, respiratory disorders (up to respiratory arrest and suffocation), cardiac disorders and blood vessel disorders (from irregular heart rhythm, low blood pressure to cardiac arrest), fluid and electrolyte loss (from dehydration, oliguria to renal failure), increased or decreased blood glucose levels (especially in children), ketosis (a metabolic disorder involving excessive production of ketone bodies), gastrointestinal bleeding, blood coagulation disorders, neurological disorders manifesting as lethargy, confusion, and coma, and seizures.
In case of overdose, consult a doctor or pharmacist immediately, and in case of severe overdose, take the patient to the hospital immediately.
Treatment of overdose involves gastric lavage, administration of activated charcoal, and alkaline diuresis.
In severe cases, forced alkaline diuresis, peritoneal dialysis, or hemodialysis may be necessary.
The effects of caffeine overdose, including seizures, should be treated symptomatically.

Missing a dose of Dampiryna

Do not take a double dose to make up for a missed dose.

Stopping treatment with Dampiryna

In case of doubts related to the use of the medicine, consult a doctor or pharmacist.

• Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The frequency of side effects is defined as follows:
Very common: may occur in more than 1 in 10 people
Common: may occur in 1 in 10 people
Uncommon: may occur in 1 in 100 people
Rare: may occur in 1 in 1,000 people
Very rare: may occur in 1 in 10,000 people
Not known: frequency cannot be estimated from the available data
After taking acetylsalicylic acid, the following have occurred:
Common: stomach pain and abdominal pain, heartburn, nausea, vomiting, indigestion, increased risk of bleeding.
Rare: gastrointestinal inflammation, potentially life-threatening gastrointestinal bleeding: overt (coffee grounds vomiting, black tarry stools) or occult (more frequent with higher doses); stomach or duodenal ulcers, perforation, transient liver function disorders (increased aminotransferase activity), dizziness, and tinnitus, usually symptoms of overdose, headaches, insomnia, restlessness, bleeding (postoperative, nosebleeds, bleeding from the gums, from the genitourinary system), hematomas, prolonged bleeding time, prothrombin time, thrombocytopenia.
The consequence of bleeding may be the occurrence of acute or chronic iron deficiency anemia or acute post-hemorrhagic anemia, manifested by asthenia, pallor, hypoperfusion, as well as abnormal laboratory test results, cerebral hemorrhage (especially in patients with uncontrolled hypertension and/or concomitantly taking other anticoagulant medicines) potentially life-threatening.
Palpitations, hot flashes to the face, irregular heartbeat, hypertension, rapid heartbeat, hypersensitivity reactions with clinical symptoms and abnormal laboratory test results, such as: asthma, mild to moderate skin reactions, respiratory system, cardiovascular system with symptoms such as: rash, urticaria, edema (including angioedema), respiratory and cardiac disorders, asthma.
Very rare: after long-term use of high doses of acetylsalicylic acid, renal papillary necrosis and interstitial nephritis have been reported, severe reactions, including anaphylactic shock (symptoms of shock: skin redness, itching, decreased blood pressure, nausea, vomiting).
After taking caffeine, the following have occurred: palpitations, sudden flushing, high blood pressure, tachycardia.
With the use of NSAIDs, edema, hypertension, and heart failure have been reported.
Long-term use of medicines containing acetylsalicylic acid may cause headaches that worsen with each subsequent dose.
Long-term use of painkillers, especially those containing multiple active substances, may lead to severe kidney dysfunction and kidney failure.
If coffee grounds vomiting or black, tarry stools occur, stop taking the medicine and consult a doctor.
A symptom of a severe hypersensitivity reaction may be: facial and eyelid edema, tongue and laryngeal edema with narrowing of the airways, difficulty breathing, shortness of breath up to asthma attacks, rapid heartbeat, sudden drop in blood pressure to life-threatening shock.
In case of any of the above symptoms, seek immediate medical attention.
These reactions may occur even after the first administration of the medicine.
This medicine belongs to a group of medicines that may adversely affect female fertility (see "Warning and precautions").

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, tell your doctor or pharmacist.
Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel: +48 22 49 21 301, Fax: +48 22 49 21 309, e-mail: ndl@urpl.gov.pl.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

• How to store Dampiryna

Store in a temperature below 25°C, in the original packaging.
Keep the medicine out of sight and reach of children.
Do not use the medicine after the expiry date stated on the packaging.
The expiry date stated on the packaging is the last day of the given month.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines that are no longer needed.
This will help protect the environment.

• Contents of the pack and other information

What Dampiryna contains

• The active substances of the medicine are: acetylsalicylic acid in the amount of 400 mg and caffeine in the amount of 50 mg.
• Other ingredients of the medicine are: microcrystalline cellulose and cornstarch.

What Dampiryna looks like and contents of the pack

White, round tablets with a cross, packaged in blisters of 10, in a cardboard box.
The pack contains 10 or 20 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Zakład Farmaceutyczny "Amara" Sp. z o.o.
ul. Stacyjna 5, 30-851 Kraków
Tel.: 12 657 40 40
Fax: 12 657 40 40 wew. 34
e-mail: amara@amara.pl
"CHANCE" Zakład Farmaceutyczny
Jerzy Jaworski, Maria Jaworska Spółka Jawna
Pieńków 11
05-152 Czosnów
Tel.: 22 752-13-35, Fax: 22 785-10-41

Date of last revision of the leaflet: