Tramadol and paracetamol Krka

PACKAGE LEAFLET

Package leaflet: Information for the patient

Tramadol and Paracetamol Krka 37.5 mg/325 mg film-coated tablets

Tramadol hydrochloride/paracetamol
Generic medicine
Read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

1. What Tramadol and Paracetamol Krka is and what it is used for
2. What you need to know before taking Tramadol and Paracetamol Krka
3. How to take Tramadol and Paracetamol Krka
4. Possible side effects
5. How to store Tramadol and Paracetamol Krka
6. Contents of the pack and other information

1. What Tramadolo e Paracetamolo Krka is and what it is used for

Tramadolo e Paracetamolo Krka is a combination of two analgesics (painkillers), tramadol and paracetamol, which work together to provide relief from pain.
Tramadolo e Paracetamolo Krka is intended for use in the treatment of moderate to severe pain when your doctor recommends a combination of tramadol and paracetamol.

2. What you need to know before taking Tramadol and Paracetamol Krka

Do not take Tramadol and Paracetamol Krka

• if you are allergic to paracetamol, tramadol, or any of the other ingredients of this medicine (listed in section 6)
• if you drink alcohol
• if you are taking any medicine that may make you drowsy or less alert; these include opioid painkillers such as morphine and codeine
• if you are taking monoamine oxidase inhibitors (MAOIs), for example for depression, or have taken any MAOIs within the last two weeks
• if you have severe liver problems
• if you have epilepsy that is not adequately controlled with your current medication.

Warnings and precautions
Talk to your doctor or pharmacist before taking Tramadol and Paracetamol Krka.
Take particular care with Tramadol and Paracetamol Krka:

• if you have kidney problems
• if you have liver problems or liver disease caused by alcohol, or if you have noticed that your eyes or skin have turned yellow; this may indicate jaundice or problems with the bile ducts
• if you have difficulty breathing, for example due to asthma or lung problems
• if you are dependent on other medicines used to relieve moderate to severe pain, such as morphine
• if you have epilepsy or have experienced seizures or epileptic fits
• if you have suffered a head injury, shock, or severe headaches that may or may not be associated with vomiting
• if you are taking other medicines containing paracetamol or tramadol.

Tramadol is metabolized in the liver by an enzyme. Some people have a variation of this enzyme, which may lead to different effects in them. Some people may not achieve sufficient pain relief, while others may experience serious side effects. If you notice any of the following side effects, you must stop taking this medicine and contact a doctor immediately: slow or shallow breathing, confusion, drowsiness, constricted pupils, feeling unwell or malaise, constipation, loss of appetite.

Children and adolescents
Use in children with respiratory problems
Tramadol is not recommended in children with respiratory problems, as symptoms of tramadol toxicity may be worse in these children.

Other medicines and Tramadol and Paracetamol Krka
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Important: this medicine contains paracetamol and tramadol. Inform your doctor if you are taking other medicines containing paracetamol or tramadol, so as not to exceed the maximum daily doses.
Do not take Tramadol and Paracetamol Krka together with monoamine oxidase inhibitors (MAOIs) (see section "Do not take Tramadol and Paracetamol Krka").
Tramadol and Paracetamol Krka must not be taken with the following medicines, as it may alter their action:

• carbamazepine (a medicine used to treat epilepsy or certain types of pain)
• buprenorphine, nalbuphine, or pentazocine (opioid-type painkillers). The pain-relieving effect may be reduced.

Tramadol and Paracetamol Krka may increase the risk of side effects if taken together with the following medicines:

• Triptans (used for migraine) or selective serotonin reuptake inhibitors (SSRIs, used to treat depression). Check with your doctor if you experience episodes of confusion, restlessness, fever, sweating, uncoordinated movements of limbs or eyes, uncontrollable muscle spasms, or diarrhea.
• Tranquilizers, sleeping pills, other painkillers such as morphine and codeine (also used as cough medicines), baclofen (a muscle relaxant), medicines used to lower blood pressure, antidepressants, or medicines for treating allergies. Check with your doctor if you feel drowsy or faint.
• Antidepressants, anesthetics, medicines that may affect memory, or bupropion (used to help stop smoking). The risk of seizures may increase. Your doctor will tell you whether Tramadol and Paracetamol Krka is suitable for you.
• Warfarin or phenprocoumon (for thinning the blood). The effectiveness of these medicines may be altered and bleeding may occur (see section 4).

