Doreta – composition, action, dosage, indications, contraindications

Proven content

Doreta is an analgesic drug used in clinical oncology and neurology. The preparation affects the central nervous system and may have a narcotic effect. Doreta is available as tablets only with a prescription.

Doreta – composition and indications

Doreta is a drug that contains two painkillers: paracetamol and tramadol. The combination of these two preparations has a pain relieving effect.

Doreta is recommended for use when you experience moderate to severe pain if your doctor thinks you need tramadol in combination with paracetamol.

Doreta consists of 75 mg of tramadol hydrochloride (Tramadoli hydrochloridum), corresponding to 65,88 mg of tramadol and 650 mg of paracetamol (Paracetamolum). The auxiliary substances of the drug are:

tablet core:

1. gelatinized starch, corn starch,
2. sodium carboxymethyl starch (type A),
3. microcrystalline cellulose,
4. magnesium stearate (E 470b).

tablet shell:

1. hypromeloza 3 mPas,
2. hypromeloza 6 mPas,
3. macrogol 400,
4. polysorbate 80,
5. titanium dioxide (E 171),
6. iron oxide yellow (E 172),
7. iron oxide red (E 172).

See: Paracetamol for children – action, use, dosage, side effects

Doreta – mechanism of action

Tramadol is an opioid analgesic that acts on the central nervous system. It also has antitussive properties, but it does not inhibit the respiratory system. Tramadol also does not change the gastrointestinal motility. The effects on the cardiovascular system are usually minor. The potency of tramadol is one-tenth to one-sixth that of morphine.

Mechanism of action The exact mechanism of the analgesic effect of paracetamol is unknown and may involve central and peripheral effects.

Tramadol is a drug that is absorbed fairly quickly and almost completely. The absolute bioavailability of a single 100 mg dose is approximately 75%. After repeated dosing, the bioavailability of tramadol increases to approximately 90%. Paracetamol, on the other hand, is rapidly and almost completely absorbed, mainly in the small intestine.

Taking Doret is not dependent on taking meals. Ingested food does not affect the quality of absorption of Doreta.

Doreta – dosage

Doreta is intended for use by adults and children over 12 years of age. It is not recommended for use in children under 12 years of age. The dosage of Doreta should depend on the severity of your pain. The initial dose should be the lowest dose with an effective analgesic effect.

The recommended starting dose of Doreta is one tablet. Additional doses may be taken if necessary, not to exceed a total of 4 tablets (corresponding to 300 mg of tramadol hydrochloride and 2600 mg of paracetamol) per day. Intervals between doses should be at least six hours.

Doreta dosage in elderly patients:

Dose adjustment is not usually necessary in patients up to 75 years of age without clinical evidence of hepatic or renal insufficiency. The excretion of tramadol may be delayed in patients over 75 years of age. Therefore, if necessary, the intervals between doses should be increased in accordance with the state of health of the senior.

Doreta dosage in patients with renal insufficiency and on dialysis:

In people with renal insufficiency, excretion of tramadol is delayed. In these individuals, prolongation of the dosing interval should be considered according to the state of health.

Doreta dosage in people with hepatic impairment:

In people with hepatic impairment, excretion of tramadol is delayed. In these patients, an extension of the dosing interval should also be considered according to the patient’s condition. Due to the presence of paracetamol, Doreta should not be used in people with severe liver problems.

The editorial board recommends: Heart failure is a silent epidemic in Poland. The cardiologist tells you what the symptoms are

Doreta – contraindications and warnings

The main contraindication to the use of Doreta is hypersensitivity to its active substances or excipients. In addition, the drug should not be used in the case of:

1. acute intoxication with alcohol, hypnotics, centrally acting analgesics,
2. opioids or psychotropic drugs,
3. treatment with monoamine oxidase inhibitors and within two weeks after stopping such treatment
4. severely impaired liver function,
5. epilepsy that is not adequately controlled by drugs.

The warnings regarding the use of Doreta are as follows:

1. in adults and adolescents 12 years of age and older, the maximum daily dose should not exceed 4 tablets. In order to avoid inadvertent overdose, patients should not take more than the recommended dose and take other drugs containing paracetamol (including over-the-counter drugs) or tramadol hydrochloride at the same time, without consulting a physician,
2. Doreta should not be used in people with severe renal and hepatic impairment and severe respiratory disorders,
3. tramadol should not be used as substitution therapy in opioid-dependent patients,
4. in people with convulsions, special care should be taken in connection with the use of tramadol. Convulsions have been observed in some people treated with tramadol at the recommended doses. In addition, the risk of seizures increases when the maximum recommended dose is exceeded.

Read: Once associated with demons, it still causes fear. What happens to someone during a seizure?

Doreta – precautions

It is not recommended to use Doreta concomitantly with sedative drugs such as benzodiazepines or other drugs that can cause depression, respiratory depression, sedation, coma and death.

Tolerance, mental and physical dependence may develop with the use of Doreta – especially when the drug is taken over a long period of time. Therefore, the clinical need for treatment should be monitored regularly. In people who are / have been dependent on opioids or other medicinal preparations, if treatment with Doreta is required, it should be as short as possible and monitored by a doctor.

Caution should be exercised when administering Doreta to people with head injuries, prone to seizures, biliary disorders, shock, unconsciousness of unknown origin, respiratory distress or respiratory disorders, or with elevated intracranial pressure.

