ZOMESTINE 5 MG PROLONGED-RELEASE TABLETS

Active substance: OXYCODONE HYDROCHLORIDE

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Zomestine 5 mg
prolonged-release tablets
Zomestine 10 mg
prolonged-release tablets
Zomestine 20 mg
prolonged-release tablets
Zomestine 40 mg
prolonged-release tablets
Zomestine 80 mg
prolonged-release tablets
Oxycodone 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
or nurse.
- This medicine has been prescribed for you only. Do not pass it on
to others. It may harm them, even if their sign of illness are the
same as yours.
- If you get any side effects talk to your doctor or pharmacist or nurse.
This includes any possible side effects not listed in this leaflet.
What is in this leaflet:
1. What Zomestine is and what it is used for
2. What you need to know before you take Zomestine
3. How to take Zomestine
4. Possible side effects
5. How to store Zomestine
6. Contents of the pack and other information

1. What Zomestine is and what it is used for
Zomestine is a centrally acting, strong painkiller from the group of
opioids.
Zomestine is used to treat severe pain, which can be adequately
managed only with opioid analgesics.

2. What you need to know before you take
Zomestine
Do not take Zomestine
- if you are allergic to oxycodone hydrochloride or any of the other
ingredients of this medicine (listed in section 6)
- if you suffer from severely depressed breathing (respiratory

Warnings and precautions
Talk to your doctor or pharmacist or nurse before taking Zomestine
- if you are older or debilitated
- if your lung, liver or kidney function is severely impaired (see also
section 3 “Risk patients”)
- if you suffer from myxoedema (certain illnesses of the thyroid gland),
impaired function of the thyroid gland as you may need a lower dose
- if you suffer from adrenal insufficiency (Addison’s disease)
- if you have low blood pressure (hypotension)
- if you have a mental disorder as a result of an infection (toxic
psychosis)
- if you have inflammatory bowel disease
- if you suffer from enlargement of the prostate (prostatic hypertrophy)
- If you suffer from alcoholism or are undergoing alcohol withdrawal
- if you suffer from known opioid-dependence
- if you suffer from inflammation of the pancreas (pancreatitis)
- if you have a severe headache or feel sick as this may indicate
that the pressure in your skull is increased
- if you have breathing problems such as severe pulmonary
disease. Your doctor will have told you if you have this condition.
Symptoms may include breathlessness and coughing
- if you suffer from disturbances of circulatory regulation
- if you suffer from colic of the bile duct and ureter
- if you suffer from epilepsy or have a seizure tendency
- if you take MAO inhibitors (for the treatment of depression).
- have a head injury that causes a severe headache or makes you
feel sick. This is because the tablets may make these symptoms
worse or hide the extent of the head injury
Please talk to your doctor if any of these apply to you or if any of
these conditions applied to you in the past.
Zomestine has primary dependence potential. When used for a
long time tolerance to the effects and progressively higher doses
may be required to maintain pain control.
Chronic use of Zomestine may lead to physical dependence and a
withdrawal syndrome may occur upon abrupt cessation. When a
patient no longer requires therapy with oxycodone hydrochloride,
it may be advisable to taper the dose gradually to prevent
symptoms of withdrawal.

When used as directed in patients suffering from chronic pain the
risk of developing physical or psychological dependence is
markedly reduced and needs to be weighed against the potential
benefit. Please discuss this with your doctor.
These tablets should not be taken with alcohol. Alcohol use could
increase serious side-effects of oxycodone, such as sleepiness
and drowsiness and slow and shallow breathing.
Tablets should be avoided in patients with a history of or present
alcohol and drug abuse.
Children and adolescents
Zomestine has not been investigated in children under 12 years.
Safety and efficacy have not been established therefore use in
children under 12 years of age is not recommended.
Patients older than 65 years
Frail geriatric patients who have not taken opioids before usually
need to start with the lowest dose.
Athletes should be aware that this medicine may cause a positive
reaction to “anti-doping tests”.
Use of Zomestine as a doping agent may become a health hazard.
Other medicines and Zomestine
Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines.
- Medicines that dampen the activity of the central nervous
system, e.g.
• sleeping pills or tranquillizers (sedatives, hypnotics)
• other medicines that act on the nervous system (phenothiazines,
neuroleptics) medicines used to treat allergies or vomiting
(antihistamines, antiemetics and antihypertensives)
• anaesthetics
• muscle relaxants
• other opioids or alcohol can enhance the side effects of oxycodone,
in particular depressed breathing (respiratory depression).
- Medicines with an anticholinergic effect, e.g.
• other medicines that act against parasympathetic and cholinergic
nerve fibres on the central nervous system (psychotropic medicines)
• medicines used to treat allergies (antihistamines) or vomiting
(antiemetics)
• medicines used to treat Parkinson’s disease can enhance certain
side effects of oxycodone (e.g. constipation, dry mouth or urinary
disturbances).
- Monoamine oxidase inhibitors (MAOIs) can enhance the side
effects of oxycodone (e.g. excitation, decrease or increase in
blood pressure).
- In individuals a clinically relevant increase or decrease of blood
clotting have been observed if anticoagulants of the coumarin
type (medicinal products against blood clotting) are co-applied
with Zomestine.
- Cimetidine and grapefruit juice may possibly increase the blood
levels of oxycodone, your doctor may need to re-consider the
dose for Zomestine.
- Medicines used to treat infections (e.g.
clarithromycin,

