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MYLOXIFIN 20MG/10 MG PROLONGED-RELEASE TABLETS

Active substance(s): NALOXONE HYDROCHLORIDE DIHYDRATE / OXYCODONE HYDROCHLORIDE / NALOXONE HYDROCHLORIDE DIHYDRATE / OXYCODONE HYDROCHLORIDE

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Myloxifin (Oxycodon/Naloxon) Tablets - UK - PIL

2. What you need to know before you take Myloxifin

Package Leaflet: Information for the user

Myloxifin 5 mg/2.5 mg prolonged-release tablets
Myloxifin 10 mg/5 mg prolonged-release tablets
Myloxifin 20 mg/10 mg prolonged-release tablets
Myloxifin 30 mg/15 mg prolonged-release tablets
Myloxifin 40 mg/20 mg prolonged-release tablets
Oxycodone hydrochloride/naloxone hydrochloride
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 on to 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 Myloxifin is and what it is used for
2. What you need to know before you take Myloxifin
3. How to take Myloxifin
4. Possible side effects
5. How to store Myloxifin
6. Contents of the pack and other information

1. What Myloxifin is and what it is used for
You have been prescribed Myloxifin for the treatment of severe pain, which
can be adequately managed only with opioid analgesics. Naloxone
hydrochloride is added to counteract constipation.
How Myloxifin relieves pain
Myloxifin contains oxycodone hydrochloride and naloxone hydrochloride as
active substances. Oxycodone hydrochloride is responsible for the
pain-killing effect of Myloxifin, and is a potent analgesic (“painkiller”) of the
opioid group.
The second active substance of Myloxifin, naloxone hydrochloride, is
intended to counteract constipation. Bowel dysfunction (e.g. constipation) is
a typical side effect of treatment with opioid painkillers.
Myloxifin is a prolonged-release tablet, which means that its active substances
are released over an extended period. Their action lasts for 12 hours.
These tablets are only for use in adults.

PIL Size: 600 x 200 mm, Pantone:
Date: 02/08/17

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Do not take Myloxifin
- if you are allergic to oxycodone hydrochloride, naloxone hydrorochloride
or any of the other ingredients of this medicine (listed in section 6),
- if your breathing is not able to supply enough oxygen to the blood, and
get rid of carbon dioxide produced in the body (respiratory depression),
- if you suffer from a severe chronic 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 paralytic ileus (a type of bowel obstruction) not caused by
opioids,
- if you have moderate to severe liver dysfunction.
Warnings and precautions
Talk to your doctor or pharmacist before taking Myloxifin
- if you are elderly or debilitated (weak),
- if you have paralytic ileus (a type of bowel obstruction) caused by opioids,
- if you have kidney impairment,
- if you have mild liver impairment,
- if you have severe lung impairment (i.e. reduced breathing capacity),
- if you suffer from a condition that is accompanied by common respiratory
interruptions and makes you feel sleepy during the day (sleep apnoe),
- 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 illness accompanied by a (partial) loss of reality
(psychosis), due to alcohol or intoxication with other substances
(substance-induced psychosis),
- if you suffer from gallstone problems,
- if your prostate gland is abnormally enlarged (prostate hypertrophy),
- if you suffer from alcoholism or delirium tremens,
- if your pancreas is inflamed (pancreatitis),
- if you have low blood pressure (hypotension),
- if you have high blood pressure (hypertension),
- if you have pre-existing cardiovascular disease,
- if you have a head injury (due to the risk of increased brain pressure),
- if you suffer from epilepsy or are prone to seizures,
- if you are also taking MAO inhibitors (used to treat depression or
Parkinson’s disease), e.g. medicines containing tranylcypromine,
phenelzine, isocarboxazid, moclobemide and linezolid,
- if you feel sleepy or if you fall asleep sometimes.

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Tell your doctor if any of the above has ever applied to you in the past. Also,
please tell your doctor if you develop any of the above disorders while you
are taking Myloxifin.
The most serious result of opioid overdose is respiratory depression (slow
and shallow breathing). This may also cause blood oxygen levels to fall,
resulting in possible fainting, etc..
Tell your doctor in case you have cancer associated to peritoneal metastases or
beginning bowel obstruction in advanced stages of digestive and pelvic cancers.
Children and adolescents
The safety and benefits of Myloxifin in children and adolescents below 18
years has not been established.
How to use Myloxifin correctly
Diarrhoea
If you experience severe diarrhoea at the start of treatment, this may be due
to the effect of naloxone. It may be a sign that bowel function is returning to
normal. Such diarrhoea can occur within the first 3-5 days of treatment. If
diarrhoea should persist after 3-5 days, or give you cause for concern,
please contact your doctor.
Switching to Myloxifin
If you have been using high doses of another opioid, withdrawal symptoms
may occur when you initially switch to Myloxifin treatment, e.g. restlessness,
bouts of sweating and muscle pain. If you experience such symptoms, you
may need to be specially monitored by your doctor. Myloxifin is not suitable
for withdrawal treatment.
Surgery
If you need to undergo surgery, please tell your doctors that you are taking
Myloxifin.
Long-term treatment
If used over the long term, you may become tolerant to Myloxifin. This
means you may need a higher dose to achieve the desired pain relief. Also,
long-term use of Myloxifin may lead to physical dependence. Withdrawal
symptoms may occur if treatment is stopped too suddenly (restlessness,
bouts of sweating, muscle pain). If you no longer need treatment, you should
reduce your daily dose gradually, in consultation with your doctor.
Psychological dependence
The active substance oxycodone hydrochloride alone has an abuse profile
similar to other strong opioids (strong analgesics). There is potential for
development of psychological dependence. Oxycodone hydrochloride
containing products should be avoided in patients with a present or past
abuse of alcohol, drugs or medicines.
You may notice remnants of the prolonged-release tablet in your stools. Do
not be alarmed, as the active substances (oxycodone hydrochloride and
naloxone hydrochloride) have already been released in the stomach and gut,
and absorbed into your body.

Incorrect use of Myloxifin
These tablets are not suitable for withdrawal treatment.
Myloxifin 5 mg / 2.5 mg
The tablet must be swallowed whole and not be divided, broken, chewed or
crushed.
Myloxifin 10 mg / 5 mg
The tablet must not be broken, chewed or crushed.
Myloxifin 20 mg/10 mg, 30 mg/15 mg and 40 mg/20 mg
The tablet must not be broken, chewed or crushed.
Taking chewed or crushed tablets may affect the slow release properties of
the tablet and lead to the absorption of a potentially lethal dose of oxycodone
hydrochloride (see under “If you take more Myloxifin than you should”).
Abuse
Myloxifin should never be abused, particularly if you have a drug addiction. If
you are addicted to substances such as heroin, morphine or methadone, severe
withdrawal symptoms are likely if you abuse Myloxifin because it contains the
ingredient naloxone. Pre-existing withdrawal symptoms may be made worse.
Misuse
You should never misuse Myloxifin prolonged-release tablets by dissolving
and injecting them (e.g. into a blood vessel). In particular, they contain talc,
which can cause destruction of local tissue (necrosis) and changes in lung
tissue (lung granuloma). Such abuse can also have other serious
consequences and may even be fatal.
Doping
Athletes must be aware that this medicine may cause a positive reaction to
‘anti-doping’ tests. The use of Myloxifin as a doping agent may become a
health hazard.
Other medicines and Myloxifin
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
If you take these tablets at the same time as you take other medicines, the
effect of these tablets or the other medicine may be changed. Tell your
doctor if you are taking:
-

other potent painkillers (opioids),
sleep medication and tranquilisers (sedatives, hypnotics),
medicines to treat depression (antidepressants),
medicines used to treat allergies, travel sickness or nausea
(antihistamines or antiemetics),
- medicines to treat psychiatric or mental disorder (phenothiazines,
neuroleptics, antipsychotics),
- medicines that decrease the blood’s clotting ability (coumarin
derivatives), this clotting time may be speeded up or slowed down,
- antibiotics of the macrolide type (such as clarithromycin, erythromycin
or telithromycin),

