Tramadol Almus 50 mg hard capsules EFG

Patient Information Leaflet

Introduction

Package leaflet: Information for the patient

Tramadol Almus 50 mg hard capsules EFG

tramadol hydrochloride

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

• Keep this leaflet. 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 others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

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

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

Tramadol – the active substance in this medicine – is an analgesic belonging to the opioid group that acts on the central nervous system. It relieves pain by acting on specific nerve cells in the spinal cord and brain.

Tramadol Almus is used to treat moderate to severe pain in adults and adolescents over 12 years of age.

2. What you need to know before taking Tramadol Almus

Do not take Tramadol Almus

• if you are allergic to tramadol or to any of the other components of this medicine (listed in section 6);
• in cases of acute intoxication caused by alcohol, sleeping medications, analgesics, or other psychotropic medicines (medicines that affect mood and emotions);
• if you are currently taking monoamine oxidase inhibitors (MAOIs) (a certain type of medicine used to treat depression), or if you have taken them within the last 14 days before starting treatment with this medicine (see “Taking Tramadol Almus with other medicines”);
• if you have epilepsy and your seizures are not adequately controlled by treatment;
• for the treatment of withdrawal syndrome.

Warnings and precautions

Talk to your doctor or pharmacist before taking Tramadol:

• if you think you are dependent on other analgesics (opioids);
• if you have disorders of consciousness (if you feel you might faint);
• if you are in shock (a sign of this condition may be cold sweating);
• if you have difficulty breathing;
• if you have increased intracranial pressure (for example, after head trauma or brain diseases);
• if you have liver or kidney disease;
• if you have epilepsy or suffer from seizures, as the risk of seizures may increase;
• if you suffer from depression and are taking antidepressants, as some may interact with tramadol (see “Taking Tramadol Almus with other medicines”).

There is a weak risk that you may experience a serotonin syndrome, which may occur after taking tramadol in combination with certain antidepressants or tramadol used as monotherapy. Contact a doctor immediately if you experience any symptoms related to this serious syndrome (see section 4 “Possible side effects”).

If you are in any of the situations listed above, consult your doctor before starting treatment with this medicine.

Tolerance, dependence, and addiction

This medicine contains tramadol, which is an opioid medicine. Repeated use of opioids may lead to the medicine becoming less effective (the body becomes accustomed to it, known as pharmacological tolerance). Repeated use of Tramadol Almus 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 losing control over how much medicine you take or how often you take it.

The risk of dependence or addiction varies from person to person.

The risk of becoming dependent on or addicted to Tramadol Almus may be higher if:

• You or any member of your family have abused or been dependent on alcohol, prescription medicines, or illegal drugs (“addiction”).
• You are a smoker.
• You have ever 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 Almus, it could be a sign of dependence or addiction:

• You need to use the medicine for longer than prescribed by your doctor.
• You need to use a higher dose than recommended.
• You are using the medicine for reasons other than those prescribed, for example, “to feel calm” or “to help you sleep.”
• You have made repeated 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 interrupt treatment with Tramadol Almus).

Sleep-related breathing disorders

Tramadol Almus may cause sleep-related breathing disorders such as central sleep apnea (shallow breathing or breathing pauses during sleep) and sleep-related hypoxemia (low blood oxygen levels).

The risk of central sleep apnea depends on the opioid dose. Your doctor may consider reducing the total opioid dose if you experience central sleep apnea.

Seizures have been reported in patients taking tramadol at the recommended dose. The risk may increase when the tramadol dose exceeds the maximum recommended daily dose (400 mg).

Please note that this medicine may cause physical and psychological dependence. When used over a prolonged period, its effect may decrease, requiring higher doses (development of tolerance). In patients with a tendency to misuse medicines or those with dependence, treatment with Tramadol Almus should only be carried out for short periods and under strict medical supervision.

Also inform your doctor if any of these problems occur during treatment with this medicine or if you have ever experienced them.

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, pinpoint pupils, general malaise or vomiting, constipation, loss of appetite.

Inform your doctor if you experience any of the following symptoms while taking tramadol:

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.

Taking Tramadol Almus with other medicines

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

Concomitant treatment with Tramadol Almus and MAO inhibitors (a certain type of medicine used to treat depression) should be avoided.

The effect and duration of pain relief provided by Tramadol Almus may be reduced if you take medicines containing:

• carbamazepine (for epileptic seizures).
• ondansetron (to prevent nausea).

Your doctor will advise you whether you should take this medicine and at what dose.

The risk of adverse effects increases:

• if you are taking this medicine simultaneously with other analgesics such as morphine and codeine (even when used to treat cough) and alcohol. In these cases, you may feel drowsy or dizzy. If this occurs, consult your doctor.

