Tramadol – the active substance in Tramal 100 mg – 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.

Tramal 100 mg is used for the treatment of moderately severe to severe pain.

Do not use Tramal 100 mg

· if you are allergic (hypersensitive) to tramadol or any of the other ingredients of Tramal 100 mg 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 100 mg (see “Using Tramal 100 mg together with other medicines”)

· if you su­er from epilepsy and this cannot be adequately controlled by treatment

· as a replacement in drug withdrawal

Warnings and precautions

Please talk to your doctor or pharmacist before using Tramal 100 mg,

· if you think you may be 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 fits have been described in patients using 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 100 mg can lead to mental and physical addiction. During prolonged use, Tramal 100 mg may become less effective, so that higher doses need to be used (tolerance development). In patients prone to drug abuse or addiction, treatment with Tramal 100 mg 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 using Tramal 100 mg 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 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.

Using Tramal 100 mg together with other medicines

Please tell your doctor or pharmacist if you are taking/using, have recently taken/used or might take/use any other medicines.

Tramal 100 mg must not be used together with MAO inhibitors (certain medicines to treat depression) (see “Do not use Tramal 100 mg”).

The pain-relieving effect of Tramal 100 mg can be reduced and its effect may wear o­ 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 use Tramal 100 mg and, if so, at what dosage.

The risk of side effects increases

·   if you are using Tramal 100 mg 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), such as certain medicines for depression or psychosis. The risk of seizures may increase if you are using Tramal 100 mg at the same time. Your doctor will tell you whether Tramal 100 mg is suitable for you.

·   if you are taking certain medicines for depression. These medicines and Tramal 100 mg 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 and a body temperature above 38 ˚C.

·   if you are using coumarin anticoagulants (medicines that prevent normal blood clotting), e.g. warfarin, at the same time as Tramal 100 mg. The anticoagulant effect of these medicines can be affected ed and bleeding may occur.

Using Tramal 100 mg with food and alcohol

Do not drink alcohol during treatment with Tramal 100 mg, as its effect can be enhanced. Food does not influence the effect of Tramal 100 mg.

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 using this medicine.

Only little information is available on the safety of tramadol in pregnancy. You should therefore not use Tramal 100 mg if you are pregnant.

Repeated use of Tramal 100 mg 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.

The use of tramadol whilst 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.

Clinical studies have indicated that tramadol does not affect male or female fertility.

Driving and the ability to use machines

Tramal 100 mg can lead to effects such as dizziness, light-headedness and visual disturbances (blurred vision) and may therefore affect 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.

Tramal 100 mg contains sodium

Tramal 100 mg contains sodium, but less than 1 mmol sodium (23 mg) per ampoule, i.e. it is essentially ‘sodium- free’.

Always use Tramal 100 mg exactly as your doctor has told you. You should 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. Daily doses of 8 mL Tramal 100 mg (equivalent to 400 mg tramadol hydrochloride) should not be exceeded, unless expressly prescribed by your doctor.

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

Adults and adolescents aged 12 years and older

Depending on the pain, 1 to 2 mL of Tramal 100 mg (equivalent to 50-100 mg tramadol hydrochloride) is administered.

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

For doctors or nursing staff­, further information on administering Tramal 100 mg is given at the end of this leaflet.

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 100 mg is not intended for use in children under 1 year of age.

Children aged 1 to 11 years are given 0.2 to 0.4 mL (equivalent to 10 - 20 mg tramadol hydrochloride) per 10 kilograms of body weight as a single dose. Maximum daily doses of 1.6 mL

Tramal 100 mg (equivalent to 80 mg tramadol hydrochloride) per 10 kilograms of body weight or 8 mL of Tramal 100 mg (equivalent to 400 mg tramadol hydrochloride) should not be exceeded, whereby the smaller of the two doses should be administered unless otherwise expressly prescribed by your doctor.

For doctors or nursing sta­ff, further information on administering Tramal 100 mg to children is

given at the end of this leaflet.

Elderly patients

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

Poor liver or kidney function (insufficiency)/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 use Tramal 100 mg?

Tramal 100 mg is administered intravenously, intramuscularly or subcutaneously (intravenously,

Tramal 100 mg is usually injected into a superficial blood vessel in the arm; intramuscularly, usually into the buttock muscle and subcutaneously, beneath the skin).

Alternatively, Tramal 100 mg can be diluted and used for infusion into a vein. For doctors or nursing staff­, further information on administering Tramal 100 mg is given at the end of this leaflet.

How long should you use Tramal 100 mg?

Do not under any circumstances use Tramal 100 mg 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 using Tramal 100 mg and, if so, at what dose.

If you have the impression that the effect of Tramal 100 mg is too strong or too weak, please talk to your doctor or pharmacist.

If you use more Tramal 100 mg than you should

If you accidentally administer an extra dose of Tramal 100 mg, this will generally have no negative effects. Administer the next dose of Tramal 100 mg as prescribed.

After use of 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 use Tramal 100 mg

If you have forgotten to use Tramal 100 mg, your pain may reappear. Do not use a double dose to make up for a forgotten dose. Continue using this medicine as before.

If you stop treatment with Tramal 100 mg

If you interrupt or stop your treatment with Tramal 100 mg 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 first, 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 100 mg will not have any after-effects. However, in a few patients who have been using Tramal 100 mg 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 effects occur after stopping treatment with Tramal 100 mg, please contact your doctor.

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

The following information is intended for medical or healthcare professionals only:

Instructions for handling the br eak-point ampoule

Other instructions for use

For moderately severe pain, 1 mL Tramal 100 mg (equivalent to 50 mg tramadol hydrochloride) is administered. If no pain relief occurs within 30 to 60 minutes, another 1 mL can be given.

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

For management of severe postoperative pain, even higher doses may be required within the first few hours on an on-demand basis (pain management as needed). The 24-hour requirement is generally no higher than in standard use.

Tramal 100 mg is injected intravenously, intramuscularly or subcutaneously (intravenously,

Tramal 100 mg is usually injected into a superficial blood vessel in the arm; intramuscularly into

the buttock muscle and subcutaneously beneath the skin).

Intravenous administration is slow with 1 mL Tramal 100 mg (equivalent to 50 mg tramadol hydrochloride) per minute.

Alternatively, Tramal 100 mg can be diluted with a suitable solution for infusion (e.g. 0.9% sodium chloride or 5% glucose solution) and used for intravenous infusion or patient controlled analgesia (PCA).

Incompatibilities with Tramal 100 mg

Tramal 100 mg has been shown to be incompatible (immiscible) with solutions for injection containing

– diclofenac

– indomethacin

– phenylbutazone

– diazepam

– flunitrazepam

– midazolam

– glyceryl trinitrate

How to use Tramal 100 mg for the treatment of children over 1 year of age (see “How to use Tramal 100 mg”)

Calculating the injection volume

1) Calculate the total dose of tramadol hydrochloride required in mg: body weight (kg) x dose (mg/kg).

2) Calculate the volume of diluted tramadol hydrochloride solution to be injected: divide the total dose (mg) by an appropriate concentration of diluted solution for injection (mg/mL, see table below).

For this, Tramal 100 mg is diluted with water for injections. The following overview shows which concentrations are achieved (1 mL Tramal 100 mg solution for injection contains 50 mg tramadol hydrochloride):

Dilution of Tramal 100 mg

Example: The physician would like to give a dosage of 1.5 mg tramadol hydrochloride per kilogram body weight to a child weighing 45 kg. For this, 67.5 mg tramadol hydrochloride is required. Therefore, 2 mL Tramal 100 mg is diluted with 4 mL water for injections. This results in a concentration of 16.7 mg tramadol hydrochloride per millilitre. 4 mL (approximately 67 mg tramadol hydrochloride) of the diluted solution is then administered.

Tramal® is a registered trademark of Grüenenthal GmbH licensed to STADA Arzneimittel AG

Like all medicines, Tramal 100mg 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 100 mg 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 100 mg, 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 100 mg”).

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.

To report adverse events:

·      Saudi Arabia:

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.

Keep out of the reach and sight of children.

Do not use Tramal 100 mg after the expiry date, which is stated on the carton and ampoule label after “EXP”. The expiry date refers to the last day of that month.

After opening an ampoule, discard any remaining product.

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.