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Zydol 50mg Capsules

Last Updated on eMC 31-Jan-2014 View changes  | Grunenthal Ltd Contact details

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Please click on the link to the left to view the PIL in PDF format.

Text only version for the visually impaired
Below is a text only representation of the Patient Information leaflet. The original may contain images or tables and can be viewed in PDF format using the link to the left. This PIL may be available from the RNIB in large print, Braille or audio CD. For further information please call the RNIB Medicine Leaflet line on 0800 198 5000. The product code(s) for this leaflet is/are: PL 21727/0001.



Zydol 50mg Capsules

Package leaflet: Information for the user

ZYDOL® 50 mg Capsules

Tramadol hydrochloride

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 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 Capsules is and what it is used for
2. What you need to know before you take ZYDOL Capsules
3. How to take ZYDOL Capsules
4. Possible side effects
5. How to store ZYDOL Capsules
6. Contents of the pack and other information

1. What ZYDOL Capsules is and what it is used for

Tramadol - the active substance in ZYDOL Capsules - 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 Capsules is used for the treatment of moderate to severe pain.

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 38˚C.
  • 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 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 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.

Children

ZYDOL Capsules 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 (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 pharmacist.

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 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 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.

5. How to store ZYDOL Capsules

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and the blister. The expiry date refers to the last day of that month. Do not store 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.

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 silica.

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:

Grünenthal Ltd.
Regus Lakeside House
1 Furzeground Way
Stockley Park East
Uxbridge
MiddlesexUB11 1BD
United Kingdom

Manufacturer:

Grünenthal GmbH
Zieglerstr. 6
D-52078
Germany

Other formats:

To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:

0800 198 5000 (UK Only)

Please be ready to give the following information:

Product name Reference number

ZYDOL 50 mg Capsules PL 21727/0001

This is a service provided by the Royal National Institute of the Blind.

This leaflet was last revised in:

September/2013

ZYDOL® is a registered trademark.

R-YJ-061213-08 50/030/23

Company contact details

Grunenthal Ltd

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Address

Units 1 and 2 Stokenchurch Business Park, Ibstone Road, Stokenchurch, Buckinghamshire, HP14 3FE, UK

Medical Information e-mail
Medical Information Direct Line

+44 (0)870 351 8960

Medical Information Fax

+44 (0)1494 486298

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?

Active ingredients

tramadol hydrochloride

Legal categories

POM - Prescription Only Medicine

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