Doreta sr

Patient Information Leaflet

Keep this leaflet! Foreign language information on the immediate packaging.
Doreta SR (Doreta Prolong), 75 mg + 650 mg, prolonged-release tablets
Tramadoli hydrochloridum + Paracetamolum
Doreta SR and Doreta Prolong are different trade names for the same medicine.
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of Contents

1. What Doreta SR is and what it is 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 pack and other information

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

Doreta SR is a combination medicine containing two analgesics: tramadol and paracetamol, which together relieve pain.
Doreta SR is indicated for the treatment of moderate to severe pain, when a doctor determines 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 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, analgesics, or other psychotropic medicines (medicines that may affect mood and emotions),
• when taking MAO inhibitors (certain medicines used to treat depression or Parkinson's disease) or within 14 days after stopping them,
• in patients with severe liver disease,
• in patients with epilepsy that is not adequately controlled with medication.

Warnings and precautions
Before starting treatment with Doreta SR, discuss this with your doctor or pharmacist.
Doreta SR is a medicine in the form of prolonged-release tablets. This means that the active substances tramadol and paracetamol are released over a longer period of time. If the patient has previously taken other products containing a combination of tramadol and paracetamol, special caution is required because Doreta SR prolonged-release tablets have a different dosing regimen (see section 3 "How to take Doreta SR").

Use Doreta SR with caution:

• in patients with kidney disease,
• in patients with liver disease or liver damage, or in whom yellowing of the eyes and skin occurs, which may indicate jaundice or biliary tract disease,
• in patients with severe breathing difficulties, e.g. asthma or severe lung diseases,
• in patients dependent on other pain-relieving medicines, e.g. morphine,
• in patients with epilepsy, or in whom seizures or epileptic fits have occurred,
• in patients with recent head injury, 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 will undergo anaesthesia. Inform the doctor or dentist about taking Doreta SR.
• if the patient has depression and is taking antidepressants, as some of them may interact with tramadol (see "Doreta SR with other medicines").

After taking tramadol in combination with certain antidepressants or tramadol alone, there is a small risk of developing so-called serotonin syndrome. If the patient experiences any symptoms of this severe condition, they should seek medical advice immediately (see section 4 "Possible side effects").
Inform your doctor if, during treatment with Doreta SR, the patient experiences excessive fatigue, loss of appetite, severe abdominal pain, nausea, vomiting, or low blood pressure. This may indicate adrenal insufficiency (low cortisol levels). If such symptoms occur, the doctor will decide whether hormone replacement is necessary.
Sleep-related breathing disorders
Doreta SR may cause sleep-related breathing disorders such as sleep apnoea (pauses in breathing during sleep) and sleep-related hypoxemia (low blood oxygen levels).
Symptoms may include pauses in breathing during sleep, nocturnal awakenings due to breathlessness, difficulty maintaining sleep, or excessive daytime sleepiness. If the patient or another person observes these symptoms, contact the doctor. The doctor may recommend reducing the dose.
Tramadol is metabolized in the liver by an enzyme. Some individuals have a variation of this enzyme, which may lead to different effects. In some people, pain relief may be insufficient, while in others, severe adverse effects may be more likely.
Discontinue use and contact your doctor immediately if the patient experiences any of the following adverse effects: slowed or shallow breathing, confusion, drowsiness, pinpoint pupils, nausea or vomiting, constipation, or loss of appetite.

Children and adolescents
Use in children with breathing disorders
Tramadol is not recommended in children with breathing disorders, as tramadol toxicity symptoms may be more severe in them.

Doreta SR with other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
Warning: This medicine contains paracetamol and tramadol. Inform your doctor about taking other medicines containing paracetamol or tramadol so that they can decide on further treatment. Other medicines containing tramadol or paracetamol should only be taken under medical supervision.
Do not take any other medicines containing paracetamol while taking Doreta SR, including those available without a prescription—such as painkillers or antipyretics used for colds and flu—because this increases the risk of paracetamol overdose. Paracetamol overdose can cause liver damage, which may lead to liver transplantation or even death.
Never take a higher dose of Doreta SR than prescribed by the doctor. Higher doses than recommended will not provide better pain relief but will increase the risk of severe liver damage. Symptoms of liver damage usually appear after several days. Therefore, it is important to contact a doctor immediately if an overdose has been taken, even if the patient feels well.

Concomitant use of Doreta SR with monoamine oxidase inhibitors (MAOIs) is contraindicated (see section "When not to use Doreta SR").

Doreta SR 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.

