Tramadol Stada 50 mg hard capsules EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Tramadol Stada 50 mg hard capsules EFG

Tramadol hydrochloride

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, and you should not give it to others, even if they have the same symptoms as you, because it could 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 Stada is and what it is used for
2. What you need to know before taking Tramadol Stada
3. How to take Tramadol Stada
4. Possible side effects
5. How to store Tramadol Stada
6. Contents of the pack and other information

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

Tramadol Stada is indicated for the treatment of moderate to severe pain.

2. What you need to know before taking Tramadol Stada

Do not take Tramadol Stada:

• if you are allergic to the active substance 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 acting on mood and emotions);
• if you are 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 tramadol treatment (see “Taking Tramadol Stada with other medicines”);
• if you have epilepsy that is not controlled by treatment;
• for the treatment of withdrawal syndrome.

Warnings and precautions

Talk to your doctor or pharmacist before taking Tramadol Stada:

• if you think you are dependent on other strong painkillers (opioids);
• if you experience reduced level 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 increased intracranial pressure (e.g., after head injury or brain diseases);
• if you have breathing difficulties;
• if you have epilepsy or suffer from seizures, as the risk of seizures may increase;
• if you have liver or kidney disease;
• tramadol should be used with caution if you have acute porphyria;
• if you suffer from depression and are taking antidepressants, as some may interact with tramadol (see “Other medicines and Tramadol Stada”).

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).

Tramadol is metabolized in the liver by an enzyme. Some individuals have variations in this enzyme, which may affect them differently. In some people, adequate 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, stop taking this medicine immediately and consult a doctor: slow or shallow breathing, confusion, drowsiness, constricted pupils, general malaise or vomiting, constipation, loss of appetite.

Consult your doctor, even if any of the above circumstances have occurred to you in the past.

Tolerance, dependence, and addiction

This medicine contains tramadol, which is an opioid medicine. Repeated use of opioids may lead to reduced effectiveness of the medicine (the body becomes accustomed to it, known as pharmacological tolerance). Repeated use of Tramadol Stada may also lead to dependence, abuse, and addiction, which could result in 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 lack of control over the amount of medicine you need to take or how often you need to take it.

The risk of dependence or addiction varies from person to person. The risk of becoming dependent or addicted to Tramadol Stada may be higher if:

• You or a family member have 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 symptoms while using Tramadol Stada, 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 take a higher dose than recommended;
• You are using the medicine for reasons other than prescribed, e.g., “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 stop taking Tramadol Stada”).

Sleep-related breathing disorders

Tramadol may cause sleep-related breathing disorders, such as sleep apnea (pauses in breathing during sleep) and sleep-related hypoxemia (low blood oxygen levels). Symptoms may include breathing pauses during sleep, nighttime awakenings due to shortness of breath, difficulty maintaining sleep, or excessive daytime sleepiness. If you or someone else notices these symptoms, contact your doctor. Your doctor may consider reducing the dose.

Talk to your doctor, pharmacist, or nurse 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. These may be signs of adrenal insufficiency (low cortisol levels). If you have these symptoms, contact your doctor, who will decide whether you need hormonal supplements.

There is a small risk of developing serotonin syndrome after taking tramadol, either in combination with certain antidepressants or with tramadol alone. Seek immediate medical advice if you experience any symptoms related to this serious condition (see section 4, “Possible side effects”).

Children and adolescents

Use in children with breathing problems

Tramadol is not recommended in children with breathing problems, as symptoms of tramadol toxicity may worsen in these children.

Other medicines and Tramadol Stada

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

Concomitant use of tramadol with monoamine oxidase inhibitors (MAOIs), a certain type of medicine used to treat depression, should be avoided.

The effect and duration of pain relief from tramadol 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 tramadol and at what dose.

Concomitant use of tramadol with sedative medicines such as benzodiazepines or related medicines increases the risk of sedation, respiratory depression, coma, or even death. For this reason, concomitant use should only be considered when no other treatment options are available. However, if your doctor prescribes tramadol together with sedatives, the dose and duration of concomitant treatment must be limited by your doctor.

Inform your doctor about all sedative medicines you are taking and follow your doctor’s dosing instructions carefully. It may be helpful to inform friends or relatives so they are aware of the signs and symptoms mentioned above. Contact your doctor if you experience such symptoms.

The risk of adverse effects increases:

• if you are taking tramadol together with tranquilizers, sleeping medicines, 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 happens, consult your doctor;
• if you are taking medicines that may lower the seizure threshold or provoke seizures, such as certain antidepressants or antipsychotics. The risk of seizures increases if you take tramadol together with these medicines. Your doctor will advise you whether tramadol is suitable for you;
• if you are taking antidepressants, tramadol may interact with these medicines and you may experience serotonin syndrome (see section 4, “Possible side effects”);
• if you are taking anticoagulant cumarins such as acenocoumarol (Sintrom®), as this may increase the risk of bleeding;
• if you are taking drugs that may increase tramadol accumulation and thus its adverse effects (e.g., ritonavir, quinidine, paroxetine, fluoxetine, sertraline, amitriptyline, isoniazid, ketoconazole, and erythromycin);
• if you are taking gabapentin or pregabalin to treat epilepsy or nerve-related pain (neuropathic pain).

