Europe — EMA
Novalgin Tropfen (Metamizole Sodium Monohydrate)
GNH USA supplies Novalgin Tropfen (Metamizole Sodium Monohydrate), a non‑opioid analgesic for postoperative pain, colic and fever.
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What is Metamizole Sodium Monohydrate?
Metamizole Sodium Monohydrate, the active ingredient in Novalgin Tropfen, is a pyrazolone (non‑opioid analgesic) presented as an oral solution (drops) for oral use. It treats mild to moderate pain, postoperative pain, colic, visceral pain and fever in adults and is approved for prescription use in the EU.
GNH USA supplies Novalgin Tropfen as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide, with a focus on quality assurance and regulatory compliance.
What is Metamizole Sodium Monohydrate used for?
Metamizole Sodium Monohydrate is used for pain and fever management across several clinical situations.
- Mild to moderate pain: provides analgesia to relieve everyday discomfort. - Post‑operative pain: helps control pain after surgical procedures. - Colic and visceral pain: eases spasm‑related abdominal discomfort. - Fever: reduces elevated body temperature in febrile states.
What are the side effects of Metamizole Sodium Monohydrate?
Novalgin Tropfen may cause a range of adverse reactions.
Common Side Effects: - Nausea: mild to moderate upset stomach. - Dizziness: transient light‑headedness. - Headache: occasional mild headache. - Hypotension: occasional drop in blood pressure. - Skin rash: mild erythematous reactions. - Vomiting: occasional episodes.
Serious or Rare Side Effects: - Agranulocytosis: severe reduction in white blood cells. - Anaphylaxis: life‑threatening allergic reaction. - Stevens‑Johnson syndrome: severe skin and mucous membrane disorder. - Hepatic dysfunction: elevated liver enzymes. - Blood dyscrasias: abnormal blood cell counts. - Severe cutaneous adverse reactions: toxic epidermal necrolysis.
What precautions apply to Metamizole Sodium Monohydrate?
Before prescribing Novalgin Tropfen, consider the following safety measures.
- Monitor blood counts: regular CBC to detect agranulocytosis. - Avoid in known hypersensitivity: do not use in patients allergic to pyrazolones. - Use cautiously in renal impairment: adjust therapy based on renal function. - Do not combine with other NSAIDs: increased risk of gastrointestinal and renal effects. - Pregnancy and lactation: avoid unless clearly necessary, as safety is unknown. - Store at ambient temperature: keep in the original container, protect from moisture and light.
What does Metamizole Sodium Monohydrate interact with?
Novalgin Tropfen can interact with several drug classes.
Major Interactions (Avoid): - Concurrent pyrazolones or strong COX inhibitors: heightened risk of agranulocytosis. - Combination with anticoagulants: increased bleeding tendency. - Co‑administration with sulfonamides: possible cross‑reactivity leading to severe skin reactions.
Moderate Interactions (Monitor Closely): - Use with diuretics: may enhance hypotensive effect. - Combination with antihypertensives: monitor blood pressure closely. - Co‑use with other analgesics (e.g., paracetamol): may increase total analgesic load and risk of toxicity.