The concomitant use of Tramadol Almus with sedatives or medicines for insomnia (such as benzodiazepines) or gabapentin or pregabalin for treating epilepsy or nerve-related pain (neuropathic pain) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, or may be potentially fatal. Therefore, concomitant use should only be considered when no other treatment options are possible. However, if your doctor prescribes tramadol with sedative medicines, they will limit the dose and duration of concomitant treatment.

Inform your doctor about all sedative medicines you are taking and strictly follow your doctor’s dosage recommendations. It may be helpful to inform your friends and family about the signs and symptoms mentioned above. Contact your doctor if you experience any of these symptoms.

• 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 simultaneously with these medicines. Your doctor will tell you whether Tramadol is suitable for you;
• if you are taking medicines for depression. Tramadol may interact with these medicines and you may experience serotonin syndrome (see section 4 “Possible side effects”);
• if you are taking coumarin anticoagulants (blood-thinning medicines) such as warfarin while taking Tramadol. The effect of these medicines on blood clotting may be affected, leading to bleeding;
• if you are taking medicines that may increase the accumulation of tramadol and, therefore, its adverse effects (for example, ritonavir, quinidine, paroxetine, fluoxetine, sertraline, amitriptyline, isoniazid, ketoconazole, and erythromycin).

Taking Tramadol Almus with food, drinks, and alcohol

Do not consume alcohol during treatment with this medicine, as its effects may be intensified.

Food does not affect the action of Tramadol.

Children and adolescents

Use in children with respiratory problems.

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

Pregnancy, breastfeeding, and fertility

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.

There is very limited information available on the safety of tramadol in pregnant women. Therefore, you should not take this medicine if you are pregnant.

Chronic treatment during pregnancy may cause withdrawal syndrome in newborns.

Tramadol is excreted in breast milk. For this reason, you should not take this medicine more than once during breastfeeding, or if you take Tramadol Almus more than once, you must stop breastfeeding.

Based on human experience, there is no indication that tramadol affects fertility in men or women.

Driving and using machines

Ask your doctor whether you can drive or use machines while taking this medicine. It is important to observe how this medicine affects you before driving or operating machinery. Do not drive or use machines 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 a change in formulation, and/or when taking it together with other medicines.

This medicine contains less than 1 mmol of sodium (23 mg) per 50 mg of tramadol hydrochloride; thus, it is essentially “sodium-free.”

3. How to take Tramadol Almus

Follow exactly the instructions for using this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Before starting treatment and regularly during treatment, your doctor will also explain to you what you can expect from using this medicine, 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).

The dose should be adjusted according to the intensity of pain and your individual sensitivity to pain. Normally, the lowest dose that relieves pain should be taken. Do not take more than 400 mg of tramadol hydrochloride per day unless your doctor has specifically instructed you to do so.

Unless your doctor has given you different instructions, the recommended dose is:

Adults and adolescents over 12 years of age

The usual initial dose is 1-2 capsules (equivalent to 50-100 mg of tramadol hydrochloride).

Depending on the pain, the effect may last between 4-6 hours.

Children

This medicine is not recommended for children under 12 years of age.

Elderly patients

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

Patients with hepatic or renal impairment/patients on dialysis

If you have severe liver or kidney disease, treatment with this medicine is not recommended. If you have moderate liver or kidney disorders, your doctor may extend the dosing intervals.

How and when should I take Tramadol?

Tramadol capsules are for oral use.

The capsules should be swallowed whole, without dividing or chewing, and with sufficient liquid. The capsules may be taken on an empty stomach or with food.

For how long should you take Tramadol?

This medicine should not be used for longer than strictly necessary. If prolonged treatment is required, your doctor will monitor you at short, regular intervals (if necessary with treatment interruptions) to determine whether treatment with this medicine should continue and at what dose.

If you feel that the effect of this medicine is too strong or too weak, inform your doctor or pharmacist.

If you take more Tramadol Almus than you should

If you have taken an extra dose by mistake, you will generally not experience any negative effects. You should take the next dose as prescribed.

After taking very high doses of tramadol, symptoms such as pupil constriction, vomiting, decreased blood pressure, increased pulse rate, collapse, decreased level of consciousness up to coma (deep unconsciousness), epileptic seizures, and breathing difficulties which may lead to respiratory arrest can occur. In such a case, call a doctor immediately!

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone 91 562 04 20, stating the medicine and the amount taken. It is recommended to bring the medicine’s package leaflet to the healthcare professional.

If you forget to take Tramadol Almus

If you forget to take this medicine, your pain is likely to return. Do not take a double dose to make up for forgotten doses; simply continue taking Tramadol Almus as you have been doing.

