Doreta

Leaflet accompanying the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Doreta, 37.5 mg + 325 mg, coated tablets

Tramadol hydrochloride+ Paracetamol

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Doreta and what is it 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 packaging and other information

1. What is Doreta and what is it used for

Doreta is a combination medicine that contains two painkillers: tramadol and paracetamol, which together relieve pain.
The indication for use of Doreta is moderate to severe pain, if the doctor considers that tramadol in combination with paracetamol is required.
Doreta is intended for use in adults and adolescents over 12 years of age.

2. Important information before taking Doreta

When not to take Doreta

Warnings and precautions

Before starting to take Doreta, you should discuss it with your doctor:

You should talk to your doctor if you experience any of the following symptoms while taking Doreta: excessive fatigue, loss of appetite, severe abdominal pain, nausea, vomiting or low blood pressure. This may indicate that the patient has adrenal insufficiency (low cortisol levels). If such symptoms occur, you should contact your doctor, who will decide whether the patient needs hormone replacement.
Respiratory disorders during sleep
Doreta may cause respiratory disorders during sleep, such as sleep apnea (pauses in breathing during sleep) and sleep-related hypoxemia (low oxygen levels in the blood). Symptoms may include pauses in breathing during sleep, nighttime awakenings due to shortness of breath, difficulty maintaining sleep or excessive daytime sleepiness. If the patient or another person observes these symptoms, they should contact their doctor. The doctor may recommend a dose reduction.
Serotonin syndrome
After taking tramadol in combination with certain antidepressants or tramadol alone, there is a small risk of so-called serotonin syndrome. If the patient experiences any symptoms of this syndrome with a severe course, they should immediately consult a doctor (see section 4 "Possible side effects").
Tramadol is converted in the liver by an enzyme. In some people, there is a certain variation of this enzyme, which can have different effects. In some people, pain relief may not be sufficient, and in others, the risk of severe side effects may be higher.
You should stop taking the medicine and immediately contact your doctor if you experience any of the following side effects: slowed breathing or shallow breathing, feeling of confusion, drowsiness, pinpoint pupils, nausea or vomiting, constipation, loss of appetite.
If any of the above situations have occurred to the patient in the past or have occurred while taking Doreta, they should inform their doctor about it. The doctor will decide whether to continue taking the medicine.

Children and adolescents

Use in children with respiratory disorders
Tramadol is not recommended for use in children with respiratory disorders, as the symptoms of tramadol toxicity may be exacerbated in them.

Doreta and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.

Warning: This medicine contains paracetamol and tramadol. You should inform your doctor about taking other medicines containing paracetamol or tramadol to avoid exceeding the maximum daily dose.

Taking Doreta with monoamine oxidase inhibitors (MAOIs) is contraindicated(see section "When not to take Doreta").
It is not recommended to take Doreta at the same time as the following medicines:

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

The risk of side effects increases if the patient takes:

• triptans (medicines used to treat migraines) or selective serotonin reuptake inhibitors (SSRIs, medicines used to treat depression). You should contact your doctor if you experience disorientation, anxiety, especially motor anxiety, fever, excessive sweating, uncontrolled movements of the limbs or eyeballs, uncontrolled muscle spasms or diarrhea.
• other painkillers, such as morphine and codeine (also used to treat cough), baclofen (a muscle relaxant), antihypertensive drugs, or antihistamines. You should contact your doctor if you experience drowsiness or fainting.
• sedatives, sleeping pills.
• medicines that can cause seizures (convulsions), such as certain antidepressants or antipsychotics, anesthetics, mood-altering drugs, or bupropion (a medicine used to quit smoking). The risk of seizures may increase if the patient takes Doreta at the same time as these medicines. The doctor will inform the patient whether Doreta is suitable for them.
• 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, and bleeding may occur (see section 4). Any prolonged or unexpected bleeding should be reported to the doctor immediately.
• flucloxacillin (an antibiotic), due to the serious risk of a blood and body fluid disorder (metabolic acidosis with a large anion gap), which requires emergency treatment and may occur especially in patients with severe kidney function disorders, sepsis (a condition where bacteria and their toxins circulate in the blood, leading to organ damage), malnutrition, chronic alcoholism, as well as in patients taking maximum daily doses of paracetamol.

Taking Doreta at the same time as sedatives, such as benzodiazepines or related drugs, increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and can be life-threatening. Therefore, concurrent use of these medicines should only be considered when other treatment options are not possible. If the doctor has prescribed Doreta together with sedatives, the attending doctor should limit the dose and duration of concurrent treatment. You should inform your doctor about all sedatives you are taking and strictly follow the doctor's dosage recommendations. It may be helpful to inform friends or relatives to be aware of the possibility of these subjective and objective symptoms. In case of such symptoms, you should contact your doctor.
The effect of Doreta may change if it is taken at the same time as:

• metoclopramide, domperidone or ondansetron (medicines used to treat nausea and vomiting),
• cholestyramine (a medicine used to lower blood cholesterol levels).

The doctor will decide which medicines can be safely taken at the same time as Doreta.

Doreta with food and alcohol

Doreta may cause drowsiness. Alcohol increases the feeling of drowsiness. You should not drink alcohol while taking Doreta.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before taking this medicine.

Since Doreta contains tramadol, you should not take this medicine during pregnancy or breastfeeding. If you become pregnant while being treated with Doreta, you should consult your doctor before taking any more tablets.

Breastfeeding
Tramadol is excreted into breast milk. Therefore, Doreta should not be used more than once during breastfeeding or, if Doreta is used more than once, breastfeeding should be stopped.
Fertility
Based on the use of tramadol in humans, it is suggested that tramadol does not affect fertility in women and men. There is no available data on the effect of combined tramadol and paracetamol treatment on fertility.
You should consult your doctor or pharmacist before taking any medicine.

Driving and using machines

Doreta may cause drowsiness, which may affect your ability to drive and use machines.

Doreta contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per dose, which means that the medicine is considered "sodium-free".

3. How to take Doreta

This medicine should always be taken according to the doctor's recommendations. In case of doubts, you should consult a doctor or pharmacist.
Doreta should be used for the shortest possible time.
The medicine should not be used in children under 12 years of age.
The dose should be adjusted according to the severity of the pain and the individual patient's response to treatment.
You should take the smallest dose that effectively relieves the pain.
If the doctor has not recommended otherwise, the recommended dose of Doreta is 2 tablets for adults and adolescents over 12 years of age.
If necessary, the doctor may recommend taking additional doses. Additional doses should not be taken more frequently than every 6 hours.

Do not take more than 8 tablets per day.

Do not take Doreta more frequently than recommended by your doctor.

Elderly patients

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

Patients with renal or hepatic impairment, dialysis patients

Doreta should not be taken in case of severe liver or kidney impairment.
In case of mild or moderate impairment, the doctor may recommend prolonging the time intervals between doses.

Method of administration

Tablets should be taken orally.
Tablets should be taken whole, with a liquid. They should not be broken or chewed.
If you feel that the effect of Doreta is too strong (i.e., drowsiness or breathing problems occur) or too weak (i.e., insufficient pain relief), you should consult your doctor. If there is no improvement, you should contact your doctor.

Taking a higher dose of Doreta than recommended

In case of taking a higher dose of Doreta than recommended, even if you feel well, you should immediately consult a doctor or pharmacist. There is a risk of liver damage, the symptoms of which may occur later.
In case of overdose, you should immediately consult a doctor, even if you feel well, as there is a risk of delayed, severe liver damage.
In case of taking a higher dose of Doreta than recommended, severe circulatory disorders, disorders of consciousness up to coma, seizures or respiratory disorders, malaise, vomiting, weight loss, or abdominal pain may occur.

Missing a dose of Doreta

In case of missing a dose, the pain may return. You should not take a double dose to make up for the missed dose, but continue taking the medicine according to the established schedule.

Stopping treatment with Doreta

You should not suddenly stop taking this medicine without your doctor's recommendation. If you want to stop taking the medicine, you should discuss it with your doctor, especially if you have been taking it for a long time.
The doctor will advise you when and how to stop taking the medicine; this may involve gradually reducing the dose to minimize the risk of side effects (withdrawal symptoms). In case of sudden cessation of Doreta, you may experience malaise. You may feel anxious, agitated, nervous, or restless, have insomnia or gastrointestinal disorders.
If you have any further doubts about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Doreta can cause side effects, although not everybody gets them.
Very common (may affect more than 1 in 10 people):

• nausea,
• dizziness, drowsiness.