The effectiveness of Tramadol and Paracetamol Krka may be altered if taken simultaneously with the following medicines:

• Metoclopramide, domperidone, or ondansetron (medicines used to treat nausea and vomiting/feeling unwell)
• Colestyramine (a medicine used to reduce cholesterol in the blood)
• Ketoconazole or erythromycin (medicines used to treat infections)

Concomitant use of Tramadol and Paracetamol Krka with sedative medicines such as benzodiazepines or related medicines increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening. For this reason, concomitant use should only be considered when no other treatment options are available.
However, if your doctor prescribes Tramadol and Paracetamol Krka together with sedative medicines, the dose and duration of concomitant therapy must be limited by your doctor.
Inform your doctor about all sedative medicines you are taking and follow their dosage recommendations carefully. It may be helpful to inform friends or family members about the signs and symptoms listed above. Contact your doctor if these symptoms occur.

Tramadol and Paracetamol Krka with food, drinks, and alcohol
Tramadol and Paracetamol Krka can be taken with or without food.

• Tramadol and Paracetamol Krka may cause drowsiness. Alcohol can increase drowsiness. Alcohol enhances the sedative effects of opioid analgesics and impairs reflexes, making it dangerous to drive vehicles or operate machinery. Avoid consuming alcoholic beverages and medicines containing alcohol.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
As Tramadol and Paracetamol Krka is a fixed combination of active substances including tramadol, it should not be used during pregnancy.
Breastfeeding
Tramadol passes into breast milk. Therefore, you should not take Tramadol and Paracetamol Krka more than once while breastfeeding; alternatively, if you take Tramadol and Paracetamol Krka more than once, you must stop breastfeeding.

Driving and using machines
Do not drive, operate machinery, or perform any other activities requiring alertness until you know how Tramadol and Paracetamol Krka affects you. Tramadol and Paracetamol Krka may cause drowsiness.

Tramadol and Paracetamol Krka contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially 'sodium-free'.

3. How to take Tramadol and Paracetamol Krka

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
The usual initial dose is 2 tablets. If necessary, further doses may be taken every 6 hours,
according to your doctor's recommendations.
Do not take more than 8 tablets per day (equivalent to 300 mg of tramadol hydrochloride and 2,600 mg of
paracetamol).
Dosage should be adjusted according to the intensity of pain and individual sensitivity to pain.
In general, the lowest effective dose providing pain relief should be used.
Severe liver disease (liver failure)
Patients with severe liver impairment must not take Tramadol and Paracetamol Krka.
If you have mild or moderate liver impairment, your doctor may recommend prolonging
the dosing interval.
Use in children
The use of Tramadol and Paracetamol Krka is not recommended in children under 12 years of age.
Elderly patients
In elderly patients (over 75 years of age), elimination of tramadol may be delayed. If this applies to you, your doctor may recommend prolonging the dosing interval.
The tablets should be swallowed with liquid. The tablets must not be chewed or crushed.
The tablets should be taken for the shortest possible duration.
If you think that the effect of Tramadol and Paracetamol Krka is too strong (e.g. if you feel very
drowsy or have difficulty breathing) or too weak (e.g. pain relief is inadequate),
contact your doctor or pharmacist. If symptoms do not improve, see your doctor.
If you take more Tramadol and Paracetamol Krka than you should
In case of overdose, seek immediate medical help, even if you feel well, due to the risk of severe and delayed liver damage. If you take more Tramadol and Paracetamol Krka than you should, you may experience serious symptoms related to blood circulation to organs, disturbances in consciousness up to coma, seizures, or you may have difficulty breathing, feel unwell, vomit, lose weight or experience abdominal pain.
If you forget to take Tramadol and Paracetamol Krka
Do not take a double dose to make up for the forgotten tablet.
If you forget to take a dose of Tramadol and Paracetamol Krka, take the next tablet at the usual time.
If you stop taking Tramadol and Paracetamol Krka
If you have been using Tramadol and Paracetamol Krka for some time, you should talk to your doctor before stopping treatment, as your body may have become accustomed to it.
Do not stop taking this medicine suddenly, unless your doctor tells you to. If you intend to stop taking the medicine, discuss it with your doctor first, especially if you have been taking it for a long time. Your doctor will advise you when and how to stop, which may involve gradually reducing the dose to reduce the likelihood of developing unnecessary adverse effects (withdrawal symptoms). If you suddenly stop taking Tramadol and Paracetamol Krka, you may feel unwell. You may experience anxiety, agitation, nervousness, insomnia, hyperactivity, tremors and/or stomach disturbances.
If you have any questions about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.

