Patient leaflet - Tramadol Hydrochloride capsules 50 mg

1. WHAT TRAMADOL IS AND WHAT IT IS USED FOR

This medicine has been prescribed for you for Management (treatment and prevention) of moderate to severe pain.

It contains the tramadol hydrochloride, which belongs to a class of medicines called opioids, which are ‘pain relievers’. This medicine has been prescribed to you and should not be given to anyone else. Opioids can cause addiction and you may get withdrawal symptoms if you stop taking it suddenly. Your prescriber should have explained how long you will be taking it for and when it is appropriate to stop, how to do this safely.

2. WHAT YOU NEED TO KNOW

BEFORE YOU TAKE TRAMADOL

Do not take Tramadol,

if you are allergic to Tramadol hydrochloride or to any of the other ingredients of this medicine (listed in section 6)
in acute poisoning with alcohol, sleeping pills, pain relievers or other psychotropic medicines (medicines that affect mood and emotions)
if you are taking or you have taken in the last two weeks, monoamine oxidase inhibitors (MAOIs), these are medicines to treat depression (see ‘Other medicines and Tramadol Capsules’)
if you have epilepsy and your fits are not adequately controlled by treatment
as a substitute in drug withdrawal.

Warnings and precautions

Talk to your doctor before taking Tramadol Capsules if you:

suffer from consciousness disorders (if you feel that you are going to faint)
are in a state of shock (cold sweat may be a sign of this)
suffer from increased pressure in the brain (possibly after a head injury or brain disease)
suffer from depression and you are taking antidepressants as some of them may interact with tramadol (see ‘Other medicines and Tramadol Capsules’)
have recently had an accident where you may still be in shock (cold sweats may be a sign of this)
find it difficult to breathe, or your breathing is slower than normal
have a tendency towards epilepsy or fits because the risk of a fit may increase
have severe liver or kidney problems
have previously suffered from withdrawal symptoms such as agitation, anxiety, shaking or sweating, when you have stopped taking alcohol or drugs

Tolerance, dependence, and addiction

This medicine contains tramadol which is an opioid medicine. Repeated use of opioids can result in the drug being less effective (you become accustomed to it, known as tolerance). Repeated use of Tramadol capsules can also lead to dependence, abuse and addiction, which may result in life-threatening overdose. The risk of these side effects can increase with a higher dose and longer duration of use.

Dependence or addiction can make you feel that you are no longer in control of how much 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 greater risk of becoming dependent on or addicted to Tramadol capsules if:

You or anyone in your family have ever 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 whilst taking Tramadol capsules, 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 are using the medicine for reasons other than prescribed, for instance, ‘to stay calm’ or ‘help you sleep’.
You have made repeated, unsuccessful attempts to quit or control the use of the medicine.
When you stop taking the medicine you feel unwell, and you feel better once taking the medicine again (see section 4 ‘Drug Withdrawal’).

If you notice any of these signs, speak to your doctor to discuss the best treatment pathway for you, including when it is appropriate to stop and how to stop safely (see section 3, ‘If you stop taking Tramadol capsules’).

Tramadol contains an active substance that belongs to the group of opioids. Tramadol can cause sleep-related breathing disorders such as sleep apnoea (breathing pauses during sleep) and sleep related hypoxemia (low oxygen level in the blood). The symptoms can include breathing pauses during sleep, night awakening due to shortness of breath, difficulties to maintain sleep or excessive drowsiness during the day. If you or another person observe these symptoms, contact your doctor. A dose reduction may be considered by your doctor.

The risk of experiencing central sleep apnea is dependent on the dose of opioids. Your doctor may

consider decreasing your total opioid

dosage if you experience central sleep

apnea.

Epileptic fits have been reported in patients taking tramadol at the recommended dose level. The risk may be increased when

doses of tramadol exceed the

recommended upper daily dose limit

(400mg).

There is a small risk that you may experience a so-called serotonin syndrome that can occur after having taken tramadol in combination with certain antidepressants or tramadol alone. Seek medical advice immediately if you have any of the symptoms related to this serious syndrome (see section 4 ‘Possible side effects’).

Tramadol is transformed in the liver by an enzyme. Some people have a variation of this enzyme and this can affect people in different ways. In some people, they may not get enough pain relief, but other people are more likely to get serious side effects. If you notice any of the following side effects, you must stop taking this medicine and seek immediate medical advice: slow or shallow breathing, confusion, sleepiness, small pupils, feeling or being sick, constipation, lack of appetite.

