2. What you need to know before you take ZYDOL Capsules
Do not take ZYDOL Capsules,
- 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 Capsules (see “Other medicines and ZYDOL Capsules”);
- 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 Capsules
- 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 Capsules may lead to physical and psychological addiction. When ZYDOL Capsules 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 Capsules 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 Capsules treatment or if they applied to you
in the past.
Other medicines and ZYDOL Capsules
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
ZYDOL Capsules should not be taken together with MAO inhibitors (certain medicines for the treatment of depression).
The pain-relieving effect of ZYDOL Capsules 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 Capsules, and what 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 ZYDOL Capsules. 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 Capsules at the same time. Your doctor will tell you whether ZYDOL
Capsules is suitable for you.
- if you are taking certain antidepressants, ZYDOL Capsules 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
- if you take coumarin anticoagulants (medicines for blood thinning), e.g. warfarin, together with ZYDOL Capsules.
The effect of these medicines on blood clotting may be affected and bleeding may occur.
ZYDOL Capsules with food and alcohol
Do not drink alcohol during treatment with ZYDOL Capsules as its effect may be intensified.
Food does not influence the effect of ZYDOL Capsules.
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
Capsules 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 Capsules 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!
3. How to take ZYDOL Capsules
Always take this medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are
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 or two ZYDOL capsules (equivalent to 50 mg – 100 mg tramadol hydrochloride)
Your doctor may prescribe a different, more appropriate dosage of ZYDOL
Capsules if necessary.
Do not take more than 8 ZYDOL capsules (equivalent to 400 mg tramadol hydrochloride) daily, except if your doctor has
instructed you to do so.
ZYDOL Capsules is not suitable for children below the age of 12 years.
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 ZYDOL Capsules. 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 Capsules?
ZYDOL Capsules are for oral use.
Always swallow ZYDOL Capsules whole, not divided or chewed, with sufficient liquid, preferably in the morning and
evening. You may take the capsule on an empty stomach or with meals.
How long should you take ZYDOL Capsules?
You should not take ZYDOL Capsules 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
Capsules and at what dose.
If you have the impression that the effect of ZYDOL Capsules is too strong or too weak, talk to your doctor or
If you take more ZYDOL Capsules 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 Capsules 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 difficulties or shallow breathing.
If you forget to take ZYDOL Capsules
If you forget to take the capsule, pain is likely to return. Do not take a double dose to make up for forgotten
individual doses, simply continue taking the capsule as before.
If you stop taking ZYDOL Capsules
If you interrupt or finish treatment with ZYDOL Capsules 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 Capsules is stopped. However, on rare occasions,
people who have been taking ZYDOL Capsules 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 Capsules, 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, this medicine 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 Capsules are nausea and dizziness, which occur in more than 1 in
Very common: may affect more than 1 in 10 people
- 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)
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 Capsules. 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. If ZYDOL Capsules 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 Capsules”).
- 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
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.
6. Contents of the pack and other information
What ZYDOL Capsules contains
The active substance is tramadol hydrochloride.
Each capsules contains 50 mg tramadol hydrochloride.
The other ingredients are:
Capsule powder: Microcrystalline cellulose, sodium starch glycolate, magnesium stearate and colloidal anhydrous
Capsule shell: gelatine, sodium laurelsulfate, yellow iron oxide (E172) and titanium dioxide (E171).
What ZYDOL Capsules looks like and contents of the pack
ZYDOL Capsules are yellow/yellow shiny hard gelatin capsules.
ZYDOL Capsules are packed in blisters strips and are supplied in boxes of 10, 20, 30, 50, 100 or 500 capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Regus Lakeside House
1 Furzeground Way
Stockley Park East
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