Doreta

LEAFLET INCLUDED IN THE PACKAGING: PATIENT INFORMATION

Warning! Keep the leaflet, the information on the immediate packaging is 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 taking 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.
• If you have 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 you experience any side effects, including any not listed in this leaflet, you should tell your 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 pack 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 the 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:

• if you are allergic to paracetamol, tramadol or any of the other ingredients of this medicine (listed in section 6),
• in case of acute alcohol intoxication, sleeping pills, painkillers or other psychotropic drugs (used to treat mental disorders),
• in case of concurrent use of MAO inhibitors (certain drugs used to treat depression or Parkinson's disease) and for 14 days after their withdrawal,
• 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, you should discuss it with your doctor or pharmacist.
You should be particularly careful when taking Doreta:

• in patients with kidney disease,
• in patients with liver disease or alcoholic liver damage or in whom yellowing of the eyes and skin has occurred, which may indicate jaundice or bile duct disease,
• in patients with breathing difficulties, such as asthma or lung problems,
• in patients who are dependent on other drugs used to relieve moderate and severe pain, such as morphine,
• in patients with epilepsy or who have had seizures or epileptic seizures,
• in patients with head injuries, in shock or with severe headache, with or without vomiting,
• if you are taking other medicines that contain paracetamol or tramadol,
• if you are taking other painkillers that contain buprenorphine, nalbuphine or pentazocine,
• if you are to be given anesthesia. You should inform your doctor or dentist that you are taking Doreta.
• if you have depression and are taking antidepressants, as some of them may interact with tramadol (see "Doreta and other medicines").

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.
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").
Breathing disorders during sleep
Doreta may cause breathing 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.
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, it is more likely to experience severe side effects.
You should stop taking the medicine and immediately contact your doctor if you experience any of the following side effects: slow breathing or shallow breathing, confusion, drowsiness, pinpoint pupils, nausea, or vomiting, constipation, loss of appetite.

Children and adolescents

Use in children with breathing disorders.
Tramadol is not recommended for use in children with breathing 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 the 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 that contain 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, as it may affect their proper functioning:

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

Taking Doreta at the same time as the following medicines may increase the risk of side effects:

• 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 contractions, or diarrhea.
• sedatives, sleeping pills, other painkillers such as morphine and codeine (also used to treat cough), baclofen (a muscle relaxant), antihypertensive drugs, antidepressants, or antihistamines. You should contact your doctor if you experience drowsiness or fainting.
• medicines that can cause seizures (fits), such as certain antidepressants, antipsychotics, anesthetics, mood stabilizers, or bupropion (a medicine used to quit smoking). The risk of seizures may increase if you take Doreta at the same time as these medicines. Your doctor will inform you 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, and bleeding may occur (see section 4). You should immediately report any prolonged or unexpected bleeding to your doctor.
• flucloxacillin (an antibiotic), due to the serious risk of a blood and fluid disorder (metabolic acidosis with a large anion gap), which requires emergency treatment and may occur especially in patients with severe kidney dysfunction, 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.

The effect of Doreta may change if it is taken at the same time as the following medicines:

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

Taking Doreta at the same time as sedatives, such as benzodiazepines or similar medicines, increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and can be life-threatening. Therefore, concurrent use should only be considered when other treatment options are not possible.
If your doctor has prescribed Doreta with sedatives, your doctor should limit the dose and duration of concurrent treatment.
You should inform your doctor about all sedatives you are taking and strictly follow your doctor's dosage recommendations. It may be helpful to inform your friends or relatives to be aware of the above symptoms. If such symptoms occur, you should contact your doctor.

Doreta with food, drink, and alcohol

Doreta can be taken with or without food.
Taking Doreta may cause drowsiness. Drinking alcohol may increase drowsiness. Alcohol: enhances the sedative effect of opioid painkillers, which can affect concentration and make driving or operating machinery dangerous; you should avoid drinking alcoholic beverages and taking medicines that contain alcohol.

• Taking Doreta may cause drowsiness. Drinking alcohol may increase drowsiness.

Do not drink alcoholic beverages or take medicines that contain alcohol.

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.
Pregnancy
Since Doreta is a combination of two active substances, including tramadol, it should not be taken during pregnancy.
Breastfeeding
Tramadol is excreted into 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 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 on fertility of combination treatment with tramadol and paracetamol.

Driving and using machines

You should not drive vehicles, operate machinery, or perform other activities that require concentration until you know how Doreta affects you.
Doreta may cause drowsiness.

Doreta contains sodium

This medicinal product 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 exactly as your doctor has told you. If you are not sure, you should ask your doctor or pharmacist.
The initial dose is usually two tablets. If necessary, further doses can be taken every six hours, as directed by your doctor.
You should not take more than 8 tablets per day (which corresponds to 300 mg of tramadol hydrochloride and 2600 mg of paracetamol).
The dose of the medicine should be adjusted according to the severity of the pain and the individual patient's sensitivity to pain. In general, you should take the smallest effective dose that relieves the pain.

