Doreta

 

Doreta

Doreta is a combination medication containing two active ingredients:

• Tramadol — 37.5 mg or 75 mg\
  
  This is a centrally acting analgesic from the opioid group. It binds to receptors in the brain and spinal cord, blocking the transmission of pain impulses.
  
  

• Paracetamol (Acetaminophen) — 325 mg or 650 mg\
  
  A well-known antipyretic and pain reliever that works by inhibiting prostaglandin synthesis in the central nervous system.
  
  

Tramadol in the preparation is presented as hydrochloride (salt form), which improves its solubility and absorption in the body. The combination of these two substances allows simultaneous action on pain through different mechanisms — both central and peripheral.

Doreta comes in film-coated tablets. This ensures convenient administration and reduces irritation to the stomach.

The following dosages are available:

• 37.5 mg tramadol / 325 mg paracetamol

• 75 mg tramadol / 650 mg paracetamol

Each tablet contains a precisely balanced ratio of components, providing a fast and stable analgesic effect. The doctor selects the dosage individually, depending on pain intensity and the body's response to treatment.

Doreta is prescribed for short-term treatment of moderate to severe pain, especially in cases where common painkillers (such as paracetamol, ibuprofen, or other NSAIDs) are not sufficiently effective.

This may include:

• acute pain after surgery

• pain from injuries or bruises;

• pain from inflammatory diseases of the musculoskeletal system (such as osteoarthritis, sciatica);

• oncological pain;

• neurological pain (neuralgia, radicular syndrome).

Important to remember: Doreta is not used as a first-line treatment, but in cases where weaker analgesics don't provide the needed effect. The treatment course should be as short as possible to avoid developing dependence.

How to take Doreta:

Take Doreta with plenty of water. Don't chew or break the tablet — the coating helps the medicine work properly in your body.

How much to take:

• Starting dose — 1 tablet (37.5 mg tramadol + 325 mg paracetamol) every 6 hours.

• Maximum daily amount:

• 8 tablets (if using 37.5/325 mg strength),

• or 4 tablets (if using 75/650 mg strength).

Wait at least 6 hours between tablets.

Don't take Doreta for more than 5 days in a row without talking to your doctor. This is important because tramadol (one of the ingredients) can become habit-forming if used for too long, and paracetamol can harm your liver if you take too much.

If your pain doesn't get better after a few days or if you need to take more medicine for relief, talk to your doctor about changing your treatment.

Who should not take this medicine:

Before starting Doreta, make sure you don't have any conditions that might make this medicine unsafe for you. The combination of tramadol and paracetamol needs special care, especially if you have problems with metabolism, liver, or your nervous system.

Do not take this medicine if you have:

• Allergy to tramadol, paracetamol, or any of the auxiliary components of the medication.

• Severe liver failure — with impaired liver function, the risk of toxic damage increases, especially from paracetamol.

• Severe renal failure (creatinine clearance <10 ml/min) — the medication can accumulate in the body and cause side effects.

• Epilepsy poorly controlled by treatment — tramadol can lower the seizure threshold.

• Alcohol or drug dependence — tramadol can enhance psychoactive effects and cause habituation.

• Concurrent use of MAO inhibitors (e.g., moclobemide, selegiline) or within 14 days after their discontinuation — serious side effects may develop (up to serotonin syndrome).

If the patient has concomitant chronic diseases, especially of the liver, kidneys, or central nervous system — it's necessary to discuss the possibility of taking the medication with a doctor beforehand.

The use of Doreta requires caution in a number of clinical situations. The medication can cause side effects, especially when exceeding the dosage or with prolonged use.

Features that need to be considered:

• Risk of habituation: tramadol belongs to opioid analgesics and with prolonged use can cause psychological and physical dependence.

• Patients with liver and kidney diseases: require dosage adjustment and stricter control. In such patients, metabolism and excretion of the active substances slow down, which can lead to medication accumulation.

• Seizures: tramadol lowers the seizure threshold. It is used with particular caution in people with epilepsy, traumatic brain injuries, brain tumors, or when taking medications that promote seizures (e.g., antidepressants, neuroleptics).

• Sedative effect: the medication can enhance the effects of alcohol, sleeping pills, and tranquilizers, leading to pronounced depression of the central nervous system.

• Withdrawal syndrome: with abrupt discontinuation of the medication after prolonged use, withdrawal symptoms may occur — anxiety, irritability, insomnia, tremors, sweating.

To minimize risks, it is recommended to take Doreta only as prescribed by a doctor, strictly following the dosage and duration of the course. If side effects appear, the treatment should be reviewed.

The combination of tramadol and paracetamol can interact with a number of other medications, enhancing side effects or reducing treatment effectiveness. This is especially important to consider in combination therapy.

