Doreta

Package leaflet: Information for the patient

Doreta, 37.5 mg + 325 mg, oral suspension tablets
Tramadoli hydrochloridum + Paracetamolum
Please read the entire leaflet carefully before using this medicine, as it contains important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are identical.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform the doctor or pharmacist. See section 4.

Table of contents

1. What Doreta is and what it is used for
2. Important information before taking Doreta
3. How to take Doreta
4. Possible side effects
5. How to store Doreta
6. Contents of the pack and other information

1. What Doreta is and what it is used for

Doreta is a combination medicine containing two analgesic agents: tramadol and paracetamol, which together relieve pain.
Doreta is indicated for the treatment of moderate to severe pain, when the physician considers it necessary to administer tramadol in combination with paracetamol.
Doreta is intended for use in adults and adolescents over 12 years of age.

2. Important information before using Doreta

When not to use Doreta

• if the patient is allergic to tramadol hydrochloride, paracetamol, or any of the other components of this medicine (listed in section 6),
• in case of acute intoxication with alcohol, hypnotics, analgesics, or other psychotropic medicines (medicines that may affect mood and emotions),
• when taking monoamine oxidase inhibitors (MAOIs) (some medicines used in the treatment of depression or Parkinson's disease) or if they have been taken within the last 14 days before starting treatment with Doreta,
• in patients with severe liver disease,
• in patients with epilepsy that is not adequately controlled with medication.

Warnings and precautions
Before starting to take Doreta, discuss with your doctor:

• if you are taking other medicines containing tramadol or paracetamol.
• if you have liver damage or liver disease, or if you experience yellowing of the eyes or skin. This may be due to jaundice or biliary tract disease.
• if you have kidney disease.
• if you have breathing problems, such as asthma or other lung diseases.
• if you have epilepsy or a history of seizures.
• if you have depression and are taking antidepressants, as some of these may interact with tramadol (see "Doreta with other medicines").
• if you have recently suffered a head injury, shock, or severe headaches accompanied by vomiting.
• if you have a history of dependence on any drugs, including analgesics such as morphine.
• if you are taking other painkillers containing buprenorphine, nalbuphine, or pentazocine.
• if you are due to undergo anesthesia. Inform your doctor or dentist that you are taking Doreta.

During treatment with Doreta, inform your doctor immediately if:
If the patient has severe illnesses, including severe kidney dysfunction or sepsis
(when bacteria and their toxins circulate in the blood, leading to organ damage) or malnutrition,
chronic alcoholism, or if the patient is also taking flucloxacillin (an antibiotic).
Severe illness known as metabolic acidosis (an abnormality in blood and
body fluids) has been reported in patients who take paracetamol regularly over a long
period or who take paracetamol together with flucloxacillin. Symptoms of metabolic acidosis may
include: severe breathing difficulties, including rapid deep breathing, drowsiness,
nausea, and vomiting.
Tolerance, dependence, and addiction
This medicine contains tramadol, which is an opioid medicine. Repeated use of opioids may
cause the medicine to become less effective (the patient becomes accustomed to the medicine, known as
tolerance). Repeated use of Doreta may also lead to dependence, abuse, and addiction, which may result in life-threatening overdose. The risk of these
adverse effects may increase with dose and longer duration of use.
Dependence may cause the patient to lose control over the dose or frequency of medicine intake.
The risk of dependence varies among individuals. The risk of dependence on Doreta may be
higher if:

• the patient or a family member has ever abused or been dependent on alcohol, prescription medicines, or illegal drugs ("addiction");
• the patient smokes tobacco;
• the patient has ever had mood disorders (depression, anxiety, or personality disorders) or has been treated by a psychiatrist for other mental illnesses.

If any of the following symptoms occur during treatment with Doreta, this may
indicate dependence:

• the patient needs to take the medicine longer than prescribed by the doctor,
• the patient needs to take a higher dose than recommended,
• the patient uses the medicine for reasons other than prescribed, e.g., "to calm down" or "to help sleep",
• the patient has made repeated unsuccessful attempts to stop or control medicine use,
• after stopping the medicine, the patient feels unwell and feels better after taking the medicine again ("withdrawal effects").

