Doreta Sr

Leaflet accompanying the packaging: patient information

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

Doreta SR (Doreta Prolong), 75 mg + 650 mg, prolonged-release tablets

Tramadol hydrochloride+ Paracetamol
Doreta SR and Doreta Prolong are different trade names for the same medicine.

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.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• 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 SR and what is it used for
• 2. Important information before taking Doreta SR
• 3. How to take Doreta SR
• 4. Possible side effects
• 5. How to store Doreta SR
• 6. Contents of the packaging and other information

1. What is Doreta SR and what is it used for

Doreta SR is a combination medicine containing two painkillers: tramadol and paracetamol, which together relieve pain.
The indication for use of Doreta SR is moderate to severe pain, if the doctor considers that tramadol in combination with paracetamol in the form of prolonged-release tablets is required.
Doreta SR should only be used in adults and adolescents over 12 years of age.

2. Important information before taking Doreta SR

When not to take Doreta SR

• in acute alcohol intoxication, with sleeping pills, painkillers or other psychotropic medicines (medicines that can affect mood and emotions),
• when taking monoamine oxidase inhibitors (some medicines 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 SR, you should discuss it with your doctor or pharmacist.
Doreta SR is a prolonged-release tablet. This means that the active substances tramadol and paracetamol are released over a longer period. If the patient has previously taken other products containing a combination of tramadol and paracetamol, they should be particularly careful, as Doreta SR has a different dosing schedule (see section 3 "How to take Doreta SR").
You should be careful when taking Doreta SR:

• in patients with kidney disease,
• in patients with liver disease or liver damage, or in whom yellowing of the eyes and skin has occurred, which may indicate jaundice or bile duct disease,
• in patients with severe breathing difficulties, such as asthma or severe lung disease,
• in patients addicted to other painkillers, such as morphine,
• in patients with epilepsy, or in whom seizures or epilepsy have occurred,
• in patients with recent head injuries, in shock or with severe headache associated with vomiting,

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").
The patient should tell their doctor if they experience excessive fatigue, loss of appetite, severe abdominal pain, nausea, vomiting or low blood pressure while taking Doreta SR.
This may indicate that the patient has adrenal insufficiency (low cortisol levels). If such symptoms occur, the doctor will decide whether the patient needs hormone replacement therapy.
Respiratory disorders during sleep
Doreta SR 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 reducing the dose.
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.
The patient should stop taking the medicine and immediately contact their doctor if they experience any of the following side effects: slowed breathing or shallow breathing, confusion, drowsiness, pinpoint pupils, nausea or vomiting, constipation, or loss of appetite.

Children and adolescents

Use in children with respiratory disorders
Tramadol should not be used in children with respiratory disorders, as the symptoms of tramadol toxicity may be exacerbated in them.

Doreta SR and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

Warning: This medicine contains paracetamol and tramadol. The doctor should be informed about the use of other medicines containing paracetamol or tramadol, so that they can decide on further treatment. Other medicines containing tramadol or paracetamol can only be taken under

medical supervision.

While taking Doreta SR, the patient should not take any other medicines containing paracetamol, including those available without a prescription - for example, painkillers or antipyretics used for colds and flu, as this

increases the risk of paracetamol overdose. Paracetamol overdose can
cause liver damage, which can lead to liver transplantation or even
death.
The patient should never take a higher dose of Doreta SR than prescribed by their doctor. Higher
doses than recommended will not provide better pain relief, but will increase the risk of very
serious liver damage.Symptoms of liver damage usually appear after a few days. Therefore, it is important to seek medical help immediately if a higher dose than recommended is taken, even if the patient feels well.
Taking Doreta SR with monoamine oxidase inhibitors (MAOIs) is contraindicated(see
section "When not to take Doreta SR").
It is not recommended to take Doreta SR with 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.

