Zeridame SR 100mg, 150mg, 200mg
Prolonged Release Tablets
Tramadol Hydrochloride
What you should know about Zeridame SR.
Please read this leaflet carefully before you start taking your medicine.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
If any of the side effects are serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
- 1. What Zeridame SR is and what it is used for.
- 2. Before you take Zeridame SR.
- 3. How to take Zeridame SR.
- 4. Possible side effects.
- 5. Storing Zeridame SR.
- 6. Further information.
What Is Zeridame Sr And What Is It Used For.
Zeridame SR is a pain killer. Zeridame SR eases the pain by inhibition of certain chemicals of the central nervous system
(in the brain and the spinal cord).
Zeridame SR can be used in adults and adolescents over 12 years of age. It is used for the treatment of moderate to severe
pain.
Zeridame SR is not suitable for children under the age of 12 years.
Before You Take Zeridame Sr.
DO NOT take Zeridame SR:
- If you are allergic (hypersensitive) to tramadol hydrochloride or to any of the other ingredients of Zeridame SR.
- If you have recently drunk too much alcohol or taken too many sleeping tablets, pain killers, opiates or any medicines that work via the brain (psychotropic medicines).
- When using certain medicines against depression (so-called MAO-inhibitors) or when these have been used the last 14 days.
- If you suffer from epilepsy that is not controlled by medication.
- For the treatment of withdrawal symptoms in drug addicts.
Take special care with Zeridame SR if:
- You have recently had any head injuries, or an increased pressure in the head (e.g. after an accident)
- You suffer from disorders of the kidneys or liver (see section 3: how to take Zeridame SR)
- You suffer from difficulty to breathe
- You have a tendency towards epilepsy or fits because the risk of a fit may increase. Seizures 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 (400 mg). - You suffer from addiction to opiates
- You suffer from shock (cold sweat may be a sign of this)
Contact your doctor if any of the above warnings are applicable, or have been in the past.
Please note that Zeridame SR may lead to physical and psychological addiction. When Zeridame SR 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 Zeridame SR should only be carried out for short periods and under strict medical supervision.
Taking other medicines:
Please tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines, including medicines without a prescription.
Do not take Zeridame SR at the same time, or within 14 days of taking medicines called monoamine oxidase inhibitors (moclobemide or phenelzine for depression, selegiline for Parkinson’s disease).
The pain relieving effect of Zeridame SR may be weakened and / or shortened if you also take medicines containing:
- Carbamazepine (used to treat epilepsy)
- Buprenorphine, nalbuphine, or pentazocine (pain killers)
- Ondansetron (used to stop you feeling sick)
In isolated cases the side effects of selective serotonin re-uptake inhibitors (SSRI’s) (certain antidepressants) can be
intensified by concomitant use of tramadol. The side effects can be that intense that you speak of a Serotonin syndrome.
Signs of serotonin syndrome can be: confusion, agitation, fever, sweating, reduced coordination, increased sensitiveness
to stimuli, spasms and diarrhoea. If this happens you should always contact the doctor. Stopping the SSRI mostly gives quick improvement.
The risk of side effects is greater if you take Zeridame SR at the same time as:
- Sedative medicines such as tranquillisers, sleeping pills, antidepressants and strong pain relievers (morphine,
codeine, pethidine). You may feel excessively drowsy or feel that you might faint - Tricyclic antidepressant and antipsychotic medicines. There may be an increased risk of epileptic fits
- Blood thinning medicines, such as warfarin. The dose of these medicines may need reducing, otherwise there could
be an increased risk of serious bleeding - Anticonvulsant drugs taken with tramadol can lower the seizure threshold and the risk of convulsions may increase
in these patients
Taking Zeridame SR with food and drink:
Zeridame SR should not be used in combination with alcohol.
Pregnancy:
Ask your doctor or pharmacist for advice before taking any medicine.
Tramadol passes the placenta. There are not enough details known to judge the possible harm in human. Long term
treatment during pregnancy may lead to withdrawal symptoms in the newborn after birth, as a consequence of addiction. Therefore tramadol should not be taken during pregnancy. Your doctor will advise you.
Breastfeeding:
Ask your doctor or pharmacist for advice before taking any medicine.
Generally, the use of Zeridame SR is not recommended during breast feeding. Small amounts of tramadol are excreted into
breast milk. On a single dose it is usually not necessary to interrupt breast feeding. Please ask your doctor for advice.
Driving and using machines:
Zeridame SR can cause drowsiness and dizziness, and blurred vision. Because of this Zeridame SR can affect your ability to
drive and operate machinery. This can be intensified by alcohol or by medicine that acts or works via the brain.
Do not drive a car or do other activities that need you to be alert, until you know how tramadol affects you. Please see 4.
Possible Side Effects for a full list of possible effects that may impair alertness and coordination.
How To Take Zeridame Sr Tablets.
Dose
Always use Zeridame SR exactly as your doctor has told you.
You should check with your doctor or pharmacist if you are not sure. The daily dose is adjusted by your doctor to the
seriousness of the pain and the sensitivity of you, the patient.
The usual dosage is:
Adults and adolescents over 12 years of age:
- The starting dose is:
- Zeridame SR 100mg: one tablet (100mg tramadol hydrochloride) twice a day.
- If this is not sufficient to kill the pain the dose can be increased to:
- Zeridame SR 150mg: one tablet (150mg tramadol hydrochloride) twice a day or
- Zeridame SR 200mg: one tablet (200mg tramadol hydrochloride) twice a day.
If the dose you are prescribed cannot be achieved with this strength tablet, other strengths of this medicinal product are
available to achieve the dose.
Other dosage:
Tell your doctor if you suffer from disorders of the liver or kidneys. The dosage will have to be adjusted or Zeridame SR
should not be used; use of Zeridame SR in patients with severe liver or kidney disorders is not recommended.
If you are older than 75 years the dosage should be adjusted.
Method of administration:
Zeridame SR is a tablet with a special core to let out the active ingredient slowly and long-lasting in the body. Because of this
it can take a bit longer before you notice the effect.
Swallow the tablet whole (without chewing or breaking), with a glass of water. Preferably administer in the morning and
evening. The tablets may be taken on an empty stomach or during a meal.
Duration of the treatment with Zeridame SR
Your doctor will tell you how long you should use Zeridame SR. This depends on the cause of the pain. Do not use
Zeridame SR any longer than necessary.
If you notice that Zeridame SR is too strong or is not enough, talk to your doctor or pharmacist.
If you take more Zeridame SR than you should:
If you have taken too many Zeridame SR you should immediately contact your doctor, nearest hospital or clinic.
The possible symptoms that may occur are: pin-point pupils, vomiting, a fall in blood pressure, a fast heartbeat, collapse,
disturbed consciousness including coma (deep unconsciousness), epileptic fits and difficulties in breathing.
If you forget to take Zeridame SR:
If you forgot to take the tablets, pain is likely to return. Do not take a double dose to make up for forgotten individual doses,
simply continue taking tablets as before.
If you stop taking Zeridame SR:
If you interrupt or finish treatment with Zeridame SR too soon, pain is likely to return. If you wish to stop treatment on
account of unpleasant effects, please tell your doctor.
Generally there will be no after effects when treatment with Zeridame SR is stopped. However, on rare occasions, people
who have been taking Zeridame SR tablets 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). If you experience any of these complaints after stopping Zeridame SR, please consult your doctor.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible Side Effects.
Like all medicines, Zeridame SR tablets can have side effects, although not everybody gets them.
The following side effects can occur:
Very common (in more than 1 out of 10 patients): nausea and dizziness.
Common (in more than 1 out of 100 patients but in less than 1 out of 10 patients): headache; confusion, vomiting,
constipation, dry mouth, sweating.
Uncommon (in more than 1 out of 1000 patients but in less than 1 out of 100 patients): heart palpitations, irregular heart
beat, low blood pressure (especially when standing up), cardiovascular collapse, qualm, pressure on the stomach, feeling of fullness, itch, rash and rash with severe itch and forming of lumps (hives or urticaria)
Rare (in more than 1 out of 10000 patients but in less than 1 out of 1000 patients): blurred vision, slower heartbeat than normal, increase in blood pressure, changes in appetite, itch or tingling without cause, shaking, breathing slower than normal, convulsions, hallucinations, confusion, sleep disturbances and nightmares, allergic reactions (e.g. shortness of breath), tightness of the chest by cramp of the muscles of the airways (bronchospasm), gasping, sudden fluid accumulation in the skin and mucosa (e.g. throat or tongue), respiration difficulties and/or itch and hypersensitiveness. Also reported: mood changes, changes in activity, changes in the observation or the ability to make decisions, muscle weakness, difficulties passing water, involuntary muscle contractions, abnormal coordination, and syncope.
Side Effects that occur at withdrawal, identical to withdrawal symptoms with opiates, can be: agitation, anxiety, fear, nervousness, sleeplessness, motorial agitation (hyperkinesias), shaking (tremor) and gastro-intestinal disorders.
Allergic reaction (e.g difficulty in breathing, wheezing, swelling of skin) and shock (sudden circulation failure) have occurred in
very rare cases (in less than one out of 10000 patients). You should see a doctor immediately if you experience symptoms such as swollen face, tongue and/or throat
and/or difficulty to swallow or hives together with difficulties in breathing.
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
How To Store Zeridame Sr
- Keep out of the reach and sight of children.
Do not use Zeridame SR after the expiry date which is stated on the blister and / or bottle and the carton after “exp”. The
expiry date refers to the last day of that month.*
*(Only the marketed pack type/s will be referred to in the final version)
- Store in the original package in order to protect from moisture.
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.
Further Information
What Zeridame SR contains:
The active substance is: tramadol hydrochloride
- 1 tablet of Zeridame SR 100mg, contains 100mg tramadol hydrochloride.
- 1 tablet of Zeridame SR 150mg, contains 150mg tramadol hydrochloride.
- 1 tablet of Zeridame SR 200mg, contains 200mg tramadol hydrochloride.
The other ingredients are: calcium hydrogen phosphate (E341), hydroxypropyl cellulose (E463), colloidal silicon dioxide
(E551), and magnesium stearate (E470b).
What Zeridame SR looks like and contents of the pack:
Zeridame SR 100mg Prolonged Release Tablets are off white, round biconvex tablets.
Zeridame SR 150mg Prolonged Release Tablets are off white, capsule shaped tablets.
Zeridame SR 200mg Prolonged Release Tablets are off white, capsule shaped tablets.
Zeridame SR 100mg; 150mg; 200mg: packs of *10, 20, 30, 50, 60, 90, 100, 120, 180 or 500 white tablets in blisters or in plastic
tablet containers. Not all pack sizes may be marketed.
*(Only the final size/s and appropriate statement/s will be stated on the final version)
Marketing Authorisation Holder and manufacturer:
Marketing Authorisation Holder:
Manufacturer:
Limassol
This medicinal product is authorised in the Member States of the EEA under the following names:
- The Netherlands - Tramadol HCl Retard 100 mg, 150 mg, 200 mg
- Austria - Tramadolhydrochlorid Actavis 100 mg, 150 mg, 200 mg Retardtabletten
- Czech Republic - Tramadol Retard Actavis 100 mg, 150 mg, 200 mg
- Denmark - Tramadol Retard Actavis 100 mg, 150 mg, 200 mg
- Finland - Trambo Retard 100 mg; 150 mg; 200 mg
- Poland - Travictol 100 mg, 150 mg, 200 mg
- Portugal - Tramadol Actavis
- Sweden - Tramadol Retard Actavis 100 mg, 150 mg, 200 mg
- Slovakia - Tramadol Retard Actavis 100 mg, 150 mg, 200 mg
Revision date of leaflet: July 2007
MCHPL000
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