Tramadol/paracetamol teva 37,5 mg/325 mg comprimidos recubiertos con pelicula efg

Patient Information Leaflet

Tramadol/Paracetamol Teva 37.5 mg/325 mg

Film-coated tablets EFG

Tramadol hydrochloride / paracetamol

Read this leaflet carefully before you start to take 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. Do not give it to others, even if they have the same symptoms of the disease, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

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

3.How to take Tramadol/Paracetamol Teva

4.Possible side effects

5Storage of Tramadol/Paracetamol Teva 3

6.Contents of the pack and additional information

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

This medication is usedfor the symptomatic treatment of moderate to severe pain whenever your doctor believes that the combination of tramadol and paracetamol is necessary.

Tramadol/Paracetamol Tevashould only be used by adults and adolescents over 12years old.

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 medication for insomnia, potent analgesics, or other psychotropic drugs (medicines that can 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 in the last 14 days before treatment with Tramadol/Paracetamol Teva;
• if you have a severe liver disorder;
• if you have uncontrolled epilepsy.

Warnings and precautions

Consult your doctor before starting to take Tramadol/Paracetamol Teva.

• if you are taking other medicines that contain paracetamol or tramadol;
• if you have liver problems or liver disease or if you notice that your eyes or skin turn yellow. This may be indicative of jaundice or problems with your bile ducts;
• if you have kidney problems;
• if you have severe respiratory difficulties, for example asthma or severe lung problems;
• if you have epilepsy or have already 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-relieving medication, for example morphine;
• if you are taking other pain-relieving medicines that contain buprenorphine, nalbuphine or pentazocine;
• if you are to be anaesthetized. Tell 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").

Inform your doctor immediately if you experience any of the following during treatment with Tramadol/Paracetamol Teva:

• if you have severe diseases, such as severe kidney failure or sepsis (when bacteria and their toxins circulate in the blood, causing damage to organs), or if you have malnutrition, chronic alcoholism or are also taking flucloxacillin (an antibiotic). A serious disease called metabolic acidosis (a blood and fluid anomaly) has been reported in patients in these situations when using paracetamol at regular doses for a prolonged period or when taking paracetamol with flucloxacillin. Symptoms of metabolic acidosis may include: severe difficulty breathing with deep and rapid breathing, drowsiness, feeling unwell (nausea) and vomiting.

Respiratory disorders related to sleep:

Tramadol/paracetamol may cause respiratory disorders related to sleep such as sleep apnea (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 lack of breathing, difficulty maintaining sleep or excessive daytime somnolence. If you or someone else observes 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 and this may affect each person differently. In some people, it may be possible to achieve insufficient pain relief, while others may be more likely to experience severe adverse effects. If you notice any of the following adverse effects, stop taking this medicine and consult a doctor immediately: slow or shallow breathing, confusion, drowsiness, constricted pupils, general feeling of being unwell or vomiting, constipation, loss of appetite.

If any of the above points have occurred in the past or occur while taking tramadol/paracetamol, make sure your doctor knows. They may decide whether you should continue using this medicine.

Speak 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 indicative of adrenal insufficiency (low cortisol levels). If you experience these symptoms, contact your doctor, who will decide whether you need to take hormone supplements.

There is a weak risk that you may experience a serotonin syndrome that can occur after taking tramadol in combination with certain antidepressants or tramadol monotherapy. Consult your doctor immediately if you experience any of the symptoms associated with this serious syndrome (see section 4 "Possible adverse effects").

Tolerance, dependence and addiction

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

Dependence or addiction can cause a feeling of lack of control over the amount of medication you should use or the frequency with which you should use 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 experienced dependence on it, prescription medications or illegal drugs ("addiction").
• You are a smoker.
• You have had any mental health problems (depression, anxiety or personality disorder) or have been treated by a psychiatrist for other mental health conditions.
• If you notice any of the following symptoms while using tramadol/paracetamol, it could be a sign of dependence or addiction:

• You need to use the medication for longer than indicated by your doctor.
• You need to use a higher dose than recommended.
• You are using the medication for reasons other than those prescribed, for example, "to feel calm" or "to help you sleep".
• You have made repeated and unsuccessful attempts to stop using the medication or control your use.
• You feel unwell when you stop using the medication, and you feel better once you take it again ("withdrawal symptoms").

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

Children and adolescents

Do not recommend use in children under 12 years old.

Use in children with respiratory problems:

Do not recommend the use of tramadol in children with respiratory problems, as the symptoms of tramadol toxicity may worsen in these children.

Use of Tramadol/Paracetamol Teva with other medicines

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medication.

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

Youmust nottake Tramadol/Paracetamol Teva withmonoamine oxidase inhibitors ("MAOIs")(see "Do not take Tramadol/Paracetamol Teva").

Do not recommend taking Tramadol/Paracetamol Teva with the following:

-carbamazepine (a medicine normally used to treat epilepsy or some types of pain such as trigeminal neuralgia attacks),

-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 anomaly (called metabolic acidosis) that requires urgent treatment (see section 2).

The risk of adverse effects increases if you are taking:

• triptans (for migraines) or selective serotonin reuptake inhibitors, SSRIs (for depression). If you experience confusion, restlessness, fever, sweating, uncoordinated limb or eye movements, uncontrollable muscle spasms or diarrhea, you should call your doctor.
• other pain-relieving medications such as morphine and codeine (also used to treat cough), baclofen (muscle relaxant) blood pressure-lowering medications, allergy medications.You may feel drowsy or feel like fainting. If this happens, tell your doctor.
• gabapentin or pregabalin for treating epilepsy or pain due to nervous system problems (neuropathic pain)
• Medicines that may cause seizures such as certain antidepressants or antipsychotics. The risk of seizures may increase if you take Tramadol/Paracetamol Teva simultaneously. Your doctor will tell you if Tramadol/Paracetamol Teva is suitable for you
• antidepressants. Tramadol/Paracetamol Teva may interact with these medications and you may experiencea serotonin syndrome (see section 4 "Possible adverse effects").
• warfarin or phenprocoumon (to prevent blood clots). The effectiveness of these medications may be altered and bleeding may occur. You should inform your doctor immediately of any prolonged or unexpected bleeding.

The effectiveness ofTramadol/Paracetamol Tevamay be altered if you are also taking:

-metoclopramide, domperidone or ondansetron (medicines for treating nausea and vomiting),

-colestiramine (medicine that reduces cholesterol in the blood),

Your doctor will tell youwhich medicines are safe to take withTramadol/Paracetamol Teva.

Tramadol/Paracetamol Teva with food, drinks and alcohol

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

Pregnancy, breastfeeding and fertility

Pregnancy

If you are pregnant or breastfeeding, or think you may be 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 during treatment withTramadol/ParacetamolTeva, consult your doctor before taking more tablets.

Breastfeeding

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

Based on human experience, it is suggested that tramadol has no influence on female or male 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 Tevamay cause drowsiness and may affect your ability to drive or use tools or machines safely.

Tramadol/Paracetamol Teva contains sodium

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

Follow exactly the administration instructions of this medication as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

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

You must takeTramadol/Paracetamol Tevafor the shortest time possible.

It is not recommended for use in children under 12 years of age.

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

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

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

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

Do not takeTramadol/Paracetamol Tevamore frequently than your doctor has indicated.

Older adults

In elderly patients (over 75 years old), the elimination of tramadol may be delayed. If this happens, your doctor may recommend increasing the interval between doses.

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

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

Administration form:

The tablets are for oral administration.

Swallow the tablets whole with sufficient liquid, do not break or chew them.

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

If you take moreTramadol/Paracetamol Tevathan you should

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

In case of overdose or accidental ingestion, call the Toxicological Information Service, phone 91 562 04 20 indicating the medication and the amount taken.

If you forgot to take Tramadol/Paracetamol Teva

If you forgot to take the tablets, it is likely that the pain will recur. Do not take a double dose to compensate for the missed doses, simply continue taking the tablets as usual.

If you interrupt treatment with Tramadol/Paracetamol Teva

You should not stop taking this medication suddenly unless your doctor tells you to. If you want to stop taking your medication, talk to your doctor first, especially if you have been taking it for a long time. Your doctor will inform you when and how to stop it, which can be done by gradually reducing the dose to reduce the risk of unnecessary adverse effects (withdrawal symptoms).

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

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

If you experience any of the following, stop treatment and consult a doctor immediately. Do not take the medicine again.

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

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

Other reported side 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, diarrhea), stomach pain, dry mouth,

-itching, sweating (hyperhidrosis),

-headache, agitation,

-confusion, sleep disorders, mood changes (anxiety, nervousness, feeling elated).

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

-increased heart rate or blood pressure, heart rhythm or frequency disorders,

-tingling, numbness or pins and needles in the extremities, ear noises, involuntary muscle spasms,

-depression, nightmares, hallucinations (hearing, seeing or perceiving something that does not exist in reality),memory loss,

-difficulty breathing

-difficulty swallowing,blood in the stool,

-skin reactions (for example, skin rashes, urticaria),

-increased liver enzyme values,

-presence of albumin in the urine, difficulty or pain when urinating,

-chills, hot flashes, chest pain.

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

-seizures,difficulty performing coordinated movements,

-transient loss of consciousness (syncope),

-drug dependence,

-delirium,

-blurred vision

-pupil constriction (miosis),

-excessive pupil dilation (mydriasis),

-transient loss of consciousness (syncope),

-speech disorder.

Not known (cannot be estimated from available data):

- Decreased blood sugar levels (hypoglycemia).

- Serotonin syndrome, which may manifest 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, diarrhea) (see section 2 "what you need to know before taking Tramadol/Paracetamol Teva).

The following side effects recognized have been reported by people who have taken medications containing only tramadol or only paracetamol.

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

• Unknown frequency (cannot be estimated from available data): a serious disease that can make the blood more acidic (denominated metabolic acidosis) in seriously ill patients using paracetamol (see section 2).

-dizziness when getting up after being lying down or sitting,low 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 with the antibiotic flucloxacillin may induce an anomaly in the blood and fluids (metabolic acidosis with high anion gap) when there is an increase in plasma acidity.
• The use of tramadol/paracetamol with medications 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 that may manifest as sudden swelling of the face and neck, difficulty breathing or low blood pressure and dizziness. If this happens,stop treatment and consult your doctor immediately. Do not take this medicine again.

In rare cases, using a medicine like tramadol, may make you dependent, making it difficult to stop taking it.

In rare cases, people who have been taking tramadol for some time may feel unwell if they stop treatment abruptly. They may feel agitated, anxious, nervous or shaky. They may be hyperactive, have difficulty sleeping and experience digestive and intestinal problems. Very few people may also experience panic attacks, hallucinations, unusual perceptions such as itching, tingling and numbness, and ear noises (tinnitus). If you experience any of these symptoms after stopping treatment with Tramadol/Paracetamol Teva, consult your doctor.

Unknown frequency: hiccups.

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

There have been reports of rare severe skin reactions with paracetamol.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep out of the sight and reach of children.

Store this medication in a safe and protected place, to which no other people can access. This medication may cause serious harm or even be fatal to individuals who have not been prescribed it.

Do not use this medication after the expiration date that appears on the carton and blister after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy.If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need.By doing so, you will help protect the environment.

Composition of Tramadol/Paracetamol Teva

• The active ingredients aretramadol hydrochlorideandparacetamol.

Each film-coated tablet contains 37.5mg oftramadol hydrochlorideand 325mg of paracetamol.

The other components are: tablet core: kollicoat IR [polyvinyl alcohol macrogol 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).

Appearance of the product and contents of the package

Tramadol/Paracetamol Tevafilm-coated tablets areorange in color, in capsule shape, engraved with T37.5 on one side and A325 on the other side.

Tramadol/Paracetamol Tevais presented in carton boxes with blister packs of 2, 10, 15, 20, 30, 40, 60, and 90tablets and bottles with 10tablets and 100tablets.

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Teva Pharma S.L.U.

C/ Anabel Segura nº 11, Edificio Albatros B, 1st floor

Alcobendas 28108 Madrid

Responsible 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 authorized in the Community under the following names:

Belgium: Tramadol/Paracetamol Teva 37.5 mg/325 mg filmomhulde tabletten

Slovenia: Tramadol/Paracetamol Teva37.5mg/325mg film‑coated tablets

Spain: Tramadol/Paracetamol Teva 37,5 mg/325 mg comprimidos recubiertos con película EFG

France: TRAMADOL/PARACETAMOL TEVA

Netherlands: Tramadol HCl/Paracetamol 37,5/325 mg Teva

Poland: PADOLTEN 37.5mg/325mg film‑coated tablets

United Kingdom (Northern Ireland): Tramadol hydrochloride/Paracetamol

Last review date of this leaflet:February 2025

The detailed information of this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.es/.