Concomitant use of Doreta SR with the following medicines may increase the risk of adverse effects:

• triptans (medicines used to treat migraine) or selective serotonin reuptake inhibitors (SSRIs, medicines used to treat depression). Contact your doctor if confusion, agitation (especially motor agitation), fever, excessive sweating, uncontrolled limb or eye movements, uncontrolled muscle spasms, or diarrhoea occur.
• sedatives, sleeping medicines, other painkillers such as morphine and codeine (also used to treat cough), baclofen (a muscle relaxant), antihypertensive medicines, antidepressants, or antihistamines. Contact your doctor if drowsiness or fainting occurs.
• medicines that may cause seizures (epileptic fits), such as certain 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 (see section 4). Inform your doctor immediately if any prolonged or unexpected bleeding occurs.
• flucloxacillin (an antibiotic), due to a serious risk of a disorder affecting blood and body fluids (metabolic acidosis with high anion gap), which requires urgent treatment and may occur particularly 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, and in patients taking maximum daily doses of paracetamol.

The effect of Doreta SR may be altered when taken simultaneously with the following medicines:

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

Concomitant use of Doreta SR and sedative medicines 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 when other treatment options are not possible. If, however, your doctor has prescribed Doreta SR together with sedative medicines, the doctor should limit the dose and duration of concomitant treatment. Inform your doctor about all sedative medicines being taken and strictly follow the doctor's dosing instructions. It may be helpful to inform friends or family members so they are aware of the above-mentioned symptoms. If such symptoms occur, contact your doctor.

Doreta SR with food, drink, and alcohol
Doreta SR can be taken with or without food.
Doreta SR may cause drowsiness. Drinking alcohol may increase drowsiness; therefore, it is best to avoid alcoholic beverages while taking Doreta SR.

Pregnancy, breastfeeding, and effects on fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her 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 in the milk of breastfeeding women. 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 on fertility of the combination of tramadol and paracetamol.

Driving and operating machinery
Doreta SR may cause drowsiness. Do not drive, operate machinery, or perform other tasks requiring concentration until you know how Doreta SR affects you.

Doreta SR contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, meaning the medicine is considered "sodium-free".

3. How to use Doreta SR

This medicine should always be taken as directed by your doctor. If in doubt, consult your doctor or pharmacist.
The initial dose is usually one to two tablets. If necessary, subsequent doses may be taken every 12 hours, according to your doctor's instructions.
Do not take more than 4 tablets per day (corresponding to 300 mg of tramadol hydrochloride and 2600 mg of paracetamol).
The dose should be adjusted according to the intensity of pain and the individual patient's sensitivity to pain. In general, the lowest effective dose providing adequate pain relief should be used.

Severe liver disease (liver failure)
Patients with severe liver failure should not take Doreta SR.
In patients with mild or moderate liver impairment, the doctor may increase the dosing intervals.

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

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

Method of administration
Tablets should be swallowed whole with liquid. Tablets must not be broken or chewed.
The medicine should be used for the shortest possible duration.
If you feel that the effect of Doreta SR is too strong (e.g. excessive drowsiness or breathing difficulties) or too weak (e.g. pain is not adequately relieved), consult your doctor or pharmacist. If there is no improvement, contact your doctor.

Taking more than the recommended dose of Doreta SR
In case of overdose, seek immediate medical help or
contact the locally designated centre(s):

• Poison Control Centre – Warsaw, Piłsudskiego 33, 05-074 Halinów, tel. 607 218 174; fax: 22 789 97 05; e-mail: [email protected]
• Pomeranian Centre of Toxicology, Kartuska 4/6, 80-104 Gdańsk, tel./fax (058) 682 19 39; (058) 682 57 67; e-mail: [email protected]
• Toxicological Information Centre, Department of Toxicology named after Dr. Wanda Błeńska, Franciszek Raszei City Hospital, Mickiewicza 2, 60-834 Poznań, tel./fax: 061-224 52 65; e-mail: [email protected]
• Laboratory and Toxicological Information Unit, Jagiellonian University Medical College, Kopernika 15, 31-501 Kraków, tel./fax: 012-424 83 56 or 57; e-mail: [email protected]

Bring any remaining medicine, this leaflet, or the packaging with you.
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, medical help should be obtained as early as possible. The shorter the time between ingestion and antidote treatment, the greater the likelihood of preventing liver damage.
After taking more than the recommended dose of Doreta SR, severe circulatory disturbances, disturbances of consciousness up to coma, seizures or breathing problems, malaise, vomiting, weight loss, or abdominal pain may also occur.

