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Fortral Injection 30mg / 1ml

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

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.

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

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’

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

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.

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

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.

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.

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.





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