TRAMADOL/PARACETAMOL ALMUS 37.5 mg/325 mg FILM-COATED TABLETS

2. What you need to know before you take Tramadol/Paracetamol Almus

Do not take Tramadol/Paracetamol Almus if you:

• are allergic (hypersensitive) to tramadol, paracetamol, or any of the other ingredients of this medicine (listed in section 6).
• have acute alcohol intoxication, if you have taken any medication for the treatment of insomnia, potent analgesics (opioids), or psychotropic drugs (drugs that can alter the level of consciousness).
• are taking, or have taken in the last 14 days, monoamine oxidase inhibitors (MAOIs) (certain medicines used for the treatment of depression or Parkinson's disease).
• 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 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 a sign of jaundice or problems with your bile ducts;
• If you have kidney problems;
• If you have severe breathing 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 for pain relief, for example, morphine;
• If you are taking other pain medications that contain buprenorphine, nalbuphine, or pentazocine;
• If you are going 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 with other medicines").

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

• 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 are also taking flucloxacillin (an antibiotic). A severe disease called metabolic acidosis (an anomaly in the blood and fluids) has been reported in patients in these situations when paracetamol is used at regular doses for a prolonged period or when paracetamol is taken with flucloxacillin. The symptoms of metabolic acidosis may include: severe breathing difficulties with deep and rapid breathing, drowsiness, feeling unwell (nausea) and vomiting.

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

Sleep-Related Breathing Disorders

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

If you have or have had any of these problems while taking Tramadol/Paracetamol Almus, please inform your doctor. He will decide if you should continue taking this medicine.

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 present any of these symptoms, inform your doctor, 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 alone. Consult a doctor immediately if you present any of the symptoms related to 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 can make the medicine less effective (you get used to it, which is 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 side effects may increase with a higher dose and longer use.

Dependence or addiction can make you feel that you no longer control the amount of medicine you need to take or how often you need to take it.

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

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

If you notice any of the following signs while taking Tramadol/Paracetamol Almus, it could be a sign that you have become dependent or addicted:

• You need to take the medicine for longer than advised by your doctor
• You need to take more than the recommended dose
• You use the medicine for reasons other than those prescribed, for example, "to calm down" or "to sleep"
• You have repeatedly tried and failed to stop or control the use of the medicine
• When you stop taking the medicine, 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 so that he can indicate the best treatment for you, including when it is appropriate to stop taking it and how to do it safely (see section 3, If you stop taking Tramadol/Paracetamol Almus).

Children and Adolescents

Use in children with respiratory problems

Tramadol is not recommended for use in children with respiratory problems, as the symptoms of tramadol toxicity can worsen in these children.

Taking Tramadol/Paracetamol Almus with other medicines

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

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

You must not takeTramadol/Paracetamol Almus with monoamine oxidase inhibitors (MAOIs) (see section "Do not take Tramadol/Paracetamol Almus").

The use of Tramadol/Paracetamol Almus is contraindicated if you are being treated with:

• Carbamazepine (a medicine normally used to treat epilepsy or certain 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 side 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, uncontrolled muscle contractions, or diarrhea, you should call your doctor.
• Sedatives, sleeping pills, other analgesics such as morphine and codeine (also when used for the treatment of cough), baclofen (muscle relaxant), some medicines to lower blood pressure, antidepressants, or medicines for the treatment of allergies. You may feel drowsy or dizzy. If this happens, consult your doctor.
• Antidepressants, anesthetics, neuroleptics (medicines that affect mood) or bupropion (a medicine used as an aid to stop smoking). The risk of having a seizure may increase. Your doctor will tell you if Tramadol/Paracetamol Almus is suitable for you.
• Warfarin or phenprocoumon (a medicine used to prevent blood clots). The effectiveness of these medicines may be altered, and there is a risk of bleeding. You should inform your doctor immediately of any prolonged or unexpected bleeding.
• Gabapentin or pregabalin for the treatment of 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 (medicines for the treatment of nausea and vomiting),
• Colestyramine (a medicine that lowers cholesterol in the blood),
• Ketoconazole and erythromycin (medicines used against infections).

The risk of side effects increases,

• If you are taking medicines that can cause or facilitate seizures, such as certain antidepressants or antipsychotics. The risk of seizures increases if you take Tramadol/Paracetamol Almus at the same time as these medicines. Your doctor will tell you if Tramadol/Paracetamol is suitable for you.
• If you are taking medicines for the treatment of depression. Tramadol/Paracetamol Almus can interact with these medicines, and you may experience a serotonin syndrome (see section 4 "Possible side effects").

Other medicines and paracetamol

Tell your doctor or pharmacist if you are taking:

• Flucloxacillin (an antibiotic), due to a serious risk of alteration of the blood and fluids (metabolic acidosis with high anion gap) that should be treated urgently (see section 2).

Your doctor will know which medicines 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, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Because Tramadol/Paracetamol Almus 37.5 mg/325 mg tablets contain tramadol, it is not recommended to use this medicine during pregnancy.

Tramadol is excreted in breast 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 stop breastfeeding.

Driving and using machines

Ask your doctor if you can drive or use machines during treatment with Tramadol/Paracetamol Almus 37.5 mg/325 mg tablets. It is important that before driving or using machines, you observe how this medicine affects you. Do not drive or use machines if you feel drowsy, dizzy, have blurred vision, or double vision, or have difficulty concentrating. Be especially careful at the start of treatment, after a dose increase, after a change in formulation, and/or when taking it in combination with other medicines.

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

3. How to take Tramadol/Paracetamol Almus

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Before starting treatment and regularly during treatment, 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 stop it (see also section 2).

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

Use in children

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

Use in adults

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

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

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

Do not take Tramadol/Paracetamol Almus more frequently than indicated by your doctor. 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.

Elderly patients

In elderly 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.

Patient with liver or kidney impairment/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.

Method of administration

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 think 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), tell 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 serious liver damage that may only become apparent later.

In case of overdose or accidental ingestion, consult the Toxicology Information Service, telephone 91 562 04 20. It is recommended to take the packaging and the leaflet of the medicine to the healthcare professional.

If you forget to take Tramadol/Paracetamol Almus:

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

Do not stop taking this medicine suddenly unless your doctor tells you to. If you want to stop taking your medicine, 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 likelihood of unnecessary side effects (withdrawal symptoms). If you have any other questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, Tramadol/Paracetamol Almus can cause adverse effects, although not all people suffer from them.

Very frequent: more than 1 in 10 treated people:

• nausea.
• dizziness, drowsiness.

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

• vomiting, digestive problems (constipation, flatulence, diarrhea), stomach pain, dry mouth.
• itching, increased sweating.
• headache, agitation.
• confusion, sleep disorders, mood changes (anxiety, nervousness, euphoria, feeling "high" all the time).

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

• tachycardia, hypertension, cardiac rhythm and frequency disorders.
• difficulty or pain when urinating.
• skin reactions (e.g., rashes, hives).
• tingling, numbness, or pinching sensation in the limbs, ringing in the ears, 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 treated people:

• seizures, difficulty performing coordinated movements.
• addiction.
• blurred vision.

Frequency not known: cannot be estimated from available data:

• decrease in blood sugar levels (hypoglycemia).
• hypotension.
• serotonin syndrome, which can manifest through 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 (called metabolic acidosis) in patients with severe illness using paracetamol (see section 2).

The following recognized adverse effects 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 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 rashes, indicating allergic reactions that can manifest through sudden swelling of the face and neck, shortness of breath, or a drop in blood pressure and dizziness. If this happens, stop treatment and consult your doctor immediately. You should not take this medicine again.
• In rare cases, using a medicine like tramadol can create dependence, 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 trembling. They may be hyperactive, have difficulty sleeping, and have digestive and intestinal disorders. Very few people may also have panic attacks, hallucinations, unusual perceptions such as itching, tingling, and numbness, and ringing in the ears (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 result in nosebleeds or bleeding in the gums. 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 adverse effects, consult your doctor or pharmacist, even if they are adverse effects that do not appear in this prospectus.

Reporting Adverse Effects

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

5. Conservation of Tramadol/Paracetamol Almus

It does not require special storage conditions.

Keep this medicine out of sight and reach of children.

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

Do not use this medicine after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be thrown away through drains or into the trash. Deposit the packaging and medicines you no longer need at the SIGRE Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Packaging Content and Additional Information

Composition of Tramadol/Paracetamol Almus

• The active ingredients 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:

Core of the tablet:

Pregelatinized corn starch, sodium carboxymethyl starch (Type A) of potato, microcrystalline cellulose (Avicel PH 102), magnesium stearate.

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

Appearance of the Product and Packaging Content

Tramadol/Paracetamol Almus 37.5/325 mg film-coated tablets EFG, are presented in the form of pale yellow tablets packaged in blisters.

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

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Almus Pharmaceutical, S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona), Spain

Phone: 93 739 71 80

Email: [email protected]

Manufacturer:

Laboratorium Sanitatis, S.L.

• T. Álava - C/ Leonardo da Vinci, 11

01510, Miñano (Álava)

Spain

Date of the Last Revision of this Prospectus:February 2025

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