Taking Doreta SR with 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). The patient should contact their doctor if they experience confusion, agitation, especially motor, fever, excessive sweating, uncontrolled movements of the limbs or eyeballs, uncontrolled muscle spasms or diarrhea.
• sedatives, sleeping pills, other painkillers such as morphine and codeine (also used to treat cough), baclofen (a muscle relaxant), antihypertensive medicines, antidepressants or antihistamines. The patient should contact their doctor if they experience drowsiness or fainting.
• medicines that can cause seizures (epileptic fits), such as certain antidepressants or antipsychotics. The risk of seizures may increase if Doreta SR is taken at the same time. The doctor will inform the patient whether Doreta SR is suitable for them.
• certain antidepressants. Doreta SR 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). The patient should immediately inform their doctor if they experience any prolonged or unexpected bleeding.
• 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 in which 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 SR may be altered if it is taken with 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 SR and 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 the doctor has prescribed Doreta SR with sedatives, the doctor should limit the dose and duration of concurrent treatment. The patient should inform their doctor about all sedatives they are taking and strictly follow the doctor's dosage recommendations. It may be helpful to inform friends or relatives to be aware of the above symptoms. If such symptoms occur, the patient should contact their doctor.

Doreta SR with food, drink and alcohol

Doreta SR can be taken with or without food.
Taking Doreta SR may cause drowsiness. Drinking alcohol may increase drowsiness, so it is best not to drink alcoholic beverages while taking Doreta SR.

Pregnancy, breastfeeding and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.

Pregnancy

Since Doreta SR is a combination medicine containing two active substances, including tramadol, it should not be taken during pregnancy.

Breastfeeding

Tramadol is excreted into breast milk. Therefore, Doreta SR should not be used more than once during breastfeeding, or if Doreta SR is taken more than once, breastfeeding should be discontinued.

Fertility

Human data do not indicate an effect of tramadol on fertility in men or women.
There are no data on the effect of the combination of tramadol and paracetamol on fertility.

Driving and using machines

Doreta SR may cause drowsiness. The patient should not drive vehicles, operate machines or perform other activities that require concentration until they know how Doreta SR affects them.

Doreta SR 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 SR

This medicine should always be taken exactly as prescribed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
The initial dose is usually one to two tablets. If necessary, further doses can be taken every 12 hours, as prescribed by the doctor.
The patient should not take more than 4 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 patient's individual sensitivity to pain. In general, the smallest effective dose that relieves pain should be used.

Severe liver disease (impairment)

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

Use in children

Doreta SR should not be used 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 whole, with a drink of water. The tablets should not be broken or chewed.
The medicine should be used for the shortest possible period.
If the patient feels that the effect of Doreta SR is too strong (i.e., severe drowsiness or breathing difficulties occur) or too weak (i.e., the pain is not sufficiently relieved), they should consult their doctor or pharmacist. If there is no improvement, the patient should contact their doctor.

Taking a higher dose of Doreta SR than recommended

In case of overdose, the patient should immediately seek medical help or
contact the designated poison control center:

• Poison Control Center - Warsaw, ul. Piłsudskiego 33, 05-074 Halinów tel. 607 218 174; fax: 22 789 97 05; e-mail: okzit@burdpi.pol.pl
• Pomeranian Toxicology Center, ul. Kartuska 4/6, 80-104 Gdańsk tel./fax (058) 682 19 39; (058) 682 57 67; e-mail: pct@pctox.pl
• Toxicology Information Center, Department of Toxicology, Franciszek Raszeja Municipal Hospital, ul. Mickiewicza 2, 60-834 Poznań tel./fax: 061- 224 52 65; e-mail: oit.poznan@op.pl
• Toxicology Information and Laboratory Analysis Laboratory, Jagiellonian University Collegium Medicum, ul. Kopernika 15, 31-501 Kraków tel./fax: 012 - 424 83 56 or 57; e-mail: oit@cm-uj.krakow.pl

The patient should take any remaining medicine, this leaflet or packaging with them.
Paracetamol overdose is potentially fatal due to irreversible liver damage. There is a serious risk of liver damage, even if the patient feels well.To avoid liver damage, the patient should seek medical help as soon as possible. The sooner the treatment is started, the higher the probability of preventing liver damage.
In case of taking a higher dose of Doreta SR than recommended, severe circulatory disorders, impaired consciousness up to coma, seizures or respiratory disorders, malaise, vomiting, weight loss or abdominal pain may also occur.

