Tramadol – the active substance in Tramal Capsules – is a centrally acting analgesic (painkiller) belonging to the opioid group. It achieves its pain-relieving effect by acting on specific nerve cells in the spinal cord and brain.

•  if you are allergic to tramadol or any of the other ingredients of this medicine (listed in section 6).

•  in acute cases of intoxication with alcohol, sleeping pills, painkillers or other psychotropic agents (medicines that affect the mood and emotions)

•  if you are also taking MAO inhibitors (certain antidepressants) or have taken them within the last 14 days before treatment with Tramal Capsules (see “Other medicines and Tramal Capsules”)

•  if you suffer from epilepsy and this cannot be adequately controlled by treatment

•  as a replacement in drug withdrawal

Warnings and precautions

Talk to your doctor or pharmacist before taking Tramal Capsules

•  if you believe that you are dependent on other painkillers (opioids);

•  if your consciousness is impaired (if you feel as if you are going to faint),

•  if you are in a state of shock (cold sweats may be a sign of this),

•  if you have a condition with increased pressure on the brain (possibly after a head injury or brain disease),

•  if you have di culties in breathing,

•  if you are prone to epilepsy or seizures,

•  if you have a liver or kidney disorder.

Epileptic   have been described in patients taking tramadol at the recommended dose. The risk may be increased if the maximum recommended daily dose of 400 mg tramadol is exceeded.

Please note that Tramal Capsules can lead to mental and physical addiction. During prolonged use, Tramal Capsules may become less effective, so that higher doses need to be taken (tolerance development). In patients prone to drug abuse or addiction, treatment with Tramal Capsules should therefore only be of short duration and monitored very closely by a doctor.

Also, please tell your doctor if any of these problems occurs while you are taking Tramal

Capsules, or if this information has ever applied to you in the past.

Tramadol is transformed in the liver by an enzyme. Some people have a variation of this enzyme and this can affect people in di erent 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.

Other medicines and Tramal Capsules

Tell your doctor or pharmacist if you are taking/using, have recently taken/used or might

take/use any other medicines.

Tramal Capsules must not be taken together with MAO inhibitors (certain medicines to

treat depression) (see “Do not take Tramal Capsules”).

The pain-relieving effect of Tramal Capsules can be reduced and their effect may wear off more quickly if you are taking medicines containing the following active substances:

• carbamazepine( for epileptic fits )

•  ondansetron (for nausea)

Your doctor will tell you whether you can take Tramal Capsules and, if so, at what dosage. The risk of side effects increases

•  if you are taking Tramal Capsules at the same time as medicines that also suppress

brain function. You may feel light-headed or as if you are about to faint. If this happens, please tell your doctor. These other medicines include sedatives, sleeping pills and certain painkillers such as morphine and codeine (also when used as cough medicine), as well as alcohol.

•  if you are taking medicines that can trigger seizures (fits)  e.g. certain medicines for depression or psychosis. The risk of seizures may increase if you are taking Tramal Capsules at the same time. Your doctor will tell you whether Tramal Capsules are suitable for you.

•  if you are taking certain medicines for depression. These medicines and Tramal Capsules may interact with each other and you may experience symptoms such as involuntary rhythmic muscle twitching, including nystagmus (twitching of the muscles that control eye movement), restlessness, excessive sweating, involuntary tremors,heightened reflexes, increased muscle tension,body temperature above 38 C.

•  if you are taking coumarin anticoagulants (medicines that prevent normal blood clotting),

e.g. warfarin, at the same time as Tramal Capsules. The anticoagulant effect of these

medicines can be a ected and bleeding may occur.

Tramal Capsules with food and alcohol

Do not drink alcohol during treatment with Tramal Capsules, as its effect can be enhanced effect of Tramal Capsules.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Only little information is available on the safety of tramadol in pregnancy. You should therefore not take Tramal Capsules if you are pregnant.