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

• vomiting, digestive disorders (constipation, bloating, diarrhea), stomach pain, dry mouth,
• itching, excessive sweating,
• headache, tremors,
• confusion, sleep disorders, mood changes (anxiety, nervousness, abnormal feeling of happiness).

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

• increased heart rate or blood pressure, disorders of heart rate or rhythm,
• tingling, numbness or prickling sensation in the limbs, ringing in the ears, involuntary muscle twitching,
• depression, nightmares, hallucinations (hearing, seeing or feeling things that are not really there), memory lapses,
• breathing difficulties,
• difficulty swallowing, blood in the stool (black stool),
• skin reactions (e.g., rash, hives),
• increased liver enzyme values,
• presence of albumin in the urine, difficulty urinating or pain,
• chills, hot flashes, chest pain.

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

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

Very rare (may affect up to 1 in 10,000 people):

• drug abuse.

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

• decreased blood sugar levels,

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

• feeling of fainting when standing up from a sitting or lying position, slow heartbeat, fainting, changes in appetite, weakness, slow or shallow breathing, changes in mood, changes in activity, changes in perception, worsening of asthma.
• taking Doreta with blood-thinning medicines (e.g., phenprocoumon, warfarin) may increase the risk of bleeding. You should immediately report any prolonged or unexpected bleeding to your doctor.
• 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, you should stop taking this medicine and immediately consult a doctor. You should not take this medicine again.

Rarely, in patients taking tramadol for a period of time, a feeling of malaise may occur in case of sudden withdrawal of the medicine.
Patients may experience anxiety, agitation, nervousness, or restlessness, excessive activity, insomnia, or gastrointestinal disorders. In a very small number of patients, panic attacks, hallucinations, unusual sensations such as itching, tingling, numbness of the skin, and ringing in the ears may occur. If you experience any of these symptoms or any other unusual symptoms, you should consult your doctor or pharmacist as soon as possible.
Frequency not known: hiccups
Serotonin syndrome, the symptoms of which may include changes in mental state (e.g., agitation, hallucinations, coma), as well as other symptoms, such as fever, rapid heartbeat, unstable blood pressure, involuntary muscle contractions, muscle stiffness, lack of coordination, and (or) gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea) (see section 2 "Important information before taking Doreta").
In exceptional cases, blood tests may show certain disorders, such as a low platelet count, which can cause nosebleeds or bleeding gums.
Very rarely, cases of severe skin reactions have been reported after taking medicines containing paracetamol.
Rarely, cases of respiratory depression have been reported after taking medicines containing tramadol.

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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.
By reporting side effects, you can help gather more information on the safety of this medicine.

5. How to store Doreta

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
There are no special precautions for storage.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Doreta contains

• The active substances of Doreta are tramadol hydrochloride and paracetamol. Each coated tablet contains 37.5 mg of tramadol hydrochloride, which corresponds to 32.94 mg of tramadol, and 325 mg of paracetamol.
• Other ingredients are: tablet core:corn starch, maize starch, sodium carboxymethyl cellulose (type A), microcrystalline cellulose (E 460), and magnesium stearate (E 470b) tablet coating: hypromellose (E 464), titanium dioxide (E 171), macrogol 400, yellow iron oxide (E 172), and polysorbate 80. See section 2 "Doreta contains sodium".

What Doreta looks like and contents of the packaging

The coated tablets are yellow-brown, oval, and slightly convex on both sides.
Packaging:10, 20, 30, 60, or 90 coated tablets in blisters in a cardboard box
To obtain more detailed information, you should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Romania, the country of export:

KRKA, d.d., Novo mesto
Šmarješka cesta 6
8501 Novo mesto
Slovenia

Manufacturer:

KRKA, d.d., Novo mesto
Šmarješka cesta 6
8501 Novo mesto
Slovenia
TAD Pharma GmbH
Heinz-Lohmann-Straße 5
27472 Cuxhaven
Germany

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
Marketing authorization number in Romania, the country of export:6991/2014/02
6991/2014/03
6991/2014/04
6991/2014/05
6991/2014/06
6991/2014/07
6991/2014/08
6991/2014/09
6991/2014/10
6991/2014/11
Parallel import authorization number:373/18

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Date of leaflet approval: 18.12.2023

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