Tramadol and paracetamol Aurobindo

Patient Information Leaflet

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

Generic medicine
Please read this entire leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Tramadolo e Paracetamolo Aurobindo is a combination of two painkillers, tramadol and paracetamol,
which work together to reduce pain.
Tramadolo e Paracetamolo Aurobindo is used to treat moderate to severe pain, when your doctor considers it necessary to use a combination of tramadol hydrochloride and paracetamol.
Tramadolo e Paracetamolo Aurobindo should only be used in adults and adolescents over 12 years of age.

2. What you should know before taking Tramadol and Paracetamol Aurobindo

Do not take Tramadol and Paracetamol Aurobindo

• If you are allergic to tramadol hydrochloride, paracetamol, or any of the other ingredients of this medicine (listed in section 6).
• In case of acute alcohol intoxication, sleeping pills, painkillers, or other antipsychotic medicines (medicines that alter mood and emotions).
• If you are currently taking medicines called monoamine oxidase inhibitors (MAOIs), a type of medicine used to treat depression or Parkinson’s disease, or if you have taken them within the previous 14 days before treatment with Tramadol and Paracetamol Aurobindo.
• If you have severe liver problems.
• If you have epilepsy that is not adequately controlled with available medicines.

Warnings and precautions
Talk to your doctor or pharmacist before taking Tramadol and Paracetamol Aurobindo:

• if you are taking other medicines containing paracetamol or tramadol;
• if you have liver problems or disease, or if you notice that your eyes or skin turn yellow; this could indicate jaundice or problems with your bile ducts;
• if you have kidney problems;
• if you have significant breathing difficulties, such as asthma or severe lung problems;
• if you have epilepsy or have experienced seizures or epileptic fits;
• if you have recently suffered a head injury, shock, or severe headaches associated with vomiting;
• if you are dependent on other medicines, including those used to relieve pain, such as morphine;
• if you are taking other pain medicines containing buprenorphine, nalbuphine, or pentazocine;
• if you are about to receive an anaesthetic (inform your doctor or dentist that you are taking Tramadol and Paracetamol Aurobindo);
• if you are taking antidepressants, because some of them may interact with tramadol (see "Other medicines and Tramadol and Paracetamol Aurobindo");
• There is a small but possible risk that you may develop serotonin syndrome, which may occur after taking tramadol together with certain antidepressants or tramadol used alone. Contact your doctor immediately if you experience any of the symptoms associated with this serious condition (see section 4 "Possible side effects").

If any of the above situations have affected you in the past or currently affect you while taking Tramadol and Paracetamol Aurobindo, make sure your doctor is aware. Your doctor will decide whether you should continue taking this medicine.
During treatment with Tramadol and Paracetamol Aurobindo, inform your doctor immediately:
If you have serious illnesses, including severe renal impairment or sepsis (when bacteria and their toxins circulate in the blood causing organ damage), malnutrition, chronic alcoholism, or if you are also taking flucloxacillin (an antibiotic). In patients with these conditions, a serious condition called metabolic acidosis (an abnormality in blood and body fluids) has been reported when paracetamol is used regularly over a prolonged period or when paracetamol is taken together with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties with deep, rapid breathing, drowsiness, nausea, and vomiting.

Tolerance, dependence and abuse
This medicine contains tramadol, which is an opioid substance. Repeated use of opioids may make the medicine less effective (you become accustomed to it, a phenomenon known as drug tolerance). Repeated use of Tramadol and Paracetamol Aurobindo may also lead to dependence, abuse, and addiction, which could result in a potentially fatal overdose. The risk of these adverse effects may increase with higher doses and prolonged duration of use.
Dependence or addiction may make you feel that you no longer have control over the amount of medicine needed or how often you must use it.
The risk of developing dependence or addiction varies from person to person. You may have a higher risk of becoming dependent on or addicted to Tramadol and Paracetamol Aurobindo if:

• you or a family member have previously suffered from alcohol, prescription medicine, or illegal substance abuse or dependence ("addiction");
• you are a smoker;
• you have previously had mood disorders (depression, anxiety, or a personality disorder) or have been treated by a psychiatrist for other mental illnesses.

If you notice any of the following symptoms while using Tramadol and Paracetamol Aurobindo, it may be a sign of dependence or addiction:

• you feel the need to use the medicine for longer than prescribed by your doctor;
• you feel the need to take a higher dose than recommended;
• you use the medicine for reasons other than those prescribed, for example, "to stay calm" or "to help sleep";
• you have repeatedly tried to stop or control use of this medicine without success;
• you feel unwell when stopping treatment with the medicine, and feel better when restarting it ("withdrawal effects").

If you notice any of these symptoms, talk to your doctor to discuss the best treatment approach for you, including whether it is appropriate to stop treatment and how to stop safely (see section 3, "If you stop taking Tramadol and Paracetamol Aurobindo").
Tramadol is metabolized in the liver by an enzyme. Some people have a variation in this enzyme, which may lead to different effects in them. Some people may not get 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, or loss of appetite.

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

Sleep-related breathing disorders
Tramadol and Paracetamol Aurobindo may cause sleep-related breathing disorders such as sleep apnoea (pauses in breathing during sleep) and sleep-related hypoxaemia (low oxygen levels in the blood). Symptoms may include pauses in breathing during sleep, nighttime awakenings due to breathlessness, difficulty maintaining sleep, or excessive daytime sleepiness. If you or someone else notices these symptoms, contact your doctor, who may consider reducing the dose.

Talk to your doctor or pharmacist if you notice any of the following symptoms while taking Tramadol and Paracetamol Aurobindo:
Extreme tiredness, loss of appetite, severe abdominal pain, nausea, vomiting, or low blood pressure. These symptoms may indicate adrenal insufficiency (low cortisol levels). If you experience these symptoms, contact your doctor, who will decide whether hormone replacement therapy is needed.

Other medicines and Tramadol and Paracetamol Aurobindo
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

• flucloxacillin (an antibiotic), due to a serious risk of blood and fluid abnormalities (called metabolic acidosis) that require urgent treatment (see section 2).

Important: this medicine contains tramadol and paracetamol. Inform your doctor if you are taking any other medicine containing tramadol or paracetamol, so as not to exceed the maximum daily doses.
Do not take Tramadol and Paracetamol Aurobindo together with monoamine oxidase inhibitors (MAOIs) (see section "Do not take Tramadol and Paracetamol Aurobindo").
Tramadol and Paracetamol Aurobindo should be avoided with the following medicines:

• carbamazepine (a medicine commonly used to treat epilepsy or certain types of pain, such as sudden attacks of facial pain called trigeminal neuralgia);
• buprenorphine, nalbuphine, or pentazocine (opioid-type painkillers). The pain-relieving effect may be reduced.

Taking Tramadol and Paracetamol Aurobindo may increase the risk of side effects if you are also taking the following medicines:

• certain antidepressants: {medicinal product name} may interact with these medicines and you may develop serotonin syndrome (see section 4 "Possible side effects");
• tranquillisers, sleeping pills, other painkillers such as morphine and codeine (including cough medicines containing codeine), baclofen (a muscle relaxant), medicines to lower blood pressure, antidepressants, or antihistamines for allergies. You may feel drowsy or faint. If this happens, inform your doctor;
• antidepressants, anaesthetics, neuroleptics (medicines that alter mental state), or bupropion (used to help stop smoking). This may increase the risk of seizures. Your doctor will advise whether Tramadol and Paracetamol Aurobindo is suitable for you;
• warfarin or phenprocoumon (used to thin the blood). The effectiveness of these medicines may be altered, leading to bleeding. Any prolonged or unexpected bleeding should be reported to your doctor immediately;
• gabapentin or pregabalin, used to treat epilepsy or nerve-related pain (neuropathic pain).

The effectiveness of Tramadol and Paracetamol Aurobindo may also be altered if you take the following medicines:

• metoclopramide, domperidone, or ondansetron (medicines used to treat nausea and vomiting);
• colestyramine (a medicine used to lower blood cholesterol);
• ketoconazole or erythromycin (medicines used to treat infections).

Your doctor will advise which medicines can be taken with Tramadol and Paracetamol Aurobindo.
Concomitant use of Tramadol and Paracetamol Aurobindo 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 Aurobindo together with sedative medicines, the dose and duration of treatment should be limited.
Inform your doctor about all sedative medicines you are taking and follow their dosage recommendations carefully. It may be helpful to inform family members or friends about the possibility of the above-mentioned signs and symptoms. If you develop such symptoms, contact your doctor.

Tramadol and Paracetamol Aurobindo with food, drinks and alcohol
Tramadol and Paracetamol Aurobindo may make you feel drowsy. Alcohol may increase drowsiness, so it is best not to drink alcohol while taking Tramadol and Paracetamol Aurobindo.

Pregnancy, breastfeeding and fertility
Because Tramadol and Paracetamol Aurobindo contains tramadol, you must not take this medicine during pregnancy or while breastfeeding. If you become aware that you are pregnant while being treated with Tramadol and Paracetamol Aurobindo, consult your doctor before taking any further tablets.
Breastfeeding
Tramadol is excreted in breast milk. For this reason, you must not take Tramadol and Paracetamol Aurobindo more than once during breastfeeding, or alternatively, if you take Tramadol and Paracetamol Aurobindo more than once, you must stop breastfeeding.
Experience in humans does not suggest that tramadol alters male or female fertility. There are no data available on fertility changes caused by the combination of tramadol and paracetamol.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
Tramadol and Paracetamol Aurobindo may cause drowsiness, which may affect your ability to drive or operate machinery safely.

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

3. How to take Tramadol and Paracetamol Aurobindo

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Before starting treatment and regularly during treatment, your doctor will discuss with you what to expect from the use of Tramadol and Paracetamol Aurobindo, when and for how long it is necessary to use it, when to contact the doctor, and when treatment should be stopped (see also section 2).
You should take Tramadol and Paracetamol Aurobindo for the shortest possible duration. Use in children under 12 years of age should be avoided.
Unless otherwise prescribed by your doctor, the recommended initial dose for adults and adolescents over 12 years of age is 2 tablets.
If needed, additional doses may be taken as recommended by your doctor. The minimum interval between doses must be at least 6 hours.
Do not take more than 8 film-coated tablets of Tramadol and Paracetamol Aurobindo per day. Do not take Tramadol and Paracetamol Aurobindo more frequently than your doctor has instructed.
Your doctor may increase the interval between doses:

• if you are over 75 years of age;
• if you have kidney problems;
• if you have liver problems.

Method of administration
The tablets are for oral use.
Swallow the tablets whole with a sufficient amount of liquid. The tablets must not be broken or chewed.
If you think that the effect of Tramadol and Paracetamol Aurobindo is too strong (for example, if you feel very sleepy or have difficulty breathing), or too weak (for example, inadequate pain relief), contact your doctor.
If you take more Tramadol and Paracetamol Aurobindo than you should
In case of overdose, seek immediate medical help, even if you feel well. There is a risk of severe liver damage, which may occur later.
If you forget to take Tramadol and Paracetamol Aurobindo
If you forget to take the tablets, your pain may return.
Do not take a double dose to make up for forgotten individual doses; simply continue taking the tablets as before.
If you stop taking Tramadol and Paracetamol Aurobindo
Do not stop taking this medicine abruptly unless instructed by your doctor. If you intend to stop taking the medicine, discuss this 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).
Generally, there are no after-effects following discontinuation of treatment with Tramadol and Paracetamol Aurobindo.
Rarely, people who have been using a medicine containing tramadol for some time may feel unwell if treatment is stopped abruptly (see section 4 “Possible side effects”). If you have been taking Tramadol and Paracetamol Aurobindo for some time and wish to stop treatment, you should speak with your doctor, as your body may have become accustomed to Tramadol and Paracetamol Aurobindo.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

• Nausea.
• Dizziness, drowsiness.

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

• Vomiting, digestive problems (constipation, flatulence, diarrhoea), stomach ache, dry mouth.
• Itching, sweating (hyperhidrosis).
• Headache, tremor.
• Confusion, sleep disturbances, mood changes (anxiety, nervousness, feeling "wired").

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

• Increased pulse rate or blood pressure, disturbances in heart rhythm and heart rate.
• Difficulty or pain when passing urine.
• Skin reactions (e.g., skin irritation, urticaria).
• Numbness or tingling and pinprick sensations in the limbs, ringing in the ears, involuntary muscle contractions.
• Depression, nightmares, hallucinations (hearing, seeing or feeling things that are not real), memory loss.
• Difficulty swallowing, blood in the faeces.
• Tremors, hot flushes, chest pain.
• Difficulty breathing.

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

• Seizures, difficulty performing coordinated movements.
• Drug dependence.
• Blurred vision.
• Transient loss of consciousness (syncope).
• Contraction of the pupil (miosis).
• Speech disorders.
• Excessive dilation of the pupils (mydriasis).

Not known (frequency cannot be estimated from the available data):

• Reduction in blood sugar levels.
• Hiccups.
• Serotonin syndrome, which may present as changes in mental state (e.g., agitation, hallucinations, coma) and other effects 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 “What you need to know before taking Tramadol and Paracetamol Aurobindo”).

The following side effects have been reported by patients using medicines containing only tramadol or only paracetamol. However, if you experience any of these while taking Tramadol and Paracetamol Aurobindo, 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, altered perception, worsening of pre-existing asthma. In rare cases, skin irritation indicating an allergic reaction may occur, which can manifest as sudden swelling of the face and neck, difficulty breathing or drop in blood pressure and fainting. If this occurs, stop treatment immediately and consult your doctor without delay. You must not take this medicine again.

In some rare cases, use of a medicine containing tramadol may lead to dependence and make it difficult to stop treatment. In rare instances, people who have been taking a medicine containing tramadol for some time have experienced discomfort if treatment is stopped abruptly. You may feel restless, anxious, nervous or insecure. You may feel overactive, have difficulty sleeping, and experience stomach or intestinal disturbances. A few people may also experience panic attacks, hallucinations, unusual perceptions such as muscle contractions, tingling and numbness, and ringing in the ears (tinnitus). If you experience any of these symptoms after stopping Tramadol and Paracetamol Aurobindo, you should consult your doctor. In exceptional cases, blood tests may reveal certain abnormalities, for example, low platelet count, which may cause coagulation disorders or bleeding gums. The use of Tramadol and Paracetamol Aurobindo together with other medicines used for blood thinning (e.g., phenprocoumon, warfarin) may increase the risk of bleeding. Any prolonged or unexpected bleeding must be reported immediately to your doctor. Very rare cases of serious skin reactions have also been observed.

Frequency not known (cannot be estimated from the available data): a serious condition that may make the blood more acidic (called metabolic acidosis), in patients with severe illness who are taking paracetamol (see section 2).

Reporting of side effects

If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Tramadol and Paracetamol Aurobindo

Keep this medicine out of the sight and reach of children.
Store this medicine in a safe and secure place, inaccessible to other people. Use by other individuals for whom it has not been prescribed may cause serious harm or be fatal.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the label, the carton, and the blister after EXP. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Tramadolo e Paracetamolo Aurobindo contains

• The active substances are tramadol hydrochloride and paracetamol. Each film-coated tablet contains 37.5 mg of tramadol hydrochloride and 325 mg of paracetamol.
• The other components are: Tablet core: maize starch, powdered cellulose, sodium starch glycolate (type A), pregelatinized starch, magnesium stearate.

Tablet coating: hypromellose, titanium dioxide (E171), macrogol 400, yellow iron oxide (E172), polysorbate 80.

Description of the appearance of Tramadolo e Paracetamolo Aurobindo and package contents
Film-coated tablets.
Light yellow, oblong, biconvex film-coated tablets with "I 03" printed on one side and smooth on the other side.
Tramadolo e Paracetamolo Aurobindo film-coated tablets are available in packs containing PVC/PVdC-aluminum foil blisters and in white opaque HDPE containers with polypropylene closure.
Pack sizes:
Blister packs: 10, 20, 30, 60, 90 and 100 film-coated tablets.
HDPE container: 30, 250 and 1000 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Aurobindo Pharma (Italia) S.r.l., via San Giuseppe 102 - 21047 Saronno (VA)

Manufacturer
APL Swift Services (Malta) Limited - HF26, Hal Far Industrial Estate, Hal Far, Birzebbugia - BBG 3000 - Malta

This medicinal product is authorized in the European Economic Area countries under the following names:
Belgium Tramadol/Paracetamol AB 37.5 mg/325 mg film-coated tablets
Italy Tramadolo e Paracetamolo Aurobindo
Malta Tramadol/Paracetamol Aurobindo 37.5mg/325mg, film-coated tablets
Netherlands Tramadol HCl/Paracetamol Aurobindo 37.5/325 mg, film-coated tablets
Portugal Tramadol + Paracetamol Aurobindo
Spain Tramadol/Paracetamol Aurovitas 37.5mg/325mg, film-coated tablets EGF