Missing a dose of Doreta SR

The patient should not take a double dose to make up for a missed dose.
If a dose is missed, the patient should take the next tablet at the usual time.

Stopping treatment with Doreta SR

If the patient has been taking Doreta SR for some time, they should consult their doctor before stopping treatment, as their body may have become accustomed to the medicine. The patient should not suddenly stop taking this medicine without their doctor's advice. If the patient wants to stop taking the medicine, they should discuss it with their doctor, especially if they have been taking it for a long time. The doctor will advise 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 treatment with Doreta SR is stopped abruptly, the patient may experience malaise. The patient may feel anxious, agitated, nervous, sleepless, overactive, trembling and (or) gastrointestinal disorders.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

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

• nausea,
• dizziness,
• drowsiness. These 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 frequency disorders,
• difficult or painful urination, 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,
• hot flashes,
• chest pain,
• involuntary muscle twitching,
• tingling and numbness,
• shortness of breath,
• elevated liver enzyme activity.

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

• drug dependence,
• seizures, coordination problems,
• blurred vision,
• pupil constriction,
• pupil dilation,
• speech disorders,
• delirium,
• transient loss of consciousness.

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 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 SR").

The following side effects have been reported by patients taking medicines containing only tramadol hydrochloride or paracetamol. If any of these side effects occur while taking Doreta SR, the patient should inform their doctor:

• feeling of fainting when standing up from a sitting or lying position, slow heartbeat, fainting, changes in appetite, decreased muscle strength, slow or shallow breathing, mood changes, changes in activity, changes in perception, worsening of asthma symptoms.
• 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, the patient should stop taking this medicine and immediately consult a doctor. The patient should not take this medicine again.

Rarely, patients taking tramadol for a period of time may experience malaise when the medicine is stopped abruptly. Patients may feel anxious, agitated, nervous or restless, sleepless, overactive, trembling 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 any of these symptoms or any other unusual symptoms occur, the patient should consult their 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 nosebleeds or bleeding gums.
Very rarely, cases of severe skin reactions have been reported after taking medicines containing paracetamol.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their 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, more information can be collected on the safety of the medicine.

5. How to store Doreta SR

The medicine should be stored out of sight and reach of children.
The patient should not take 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. The patient should ask their 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 SR contains

• The active substances of the medicine are tramadol hydrochloride and paracetamol. Each prolonged-release tablet contains 75 mg of tramadol hydrochloride, which corresponds to 65.88 mg of tramadol, and 650 mg of paracetamol.
• The other ingredients are:
• tablet core: corn starch, hypromellose 2208/100, copovidone, croscarmellose sodium, yellow iron oxide (E 172), microcrystalline cellulose, anhydrous colloidal silica and sodium stearyl fumarate;
• tablet coating: polyvinyl alcohol, macrogol 3350 and talc. See section 2 "Doreta SR contains sodium".

What Doreta SR looks like and contents of the pack

White to almost white on one side and light yellow on the other side, oval, biconvex, bilayer tablets, approximately 20 mm in length and 11 mm in width.
Packaging:10, 20 or 30 prolonged-release tablets in blisters, in a cardboard box.
For more detailed information, the patient should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in the Czech Republic, 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
Marketing authorization number in the Czech Republic, the country of export:65/575/15-C

Parallel import authorization number: 78/23

This medicine is authorized in the Member States of the European Economic Area under the following names:
Date of approval of the leaflet: 28.04.2023
[Information about the trademark]