PACKAGE LEAFLET: INFORMATION FOR THE USER

Larapam 100 mg, 150 mg, 200 mg SR Tablets

Tramadol hydrochloride

What is in this leaflet:

1.    What Larapam SR Tablets are and what they are used for

2.    What you need to know before you take Larapam SR Tablets

3.    How to take Larapam SR Tablets

4.    Possible side effects

5.    How to store Larapam SR Tablets

6.    Contents of the pack and other information

What Larapam SR Tablets are and what they are used for

Tramadol, the active substance in Larapam SR Tablets, is a painkiller (analgesic) of the opioid group. Its pain alleviating effect is due to its influence on specific nerve cells in the spinal cord and in the brain.

Larapam SR Tablets are used in the treatment of moderate to severe pain.

What you need to know before you take Larapam SR Tablets

•    ondansetron (used to reduce vomiting)

The risk of side effects is greater if you take Larapam SR

Tablets at the same time as:

•    sedative medicines such as tranquillizers, sleeping pills, antidepressants and other pain relievers (morphine, codeine). You may feel excessively drowsy or feel that you might faint.

•    medicines which may cause convulsions (fits), such as certain antidepressants or antipsychotics. The risk having a fit may increase if you take Larapam SR Tablets at the same time. Your doctor will tell you whether Larapam SR Tablets is suitable for you.

•    certain antidepressants. Larapam SR Tablets 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.

•    medicines that inhibit blood clotting, such as warfarin. The dose of these medicines may need to be reduced, otherwise there could be an increased risk of potentially serious bleeding.

Larapam SR Tablets with alcohol

Do not drink alcohol while taking Larapam SR Tablets; this could enhance the effects of the medicine.

Do not take Larapam SR Tablets:

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

•    if you have acute intoxication with alcohol, sleeping agents, painkillers, opioids or other psychotropic agents (medicines which influence mood, emotional status and disposition)

•    if you are taking, or have taken in the last two weeks, certain medicines called “monoamine oxidase inhibitors” or MAOIs (used to treat depression). (see “Taking other medicines”)

•    if you have epilepsy that is not controlled with your current medicine

•    as a drug substitute for the treatment of drug addiction Warnings and precautions

Talk to your doctor before taking Larapam SR Tablets if you:

•    think you may already be dependent on other opioid painkillers

•    react sensitively to opiates

•    have a consciousness disturbance or are in shock (cold sweat can be an indication of this)

•    have difficulty in breathing

•    have a head injury or brain diseases that may cause elevated pressure in the skull

•    have a liver or kidney disorder

•    suffer from epilepsy or seizures (fits) or have had them in the past.

•    have or ever had a blood level low in sodium

If any of the above applies to you, please talk to your doctor before starting to take this medicine.

Please note that psychological and physical dependence can develop in patients on Larapam SR Tablets. During long-term use, the effects of this medicine may weaken, with the result that it becomes necessary to use a higher dose (development of tolerance). For this reason, Larapam SR Tablets must be used for short periods only and under strict medical supervision in patients at risk of developing drug dependence.

Please also inform your doctor if any of these problems develops while you are taking this medicine and if you have experienced such problems in the past.

Other medicines and Larapam SR Tablets

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

Do not take Larapam SR Tablets at the same time as medicines called “monoamine oxidase inhibitors” (which are used to treat depression), or if you have taken one in the past 2 weeks. The combination could result in a serious, potentially life threatening interaction.

The pain-relieving effect of Larapam SR Tablets may be weakened and/or shortened if you also take medicines containing:

•    carbamazepine (used to treat epilepsy)

•    pentazocine, nalbuphine or buprenorphine

(painkillers)    00000000

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.

Pregnancy: There is very little information regarding the safety of tramadol in human pregnancy, therefore this medicine should not be used in pregnant women.

Breast-feeding: Very small quantities of tramadol are excreted into breast milk. As a rule, it is not necessary to interrupt breast-feeding after taking a single dose of tramadol. If repeated administration is necessary you should suspend breast-feeding. If you have to take tramadol for several days, i.e. for more than 2 to 3 days, you must not breast-feed.

Driving and using machines

This medicine may cause side effects such as drowsiness and blurred vision. If this happens, do not drive or use any tools or machines and do not perform any hazardous tasks.

How to take Larapam SR Tablets

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

•    Swallow the tablets whole with a glass of water.

•    Do not break or chew the tablets.

•    The tablets can be taken with or without food.

The recommended doses are given below. Your doctor may gradually increase or decrease your dose depending on how you respond to the treatment.

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.

It is important that you do not continue to take this medicine for longer than absolutely necessary.

Adults and children aged 12 years and over:

•    The recommended initial dose is 100 mg twice daily.

•    Take one tablet in the morning and one in the evening. There must be a minimum interval of 8 hours between each dose.

As a general rule, you should take no more than the minimum dose you require to control your pain. You should not take a dose of more than 400 mg of the active substance daily unless there are specific medical reasons for this.

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Use in children under 12 years:

This medicine is not recommended in children under 12 years.

Older people:

•    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 Larapam SR Tablets. If in your case the insufficiency is mild or moderate, your doctor may recommend prolonging the dosage interval.

If you take more Larapam SR Tablets than you should

If you take one prolonged release tablet more than prescribed by mistake this will not normally have any negative consequences for you. Continue to take Larapam SR Tablets as your pain recurs as usual.

If you have taken an excessive dose of the medicine the following signs can occur: pin-point pupils, vomiting (being sick), a fall in blood pressure, rapid heartbeat, collapse, disturbed consciousness including coma, epileptic fits and difficulties in breathing. If you observe any of these symptoms or if a child accidentally takes this medicine, immediately contact the nearest doctor or hospital for help!

If you forget to take Larapam SR Tablets

You may experience recurrence of pain. Do not take a double dose to make up for a forgotten dose, but continue to take the preparation as prescribed.

If you stop taking Larapam SR Tablets

If you interrupt or prematurely stop treatment with Larapam SR Tablets, your pain will return. If you decide you wish to stop taking this preparation because of unpleasant side effects, please consult your doctor.

There will normally be no after-effects when you stop taking Larapam SR Tablets. However, in a few cases in which patients have been taking Larapam SR Tablets for a very long period, there have been after-effects such as restlessness, anxiety, nervousness, insomnia, tremor or gastrointestinal upset. If you experience any of these side effects when you stop taking Larapam SR Tablets, please consult your doctor.

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

•    hallucinations, confusion

•    breathing difficulties, worsening of asthma

•    blurred vision

•    reduced muscle strength

•    difficulty in passing urine, producing less urine than normal

•    drug dependence (addiction), withdrawal symptoms may occur when treatment is stopped (see “If you stop taking Larapam SR Tablets”).

•    involuntary muscle contractions

•    lack of coordination

•    loss of consciousness

•    anxiety

•    difficulty and pain when passing urine

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

•    sudden onset of skin redness

•    a feeling of dizziness or “spinning”

•    blood tests which show changes in the way the liver is working

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

•    blood level low in sodium

•    decrease in blood sugar level

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 (www.mhra.gov.uk/ yellowcard). By reporting side effects you can help provide more information on the safety of this medicine.

How to store Larapam SR Tablets

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

Do not use this medicine after the expiry date which is stated on the package after “ Do not use after:” or “EXP:” The expiry date refers to the last day of that month.

Do not store Larapam SR Tablets above 25°C.

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.

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

Serious side effects

This medicine can occasionally cause allergic reactions although serious allergic reactions are rare (may affect up to 1 in 1,000 people). Stop taking this medicine and tell your doctor straight away if you experience any of the following symptoms of a serious allergic reaction:

•    sudden wheezing, difficulty in breathing or dizziness

•    swelling of the face or throat

Other possible side effects

Tell your doctor if any of the following side effects bothers you:

Very common (may affect more than 1 in 10 people):

•    feeling or being sick (nausea)

•    dizziness

Common (may affect up to 1 in 10 people):

•    headache

•    drowsiness, fatigue

•    constipation, dry mouth

•    sweating

•    vomiting

Uncommon (may affect up to 1 in 100 people):

•    faster, stronger or irregular heartbeat

•    collapse or a fall in blood pressure on standing up, which causes dizziness, light-headedness or fainting

•    retching, a feeling of pressure in the stomach, stomach bloating

•    pruritus, rash, and raised, red, itchy skin rash (hives)

•    diarrhoea

Rare (may affect up to 1 in 1,000 people):

•    slower heartbeat

•    rise in blood pressure

•    changes in appetite

•    tingling or numbness in the hands and feet

•    tremor

•    epileptic-like seizures

•    difficulty sleeping, nightmares

•    mood changes

•    changes in activity (usually reduced, sometimes increased)

•    changes in sensory perception and impairment of

the ability to recognise, which can lead to inappropriate decisions

What Larapam SR Tablets contains

The active substance is tramadol hydrochloride. Each Larapam SR tablet contains 100, 150 or 200 mg tramadol hydrochloride.

The other ingredients are: calcium hydrogen phosphate dihydrate (E341), colloidal anhydrous silica (E551), hyprolose (E463), magnesium stearate (E470B).

What Larapam SR Tablets looks like and contents of the pack

Larapam SR Tablets 100, prolonged-release tablet: the tablets are off white and round.

Larapam SR Tablets 150, prolonged-release tablet: the tablets are off white and capsule-shaped.

Larapam SR Tablets 200, prolonged-release tablet: the tablets are off white and capsule-shaped.

The contents of the packages are 10, 20, 30, 50, 60, 100 and 100x1 (unit dose) tablets in PVC/Aluminium blisters.

Not all package sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder Sandoz Limited

Frimley Business Park, Frimley Camberley, Surrey, GU16 7SR

Manufacturer Salutas Pharma GmbH Otto-von-Guericke-Allee 1 39179 Barleben, Germany

This leaflet was last revised in 07/2014.

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