Zytram Bid 75 mg prolonged-release tablets

Package leaflet: Information for the patient

Introduction

Package leaflet: information for the patient

Zytram BID 75 mg prolonged-release tablets

Tramadol hydrochloride

Read the entire leaflet carefully before you start taking 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, 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 adverse effects not listed in this leaflet. See section 4.

Contents of this leaflet

1. What Zytram BID tablets are and what they are used for
2. What you need to know before taking Zytram BID tablets
3. How to take Zytram BID tablets
4. Possible adverse effects
5. How to store Zytram BID tablets
6. Contents of the pack and other information

1. What Zytram BID tablets are and what they are used for

These tablets have been prescribed by your doctor for the treatment of moderate to severe pain over a 12-hour period. The tablets contain tramadol as the active substance, which is a potent analgesic (or painkiller) belonging to a group of medicines called opioids.

These tablets are intended for use only in adults and adolescents over 12 years of age.

2. What you need to know before taking Zytram BID tablets.

Do not take Zytram BID tablets

• If you are allergic to tramadol or to any of the excipients or other components of this medicine (listed in section 6);
• If you have consumed excessive alcohol or taken higher-than-recommended doses of sleeping pills, painkillers, or psychotropic medicines (used to treat psychiatric or mental disorders);
• If you are taking monoamine oxidase inhibitor (MAOI) medicines (for example: tranilcipromine, phenelzine, isocarboxazide, moclobemide, and linezolid), or if you have taken such medicines within the last two weeks;
• To treat withdrawal symptoms caused by stopping another strong painkiller.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take these tablets if:

• You have or have had any type of addiction to alcohol or drugs;
• You have or have had epilepsy, seizures, tremors, or convulsions;
• You suffer from severe headaches, or feel unwell due to a head injury, or if you have increased intracranial pressure (for example, due to a brain disorder). The tablets may worsen symptoms or mask a head injury;
• You have severe liver or kidney disease;
• You are in shock (suddenly feel very dizzy, tired, cold, shaky, and pale);
• You have slow or weaker-than-normal breathing (respiratory depression);
• You suffer from depression and are taking antidepressants, as some may interact with tramadol (see “Other medicines and Zytram BID prolonged-release tablets”);
• You suffer from constipation.

Sleep-related breathing disorders

Zytram BID tablets may cause sleep-related breathing disorders such as central sleep apnea (pauses in breathing during sleep) and sleep-related hypoxemia (low blood oxygen levels). These 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.

Tolerance, dependence, and addiction

This medicine contains tramadol, which is an opioid medicine. Repeated use of opioids may make the medicine less effective (you become accustomed to it, known as tolerance). Repeated use of Zytram BID may also lead to dependence, abuse, and addiction, which could potentially result in a 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 have control over how much medicine you 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 Zytram BID if:

• You or a family member has a history of alcohol abuse or dependence.
• You are a smoker.
• You have previously had problems with your mood (depression, anxiety, or a personality disorder) or have received treatment from a psychiatrist for other mental illnesses.

If you notice any of the following signs while taking Zytram BID, it could be a sign that you have become dependent or addicted:

• You need to take the medicine for longer than recommended by your doctor.
• You need to take higher doses than recommended.
• You are using the medicine for reasons other than those prescribed, for example, “to calm down” or “to help you sleep.”
• You have made repeated unsuccessful attempts to stop or control the use of the medicine.
• You feel unwell when you stop taking the medicine and feel better when you take it again (“withdrawal symptoms”).

If you notice any of these signs, talk to your doctor to discuss the best therapeutic strategy for your case, including when it is appropriate to stop taking the medicine and how to do so safely (see section 3, “If you stop taking Zytram BID”).

Talk to your doctor or pharmacist if you experience any of the following symptoms while taking Zytram BID: 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, who will decide whether you need hormonal supplementation.

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, loss of appetite.

Occasionally, increased sensitivity to pain (hyperalgesia) may occur, which does not respond to further increases in tramadol dose, especially at high doses. It may be necessary to reduce the tramadol dose or switch to an alternative opioid.

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

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.

Other medicines and Zytram BID prolonged-release tablets

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicine. Taking other medicines together with these tablets may alter the effect of these tablets or of the other medicine.

The concomitant use of Zytram BID and sedative medicines, such as benzodiazepines or related medicines, increases the risk of drowsiness, difficulty breathing (respiratory depression), coma, and may be fatal. For this reason, concomitant use should only be considered when no other treatment options are possible.

However, if your doctor prescribes Zytram BID together with sedative medicines, your doctor should limit the dose and duration of concomitant treatment.

