Dampiryna

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

DAMPIRYNA, 400 mg + 50 mg, tablets
Acetylsalicylic acid + Caffeine
Please read this leaflet carefully before taking the medicine, as it contains important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as directed by the physician.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse effects, including any possible adverse effects not listed in this leaflet, inform your doctor or pharmacist.
• If there is no improvement after 3 days or if your condition worsens, contact your doctor.

Table of contents:

1. What Dampiryna is and what it is 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 Dampiryna is and what it is used for

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

• Important information before taking Dampiryna

When not to take Dampiryna:

• if you are allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6),
• in case of hypersensitivity to salicylates or other non-steroidal anti-inflammatory drugs (NSAIDs),
• if you have a bleeding tendency,
• if you have severe heart failure, severe liver failure, or severe kidney failure,
• if you have gout,
• if you have peptic ulcer disease of the stomach or duodenum,
• if you have severe cardiovascular disease or severe arterial hypertension uncontrolled by antihypertensive drugs,
• if you have a history of bronchial asthma attacks induced by salicylates or substances with similar action, particularly NSAIDs,
• if you are concurrently taking methotrexate (used, among others, in oncological 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 condition causing liver and brain damage,
• if you are in the third trimester of pregnancy or breastfeeding.

Warnings and precautions:
When to exercise special caution when taking Dampiryna:

• if you have hypersensitivity to anti-rheumatic drugs or other allergenic substances,
• during the first and second trimesters of pregnancy,
• if you are concurrently taking anticoagulant drugs, e.g. coumarin derivatives, heparins,
• if you have impaired liver or kidney function,
• if you have hyperthyroidism,
• if you have a history of peptic ulcer disease or gastrointestinal bleeding,
• if you have a genetic disorder involving deficiency of the enzyme glucose-6-phosphate dehydrogenase.

Acetylsalicylic acid may cause bronchospasm and provoke asthma attacks or other hypersensitivity reactions. Patients with bronchial asthma, chronic respiratory diseases, hay fever, nasal polyps, or those with allergic reactions to other substances (e.g. skin reactions, itching, urticaria) are particularly at risk.
Patients scheduled for 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 predisposed to reduced uric acid excretion, the medicine may trigger an attack of gout.
This medicine belongs to a group of medicines that may adversely affect female fertility. This effect is reversible and resolves after discontinuation of therapy.
The risk of gastrointestinal bleeding is increased when the medicine is taken concurrently with alcohol or corticosteroids.
Patients with bronchial asthma, chronic respiratory diseases, or allergies to any substances are at risk of developing dyspnea. Such individuals should consult their doctor before using the medicine. Patients with coagulation disorders or uncontrolled hypertension should also seek medical advice.
Long-term use of analgesics, especially combination products, may lead to permanent kidney damage.
Consult your doctor even if the above warnings relate to conditions that occurred in the past.

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

Dampiryna with other medicines
Inform your doctor about all medicines you are currently taking, have recently taken, or 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 primarily in oncological diseases) on bone marrow; acetylsalicylic acid should not be used concurrently with methotrexate administered at doses of 15 mg per week or higher; concurrent use of methotrexate at doses lower than 15 mg per week requires special caution;
• the effect of anticoagulant drugs (e.g. coumarin derivatives, heparin), thrombolytic drugs (dissolving intravascular clots, e.g. streptokinase, urokinase), and antiplatelet agents (e.g. ticlopidine), which may increase the risk of prolonged bleeding time and hemorrhage;
• the risk of peptic ulcer disease and gastrointestinal bleeding when used concurrently with corticosteroids, other non-steroidal anti-inflammatory drugs, including high-dose salicylates, or when alcohol is consumed during treatment; after discontinuation of systemic glucocorticoids (except 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 plasma concentration;
• the effect of antidiabetic drugs, 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, among others, in depression treatment), which may increase the risk of upper gastrointestinal bleeding.

