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DOLPAR XL 100MG PROLONGED-RELEASE TABLETS

Active substance(s): TRAMADOL HYDROCHLORIDE / TRAMADOL HYDROCHLORIDE

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Ref: 1591/160117/1/F

Dolpar XL 100mg prolonged-release Tablets
(tramadol hydrochloride)
Patient Information 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 pharmacist or nurse.
* 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 or nurse. This
includes any possible side effects not listed in this leaflet. See Section 4.
Your medicine is called Dolpar XL 100mg prolonged-release Tablets but will
be referred to as Dolpar XL throughout the leaflet. Please note that the
leaflet also contains information about other strengths of the medicine,
Dolpar XL 200mg prolonged-release Tablets and Dolpar XL 300mg
prolonged-release Tablets.
What is in this leaflet:
1 What Dolpar XL is and what it is used for.
2 What you need to know before you take Dolpar XL
3 How to take Dolpar XL
4 Possible side effects
5 How to store Dolpar XL
6 Contents of the pack and other information

The risk of side effects increases
* if you are taking medicines which may cause convulsions (fits), such as
certain antidepressants or antipsychotics. The risk of having a fit may
increase if you take Dolpar XL at the same time. Your doctor will tell you
whether Dolpar XL is suitable for you.
* if you are taking certain antidepressants. Dolpar XL 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.
This medicine may also interact with the following medicines:
* morphine-like drugs such as cough medicines or substitution treatments
such as methadone
* other painkillers
* warfarin (a blood thinner)
* benzodiazepines and other treatments for anxiety
* some treatments for high blood pressure
* antihistamines (for allergies) that cause sleepiness
* thalidomide (for certain cancers and skin conditions)
* barbiturates (sleeping pills)
* neuroleptics, phenothiazine, butyrophenine (to treat mental illness)
* baclophene (a muscle relaxant)
Please tell your doctor or pharmacist if you are taking or have recently
taken any other medicines, including medicines obtained without a
prescription.
Dolpar XL with food and drink and alcohol
Drinking alcohol is not recommended during treatment.

1

What Dolpar XL is and what it is used for

This medicine is used to treat moderate to severe pain in adults and children
over 12 years.
It belongs to a group of painkiller medicines called opiate analgesics.

Pregnancy and breast-feeding and fertility
This medicine should not be taken during pregnancy unless absolutely
necessary.
If you discover that you are pregnant while you are taking this
medication, you should consult your doctor as soon as possible, who
will adjust the treatment to your condition.

2

What you need to know before you take Dolpar XL

Do not take Dolpar XL:
* If you are allergic to tramadol or any of the other ingredients of this
medicine (listed in section 6).
* If you are taking linezoid (an antibiotic used to treat severe bacterial
infections such as MRSA)
* In acute poisoning with alcohol, sleeping pills, pain relievers or other
psychotrop medicines (medicines that affect mood and emotions).
* If you are taking, or have taken in the last two weeks, MAOIs (medicines
used to treat depression).
* If you are suffering from severe liver disease or severe kidney disease.
* If you are suffering from epilepsy, not adequately controlled by treatment.
* If you are breastfeeding, in the case of long-term treatment (more than 2 to
3 days).
If you are not sure, it is important to ask your doctor or pharmacist for
advice.
Warning and precautions
Talk to your doctor or pharmacist or nurse before taking Dolpar XL. Tell your
doctor if you are addicted to another drug, are being treated for withdrawal
from another drug or are dependent on another drug. This medicine may
cause a psychic or physical dependence (addiction) with long-term use. In
patients with a tendency to become addicted to drugs, this medicine should
only be used for very short periods and under strict medical supervision.
This medicine should be used with caution in the case of:
* reduced consciousness
* brain trauma or any brain disorder such as infection or tumour
* state of shock (cold sweat may be a sign of it)
* breathing difficulties
* a history of epileptic seizures
* kidney or liver disorders
* an increase in normal brain pressure causing symptoms such as headache
and vomiting (increased intracranial pressure)
* diabetes

You can usually continue breast-feeding if you take one single dose.
If your treatment lasts for more than 2 to 3 days, breast-feeding may be
interrupted. You must not breast-feed during long-term treatment.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Dolpar XL may cause drowsiness. Do not drive or do other activities where
you need to be alert (for example using any tools or machines), until you
know how the medication affects you. Do not take with alcohol or drugs that
make you sleepy.
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:
* The medicine has been prescribed to treat a medical or dental problem
and
* You have taken it according to the instructions given by the prescriber or in
the information provided with the medicine and
* 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.

3

How to take Dolpar XL

Always take this medicine exactly as your doctor or pharmacist has
told you. 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.

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).

Adults and children over 12 years of age - the usual starting dose is 100mg,
once daily.
The usual dose after this is 200mg, once daily. If there is not enough pain
relief, the maximum dose is up to 300 or 400mg once daily.

If you are not sure, do not hesitate to consult your doctor or
pharmacist for advice.

Elderly patients (up to 75 years of age) - no dose adjustment is needed.

Children and adolescents
The use of this medicine is not recommended in children under 12 years of
age.

Elderly patients (above 75 years of age) - 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.

Other medicines and Dolpar XL
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any of the following medicines as they may interact with your Doplar.
* Carbamazepine (used for the treatment of epilepsy)
* Buprenorphine, nalbuphine, pentazocine (other painkillers)
* Alcohol
* Naltrexone (used for alcohol or drug abuse).

Severe liver or kidney disease (insufficiency)/dialysis patients
Patients with severe liver and/or kidney insufficiency should not take Dolpar
XL. If in your case the insufficiency is mild or moderate your doctor may recommend prolonging the dosage interval.

This medicine may cause seizures at therapeutic doses and in particular
when taking high doses and in combination with other medicines including:
* bupropion (used to help stopping smoking)
* mefloquine (a treatment for malaria)

These are oral tablets, Swallow the tablets whole with a glass of water,
preferably in the evening. Dolpar XL may be taken with food or drink. Do not
chew or crush them.
Dolpar XL tablets should be taken once every 24 hours.
Strictly follow your doctor’s advice at all times.

Ref: 1591/160117/1/B

Dolpar XL 100mg prolonged-release Tablets
(tramadol hydrochloride)
Patient Information Leaflet (continued)
If you take more Dolpar XL than you should
Contact your doctor immediately.
If you forget to take Dolpar XL
Do not take a double dose to make up for a forgotten tablet.
If you stop taking Dolpar XL
Rarely when some people stop taking Dolpar XL after long-term use, they
get withdrawal symptoms. They may feel agitated, anxious, nervous or
shaky. They may become over-active and have difficulty sleeping. These
effects usually disappear in a few days. Tell your doctor if this happens to
you.
If you have any further questions on the use of this medicine, ask your
doctor or pharmacist or nurse.

4

Possible side effects

Like all medicines, this medicine can cause side effects, although not
everybody gets them. All medicines can cause allergic reactions, although
serious allergic reactions are very rare. Tell your doctor straight away if you
get any sudden wheeziness, difficulty in breathing, swelling of the eyelids,
face or lips, rash or itching (especially affecting your whole body).
Serious side effects
If you notice any of these symptoms, stop taking the tablets and
consult your doctor straight away.
* fits (convulsions),
* breathing difficulties,
* rash or allergic reaction of any kind,
The following side effects have also been reported:
Very common: may affect more than 1 in 10 people
* feeling sick (nausea),
* dizziness.
Common: may affect up to 1 in 10 people
* constipation,
* sweating,
* dry mouth,
* confusion
* headache
* vomiting.
Uncommon: may affect up to 1 in 100 people
* gastrointestinal irritation (a feeling of pressure in the stomach and wind),
* cardiac and vascular problems (increased heart rate, low blood pressure
on standing, feeling unwell with drop in blood pressure),
* skin reactions (itching, rash, hives),
Rare: may affect up to 1 in 1,000 people
* muscle weakness,
* changes in appetite,
* feelings of numbness, itch or pins and needles, tremors,
* slow heart rate or breathing,
* increase in blood pressure,
* blurred vision,
* difficulty in passing urine,
* mood changes (such as feeling unusually happy),
* changes in activity (such as being less active), and changes in thought,
* hallucinations (seeing or hearing things),
* confusion,
* trouble with sleep, nightmares,
* allergic reactions,
* worsening of asthma
* dependence (side effects that occur when you stop taking the drug),
* epileptic fits.
* in a few isolated cases increases in liver enzymes,
* low levels of blood sugar.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. 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 Dolpar XL

Keep out of the sight and reach of children.
Do not store above 30°C.
Do not take Dolpar XL after the expiry date which is stated on the blister
label or carton. The expiry date refers to the last day of the month.
If your doctor tells you to stop taking this medicine, return any unused
tablets to your pharmacist (chemist) for safe disposal. Only keep this
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 that are no longer
required. These measures will help to protect the environment.

6

Contents of the pack and other information

What Dolpar XL contains:
Each prolonged release tablet contains 100mg of tramadol hydrochloride
released over 24 hours.
Also contains polyvinyl acetate, povidone, sodium lauryl sulphate and silica
(Kollidon SR), xanthan gum, hydrogenated vegetable oil (from cotton seed),
magnesium stearate (vegetable origin), silica colloidal anhydrous,
hydroxypropyl distarch phosphate maize – (E1442) (Contramid).
What Dolpar XL look like and contents of the pack
Dolpar XL is a white to off white, plain, bevelled edge, round biconvex tablet.
Each pack contains 30 Tablets.
Manufacturer and Licence Holder
Manufactured by Endo Ventures Limited, First Floor, Minerva House,
Simmonscourt Road, Ballsbridge, Dublin 4, Ireland and procured from within
the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited,
Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire,
B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or
pharmacist. They will have additional information about this medicine and
will be able to advise you.

POM

CD

PL 15184/1678

Dolpar XL100mg
prolonged-release Tablets

Revision date: 16/01/17

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527
505414 to obtain the leaflet in a format suitable for you

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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