- antifungal medicines of the azole type (e.g. ketoconazole, voriconazole,
itraconizole or posaconizole),
- a specific type of medicine known as a protease inhibitor used to treat
HIV (examples include ritonavir indinavir, nelfinavir or saquinavir),
- cimetidine (a medicine for stomach ulcers, indigestion or heartburn),
- rifampicin (used to treat tuberculosis),
- carbamazepine (used to treat seizures, fits or convulsions and certain
pain conditions),
- phenytoin (used to treat seizures, fits or convulsions),
- a herbal remedy called St John’s Wort (also known as Hypericum perforatum)
- quinidine (a medicine to treat an irregular heartbeat).
No interactions are expected between Myloxifin and paracetamol,
acetylsalicylic acid or naltrexone.
Myloxifinwith food and drink and alcohol
Drinking alcohol whilst taking Myloxifin may make you feel more sleepy or
increase the risk of serious side effects such as shallow breathing with a
risk of stopping breathing, and loss of consciousness. It is recommended not
to drink alcohol while you’re taking Myloxifin.
You should avoid drinking grapefruit juice while you are taking Myloxifin.
Pregnancy and breast-feeding
If you are pregnant or breastfeeding, think you may be pregnant or are
planning to have a baby, ask your doctor or pharmacist for advice before
taking this medicine.
Pregnancy
Use of Myloxifin should be avoided to the extent possible during pregnancy.
If used over prolonged periods during pregnancy, oxycodone hydrochloride
may lead to withdrawal symptoms in newborn infants. If oxycodone
hydrochloride is given during childbirth, respiratory depression (slow and
shallow breathing) may occur in the newborn infant.
Breast-feeding
Breast-feeding should be discontinued during treatment with Myloxifin. Oxycodone
hydrochloride passes into breast milk. It is not known whether naloxone
hydrochloride also passes into breast milk. Therefore, a risk for the suckling infant
cannot be excluded in particular following intake of multiple doses of Myloxifin.

3. How to take Oxycodone/Naloxone Myloxifin
Always take this medicine exactly as your doctor has told you. Check with
your doctor or pharmacist if you are not sure.
Myloxifin is a prolonged-release tablet, which means that its active substances
are released over an extended period. Their action lasts for 12 hours. Do not
break, chew or crush the tablets. Taking broken, chewed or crushed tablets
may lead to the absorption of a potentially lethal dose of oxycodone
hydrochloride (see section 3 “If you take more Myloxifin than you should”).
Unless otherwise prescribed by your doctor, the usual dose is:
For the treatment of pain
Adults
The usual starting dose is 10 mg oxycodone hydrochloride/5 mg naloxone
hydrochloride as prolonged-release tablet(s) every 12 hours.
Your doctor will decide how much Myloxifin you should take every day and
how to divide your total daily dose into morning and evening doses. Your
doctor will also decide on any necessary dose adjustments during
treatment. Your dose will be adjusted according to 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, Myloxifin treatment can
be started at a higher dose.
The maximum daily dose is 160 mg oxycodone hydrochloride and 80 mg
naloxone hydrochloride. If you need a higher dose, your doctor may give you
additional oxycodone hydrochloride without naloxone hydrochloride.
However, the maximum daily dose of oxycodone hydrochloride should not
exceed 400 mg. The beneficial effect of naloxone hydrochloride on bowel
activity may be affected if additional oxycodone hydrochloride is given
without additional naloxone hydrochloride.
If you are switched from Myloxifin to another strong opioid pain medication
you have to anticipate, that your bowel function will probably worsen.
If you experience pain between two doses of Myloxifin, you probably may
need a rapid-acting painkiller. Myloxifin is not suitable for this. In this case,
please talk to your doctor.

Driving and using machines
Myloxifin may affect your ability to drive or operate machines. In particular,
this is likely at the start of Myloxifin therapy, after a dose increase or after
switching from a different medication. However, these side effects disappear
once you are on a stable Myloxifin dose.

If you have the impression that the effect of Myloxifin is too strong or too
weak, please talk to your doctor or pharmacist.

Oxycodone/Naloxone Myloxifin has been associated with sleepiness and
episodes of abruptly falling asleep. If you have this side effect, you must not
drive or operate machinery. Talk to your doctor if these side effects occur.

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

For the treatment of pain
For doses not realisable/practicable with this strength other strengths of this
medicinal product are available.

Ask your doctor whether you may drive or operate machines.

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Myloxifin (Oxycodon/Naloxon) Tablets - UK - PIL

Use in children and adolescents below 18 years of age
Myloxifin has not yet been studied in children and adolescents under 18
years of age. Its safety and effectiveness have not been proven in children
and adolescents. For this reason, Myloxifin use in children and adolescents
under 18 years of age is not recommended.
Method of administration
For oral use.
Take Myloxifin every 12 hours, according to a fixed time schedule (e.g. at 8
o’clock in the morning and 8 o’clock in the evening).
Myloxifin 5 mg / 2.5 mg
You should take Myloxifin with sufficient liquid (½ glass of water). The tablet
must be swallowed whole and not broken, chewed or crushed. The tablet
may be taken with or without food.
Myloxifin 10 mg/5 mg, 20 mg/10 mg, 30 mg/15 mg and 40 mg/20 mg
You should take Myloxifin with sufficient liquid (½ glass of water). The tablet
can be divided into equal doses. The tablet must not be broken, chewed or
crushed. The tablet may be taken with or without food.
Duration of use
In general, you should not take Myloxifin for any longer than you need to. If
you are on long-term treatment with Myloxifin, your doctor should regularly
check whether you still need Myloxifin.
If you take more Myloxifin than you should
If you have taken more than the prescribed dose of Myloxifin you must
inform your doctor immediately.
An overdose may result in:
- narrowed pupils,
- slow and shallow breathing (respiratory depression),
- drowsiness up to loss of consciousness,
- low muscle tone (hypotonia),
- reduced pulse rate, and
- a drop in blood pressure.
In severe cases, loss of consciousness (coma), fluid on the lungs and
circulatory collapse may occur, which may be fatal in some cases.
You should avoid situations which require a high level of alertness, e.g. driving.
If you forget to take Myloxifin
If you forget to take Myloxifin or if you take a dose lower than the one
prescribed, you may not feel any painkilling effect.
If you forget to take your dose, please follow the instructions below:
- if your next usual dose is due in 8 hours’ time or more: take the forgotten
dose immediately and continue with your normal dosing schedule.

PIL Size: 600 x 200 mm, Pantone:
Date: 02/08/17

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- if your next usual dose is due within less than 8 hours’ time: take the
forgotten dose. Then, wait another 8 hours before taking your next
dose. Try to get back on track with your original dosing schedule (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 forgotten dose.
If you stop taking Myloxifin
Do not stop your treatment with Myloxifin without consulting your doctor.
If you do not require any further treatment, you must reduce the daily dose
gradually after talking to your doctor. In this way, you will avoid withdrawal
symptoms, such as restlessness, bouts of sweating and muscle pain.
If you have any further questions on the use of this medicine, ask your
doctor or pharmacist

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not
everybody gets them.
Important side effects to look out for, and what to do if you are affected
If you are affected by any of the following important side effects, consult
your nearest doctor immediately.
Slow and shallow breathing (respiratory depression) is the main danger of an
opioid overdose. It mostly occurs in elderly and debilitated (weak) patients.
Opioids can also cause a severe drop in blood pressure in susceptible patients.
Side effects are subdivided below into three sections treatment of pain,
treatment with the active substance oxycodone hydrochloride alone.
The following side effects were observed in patients with pain
treatment
Common (may affect up to 1 in 10 people)
- decreased appetite up to loss of appetite
- difficulty in sleeping, tiredness or exhaustion, a feeling of unusual
weakness
- a feeling of dizziness or 'spinning', headache, drowsiness
- vertigo
- hot flushes
- abdominal pain, constipation, diarrhoea, dry mouth, indigestion, vomit
(be sick), feeling sick, wind
- itchy skin, skin reactions, sweating
- general weakness
Uncommon (may affect up to 1 in 100 people)
- hypersensitivity/ allergic reactions
- restlessness, abnormal thoughts, anxiety, confusion, depression,
nervousness
- epileptic seizures (especially in persons with epileptic disorder or
predisposition to seizures), difficulties to concentrate, speech disorder,
fainting, shaking