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

• uricosuric drugs used in gout treatment that increase uric acid excretion from the body (e.g. benzbromarone, probenecid), which may exacerbate symptoms of gout,
• diuretics,
• certain antihypertensive drugs (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 antihistamines), as caffeine inhibits their effect,
• drugs causing more frequent heart contractions (e.g. thyroxine), as caffeine enhances their effect,
• theophylline (a medicine used in 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 (hypnotic drugs), as they accelerate caffeine metabolism,
• certain antibiotics, as they may delay caffeine and its metabolite excretion.
  Smoking accelerates caffeine metabolism. Caffeine increases the risk of dependence on substances with ephedrine-like action (contained in cardiac drugs). Dampiryna may be used concurrently with the above-mentioned medicines (except methotrexate at doses of 15 mg per week or higher) only after consultation with a doctor.

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 meals, and swallow the tablets with plenty of water.

Pregnancy, breastfeeding, and effect on fertility
The medicine may be used during the first 6 months of pregnancy (I and II trimesters) only after consultation with a doctor. Use during the last three months of pregnancy (III trimester) is contraindicated. If pregnancy occurs during long-term use of the medicine, inform your doctor.
Do not use the medicine during breastfeeding.
This medicine may adversely affect fertility in women (see section "Warnings and precautions").

Driving and operating machinery
This product does not impair psycho-physical performance, ability to drive vehicles, or operate machinery.

• How to take Dampiryna

In case of pain, the recommended dose is:
Adults: 1 to 2 tablets at a time (corresponding to 400 mg to 800 mg of acetylsalicylic acid and 50 mg to 100 mg of caffeine). The single dose may be repeated if necessary, but no more frequently than every 4 to 8 hours. Do not exceed 6 tablets (i.e. 2400 mg of acetylsalicylic acid and 300 mg of caffeine) per day.
Adolescents over 12 years of age: ½ to 1 tablet at a time (corresponding to 200 mg to 400 mg of acetylsalicylic acid and 25 mg to 50 mg of caffeine). The single dose may be repeated if necessary, but no more frequently than every 4 to 8 hours. Do not exceed 3 tablets (i.e. 1200 mg of acetylsalicylic acid and 150 mg of caffeine) per day.
The tablets should be taken orally, after meals, with plenty of water.
Do not use the medicine for longer than 3 days without consulting a doctor.
Warning: alcohol may increase the risk of gastrointestinal adverse effects, such as mucosal ulceration or bleeding.
This medicine should always be taken exactly as described in this patient leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Taking more than the recommended dose of Dampiryna
Poisoning with the active substance in Dampiryna may result from long-term use of the medicine (mild poisoning) or overdose (severe poisoning), which may be life-threatening, e.g. after accidental ingestion by children or elderly individuals.
Symptoms of mild poisoning include: dizziness (including labyrinthine origin), tinnitus, hearing loss, excessive sweating, nausea and vomiting, headache, confusion (mental disturbances with disorientation, thinking and speech disorders, hallucinations, illusions, anxiety, and psychomotor agitation), rapid breathing, deep breathing, and symptoms of respiratory alkalosis (visual disturbances, fainting).
In case of severe poisoning, additional symptoms may include: high fever, respiratory disturbances (up to respiratory arrest and suffocation), cardiovascular disturbances (from irregular heartbeat and low blood pressure to cardiac arrest), fluid and electrolyte loss [due to dehydration, oliguria (reduced daily urine output below 400–500 ml in adults) up to kidney failure], increased or decreased blood glucose concentration (especially in children), ketoacidosis (a metabolic disorder involving excessive production of ketone bodies), gastrointestinal bleeding, coagulation disorders, and neurological disturbances manifesting as lethargy, confusion up to coma, and convulsive seizures.
In case of overdose, seek immediate medical advice from a doctor or pharmacist, and in case of severe poisoning, the patient should be immediately transported to a hospital.
Treatment of poisoning includes gastric lavage, administration of activated charcoal, and alkaline diuresis. In severe cases, forced alkaline diuresis, peritoneal dialysis, or hemodialysis may be necessary.
Caffeine overdose effects, including convulsions, should be treated symptomatically.

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

Discontinuation of Dampiryna
If you have any doubts regarding the use of the medicine, consult your doctor or pharmacist.

