Europe — EMA
Claradol Cafeine (Paracetamol, Caffeine)
Claradol Cafeine – OTC oral analgesic with paracetamol and caffeine for headache, fever, and mild pain relief. Uses, safety, and FAQs.
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What is Paracetamol, Caffeine?
Claradol Cafeine is an over‑the‑counter oral medication that combines paracetamol and caffeine. While the exact strength is not specified in the available data, the product is formulated for systemic absorption after oral administration. It belongs to the analgesic/antipyretic class and is marketed in the European Union. The combination leverages paracetamol’s pain‑relieving properties together with caffeine’s central nervous system stimulant effect for temporary relief of common discomforts.
What is Paracetamol, Caffeine used for?
Claradol Cafeine is indicated for the short‑term relief of several mild to moderate pain conditions and fever.
- Headache, including tension‑type and early migraine symptoms. - Fever associated with viral or bacterial infections. - Mild to moderate musculoskeletal pain such as backache or sprain. - Toothache or dental pain following procedures. - Menstrual discomfort and associated lower‑abdominal cramps. - Common cold‑related aches and pains. - Other occasional uses as advised by a pharmacist.
What are the side effects of Paracetamol, Caffeine?
The safety profile of Claradol Cafeine reflects the known effects of paracetamol and caffeine, which are generally well tolerated when used as directed, but certain reactions may occur.
Common: - Nausea or mild stomach discomfort, which usually resolves without medical attention. - Insomnia or difficulty sleeping, especially if taken later in the day. - Restlessness or feeling jittery, related to caffeine’s stimulant effect. - Slight increase in heart rate or palpitations, often transient.
Serious: - Allergic reactions such as rash, itching, swelling of the face, lips, or tongue, which require prompt evaluation. - Signs of liver injury (e.g., dark urine, jaundice, persistent fatigue) with excessive paracetamol intake. - Severe skin reactions including Stevens‑Johnson syndrome or toxic epidermal necrolysis, which are medical emergencies.
What precautions apply to Paracetamol, Caffeine?
When considering Claradol Cafeine, several precautionary measures help ensure safe and effective use.
- Do not exceed the recommended daily dose of paracetamol (typically 4 g per day). - Avoid use in patients with known liver disease or impaired hepatic function. - Limit caffeine intake from other sources to reduce the risk of overstimulation. - Use caution in individuals with hypertension, cardiac arrhythmias, or anxiety disorders. - Pregnant or breastfeeding women should consult a healthcare professional before use. - Children should only use formulations specifically approved for their age and weight.
What does Paracetamol, Caffeine interact with?
Claradol Cafeine may interact with other medicines, and awareness of these interactions can reduce adverse effects.
Avoid: - Alcohol or other hepatotoxic drugs (e.g., high‑dose ibuprofen) that increase liver load. - Other caffeine‑containing products (energy drinks, certain analgesics) to avoid excess stimulant effect.
Use with caution: - Anticoagulants such as warfarin, as paracetamol may affect bleeding risk. - Anticonvulsants (carbamazepine, phenytoin) that can alter paracetamol metabolism. - Certain antidepressants, especially MAO inhibitors, which may increase caffeine‑related side effects. - Diuretics or antihypertensive agents, because caffeine may counteract blood‑pressure control.