Very common side effects (may affect more than 1 in 10 people):

• nausea,
• dizziness,
• drowsiness. These are usually mild and not concerning.

Common side effects (may affect up to 1 in 10 people):

• vomiting,
• digestive problems (constipation, flatulence, diarrhoea),
• stomach ache,
• dry mouth,
• headache,
• tremor,
• confusion,
• sleep disturbances,
• mood changes (anxiety, nervousness, euphoria (feeling “high” all the time)),
• increased sweating,
• itching.

Uncommon side effects (may affect up to 1 in 100 people):

• high blood pressure, disturbances in heart rhythm and rate,
• difficulty or pain passing urine, protein in urine,
• skin reactions (hives, rash),
• tinnitus (ringing sensation in the ears),
• depression,
• nightmares,
• hallucinations (hearing, seeing or feeling things that do not exist),
• memory loss,
• difficulty swallowing,
• blood in the stools,
• tremors,
• hot flushes,
• chest pain,
• involuntary muscle spasms,
• unusual burning sensation (feeling as if on pins and needles),
• shortness of breath,
• elevated liver enzymes.

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

• drug dependence,
• seizures, difficulty performing coordinated movements,
• blurred vision,
• 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):

• reduction in blood sugar levels.

The following side effects have been reported and recognized in people using medicines containing only tramadol hydrochloride or only paracetamol. However, if you experience any of these side effects while taking Tramadolo e Paracetamolo Krka, you must inform your doctor:

• feeling faint when standing up from a lying or sitting position, slow heart rate, fainting, changes in appetite, muscle weakness, slower or weaker breathing, mood changes, changes in activity, altered perception, worsening of asthma.
• In some rare cases, you may develop a skin rash indicating an allergic reaction, which may present as sudden swelling of the face and neck, difficulty breathing, or a drop in blood pressure and fainting. If this happens to you, stop treatment immediately and seek medical help without delay. Do not take the medicine again. In rare cases, use of a medicine of the same type as tramadol may lead to dependence, making it difficult to stop taking it. In rare instances, people who have taken tramadol for some time may feel unwell if treatment is stopped abruptly. They may feel restless, anxious, nervous, or tremble. They may become hyperactive, have difficulty sleeping, and experience stomach or intestinal disturbances. Very few people may also experience panic attacks, hallucinations, or unusual sensations such as itching, tingling, numbness, and tinnitus (ringing in the ears). If you notice any of these effects or any other unusual symptoms, inform your doctor or pharmacist as soon as possible. In exceptional cases, blood tests may reveal certain abnormalities, for example a low platelet count which may cause nosebleeds or bleeding gums. Very rare cases of severe skin reactions caused by medicines containing paracetamol have been reported.

The use of Tramadolo e Paracetamolo Krka together with medicines used to thin the blood (e.g. phenprocoumon, warfarin) may increase the risk of bleeding. Any prolonged or unexpected bleeding should be reported to your doctor immediately.

Reporting of side effects

If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Tramadol and Paracetamol Krka

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Tramadolo e Paracetamolo Krka contains

• The active substances are tramadol hydrochloride and paracetamol. Each film-coated tablet contains 37.5 mg of tramadol hydrochloride, equivalent to 32.94 mg of tramadol, and 325 mg of paracetamol.
• The other components are:
  • Tablet core: pregelatinized maize starch, sodium starch glycolate (type A), microcrystalline cellulose (E460), and magnesium stearate (E470b).
  • Coating: hypromellose, titanium dioxide (E171), macrogol 400, yellow iron oxide (E172), polysorbate 80.

Description of the appearance of Tramadolo e Paracetamolo Krka and the contents of the pack
The film-coated tablets are yellow-brown, oval, slightly biconvex.
Packages containing 2 film-coated tablets (blister pack of 2 tablets) or 10, 20, 30, 40, 50, 60, 70, 80, 90, and 100 film-coated tablets (blister packs of 10 tablets) are available.
Not all pack sizes may be marketed.

Marketing Authorization Holder
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer responsible for batch release
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz Lohmann Straße 5, 27472 Cuxhaven, Germany

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

This patient information leaflet was last approved on