If any of these symptoms occur, talk to your doctor to discuss the best treatment approach, including when and how to stop the medicine safely (see section 3, "Stopping Doreta").
Breathing problems during sleep
Doreta contains an active substance belonging to the opioid group. Opioids may cause
breathing problems during sleep, such as central sleep apnea (shallow or interrupted breathing
during sleep) and sleep-related hypoxemia (low oxygen levels in the blood).
The risk of central sleep apnea depends on the opioid dose. Your doctor may consider
reducing the total opioid dose if central sleep apnea occurs.
There is a small risk of developing serotonin syndrome after taking tramadol alone or in combination with certain antidepressants. If any symptoms of this serious condition occur, the patient should seek medical advice immediately (see section 4, "Possible side effects").
Tramadol is metabolized in the liver by an enzyme. Some individuals have a genetic variation of this enzyme, which may lead to different effects. In some people, pain relief may be insufficient, while in others, severe adverse effects are more likely.
Stop taking the medicine and contact your doctor immediately if any of the following adverse effects occur: slowed or shallow breathing, confusion, drowsiness, pinpoint pupils, nausea or vomiting, constipation, or loss of appetite.
If any of the above-mentioned conditions have occurred in the past or during treatment with Doreta, inform your doctor. The doctor will decide whether treatment should continue.
Children and adolescents
Use in children with breathing disorders
Tramadol is not recommended in children with breathing disorders, as symptoms of tramadol toxicity may be more pronounced in them.
Talk to your doctor if any of the following symptoms occur during treatment with Doreta: excessive fatigue, loss of appetite, severe abdominal pain, nausea, vomiting, or low blood pressure. These may indicate adrenal insufficiency (low cortisol levels). If such symptoms occur, contact your doctor, who will decide whether hormone replacement is necessary.
Doreta with other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
Warning: This medicine contains paracetamol and tramadol. Inform your doctor if you are taking
other medicines containing paracetamol or tramadol to avoid exceeding the maximum
daily dose.
Concomitant use of Doreta with monoamine oxidase inhibitors (MAOIs) is contraindicated (see section "When not to use Doreta").
Doreta should not be used simultaneously with the following medicines:

• carbamazepine (a medicine used to treat epilepsy or certain types of pain such as severe facial pain known as trigeminal neuralgia),
• buprenorphine, nalbuphine, or pentazocine (opioid painkillers). The analgesic effect may be reduced.

Inform your doctor or pharmacist if you are taking:

• flucloxacillin (an antibiotic), due to the risk of a serious blood and fluid disorder (called metabolic acidosis), which requires urgent treatment (see section 2).

The risk of adverse effects increases if the patient is taking:
triptans (medicines used to treat migraine) or selective serotonin reuptake inhibitors (SSRIs) (used to treat depression). If confusion, agitation, fever, sweating, uncoordinated limb or eye movements, involuntary muscle contractions, or diarrhea occur, contact your doctor.
other painkillers such as morphine and codeine (also used to treat cough),
baclofen (a muscle relaxant), blood pressure-lowering medicines, or antihistamines.
Contact your doctor if drowsiness or fainting occurs.
Concomitant use of Doreta with sedatives such as benzodiazepines or similar medicines increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening. Therefore, concomitant use should only be considered if other treatment options are not possible. If your doctor prescribes Doreta together with sedative medicines, the doctor should limit the dose and duration of concomitant treatment. Inform your doctor about all sedative medicines you are taking and strictly follow the doctor's dosing instructions. It may be helpful to inform friends or family members about the above-mentioned symptoms. If such symptoms occur, contact your doctor.
medicines that may cause seizures, such as certain antidepressants or antipsychotics. The risk of seizures may increase if the patient takes Doreta together with these medicines. Your doctor will advise whether Doreta is suitable for you.
certain antidepressants. Doreta may interact with these medicines and cause serotonin syndrome (see section 4, "Possible side effects").
warfarin or phenprocoumon (medicines used to thin the blood). The effect of these medicines may change, leading to bleeding. Report any prolonged or unexpected bleeding to your doctor immediately.
gabapentin or pregabalin used to treat epilepsy or nerve-related pain (neuropathic pain).
The effect of Doreta may change if taken simultaneously with:
metoclopramide, domperidone, or ondansetron (medicines used to treat nausea and/or vomiting),
cholestyramine (a medicine used to lower blood cholesterol levels).
Your doctor will decide which medicines can be safely used together with Doreta.
Doreta with food and alcohol
Doreta may cause drowsiness. Alcohol intensifies drowsiness. Do not drink alcohol while taking Doreta.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a child, consult your doctor or pharmacist before using this medicine.
Because Doreta contains tramadol, do not take this medicine during pregnancy or
breastfeeding. If you become pregnant while taking Doreta, consult your doctor before taking further tablets.
Breastfeeding
Tramadol is excreted in breast milk. Therefore, Doreta should not be used more than once during breastfeeding, or if Doreta is taken more than once, breastfeeding should be discontinued.
Fertility
Based on human experience with tramadol, it is suggested that tramadol does not affect fertility in men and women. There are no available data on the effect on fertility of combined treatment with tramadol and paracetamol.
Before taking any medicine, consult your doctor or pharmacist.
Driving and operating machinery
Doreta may cause drowsiness, which may affect the ability to drive and operate machinery.
Doreta contains sucrose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should
consult a doctor before taking the medicine.

3. How to use Doreta

This medicine should always be used as directed by a doctor. If in doubt, consult a doctor or pharmacist.
Before starting treatment and regularly during treatment, the doctor will discuss with the patient what effects to expect from using Doreta, when and for how long it should be taken, when to contact the doctor, and when it should be discontinued (see also section 2).
Doreta should be used for the shortest duration possible.
Do not use this medicine in children under 12 years of age.
The dose should be adjusted according to the intensity of pain and the individual patient's response to treatment.
Use the lowest effective dose that controls the pain.
Unless otherwise directed by a doctor, the recommended dose of Doreta is 2 tablets for adults and adolescents aged 12 years and older.
If needed, the doctor may recommend taking additional doses. Do not take subsequent doses more frequently than every 6 hours.
Do not take more than 8 tablets of Doreta per day.
Do not take Doreta more often than prescribed by a doctor.

Elderly patients
In patients over 75 years of age, elimination of tramadol from the body may be delayed. In these patients, the doctor may recommend extending the time interval between doses.

Patients with renal impairment, those undergoing dialysis, or with hepatic impairment
Do not take Doreta in cases of severe hepatic and/or renal impairment.
In cases of mild or moderate impairment, the doctor may recommend increasing the time interval between doses.

Method of administration
The tablet for oral suspension should be dissolved in a glass of drinking water, stirred with a teaspoon, and the resulting suspension should be drunk. Alternatively, the tablet may be swallowed whole with sufficient liquid.
If the effect of Doreta seems too strong (e.g. drowsiness or breathing difficulties occur) or too weak (e.g. inadequate pain relief), consult a doctor.

Taking more than the recommended dose of Doreta
If more than the recommended dose is taken, even if feeling well, seek immediate advice from a doctor or pharmacist. There is a risk of liver damage, the symptoms of which may appear later.

Missed dose of Doreta
If a dose is missed, pain may return. Do not take a double dose to make up for the missed dose; continue treatment according to the prescribed schedule.

Stopping Doreta
Do not suddenly stop using this medicine without medical advice. If the patient wishes to discontinue treatment, this should be discussed with the doctor, especially if the medicine has been taken long-term.
The doctor will advise when and how to stop taking Doreta; this may involve gradually reducing the dose to minimize the likelihood of adverse effects (withdrawal symptoms).

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Very common (may occur in more than 1 out of 10 patients):

• nausea,
• dizziness, drowsiness.

Common (may occur in up to 1 out of 10 patients):

• vomiting, digestive disorders (constipation, bloating, diarrhoea), stomach pain, dry mouth,
• itching, excessive sweating,
• headache, tremor,
• confusion, sleep disturbances, mood changes (anxiety, nervousness, pathological euphoria).

Uncommon (may occur in up to 1 out of 100 patients):

• increased heart rate or arterial blood pressure, disturbances in heart rate or rhythm,
• tingling, numbness or pins and needles sensation in the limbs, tinnitus, involuntary muscle twitching,
• depression, nightmares, hallucinations (hearing, seeing or feeling things that are not real), memory lapses,
• difficulty breathing,
• difficulty swallowing, blood in stool (black, tarry stools),
• skin reactions (e.g. rash, urticaria),
• increased liver enzyme values,
• presence of albumin in urine, difficulty urinating or pain,
• chills, hot flushes, chest pain.

