Leaflet: information for the user

Tramadol/ParacetamolAlmus 37.5 mg/ 325 mg film-coated tablets

Tramadol/paracetamol hydrochloride

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, consult 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 as you, 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.

Tramadol/ParacetamolAlmus, is a combination of two analgesics: Tramadol and paracetamol, which act together to relieve pain.

It is indicated for symptomatic treatment of moderate to intense pain whenever your doctor believes that the combination of tramadol and paracetamol is necessary.

Should only be used by adults and children over 12 years old.

Do not take Tramadol/Paracetamol Almus if you:

- are allergic (hypersensitive) to tramadol, paracetamol, or any of the other components of this medicine (listed in section 6).

- have acute alcohol intoxication, if you have taken any medication for insomnia, potent analgesics (opioids), or psychotropic drugs (drugs that can alter the level of consciousness).

- are taking monoamine oxidase inhibitors (MAOIs) (certain medications used to treat depression or Parkinson's disease), or if you have taken them in the last 14 days before treatment with Tramadol/Paracetamol Almus.

- have severe liver disease.

- have uncontrolled epilepsy.

Warnings and precautions

Consult your doctor before starting to take Tramadol/Paracetamol Almus:

- if you are taking other medications 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 are epileptic or have had seizures;

- if you have recently had a head injury, severe headaches associated with vomiting;

- if you have dependence on any other medication used to relieve pain, for example, morphine;

- if you are taking other pain medications that contain buprenorphine, nalbuphine, or pentazocine;

- if you are to be anesthetized. Tell your doctor or dentist that you are using Tramadol/Paracetamol Almus.

Consult your doctor or pharmacist before starting to take Tramadol/Paracetamol Almus.

If you suffer from depression and are taking antidepressants, as some may interact with tramadol (see "Taking Tramadol/Paracetamol Almus and other medications").

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

- if you have severe illnesses, 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 if you are also taking flucloxacillin (an antibiotic). A serious condition 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 respiratory difficulty with deep and rapid breathing, drowsiness, feeling unwell (nausea) and vomiting.

The tramadol is metabolized in the liver by an enzyme. Some people have a variation of this enzyme, and this can 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 medication and consult a doctor immediately: slow or shallow breathing, confusion, drowsiness, constricted pupils, general feeling of discomfort or vomiting, constipation, loss of appetite.

Respiratory disorders related to sleep

Tramadol/Paracetamol Almus may cause respiratory disorders related to sleep, such as central sleep apnea (pause in breathing during sleep) and sleep-related hypoxemia (low oxygen level in the blood). These symptoms may include: pause in breathing during sleep, nocturnal awakening due to difficulty breathing, difficulty maintaining sleep or excessive daytime somnolence. If you or someone else observes these symptoms, consult your doctor. Your doctor may consider reducing the dose.

If you experience or have experienced any of the following problems while taking Tramadol/Paracetamol Almus, please inform your doctor. He will decide if you should continue taking this medication.

Talk to your doctor if you experience any of the following symptoms while taking Tramadol/Paracetamol Almus:

Extreme fatigue, loss of appetite, severe abdominal pain, nausea, vomiting, or low blood pressure. This may indicate that you have adrenal insufficiency (low cortisol levels). If you experience any of these symptoms, inform your doctor, and he will decide if you should take a hormonal supplement.

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 medication contains tramadol, which is an opioid medication. Repeated use of opioids can make the medication less effective (you become tolerant of it, known as tolerance). Repeated use of Tramadol/Paracetamol Almus can also lead to dependence, abuse, and addiction, which can result in a potentially fatal overdose. The risk of these adverse effects may increase with a higher dose and longer duration of use.

Dependence or addiction can make you feel like you no longer control the amount of medication you need to take or the frequency with which you need to take it.

The risk of becoming dependent or addicted to Tramadol/Paracetamol Almus varies from person to person. You may have a higher risk of becoming dependent or addicted to Tramadol/Paracetamol Almus if:

• You or a family member has abused or been dependent on alcohol, prescription medications, or illegal drugs ("addiction").
• You are a smoker.
• You have had problems with your mood (depression, anxiety, or personality disorder) or have been treated by a psychiatrist for other mental illnesses.

If you notice any of the following signs while taking [product name], it could be a sign that you have become dependent or addicted:

• You need to take the medication for a longer period than advised by your doctor.
• You need to take more than the recommended dose.
• You use the medication for reasons other than those prescribed, for example, "to stay calm" or "to sleep".
• You have repeatedly and unsuccessfully tried to stop or control the use of the medication.
• When you stop taking the medication, you feel unwell, and you feel better when you take it again ("withdrawal effect").

If you observe any of these signs, talk to your doctor to determine the best course of treatment for you, including when it is appropriate to stop taking it and how to do it safely (see section 3, If you interrupt treatment with Tramadol/Paracetamol Almus).

Children and adolescents

Use in children with respiratory problems

Tramadol should not be used in children with respiratory problems, as the symptoms of tramadol toxicity may worsen in these children.

Taking Tramadol/Paracetamol Almus with other medications

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

Important: This medication 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 not takeTramadol/Paracetamol Almus with monoamine oxidase inhibitors (MAOIs) (see "Do not take Tramadol/Paracetamol Almus").

Tramadol/Paracetamol Almus is contraindicated in the following situations:

- Carbamazepine (a medication normally used to treat epilepsy or some types of pain, such as severe facial pain called trigeminal neuralgia).

- Buprenorphine, nalbuphine, or pentazocine (opioid analgesic). Pain relief may be reduced.

The risk of adverse effects increases if you also use:

- Triptans (for the treatment of migraines) or selective serotonin reuptake inhibitors (SSRIs) (for the treatment of depression). If you experience confusion, agitation, fever, sweating, uncoordinated movements of the limbs or eyes, involuntary muscle contractions, or diarrhea, you should call your doctor.

- Sedatives, sleeping pills, other analgesics such as morphine and codeine (also when used to treat cough), baclofen (muscle relaxant), some medications to lower blood pressure, antidepressants, or medications for allergies. You may feel drowsy or dizzy. If this occurs, consult your doctor.

- Antidepressants, anesthetics, neuroleptics (medications that affect mood) or bupropion (medication used as a smoking cessation aid). The risk of having a seizure may increase. Your doctor will tell you if Tramadol/Paracetamol Almus is suitable for you.

- Warfarin or phenprocoumon (medication used to prevent blood clots). The effectiveness of these medications may be altered, and there is a risk of bleeding. Inform your doctor immediately of any prolonged or unexpected bleeding.

- Gabapentin or pregabalin for treating epilepsy or pain due to nerve problems (neuropathic pain).

The effectiveness of Tramadol/Paracetamol Almus may be altered if you also use:

- Metoclopramide, domperidone, or ondansetron (medications for nausea and vomiting),

- Cholestyramine (medication that reduces cholesterol in the blood),

- Ketoconazole and erythromycin (medications used to treat infections).

The risk of adverse effects increases if you are taking medications that facilitate or may cause seizures, such as certain antidepressants or antipsychotics. The risk of seizures increases if you take Tramadol/Paracetamol Almus simultaneously with these medications. Your doctor will tell you if Tramadol/Paracetamol Almus is suitable for you.

The risk of adverse effects increases if you are taking medications for depression. Tramadol/Paracetamol Almus may interact with these medications and may experience a serotonin syndrome (see section 4 "Possible adverse effects").

Other medications and paracetamol

Inform your doctor or pharmacist if you are taking:

- Flucloxacillin (antibiotic), due to a serious risk of blood and fluid imbalance (metabolic acidosis with high anion gap) that must be treated urgently (see section 2).

Your doctor will know which medications are safe to use with Tramadol/Paracetamol Almus.

Taking Tramadol/Paracetamol Almus with food and drinks

Tramadol/Paracetamol Almus may make you feel drowsy. Alcohol may make you feel more drowsy, so it is recommended not to drink alcohol while taking Tramadol/Paracetamol Almus.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medication. Due to the fact that Tramadol/Paracetamol Almus 37.5 mg/325 mg tablets contain tramadol, it is not recommended to use this medication during pregnancy.

Tramadol is excreted inbreast milk. For this reason, you should not take Tramadol/Paracetamol Almus 37.5/325 mg more than once during breastfeeding, or if you take Tramadol/Paracetamol Almus 37.5/325 mg more than once, you should interrupt breastfeeding.

Driving and operating machinery

Ask your doctor if you can drive or operate machinery during treatment with Tramadol/Paracetamol Almus 37.5 mg/325 mg tablets. It is essential to observe how this medication affects you before driving or operating machinery. Do not drive or operate machinery if you feel drowsy, dizzy, have blurred vision, or double vision, or have difficulty concentrating. Be particularly careful at the start of treatment, after increasing the dose, after changing the formulation, and/or when taking it with other medications.

This medication contains less than 23 mg of sodium (1 mmol) per tablet; it is essentially "sodium-free".

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

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

You should take Tramadol/Paracetamol Almus for the shortest time possible. The dose should be adjusted to the intensity of the pain and your individual sensitivity. Normally, you should use the lowest dose possible that produces pain relief.

Use in children

This medication is not recommended for use in children under 12 years old.

Use in adults

Unless your doctor prescribes something different, the recommended starting dose for adults and adolescents over 12 years old is 2 tablets.

If necessary, you can increase the dose as recommended by your doctor. The shortest interval between doses should be at least 6 hours.

Do not take more than 8 tablets of Tramadol/Paracetamol Almus per day.

Do not take Tramadol/Paracetamol Almus more frequently than your doctor has indicated. Your doctor may increase the interval between doses:

• If you are over 75 years old.
• If you have kidney problems.
• If you have liver problems.

Older patients

In older patients (over 75 years old), the elimination of tramadol may be slow. If this is your case, your doctor may recommend prolonging the dosing intervals.

Patients with liver or kidney insufficiency/patients on dialysis

If you have severe liver or kidney disease, treatment with Tramadol/Paracetamol is not recommended. If you have moderate liver or kidney problems, your doctor may prolong the dosing intervals.

Administration form

Tramadol/Paracetamol Almus is presented in the form of tablets for oral administration. The tablets should be swallowed whole with sufficient liquid. They should not be broken or chewed.

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

If you take more Tramadol/Paracetamol Almus than you should:

If you have taken more Tramadol/Paracetamol Almus than you should, even if you feel well, consult your doctor immediately, as there is a risk of severe liver damage that will only become apparent later.

In case of overdose or accidental ingestion, consult the Toxicological Information Service, phone 91 562 04 20. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you forgot to take Tramadol/Paracetamol Almus:

If you forgot to take a dose of Tramadol/Paracetamol Almus, it is likely that the pain will reappear. 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 Almus:

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 interrupt it, which can be done by gradually reducing the dose to reduce the likelihood of unnecessary adverse effects (withdrawal symptoms). If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, Tramadol/Paracetamol Almus can cause side effects, although not everyone will experience them.

Very common:more than 1 in 10 people treated:

- nausea.

- dizziness, drowsiness.

Common:less than 1 in 10, but more than 1 in 100 people treated:

- vomiting, digestive problems (constipation, flatulence, diarrhea), stomach pain, dry mouth.

- itching, increased sweating.

- headache, agitation.

- confusion, sleep disorders, mood changes (anxiety, nervousness, euphoria, feeling "on edge" all the time).

Uncommon:less than 1 in 100, but more than 1 in 1,000 people treated:

- tachycardia, hypertension, cardiac rhythm and frequency disorders.

- difficulty or pain urinating.

- skin reactions (e.g. rashes, urticaria).

- sensation of 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 swallowing, blood in the stool.

- chills, hot flashes, chest pain.

- difficulty breathing.

Rare:less than 1 in 1,000, but more than 1 in 10,000 people treated:

- convulsions, difficulty performing coordinated movements.

- addiction.

- blurred vision.

Frequency not known:cannot be estimated from available data:

- decreased blood sugar levels (hypoglycemia).

- hiccups.

- serotonin syndrome, which can 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 stiffness, lack of coordination, and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhea) (see section 2 "what you need to know before taking Tramadol/Paracetamol Almus").

- a serious disease that can make the blood more acidic (designated as metabolic acidosis) in patients with severe disease who use paracetamol (see section 2).

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 those symptoms while taking Tramadol/Paracetamol Almus, you should tell your doctor:

Feeling of dizziness when standing up after 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 asthma.

- In rare cases, skin eruptions, indicating allergic reactions that can manifest as sudden swelling of the face and neck, shortness of breath, or a drop in blood pressure and dizziness. If this happens, interrupt treatment and consult your doctor immediately. Do not take this medicine again.

- In rare cases, using a medicine like tramadol, can 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 gastrointestinal and intestinal disorders. 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 Almus, please consult your doctor. In exceptional cases, blood tests may reveal certain abnormalities, such as low platelet count, which can cause nasal or gum bleeding. The use of Tramadol/Paracetamol Almus with anticoagulants (e.g. phenprocoumon, warfarin) may increase the risk of bleeding. You should inform your doctor immediately about any prolonged or unexpected bleeding.

If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is not listed in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use. Website:www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

This medication does not require special storage conditions.

Keep this medication out of the sight and reach of children.

Store this medication in a safe and protected place, where other people cannot access it. It can cause serious harm and be fatal to individuals who have not been prescribed it.

Do not usethis medicationafter the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Deposit the packaging and unused medications at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medications. By doing so, you will help protect the environment.

Composition of Tramadol/ParacetamolAlmus

- The active principles are tramadol hydrochloride and paracetamol.

Cada comprimido recubierto con película contiene 37,5 mg de hidrocloruro de tramadol y 325 mg de paracetamol.

- The other components are:

Core of the tablet:

Maize pregelatinized starch, sodium carboxymethyl starch (Type A) from potato, microcrystalline cellulose (Avicel PH 102), magnesium stearate.

Coating: OPADRY yellow YS-15B82958 (hypromellose, polyethylene glycol, titanium dioxide (E171), iron oxide yellow (E172), polysorbate 80).

Appearance of the product and contents of the packaging

Tramadol/Paracetamol Almus 37,5/325 mg coated tablets, are presented in the form of pale yellow tablets packaged in blisters.

Tramadol/Paracetamol Almus is presented in packaging of 20, 60 and 100 tablets.

Only some sizes of packaging may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holderof the marketing authorization:

Almus Farmacéutica, S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona), Spain

Telephone: 93 739 71 80

Email:[email protected]

Responsible for manufacturing:

Laboratorium Sanitatis, S.L.

P. T. Álava - C/ Leonardo da Vinci, 11

01510, Miñano (Álava)

Spain

Last review date of this leaflet:February 2025

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