Doreta

Package leaflet: Information for the patient

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

• Keep this leaflet in case you need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm someone else, even if their symptoms are similar.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform the doctor or pharmacist. See section 4.

Table of contents of the leaflet

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 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 over 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 alcohol intoxication, sedatives, analgesics, or other psychotropic medicines (used to treat psychiatric disorders),
• during concomitant use of MAO inhibitors (certain 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 with your doctor:

• if you are taking other medicines containing tramadol or paracetamol.
• if you have liver damage or liver disease, or yellowing of the eyes and skin. This may be due to jaundice or biliary tract disease.
• if you have kidney disease.
• if you have respiratory disorders, e.g. asthma or other lung diseases.
• if you have epilepsy or a history of seizures.
• if the patient has depression and is taking antidepressants, as some of these may interact with tramadol (see "Doreta with other medicines").
• if you have recently suffered a head injury, shock, or severe headaches accompanied by vomiting.
• if you have a history of dependence on any drugs, including analgesics such as morphine.
• if you are taking other analgesics containing buprenorphine, nalbuphine, or pentazocine.
• if the patient is to undergo anaesthesia. Inform the doctor or dentist that you are taking Doreta.

Talk to your doctor if any of the following symptoms occur during treatment with 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.

Sleep-related breathing disorders
Doreta may cause breathing disorders during sleep, such as sleep apnoea (pauses in breathing during sleep) and sleep-related hypoxia (low blood oxygen levels). Symptoms may include breathing pauses during sleep, nocturnal awakenings due to breathlessness, difficulty maintaining sleep, or excessive daytime sleepiness. If the patient or another person observes these symptoms, contact a doctor. The doctor may recommend reducing the dose.

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

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, the risk of severe adverse effects may be higher.

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

If any of the conditions described above have previously affected the patient or occur during treatment with Doreta, inform your doctor. The doctor will decide whether treatment should continue.

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 pronounced in these patients.

Doreta with 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 about any 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").

Doreta 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 analgesics). The analgesic effect may be reduced.

The risk of adverse effects increases if the patient is taking:

• 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 restlessness), fever, excessive sweating, uncontrolled limb or eye movements, uncontrolled muscle contractions, or diarrhoea occur.
• other analgesics such as morphine and codeine (also used to treat cough), baclofen (a muscle relaxant), antihypertensive medicines, or antihistamines. Contact your doctor if drowsiness or fainting occurs.
• sedatives or sleeping medicines.
• medicines that may cause seizures (fits), such as certain antidepressants, antipsychotics, anaesthetics, mood-altering medicines, or bupropion (used for smoking cessation). 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 fluid and electrolyte 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 in patients taking the maximum daily dose of paracetamol.

Concomitant use of Doreta and sedatives such as benzodiazepines or related medicines 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, the prescribing doctor should limit the dose and duration of concomitant treatment. Inform your doctor about all sedative medicines you are taking and strictly follow the doctor's dosing instructions. It may be helpful to inform family members or friends so they are aware of the possibility of the above-mentioned subjective and objective symptoms. If such symptoms occur, contact your doctor.

The effect of Doreta may be altered if taken simultaneously 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 may intensify this effect. Do not drink alcohol while taking Doreta.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant, breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult her doctor or pharmacist before using this medicine.

Because Doreta contains tramadol, this medicine should not be taken during pregnancy or breastfeeding. If the patient becomes pregnant while being treated with Doreta, she should consult her doctor before taking further tablets.

Breastfeeding
Tramadol is excreted in 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 men and women. There are no available data on the effect on fertility with combined treatment with tramadol and paracetamol.

Before taking any medicine, consult your doctor or pharmacist.

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

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

3. How to use Doreta

This medicine should always be used as directed by the physician. If in doubt, consult a doctor 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 the 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 use more than 8 tablets per day.
Do not take Doreta more frequently than directed 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, those undergoing 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 problems) or too weak (e.g., inadequate pain relief), consult a physician. If there is no improvement, contact the physician.

Overdose of Doreta
If more than the recommended dose is taken, even if the patient feels well, seek immediate medical advice from a doctor or pharmacist. There is a risk of liver damage, the symptoms of which may appear later.
In case of overdose, seek medical advice immediately, even if the patient feels well, because there is a risk of delayed, severe liver damage.
Following an overdose of Doreta, severe circulatory disturbances, disturbances of consciousness up to coma, seizures, or respiratory disturbances, malaise, vomiting, weight loss, or abdominal pain may occur.

Missed 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 according to the prescribed schedule.

Discontinuation of Doreta
Do not abruptly stop using this medicine without medical advice. If the patient wishes to discontinue treatment, this should be discussed with the physician, especially if the medicine has been used long-term.
The physician will advise when and how to stop the medicine; this may involve gradually reducing the dose to minimize the likelihood of withdrawal symptoms.
If Doreta is discontinued abruptly, malaise may occur. The patient may experience anxiety, agitation, nervousness, insomnia, excessive activity, 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 users):

• nausea,
• dizziness, drowsiness.

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

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

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

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

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

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

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

• 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 taking medicines containing only tramadol or paracetamol. However, if any of these adverse effects occur during treatment with 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 progress rapidly to facial and neck swelling, breathing difficulties, or a drop in blood pressure and fainting; if such symptoms occur, stop taking this medicine and seek medical advice immediately. 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 abruptly.
Patients may experience restlessness, anxiety, nervousness, tremor, hyperactivity, insomnia, or gastrointestinal disturbances. In a very small number of patients, panic attacks, hallucinations, or 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, consult your doctor or pharmacist as quickly as possible.
Frequency not known: hiccups.
Serotonin syndrome, which may present with changes in mental status (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 a low number of platelets, which may lead to nosebleeds or bleeding gums.

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

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

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 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 the medicine Doreta

Keep the medicine out of the 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 instructions apply.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging 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, corn starch, sodium carboxymethyl starch (type A), microcrystalline cellulose (E 460), and magnesium stearate (E 470b); coating: hypromellose (E 464), titanium dioxide (E 171), macrogol 400, yellow iron oxide (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-shaped and slightly biconvex.
Packs: 10, 20, 30, 60 or 90 coated tablets in blister packs contained in a cardboard carton.
For further information, please contact the responsible party or the parallel importer.
Responsible entity in Romania, 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 in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
Marketing authorisation numbers in Romania, 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: 373/18
This medicinal product is authorised in the European Economic Area and the United Kingdom (Northern Ireland)
under the following names: