Tramadol/paracetamol Teva 37.5 mg/325 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

Tramadol/Paracetamol Teva 37.5 mg/325 mg

film-coated tablets EFG

tramadol hydrochloride/paracetamol

Read the entire leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet:

1. What Tramadol/Paracetamol Teva is and what it is used for

2. What you need to know before taking Tramadol/Paracetamol Teva

3. How to take Tramadol/Paracetamol Teva

4. Possible side effects

5. Storage of Tramadol/Paracetamol Teva 3

6. Contents of the pack and other information

1. What Tramadol/Paracetamol Teva is and what it is used for

Tramadol/Paracetamol Teva is a combination of two analgesics, tramadol and paracetamol, which work together to relieve pain.

This medicine is used for the symptomatic treatment of moderate to severe pain, when your doctor considers that the combination of tramadol and paracetamol is necessary.

Tramadol/Paracetamol Teva should only be used by adults and adolescents over 12 years of age.

2. What you need to know before taking Tramadol/Paracetamol Teva

Do not take Tramadol/Paracetamol Teva

• if you are allergic to tramadol, paracetamol, or any of the other ingredients of this medicine (listed in section 6);
• in case of acute alcohol intoxication, if you have taken any medicines for the treatment of insomnia, strong painkillers, or other psychotropic medicines (medicines that may alter mood and emotions);
• if you are also taking MAO inhibitors (certain medicines used to treat depression or Parkinson's disease), or if you have taken them within the last 14 days before starting treatment with Tramadol/Paracetamol Teva;
• if you have severe liver impairment;
• if you have epilepsy that is not adequately controlled with your current treatment.

Warnings and precautions

Talk to your doctor before starting to take Tramadol/Paracetamol Teva:

• if you are taking other medicines containing paracetamol or tramadol;
• if you have liver problems or liver disease, or if you notice that your eyes or skin turn yellow. This may indicate jaundice or problems with your bile ducts;
• if you have kidney problems;
• if you have severe breathing difficulties, such as asthma or serious lung conditions;
• if you have epilepsy or have previously experienced seizures or convulsions;
• if you have recently suffered a head injury, shock, or severe headaches associated with vomiting;
• if you are dependent on any other pain-relief medicines, for example morphine;
• if you are taking other pain medicines containing buprenorphine, nalbuphine, or pentazocine;
• if you are due to undergo anesthesia. Inform your doctor or dentist that you are using Tramadol/Paracetamol Teva.
• If you suffer from depression and are taking antidepressants, as some may interact with tramadol (see “Other medicines and Tramadol/Paracetamol Teva”).

During treatment with Tramadol/Paracetamol Teva, inform your doctor immediately:

• If you have serious conditions such as severe renal failure or sepsis (when bacteria and their toxins circulate in the blood, causing organ damage), or if you suffer from malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic). A serious condition called metabolic acidosis (an imbalance in blood and body fluids) has been reported in patients in these situations when paracetamol is used at regular doses over a prolonged period or when paracetamol is taken together with flucloxacillin. Symptoms of metabolic acidosis may include: severe difficulty breathing with deep and rapid breathing, drowsiness, feeling unwell (nausea), and vomiting.

Sleep-related breathing disorders:

Tramadol/paracetamol may cause sleep-related breathing disorders such as sleep apnea (pauses in breathing during sleep) and sleep-related hypoxemia (low oxygen levels in the blood). Symptoms may include breathing pauses during sleep, waking up at night due to difficulty breathing, trouble staying asleep, or excessive daytime sleepiness. If you or someone else notices these symptoms, contact your doctor. Your doctor may consider reducing the dose.

Tramadol is metabolized in the liver by an enzyme. Some people have a variation of this enzyme, which may affect individuals differently. In some people, sufficient pain relief may not be achieved, while others may be more likely to experience serious adverse effects. If you notice any of the following adverse effects, you must stop taking this medicine and consult a doctor immediately: slow or shallow breathing, confusion, drowsiness, constricted pupils, general malaise, vomiting, constipation, or loss of appetite.

If any of the above conditions have occurred in the past or occur while you are taking tramadol/paracetamol, make sure your doctor is aware. Your doctor will decide whether you should continue using this medicine.

Talk to your doctor, pharmacist, or nurse if you experience any of the following symptoms while taking Tramadol/Paracetamol Teva: extreme fatigue, loss of appetite, severe abdominal pain, nausea, vomiting, or low blood pressure. These may be signs of adrenal insufficiency (low cortisol levels). If you experience these symptoms, contact your doctor, who will decide whether you need hormonal supplementation.

There is a weak risk that you may develop a serotonin syndrome after taking tramadol in combination with certain antidepressants or tramadol as monotherapy. Seek immediate medical advice if you experience any symptoms associated with this serious syndrome (see section 4 “Possible side effects”).

Tolerance, dependence, and addiction

This medicine contains tramadol, which is an opioid medicine. Repeated use of opioids may cause the medicine to become less effective (the body becomes accustomed to it, known as pharmacological tolerance). Repeated use of tramadol/paracetamol may also lead to dependence, abuse, and addiction, which could result in a potentially fatal overdose. The risk of these adverse effects may be higher with higher doses and prolonged use.

Dependence or addiction may cause a feeling of loss of control over the amount of medicine you need to take or how often you need to take it.

The risk of dependence or addiction varies from person to person. The risk of becoming dependent or addicted to [product name] may be higher if:

• You or any member of your family have abused alcohol or been dependent on alcohol, prescription medicines, or illegal drugs (“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/paracetamol, this could be a sign of dependence or addiction:

• You need to use the medicine for longer than prescribed by your doctor.

• You need to take a higher dose than recommended.

• You are using the medicine for reasons other than prescribed, for example, “to feel calm” or “to help you sleep.”

• You have made repeated but unsuccessful attempts to stop using the medicine or control its use.

• You feel unwell when you stop taking the medicine, and feel better once you take it again (“withdrawal effects”).

• If you notice any of these signs, consult your doctor to determine the best treatment approach for you, when it is appropriate to stop the medicine, and how to do so safely (see section 3, if you stop treatment with Tramadol/Paracetamol Teva).

Children and adolescents

Use is not recommended in children under 12 years of age.

Use in children with breathing problems:

The use of tramadol is not recommended in children with breathing problems, as symptoms of tramadol toxicity may worsen in these children.

Taking Tramadol/Paracetamol Teva with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Important: this medicine contains paracetamol and tramadol. Inform your doctor if you are taking any other medicine containing paracetamol or tramadol, so that you do not exceed the maximum daily dose.

You must not take Tramadol/Paracetamol Teva together with monoamine oxidase inhibitors (“MAOIs”) (see section “Do not take Tramadol/Paracetamol Teva”).

It is not recommended to take Tramadol/Paracetamol Teva with the following:

• carbamazepine (a medicine usually used to treat epilepsy or certain types of pain such as severe facial pain attacks known as trigeminal neuralgia),
• buprenorphine, nalbuphine, or pentazocine (opioid analgesics). Pain relief may be reduced.

Inform your doctor or pharmacist if you are taking:

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

The risk of adverse effects increases if you are taking:

• triptans (for migraine) or selective serotonin reuptake inhibitors (SSRIs) (for depression). If you experience confusion, restlessness, fever, sweating, uncoordinated movements of limbs or eyes, uncontrollable muscle spasms, or diarrhea, contact your doctor.
• other pain relievers such as morphine and codeine (also used to treat cough), baclofen (muscle relaxant), medicines used to lower blood pressure, or medicines to treat allergies. You may feel drowsy or faint. If this occurs, inform your doctor.
• concomitant use of tramadol/paracetamol and sedative medicines such as benzodiazepines or related medicines increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening. Because of this, concomitant use should only be considered when no other treatment options are available. However, if your doctor prescribes tramadol/paracetamol together with sedative medicines, the dose and duration of concomitant treatment must be limited by your doctor. Discuss with your doctor all sedative medicines you are taking and follow your doctor’s instructions exactly. It may be helpful to inform friends or family members to watch for the signs and symptoms mentioned above. Contact your doctor if you experience these symptoms.
• gabapentin or pregabalin for treating epilepsy or nerve-related pain (neuropathic pain),
• medicines that may provoke seizures, such as certain antidepressants or antipsychotics. The risk of seizures may increase if you take Tramadol/Paracetamol Teva simultaneously. Your doctor will advise whether Tramadol/Paracetamol Teva is suitable for you,
• certain antidepressants. Tramadol/Paracetamol Teva may interact with these medicines and may cause serotonin syndrome (see section 4 “Possible side effects”).
• warfarin or phenprocoumon (to prevent blood clots). The effectiveness of these medicines may be altered and bleeding may occur. You must inform your doctor immediately of any prolonged or unexpected bleeding.

The effectiveness of Tramadol/Paracetamol Teva may be affected if you are also taking:

• metoclopramide, domperidone, or ondansetron (medicines for treating nausea and vomiting),
• colestyramine (a medicine that lowers blood cholesterol),

Your doctor will advise you which medicines are safe to take with Tramadol/Paracetamol Teva.

Tramadol/Paracetamol Teva with food, drinks, and alcohol

Tramadol/Paracetamol Teva may make you feel drowsy. Alcohol may increase drowsiness, so it is best not to drink alcohol while taking Tramadol/Paracetamol Teva.

Pregnancy, breastfeeding, and fertility

Pregnancy

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Because this medicine contains tramadol, you should not take this medicine during pregnancy. If you become pregnant while being treated with Tramadol/Paracetamol Teva, consult your doctor before taking any further tablets.

Breastfeeding

Tramadol is excreted in breast milk. Therefore, you should not take Tramadol/Paracetamol Teva more than once during breastfeeding, or if you take Tramadol/Paracetamol Teva more than once, you must stop breastfeeding.

Based on human experience, it is suggested that tramadol has no influence on male or female fertility. There are no data available on the influence of the combination of tramadol/paracetamol on fertility.

Consult your doctor or pharmacist before taking any medicine.

Driving and using machines

Tramadol/Paracetamol Teva may cause drowsiness and may affect your ability to drive or operate tools or machinery safely.

Tramadol/Paracetamol Teva contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which is considered “essentially sodium-free”.

3. How to take Tramadol/Paracetamol Teva

Follow exactly the instructions given by your doctor for taking this medicine. If you have any doubts, consult your doctor or pharmacist.

Before starting treatment and regularly during treatment, your doctor will also explain to you what you can expect from using tramadol/paracetamol, when and for how long you should use it, when you should contact your doctor, and when you should stop using it (see also section 2).

You should take Tramadol/Paracetamol Teva for the shortest possible time.

Use in children under 12 years of age is not recommended.

The dose should be adjusted according to the intensity of pain and your individual sensitivity to pain. In general, the lowest effective dose that relieves pain should be used.

The recommended starting dose, unless otherwise prescribed by your doctor, is 2 tablets for adults and adolescents over 12 years of age.

If necessary, additional doses may be taken as recommended by your doctor. The shortest interval between doses must be at least 6 hours.

Do not take more than 8 film-coated tablets of Tramadol/Paracetamol Teva per day.

Do not take Tramadol/Paracetamol Teva more frequently than prescribed by your doctor.

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 increasing the dosing interval.

Patients with severe renal or hepatic impairment (insufficiency)/dialysis

Patients with severe renal and/or hepatic insufficiency must not take tramadol/paracetamol. If your condition involves mild or moderate impairment, your doctor may recommend increasing the interval between doses.

Method of administration:

The tablets are for oral use.

Swallow the tablets whole with sufficient liquid. They must not be split or chewed.

If you feel that the effect of Tramadol/Paracetamol Teva is too strong (for example, you feel very drowsy or have difficulty breathing) or too weak (for example, you do not get adequate pain relief), inform your doctor.

If you take more Tramadol/Paracetamol Teva than you should

In such cases, consult your doctor or pharmacist immediately, even if you feel well. There is a risk of liver damage, which may only become apparent later.

In case of overdose or accidental ingestion, call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and the amount taken.

If you forget to take Tramadol/Paracetamol Teva

If you forget to take the tablets, your pain may return. Do not take a double dose to make up for forgotten doses; simply continue taking the tablets as usual.

If you stop taking Tramadol/Paracetamol Teva

You must not stop taking this medicine suddenly unless your doctor tells you to. If you wish to stop taking your medicine, speak to 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 experiencing unnecessary adverse effects (withdrawal symptoms).

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

4. Possible adverse effects

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

If you experience any of the following, stop treatment immediately and seek medical help. You must not take this medicine again.

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

• Skin rash indicating an allergic reaction, with sudden swelling of the face and neck, difficulty breathing, or low blood pressure and fainting.

Other reported adverse effects include:

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 pain, dry mouth,
• itching, sweating (hyperhidrosis),
• headache, restlessness,
• confusion, sleep disorders, mood changes (anxiety, nervousness, feeling elated).

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

• increased pulse or blood pressure, disturbances in heart rate or rhythm,
• tingling, numbness, or prickling sensations in the limbs, ringing in the ears, involuntary muscle spasms,
• depression, nightmares, hallucinations (hearing, seeing, or sensing something that does not exist in reality), memory loss,
• difficulty breathing,
• difficulty swallowing, blood in the stools,
• skin reactions (e.g. rashes, hives),
• increased levels of liver enzymes,
• presence of albumin in the urine, difficulty or pain when urinating,
• chills, hot flushes, chest pain.

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

• seizures, difficulty performing coordinated movements,
• temporary loss of consciousness (syncope),
• drug dependence,
• delirium,
• blurred vision,
• constriction of the pupils (miosis),
• excessive dilation of the pupils (mydriasis),
• temporary loss of consciousness (syncope),
• speech disorder.

Not known (cannot be estimated from available data):

• Decrease in blood sugar levels (hypoglycaemia).
• Serotonin syndrome, which may present with changes in mental status (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/Paracetamol Teva").

The following adverse effects have been reported in people taking medicines containing tramadol alone or paracetamol alone.

However, if you experience any of these symptoms while taking Tramadol/Paracetamol Teva, you should inform your doctor:

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

• Dizziness upon standing up from lying or sitting down, slow heart rate, fainting, changes in appetite, muscle weakness, slower or weaker breathing, mood changes, changes in activity, changes in perception, worsening of existing asthma.

  • The use of paracetamol alone or when taken together with the antibiotic flucloxacillin may induce a blood and fluid disorder (metabolic acidosis with high anion gap) when there is an increase in plasma blood acidity.
  • The use of tramadol/paracetamol together with medicines used to thin the blood (e.g. phenprocoumon, warfarin) may increase the risk of bleeding. Any unexpected or prolonged bleeding should be reported to your doctor immediately.
  • In rare cases, skin rashes indicating allergic reactions may occur, which may present as sudden swelling of the face and neck, shortness of breath, or drop in blood pressure and dizziness. If this happens, stop treatment and consult your doctor immediately. You must not take this medicine again.

In rare cases, using a medicine such as tramadol may lead to dependence, making it difficult for you to stop taking it.

Rarely, people who have been taking tramadol for some time may feel unwell if treatment is stopped abruptly. They may feel restless, anxious, nervous, or shaky. They may become hyperactive, have difficulty sleeping, and experience gastrointestinal and intestinal disturbances. Very few people may also experience panic attacks, hallucinations, unusual perceptions such as itching, tingling, or numbness, and ringing in the ears (tinnitus). If you experience any of these symptoms after stopping treatment with Tramadol/Paracetamol Teva, consult your doctor.

Frequency not known: hiccups.

In exceptional cases, blood tests may reveal certain abnormalities, for example, low platelet count, which may result in nosebleeds or bleeding gums.

Very rare cases of serious skin reactions have been reported with paracetamol.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Tramadol/Paracetamol Teva

Keep out of the sight and reach of children.

Store this medicine in a safe and secure place, inaccessible to other people. This medicine may cause serious harm or even be fatal to individuals for whom it has not been prescribed.

Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE Point in your pharmacy. If you are unsure, please ask your pharmacist how to properly dispose of unused medicines and packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Tramadol/Paracetamol Teva

• 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: Kollicoat IR coating [polyvinyl alcohol-polyethylene glycol copolymer], pregelatinized maize starch, microcrystalline cellulose, sodium starch glycolate (type A) from potato, hypromellose, magnesium stearate; film coating: Opadry II beige 85F97409: polyvinyl alcohol, titanium dioxide (E171), macrogol, talc, yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172).

Nature of the product and pack sizes

Tramadol/Paracetamol Teva film-coated tablets are peach-coloured, capsule-shaped, engraved with T37.5 on one side and A325 on the other.

Tramadol/Paracetamol Teva is available in cardboard boxes containing blister packs of 2, 10, 15, 20, 30, 40, 60 and 90 tablets, and bottles containing 10 and 100 tablets.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Teva Pharma S.L.U.
C/ Anabel Segura nº 11, Edificio Albatros B, 1st floor
Alcobendas 28108 Madrid, Spain

Manufacturer

Teva Operations Poland Sp. z o.o.
Mogilska 80, 31-546 Krakow, Poland

or:

PLIVA HRVATSKA D.O.O. (PLIVA CROATIA LTD)
Prilaz baruna Filipovica 25, 10000 Zagreb, Croatia

This medicinal product is authorised in Member States under the following names:

Belgium: Tramadol/Paracetamol Teva 37.5 mg/325 mg filmomhulde tabletten
Slovenia: Tramadol/Paracetamol Teva 37.5 mg/325 mg film-coated tablets
Spain: Tramadol/Paracetamol Teva 37.5 mg/325 mg film-coated tablets EFG
France: TRAMADOL/PARACETAMOL TEVA
Netherlands: Tramadol HCl/Paracetamol 37.5/325 mg Teva
Poland: PADOLTEN 37.5 mg/325 mg film-coated tablets
United Kingdom (Northern Ireland): Tramadol hydrochloride/Paracetamol

Date of the most recent review of this leaflet: February 2025

Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.es/.