PENTAZOCINE TABLETS BP 25 MG - patient leaflet, side effects, dosage

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 onto 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. See section 4.

What is in this leaflet:

• 1. What Pentazocine is and what it is used for

• 2. What you need to know before you take Pentazocine

• 3. How to take Pentazocine

• 4. Possible side effects

• 5. How to store Pentazocine

• 6. Contents of the pack and other information

1. what pentazocine is and what it is used for

This medicine has been prescribed for you for moderate to severe pain

It contains Pentazocine which belongs to a class of medicines called opioids, which are ‘pain relievers’.

This medicine has been prescribed to you and should not be given to anyone else.

Opioids can cause addiction and you may get withdrawal symptoms if you stop taking it suddenly. Your prescriber should have explained how long you will be taking it for and when it is appropriate to stop, how to do this safely.

2. what you need to know before you take pentazocine you are allergic to pentazocine, analgesics or to any of the other ingredients of this medicine (listed in section 6)

• You suffer from heart failure due to lung disease
• You suffer from a brain condition (including raised pressure in the skull) or head injury
• You suffer from asthma, lung disease or have breathing difficulties, especially if you have blue

discoloration of the skin (cyanosis) or cough up a lot of phlegm

• You suffer from alcoholism or are a heavy drinker
• You have porphyria (a group of rare inherited or acquired disorders where there is a problem with the production of haem (used to make haemoglobin in red blood cells) within the body)

Warnings and precautions

Talk to your doctor before taking Pentazocine:

• If you have ever suffered from drug dependency or abuse as taking a pain reliever regularly for a long time may lead to a dependence (addiction)
• If you have been regularly taking other pain-relieving medicines for several months or longer as taking a pain reliever too often or for too long can cause or worsen headaches. Headaches caused by overuse of medicine should not be treated by further increasing the dose.
• If you suffer from phaeochromocytoma (untreated tumour of the adrenal gland)
• If you suffer from severe kidney or liver problems
• If you are elderly, as you may be especially sensitive to the effects of Pentazocine
• If you have a history of or suffer from fits or seizures
• If you take other analgesic medicines (See “Other medicines and Pentazocine”)
• If you have an underactive thyroid gland (hypothyroidism)
• If you have a condition in which the adrenal glands do not produce adequate amounts of steroid hormones (adrenocortical insufficiency)
• If you suffer from inflammation (swelling) of the prostate (prostatic hypertrophy)
• If you suffer from inflammatory or obstructive bowel disorders
• You are taking medicines used to treat major depressive episodes, known as Monoamine Oxidase Inhibitors (MAOIs) (See “Other medicines and Pentazocine”). Treatment with Pentazocine should only be started 2 weeks after discontinuing treatment with an MAOI

Talk to your prescriber before taking this medicine if you:

• are or have ever been addicted to opioids, alcohol, prescription medicines, or illegal drugs.
• have previously suffered from withdrawal symptoms such as agitation, anxiety, shaking or sweating, when you have stopped taking alcohol or drugs.
• feel you need to take more of Pentazocine to get the same level of pain relief, this may mean you are becoming tolerant to the effects of this medicine or are becoming addicted to it. Speak to your prescriber who will discuss your treatment and may change your dose or switch you to an alternative pain reliever.

Taking this medicine regularly, particularly for a long time, can lead to addiction. Your prescriber should have explained how long you will be taking it for and when it is appropriate to stop, how to do this safely.

Rarely, increasing the dose of this medicine can make you more sensitive to pain. If this happens, you need to speak to your prescriber about your treatment.

Addiction can cause withdrawal symptoms when you stop taking this medicine. Withdrawal symptoms can include restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat (palpitations), increased blood pressure, feeling or being sick, diarrhoea, loss of appetite, shaking, shivering or sweating. Your prescriber will discuss with you how to gradually reduce your dose before stopping the medicine. It is important that you do not stop taking the medicine suddenly as you will be more likely to experience withdrawal symptoms.

Opioids should only be used by those they are prescribed for. Do not give your medicine to anyone else. Taking higher doses or more frequent doses of opioid, may increase the risk of addiction. Overuse and misuse can lead to overdose and/or death.