erythromycin and telithromycin) or to treat fungal infections (e.g.
ketoconazole, voriconazole, itraconazole, and posaconazole)
may possibly increase the blood levels of oxycodone, your doctor
may need to re-consider the dose for Zomestine.
- Medicines such as paroxetine (antidepressant), fluoxetine
(antidepressant), antibiotics (e.g. clarithromycin, erythromycin
and telithromycin), azol-antifungals (e.g. ketoconazole,
voriconazole, itraconazole, and posaconazole), protease
inhibitors (e.g. boceprevir, ritonavir, indinavir, nelfinavir and
saquinavir) and quinidine (used in the treatment of heart
diseases), may possibly increase the blood levels of oxycodone,
your doctor may need to re-consider the dose for Zomestine.
- Medicines such as rifampicin, carbamazepine, phenytoin and St
John´s Wort may possibly decrease the blood levels of oxycodone,
your doctor may need to re-consider the dose for Zomestine.

- You have taken it according to the instructions given by the
prescriber or in the information provided with the medicine and
- 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. The treating
physician must assess the individual situation.
To look at the possible side effects affecting the motor skills and
concentration see section 4. “Possible side effects”.

Zomestine with food, drink and alcohol
Drinking alcohol whilst taking Zomestine 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 Zomestine. You can take Zomestine with or without food.

Always take this medicine exactly as your doctor or pharmacist has
told you. Check with your doctor or pharmacist if you are not sure.
For doses not realisable/practicable with this medicinal product
other strengths and medicinal products are available.

Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant
or are planning to have a baby, ask your doctor or pharmacist for
advice before taking this medicine.
Pregnancy
You should not take Zomestine during pregnancy. There are no
adequate data from the use of oxycodone in pregnant women.
Oxycodone crosses the placenta into the blood circulation of the baby.
Prolonged use of oxycodone during pregnancy can cause
withdrawal symptoms in newborns. Infants born to mothers who
have received oxycodone during the last 3-4 weeks before labour
can cause severe breathing difficulties in the newborn. Zomestine
should only be used during pregnancy if the benefit outweighs the
possible risks to the baby.
Breast-feeding
Oxycodone may pass into breast milk and may cause breathing
difficulties in the newborn. Zomestine should therefore not be used
during breast-feeding.
Driving and using machines
The medicine can affect your ability to drive as it may make you
sleepy or dizzy. Oxycodone impairs alertness and reactivity to
such an extent that the ability to drive and operate machinery is
affected or ceases altogether.
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:
- The medicine has been prescribed to treat a medical or dental
problem and

600 mm

Zomestine contains sucrose
This medicinal product contains sucrose. If you have been told by
your doctor that you have an intolerance to some sugars, contact
your doctor before you take this medicinal product.

3. How to take Zomestine

The recommended dose is
Zomestine 5 mg prolonged-release tablets
Adults and adolescents (over 12 years of age)
The usual initial dose is 10 mg of oxycodone hydrochloride in 12
hourly intervals.
Further determination of the daily dose, the division into the single
doses and any dose adjustments during the further course of
therapy are performed by the treating physician and depend on
the previous dosage.
Patients who have already taken opioids can start treatment with higher
dosages taking into account their experience with opioid treatment.
Some patients who receive Zomestine 5 mg prolonged-release
tablets according to a fixed schedule need rapidly acting
painkillers as rescue medication to control breakthrough pain.
Zomestine 5 mg prolonged-release tablets are not intended for the
treatment of breakthrough pain.
For the treatment of non-cancer pain a daily dose of 40 mg of
oxycodone hydrochloride is generally sufficient, but higher
dosages may be necessary. Patients with cancer pain usually
require dosages from 80 to 120 mg of oxycodone hydrochloride
which may be increased up to 400 mg in individual cases.
The treatment needs to be controlled regularly with regard to pain
relief and other effects in order to achieve the best pain therapy
possible as well as to be able to treat any occurring side effects in
good time and to decide whether treatment should be continued.
Zomestine 10 mg prolonged-release tablets
Adults and adolescents (over 12 years of age)
The usual initial dose is one prolonged-release tablet (10 mg of
oxycodone hydrochloride) in 12 hourly intervals.
Further determination of the daily dose, the division into the single
doses and any dose adjustments during the further course of
therapy are performed by the treating physician and depend on

the previous dosage.
Patients who have already taken opioids can start treatment with higher
dosages taking into account their experience with opioid treatment.
Some patients who receive Zomestine 10 mg prolonged-release
tablets according to a fixed schedule need rapidly acting
painkillers as rescue medication to control breakthrough pain.
Zomestine 10 mg prolonged-release tablets are not intended for
the treatment of breakthrough pain.
For the treatment of non-cancer pain a daily dose of 40 mg of
oxycodone hydrochloride (twice daily two prolonged-release
tablets) is generally sufficient, but higher dosages may be
necessary. Patients with cancer pain usually require dosages from
80 to 120 mg of oxycodone hydrochloride which may be increased
up to 400 mg in individual cases.
The treatment needs to be controlled regularly with regard to pain
relief and other effects in order to achieve the best pain therapy
possible as well as to be able to treat any occurring side effects in
good time and to decide whether treatment should be continued.
Zomestine 20 mg prolonged-release tablets
Adults and adolescents (over 12 years of age)
The usual initial dose is 10 mg oxycodone hydrochloride in 12 hourly
intervals. Your doctor will prescribe the dose required to treat pain.
Further determination of the daily dose, the division into the single
doses and any dose adjustments during the further course of
therapy are performed by the treating physician and depend on
the previous dosage.
Patients who have already taken opioids can start treatment with
higher dosages taking into account their experience with opioid
treatment.
Some patients who receive Zomestine 20 mg prolonged-release
tablets according to a fixed schedule need rapidly acting
painkillers as rescue medication to control breakthrough pain.
Zomestine 20 mg prolonged-release tablets are not intended for
the treatment of breakthrough pain.
For the treatment of non-cancer pain a daily dose of 40 mg of
oxycodone hydrochloride (twice daily one prolonged-release
tablets) is generally sufficient, but higher dosages may be
necessary. Patients with cancer pain usually require dosages from
80 to 120 mg of oxycodone hydrochloride which may be increased
up to 400 mg oxycodone hydrochloride in individual cases.
The treatment needs to be controlled regularly with regard to pain
relief and other effects in order to achieve the best pain therapy
possible as well as to be able to treat any occurring side effects in
good time and to decide whether treatment should be continued.
Zomestine 40 mg prolonged-release tablets
Adults and adolescents (over 12 years of age
The usual initial dose is 10 mg oxycodone hydrochloride in 12 hourly
intervals. Your doctor will prescribe the dose required to treat pain.
Further determination of the daily dose, the division into the single
doses and any dose adjustments during the further course of
therapy are performed by the treating physician and depend on
the previous dosage.
402

200 mm

PACKAGE LEAFLET: Information for the user

depression) with too little oxygen in the blood (hypoxia) and/or
too much carbon dioxide (hypercapnia) in the blood
- if you suffer from severe chronic obstructive lung disease, cor
pulmonale (cardiac changes due to chronic overload of lung
circulation) or acute, severe bronchial asthma
- if you suffer from intestinal paralysis (paralytic ileus)
- if you have an acute abdomen or suffer from a delayed gastric
emptying
- have a heart problem after long-term lung disease (cor pulmonale);
- have severe kidney problems or moderate to severe liver
problems. If you have other long-term kidney or liver problems you
should only take these tablets if recommended by your doctor;
- have ongoing problems with constipation;
- If you have intolerance to some sugars