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- vision impairment
- chest tightness especially if you already have coronary heart disease,
palpitations
- drop in blood pressure, rise in blood pressure
- difficulties of breathing, runny nose, cough
- abdominal bloating
- hepatic enzymes increased, biliary colic
- muscle cramps, muscle twitches, muscle pain
- increased urge to urinate
- withdrawal symptoms such as agitation, chest pain, chills, generally
feeling unwell, pain, swelling of hands, ankles or feet
- weight loss
- injuries from accidents
- reduced sexual drive
- lack of energy
- thirst
- altered taste
Rare (may affect up to 1 in 1,000 people)
- increase in pulse rate
- yawning
- dental changes
- weight gain
Not known (frequency cannot be estimated from the available data)
- euphoric mood, hallucinations, nightmares
- tingling skin (pins and needles), severe drowsiness
- shallow breathing
- belching
- difficulties in passing urine
- erectile dysfunction
The active substance oxycodone hydrochloride, if not combined with
naloxone hydrochloride, is known to have the following differing
side-effects
Oxycodone can cause breathing problems (respiratory depression), reduction
in size of the pupil in the eye, cramping of the bronchial muscles and
cramping of the smooth muscles, as well as depression of the cough reflex.
Common (may affect up to 1 in 10 people)
- altered mood and personality changes (e.g. depression, feeling of
extreme happiness), decreased activity, increased activity
- hiccups
- difficulties in passing urine
Uncommon (may affect up to 1 in 100 people)
- dehydration
- agitation, perception disturbances (e.g. hallucination, derealisation),
drug dependence
- impaired concentration, migraines, increased muscle tension,
involuntary muscle contractions, reduced sensitivity to pain or touch,
abnormal coordination

- difficulties in hearing
- vocal changes (dysphonia)
- difficulties in swallowing, a condition where the bowel stops working
properly (ileus), mouth ulcers, sore gums
- dry skin
- swelling due to water retention, drug tolerance
- flushing of skin
- a decrease in sex hormone levels which may affect sperm production
in men or the menstrual cycle in females
Rare (may affect up to 1 in 1,000 people)
- infections such as cold sores or herpes (which may cause blisters
around the mouth or genital area)
- increased appetite
- black (tarry) stools, bleeding gums
- itching rash (urticaria)
Not known (frequency cannot be estimated from the available data)
- acute generalised allergic reactions (anaphylactic reactions)
- problems with bile flow
- absence of menstrual periods
- withdrawal symptoms in the newborn
- tooth decay
- aggression
- an increase in sensitivity to pain
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 MHRA Yellow Card Scheme, website:
www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide
more information on the safety of this medicine.

5. How to store Oxycodone/Naloxone Myloxifin
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton,
bottle or blister after “EXP”. The expiry date refers to the last day of that month.
Blister: Do not store above 25°C.
Bottles: Do not store above 30 °C. Shelf life after first opening: 3 months.
Do not throw away any medicines via wastewater or household waste. Ask
your pharmacist how to throw away medicines you no longer use. These
measures will help protect the environment.

