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FORTRAL INJECTION 30MG/ML

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PATIENT INFORMATION LEAFLET

FORTRAL INJECTION 30MG/ML
(Pentazocine, as lactate)
Read all of this leaflet carefully before you are given this
medicine.
• Keep this leaflet. You may need to read it again.
• If you have further questions, please ask your doctor, nurse 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.
• If any of the side effects gets serious, or if you notice any side effects
not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Fortral is and what it is used for
2. Before you are given Fortral
3. How Fortral is given
4. Possible side effects
5. How Fortral is stored
6. Further information
1. WHAT FORTRAL IS AND WHAT IT IS USED FOR
The name of your medicine is Fortral Injection 30mg/ml (called Fortral
throughout this leaflet). Fortral contains a medicine called pentazocine
(as lactate). Pentazocine belongs to a group of medicines called
analgesics (painkillers).
Fortral is used to treat moderate to severe pain.

2. BEFORE YOU ARE GIVEN FORTRAL
Do not have Fortral and tell your doctor if:
• You are allergic (hypersensitive) to pentazocine or any of the other
ingredients in your medicine (listed in Section 6: Further information).
Signs of an allergic reaction include a rash and breathing problems.
There can also be swelling of the legs, arms, face, throat or tongue
• You have asthma or other breathing problems
• You are dependent on alcohol
• You have recently suffered a head injury
• You have raised pressure in the brain (raised intracranial pressure)
• You have heart failure due to lung problems
Do not have Fortral if any of the above applies to you. If you are not
sure, talk to your doctor or pharmacist before this medicine is given to
you.
Take special care and check with your doctor before having
Fortral if:
• You have a tumour near your kidney (phaeochromocytoma)
• You have recently had a heart attack
• You have liver, kidney, pancreas or gall bladder problems
• You have epilepsy or have ever had fits or seizures
• You have porphyria. This medicine may cause an attack
• You have bowel problems such as inflammation or blockages
• You have prostate problems
• You have an under-active thyroid or adrenal gland
• You have stomach pains that are unexplained
• You are or have ever been dependent on a drug
• You smoke tobacco. This may make Fortral work less well

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If you are not sure if any of the above apply to you, talk to your
doctor or pharmacist before this medicine is given to you.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently
taken any other medicines. This includes medicines obtained without a
prescription, including herbal medicines. This is because Fortral can
affect the way some other medicines work. Also, some other medicines
can affect the way Fortral works.
Tell your doctor if you are taking any of the following
medicines:
• Medicines to treat depression called MAOIs (monoamine oxidase
inhibitors). Also tell your doctor if you have taken them in the last 2
weeks. MAOIs are medicines such as moclobemide, phenelzine
and tranylcypramine
• Medicines which make you drowsy or sleepy (CNS depressants),
including alcohol and other strong pain killers
• Tricyclic antidepressants – used to treat depression
• Morphine or diamorphine (opioids) – used to treat pain
• Doxapram – used to help breathing
• Naloxone – used to treat a drug overdose
• Chlorpromazine or trifluoperazine (phenothiazines) – used to treat
mental illness
If you are not sure if any of the above apply to you, talk to your doctor
or pharmacist before this medicine is given to you.
Having Fortral with food and drink
Do not drink alcohol while you are being treated with this medicine.
This is because alcohol can change the way Fortral works and can
make some side effects of Fortral worse.

Pregnancy and breast-feeding
Talk to your doctor before having this medicine if:
• You are pregnant, think you may be pregnant or plan to get
pregnant. This is because taking Fortral during pregnancy may
cause your baby to have breathing problems or be dependent on
Fortral when it is first born. If you take Fortral while you are in the
late stages of pregnancy your baby will need special monitoring when
born
• You are breast-feeding or planning to breast-feed
Driving and using machines
You may feel dizzy, sleepy or have a change in behaviour (euphoria)
after having this medicine. If this happens, do not drive or use any
tools or machines.
Important information about some of the ingredients of Fortral
• Sodium: Fortral contains 1.1mg of sodium in each 30mg dose. This
is a very small amount so this medicine is classed as ‘sodium free’
3. HOW FORTRAL IS GIVEN
Fortral will be given to you by a doctor or nurse. The injection will be
given either under the skin (subcutaneous), into a muscle
(intramuscular) or into the blood (intravenous).
How much Fortral is given
Adults and children aged 12 years and over
• The usual starting dose of Fortral is 30mg to 60mg
• Injections may be repeated every 3 to 4 hours
• You should not be given more than 360mg in 24 hours
Children over 1 year and under 12 years of age
• Your child’s doctor will work out the dose for your child. The dose
will depend on their weight and how the injection is given
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Children under 1 year of age
• Fortral should not be given to children under 1 year of age
Elderly and people with liver or kidney problems
• Your doctor may give you a lower dose
If you have more Fortral than you should
• It is unlikely that your doctor or nurse will give you too much
medicine. Your doctor or nurse will monitor your progress and check
how much medicine you are given. Always ask if you are not sure
why you are being given a medicine
• Having too much Fortral may make you feel drowsy or dizzy with an
increased or rapid heartbeat. You may also feel very cold and
restless, with writhing movements, stiffness or shaking
• If you think you have had too much Fortral, or you start getting any of
these symptoms tell your doctor or nurse straight away.
If you are away from the hospital, speak to your doctor or nurse
straight away or go to the nearest casualty department
Changing or stopping treatment
Chronic usage of Fortral may lead to tolerance and dependence.
If you have had regular daily doses of Fortral for a long time, your
doctor will not suddenly increase your dose or stop your treatment.
4. POSSIBLE SIDE EFFECTS
As with all medicines, Fortral can cause side effects, although not
everybody gets them.
The following side effects can happen with this medicine:
Stop taking Fortral and see a doctor or go to a hospital straight
away if:
• You get swelling of the hands, feet, ankles, face, lips or throat which
may cause difficulty in swallowing or breathing. You could also

notice an itchy, lumpy rash (hives) or nettle rash (urticaria).
This may mean you are having an allergic reaction to Fortral
• You have a severe rash, with blistering of the skin. Layers of the skin
may peel off. You may also feel generally unwell, have a fever, chills
and aching muscles. This may mean you are suffering from toxic
epidermal necrolysis
Tell your doctor or pharmacist if any of the following side effects
gets serious or lasts longer than a few days:
• Feeling tired, drowsy, dizzy or light-headed
• Sweating more than usual
• Pain, hardening, thickening or swelling of the skin where the injection
was given
• Aching limbs where the injection was given
• Stomach pain, feeling sick (nausea), being sick (vomiting) or dry
mouth
• Constipation
• A fast or slow heartbeat
• Headache
• Changes in mood such as feeling unusually happy
• Seeing or hearing things that aren’t there (hallucinations)
• Nightmares, problems sleeping or numbness and tingling (pins and
needles)
• Feeling lost or confused
• Fits (seizures), muscle tremors or fainting
• Blurred vision or very small pupils
• Severe headache which could be due to raised pressure in the brain
• Problems passing urine
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If any of the side effects gets serious, lasts longer than a few days or
you notice any side effects not listed in this leaflet, please tell your
doctor or pharmacist.
Tell your doctor as soon as possible if you think you may have
become dependent on Fortral
Having Fortral injections regularly for a long time can make you become
dependent on them. This may mean that you feel as if you need to have
Fortral more often or at a higher dose to get the same level of pain relief.
Being dependent on Fortral can cause the following effects if treatment
is suddenly stopped.:
• Feeling sick (nausea), being sick (vomiting), feeling nervous,
restless, dizzy, feverish, having stomach pains, a runny nose, a
fever, chills or weeping eyes
If you are pregnant see section 2 ‘Pregnancy and breast-feeding’. This
is because taking this medicine while you are pregnant could cause
your baby to become dependent on Fortral.
5. HOW FORTRAL IS STORED
The doctor and hospital pharmacist are usually responsible for storing,
using and disposing of Fortral correctly.
Keep this medicine in a safe place out of the reach and sight of children.
Do not use this medicine after the expiry date shown on the pack.
Store your medicine in the original packaging in order to protect from
moisture.

Store this medicine in a dark place to protect from light.
The doctor, nurse or pharmacist will usually be responsible for disposing of
any unwanted Fortral. If you have any unwanted medicine, please return it
to a pharmacist. Do not dispose of medicines, which are no longer needed,
by flushing down a toilet or sink or by throwing out with your normal
household rubbish. This will help protect the environment.
6. FURTHER INFORMATION
What Fortral Injection 30mg/ml contains
• The active substance of Fortral Injection 30mg/ml is pentazocine.
Each 1ml ampoule contains 30mg pentazocine as a solution of
pentazocine lactate. Each 2ml ampoule contains 60mg pentazocine
as a solution of pentazocine lactate
• The other ingredients are sodium chloride, lactic acid and water for
injections
What Fortral Injection 30mg/ml looks like and contents of pack
Fortral Injection 30mg/ml is a solution for injection. The solution comes
in 1ml or 2ml ampoules. Boxes of Fortal contain 2 or 10 ampoules.
The Marketing Authorisation Holder is
Winthrop Pharmaceuticals, PO Box 611, Guildford, Surrey, GU1 4YS
The Manufacturer is
Sanofi Winthrop Industrie, 1, Rue de la Vierge, 33440 Ambares,
France
This leaflet was last updated in August 2008
Winthrop is a registered trademark.
©2008 Winthrop Pharmaceuticals.

217606
125 x 210mm DC

• Breathing problems such as breathlessness or wheezing
• You get infections more easily than usual. This could be because of
a blood problem

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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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