Patients who have already taken opioids can start treatment with higher
dosages taking into account their experience with opioid treatment.
Some patients who receive Zomestine 40 mg prolonged-release
tablets according to a fixed schedule need rapidly acting
painkillers as rescue medication to control breakthrough pain.
Zomestine 40 mg prolonged-release tablets are not intended for
the treatment of breakthrough pain.
For the treatment of non-cancer pain a dose of 40 mg of
oxycodone hydrochloride (twice daily ½ prolonged-release
tablets) is generally sufficient, but higher dosages may be
necessary. Patients with cancer pain usually require dosages from
80 to 120 mg of oxycodone hydrochloride which may be increased
up to 400 mg oxycodone hydrochloride in individual cases.
The treatment needs to be controlled regularly with regard to pain
relief and other effects in order to achieve the best pain therapy
possible as well as to be able to treat any occurring side effects in
good time and to decide whether treatment should be continued.
Zomestine 80 mg prolonged-release tablets
Adults and adolescents (over 12 years of age)
The usual initial dose is 10 mg oxycodone hydrochloride in 12 hourly
intervals. Your doctor will prescribe the dose required to treat pain.
Further determination of the daily dose, the division into the single
doses and any dose adjustments during the further course of
therapy are performed by the treating physician and depend on
the previous dosage.
Patients who have already taken opioids can start treatment with higher
dosages taking into account their experience with opioid treatment.
Some patients who receive Zomestine 80 mg prolonged-rease
tablets according to a fixed schedule need rapidly acting
painkillers as rescue medication to control breakthrough pain.
Zomestine 80 mg prolonged-rease tablets are not intended for the
treatment of breakthrough pain.
For the treatment of non-cancer pain a dose of 40 mg of oxycodone
hydrochloride is generally sufficient, but higher dosages may be
necessary. Patients with cancer pain usually require dosages from
80 to 120 mg of oxycodone hydrochloride which may be increased
up to 400 mg oxycodone hydrochloride in individual cases.
The treatment needs to be controlled regularly with regard to pain
relief and other effects in order to achieve the best pain therapy
possible as well as to be able to treat any occurring side effects in
good time and to decide whether treatment should be continued.
Patients older than 65 years
In frail geriatric patients who have not yet taken opioids, the usual
initial dose is one tablet of 5 mg in 12 hourly intervals. Your doctor
will prescribe the dose required to treat pain. However, tell your
doctor if the dose you are taking does not control your pain.
Risk patients
If you have impaired kidney and/or liver function or if you have a
low body weight your doctor may prescribe a lower starting dose.

Method and duration of administration
Zomestine 5 mg prolonged-release tablets
Swallow the prolonged-release tablets whole with a sufficient amount
of liquid (½ glass of water) with or without food in the morning and in
the evening following a fixed schedule (e.g. at 8 a.m. and 8 p.m.).
Zomestine Accord 10 mg, 20 mg, 40 mg, 80 mg prolonged-release
tablets
Swallow the prolonged-release tablets either whole or broken up
with a sufficient amount of liquid (½ glass of water) with or without
food in the morning and in the evening following a fixed schedule
(e.g. at 8 a.m. and 8 p.m.).
The prolonged-release tablets must not be crushed or chewed as
this leads to rapid oxycodone release due to the damage of the
prolonged-release properties. The administration of chewed or
crushed Zomestine leads to a rapid release and absorption of a
potentially fatal dose of oxycodone (see section “If you take more
Zomestine than you should”).
Zomestine are for oral use only. In case of abusive injection
(injection in a vein) the tablet excipients may lead to destruction
(necrosis) of the local tissue, change of lung tissue (granulomas of
the lung) or other serious, potentially fatal events.
Your doctor will adjust the dosage depending on the pain intensity
and how you respond to the treatment. Take the number of
prolonged-release tablets determined by your doctor twice daily.
Opening instruction for the blister package:
this medicinal product is packed in a child-resistant blister. You
cannot press out the prolonged-release tablets through the blister
package. Please observe the following opening instruction for the
blister package:
1. Tear off a single dose along the perforation line of the blister package.
2. Hereby an unsealed area is accessible which is located at the
position, where the perforation lines have crossed.
3. Pull at the unsealed "strap" to peel off the cover seal.
If you take more Zomestine than you should
If you have taken more Zomestine as prescribed you should
inform your doctor or your local poison control center immediately.
The following symptoms may occur: constricted pupils (miosis),
depressed breathing (respiratory depression), skeletal muscle
flaccidity and drop in blood pressure. In severe cases circulatory
collapse, mental and motor inactivity (torpor), unconsciousness
(coma), slowing of the heart rate and accumulation of water in the
lungs (non-cardiogenic lung oedema) may occur; abuse of high
doses of strong opioids such as oxycodone can be fatal. In no
case you should expose yourself to situations requiring elevated
concentration e.g. driving a car.
If you forget to take Zomestine
If you use a smaller dose of Zomestine than directed or you miss
the intake of the tablets, pain relief will consequently be insufficient
or cease altogether.
You can make up for a forgotten tablet if the next regular intake is
not due for at least another 8 hours. You can then continue to take