Talk to your doctor or pharmacist if you experience any of the following symptoms while taking Tramadol Capsules:

Extreme fatigue, lack of appetite, severe abdominal pain, nausea, vomiting or low blood pressure. This may indicate that you have adrenal insufficiency (low cortisol levels). If you have these symptoms, contact your doctor, who will decide if you need to take hormone supplement.

If any of the above apply to you, or if they applied to you in the past, please talk to your doctor or pharmacist for advice if you have not already done so.

Other medicines and Tramadol Capsules

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

Monoamine oxidase inhibitors (MAOIs); - if you are, or have taken in the last two weeks, an antidepressant medicine called a monoamine – oxidase inhibitors (MAOIs).
The pain relief effect of tramadol may be weakened and/or shortened if you also take medicines containing: -
- Carbamazepine (used to treat epilepsy)
- Buprenorphine, nalbuphine, or pentazocine (pain killers)
- Ondansetron (prevents nausea)
- Medicines used to treat infections such as ketoconazole and erythromycin

Your doctor will tell you whether you should take Tramadol Capsules and what dose.

The risk of side effects increases if you are taking:

medicines which may cause convulsions (fits), such as certain antidepressants or antipsychotics. The risk of having a fit may increase if you take Tramadol capsules at the same time. Your doctor will tell you whether Tramadol capsules is suitable for you.
certain antidepressants. Tramadol capsules may interact with these medicines and you may experience serotonin syndrome (see section 4 ‘Possible side effects’).
other pain relievers such as morphine and codeine (also as cough medicine), and alcohol while you are taking Tramadol capsules. You may feel drowsier or feel that you might faint. If this happens tell your doctor.
tranquillizers or sleeping pills (e.g. benzodiazepines) at the same time as Tramadol capsules. This increases the risk of drowsiness, difficulties in breathing (respiratory depression), coma and may be life-threatening. Because of this, concomitant use should only be considered when other treatment options are not possible. However, if your doctor prescribes tramadol together with sedating medicines the dose and the
duration of concomitant treatment should be limited by your doctor. Please tell your doctor about all sedating medicines you are taking and follow your doctor’s dose recommendation closely. It could be
helpful to inform friends or relatives to be aware of the signs and symptoms stated above. Contact your doctor when experiencing such symptoms
coumarin anticoagulants (medicines for blood thinning) e.g. warfarin, together with Tramdol capsules. The effect of these medicines on blood clothing may be affected and bleeding may occur
gabapentin or pregabalin to treat epilepsy or pain due to nerve problems (neuropathic pain).

Tramadol Capsules with food and drink:

Food does not influence the effect of Tramadol. You should NOT drink alcohol whilst taking this medicine as its effect may be intensified.

Children and adolescents

Use in children with breathing problems: Tramadol is not recommended in children with breathing problems, since the symptoms of tramadol toxicity may be worse in these children.

Pregnancy, breast-feeding and fertility:

Pregnancy

Do not take Tramadol Capsules if you are pregnant or think you might be pregnant unless you have discussed this with your prescriber and the benefits of treatment are considered to outweigh the potential harm to the baby.

If you use Tramadol capsules during pregnancy, your baby may become dependent and experience withdrawal symptoms after the birth which may need to be treated.

Breast-feeding

Do not take Tramadol capsules while you are breastfeeding as tramadol hydrochloride passes into breast milk and will affect your baby.

There is very little information regarding the safety of tramadol in human pregnancy. Therefore, you should not use Tramadol if you are pregnant. Chronic use during pregnancy may lead to withdrawal symptoms in newborns.

Fertility

Based on human experience tramadol is suggested not to influence female or male fertility. Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines:

Tramadol can cause drowsiness, dizziness and blurred vision and therefore may impair your reactions. If you feel that your reactions are affected, do not drive a car or other vehicle, do not use electric tools or operate machinery.

The medicine can affect your ability to drive as it may make you sleepy or dizzy.

Do not drive while taking this medicine until you know how it affects you.
It is an offence to drive if this medicine affects your ability to drive.
However, you would not be committing an offence if:
- The medicine has been prescribed to treat a medical or dental problem and
- You have taken it according to the instructions given by the prescriber or in the information provided with the medicine and
- It was not affecting your ability to drive safely

Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.