Main drug interactions:

• Antidepressants and neuroleptics — may increase the risk of seizures when used together with tramadol. This is especially true for medications that lower the seizure threshold (e.g., selective serotonin reuptake inhibitors — SSRIs).

• Sedatives and alcohol — enhance the depressant effect on the central nervous system, which can lead to drowsiness, dizziness, respiratory depression.

• Warfarin and other anticoagulants — possible enhancement of the blood-thinning effect, especially with prolonged use of paracetamol. Monitoring of coagulation parameters is necessary.

• MAO inhibitors — contraindicated for concurrent use, possible risk of serotonin syndrome and other severe reactions.

• Anticonvulsant medications — may reduce the effectiveness of tramadol, as well as increase the risk of seizures.

Before starting Doreta, it's important to inform your doctor about all medications you're taking (including over-the-counter ones) to avoid dangerous combinations.

The combination of tramadol and paracetamol requires special caution when used in women during pregnancy and lactation. Data on safety for use in this category of patients are limited.

Pregnancy:

• The medication is not recommended for use during pregnancy due to insufficient data and potential risk to the foetus.

• Especially undesirable in the third trimester, as it can cause respiratory depression in the newborn or withdrawal syndrome.

Breastfeeding:

• Tramadol and its metabolites pass into breast milk.

• The medication is contraindicated during lactation, as even small doses can cause respiratory depression, drowsiness, or other side effects in the infant.

Fertility:

• Data on the medication's effect on fertility are insufficient. However, prolonged use of tramadol in men and women theoretically can affect reproductive function.

Doreta can cause side effects in the nervous system: drowsiness, dizziness, decreased concentration and reaction.

While taking the medication, it is recommended to:

• refrain from driving a car and operating dangerous machinery;

• avoid activities requiring high reaction speed and mental concentration, especially during the first days of treatment or when increasing the dose.

If you notice decreased concentration, unclear thinking, or sluggishness — stop driving until you consult with a doctor.

Like any combination pain reliever, Doreta can cause side effects. Most of them are related to tramadol's effect on the central nervous system and paracetamol — on the liver and digestive tract.

The frequency of manifestations can vary from very common to rare but serious.

Common (more than 1 in 10):

• Nausea — the most common side effect, especially at the beginning of treatment.

• Dizziness.

• Drowsiness — can reduce concentration and ability to drive.
  
  

Rare (less than 1 in 1000):

• Allergic reactions (skin rash, itching).

• Orthostatic hypotension — sharp decrease in blood pressure when standing up.

• Palpitations.

• Gastrointestinal: constipation, diarrhoea, dry mouth.
  
  

Potentially dangerous complications include:

• Respiratory depression (especially with overdose or in the elderly).

• Seizures — possible with exceeding doses or in patients with neurological diseases.

• Liver dysfunction — with prolonged use or exceeding doses of paracetamol.
  
  

If any alarming symptoms appear (especially difficult breathing, severe rash, confusion), you should immediately stop taking the medication and consult a doctor.

Overdose of Doreta can be life-threatening, especially due to the cumulative action of tramadol and the toxicity of paracetamol to the liver. It can be accidental (exceeding the dose) or intentional (including with suicidal intentions).

Main symptoms:

• Tramadol: respiratory depression, drowsiness up to coma, seizures.

• Paracetamol: toxic liver damage — may not manifest immediately, but progress within 24-72 hours to liver failure.
  
  

Emergency measures:

• Immediate hospitalisation, even if symptoms are mild.

• Antidotes:
  
  

• Naloxone — for symptoms of tramadol overdose.

• N-acetylcysteine — for paracetamol intoxication (effective in the first 8 hours).
  
  

Symptomatic therapy is also conducted (maintaining respiration, liver function, controlling pressure and water-salt balance).

Overdose requires immediate medical intervention, as severe complications can develop even with a seemingly "moderate" excess of the dose.

Doreta combines two active substances that complement each other's action, providing a powerful analgesic effect both at the level of the central nervous system and at the periphery.

• Tramadol is a centrally acting opioid analgesic. It binds to μ-opioid receptors in the brain and spinal cord, reducing pain perception. Additionally, it inhibits the reuptake of serotonin and noradrenaline, which enhances its analgesic effect by strengthening descending inhibitory pathways in the CNS.
  
  

• Paracetamol (acetaminophen) is a non-narcotic analgesic and antipyretic agent. Its main mechanism is related to blocking the cyclooxygenase (COX) enzyme in the central nervous system, which leads to a decrease in the synthesis of prostaglandins — substances involved in the development of pain and fever.
  
  

Thanks to the combined action of tramadol and paracetamol, the medication is effective for pains of different origins — from postoperative to inflammatory or neuralgic.