Repeated oral use of Tramal Capsules during pregnancy can lead to tramadol addiction in the unborn child and hence withdrawal symptoms in the newborn baby after delivery. Tramadol is excreted into breast milk. For this reason, you should not take Tramal Capsules more than once during breast-feeding, or alternatively, if you take Tramal Capsules more than once, you should stop breast-feeding.

Taking tramadol whil breast-feeding is generally not recommended. Tramadol is excreted in very small amounts in breast milk. A single dose of tramadol does not generally require discontinuation of breast-feeding. Please ask your doctor for advice.

Experience from use in humans suggests that tramadol does not a effect male or female fertility.

Driving and using machines

Tramal Capsules can lead to effects such as dizziness, light-headedness and visual disturbances (blurred vision) and may therefore a effect your reaction skills. If you feel that your reaction skills are impaired, do not drive a car or any other vehicle, do not operate any electrical tools or machines and do not work without suitable safeguards.

Always take Tramal Capsules exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

The dosage should be adjusted to the intensity of your pain and your individual sensitivity. Basically, the lowest analgesic (pain-relieving) dose should be selected. Do not take more than 8 Tramal capsules (equivalent to 400 mg tramadol hydrochloride) a day, unless expressly prescribed by your doctor.

Unless otherwise prescribed by the doctor, the usual dose is:

Adults and adolescents aged 12 years and older

For moderately severe pain, 1 capsule of Tramal (equivalent to 50 mg tramadol

hydrochloride).

If no pain relief occurs within 30 to 60 minutes, a second capsule can be taken.

If a greater requirement is expected for severe pain, 2 capsules of Tramal (equivalent to 100 mg tramadol hydrochloride) are taken as a single dose.

The effect lasts for 4 to 8 hours, depending on the pain.

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.

Tramal Capsules are not intended for use in children under 12 years.

Elderly patients

In elderly patients (over 75 years of age), the excretion of tramadol may be delayed. If this affects you, your doctor may recommend extending the intervals between doses.

Poor liver or kidney function (insuffciency)/patients on dialysis  

If you have poor liver and/or kidney function, your doctor may recommend extending the

intervals between doses.

How and when should you take Tramal Capsules? Oral use.

Always take Tramal Capsules whole, not chewed and not divided, with suffcient liquid. You can take the capsules on an empty stomach or with meals.

How long should you take Tramal Capsules?

Do not under any circumstances take Tramal Capsules for longer than absolutely necessary. If prolonged pain management seems necessary, your doctor will check regularly at short intervals (if necessary, with breaks in treatment) whether you are to continue taking Tramal Capsules and, if so, at what dose.

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

If you take more Tramal Capsules than you should

If you accidentally take an extra dose of Tramal Capsules, this will generally have no negative effects. Take the next dose of Tramal Capsules as prescribed.

After taking excessively high doses, the following may occur: narrow pupils, vomiting, a drop in blood pressure, rapid heartbeat, circulatory collapse, impaired consciousness and even coma (deep unconsciousness), epileptiform seizures and impaired breathing or even respiratory arrest. If these signs should occur, seek medical assistance immediately.

If you forget to take Tramal Capsules

If you have forgotten to take Tramal Capsules, your pain may reappear. Do not take adouble dose to make up for a forgotten dose. Continue taking your capsules as before.

If you stop taking Tramal Capsules

If you interrupt or stop your treatment with Tramal Capsules too soon, this will probably cause your pain to reappear. If you wish to stop treatment due to unpleasant side

effects, please contact your doctor.

You should not suddenly stop taking this medicine unless your doctor tells you to. If you want to stop taking your medicine, discuss this with your doctor particularly if you have been taking it for a long time. Your doctor will advise you when and how to stop, which may be by lowering the dose gradually to reduce the chance of developing unnecessary side effects (withdrawal symptoms).