• Possible side effects

Like all medicines, this medicine may cause side effects, although not everybody will experience them.
The frequency of side effects is defined as follows:
Very common: may affect more than 1 in 10 people
Common: may affect 1 in 10 people
Uncommon: may affect 1 in 100 people
Rare: may affect 1 in 1,000 people
Very rare: may affect 1 in 10,000 people
Not known: frequency cannot be estimated from available data

After administration of acetylsalicylic acid, the following occurred:
Common: stomach and abdominal pain, heartburn, nausea, vomiting, indigestion, increased risk of bleeding.
Rare: gastrointestinal inflammation, potentially life-threatening gastrointestinal bleeding: overt (coffee-ground vomitus, melena) or occult (bleeding occurs more frequently with higher doses); peptic ulcer disease of the stomach or duodenum, perforation, transient disturbances in liver function (increased aminotransferase activity), dizziness and tinnitus (usually symptoms of overdose), headache, insomnia, restlessness, hemorrhages (postoperative, nasal, gingival, genitourinary), bruising, prolonged bleeding time, prolonged prothrombin time, thrombocytopenia. Bleeding may lead to acute or chronic iron-deficiency anemia or acute hemorrhagic anemia, manifesting as asthenia, pallor, hypoperfusion, and abnormal laboratory results, as well as intracerebral hemorrhage (especially in patients with uncontrolled hypertension and/or concurrently using other anticoagulant drugs), potentially life-threatening. Palpitations, facial flushing, irregular heartbeat, hypertension, tachycardia, hypersensitivity reactions with clinical symptoms and abnormal laboratory results, such as: asthma, mild to moderate skin, respiratory, or cardiovascular reactions with symptoms such as: rash, urticaria, edema (including angioedema), breathing difficulties, and cardiovascular disturbances, bronchial 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, skin itching, drop in blood pressure, nausea, vomiting).

After administration of caffeine, the following occurred: palpitations, sudden flushing, high blood pressure, tachycardia.

Edema, hypertension, and heart failure have been reported during NSAID treatment.
Long-term use of medicines containing acetylsalicylic acid may cause headache that worsens with subsequent doses.
Long-term use of analgesics, particularly those containing multiple active substances, may lead to severe kidney dysfunction and kidney failure.

If coffee-ground vomitus or black, tarry stools occur, discontinue the medicine and consult a doctor.
Symptoms of severe hypersensitivity reaction may include: facial and eyelid swelling, tongue and larynx edema with airway constriction, breathing difficulties, dyspnea up to asthma attacks, tachycardia, sudden drop in blood pressure up to life-threatening shock.
If any of the above symptoms occur, seek immediate professional medical help. These reactions may occur even after the first dose of the medicine.
This medicine belongs to a group of medicines that may adversely affect female fertility. This effect is reversible and resolves after discontinuation of therapy.

Reporting of side effects
If you experience any adverse effects, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel: +48 22 4921301, Fax: +48 22 4921309; e-mail: [email protected].
Adverse effects can also be reported to the Marketing Authorisation Holder.
Reporting of adverse effects helps to gather more information on the safety of the medicine.

• How to store Dampiryna

Store below 25°C, in the original packaging.
Keep the medicine out of sight and reach of children.
Do not use after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Do not dispose of medicines via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

• Contents of the pack and other information

What Dampiryna contains

• The active substances are: acetylsalicylic acid 400 mg and caffeine 50 mg.
• Other ingredients: microcrystalline cellulose and pregelatinized starch.

What Dampiryna looks like and contents of the pack
White, round tablets with a cross, packed in PVC/PVDC/Aluminum blisters, 10 tablets per blister, in a cardboard box.
The pack contains 10 or 20 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Amara Pharmaceutical Company Ltd.
Stacyjna 5, 30-851 Kraków
Tel.: 12 657 40 40
Fax: 12 657 40 40 ext. 34
e-mail: [email protected]

"CHANCE" Pharmaceutical Company
Jerzy Jaworski, Maria Jaworska Partnership
Pieńków 11
05-152 Czosnów
Tel.: 22 752-13-35, Fax: 22 785-10-41