Doreta

Package leaflet: Information for the patient

Warning! Keep this leaflet. Information on the immediate packaging in a foreign language.
Doreta, 37.5 mg + 325 mg, coated tablets
Tramadoli hydrochloridum + Paracetamolum
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. This medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents

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

Doreta is a combination medicine containing two pain-relieving substances: tramadol and paracetamol,
which together act to relieve pain.
Doreta is indicated for the treatment of moderate to severe pain, when the doctor considers it necessary to administer tramadol in combination with paracetamol.
Doreta is intended for use in adults and adolescents above 12 years of age.

2. Important information before using Doreta

When not to use Doreta

• if the patient is allergic to tramadol hydrochloride, paracetamol, or any of the other ingredients of this medicine (listed in section 6),
• in case of acute intoxication with alcohol, hypnotics, opioids, or other psychotropic medicines (used to treat psychiatric disorders),
• during concomitant use of monoamine oxidase inhibitors (MAOIs) (some medicines used to treat depression or Parkinson's disease) and within 14 days after their discontinuation,
• 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, discuss the following with your doctor:

• if you are taking other medicines containing tramadol or paracetamol,
• if you have liver damage or liver disease, or if you experience yellowing of the eyes or skin. This may be due to jaundice or biliary tract disease,
• if you have kidney disease,
• if you have respiratory disorders, such as asthma or other lung diseases,
• if you have epilepsy or a history of seizures,
• if you suffer from depression and are taking antidepressant medicines, as some of them may interact with tramadol (see "Doreta and other medicines"),
• if you have recently sustained a head injury, shock, or suffer from severe headaches accompanied by vomiting,
• if you have a history of drug dependence, including opioids such as morphine,
• if you are taking other painkillers containing buprenorphine, nalbuphine, or pentazocine,
• if you are scheduled for anaesthesia. Inform your doctor or dentist that you are taking Doreta.

Talk to your doctor if any of the following symptoms occur while taking Doreta: excessive fatigue, loss of appetite, severe abdominal pain, nausea, vomiting, or low blood pressure. These may indicate adrenal insufficiency (low cortisol levels). If such symptoms occur, contact your doctor, who will decide whether hormone replacement is necessary.

Breathing disorders during sleep
Doreta may cause breathing disorders during sleep, such as sleep apnoea (pauses in breathing during sleep) and sleep-related hypoxemia (low oxygen levels in the blood). Symptoms may include pauses in breathing during sleep, nocturnal awakenings due to breathlessness, difficulty maintaining sleep, or excessive daytime sleepiness. If you or someone else observes these symptoms, contact your doctor. Your doctor may recommend reducing the dose.

Serotonin syndrome
There is a small risk of developing serotonin syndrome when tramadol is taken together with certain antidepressants or when tramadol is taken alone. If you experience any symptoms of this serious condition, seek immediate medical advice (see section 4 "Possible side effects").

Tramadol is metabolized in the liver by an enzyme. Some individuals have a genetic variation of this enzyme, which may lead to different effects. In some people, pain relief may be insufficient, while in others, the risk of severe adverse reactions may be higher.

Stop taking the medicine and contact your doctor immediately if you experience any of the following adverse effects: slow or shallow breathing, confusion, drowsiness, pinpoint pupils, nausea or vomiting, constipation, or loss of appetite.

If any of the above conditions have occurred in the past or arise during treatment with Doreta, inform your doctor. Your doctor will decide whether to continue treatment.

Children and adolescents
Use in children with breathing disorders
Tramadol is not recommended in children with respiratory disorders, as symptoms of tramadol toxicity may be more pronounced in this population.

Doreta and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.

Warning: This medicine contains paracetamol and tramadol. Inform your doctor if you are taking other medicines containing paracetamol or tramadol to avoid exceeding the maximum daily dose.

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

Do not use Doreta together 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 pain-relieving effect may be reduced.