If you stop taking Tramadol Almus

If you stop or discontinue treatment with this medicine too soon, your pain is likely to reappear. If you wish to stop treatment due to adverse effects, consult your doctor.

You should not stop taking this medicine suddenly unless instructed by your doctor. 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 minimize the likelihood of experiencing unnecessary adverse effects (withdrawal symptoms).

Generally, adverse effects do not commonly occur when stopping treatment with tramadol. However, on rare occasions, people who have been taking Tramadol Almus 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, or experience digestive and intestinal transit problems. Very few people may experience panic attacks, hallucinations, unusual sensations such as itching, tingling, and numbness, or ringing in the ears (tinnitus). Very rarely, additional unusual central nervous system symptoms have been reported, such as confusion, delirium, changes in personality perception (depersonalization), changes in perception of reality (derealization), and delusions of persecution (paranoia). If you experience any of these symptoms after stopping treatment with this medicine, consult your doctor.

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 experiences them.

You must consult your doctor immediately if you experience symptoms of an allergic reaction such as swelling of the face, tongue and/or throat and/or difficulty swallowing and rash together with difficulty breathing.

The most common adverse effects during treatment with tramadol are nausea and dizziness, which occur in more than 1 in 10 people.

Very common: may affect more than 1 in 10 people

• nausea
• dizziness

Common: may affect up to 1 in 10 people

• headache, numbness
• fatigue
• constipation, dry mouth, vomiting
• sweating (hyperhidrosis)

Uncommon: may affect up to 1 in 100 people

• effects on the heart and blood circulation (strong heartbeats and rapid heartbeat, feeling of dizziness or collapse). These adverse effects may occur particularly in patients who are standing up or performing physical exertion
• urge to vomit (nausea), gastrointestinal discomfort (e.g. sensation of pressure in the stomach, bloating), diarrhea
• skin reactions (e.g. itching, rash)

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

• allergic reactions (e.g. difficulty breathing, wheezing, skin swelling) and shock (sudden circulatory failure) have occurred in very rare cases
• slow heartbeat
• increased blood pressure
• abnormal sensations (e.g. itching, tingling, numbness), tremor, epileptic seizures, muscle jerks, uncoordinated movements, temporary loss of consciousness (syncope), speech disorders
• epileptic seizures occur mainly after use of high doses of tramadol or when taken simultaneously with another medicine that may trigger them
• changes in appetite
• hallucinations, confusion, sleep disturbances, delirium, anxiety, and nightmares
• psychological disturbances may occur after treatment with tramadol. Their intensity and nature may vary (depending on the patient's personality and duration of treatment). These may present as mood changes (usually euphoria, occasionally irritability), changes in activity (usually decreased, occasionally increased), and reduced cognitive and sensory perception (sensory and perceptual disturbances that may lead to impaired judgment)
• may lead to drug dependence. When treatment is abruptly discontinued, withdrawal syndrome may occur (see section “If you stop taking Tramadol Almus”)
• blurred vision, pupil constriction (miosis), excessive pupil dilation (mydriasis)
• slow breathing, shortness of breath (dyspnea)
• cases of worsening asthma have been reported; however, it has not been established whether they were caused by tramadol. If recommended doses are exceeded or if tramadol is taken concomitantly with other medicines that depress brain function, respiratory rate may decrease
• muscle weakness
• difficulty or pain when urinating, less urine than normal (dysuria)

Very rare: may affect up to 1 in 10,000 people

• increased liver enzymes

Frequency not known: frequency cannot be estimated from the available data

• decrease in blood sugar levels
• hiccups
• serotonin syndrome, which may present as 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, diarrhea) (see section 2 “What you need to know before taking Tramadol Almus”).

Reporting of adverse effects

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

5. Storage of Tramadol Almus

Keep this medicine 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 pack. The expiry date refers to the last day of the month indicated.

Keep the capsules in their original packaging.

Medicines must not be disposed of via wastewater drains or household waste. Return unused medicines and their packaging to the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Tramadol Almus

• The active substance is tramadol hydrochloride. Each hard capsule contains 50 mg of tramadol hydrochloride.
• Other components:

Capsule contents: Microcrystalline cellulose, sodium starch glycolate from potato (type A), colloidal anhydrous silica, and magnesium stearate.

Capsule shell: Gelatin and titanium dioxide (E171).

Appearance of Tramadol Almus and contents of the pack

White hard gelatin capsules containing white or almost white powder.

Pack sizes: 10, 20, 30, 60 and 100 capsules.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Almus Farmacéutica, S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona), Spain

Telephone: 93 739 71 80

Email: [email protected]

Manufacturer

Rx Farma (Malta) Limited

Kw20a, Zona Industrijali Ta’Kordin, Paola, PLA 3000, Malta

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

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

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