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PENTAZOCINE CAPSULES BP 50MG

Active substance(s): PENTAZOCINE HYDROCHLORIDE

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Pentazocine Capsules 50mg
Read all of this leaflet carefully
before you start taking this
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.

Index
1 W
 hat Pentazocine capsules
are and what they are used
for
2 Before you take
3 How to take
4 Possible side effects
5 How to store
6 Further information
1

 hat Pentazocine capsules are
W
and what they are used for

Pentazocine capsules belong to a group of
medicines called analgesics and are used for
the relief of moderate to severe pain.


2

Before you take

Do not take Pentazocine capsules and
tell your doctor if you have:

• an allergy (hypersensitivity) to pentazocine







or any of the ingredients in the capsule (see
section 6)
difficulty breathing, including respiratory
depression or if you have blue lips or cough
up a lot of phlegm
suffered a head injury or raised pressure in
the skull (may cause painful eyes, changes in
vision or headache behind the eyes) or have
brain disease
asthma
heart failure secondary to chronic
lung disease
porphyria (a genetic disease that can cause
skin blisters, abdominal pain and brain or
nervous system disorders).

Check with your doctor or pharmacist
before taking Pentazocine capsules if you
have:
• severe liver or kidney problems
• diseased adrenal glands such as Addison’s

disease

Continued top of next column

• i nflammatory or obstructive bowel disease
• an enlarged prostate gland and have

difficulty urinating and are male

• an underactive thyroid gland
• had a recent heart attack
• suffered from drug abuse or dependence
Other important warnings:
• t aking a painkiller for headaches too often

or for too long can make them worse.

Taking other medicines

Please tell your doctor or pharmacist if you
are taking or have recently taken any other
medicines, including medicines obtained
without a prescription. Especially:
• Monoamine Oxidase Inhibitors (MAOIs,
e.g. moclobemide) used for depression.
Pentazocine capsules should not be taken
within 14 days of stopping the MAOI
• phenothiazines (eg chlorpromazine) used to
treat some mental illnesses
• doxapram used in severe breathing difficulties
• ethyl alcohol (a form of alcohol)

Driving and using machines

Pentazocine capsules may cause sedation
especially if taken with alcohol. Make sure you
are not affected before you drive or operate
machinery.
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.

Pregnancy and breast-feeding

If you are pregnant, planning to become
pregnant or are breast-feeding ask your doctor
or pharmacist for advice before taking this
medicine.

Sugar intolerance

If you have been told you have an intolerance
to some sugars, contact your doctor before
taking this medicine, as it contains a type of
sugar called lactose.
Continued over page

3

How to take

• Others – tremor, skin rash or itchy skin, flushed

Do not drink alcohol whilst taking Pentazocine
capsules. Swallow the capsules with water, after
meals.

Reporting of side effects

face, increased sweating, low body temperature,
chill, slow breathing rate, lack of sexual desire,
changes in contractions during labour

Always take Pentazocine capsules exactly as your
doctor has told you. If you are not sure, check with
your doctor or pharmacist.

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

Doses:

• Adults: initially 50mg every 4 hours followed by

50-100mg every 3 to 4 hours. Maximum daily
dose of 12 capsules
• Children under 12 years old: Recommended to
use another dosage form such as the tablets.
• Elderly with damaged liver or kidneys: Your
doctor may give you a smaller dose.

By reporting side effects you can help provide more
information on the safety of this medicine.

5

If you take more than you should

If you (or someone else) swallow a lot of
capsules at the same time, or you think a child
may have swallowed any contact your nearest
hospital casualty department or tell your
doctor immediately. Symptoms of an overdose
include coma, fits, drowsiness, fast heart beat,
hallucinations, low or high blood pressure, slow
breathing rate.

Further information

If you forget to take the capsules

What Pentazocine capsules contain

If you stop taking the capsules

the capsules work) is 50mg of pentazocine
hydrochloride.
• The other ingredients in the capsule are lactose,
magnesium stearate, povidone.
• The capsule shell contains gelatin, titanium
dioxide (E171), iron oxide (E172)
• The printing ink contains shellac, propylene
glycol, sodium hydroxide, povidone, titanium
dioxide (E171)

Do not take a double dose to make up for a
forgotten dose. If you forget to take a dose take it
as soon as you remember it and then take the next
dose at the right time.
Talk to your doctor before you stop taking the
capsules and follow their advice.

4

6

How to store

Keep out of the reach and sight of children.
Store below 25°C in a dry place.
Do not use Pentazocine capsules after the expiry
date stated on the label/carton/bottle. The expiry
date refers to the last day of that month.
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.

Possible side effects

Like all medicines, Pentazocine capsules can cause
side effects, although not everybody gets them.
Please tell your doctor or pharmacist if you notice
any of the following effects or any effects not listed.
Stop taking Pentazocine capsules and contact
your doctor at once if you experience symptoms of
an allergic reaction such as swelling of the face, lips,
tongue or throat, difficulty swallowing or breathing,
skin rash or itchy skin, flushed face.
Tell your doctor if you notice any of the following
side effects or notice any other effects not listed:
• Gastrointestinal system - constipation, feeling
or being sick, dry mouth, abdominal pain (may be
caused by spasm of the bile ducts)
• Heart - slow or fast heart rate, palpitations, low or
high blood pressure
• Urinary system - difficulty in passing urine
• Nervous system - ‘spinning’ sensation, confusion,
drowsiness, sedation, light-headedness,
disorientation, dizziness, mood changes,
hallucinations (seeing or hearing things that
are not real), fits, increased pressure in the skull
(painful eyes, changes in vision or headache
behind the eyes), headache, difficulty sleeping,
nightmares, ‘pins and needles’, fainting, extremes
of being happy or sad
• Lungs - difficulty breathing
• Eyes - blurred or double vision, extremely small
pupils

Continued top of next column
50885290 AAAI6853

• The active substance (the ingredient that makes

What Pentazocine capsules look like and
contents of the pack
Pentazocine capsules are orange and grey, hard
gelatin capsules.
Pack sizes are 28 capsules.
Marketing Authorisation Holder and
Manufacturer
Actavis, Barnstaple, EX32 8NS, UK.
This leaflet was last revised in January
2016.

Actavis, Barnstaple, EX32 8NS, UK

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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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