Doreta Sr

Leaflet accompanying the packaging: patient information

Doreta SR, 75 mg + 650 mg, prolonged-release 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.
• 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.
• 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 using Doreta SR
• 3. How to use 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 using Doreta SR is moderate to severe pain, if the doctor considers that tramadol should be administered in combination with paracetamol in the form of prolonged-release tablets.
Doreta SR should only be used in adults and adolescents over 12 years of age.

2. Important information before using Doreta SR

When not to use Doreta SR

• if the patient is allergic to paracetamol, tramadol or any of the other ingredients of this medicine (listed in section 6),
• in acute alcohol intoxication, sedatives, painkillers or other psychotropic drugs (drugs that can affect mood and emotions),
• when using monoamine oxidase inhibitors (MAOIs) (some 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 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 use Doreta SR").
Caution should be exercised when using 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 epileptic seizures have occurred,
• in patients with recent head injuries, in shock or with severe headache associated with vomiting,
• if the patient is taking other medicines containing paracetamol or tramadol,
• if the patient is taking other painkillers containing buprenorphine, nalbuphine or pentazocine,
• if the patient is to be anaesthetized. The doctor or dentist should be informed about the use of Doreta SR.
• if the patient has depression and is taking antidepressants, as some of them may interact with tramadol (see "Doreta SR and other medicines").

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").
Tolerance, dependence and addiction
This medicine contains tramadol, which is an opioid medicine. Repeated use of opioids can make the medicine less effective (the patient gets used to the medicine, which is called tolerance). Repeated use of Doreta SR can also lead to the development of dependence, abuse and addiction, which can result in life-threatening overdose.
The risk of these side effects may increase with the dose and longer duration of use.
Dependence can make it difficult for the patient to control the dose they should take or how often they take it.
The risk of dependence varies from person to person. The risk of dependence on Doreta SR may be higher if:

• the patient or someone in their family has ever abused or been dependent on alcohol, prescription drugs or illegal drugs ("addiction");
• the patient smokes;
• 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 while taking Doreta SR, it may indicate dependence:

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

If the patient experiences any of these symptoms, they should talk to their doctor to discuss the best course of treatment, including when to stop the medicine and how to do it safely (see section 3 "Stopping Doreta SR").
Sleep apnea
Doreta SR contains an active substance belonging to the opioid group. Opioids can cause sleep apnea, such as central sleep apnea (shallow/broken breathing during sleep) and sleep-related hypoxemia (low oxygen levels in the blood).
The risk of central sleep apnea depends on the opioid dose. The doctor may consider reducing the total opioid dose if the patient has experienced central sleep apnea.
Tramadol is converted in the liver by an enzyme. In some people, there is a certain variant of this enzyme, which can have different effects. In some people, pain relief may not be sufficient, and in others, serious side effects are more likely to occur.
The use of Doreta SR should be stopped and the doctor should be contacted immediately if the patient experiences any of the following side effects: slow 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.
The doctor should be told if, while taking Doreta SR, the patient experiences 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, the doctor will decide whether the patient needs hormone replacement therapy.

Doreta SR and other medicines

The doctor or pharmacist should be told about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.

Note: 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, you 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.
Never take a higher dose of Doreta SR than prescribed by your 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 as soon as possible if too much of the medicine has been taken, even if the patient feels well.
Using Doreta SR with monoamine oxidase inhibitors (MAOIs) is contraindicated(see section "When not to use Doreta SR").
It is not recommended to use Doreta SR 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 doctor or pharmacist should be told if the patient is taking:

• 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 disorders, 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 the maximum daily dose of paracetamol, especially if the patient takes the maximum daily dose of paracetamol for a long time. Metabolic acidosis with a large anion gap is a serious disease that requires emergency treatment.
• gabapentin or pregabalin for the treatment of epilepsy or nerve pain (neuropathic pain).

Using Doreta SR 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). The doctor should be consulted if symptoms such as disorientation, anxiety, especially motor anxiety, fever, excessive sweating, uncontrolled movements of the limbs or eyeballs, uncontrolled muscle spasms or diarrhea occur.
• sedatives, sleeping pills, other painkillers such as morphine and codeine (also used to treat cough), baclofen (a muscle relaxant), antihypertensive drugs, antidepressants or antihistamines. The doctor should be consulted if drowsiness or fainting occurs. Concomitant use of Doreta SR and sedatives, such as benzodiazepines or similar drugs, increases the risk of drowsiness, breathing difficulties (respiratory depression), coma and can be life-threatening. For this reason, concomitant use should only be considered if other treatment options are not possible. However, if the doctor has prescribed Doreta SR together with sedatives, the doctor should limit the dose and duration of concomitant treatment. The patient should inform the 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 doctor should be consulted.
• medicines that can cause seizures (epileptic seizures), such as some antidepressants or antipsychotics. The risk of seizures may increase if Doreta SR is taken concomitantly. 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. The doctor should be informed immediately if any prolonged or unexpected bleeding occurs.

