Zydol Sr 150 Mg Prolonged-Release Tablets
S1581 LEAFLET Zydol SR 150mg 20140527
PACKAGE LEAFLET: INFORMATION FOR THE USER ZYDOL® SR 150mg PROLONGED RELEASE TABLETS (tramadol hydrochloride)
This medicine is known by ZYDOL SR 150 mg Prolonged Release Tablets but will be referred to as ZYDOL SR in this leaflet.
Information for other strengths of ZYDOL SR (ZYDOL SR 100mg PROLONGED RELEASE TABLETS and ZYDOL SR 200mg PROLONGED RELEASE TABLETS) also may be present in this leaflet.
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or your pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet (section 4).
In this leaflet:
1. What ZYDOL SR is and what it is used for
2. What you need to know before you take ZYDOL SR
3. How to take ZYDOL SR
4. Possible side effects
5. How to store ZYDOL SR
6. Contents of the pack and other information
1. WHAT ZYDOL SR IS AND WHAT IT IS USED FOR
Tramadol - the active substance in ZYDOL SR - 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.
ZYDOL SR is used for the treatment of moderate to severe pain.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ZYDOL SR
Do not take ZYDOL SR,
- if you are allergic to tramadol or any of the other ingredients of this medicine (listed in section 6);
- 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 before treatment with ZYDOL SR (see “Other medicines and ZYDOL SR”);
- if you are an epileptic and your fits are not adequately controlled by treatment;
- as a substitute in drug withdrawal.
Warnings and precautions
Talk to your doctor before taking ZYDOL SR
- 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 in 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;
Epileptic fits 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).
Please note that ZYDOL SR may lead to physical and psychological addiction. When ZYDOL 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 ZYDOL SR 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 ZYDOL SR treatment or if they applied to you in the past. Other medicines and ZYDOL SR
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
ZYDOL SR should not be taken together with MAO inhibitors (certain medicines for the treatment of depression).
The pain-relieving effect of ZYDOL SR 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 ZYDOL SR, and wh at 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 wh i l e you are taking ZYDOL SR. 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 having a fit may increase if you take ZYDOL SR at the same time. Your doctor will tell you whether ZYDOL SR is suitable for you.
- if you are taking certain antidepressants ZYDOL SR 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 38C.
- if you take coumarin anticoagulants (medicines for blood thinning),e.g. warfarin, together with ZYDOL SR. The effect of these medicines on blood clotting may be affected and bleeding may occur.
ZYDOL SR with food and alcohol
Do not drink alcohol during treatment with ZYDOL SR as its effect may be intensified. Food does not influence the effect of ZYDOL SR.
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.
There is very little information regarding the safety of tramadol in human pregnancy. Therefore you should not use ZYDOL SR 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. On a single dose it is usually not necessary to interrupt breast-feeding. Please ask your doctor for advice.
Driving and using machines
ZYDOL SR 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, and do not work without a firm hold!
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:
o The medicine has been prescribed to treat a medical or dental problem and
o You have taken it according to the instructions given by the prescriber or in the information provided with the medicine and
o 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.
ZYDOL SR contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. This is because the tablets contain lactose
3. HOW TO TAKE ZYDOL SR
Always take this medicine 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 One ZYDOL SR 100 mg prolonged-release tablet twice daily (equivalent to 200 mg tramadol hydrochloride per day), preferably in the morning and evening.
One ZYDOL SR 150 mg prolonged-release tablet twice daily (equivalent to 300 mg tramadol hydrochloride per day), preferably in the morning and evening.
One ZYDOL SR 200 mg prolonged-release tablet twice daily (equivalent to 400 mg tramadol hydrochloride per day), preferably in the morning and evening.
Your doctor may prescribe a different, more appropriate dosage strength of ZYDOL SR if necessary.
Do not take more than 400 mg tramadol hydrochloride daily, except if your doctor has instructed you to do so.
Children
ZYDOL SR is 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 (insufficiencv)/dialvsis patients
Patients with severe liver and/or kidney insufficiency should not take ZYDOL SR. If in your case the insufficiency is mild or moderate, your doctor may recommend prolonging the dosage interval.
How and when should you take ZYDOL SR?
ZYDOL SR tablets are for oral use.
Always swallow ZYDOL SR tablets whole, not divided or chewed, with sufficient liquid, preferably in the morning and evening. You may take the tablets on an empty stomach or with meals.
How long should you take ZYDOL SR?
You should not take ZYDOL SR 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 ZYDOL SR tablets and at what dose.
If you have the impression that the effect of ZYDOL SR is too strong or too weak, talk to your doctor or pharmacist.
If you take more ZYDOL SR 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.
If you (or someone else) swallow a lot of ZYDOL SR tablets at the same time you should go to hospital or call a doctor straight away. Signs of an overdose include very small pupils, being sick, a fall in blood pressure, a fast heart beat, collapse, unconsciousness, fits and breathing difficulty or shallow breathing.
If you forget to take ZYDOL SR
If you forget 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 the tablets as before.
If you stop taking ZYDOL SR
If you interrupt or finish treatment with ZYDOL 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 ZYDOL SR is stopped. However, on rare occasions, people who have been taking ZYDOL 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 confused, hyperactive, have difficulty sleeping and have stomach or bowel disorders. Very few people may get panic attacks, delusions, paranoia, hallucinations or feeling a loss of identity. They may experience unusual perceptions such as itching, tingling and numbness, and “ringing” in the ears (tinnitus). If you experience any of these complaints after stopping ZYDOL SR, 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, ZYDOL SR can cause side effects, although not everybody gets them.
You should see a doctor immediately if you experience symptoms of an allergic reaction such as swollen face, tongue and/or throat, and/ or difficulty swallowing or hives together with difficulties in breathing.
The most common side effects during treatment with ZYDOL SR are nausea and dizziness, which occur in more than 1 in 10 people. Very common: may affect more than 1 in 10 people
• dizziness
• nausea (feeling sick)
Common: may affect up to 1 in 10 people
• headaches, drowsiness
• tiredness, weariness, weakness, low energy
• constipation, dry mouth, vomiting (being sick)
• sweating
Uncommon: may affect up to 1 in 100 people
• effects on the heart and blood circulation (pounding of the heart, fast heartbeat, feeling faint or collapse). These adverse effects may particularly occur in patients in an upright position or under physical strain.
• urge to sick (retching), stomach trouble (e.g. feeling of pressure in the stomach, bloating), diarrhoea
• skin reactions (e.g. itching, rash)
Rare: may affect up to 1 in 1,000 people
• slow heartbeat
• increase in blood pressure
• abnormal sensations (e.g. itching, tingling, numbness), trembling, epileptic fits, muscle twitches, uncoordinated movement, transient loss of consciousness (syncope).
• 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.
• changes in appetite
• hallucination, confusional state, sleep disorders, delirium, anxiety and nightmares
• Psychological complaints may appear after treatment with ZYDOL SR. 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 judgment).
• Drug dependence may occur.
• blurred vision
• slow breathing, shortness of breath (dyspnoea)
• Worsening of asthma has been reported, however it has not been established whether it was caused by tramadol. If the recommended doses are exceeded, or if other medicines that depress brain function are taken at the same time, breathing may slow down.
• weak muscles
• passing water difficult or painful, less urine than normal.
Very rare: may affect up to 1 in 10,000 people
• increase in liver enzyme values
Not known: frequency cannot be estimated from the available data
• decrease in blood sugar level
• speech disorders
• dilated pupils.
If ZYDOL SR 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 ZYDOL SR”).
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 at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE ZYDOL SR
• KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
• Do not store above 30°C.
• Do not use ZYDOL SR after the expiry date which is stated on the label and carton. The expiry date refers to the last day of the month.
• If your doctor tells you to stop using the medicine, please take it back to the pharmacist for safe disposal. Only keep the medicine if your doctor tells you to.
• If the medicine becomes discoloured or shows any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do.
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. CONTENTS OF THE PACK AND OTHER INFORMATION
What ZYDOL SR contains
• Each prolonged release tablet contains 150 mg of tramadol hydrochloride
• It also contains following other ingredients:
Tablet core: Hypromellosa 100,000 CPS, colloidal anhydrous silica, magnesium stearate, microcrystalline cellulose
Tablet coating: Hypromellose 6 mPas, lactose monohydrate, macrogol 6000, propylene glycol, talc, titanium dioxide, red iron oxide (E172), quinoline yellow lake (E 104)
What ZYDOL SR looks like and contents of the pack
The tablets are pale, orange, round film coated tablets marked with
‘T2' on one side and the manufacturer's logo on the other side.
Zydol SR is supplied in packs of 10, 30 and 60 tablets.
Product Licence holder
Procured from within the EU and repackaged by the Product Licence holder: S & M Medical Ltd, Chemilines House,
Alperton Lane, Wembley, HA0 1DX.
Manufacturer
This product is manufactured by Grunenthal GmbH,
Zieglerstrasse 6, Aachen D-52078, Germany.
I POM | PL 19488/1581 Leaflet revision date: 27 May 2014 ZYDOL is a registered trade mark of Grunenthal GmbH, Germany.
S1581 LEAFLET Zydol SR 150mg 20140527