Regarding children, care should be taken when using tramadol after surgery, as side effects, including respiratory depression, may occur. The use of tramadol is also not recommended in children whose respiratory function may be impaired, including children with neuromuscular disorders, severe heart or respiratory diseases, infections of the upper respiratory tract or lungs, multiple injuries or after major surgery. These factors may worsen symptoms of opioid toxicity.

Tramadol hydrochloride may cause drowsiness and dizziness, which may be aggravated by alcohol or drugs that depress the central nervous system. If affected, you should not drive or operate machinery.

In some people, paracetamol overdose can cause toxic liver damage.

Prescriptions for drugs can be obtained not only after visiting the office. Make an appointment for a teleconsultation to receive an e-prescription for the medicine you need. The doctor may also extend the prescription or change the dosage.

Doreta – pregnancy and breastfeeding

Pregnancy and breastfeeding If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking Doreta. However, this preparation is a combination of two active substances, including tramadol, and should not be taken during pregnancy.

Moreover, tramadol is excreted in breast milk. For this reason, Doreta should not be used more than once during breast-feeding or if you take Doreta more than once, breast-feeding should be discontinued.

Doreta – side effects

The most common side effects are nausea, dizziness and somnolence. In addition, the frequency of side effects is also defined as those likely to occur frequently, uncommonly, rarely, very rarely and as not known.

Common side effects (may affect up to 1 in 10 people):

1. vomiting,
2. digestive disorders (constipation, flatulence, diarrhea),
3. stomach pain,
4. dry mouth
5. headaches,
6. trembling,
7. confusion,
8. sleep disturbances,
9. mood changes (anxiety, nervousness, euphoria – a constant feeling of being high),
10. increased sweating
11. itching

Uncommon side effects (may affect up to 1 in 100 people):

1. high blood pressure, abnormal heart rhythm and heart rate,
2. difficult or painful urination, protein in the urine,
3. skin reactions (hives, rashes),
4. ringing in the ears
5. depression,
6. nightmares
7. hallucinations (hearing, seeing or feeling things that are not really there)
8. memory loss,
9. difficulty swallowing
10. blood in the stool
11. chills,
12. hot flushes,
13. pain in the chest,
14. involuntary muscle twitching
15. a feeling of tingling and numbness
16. dyspnoea,
17. increase in liver enzymes.

Rare side effects (may affect up to 1 in 1000 people):

1. drug addiction,
2. convulsions, problems with coordination of movements,
3. blurred vision
4. temporary loss of consciousness.

Very rare side effects (may affect up to 1 in 10000 people):

1. drug abuse.

Not known side effects (frequency cannot be estimated from the available data):

1. decrease in blood sugar.

The above side effects have been reported by people taking medicines containing only tramadol hydrochloride or paracetamol. However, if you experience any of these side effects while taking Doreta, please inform your doctor:

1. feeling faint when rising from a sitting or lying position, slow heart rate, fainting, changes in appetite, muscle weakness, slower or weaker breathing, mood changes, changes in activity, changes in perception, worsening of asthma,
2. in some rare cases, a skin rash indicating an allergic reaction may develop into sudden swelling of the face and neck, difficulty breathing or a drop in blood pressure and fainting. If such symptoms occur, stop taking Doreta and see a doctor immediately. Do not take this medication again.

Rarely, people taking tramadol for some time may feel unwell if they stop taking it suddenly. However, you may experience agitation, restlessness, nervousness or shakiness, overactivity, insomnia, or gastrointestinal disturbances.

A very small number of people may experience panic attacks, hallucinations, unusual sensations like itching, tingling, numbness of the skin and ringing in the ears. If you have any of these symptoms, or any other unusual symptom, please contact your doctor or pharmacist as soon as possible.

The use of Doreta with blood thinners (e.g. phenprocoumon, warfarin) may increase the risk of bleeding. Any prolonged or unexpected bleeding should be reported to your doctor immediately.

Doreta – overdose

Doreta in its composition contains tramadol and paracetamol, therefore, as a result of an overdose, symptoms may appear:

1. only resulting from an overdose of tramadol,
2. only resulting from paracetamol overdose,
3. resulting from overdosage with tramadol and paracetamol.

Symptoms of tramadol overdose:

1. constriction of the pupil,
2. vomiting,
3. circulatory collapse,
4. disturbances of consciousness,
5. coma, convulsions,
6. respiratory depression up to and including stopping breathing.

Symptoms of paracetamol overdose:

The risk of overdosing is especially relevant for young children. Symptoms of paracetamol overdose in the first 24 hours include pallor, nausea, vomiting, anorexia and abdominal pain. Symptoms of liver damage may appear 12 to 48 hours after taking the medicine.

Glucose metabolism disorders and metabolic acidosis are also possible. In cases of severe poisoning, liver failure may lead to encephalopathy, coma and death. Acute renal failure with acute tubular necrosis can occur even in the absence of severe liver damage. There have also been reports of arrhythmias and pancreatitis.

Check also other moderate and severe pain relievers

Doreta – discontinuation of use

Please consult your doctor before stopping treatment with Doreta. Do not discontinue Doreta yourself, without the knowledge of your doctor, especially if it has been used for a long time. Your doctor will advise you when and how to stop taking this medicine, this may be a gradual reduction in the dose to reduce the likelihood of side effects (withdrawal symptoms).

If you suddenly stop taking Doreta, you may feel unwell, restlessness, agitation, nervousness, insomnia, overactivity, tremors and / or upset stomach. If you have any further questions about the use of this medicine, ask your doctor or pharmacist.