Severe liver disease (impairment)

Patient with severe liver impairment should not take Doreta.
In patients with mild or moderate liver impairment, the doctor may increase the intervals between doses.

Use in children

Doreta is not recommended for use in children under 12 years of age.

Elderly patients

In elderly patients (over 75 years of age), the elimination of tramadol may be delayed. The doctor may increase the intervals between doses.

Method of administration

The tablets should be swallowed with a drink of water. The tablets should not be crushed or chewed.
The medicine should be taken for the shortest possible period.
If you feel that the effect of Doreta is too strong (i.e., you experience drowsiness or breathing difficulties) or too weak (i.e., insufficient pain relief), you should consult your doctor or pharmacist. If there is no improvement, you should contact your doctor.

Taking a higher dose of Doreta than recommended

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 breathing disorders, malaise, vomiting, weight loss, or abdominal pain may occur.

Missing a dose of Doreta

You should not take a double dose to make up for a missed dose.
If you miss a dose of Doreta, you should take the next tablet at the usual time.

Stopping treatment with Doreta

If you have been taking Doreta for a while, you should consult your doctor before stopping treatment, as your body may have become accustomed to the medicine. You should not suddenly stop taking this medicine without your doctor's advice. If you want to stop taking Doreta, you should discuss it with your doctor, especially if you have been taking it for a long time. Your 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). If you suddenly stop taking Doreta, you may experience malaise. You may feel anxious, agitated, nervous, sleepless, overactive, trembling, and (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 side effects (may affect more than 1 in 10 people):

• nausea,
• dizziness,
• drowsiness. The above symptoms are usually mild and not very troublesome.

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

• vomiting,
• digestive disorders (constipation, bloating, diarrhea),
• abdominal pain,
• dry mouth,
• headache,
• tremor,
• disorientation,
• sleep disorders,
• mood changes (anxiety, nervousness, euphoria - a constant feeling of elevated mood),
• increased sweating,
• itching.

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

• high blood pressure, heart rhythm and rate disorders,
• difficult or painful urination, presence of protein in the urine,
• skin reactions (hives, rashes),
• ringing in the ears,
• depression,
• nightmares,
• hallucinations (hearing, seeing, or feeling things that do not exist in reality),
• memory loss,
• difficulty swallowing,
• blood in the stool,
• chills,
• flushing,
• chest pain,
• involuntary muscle twitching,
• feeling of tingling and numbness,
• shortness of breath,
• increased liver enzyme activity.

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

• drug dependence,
• seizures, coordination problems,
• blurred vision,
• delirium (confusion and altered level of consciousness),
• transient loss of consciousness,
• pupil constriction,
• speech disorders,
• pupil dilation.

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

• drug abuse.

Side effects with unknown frequency (frequency cannot be estimated from available data):

• decreased blood sugar levels,
• hiccups,
• serotonin syndrome, the symptoms of which may include changes in mental status (e.g., agitation, hallucinations, coma), as well as other symptoms, such as fever, rapid heart rate, 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").

The following side effects have been reported by patients taking medicines that contain only tramadol hydrochloride 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 heart rate, fainting, changes in appetite, decreased muscle strength, slow or shallow breathing, mood changes, changes in activity, changes in perception, worsening of asthma.
• 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 who have been taking tramadol for a period of time, a feeling of malaise may occur when the medicine is suddenly stopped. Patients may experience agitation, anxiety, nervousness, or tremors, excessive activity, sleeplessness, or gastrointestinal disorders. In a very small number of patients, panic attacks, hallucinations, unusual sensations such as itching, tingling, or 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.
In exceptional cases, blood tests may reveal certain disorders, such as a low platelet count, which can cause bleeding from the nose or gums.
Very rarely, cases of severe skin reactions have been reported after taking medicines that contain paracetamol.
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.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C
02-222 Warsaw
phone: +48 22 49 21 301
fax: +48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
By reporting side effects, you can help provide 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 stated.
There are no special storage precautions.
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 pack 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.
• The other ingredients are:
• tablet core:corn starch, maize starch, sodium carboxymethylcellulose (type A), microcrystalline cellulose (Avicel PH 102), magnesium stearate;
• tablet coating: hypromellose, titanium dioxide (E 171), macrogol 400, yellow iron oxide (E 172), polysorbate 80. See section 2 "Doreta contains sodium".

What Doreta looks like and contents of the pack

The coated tablets are yellow-brown, oval, and slightly convex on both sides.
Packaging: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 the 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:

Medezin Sp. z o.o.
Zbąszyńska Street 3
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
Zbąszyńska Street 3
91-342 Łódź
CEFEA Sp. z o.o. Sp. komandytowa
Działkowa Street 56
02-234 Warsaw
SHIRAZ PRODUCTIONS Sp. z o.o.
Tymiankowa Street 24/28
95-054 Ksawerów
Marketing authorization number in Romania, the country of export: 6991/2014/04
6991/2014/02
6991/2014/03
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: 326/18

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 approval of the leaflet: 27.09.2023

[Information about the trademark]