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MercuryPharma

PACKAGE LEAFLET: INFORMATION FOR THE USER

Tramadol 100mg/ml oral drops, solution

Tramadol hydrochloride

The name of your medicine is Tramadol 100mg/ml oral drops, solution. It will be referred to as ‘Tramadol oral drops” for ease of use hereafter.

In this leaflet:

1.    What Tramadol oral drops is and what it is used for

2.    Before you take Tramadol oral drops

3.    How to take Tramadol oral drops

4.    Possible side effects

5.    How to store Tramadol oral drops

6.    Further information

1. WHAT TRAMADOL ORAL DROPS IS AND WHAT IT IS USED FOR

Tramadol (tramadol hydrochloride) -the active substance in Tramadol oral drops - is a painkiller belonging to the class of opioids that acts on the central nervous system. It relieves pain by acting on specific nerve cells of the spinal cord and brain. Tramadol oral drops are used for the treatment of moderate to severe pain.

2. BEFORE YOU TAKE TRAMADOL ORAL DROPS

Do not take Tramadol oral drops

•    if you are allergic (hypersensitive) to tramadol or any of the other ingredients of Tramadol oral drops (see section 6: FURTHER INFORMATION)

•    in acute poisoning with alcohol, sleeping pills, pain relievers or other psychotropic medicines (medicines that affect mood and emotions)

•    if you are also taking MAO inhibitors (certain medicines used for treatment of depression) or have taken them in the last 14 days (see “Taking other medicines”)

•    if you are an epileptic and your fits are not adequately controlled by treatment

•    as a substitute in drug withdrawal.

Take special care with Tramadol oral drops

•    if you think that you are addicted to other pain relievers (opioids)

•    if you suffer from consciousness disorders (if you feel that you are going to faint)

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

•    if you suffer from increased pressure in the brain (possibly after a head injury or brain disease)

•    if you have difficulty breathing

•    if you have a tendency towards epilepsy or fits because the risk of a fit may increase

•    if you suffer from a liver or kidney disease.

In such cases please consult your doctor before taking the medicine.

Epileptic fits have been reported in patients taking tramadol at the recommended dose level. The risk may be higher when doses of tramadol exceed the recommended upper daily dose limit (400mg).

Please note that Tramadol oral drops may lead to physical and psychological addiction. When Tramadol oral drops is taken for a long time, its effect may decrease, so that higher doses have to be taken (tolerance development).

In patients with a tendency to abuse medicines or who are dependent on medicines, treatment with Tramadol oral drops should only be carried out for short periods and under strict medical supervision.

Please also inform your doctor if one of these problems occurs during treatment with Tramadol oral drops or if they applied to you in the past.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Tramadol oral drops should not be taken together with MAO inhibitors (certain medicines for the treatment of depression). The pain-relieving effect of Tramadol oral drops may be reduced and the length of time it acts may be shortened, if you take medicines which contain

•    carbamazepine (for epileptic fits)

•    pentazocine, nalbuphine or buprenorphine (pain killers)

•    ondansetron (prevents nausea).

Your doctor will tell you whether you should take Tramadol oral drops, and which dose. The risk of side effects increases

•    if you take tranquillizers, sleeping pills, other pain relievers such as morphine and codeine (also as cough medicine), and alcohol while you are taking Tramadol oral drops. You may feel drowsier or feel that you might faint. If this happens tell your doctor

•    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 oral drops at the same time. Your doctor will tell you whether Tramadol oral drops is suitable for you

•    if you are taking certain antidepressants Tramadol oral drops may interact with these medicines and you may experience symptoms such as involuntary, rhythmic contractions of muscles, including the muscles that control movement of the eye, agitation, excessive sweating, tremor, exaggeration of reflexes, increased muscle tension, body temperature above 38°C

•    if you take coumarin anticoagulants (medicines for blood thinning), e.g. warfarin, together with Tramadol oral drops. The effect of these medicines on blood clotting may be affected and bleeding may occur.

Taking Tramadol oral drops with food and drink

Do not drink alcohol during treatment with Tramadol oral drops as its effect may be intensified. Food does not influence the effect of Tramadol oral drops.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine. There is very little information regarding the safety of tramadol in human pregnancy. Therefore you should not use Tramadol oral drops if you are pregnant. Chronic use during pregnancy may lead to withdrawal symptoms in newborns.

Generally, the use of tramadol is not recommended during breast-feeding. Small amounts of tramadol are excreted into breast milk. After a single dose it is usually not necessary to interrupt breast-feeding. Please ask your doctor for advice. Driving and using machines

Tramadol oral drops may 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. Important information about some of the ingredients of Tramadol oral drops

This medicine contains sucrose. If you have an intolerance to some sugars, contact your doctor before taking this medicine. May be harmful to the teeth.

3. HOW TO TAKE TRAMADOL ORAL DROPS

Always take Tramadol oral drops 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 pain sensitivity. In general the lowest pain-relieving dose should be taken.

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

Adults and adolescents from the age of 12 years

The usual dose for adults and children aged 12 and over is 50 mg to 100 mg tramadol (20 to 40 drops), three to four times per day. The maximum allowed dose of Tramadol oral drops is generally 400 mg (160 drops) per day. For acute pain, a starting dose of 100 mg is generally required since the effect begins later than with other pain relievers. If Tramadol oral drops are taken for acute pain, the user must be aware that the effect begins somewhat later than with a number of other pain-relievers.

For chronic pain, a starting dose of 50 mg is recommended.

Children

Tramadol oral drops are not suitable for children below the age of 12 years.

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 oral drops. If in your case the insufficiency is mild or moderate, your doctor may recommend prolonging the dosage interval.

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How and when should you take Tramadol oral drops?

Tramadol oral drops are for oral use.

Mix the drops in one glass of water. Then drink the whole content of the glass.

The drops may be taken before, during or after meals.

How long should you take Tramadol oral drops?

You should not take Tramadol oral drops 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 oral drops and at what dose. If you have the impression that the effect of Tramadol oral drops is too strong or too weak, talk to your doctor or pharmacist.

If you take more Tramadol oral drops 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. After taking very high doses, pin-point pupils, vomiting, fall in blood pressure, fast heart beat, collapse, disturbed consciousness up to coma (deep unconsciousness), epileptic fits, and difficulty in breathing up to cessation of breathing may occur.

In such cases a doctor should be called immediately.

If you forget to take Tramadol oral drops

If you have forgotten to take a dose, pain is likely to return. Do not take a double dose to make up for forgotten individual doses, simply continue taking drops as before.

If you stop taking Tramadol oral drops

If you interrupt or finish treatment with Tramadol oral drops too soon, pain is likely to return. If you wish to slop treatment, please tell your doctor. Generally there will be no after-effects when treatment with Tramadol oral drops is stopped. However, on rare occasions, people who have been taking Tramadol oral drops for some time may feel unwell if they abruptly stop taking them. They may feel agitated, anxious, nervous or shaky. They may be hyperactive, have difficulty sleeping and have stomach or bowel disorders. Very few people may get panic attacks, hallucinations, unusual perceptions such as Itching, tingling and numbness, and noise in the ears (tinnitus). Further unusual CNS symptoms, i.e. confusion, delusions, change of perception of the own personality (depersonalization), and change in perception of reality (derealisation) and delusion of persecution (paranoia) have been seen very rarely. If you experience any of these complaints after stop taking Tramadol oral drops, please consult your doctor. 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 oral drops can cause side effects, although not everybody gets them. Usually the frequency of side effects is classified as follows:

•    very common (more than 1 out of 10 persons)

•    common (more than 1 out of 100 persons and less than 1 out of 10 persons)

•    uncommon (more than 1 out of 1,000 persons and less than 1 out of 100 persons)

•    rare (more than 1 out of 10,000 persons and less than 1 out of 1,000 persons)

•    very rare (less than 1 out of 10,000 persons)

•    not known (cannot be estimated from the available data).

You should see a doctor immediately if you experience symptoms of an allergic reaction such as swollen lace, tongue and/or throat, and/or difficulty swallowing or hives together with difficulties in breathing.

The most common side effects during treatment with Tramadol oral drops are nausea and dizziness, which occur in more than in 1 out of 10 patients.

Immune system disorders:

Uncommon: severe rash involving reddening, peeling and swelling of the skin that resembles severe burns (toxic epidermal necrolysis), severe form of skin rash with flushing, fever, blisters or ulcers (Stevens Johnson syndrome), cross reactivity with other painkillers (such as acetylsalicylic acid, ibuprofen, naproxen)

Heart and blood circulation disorders:

Uncommon: effects on the heart and blood circulation (pounding of the heart, fast heart beat, feeling faint or collapse). These adverse effects may particularly occur in patients in an upright position or under physical strain.

Rare: slow heart beat, increase in blood pressure.

Metabolism and nutrition disorders:

Not known: low sodium concentration in the blood, decrease in blood sugar level.

Nervous system disorders:

Very common: dizziness.

Common: headaches, drowsiness.

Rare: changes in appetite, abnormal sensations (e.g. itching, tingling, numbness), trembling, slow breathing, epileptic fits, muscle twitches, uncoordinated movement, transient loss of consciousness (syncope), increased muscle stiffness, taste disturbance. If the recommended doses are exceeded, or if other medicines that depress brain function are taken at the same time, breathing may slow down. 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.

Not known: speech disorders.

Psychiatric disorders:

Rare: delirium (a state of mental confusion), hallucinations, confusion, sleep disorders, anxiety and nightmares. Psychological complaints may appear after treatment with Tramadol oral drops. 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 (changes in senses and recognition, which may lead to errors in judgement). Dependence may occur. Thoughts of suicide, drug abuse and addiction.

Eye disorders

Rare: miosis (excessive constriction of the pupil of the eye), blurred vision.

Not known: excessive dilation of the pupils (mydriasis).

Respiratory disorders

Rare: shortness of breath (dyspnoea).

Worsening of asthma has been reported, however it has not been established whether it was caused by tramadol. Stomach and bowel disorders Very common: nausea.

Common: constipation, dry mouth, vomiting, indigestion (dyspepsia), abdominal pain.

Uncommon: anorexia, urge to vomit (retching), stomach trouble (e.g. feeling of pressure in the stomach, bloating), diarrhoea.

Skin disorders:

Common: sweating.

Uncommon: skin reactions (e.g. itching, rash).

Muscle disorders:

Rare: weak muscles.

Liver and biliary disorders:

Very rare: increase in liver enzyme values.

Urinary disorders:

Rare: passing urine with difficulty or pain, passing less urine than normal.

Reproductive system and breast disorders:

Common: menopausal symptoms Rare: menstrual disorders General disorders:

Common: fatigue, weakness, low energy

Rare: weight loss, allergic reactions (e.g. difficulty in breathing, wheezing, swelling of skin) and shock (sudden circulation failure) have occurred in very rare cases.

If Tramadol oral drops is taken over a long period of time dependence may occur, although the risk is very low.

When treatment is stopped abruptly signs of withdrawal may appear (see "If you stop taking Tramadol oral drops").

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE TRAMADOL ORAL DROPS

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

Store in the original package in order to protect from light.

Do not use Tramadol oral drops after the expiry date which is stated on the carton and the bottle. The expiry date refers to the last day of that month. This medicinal product does not require any special storage conditions.

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.

6. FURTHER INFORMATION

What Tramadol oral drops contains

The active substance is tramadol (as the hydrochloride).

Each 1ml oral drops, solution contains 100mg/ml Tramadol (as the hydrochloride).

The other ingredients are:

Sucrose, Saccharin sodium, Potassium sorbate (E202), Polysorbate 20, Aniseed oil, Peppermint oil, Purified water and Hydrochloric acid (for pH adjustment).

What Tramadol oral drops looks like and contents of the pack

Tramadol oral drops are delivered in boxes containing one, three or five amber glass bottles of 10ml, with an inserted dropper applicator and sealed with a child safe screw cap. The solution is clear, colourless or faint yellowish. Not all pack sizes may be marketed. Marketing Authorisation Holder

Mercury Pharmaceuticals Ltd, Capital House, 85 King William Street, London EC4N 7BL, UK Manufacturer

Amcapharm GmbH, Industriestrasse 10, 61191 Ftosbach, Germany.

This leaflet was last revised in September 2015.