Rare (may occur in up to 1 out of 1000 patients):

• seizures, difficulty maintaining coordinated movements, brief loss of consciousness (fainting),
• drug dependence,
• delirium,
• blurred vision, pinpoint pupils,
• speech disorders,
• excessive dilation of the pupils.

Very rare (may occur in up to 1 out of 10,000 patients):

• drug abuse.

Frequency not known (frequency cannot be estimated from the available data):

• decreased blood sugar concentration.

The following adverse effects have been reported by patients using medicines containing tramadol or paracetamol alone. However, if any of these adverse effects occur during treatment with Doreta, you should inform your doctor:

• feeling faint when standing up from a sitting or lying position, slow heartbeat, fainting, changes in appetite, reduced muscle strength, slower or shallower breathing, mood changes, changes in activity, changes in perception, worsening of asthma.
• taking paracetamol alone or in combination with the antibiotic flucloxacillin may cause blood and body fluid disorders (metabolic acidosis with a high anion gap) when there is increased blood plasma acidity.
• using Doreta together with anticoagulant medicines (e.g. phenprocoumon, warfarin) may increase the risk of bleeding. Any prolonged or unexpected bleeding should be reported to your doctor immediately.
• in some rare cases, a skin rash indicating an allergic reaction may develop into sudden swelling of the face and neck, breathing difficulties, or a drop in blood pressure and fainting; if such symptoms occur, stop taking this medicine and seek medical help immediately. Do not take this medicine again.

Rarely, patients who have been taking tramadol for some time may experience withdrawal symptoms upon abrupt discontinuation of the medicine.
Patients may experience restlessness, anxiety, nervousness or tremor, hyperactivity, insomnia or gastrointestinal disturbances. In a very small number of patients, panic attacks, hallucinations, unusual sensations such as itching, tingling, numbness of the skin and tinnitus may occur. If any of these symptoms or any other unusual symptoms occur, consult your doctor or pharmacist as quickly as possible.
Frequency not known: hiccups.
Serotonin syndrome, which may present with changes in mental status (e.g. agitation, hallucinations, coma), as well as other symptoms such as fever, rapid heartbeat, unstable blood pressure, involuntary muscle contractions, muscle rigidity, lack of coordination, and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhoea) (see section 2 "Important information before taking Doreta").

In exceptional cases, blood tests may reveal certain abnormalities, such as a low platelet count, which may lead to nosebleeds or bleeding gums.
Very rarely, severe skin reactions have been reported following administration of medicines containing paracetamol.
Rarely, respiratory depression has been reported following administration of medicines containing tramadol.
Frequency not known: A serious condition that may cause the blood to become more acidic (so-called metabolic acidosis) in patients with severe disease who are taking paracetamol (see section 2).

Reporting of adverse reactions
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Doreta

Keep this medicine out of sight and reach of children.
This medicine should be stored in a safe place inaccessible to others. It may cause serious harm or be fatal to individuals for whom it has not been prescribed.
Do not use this medicine after the expiry date stated on the blister and carton after: EXP.
The expiry date refers to the last day of the stated month.
There are no special storage instructions for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Doreta contains

• The active substances are tramadol hydrochloride and paracetamol. Each oral suspension tablet contains 37.5 mg of tramadol hydrochloride and 325 mg of paracetamol.
• The other components (excipients) are pregelatinized starch (corn), crospovidone (type A), microcrystalline cellulose, sucralose, magnesium stearate and orange flavour (containing sucrose, acacia gum, maltodextrin and natural orange flavouring substance). See section 2 “Doreta contains sucrose”.

What Doreta looks like and contents of the pack
White or almost white, round, biconvex tablets. Tablet size: approx. 13 mm.
Doreta is available in packs containing 10 or 30 oral suspension tablets in blisters within a cardboard box.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
This medicinal product is authorised in the European Economic Area under the following names:

For more detailed information about this medicinal product, please contact the local representative of the marketing authorisation holder:
Krka - Polska Sp. z o.o.
Równoległa 5 Street
02-235 Warsaw
telephone: +48 22 573 75 00