6. Contents of the pack and other information
What Oxycodone/Naloxone Myloxifin contains
The active substances are oxycodone hydrochloride and naloxone hydrochloride.
Myloxifin 5 mg/2.5 mg
Each prolonged-release tablet contains 5 mg of oxycodone hydrochloride
(equivalent to 4.5 mg oxycodone) and 2.5 mg of naloxone hydrochloride (as
2.74 mg naloxone hydrochloride dihydrate, equivalent to 2.25 mg naloxone).
Myloxifin 10 mg/5 mg
Each prolonged-release tablet contains 10 mg of oxycodone hydrochloride
(equivalent to 9 mg oxycodone) and 5 mg of naloxone hydrochloride (as 5.45
mg naloxone hydrochloride dihydrate, equivalent to 4.5 mg naloxone).
Myloxifin 20 mg/10 mg
Each prolonged-release tablet contains 20 mg of oxycodone hydrochloride
(equivalent to 18 mg oxycodone) and 10 mg of naloxone hydrochloride (as
10.9 mg naloxone hydrochloride dihydrate, equivalent to 9 mg naloxone).
Myloxifin 30 mg/15 mg
Each prolonged-release tablet contains 30 mg of oxycodone hydrochloride
(equivalent to 27 mg oxycodone) and 15 mg of naloxone hydrochloride (as
16.35 mg naloxone hydrochloride dihydrate, equivalent to 13.5 mg naloxone).
Myloxifin 40 mg/20 mg
Each prolonged-release tablet contains 40 mg of oxycodone hydrochloride
(equivalent to 36 mg oxycodone) and 20 mg of naloxone hydrochloride (as
21.8 mg naloxone hydrochloride dihydrate, equivalent to 18 mg naloxone).
The other ingredients are:
Tablet core
Myloxifin 5 mg/2.5 mg
Myloxifin 10 mg/5 mg
Myloxifin 20 mg/10 mg prolonged-release tablets
Myloxifin 30 mg/15 mg prolonged-release tablets
Myloxifin 40 mg/20 mg prolonged-release tablets
Polyvinyl acetate, Povidone K30, Sodium lauryl sulphate, Silica, colloidal
anhydrous, Cellulose, microcrystalline, Magnesium stearate
Tablet coating
Myloxifin 5 mg/2.5 mg
Polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc.
Myloxifin 10 mg/5 mg
Polyvinyl alcohol, titanium dioxide (E171), iron oxide red (E172), macrogol
3350, talc.
Myloxifin 20 mg/10 mg
Polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc.
Myloxifin 30 mg/15 mg
Polyvinyl alcohol, titanium dioxide (E171), iron oxide yellow (E172), macrogol
3350, talc.

Myloxifin 40 mg/20 mg
Polyvinyl alcohol, titanium dioxide (E171), iron oxide red (E172), macrogol
3350, talc.
What Myloxifin looks like and contents of the pack
Myloxifin 5 mg/2.5 mg
White, round, biconvex prolonged-release tablet with a diameter of 4.7 mm
and a height of 2.9 - 3.9 mm.
Myloxifin 10 mg/5 mg
Pink, oblong, biconvex prolonged-release tablet with break scores on both sides,
with a length of 10.2 mm, a width of 4.7 mm and a height of 3.0 - 4.0 mm.
The tablet can be divided into equal doses.
Myloxifin 20 mg/10 mg
White, oblong, biconvex prolonged-release tablet with break scores on both sides,
with a length of 11.2 mm, a width of 5.2 mm and a height of 3.3 - 4.3 mm.
The tablet can be divided into equal doses.
Myloxifin 30 mg/15 mg
Yellow, oblong, biconvex prolonged-release tablet with break scores on both
sides, with a length of 12.2 mm, a width of 5.7 mm and a height of 3.3 - 4.3 mm.
The tablet can be divided into equal doses.
Myloxifin 40 mg/20 mg
Pink, oblong, biconvex prolonged-release tablet with break scores on both sides,
with a length of 14.2 mm, a width of 6.7 mm and a height of 3.6 - 4.6 mm
The tablet can be divided into equal doses.
Myloxifin is available in:
Child-resistant blisters of 10, 14, 20, 28, 30, 50, 56, 60, 98 and 100
prolonged-released tablets or
Bottles with child-resistant screw cap containing 50, 100 or 250
prolonged-released tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Amneal Pharma Europe Limited
70 Sir John Rogerson’s Quay
Dublin 2
Ireland
Manufacturer:
Develco Pharma GmbH
Grienmatt 42
79650 Schopfheim
Germany
This leaflet was last revised in July 2017

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Liver or kidney impairment
If you have an impairment of your kidney function or a mild impairment of
your liver function, your attending doctor will prescribe Myloxifin with special
caution. If you have a moderate or severe impairment of liver function,
Myloxifin must not be used (see also section 2 “Do not take Myloxifin” and
“Warnings and precautions”).

Review - 2

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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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