Inform your doctor about all sedative medicines you are taking and follow your doctor’s recommendations regarding dosage. It may be helpful to inform friends or family members so they are aware of the signs and symptoms mentioned above. Inform your doctor if you experience such symptoms.

These tablets must not be used together with a monoamine oxidase inhibitor (MAOI), or if you have taken such medicines within the last 2 weeks (see section 2, “Do not take Zytram BID tablets”).

The risk of side effects increases:

• If you are taking medicines that may cause seizures, such as certain antidepressants or antipsychotics. The risk of having a seizure may increase if you take Zytram BID tablets at the same time. Your doctor will advise you whether Zytram BID tablets are suitable for you.
• If you are taking certain antidepressants. Zytram BID tablets may interact with these medicines, and you may experience serotonin syndrome (see section 4, “Possible side effects”).

Tell your doctor or pharmacist if you are taking:

• Sleeping medicines (tranquilizers, hypnotics, or sedatives);
• Carbamazepine for treating seizures, tremors, convulsions, and certain types of pain;
• Medicines for depression;
• Medicines for treating psychiatric or mental disorders;
• Ritonavir for treating HIV;
• Digoxin for treating heart failure or arrhythmias;
• Other strong painkillers (buprenorphine, nalbuphine, and pentazocine);
• Certain morphine-like drugs, for example, to treat cough or withdrawal syndromes;
• Barbiturates for treating seizures or for sleep;
• Benzodiazepines, to treat anxiety or for sleep;
• Gabapentin or pregabalin for treating epilepsy or nerve-related pain (neuropathic pain);
• Certain medicines to prevent blood clotting or to thin the blood (coumarin anticoagulants, such as warfarin);
• Ondansetron, to treat nausea or general malaise.

Taking Zytram BID tablets with alcohol

Talk to your doctor or pharmacist if you consume or plan to consume alcohol while taking this medicine.

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.

Pregnancy

Do not take this medicine if you are pregnant. Depending on the dose and duration of tramadol treatment, the newborn may experience slow and shallow breathing (respiratory depression) or withdrawal symptoms.

Breastfeeding

Tramadol is excreted in breast milk. Therefore, you must not take Zytram BID more than once during breastfeeding, or if you take Zytram BID more than once, you must stop breastfeeding.

Babies born to mothers who have used Zytram BID prolonged-release tablets during pregnancy may experience withdrawal symptoms, which may include high-pitched crying, irritability and restlessness, agitation (tremor), feeding difficulties, and sweating.

Driving and using machines

These tablets may cause side effects such as drowsiness, blurred vision, and dizziness, which could affect your ability to drive or operate machinery (see section 4 for a complete list of side effects). These effects are more noticeable when you start treatment with the tablets or when your dose is increased. If affected, you must not drive or use machinery.

Zytram BID tablets contain lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Zytram BID tablets

Follow exactly the instructions given by your doctor or pharmacist for taking these tablets. If in doubt, consult your doctor or pharmacist. Before starting treatment and regularly during treatment, your doctor will discuss with you what to expect from using Zytram BID, when and for how long you should take it, when to contact your doctor, and when you should stop taking it (see also section 2).

The dose should be adjusted according to the intensity of pain and your individual sensitivity. Generally, the lowest effective dose that provides pain relief should be used.

Adults and adolescents over 12 years of age

The usual initial dose is one 75 mg tablet twice daily. However, your doctor will prescribe the dose required to treat your pain. Do not exceed the dose recommended by your doctor. If you still experience pain while taking the tablets, consult your doctor. Generally, you should not take more than 400 mg per day.

Swallow the tablets with water. Do not crush, dissolve, or chew them.

Zytram BID tablets are designed to provide adequate treatment coverage over 12 hours when taken whole. If the tablet is broken, crushed, dissolved, or chewed, the entire 12-hour dose may be rapidly absorbed by your body, which can be dangerous and cause serious problems such as an overdose that could be fatal.

You should take the tablets every 12 hours. For example, if you took a tablet at 8 a.m., you should take the next tablet at 8 p.m.

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 reducing the dose.

Patients with hepatic or renal impairment / patients on dialysis

Zytram BID tablets are not recommended if you have severe liver or kidney disease. If you have mild or moderate liver or kidney disorders, your doctor may recommend reducing the dose.

Children under 12 years of age

The safety of Zytram BID in children aged 1 to 12 years has not been established.

If you take more Zytram BID tablets than you should, or if someone accidentally takes your tablets

Contact your doctor or the nearest hospital immediately. People who have taken an overdose may experience excessive drowsiness, feel very unwell or very dizzy. They may have seizures, tremors, or convulsions. They may also develop breathing difficulties that could lead to loss of consciousness or even death, and may require emergency treatment in hospital. If medical attention is needed, make sure to bring this leaflet and the remaining tablets with you.