The effect of Doreta SR may change if it is used 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 blood cholesterol levels).

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 using 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 stopped.

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

Doreta SR 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 use Doreta SR

This medicine should always be used as directed by the doctor. If you have any doubts, you should consult a doctor or pharmacist.
Before starting treatment and regularly during treatment, the doctor will discuss with the patient what to expect from using Doreta SR, when and for how long to take it, when to contact the doctor and when to stop it (see also section 2).
The initial dose is usually one to two tablets. If necessary, further doses can be taken every 12 hours, as directed by the doctor.
No more than 4 tablets should be taken 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 (failure)

Patients with severe liver failure should not take Doreta SR.
In patients with mild or moderate liver failure, 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 consult their doctor.

Taking a higher dose of Doreta SR than recommended

In case of overdose , medical help should be sought immediately or
contact should be made with the locally designated centre(s):

• -Poison Control Centre – Warsaw, ul. Piłsudskiego 33, 05-074 Halinów tel. 607 218 174; fax: 22 789 97 05; e-mail: okzit@burdpi.pol.pl
• -Pomeranian Toxicology Centre, ul. Kartuska 4/6, 80-104 Gdańsk tel./fax (058) 682 19 39; (058) 682 57 67; e-mail: pct@pctox.pl
• -Toxicology Information Centre, Department of Toxicology, Dr. Wanda Błeńska 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.
Overdose of paracetamol 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, medical help should be sought as soon as possible.
The sooner the treatment is started after the overdose, the greater the chance of preventing liver damage.
If a higher dose of Doreta SR than recommended is taken, serious circulatory disorders, impaired consciousness up to coma, seizures or respiratory disorders, malaise, vomiting, loss of appetite or abdominal pain may also occur.

Missing a dose of Doreta SR

A double dose should not be taken to make up for a missed dose.
If a dose of Doreta SR is missed, the next tablet should be taken at the usual time.

Stopping 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. Doreta SR should not be stopped abruptly without the doctor's advice. If the patient wants to stop taking the medicine, they should discuss it with their doctor, especially if the medicine has been taken for a long time. The doctor will advise when and how to stop taking the medicine; this may involve gradually reducing the dose to reduce the likelihood of side effects (withdrawal symptoms). If Doreta SR is stopped abruptly, the patient may feel unwell. The patient may experience anxiety, agitation, nervousness, insomnia, excessive activity, tremors and/or gastrointestinal disorders.
If the patient has any further doubts about using 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,
• tremors,
• 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,
• hot flashes,
• chest pain,
• involuntary muscle twitching,
• tingling or numbness,
• shortness of breath,
• elevated liver enzyme activity.

Rare side effects (may affect up to 1 in 1,000 people):

• drug dependence,
• seizures, coordination problems,
• blurred vision,
• pupil constriction,
• pupil dilation,
• speech disorders,
• delirium (confusion, altered level of consciousness),
• 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 the 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 using Doreta SR").

The following side effects have been reported in patients taking medicines containing only tramadol hydrochloride or paracetamol. However, if any of these side effects occur while taking Doreta SR, the doctor should be informed:

• feeling of fainting when standing up from a sitting or lying position, slow heartbeat, fainting, changes in appetite, weakness, slower or shallower breathing, mood changes, changes in activity, changes in perception, worsening of asthma symptoms.
• taking paracetamol alone or in combination with the antibiotic flucloxacillin may cause blood and fluid disorders (metabolic acidosis with a large anion gap), which is characterized by an increase in blood acidity.
• 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 medicine should be stopped and the doctor should be consulted immediately. The medicine should not be taken again.

Rarely, in patients taking tramadol for a period of time, a feeling of unwellness may occur when the medicine is stopped abruptly. Patients may experience agitation, anxiety, nervousness or tremors, 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 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, serious skin reactions have been reported after taking medicines containing paracetamol.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the doctor or pharmacist should be informed. 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:
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information 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 medicine should be stored in a safe place, to which other people do not have access. It can cause serious harm and be fatal to people it has not been prescribed for.
The medicine should not be used after the expiry date stated on the packaging after the abbreviation "EXP". The expiry date refers to the last day of the month stated.
The batch number is stated on the packaging after the abbreviation "Lot".
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 Doreta SR 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 (type 2208, 100 mPas), 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, coated, two-layer tablets, approximately 20 mm long and 11 mm wide.
Packaging:10, 20, 30, 50, 60, 90 and 100 prolonged-release tablets in blisters, in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder

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
This medicine is authorized in the Member States of the European Economic Area under the following names:
To obtain more detailed information on this medicine, you should contact the local representative of the marketing authorization holder:
KRKA-POLSKA Sp. z o.o.
ul. Równoległa 5
02-235 Warsaw
Phone: 22 57 37 500

Date of last revision of the leaflet: 05.10.2024