The risk of adverse effects increases if you take:

• triptans (medicines used to treat migraine) or selective serotonin reuptake inhibitors (SSRIs, medicines used to treat depression). Contact your doctor if you experience disorientation, agitation (especially motor agitation), fever, excessive sweating, uncontrolled limb or eye movements, uncontrolled muscle contractions, or diarrhoea.
• other painkillers such as morphine and codeine (also used to treat cough), baclofen (a muscle relaxant), antihypertensive medicines, or antihistamines. Contact your doctor if you experience drowsiness or fainting.
• sedatives or hypnotics (sleeping medicines),
• medicines that may cause seizures (fits), such as certain antidepressants, antipsychotics, anaesthetics, mood-altering medicines, or bupropion (a medicine used to help stop smoking). The risk of seizures may increase when Doreta is taken together with these medicines. Your doctor will advise 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, leading to bleeding (see section 4). Any prolonged or unexpected bleeding should be reported to your doctor immediately.
• flucloxacillin (an antibiotic), due to a serious risk of a blood and body fluid disorder (metabolic acidosis with a 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, or those taking the maximum daily dose of paracetamol.

Concomitant use of Doreta and sedatives such as benzodiazepines or related substances increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening. Therefore, concomitant use should only be considered when no other treatment options are available. If your doctor prescribes Doreta together with sedatives, your doctor should limit the dose and duration of combined treatment. Inform your doctor about all sedatives you are taking and strictly follow dosing instructions. It may be helpful to inform family members or friends so they are aware of the possibility of the above-mentioned symptoms. If such symptoms occur, contact your doctor.

The effect of Doreta may change if taken together with:

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

Your doctor will decide which medicines can be safely used together with Doreta.

Doreta with food and alcohol
Doreta may cause drowsiness. Alcohol intensifies drowsiness. Do not drink alcohol while taking Doreta.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine.

Because Doreta contains tramadol, do not take this medicine during pregnancy or breastfeeding. If you become pregnant while taking Doreta, consult your doctor before taking further tablets.

Breastfeeding
Tramadol is excreted in breast milk. Therefore, Doreta should not be used more than once during breastfeeding. If Doreta is taken more than once, breastfeeding must be discontinued.

Fertility
Based on human experience with tramadol, it is suggested that tramadol does not affect fertility in men or women. There are no available data on the effect on fertility of combined treatment with tramadol and paracetamol.

Before taking any medicine, consult your doctor or pharmacist.

Driving and using machines
Doreta may cause drowsiness, which may affect the ability to drive and operate machinery.

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

3. How to use Doreta

This medicine should always be used as directed by the physician. In case of doubts, consult a
physician or pharmacist.
Doreta should be used for the shortest duration possible.
Do not use this medicine in children under 12 years of age.
The dose should be adjusted according to the intensity of pain and the individual patient's response to treatment.
Use the lowest effective dose that adequately relieves pain.
Unless otherwise directed by a physician, the recommended dose of Doreta is 2 tablets for adults and adolescents aged 12 years and older.
If needed, the physician may recommend taking additional doses. Do not take subsequent doses more frequently than every 6 hours.
Do not exceed 8 tablets per day.
Do not take Doreta more frequently than prescribed by the physician.
Elderly patients
In patients over 75 years of age, elimination of tramadol from the body may be delayed. In these
patients, the physician may recommend extending the interval between doses.
Patients with renal impairment, on dialysis, or with hepatic impairment
Do not take Doreta in cases of severe hepatic and/or renal impairment.
In cases of mild or moderate impairment, the physician may recommend extending the intervals
between doses.
Method of administration
Tablets should be taken orally.
Tablets should be swallowed whole with liquid. Do not break or chew them.
If the effect of Doreta seems too strong (e.g. drowsiness or breathing difficulties) or too weak (e.g. inadequate pain relief), consult a physician. If there is no improvement, contact the physician.
Taking more than the recommended dose of Doreta
If more than the recommended dose has been taken, seek immediate medical advice from a physician or pharmacist, even if feeling well. There is a risk of liver damage, the symptoms of which may appear later.
In case of overdose, seek immediate medical advice, even if the patient feels well, because there is a risk of delayed, severe liver damage.
After taking more than the recommended dose of Doreta, serious circulatory disturbances, disturbances of consciousness up to coma, seizures, or respiratory disturbances, malaise, vomiting, weight loss, or abdominal pain may occur.
Missing a dose of Doreta
If a dose is missed, pain may return. Do not take a double dose to make up for the missed dose; continue taking the medicine as prescribed.
Stopping Doreta treatment
Do not abruptly discontinue use of this medicine without physician's advice. If a patient wishes to stop taking the medicine, this should be discussed with the physician, especially if the medicine has been used long-term.
The physician will advise when and how to discontinue the medicine; this may involve gradually reducing the dose to minimize the likelihood of withdrawal symptoms.
If Doreta is abruptly discontinued, malaise may occur. The patient may experience anxiety, agitation, nervousness, insomnia, hyperactivity, tremor, and/or gastrointestinal disturbances.
If there are any further doubts regarding the use of this medicine, consult a physician or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Very common (may occur in more than 1 in 10 patients):

• nausea,
• dizziness, drowsiness.