Taking Tramadol Stada with food and alcohol

Do not consume alcohol during treatment with tramadol, as alcohol may intensify the effects of tramadol. Food does not affect the action of tramadol.

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 use tramadol if you are pregnant.

Chronic treatment during pregnancy may cause withdrawal syndrome in the newborn after delivery.

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

Based on human experience, tramadol is not considered to affect fertility in men or women.

Driving and using machines

Ask your doctor whether you can drive or operate machinery while taking tramadol. It is important to observe how this medicine affects you before driving or operating machinery. Do not drive or operate machinery if you feel drowsy, 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 it together with other medicines.

Tramadol Stada contains lactose and sodium

This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.

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

3. How to take Tramadol Stada

Follow exactly the instructions for use of this medicine as given by your doctor. 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 Tramadol Stada, 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. Normally, the lowest possible dose that provides pain relief should be used. Do not take more than 400 mg of tramadol hydrochloride per day unless your doctor has instructed you otherwise.

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

Adults and adolescents over 12 years of age

Normally, the initial dose is 1 or 2 tramadol capsules (equivalent to 50–100 mg of tramadol).

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

Use in children

Tramadol is not recommended for children under 12 years of age.

Elderly patients

In elderly patients (over 75 years of age), tramadol elimination 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 tramadol is not recommended. If you have moderate liver or kidney disorders, your doctor may extend the dosing intervals.

How and when should you take Tramadol Stada?

Tramadol capsules are administered orally.

Swallow the capsules whole without dividing or chewing them, and with sufficient liquid.

You may take the capsules either on an empty stomach or with food.

How long should you take Tramadol Stada?

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 Stada than you should

If you have taken an extra dose by mistake, this usually does not cause adverse effects. You should take the next dose as prescribed.

After taking very high doses of tramadol, pinpoint pupils, vomiting, low 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 this case, call a doctor immediately!

In case of overdose or accidental ingestion, go immediately to a medical center or call the Toxicology Information Service at telephone number 91 562 04 20, indicating 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 Stada

If you forget to take the medicine, your pain may return. Do not take a double dose to make up for forgotten doses; simply continue taking tramadol as you have been doing.

If you stop taking Tramadol Stada

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

You should not stop taking this medicine suddenly unless your doctor tells you to do so. If you wish to stop taking your medicine, talk 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 reduce 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 for some time may feel unwell when stopping treatment abruptly. They may feel restless, anxious, nervous, or experience tremors. They may become hyperactive, have difficulty sleeping, or develop digestive and intestinal transit problems. Very few people experience panic attacks, hallucinations, unusual perceptions such as itching, tingling sensations, numbness, and 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 tramadol, 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 will experience 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, rash, and difficulty breathing.

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

Very common: may affect more than 1 in 10 people

• Dizziness.
• Nausea.

Common: may affect up to 1 in 10 people

• Headache and numbness.
• Fatigue.
• Vomiting, constipation, and dry mouth.
• Sweating (hyperhidrosis).

Uncommon: may affect up to 1 in 100 people

• Effects on the heart and blood circulation (strong heartbeats, rapid heartbeat, feeling of dizziness or collapse). These adverse effects may occur particularly in patients who are standing up or engaging in physical exertion.
• Nausea (feeling the need to vomit), gastrointestinal discomfort (e.g. feeling of fullness, heaviness), diarrhoea.
• 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, seizures, muscle twitches, uncoordinated movements, temporary loss of consciousness (syncope), speech disorders.
• Seizures occur mainly after using 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 manifest as changes in mood (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. If tramadol is used for prolonged periods, it may cause dependence, although the risk is very low. When treatment is abruptly discontinued, withdrawal syndrome may occur (see section “If you stop taking Tramadol Stada”).
• Blurred vision, excessive dilation of the pupils (mydriasis), constriction of the pupils (miosis).
• 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 available data

• Decrease in blood sugar levels.
• Hiccups.

Frequency not known (cannot be estimated from available data)

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, diarrhoea) (see section 2 “What you need to know before taking Tramadol Stada”).

Reporting of adverse effects:

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

5. Storage of Tramadol Stada

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.

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date stated on the packaging and blister 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 packaging and unused medicines at the SIGRE point in your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Package contents and additional information

Composition of Tramadol Stada

• The active substance is tramadol hydrochloride. Each capsule contains 50 mg of tramadol hydrochloride.
• The other components are: monohydrate lactose, microcrystalline cellulose, sodium carboxymethyl starch from potato (type A), magnesium stearate, povidone K 30.

Composition of the capsule shell: gelatin and titanium dioxide.

Appearance of the product and package contents

Tramadol Stada 50 mg are hard gelatin capsules. They are available in packs containing 20, 60 and 500 capsules.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

Toll Manufacturing Services, S.L.

Aragoneses, 2

28108 Alcobendas (Madrid)

Spain

Date of the most recent review of this leaflet: May 2024

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