In case of overdose or accidental ingestion, contact the Toxicology Information Service (Tel. 91.562.04.20), indicating the product and the amount ingested.

If you forget to take a Zytram BID tablet

If you remember within 6 hours of the scheduled dose, take the missed tablet immediately, then take the next tablet at the usual time. If more than 6 hours have passed, it is preferable to consult your doctor.

Do not take a double dose to make up for a missed dose.

If you stop taking Zytram BID tablets

Do not stop taking this medicine suddenly unless instructed by your doctor. If you wish to stop taking the 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 reduce the likelihood of experiencing unnecessary adverse effects (withdrawal symptoms). If you stop taking these tablets suddenly, withdrawal symptoms such as agitation, anxiety, restlessness, difficulty sleeping, unusual hyperactivity, tremors, or gastrointestinal disorders (e.g., upset stomach) may occur.

If you have any further questions about the use of these tablets, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

All medicines can cause allergic reactions, although severe allergic reactions are rare. Contact your doctor immediately if you suddenly experience shortness of breath, difficulty breathing, swelling of the eyelids, face or lips, or itching, particularly if it affects the whole body.

The most serious adverse effect is when breathing becomes slower or weaker than normal (respiratory depression).

As with all strong painkillers, there is a risk of addiction or dependence on these tablets.

Very common: may affect more than 1 in 10 patients

• Dizziness (this effect usually subsides after a few days; however, your doctor may prescribe a medicine for dizziness if it continues to be a problem)
• Vertigo

Common: may affect up to 1 in 10 patients

• Drowsiness (more common when starting the tablets or when the dose is increased, but usually subsides after a few days)
• Dry mouth
• Sweating
• Vomiting (with sensation of dizziness)

Uncommon: may affect up to 1 in 100 patients

• Headache
• Tachycardia, palpitations or severe heart problems
• Feeling of “fainting”, particularly when getting up, low blood pressure (hypotension)
• Constipation
• Abdominal pain or discomfort
• Rash, hives (urticaria) or itching

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

• Tingling or numbness
• Blurred vision
• Hallucinations
• Nightmares
• Mood changes, feeling of discomfort and uneasiness, or feeling of extreme happiness
• Changes in level of activity
• Confusion
• Problems with recognition, changes in thinking, memory and behaviour
• Seizures, tremors or convulsions
• High blood pressure (hypertension)
• Breathlessness, difficulty breathing or shortness of breath
• Worsening of asthma
• Loss of appetite
• Diarrhoea
• Pain or difficulty passing urine
• Muscle weakness
• Redness of the skin
• Bradycardia
• Fainting

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

• Withdrawal symptoms when stopping the tablets, such as restlessness, anxiety, nervousness, hyperactivity, tremors, difficulty sleeping, stomach upset
• Worsening of liver function tests (seen in blood tests)

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

• Decrease in blood sugar levels
• Unusual feeling of weakness
• Withdrawal symptoms in babies born to mothers who have used tramadol during pregnancy (see section 2 "Pregnancy, breastfeeding and fertility")
• Hiccups
• Need to take increasingly higher doses of the tablets to achieve the same level of pain relief (tolerance)
• Increased sensitivity to pain
• 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 Zytram BID prolonged-release tablets").

In some cases, the tablet matrix may be observed in the stools. This does not affect the effectiveness of the medicine.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is an effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for 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 Zytram BID tablets

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

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

Do not take these tablets after the expiry date shown on the blister and outer carton. The expiry date refers to the last day of the month indicated.

Do not store above 30°C.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their packaging to the SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to 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 Zytram BID tablets

The active substance is tramadol hydrochloride. Each tablet contains 75 mg of tramadol hydrochloride.

The other components are:

• Hydrogenated vegetable oil
• Talc
• Magnesium stearate
• Lactose monohydrate
• Macrogol
• Hypromellose (E464)
• Titanium dioxide (E171)
• Iron oxide (E172)
• Indigo carmine (E132)

Appearance of the product and contents of the pack

This medicine is presented as grey, round tablets, marked with “TBD” on one side and the dose (75) on the other, with an approximate diameter of 7 mm.

Each box contains 7, 14, 28, 30, 56 or 60 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Mundipharma Pharmaceuticals S.L.
Bahía de Pollensa, 11
28042 Madrid
Spain

Manufacturer

Mundipharma DC B.V.
Leusderend 16
3832 RC Leusden
The Netherlands

or

ZAMBON SWITZERLAND LTD
Via Industria, 13 (Cadempino)
CH-6814 – Switzerland

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

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