Other medicines and Pentazocine

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription. This includes herbal medicines.

Medicines which may interact with or be affected by Pentazocine:

• Antidepressant medicines known as Monoamine Oxidase Inhibitors (MAOI) in the past 2 weeks such as phenelzine, isocarboxazid
• Medicines which make you sleepy including:

o Phenothiazines such as trifluoperazine, used to treat anxiety, mental disorders, feeling and/or being sick (nausea, vomiting)

o Medicines used to improve breathing ability such as doxapram (respiratory stimulants)

• Tobacco smoking may decrease the effectiveness of Pentazocine
• Strong pain relievers such as diamorphine (heroin), morphine and naloxone

Concomitant use of Pentazocine and sedative medicines such as benzodiazepines or related drugs increases the risk of drowsiness, difficulties in breathing (respiratory depression), coma and may be life-threatening. Because of this, concomitant use should only be considered when other treatment options are not possible.

However, if your doctor does prescribe Pentazocine together with sedative medicines the dose and duration of concomitant treatment should be limited by your doctor.

Please tell your doctor about all sedative medicines you are taking, and follow your doctor’s dose recommendation closely. It could be helpful to inform friends or relatives to be aware of the signs and symptoms stated above. Contact your doctor when experiencing such symptoms.

Taking Pentazocine with food and drink and alcohol

• These tablets should be taken after meals.
• Do not drink alcohol while you are taking these tablets. If you drink alcohol whilst taking this medicine the sedative effect may be enhanced.

Pregnancy

Do not take pentazocine if you are pregnant or think you might be pregnant unless you have discussed this with your prescriber and the benefits of treatment are considered to outweigh the potential harm to the baby.

If you use pentazocine during pregnancy, your baby may become dependent and experience withdrawal symptoms after the birth which may need to be treated.

Breast feeding

Do not take pentazocine while you are breastfeeding as pentazocine passes into breast milk and will affect your baby.

Driving and using machines

Pentazocine may cause sedation. If affected do not drive or use 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:

o The medicine has been prescribed to treat a medical or dental problem and

o You have taken it according to the instructions given by the prescriber or in the information

provided with the medicine and

o 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.

Pentazocine contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Pentazocine contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per film-coated tablet, that is to say essentially ‘sodium-free’.

3. how to take pentazocine

Always take Pentazocine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

• These tablets are to be taken orally.
• These tablets should be taken after meals.

Your prescriber should have discussed with you, how long the course of tablets will last.

They will arrange a plan for stopping treatment. This will outline how to gradually reduce the dose and stop taking the medicine.

Adults

The usual starting dose is two 25mg tablets (50mg) every four hours, followed by 25 to 100mg of Pentazocine every three to four hours.

Elderly

Your doctor may give you a lower dose if you are elderly.

Patients with liver or kidney problems

If you have liver or kidney problems, your doctor may reduce your dose

Use in children

• Children 6 –12 years: one 25mg tablet every three to four hours as necessary.
• Children under 6 years of age: Not recommended.

If you take more Pentazocine than you should

If you accidentally take too many tablets, contact your doctor or nearest hospital emergency department immediately for advice. Remember to take this leaflet or any remaining tablets with you. Symptoms of overdose include: sleepiness or drowsiness (somnolence), slower or weaker breathing (respiratory depression), low/high blood pressure (hypotension/hy­pertension), faster heartbeat (tachycardia), seeing or hearing things that are not real (hallucinations), or fits (seizures, convulsions). Poor circulation and unconsciousness or coma may occur in more severe cases.

If you forget to take your Pentazocine

Take it as soon as you remember, unless it is nearly time for your next dose. If you miss a dose, do not take a double dose to make up for a forgotten dose.

If you stop taking Pentazocine

Do not suddenly stop taking this medicine. If you want to stop taking this medicine, discuss this with your prescriber first. They will tell you how to do this, usually by reducing the dose gradually so that any unpleasant withdrawal effects are kept to a minimum. Withdrawal symptoms such as restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat (palpitations), increased blood pressure, feeling or being sick, diarrhoea, shaking, shivering or sweating may occur if you suddenly stop taking this medicine.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. possible side effects

Like all medicines, Pentazocine can cause side effects although not everybody gets them.

Seek medical advice immediately if you develop the following symptoms:

• Allergic reactions swelling of the face, throat or tongue, difficulty breathing or dizziness
• Frequent wheezing, breathlessness, abdominal pain, diarrhoea, fever, cough and rashes due to

an increase in certain white blood cells (eosinophillia)

• Severe blistering of the skin, mouth, eyes and genitals (toxic epidermal necrolysis)

Side effects (most frequent)

• Feeling sick (nausea) or being sick (vomiting)
• Light-headedness
• Dizziness
• Sweating

Other side effects (frequency not known)

• High (hypertension) or low blood pressure (hypotension)
• Slow (bradycardia) or fast heartbeat (tachycardia)
• Feeling your heartbeat (palpitations)
• Poor circulation
• Seeing or hearing things that are not real (hallucinations). May occur occasionally
• Feeling depressed or discontented (dysphoria)
• Visual disturbances
• Headache
• Feeling disorientated
• Mood changes
• Nightmares
• Difficulty sleeping (insomnia)
• Tingling or numbness in the hands or feet (paraesthesia)
• Fainting (syncope)
• Intense feeling of well-being or elation (euphoria)
• Fits (seizures)
• Increased pressure in the skull
• Confusion
• Thought disturbances
• Reddening of the face (flushing)
• Skin rashes
• Skin rashes with the formation of wheals (urticaria)
• Skin rash or inflammation (dermatitis)
• Severe itching (pruritus)
• Constipation
• Dry mouth
• Pain in lower back or stomach caused by a spasm of the bile duct
• More prone to infections due to a severe reduction in number of white blood cells

(agranulocytosis)

• Depression of the white blood cell count, which is usually reversible
• Extremely small pupils of the eyes (miosis)
• Breathing more slowly or weakly than usual (respiratory depression)
• Muscle tremor
• Chills
• Low body temperature (hypothermia)
• Difficulty passing urine
• Changes in the rate or strength of uterine contractions
• Lack of sexual desire (decreased libido)
• Dependence and addiction (see section “How do I know if I am addicted?”)

Drug Withdrawal

When you stop taking Pentazocine, you may experience drug withdrawal symptoms, which include restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat (palpitations), increased blood pressure, feeling or being sick, diarrhoea, shaking, shivering or sweating.

How do I know if I am addicted?

If you notice any of the following signs whilst taking Pentazocine, it could be a sign that you have become addicted.

• You need to take the medicine for longer than advised by your prescriber
• You feel you need to use more than the recommended dose
• You are using the medicine for reasons other than prescribed
• When you stop taking the medicine you feel unwell, and you feel better once taking the medicine

again

If you notice any of these signs, it is important you talk to your prescriber

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 or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store pentazocine

• Keep this medicine out of the sight and reach of children
• Do not use Pentazocine after the expiry date, which is stated on the container after EXP. The

expiry date refers to the last day of that month.

• Store in a cool, dry place. Store in the original package in order to protect from light and moisture.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist

6. contents of the pack and other informationeach 25mg tablet contains pentazocine hydrochloride 25mg.

The other ingredients are: maize starch, lactose, colloidal anhydrous silica, magnesium stearate, sodium starch glycollate and water. Coating: hydromellose, ethyl cellulose, diethyl phthalate, opaspray K-1–7000 white (E171), methanol, dichloromethane.

What Pentazocine looks like and contents of the pack:

Pentazocine are white, film-coated tablets, embossed PZN 25 on one side.

Pentazocine is available in:

Pentazocine Tablets are available in packs of 100, 250, 500 or 1000 tablets.

Not all pack sizes may be marketed.

Product Licence Number:

Pentazocine 25mg Film-Coated Tablets: PL 11311/0529

Marketing Authorisation Holder and Manufacturer:

Tillomed Laboratories Ltd

220 Butterfield

Great Marlings

Luton

LU2 8DL

UK

This leaflet was last revised in March 2020

Till-Ver.6.1