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

• vomiting, gastrointestinal disturbances (constipation, bloating, diarrhoea), stomach pain, dry mouth,
• itching, excessive sweating,
• headache, tremor,
• confusion, sleep disturbances, mood changes (anxiety, nervousness, pathological euphoria).

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

• increased heart rate or arterial blood pressure, disturbances in heart rate or rhythm,
• tingling, numbness or pins and needles sensation in limbs, ringing in the ears, involuntary muscle twitching,
• depression, nightmares, hallucinations (hearing, seeing or feeling things that are not real), memory lapses,
• difficulty in breathing,
• difficulty in swallowing, blood in stool (black, tarry stools),
• skin reactions (e.g. rash, urticaria),
• increased liver enzyme levels,
• presence of albumin in urine, difficulty in passing urine or pain,
• chills, hot flushes, chest pain.

Rare (may occur in up to 1 in 1000 patients):

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

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

• drug abuse.

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

• decreased blood sugar concentration.

The following adverse effects have been reported by patients using medicines containing only tramadol or paracetamol. However, if any of these adverse effects occur while taking Doreta, 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.
• using Doreta together with blood-thinning medicines (e.g. phenprocoumon, warfarin) may increase the risk of bleeding. Any prolonged or unexpected bleeding should be reported to your doctor immediately.
• in some rare cases, a skin rash indicating an allergic reaction may develop into sudden swelling of the face and neck, breathing difficulties, or drop in blood pressure and fainting; if such symptoms occur, stop taking this medicine immediately and seek medical help without delay. Do not take this medicine again.

Rarely, patients who have been taking tramadol for some time may experience withdrawal symptoms if the medicine is stopped suddenly.
Patients may experience restlessness, anxiety, nervousness or tremor, hyperactivity, insomnia or gastrointestinal disturbances. A very small number of patients may experience panic attacks, hallucinations, unusual sensations such as itching, tingling, numbness of the skin, and ringing in the ears. If any of these symptoms, or any other unusual symptoms, occur, consult your doctor or pharmacist as quickly as possible.
Frequency not known: hiccups.
Serotonin syndrome, which may present with mental status changes (e.g. agitation, hallucinations, coma), as well as 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").

In exceptional cases, blood tests may reveal certain abnormalities, such as low platelet count, which may cause nosebleeds or bleeding gums.

Very rarely, severe skin reactions have been reported following administration of paracetamol-containing medicines.

Rarely, respiratory depression has been reported following administration of tramadol-containing medicines.

Reporting of adverse effects
If you experience any adverse effects, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. Adverse effects can also be reported directly to the Department of Monitoring Adverse Drug Reactions at the 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
Reporting adverse effects helps provide more information on the safety of this medicine.

5. How to store Doreta

No special storage instructions are required.
Keep the 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 specified month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Such measures help protect the environment.

6. Contents of the pack and other information

What Doreta contains

• The active substances in Doreta are tramadol hydrochloride and paracetamol. Each coated tablet contains 37.5 mg of tramadol hydrochloride, equivalent to 32.94 mg of tramadol and 325 mg of paracetamol.
• Other ingredients are:
• tablet core: pregelatinized starch, maize starch, sodium carboxymethyl starch (type A), microcrystalline cellulose and magnesium stearate,
• tablet coating: hypromellose, titanium dioxide (E 171), macrogol 400, iron oxide yellow (E 172) and 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.
Pack sizes: 10, 20, 30, 60 or 90 coated tablets in blisters within a cardboard carton.
For more detailed information, please contact the responsible party or the parallel importer.
Marketing Authorisation 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:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing Authorisation numbers 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 Licence number: 204/19
This medicinal product is authorised for sale in the European Economic Area and in the United Kingdom (Northern Ireland) under the following names: