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

Patient Information Leaflet

Introduction

Patient Information Leaflet

Tramadol/Paracetamol Almus 37.5 mg/325 mg Film-coated Tablets EFG

Tramadol hydrochloride/paracetamol

Read the entire leaflet carefully before you start taking this medicine, as 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 pass it on to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if the side effects are not listed in this leaflet.

Leaflet Contents

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

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

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

It is indicated for the symptomatic treatment of moderate to severe pain, whenever your doctor considers that a combination of tramadol and paracetamol is necessary.

It should only be used by adults and children over 12 years of age.

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

Do not take Tramadol/Paracetamol Almus if you:

• are allergic (hypersensitive: skin rash, facial swelling, wheezing or difficulty breathing) to tramadol, paracetamol, or any of the other ingredients of this medicine (listed in section 6).
• are experiencing acute alcohol intoxication, or have taken medicines for insomnia, strong painkillers (opioids), or psychotropic drugs (drugs that may alter consciousness level).
• are taking or have taken monoamine oxidase inhibitors (MAOIs) (certain medicines used to treat depression or Parkinson’s disease) within the last 14 days before starting treatment with Tramadol/Paracetamol Almus.
• have severe liver disease.
• have epilepsy that is not controlled by treatment.

Warnings and precautions

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

• 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 had seizures;
• If you have recently suffered a head injury, or have severe headaches associated with vomiting;
• If you are dependent on any other medicine used for pain relief, 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 Almus.

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

If you suffer from depression and are taking antidepressants, since some of them 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 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 abnormality in blood and body fluids) has been reported in patients under these circumstances 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 and rapid breathing, drowsiness, feeling unwell (nausea), and vomiting.

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 or vomiting, constipation, or 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 blood oxygen levels). Symptoms may include: pauses in breathing during sleep, waking up at night due to difficulty breathing, difficulty maintaining sleep, or excessive daytime sleepiness. If you or someone else notices these symptoms, consult your doctor. Your doctor may consider reducing the dose.

If you develop or have previously experienced any of these problems while taking Tramadol/Paracetamol Almus, please inform your doctor. Your doctor will decide whether 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 adrenal insufficiency (low cortisol levels). If you experience any of these symptoms, inform your doctor, who will decide whether you need hormonal supplementation.

There is a low risk that you may develop a serotonin syndrome, which may occur after taking tramadol in combination with certain antidepressants or tramadol used as monotherapy. Seek immediate medical advice if you experience any 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 may cause the medicine to become less effective (you become accustomed to it, known as tolerance). Repeated use of Tramadol/Paracetamol Almus may also lead to dependence, abuse, and addiction, which may result in potentially fatal overdose. The risk of these side effects may increase with higher doses and longer duration of use.

Dependence or addiction may make you feel that you no longer control the amount of medicine you need to take or how often you 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 a family member has abused 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 signs while taking [product name], 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 prescribed, e.g., "to stay calm" or "to sleep"
• You have repeatedly tried and failed to stop or control use of the medicine
• You feel unwell when you stop taking the medicine, and feel better when you take it again ("withdrawal effect")

If you notice any of these signs, speak with your doctor to determine the best treatment approach for you, including when and how to safely stop taking the medicine (see section 3, "If you stop taking Tramadol/Paracetamol Almus").

Children and adolescents

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 Almus with other medicines

Inform 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 Almus together 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 commonly used to treat epilepsy or certain types of pain, such as severe facial pain known as trigeminal neuralgia).
• Buprenorphine, nalbuphine, or pentazocine (opioid analgesics). Pain relief may be reduced.

The risk of adverse effects increases if you also use:

• Triptans (for migraine treatment) or selective serotonin reuptake inhibitors (SSRIs) (for depression treatment). If you experience confusion, agitation, fever, sweating, uncoordinated movements of limbs or eyes, uncontrollable muscle contractions, or diarrhea, contact your doctor immediately.
• Sedatives, sleeping pills, other analgesics such as morphine and codeine (also when used for cough treatment), baclofen (muscle relaxant), certain medicines for lowering blood pressure, antidepressants, or medicines for treating allergies. You may feel drowsy or dizzy. If this occurs, consult your doctor.
• Antidepressants, anesthetics, neuroleptics (medicines affecting mood), or bupropion (a medicine used to help quit smoking). The risk of seizures may increase. Your doctor will advise whether Tramadol/Paracetamol Almus is suitable for you.
• Warfarin or phenprocoumon (medicines used to prevent blood clots). The effectiveness of these medicines may be altered, increasing the risk of bleeding. Inform your doctor immediately if you experience prolonged or unexpected bleeding.
• Gabapentin or pregabalin for treating epilepsy or nerve-related pain (neuropathic pain).

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

• Metoclopramide, domperidone, or ondansetron (medicines for treating nausea and vomiting),
• Colestipol (a medicine that reduces blood cholesterol),
• Ketoconazole and erythromycin (medicines used to treat infections).

The risk of adverse effects increases:

• If you are taking medicines that may trigger or facilitate seizures, such as certain antidepressants or antipsychotics. The risk of seizures increases if you take Tramadol/Paracetamol simultaneously with these medicines. Your doctor will advise whether Tramadol/Paracetamol is suitable for you.
• If you are taking medicines for depression. Tramadol/Paracetamol may interact with these medicines and you may experience serotonin syndrome (see section 4, "Possible side effects").

Other medicines and paracetamol

Inform your doctor or pharmacist if you are taking:

• Flucloxacillin (an antibiotic), due to a serious risk of blood and fluid imbalance (metabolic acidosis with high anion gap) that requires urgent treatment (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 increase this drowsiness; therefore, 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 plan to become pregnant, consult your doctor or pharmacist before using this medicine. Because Tramadol/Paracetamol Almus 37.5 mg/325 mg tablets contain tramadol, the use of this medicine during pregnancy is not recommended.

Tramadol is excreted in breast milk. Therefore, you should not take Tramadol/Paracetamol Almus 37.5/325 mg more than once during breastfeeding. If you take Tramadol/Paracetamol Almus 37.5/325 mg more than once, you must stop breastfeeding.

Driving and using machines

Ask your doctor if you can drive or operate machinery while being treated with Tramadol/Paracetamol Almus 37.5 mg/325 mg tablets. It is important to observe how this medicine affects you before driving or operating machinery. Do not drive or operate machinery if you feel sleepy, dizzy, have blurred or double vision, or have difficulty concentrating. Exercise particular caution at the beginning of treatment, after a dose increase, after changing formulation, and/or when taking this medicine together with other medicines.

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

3. How to take Tramadol/Paracetamol Almus

Follow exactly the instructions for use of this medicine provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

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

Use in children

The use of this medicine is not recommended in children under 12 years of age.

Use in adults

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

If necessary, the dose may be increased as advised by your doctor. The shortest interval between doses must 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 prescribed by your doctor. Your doctor may increase the dosing interval:

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

Elderly patients

In elderly patients (over 75 years of age), elimination of tramadol may be slowed. If this applies to you, your doctor may recommend prolonging the dosing intervals.

Patients with hepatic or renal impairment/patients on dialysis

Tramadol/Paracetamol Almus treatment is not recommended if you have severe liver or kidney disease. If you have moderate liver or kidney disorders, your doctor may extend the dosing intervals.

Method of administration

Tramadol/Paracetamol Almus is available as tablets for oral administration. The tablets should be swallowed whole with sufficient liquid. They must not be broken or chewed.

If you feel 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 get 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 prescribed, even if you feel well, contact 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, contact the Toxicology Information Service at telephone 91 562 04 20. It is recommended to bring the medicine’s packaging and leaflet to the healthcare professional.

If you forget to take Tramadol/Paracetamol Almus:

If you forget to take a dose of Tramadol/Paracetamol Almus, the pain may return. Do not take a double dose to make up for the missed dose; simply continue taking the tablets as usual.

If you stop taking Tramadol/Paracetamol Almus:

You must not stop taking this medicine suddenly unless instructed by your doctor. If you wish to discontinue treatment, speak to your doctor first, especially if you have been taking the medicine 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, Tramadol/Paracetamol Almus can cause adverse effects, although not everyone experiences 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, diarrhoea), stomach pain, dry mouth.
• itching, increased sweating.
• headache, agitation.
• confusion, sleep disorders, mood changes (anxiety, nervousness, euphoria, feeling "high" all the time).

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

• tachycardia, hypertension, disturbances in heart rhythm and rate.
• difficulty or pain when urinating.
• skin reactions (e.g.: rashes, urticaria).
• tingling sensation, numbness, or prickling sensations in the limbs, noises in the ear, involuntary muscle spasms.
• depression, nightmares, hallucinations (hearing, seeing, or perceiving something that does not exist in reality), memory loss.
• difficulty swallowing, blood in the stools.
• chills, hot flushes, chest pain.
• difficulty breathing.

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

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

Frequency not known: cannot be estimated from available data:

• decrease in blood sugar levels (hypoglycaemia).
• hiccups.
• 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 Almus").
• a serious illness that may cause blood to become more acidic (called metabolic acidosis) in patients with severe illness who use paracetamol (see section 2).

The following adverse effects have been reported in people taking medicines containing either tramadol alone or paracetamol alone. However, if you experience any of these symptoms while taking Tramadol/Paracetamol Almus, you must inform your doctor:

Dizziness upon standing up after lying down or sitting, slow 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 may occur, indicating allergic reactions that 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 immediately and consult your doctor. You must not take this medicine again.
• In rare cases, taking a medicine such as tramadol may lead to dependence, making it difficult to stop taking it. Occasionally, people who have taken tramadol for some time may feel unwell if treatment is stopped abruptly. They may feel agitated, 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 sensations and numbness, and noises 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, for example, low platelet count, which may result in nosebleeds or bleeding gums. The use of Tramadol/Paracetamol Almus together with anticoagulants (e.g.: phenprocoumon, warfarin) may increase the risk of bleeding. You must inform your doctor immediately about any prolonged or unexpected bleeding.

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

Reporting of adverse effects

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

5. Storage of Tramadol/Paracetamol Almus

No special storage conditions are required.

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

Store this medicine in a safe and secure place where others cannot access it. It may cause serious harm or be fatal to individuals for whom it has not been prescribed.

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

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

6. Package contents and other information

Composition of Tramadol/Paracetamol Almus

• The active substances are tramadol hydrochloride and paracetamol.

Each film-coated tablet contains 37.5 mg of tramadol hydrochloride and 325 mg of paracetamol.

• Other components are:

Tablet core:

Pregelatinized maize 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), yellow iron oxide (E172), polysorbate 80).

Appearance of the medicinal product and contents of the container

Tramadol/Paracetamol Almus 37.5/325 mg film-coated tablets EFG, are pale yellow film-coated tablets presented in blister packs.

Tramadol/Paracetamol Almus is available in pack sizes of 20, 60 and 100 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Almus Farmacéutica, S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona), Spain

Telephone: 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 most recent revision of this leaflet: February 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.