In general, stopping treatment with Tramal Capsules will not have any after-effects. However, in a few patients who have been taking Tramal Capsules over a long period of time and who suddenly stop their medication, after-effects may occur. They might feel restless, anxious, nervous or shaky. They might be hyperactive or experience sleeping disorders or gastrointestinal complaints. A very small number of people might get panic attacks, hallucinations, paraesthesia (odd sensations) such as tingling, prickling and numbness, or ringing in the ears (tinnitus). Other unusual symptoms of the central nervous system, such as confusion, delusion, altered perception of oneself (depersonalisation) and reality (derealisation) and persecution mania (paranoia), have been observed very rarely. If any of these side e effects occur after stopping treatment with Tramal Capsules, please contact your doctor.

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

Like all medicines, this medicine can cause side effects, although not everybody gets

them.

You should consult a doctor immediately if you notice symptoms of an allergic reaction, such as swelling of the face, tongue and/or throat and/or difficulties in swallowing or nettle rash accompanied by breathing problems.

The most common side effects that occur during treatment with Tramal Capsules are nausea and dizziness, occurring in more than 1 in 10 patients treated

Very common (more than 1 in 10 patients treated):

Dizziness, nausea.

Common (1 to 10 in 100 patients treated):

Headache, light-headedness, exhaustion, vomiting, constipation, dry mouth, sweating (hyperhidrosis).

Uncommon (1 to 10 in 1,000 patients treated):

Effect on cardiovascular regulation (palpitations, increased heartbeat [tachycardia], suddenly feeling faint [orthostatic hypotension] or circulatory collapse). In particular, these side effects can occur in the upright position and upon physical exertion.

Retching, stomach discomfort (e.g. stomach pressure, bloating), diarrhoea.

Skin reactions (e.g. itching, rash).

Rare (1 to 10 in 10,000 patients treated):

Allergic reactions (e.g. breathlessness [dyspnoea], wheezing breath sounds

[sibilant rhonchi], accumulation of water in the tissues [angioedema] and shock reactions (sudden circulatory failure] have occurred in very rare cases.

Slowed heart rate (bradycardia). Rise in blood pressure.

Odd skin sensations (e.g. tingling, prickling, numbness), trembling (tremor), epileptiform seizures, involuntary muscle twitches, coordination problems, temporary loss of consciousness (syncope), speech disturbances.

Epileptiform seizures have mainly occurred after use of high tramadol dosages or after combined use of medicines that can trigger seizures.

Changes in appetite.

Hallucinations, confused states, sleep disorders, delirium, anxiety and nightmares.

Psychological symptoms can occur after treatment with Tramal Capsules, which can

vary individually in intensity and nature (depending on the patient’s personality and duration of use). These may include mood changes (mostly elated, but also occasionally irritated mood), changes in activity (mostly suppression; occasionally increased) and being less able to process ones thoughts and senses, which may lead to errors in decision-making (impaired sensory and cognitive performance).

Drug dependence can occur.

After discontinuation of this medicine, withdrawal reactions can occur (see “If you stop treatment with Tramal Capsules”).

Blurred vision, narrowing of the pupils (miosis), extreme pupil dilation (mydriasis). Slowed breathing (respiratory depression), shortness of breath (dyspnoea).

Slowed breathing may occur if the recommended doses are exceeded or if other medicines with a depressant effect on brain function are co-administered.

Worsening of asthma has been reported, although no causal relationship with the active substance tramadol could be established.

Reduced muscle strength (motor weakness).

Difficult or painful urination, less urine than normal (micturition disorders and dysuria).

Very rare (less than 1 in 10,000 patients treated):

Increase in liver enzyme values.

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

Decrease in blood sugar levels.

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 NPC- SFDA

To report adverse events:

The National Pharmacovigilance and Drug Safety Centre (NPC). SFDA - Fax: +966-11-205-7662

- Call NPC at +966-11-20382222, Exts: 2317-2356-2353-2354-2334-2340. - Toll free phone: 8002490000

- E-mail: npc.drug@sfda.gov.sa

- Website: www.sfda.gov.sa/npc

Other GCC States:

Please contact the relevant competent authority.

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

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

Do not use Tramal Capsules after the expiry date which is stated on the carton and blister after “EXP”. The expiry date refers to the last day of that month.

Do not store above 30°C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.