DOLCET Tramadol / Paracetamol 37.5mg / 325mg - 1 Tablet

Indications / Uses

Dolcet is used for the management of moderate to moderately severe pain. This medication works by changing the way your brain and nervous system respond to pain. It is often prescribed when non-opioid pain relievers are not effective. It should be used for the shortest duration possible to minimize the risk of dependence.

Side-effects

Dolcet common side effects include nausea, vomiting, constipation, dizziness, and drowsiness. More serious side effects, though less common, can include seizures, hallucinations, and severe allergic reactions. It's crucial to seek immediate medical attention if you experience any signs of an allergic reaction, such as rash, itching, swelling, severe dizziness, or trouble breathing. Prolonged use can lead to dependence and withdrawal symptoms.

Dosage / Direction

Adults and children 16 years of age and over: The maximum single dose of Tramadol + Paracetamol (Dolcet) is 1 to 2 tablets every 4 to 6 hours as needed for pain relief up to a maximum of 8 tablets per day. The lowest effective dose should be used for the shortest period of time.
Treatment withdrawal: Do not stop the use of Tramadol hydrochloride + Paracetamol (Dolcet) abruptly. Withdrawal symptoms may be relieved by tapering the medication (see Treatment withdrawal under Precautions).
Special Populations: Children below 16 Years of Age: The use of Tramadol + Paracetamol (Dolcet) is contraindicated in children below 12 years of age (see Contraindications). The safety and effectiveness of Tramadol + Paracetamol (Dolcet) in children aged 12 to below 16 years of age has not been established (see Contraindications and Precautions).
Elderly (65 years of age and older): No overall differences with regard to safety or pharmacokinetics were noted between subjects ≥ 65 years of age and younger subjects.
Renal impairment: In patients with creatinine clearances of less than 30 mL/min, it is recommended that the dosing interval of Tramadol + Paracetamol (Dolcet) be increased not to exceed 2 tablets every 12 hours.
Hepatic impairment: The use of Tramadol + Paracetamol (Dolcet) in patients with severe hepatic impairment is not recommended.
Administration: Tramadol + Paracetamol (Dolcet) tablets are for oral administration. Tramadol + Paracetamol (Dolcet) can be administered without regard to food.

Contraindications

Tramadol + Paracetamol (Dolcet) is contraindicated: In all children younger than 12 years of age.
In post-operative management in children younger than 18 years of age following tonsillectomy and/or adenoidectomy.
In patients who have previously demonstrated hypersensitivity to tramadol, paracetamol, any other component of this product or opioids.
In cases of acute intoxication with alcohol, hypnotics, narcotics, centrally acting analgesics, opioids or psychotropic drugs.
In patients using monoamine oxidase inhibitors (MAOIs) concurrently or within the last 14 days.
In patients with significant respiratory depression (see Precautions for Use).

Special Precautions

Patient with history of epilepsy or those with susceptibility to seizures (e.g. alcohol or drug withdrawal, metabolic disorders, CNS infection, malignancy), head injury, intracranial lesions, increased intracranial pressure, mental health conditions (e.g. anxiety disorders, depression, post-traumatic stress disorder), hypovolaemia, CV disease (e.g. acute MI), acute abdominal conditions, adrenal insufficiency (e.g. Addison's disease), delirium tremens, toxic psychosis, prostatic hyperplasia and/or urinary stricture, significant COPD or cor pulmonale, substantially decreased respiratory reserve, hypoxia, hypercapnia, pre-existing respiratory depression, thyroid dysfunction, biliary tract disease (including acute pancreatitis), history of drug abuse or acute alcoholism.

Is it safe to take it with other drugs?

Tramadol Opiodex can interact with other medications, including antidepressants, other pain relievers, and central nervous system depressants. These interactions can increase the risk of serious side effects, such as seizures or respiratory depression. Always inform your healthcare provider about all medications you are currently taking.

How should I store it?

Store between 15-30°C.