Front Side

Important information about some of the ingredients of Tramadol

Tramadol capsule contains lactose. If you have been told by your doctor that you have intolerance to some sugars, please contact your doctor before taking this medicinal product.

This medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially ‘sodium-free’.

3. HOW TO TAKE TRAMADOL

Always take Tramadol capsules exactly as your doctor has told you. You should check with your doctor if you are not sure.

Before starting treatment and regularly during treatment, your doctor will discuss with you what you may expect from using Tramadol capsules, when and how long you need to take it, when to contact your doctor, and when you need to stop it (see also section 2).

The dosage should be adjusted to the intensity of your pain and your individual pain sensitivity. In general, the lowest pain-relieving dose should be taken.

The usual doses for Tramadol are given below.

Adults and adolescents from the age of 12 years

The usual dose is 1 or 2 capsules (equivalent to 50mg

100mg tramadol hydrochloride). Depending on the pain the effect lasts for about 4-8 hours.

Your doctor may prescribe a different, more appropriate dosage of Tramadol capsules if necessary.

The maximum dose is usually 400 mg daily, except if your doctor has instructed you to do so.

Children: (Under 12 years old)

Tramadol should not be taken by children under 12 years as it is not suitable for them.

Elderly patients

In elderly patients (above 75 years) the excretion of tramadol may be delayed. If this applies to you, your doctor may recommend prolonging the dosage interval.

Severe liver or kidney disease

(insufficiency)/dialysis patients

Patients with severe liver and/or kidney insufficiency should not take Tramadol capsules. If in your case the insufficiency is mild or moderate, your doctor may recommend prolonging the dosage interval.

How and when you should take Tramadol Capsules

Tramadol Capsules are for oral use.

Always swallow Tramadol Capsules whole, not divided or chewed, with sufficient liquid, preferably in the morning and evening. You may take the capsule on an empty stomach or with meals.

How long you should take Tramadol Capsules

Your prescriber should have discussed with you, how long the course of capsules will last.

They will arrange a plan for stopping treatment. This will outline how to gradually reduce the dose and stop taking the medicine.

You should not take Tramadol Capsules for longer than necessary. If you need to be treated for a longer period, your doctor will check at regular short intervals (if necessary, with breaks in treatment) whether you should continue to take Tramadol Capsules and at what dose.

If you have the impression that the effect of Tramadol Capsules is too strong or too weak, talk to your doctor or pharmacist.

The capsules should be swallowed whole with a glass of water.

If you take more Tramadol than you should:

If you have taken an additional dose by mistake, this

will generally have no negative effects. You should take your next dose as prescribed.

If you (or someone else) swallows several of these capsules all together, or you think a child has swallowed any of these capsules, contact your doctor or pharmacist or hospital emergency department immediately. Signs of an overdose include very small pupils, being sick, a fall in blood pressure, a fast heartbeat, collapse, unconsciousness, fits and breathing difficulties or shallow breathing. Always take any capsules left over with you, also the box and leaflet as this will allow easier identification of the capsules.

If you forget to take Tramadol:

If you forget to take a dose, pain is likely to return, and you should take it as soon as you remember. If it is almost time for your next dose, do not take the missed dose and just carry on as before. Do not take a double dose to make up for a forgotten dose.

If you stop taking Tramadol

Do not suddenly stop taking his medicine. If you want to stop taking this medicine, discuss this with your prescriber first. They will tell you how to do this, usually by reducing the dose gradually so that any unpleasant withdrawal effects are kept to a minimum. Withdrawal symptoms such as restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat (palpitations), increased blood pressure, feeling or being sick, diarrhea, shaking, shivering or sweating may occur if you suddenly stop taking this medicine.

If you interrupt or finish treatment with Tramadol Capsules too soon, pain is likely to return.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Tramadol can have side effects, although not everybody gets them.

Please stop taking this medicine and contact your doctor as soon as possible if you experience any of the following rare reactions:

allergic reaction such as swollen face, tongue and/or throat, and/or difficulty swallowing or hives together with difficulties in breathing.

Usually the frequency of side effects is classified as follows:

Very Common (may affect more than 1 in 10 people)

dizziness
nausea (feeling sick)

Common (may affect up to 1 in 10 people)

vomiting (being sick)
headache
drowsiness (sleepiness)
constipation, dry mouth
sweating
fatigue including tiredness, weariness, weakness or low energy.