Each active substance in Doreta has its own pharmacokinetic characteristics. This is important to consider when prescribing the medication and choosing the dosing regimen.

• Tramadol:
  
  

• Rapidly absorbed after oral administration.

• Bioavailability — about 75%.

• Metabolised in the liver to form an active metabolite (O-desmethyltramadol), which has a more pronounced analgesic effect.

• Half-life — approximately 6 hours.
  
  

• Paracetamol:
  
  

• Quickly and almost completely absorbed from the gastrointestinal tract.

• Bioavailability — 85-98%.

• Metabolised in the liver, a small part — into toxic metabolites, which are normally neutralised by glutathione.

• Half-life — 2-3 hours.

• Excreted by the kidneys, mainly in the form of glucuronide and sulphate conjugates.
  
  

The combined use of tramadol and paracetamol provides a rapid onset of effect and its sufficient duration without the need to repeat the dose frequently.

• Doreta belongs to the pharmacological group:
• Combined analgesics — medications combining opioid analgesics and non-steroidal/non-narcotic analgesics.

In addition to the active components (tramadol and paracetamol), Doreta contains auxiliary substances. They ensure stability, bioavailability, convenience in production and administration of the medication.

The composition of auxiliary substances includes:

• Pregelatinised starch — a filler that contributes to tablet formation.

• Microcrystalline cellulose — stabilises the tablet structure, improves compressibility.

• Magnesium stearate — a lubricant that prevents sticking and ensures uniformity of mass.

• Hypromellose — a component of the film coating, regulates the release of active substances.

• Titanium dioxide — provides the white colour of the coating.

• Macrogol 400 — improves the solubility of the film coating.

• Yellow iron oxide — gives colour to the tablet (used in some dosages).

• Polysorbate 80 — stabiliser and dispersant.

It's important to familiarise yourself with the full composition, especially if the patient has an allergy or intolerance to auxiliary components (for example, to polysorbate or stearates).

• The shelf life of Doreta is 3 years from the date of manufacture. After this period, the medication should not be used — it may lose effectiveness or become unsafe.
• Always check the date on the package before taking it. Storage in proper conditions helps preserve the stability of the active substances.

To maintain the effectiveness and safety of the medication, standard storage conditions must be observed:

• Storage temperature — not above 25°C.

• Place — dry, protected from direct sunlight.

• The medication should be stored out of reach of children.

Violation of storage conditions (for example, high humidity or heat) can affect the stability of components and reduce treatment effectiveness.

Doreta comes in tablet form, packaged in:

• Blisters of 10 tablets.

• Cardboard boxes containing 20 or 30 tablets.

Each package is accompanied by instructions for medical use.
When purchasing and using the medication, ensure that the blister is not damaged, the tablets have a uniform appearance, and the expiry date has not passed.

Remaining or expired Doreta tablets should not be disposed of in sewage, toilet, or general waste. Such actions can lead to environmental pollution and the development of drug resistance in microorganisms.

The correct disposal method:

• Return the medication to a pharmacy or medical facility participating in the safe collection of expired medications.

• Follow local sanitary requirements for the disposal of medicinal products.

Store unused medication out of reach of children until it is returned.

• Doreta is registered and available in most European Union countries, as well as in some other regions. It is widely used in clinical practice due to the combination of rapid pain relief and a convenient dosing regimen.
• Before purchasing abroad, it's important to ensure that the medication is approved for sale in the corresponding jurisdiction and is available under the same trade name.

• KRKA d.d. (Slovenia)

• Doreta is available by prescription only.
• This is due to the content of tramadol, which is an opioid and requires strict control due to the potential risk of habituation, as well as possible serious side effects.

For safe use of the medication, it is necessary to strictly follow the doctor's recommendations:

• Do not use for more than 5 consecutive days without a doctor's prescription.

• Do not exceed the daily dose — risk of toxic liver damage and development of dependence.

• Avoid alcohol consumption — this can enhance the sedative effect and liver stress.

• With prolonged use, monitoring of liver function and assessment of the need to continue therapy may be required.

Information in open sources is for reference only. Before using the medication, be sure to read the official instructions and consult with a doctor.

• N02AJ13 – Tramadol in combination with paracetamol.

Doreta is used for pain syndrome of various origins. The most common indications according to the ICD-10 classification:

• G50-G59 — Disorders of nerves, nerve roots and plexuses

• G89.0 — Acute post-operative pain

• G89.1 — Chronic post-operative pain

• G89.2 — Chronic pain of unspecified origin

• G89.3 — Pain caused by malignant neoplasms

• G89.4 — Chronic pain associated with other conditions

• M15-M19 — Arthrosis

• M25.5 — Joint pain

• M79.2 — Neuralgia and neuritis, unspecified

• R52.2 — Pain of unspecified location