PARACO-DENK 1000/60 mg Suppositories

What is PARACO-DENK 1000/60 mg

PARACO-DENK 1000/60 mg Suppositories is a combination medication that contains two active ingredients: Paracetamol (1000 mg) and Codeine phosphate hemihydrate (60 mg). It is formulated as a rectal suppository, intended for use when oral administration is not suitable (e.g., in cases of nausea, vomiting, or swallowing difficulties).

• Paracetamol: An analgesic (pain reliever) and antipyretic (fever reducer) commonly used to treat mild to moderate pain and reduce fever.
• Codeine: A mild opioid analgesic that enhances the pain-relieving effects of paracetamol and is effective for managing moderate to severe pain.
• This combination is commonly used for the short-term treatment of conditions like post-operative pain, musculoskeletal pain, dental pain, and headache where stronger pain relief is required.
• The suppository form ensures rapid absorption through the rectal mucosa, providing systemic relief even when oral routes are compromised.

How to use PARACO-DENK 1000/60 mg

Proper usage of PARACO-DENK 1000/60 mg suppositories ensures both effectiveness and safety. These are meant for rectal use only and must not be ingested orally.

• Wash hands thoroughly before and after handling the suppository.
• Unwrap the suppository gently and avoid touching it too long to prevent it from melting.
• Insert the suppository pointed end first into the rectum. It may help to moisten the tip with water or a water-based lubricant.
• Lie down on your side with one leg straight and the other bent at the knee. Insert it gently and push it inside with your finger until it is fully in place.
• Remain lying down for a few minutes to help retain the suppository.
• Do not use more than the recommended dose, and avoid prolonged use without medical supervision.

Mode of Action PARACO-DENK 1000/60 mg

PARACO-DENK acts through a dual mechanism, combining the effects of both Paracetamol and Codeine to provide enhanced pain relief:

• Paracetamol:
  • Acts centrally in the brain to inhibit the enzyme cyclooxygenase (COX), which reduces the production of prostaglandins—chemicals that cause pain and inflammation.
  • Lowers elevated body temperature by acting on the hypothalamic heat-regulating center.
  • Does not possess significant anti-inflammatory properties, but is effective in pain relief and fever reduction.
• Codeine:
  • Functions as a weak opioid analgesic. After absorption, it is partially converted in the liver to morphine, which binds to opioid receptors in the central nervous system.
  • Alters the perception of pain and the emotional response to pain, thereby providing a higher threshold for discomfort.
  • Has mild antitussive (cough suppressant) properties, though this is not the intended use in this formulation.

Together, they provide synergistic pain relief suitable for moderate to severe pain where single-agent treatment is inadequate.

PARACO-DENK 1000/60 mg Interactions PARACO-DENK 1000/60 mg

Drug interactions may alter how PARACO-DENK works or increase the risk of serious side effects. It is important to disclose all medications you are taking to your healthcare provider.

• Central Nervous System Depressants: Codeine may enhance the sedative effects of alcohol, benzodiazepines, antidepressants, antihistamines, and antipsychotics.
• MAO Inhibitors: Concurrent use with monoamine oxidase inhibitors (e.g., phenelzine, isocarboxazid) may lead to serious, potentially life-threatening effects such as serotonin syndrome.
• Enzyme Inducers: Drugs such as rifampicin, carbamazepine, and phenytoin can reduce the effectiveness of paracetamol by increasing its metabolism, potentially raising liver toxicity risk.
• CYP2D6 inhibitors: Fluoxetine and paroxetine can reduce the conversion of codeine to morphine, decreasing its pain-relieving effect.
• Warfarin and other anticoagulants: Prolonged use of high-dose paracetamol may increase bleeding risk.

Always consult a healthcare professional before combining PARACO-DENK with other medications or substances.

Dosage of PARACO-DENK 1000/60 mg

Dosage should be individualized based on the patient's condition, age, weight, and response to treatment. Always follow your healthcare provider’s instructions.

• Adults and adolescents over 12 years:
  • 1 suppository (1000 mg paracetamol / 60 mg codeine) inserted rectally every 6 hours as needed.
  • Do not exceed 4 suppositories in 24 hours.
• Children under 12 years: Not recommended due to the risk of serious breathing problems and inadequate data on safety and efficacy.
• Elderly patients: Use with caution. Lower doses may be required due to reduced liver or kidney function.

Possible side effects of PARACO-DENK 1000/60 mg

Like all medicines, PARACO-DENK can cause side effects, though not everyone will experience them. Most are mild and temporary, but some may be serious.

• Common side effects:
  • Drowsiness, dizziness, and light-headedness
  • Constipation or difficulty passing stools
  • Nausea or vomiting
  • Abdominal discomfort or mild rectal irritation
• Less common but serious side effects:
  • Allergic reactions (e.g., rash, itching, swelling, especially of the face/lips/tongue, difficulty breathing)
  • Liver toxicity or failure with prolonged use or overdose of paracetamol
  • Respiratory depression, especially in higher doses or in people with compromised lung function
  • Dependence or withdrawal symptoms with prolonged use of codeine

If you notice any serious side effects or signs of overdose (e.g., confusion, shallow breathing, yellowing of the skin or eyes), seek medical help immediately.

PARACO-DENK 1000/60 mg Contraindications PARACO-DENK 1000/60 mg

This medication is not suitable for everyone. It should be avoided in the following cases:

• Known hypersensitivity to paracetamol, codeine, or any of the suppository excipients
• Children under 12 years of age due to the risk of serious breathing problems
• Patients with respiratory depression, severe asthma, or other obstructive airway diseases
• Patients with head injury or increased intracranial pressure
• People with known or suspected gastrointestinal obstruction, including paralytic ileus
• Breastfeeding women – codeine may be transferred through breast milk and cause harm to the infant
• Severe liver or kidney impairment
• History of opioid dependence or substance abuse

Always consult your doctor to ensure this medicine is appropriate for your health condition.

Storage of PARACO-DENK 1000/60 mg

Proper storage of PARACO-DENK suppositories helps maintain their efficacy and safety.

• Store at a temperature not exceeding 25°C (77°F).
• Keep away from direct sunlight, moisture, and heat sources.
• Store in the original blister packaging to protect from light and contamination.
• Keep out of reach of children and pets.
• Do not use the product after the expiration date indicated on the packaging.
• If a suppository becomes deformed or discolored, discard it safely.
• Unused or expired medication should be returned to a pharmacy for proper disposal—do not flush down the toilet or throw in household trash.

Consult your pharmacist if you have any doubts about the appearance or storage conditions of the product.