Missed dose of Doreta SR
Do not take a double dose to make up for a missed dose.
If a dose is missed, take the next tablet at the usual time.

Stopping Doreta SR treatment
If the patient has been taking Doreta SR for some time, they should consult their doctor before stopping treatment, as the body may have become accustomed to the medicine. Do not stop taking this medicine suddenly without medical advice. If the patient wishes to discontinue the medicine, 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 the medicine; this may involve gradually reducing the dose to reduce the likelihood of adverse effects (withdrawal symptoms). If Doreta SR is stopped abruptly, malaise may occur. The patient may experience anxiety, agitation, nervousness, insomnia, hyperactivity, tremor, and/or gastrointestinal disturbances.

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

4. Possible adverse effects

Like any medicine, this medicine can cause adverse effects, although they do not occur in everyone.
Very common adverse effects (may occur in more than 1 in 10 patients):

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

Common adverse effects (may occur in up to 1 in 10 patients):

• vomiting,
• gastrointestinal disturbances (constipation, bloating, diarrhoea),
• abdominal pain,
• dry mouth,
• headache,
• tremor,
• disorientation,
• sleep disturbances,
• mood changes (anxiety, nervousness, euphoria – continuous feeling of elevated mood),
• increased sweating,
• itching.

Uncommon adverse effects (may occur in up to 1 in 100 patients):

• high blood pressure, disturbances in heart rhythm and heart rate,
• difficulty or pain when urinating, presence of protein in urine,
• skin reactions (urticaria, rashes),
• tinnitus (ringing in the ears),
• depression,
• nightmares,
• hallucinations (hearing, seeing or feeling things that do not exist in reality),
• memory loss,
• difficulty swallowing,
• blood in stool,
• chills,
• hot flushes,
• chest pain,
• involuntary muscle twitching,
• tingling and numbness sensations,
• shortness of breath,
• increased liver enzyme activity.

Rare adverse effects (may occur in up to 1 in 1,000 patients):

• drug dependence,
• seizures, problems with movement coordination,
• blurred vision,
• pinpoint pupils,
• excessive dilation of pupils,
• speech disturbances,
• delirium,
• transient loss of consciousness.

Very rare adverse effects (may occur in up to 1 in 10,000 patients):

• drug abuse.

Adverse effects with unknown frequency (frequency cannot be determined from available data):

• decreased blood sugar concentration,
• hiccups,
• serotonin syndrome, which may present with changes in mental status (e.g. agitation, hallucinations, coma) and other symptoms such as fever, increased heart rate, 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 SR").

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

• feeling faint when standing up from a sitting or lying position, slow heartbeat, fainting, changes in appetite, muscle weakness, slower or shallower breathing, mood changes, changes in activity, changes in perception, worsening of asthma symptoms.
• in some rare cases, skin rash indicating an allergic reaction may progress rapidly to facial and neck swelling, breathing difficulties, drop in blood pressure and fainting; if such symptoms occur, treatment with this medicine must be stopped immediately and medical help must be sought without delay. Do not take this medicine again.

Rarely, patients who have been taking tramadol for some time may experience withdrawal symptoms
after 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 a doctor or pharmacist as quickly as possible.
In exceptional cases, blood tests may reveal certain abnormalities, such as low platelet count, which
may lead to nosebleeds or bleeding gums.
Very rarely, severe skin reactions have been reported after taking medicines containing
paracetamol.
Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions 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.
Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store Doreta SR

Keep this medicine 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 stated month.
No special storage conditions are required.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the packaging and other information

What Doreta SR contains

• The active substances in this medicine are tramadol hydrochloride and paracetamol. Each prolonged-release tablet contains 75 mg of tramadol hydrochloride, equivalent to 65.88 mg of tramadol, and 650 mg of paracetamol.
• Other components are:
  • tablet core: pregelatinized starch, corn starch, hypromellose 2208/100, copovidone, sodium croscarmellose, yellow iron oxide (E 172), microcrystalline cellulose, colloidal anhydrous silica, and sodium stearyl fumarate;
  • tablet coating: polyvinyl alcohol, polyethylene glycol 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,
two-layer tablets approximately 20 mm in length and 11 mm in width.
Packaging: 10, 20 or 30 prolonged-release tablets in blisters, packed in a cardboard box.
For more detailed information, please contact the responsible party or parallel importer.
Marketing Authorisation Holder in the Czech Republic, 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, Poland
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw, Poland
Marketing Authorisation Number in the Czech Republic, country of export: 65/575/15-C
Parallel Import Licence Number: 78/23
This medicinal product is authorised for marketing in the European Economic Area
under the following names: