SEO PLR Content Marketing Texas: Targinact 5 mg / 2.5 mg, 10 mg / 5 mg, 20 mg / 10 mg and 40 mg / 20 mg prolonged-release tablets

Targinact

5 mg/2.5 mg, 10 mg/5 mg, 20 mg/10 mg and 40 mg/20 mg prolonged-release tablets

Oxycodone hydrochloride and Naloxone hydrochloride

Read all of this package 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.

If any of the side effect become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1. What Targinact tablets are and what they are used for

2. Before you take Targinact tablets

3. How to take Targinact tablets

4. Possible side effects

5. How to store Targinact tablets

6. Further information

What Targinact tables are and what they are used for

These tablets contain the active ingredients oxycodone hydrochloride and naloxone hydrochloride. Oxycodone is for the pain-killing effect of the tablets. It is a strong analgesic ('painkiller') that belongs to a group of medicines called opioids. Naloxone is intended to bring relief from constipation. Constipation is a typical side effect of treatment with strong painkillers.

You have been prescribed these tablets for the treatment of severe pain, which requires the use of a strong painkiller (opioid analgesic).

These are prolonged-release tablets. This means that the active ingredients are slowly released from the tablets over a period of 12 hours.

Before you take Targinact tablets

Do not take Targinact tablets

if you are allergic (hypersensitive) to oxycodone or naloxone, or any of the other ingredients of the tablets;

if you have breathing problems, such as breathing more slowly or weakly than expected (respiratory depression);

if you suffer from a severe lung disease associated with narrowing of the airways (chronic obstructive pulmonary disease or COPD);

if you suffer from a condition known as cor pulmonale. In this condition, the right side of the heart becomes enlarged, due to increased pressure inside blood vessels in the lung etc. (e.g. as a result of COPD - see above);

if you suffer from severe bronchial asthma;

if you have a type of bowel obstruction (paralytic ileus) not caused by opioids;

if you have moderate to severe liver problems.

Take special care with Targinact tablets

in the case of elderly or debilitated (weak) patients;

if you have a type of bowel obstruction (paralytic ileus) caused by opioids;

if you have kidney problems;

if you have mild liver problems;

if you have severe lung problems (i.e. reduced breathing capacity);

if you have myxoedema (a thyroid disorder, with dryness, coldness and swelling ['puffiness'] of the skin, affecting the face and limbs);

if your thyroid gland is not producing enough hormones (underactive thyroid or hypothyroidism);

if your adrenal glands are not producing enough hormones (adrenal insufficiency or Addison's disease);

if you have a mental disorder as a result of an intoxication (toxic psychosis);

if you suffer from gallstone problems;

if your prostate gland is abnormally enlarged (prostate hypertrophy);

if you are or ever have been addicted to alcohol or drugs, or have previously suffered from withdrawal symptoms such as agitation, anxiety, shaking or sweating upon stopping alcohol or drugs;

if your pancreas is inflamed (pancreatitis);

if you have low blood pressure (hypotension);

if you have high blood pressure (hypertension);

if you have heart problems;

if you have a head injury (due to the risk of increased brain pressure);

if you suffer from epilepsy or are prone to fits;

if you are also taking a type of medicine known as a MAO inhibitor (used to treat depression or Parkinson's disease) e.g. medicines containing tranylcypromine, phenelzine, isocarboxazid, moclobemide and linezolid.

If any of these warnings apply to you, talk to your doctor before starting to take these tablets.

These tablets are not recommended for use in patients with advanced digestive or pelvic cancers where bowel obstruction may be a problem.

How to use Targinact tablets correctly

If you experience severe diarrhoea at the start of treatment (within the first 3-5 days) this may be due to the effect of naloxone. It may be a sign that your bowel movements are returning to normal. If diarrhoea persists after 3-5 days, or it gives you cause for concern, please contact your doctor.

If you have been using high doses of another opioid, withdrawal symptoms (such as restlessness, bouts of sweating or muscle pain) may occur when you initially switch to taking these tablets. If you experience withdrawal symptoms, you may need to be specially monitored by your doctor.

If you need to undergo surgery, please tell your doctor that you are taking these tablets.

If you have been taking these tablets for a long time, you may become tolerant. This means you may need a higher dose to achieve the desired pain relief. Long-term use of these tablets may also lead to addiction. Withdrawal symptoms may occur if treatment is stopped too suddenly. If you no longer need treatment, you should reduce your daily dose gradually, in consultation with your doctor.

As with other strong opioid painkillers, there is a risk that you may develop a psychological dependence to oxycodone.

You may notice remains of the tablet in your stools. Do not be alarmed, as the active ingredients will have already been released in the stomach and gut, and absorbed into your body.

Incorrect use of Targinact tablets

You must swallow these tablets whole so as not to affect the slow release of oxyecodone. Do not break, chew or crush these tablets. Taking broken, chewed or crushed tablets may result in your body absorbing a potentially fatal dose of oxycodone (see under 'If you take more Targinact tablets than you should').

These tablets are not suitable for withdrawal treatment.

These tablets should never be abused, particularly if you have a drug addiction. If you are addicted to drugs such as heroin, morphine or methadone, severe withdrawal symptoms are likely if you abuse these tablets because they contain the ingredient naloxone. Pre-existing withdrawal symptoms may be made worse.

You should never misuse the tablets by dissolving and injecting them (e.g. into a blood vessel). They contain talc, which can cause destruction of local tissue (necrosis) and changes in lung tissue (lung granuloma). Misuse can also have other serious consequences which may be fatal.

The use of these tablets may produce positive results in drugs tests.

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.

The risk of side effects is increased if you take these tablets at the same time as medicines which affect the way the brain works. For example, you may feel very sleepy, or breathing problems may get worse.

Examples of medicines that affect the way the brain works include:

other strong painkillers (opioids);

sleep medication and tranquillisers (sedatives, hypnotics);

antidepressants;

medicines used to treat allergies, travel sickness or nausea (antihistamines or antiemetics);

other medicines which act on the nervous system (phenothiazines, neuroleptics).

If you are taking these tablets at the same time as medicines that decrease the blood's clotting ability (coumarin derivatives), this clotting time may be speeded up or slowed down.

Taking Targinact tablets with food and drink

These tablets should not be taken with alcohol. Alcohol use could increase the risk of experiencing serious side effects, such as sleepiness, drowsiness and slow and shallow breathing.

Pregnancy and breastfeeding

Ask your doctor or pharmacist for advice before taking any medicine.

Use of these tablets during pregnancy should be avoided unless your doctor thinks treatment with this medicine is essential. If used over prolonged periods during pregnancy, oxycodone may lead to withdrawal symptoms in the newborn baby. If oxycodone is given during childbirth, the baby may have breathing problems (respiratory depression).

Breastfeeding should be stopped during treatment with these tablets as oxycodone (one of the active ingredients of your medicine) passes into breast milk.

Driving and using machines

These tablets may affect your ability to drive or operate machines. This is most likely at the start of your treatment, after a dose increase or after switching from a different medication. These side effects should disappear once you are on a stable dose.

Ask your doctor whether you may drive or operate machines.

Important information about some of the ingredients of Targinact tablets

These tablets contain lactose (milk sugar). If you have been told that you have an intolerance to some sugars, contact your doctor before taking these tablets.

How to take Targinact tablets

Always take these tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Adults

The usual starting dose is 10 mg oxycodone hydrochloride / 5 mg naloxone hydrochloride every 12 hours.

Your doctor will decide how much you should take every day and how to divide your total daily dose into morning and evening doses. They will also decide on any necessary dose adjustments during treatment depending on your level of pain and individual sensitivity. You should be given the lowest dose needed for pain relief. If you have already been treated with opioids, your treatment with these tablets may be started at a higher dose.

The maximum daily dose is 80 mg oxycodone hydrochloride and 40 mg naloxone hydrochloride. If you need a higher dose, your doctor may give you additional oxycodone without naloxone. However, the maximum daily dose of oxycodone should not exceed 400 mg. The beneficial effect of naloxone on bowel movements may be affected if additional oxycodone is given without additional naloxone.

If you experience pain between doses, you may need to take an additional fast-acting painkiller. These tablets are not suitable for this. Please talk to your doctor.

If you feel that these tablets are too strong or too weak, please talk to your doctor or pharmacist.

Liver or kidney problems

If you have kidney or mild liver problem your doctor may prescribe a lower dose. You must not take these tablets if you have moderate or severe liver problems, (see also section 2 'Do not take Targinact tablets' and 'Take special care with Targinact tablets').

Children and adolescents below 18 years of age

No studies have been carried out to show that these tablets work properly in children and adolescents, or are safe for them to take. They are therefore not recommended for use in patients under 18 years of age.

Elderly patients

In general, no dose adjustment is necessary for elderly patients with normal kidney and/or liver function.

Method of administration

Swallow your tablets whole with a glass of water. You can take these tablets with or without food. Take them every 12 hours. For instance, if you take a tablet at 8 o' clock in the morning, you should take your next tablet at 8 o'clock in the evening. Do not break, chew or crush the tablets.

Duration of use

You should not take these tables for any longer than you need to. If you have been taking them for a long time your doctor should regularly check that you still need them.

If you take more Targinact tablets than you should

If you have taken more than the prescribed dose, you must inform your doctor immediately.

An overdose may result in:

a reduction in size of pupils in the eye

breathing more slowly or weakly than expected (respiratory depression)

drowsiness or loss of consciousness

low muscle tone (hypotonia)

reduced pulse rate

a fall in blood pressure.

In severe cases, loss of consciousness (coma), fluid on the lungs and circulatory collapse may occur, which may be fatal.

You should avoid situations which require you to be alert, e.g. driving.

If you forget to take Targinact tablets,

or if you take a lower dose than the one prescribed, you may not feel any pain-killing effect.

If you forget to take your tablets and your next usual dose is due in 8 hours time or more: Take the forgotten tablet immediately and continue with your normal dosing routine.

If your next usual dose is due in less than 8 hours time: Take the forgotten tablet, then, wait another 8 hours before taking your next tablet. Try to get back in your normal dosing routine (e.g. 8 o'clock in the morning and 8 o'clock in the evening).

Do not take more than one dose within any 8 hour period.

Do not take a double dose to make up for a forgoten tablet.

If you stop taking Targinact tablets

Do not stop taking these tablets without first speaking with your doctor. If you do not require any further treatment, your doctor will advise you how to reduce the daily dose gradually. In this way, you will avoid withdrawal symptoms, such as restlessness, bouts of sweating and muscle pain.

If you have any futher questions on the use of these tablets, ask your doctor or pharmacist.

Possible side effects

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

The following terms are used to explain how frequently patients experience side effects:

Very common: affecting more than 1 in 10 people taking these tablets

Common: affecting between 1 and 10 in 100 people taking these tablets

Uncommon: affecting between 1 and 10 in 1,000 people taking these tablets

Rare: affecting between 1 and 10 in 10,000 people taking these tablets

Very rare: affecting fewer than 1 in 10,000 people taking these tablets

Not known:frequency not known

Important side effects or signs to look out for, and what to do if you are affected:

The most serious side effect is a condition where you breathe more slowly or weakly than expected (respiratory depression). It mostly occurs in elderly and weak patients. Opioids can also cause a severe drop in blood pressure in susceptible patient. If you are affected by these important side effects, consult a doctor immediately.

Other important side effects are:

Common

abdominal pain

constipation

diarrhoea

withdrawal symptoms such as agitation, anxiety, shaking or sweating

feeling hot and cold

chills

dry mouth

indigestion

wind

feeling or being sick

restlessness

loss of appetite

general weakness

fall in blood pressure

headache

itchy skin

skin reactions/rash

sweating

a feeling of dizziness or 'spinning'

changes in the results of blood tests that show how well your liver is working.

Uncommon

abdominal bloating

belching

difficulty in concentrating

tingling or numbness in the hands or feet

difficulties with speech

rise in blood pressure

chest pain

difficulty in sleeping

generally feeling unwell

swelling of the hands, ankles or feet

abnormal thoughts

anxiety

confusion

depression

a feeling of extreme happiness

hallucinations

nervousness

drowsiness

abdominal pain or discomfort

pain

weight loss

shaking

shortness of breath

impotence

palpitations

vision disturbances

hypersensitivity/allergic reactions

an increased risk of accidental injuries

chest tightness (especially if you already have heart problems)

runny nose

cough

a sudden urge to pass urine

muscle pain, cramps or twitches

Rare

epileptic fits (especially in people with epilepsy or a predisposition to fits)

feeling more sleepy than normal

fainting

nightmares

increase in pulse rate

dental changes

difficulty in passing urine

yawning

weight gain

Very rare

breathing more slowly or weakly than expected

The active ingredient oxycodone hydrochloride, if not combine with naloxone hydrochloride, is known to have the following differing side-effects:

Breathing problems, such as breathing more slowly or weakly than expected (respiratory depression), reduction in size of the pupils in the eye, muscle cramps and decreased cough reflex.

Common

altered mood and personality changes (e.g. depression, a feeling of extreme happiness)

decreased or increased activity

agitation

difficulty in passing urine

hiccups

Uncommon

voice alteration

difficulty in hearing

mouth ulcers

sore gums

flushing of the skin

migraines

changes in taste

increased muscle tension

involutary muscle contractions

reduce sensitivity to pain or touch

problems with coordination

water retention

perception disturbances (e.g. hallucinations, feeling detached)

decreased sexual drive

Rare

absence of menstrual periods

thirst

dehydration

increased appetite

infections such as cold sores or herpes (which may cause blisters around the mouth or genitals)

dark coloured, tarry stools

bleeding gums

difficulty in swallowing

dry skin

Very rare

serious allergic reactions

itchy rash

a condition where the small bowel (part of your gut) does not work properly (ileus)

Unknown

drug dependence

a need to take increasingly higher doses to obtain the same level of pain relief (tolerance)

If any of the side effects become serious, or if you notice any side effects not listed in this package leaflet, please tell your doctor or pharmacist.

How to store Targinact tablets

Keep out of the reach and sight of children.

Do not use any tablets after the expiry date which is stated on the carton and blister, after 'EXP...' The expiry date refers to the last day of the month.

Do not store above 25°C. Store in the original package in order to protect from light.

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.

Further information

What Targinact tablets contain

The active ingredients are oxycodone hydrochloride and naloxone hydrochloride.

Each 5 mg/2.5 mg tablet contains 5 mg of oxycodone hydrochloride (equivalent to 4.5 mg oxycodone), and 2.73 mg naloxone hydrochloride dihydrate (equivalent to 2.5 mg naloxone hydrochloride and 2.25 mg naloxone).

Each 10 mg/5 mg tablet contains 10 mg of oxycodone hydrochloride (equivalent to 9 mg oxycodone), and 5.45 mg naloxone hydrochloride dihydrate (equivalent to 5 mg naloxone hydrochloride and 4.5 mg naloxone).

Each 20 mg/10 mg tablet contains 20 mg of oxycodone hydrochloride (equivalent to 18 mg oxycodone) and 10.9 mg naloxone hydrochloride dihydrate (equivalent to 10 mg naloxone hydrochloride and 9 mg naloxone).

Each 40 mg/20 mg tablet contains 40 mg of oxycodone hydrochloride (equivalent to 36 mg oxycodone and 21.8 mg naloxone hydrochloride dihydrate (equivalent to 20 mg of naloxone hydrochloride and 18 mg naloxone).

The other ingredients are:

Tablet core:

hydropropylcellulose (5 mg/2.5 mg strength tablet only), povidone K30 (10 mg/5 mg, 20 mg/10 mg and 40 mg/20 mg strength tablets only), ethyl cellulose, strearyl alcohol, lactose monohydrate, talc, magnesium stearate

Tablet coat:

polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc

The 5 mg/2.5 mg tablets also contain brilliant blue (E133), the 20 mg/10 mg tablets also contain iron (III) oxide red (E172) and the 40 mg/20 mg tablets contain iron oxide yellow (E172).

What Targinact tablets look like and the contents of the pack

Targinact
5 mg/2.5 mg tablets are blue, oblong, film coated tablets, marked 'OXN' on one side and '5' on the other.

Targinact
10 mg/5 mg tablets are white, oblong, film coated tablets, marked "OXN" on one side and "10" on the other.

Targinact
20 mg/10 mg tablets are pink, oblong, film coated tablets, marked "OXN" on one side and "20" on the other.

Targinact
40 mg/20 mg tablets are yellow, oblong, film coated tablets, marked 'OXN' on one side and '40' on the other.

In each box there are 28 or 56 tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorization Holder:

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge

CB4 0GW

Manufacturers:

Mundipharma GmbH

Mundipharma Straβe 2

65549 Limburg/Lahn

Germany

Bard Pharmaceuticals Limited

Cambridge Science