Uncommon (may affect up to 1 in 100 people)

effects on the heart and blood circulation (pounding of the heart, rapid heartbeat, feeling faint or collapse), palpitation, flushing, sudden drops in blood pressure. These adverse effects may particularly occur in patients in an upright position or under physically strain
urge to sick (retching), stomach trouble (e.g. feeling of pressure in the stomach, bloating), diarrhoea
skin reactions (e.g. itching, rash)
Rare (may affect up to 1 in 1,000 people)
- allergic reactions (e.g. difficulty in
  breathing, wheezing, swelling of skin) and shock (sudden circulation failure) have occurred in very rare cases
- slow heartbeat
- increase in blood pressure
- abnormal sensations (e.g. itching, tingling, numbness), trembling, epileptic fits, muscle twitches, uncoordinated movement, transient loss of consciousness (syncope), speech disorders
- epileptic fits have occurred mainly at high doses of tramadol or when tramadol was taken at the same time as other medicines which may induce fits
- appetite changes
- hallucination, confusional state, sleep disorders, delirium, anxiety and nightmares
- Psychological complaints may appear after treatment with tramadol. Their intensity and nature may vary (according to the patient's personality and length of therapy). These may appear as a change in mood (mostly high spirits, occasionally irritated mood), changes in activity (usually suppression, occasionally increase) and decreased cognitive and sensory perception (being less aware and less able to make decisions, which may lead to errors in judgement)
- blurred vision, excessive dilation of the pupils (mydriasis), constriction of the pupil (miosis)
- slow breathing, shortness of breath (dyspnoea)
- worsening of asthma has been reported; however it has not been established whether it was caused by tramadol. If the recommended doses are exceeded, or if other medicines that depress brain function are taken at the same time, breathing may slow down
- weak muscles
- passing water difficult or painful, less urine than normal (dysuria)

Very rare (may affect up to 1 in 10,000 people).

increase in liver enzyme values

Not known (frequency cannot be estimated from the available data)

decrease in blood sugar level
dependence and addiction (see section “How do I know if I am addicted?”)
hiccups
serotonin syndrome, that can manifest as mental status changes (e.g. agitation, hallucinations, coma), and other effects, such as fever, increase in heart rate, unstable blood pressure, involuntary twitching, muscular rigidity, lack of coordination and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhoea) (see section 2 ‘What you need to know before you take Tramadol’).

Drug Withdrawal

When you stop taking Tramadol, you may experience drug withdrawal symptoms, which include restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat (palpitations), increased blood pressure, feeling or being sick, diarrhoea, shaking, shivering or sweating.

How do I know if I am addicted?

If you notice any of the following signs whilst taking Tramadol capsules, it could be a sign that you have become addicted.

You need to take the medicine for longer than advised by your prescriber
You feel you need to use more than the recommended dose
You are using the medicine for reasons other than prescribed
When you stop taking the medicine you feel unwell, and you feel better once taking the medicine again

If you notice any of these signs, it is important you talk to your prescriber.

Reporting of side effects

If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE TRAMADOL

Keep out of the sight and reach of children.

Store this medicine in a safe and secure storage space, where other people cannot access it. It can cause serious harm and be fatal to people when it has not been prescribed for them.

Do not use this medicine after the expiry date stated on the label or carton.

Do not store above 25°C. Store in the original package.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Tramadol contains

The active ingredient is: Tramadol Hydrochloride. The other ingredients are: Lactose monohydrate, Microcrystalline cellulose (E460(i)), Croscarmellose sodium (E466) and Magnesium stearate (E572).

In addition to these ingredients Capsule shell contains:

Body: Erythrosine (E127), Titanium dioxide (E171), Yellow iron oxide (E172) and Gelatin.

Cap: Indigo carmine (E132), Titanium dioxide (E171), Black iron oxide (E172), Yellow iron oxide (E172) and Gelatin.

Printing Ink: Opacode S-1-17823 black contains Shellac glaze, Black iron oxide (E172), Propylene glycol (E1520) and Ammonium hydroxide (E527).

What Tramadol looks like and contents of the pack

Tramadol Capsules are olive/yellow capsule shell, imprinted ‘TRM’ on the cap and ‘50’ on the body containing white powder.

Tramadol Capsules are available in blister packs of 10, 30, 60 and 100 capsules (Not all pack sizes may be marketed).

Marketing Authorisation Holder

Accord Healthcare Limited,

Sage House, 319, Pinner Road,

North Harrow, Middlesex, HA1 4HF,

United Kingdom.

Manufacturer