the tablets as directed.
You should also take the prolonged-release tablets if the time to
the regular next intake is shorter, but postpone the next intake by
8 hours. In principle, you should not take Zomestine more than
once every 8 hours.
Do not take a double dose to make up for a forgotten tablet.

- dry mouth, rarely accompanied by thirst and difficulty swallowing
- gastrointestinal disorders such as bellyache, diarrhoea, belching,
upset stomach (dyspepsia), loss of appetite, indigestion,
abdominal pain and discomfort
- skin disorders such as rash and itchy skin
- sweating

If you stop taking Zomestine
Do not stop treatment without informing your doctor.
When a patient no longer requires therapy with Zomestine, it may
be advisable to taper the dose gradually to prevent symptoms of
withdrawal.
If you have any further questions on the use of this medicine, ask
your doctor or pharmacist or nurse.

Uncommon (may affect up to 1 in 100 people)
- change in perception such as depersonalisation, hallucinations , a
feeling of extreme happiness, mood changes, agitation
,restlessness, speech disorders,shaking, fits or convulsions,
- difficulty in swallowing, belching, hiccups, wind, gastrointestinal
disorders (e.g. upset stomach), changes in taste.
- Loss of memory
- change in taste
- visual disturbances
- abnormally acute sense of hearing (hyperacousis)
- both increased and decreased muscle tone
- tics
- pins and needles (paraesthesia)
- urinary disorders (urinary retention, but also frequent urination),
difficulty in passing urine
- severe hypersensitivity reactions (anaphylactic reactions)
- reduced sense to pain or touch (hypoesthesia), tingling or
numbness,
- coordination disturbances
- generalized feeling of discomfort, illness, or lack of well-being (malaise)
- accelerated pulse
- widening of the blood vessels (vasodilatation)
- increased coughing
- pharyngitis
- runny nose
- voice changes
- oral ulcers
- inflammation of the gums
- inflamed mouth (stomatitis)
- flatulence
- injuries due to accidents
- pain (e.g. chest pain
- dehydration, excessive fluid in the tissues (oedema), swelling of
hands, feet or ankles, thirst
- migraine
- physical dependence with withdrawal symptoms
- allergic reactions
- dry skin, severe flaking or peeling of the skin or scaly rush
(exfoliative dermatitis)
- changes in tear secretion, blurred vision, reduction in size of
pupils in the eye
- constriction of the pupil, redness of the face, muscle spasm, high
temperature
- feeling of dizziness or ‘spinning’, a feeling of ‘faintness’
especially on standing up,
- absence of menstrual bleeding (amenorrhoea) ,disturbances of
sexual function, impotence

4. Possible side effects
Like all medicines, this medicine can cause side effects, although
not everybody gets them.
Significant side effects or signs to consider and measures to be
taken when these side effects of signs occur.
If you experience any of the following side effects, stop taking
Zomestine and contact your doctor immediately.
Depressed breathing is the most significant risk induced by
opioids and is most likely to occur in elderly or debilitated patients.
As a consequence, in predisposed patients opioids can cause
severe drops in blood pressure.
Apart from this oxycodone can cause constricted pupils, bronchial
spasms and spasms in smooth muscles and suppress the cough reflex.
Other possible side effects
Very common (may affect more than 1 in 10 people)
- itching
- Drowsiness (this is most likely when you start taking your tablets or
when your dose is increased, but it should wear off after a few days).
- Dizziness,
- Headache
- feeling or being sick
- constipation
Common (may affect up to 1 in 10 people)
- feeling weak (asthenia)
- trembling (tremor)
- several psychological side effects such as
• changes in mood (e.g. anxiety) , depression,
• changes in activity (mostly sedation, sometimes accompanied by
lethargy, occasionally increase with nervousness, twitching and
sleep disorders)
• changes in performance (thought process disorder, confusion,
amnesia, abnormal dreams)
- fainting
- depressed breathing (dyspnoea)
- bronchospasm (difficulty in breathing or wheezing)

600 mm

- a need to take increasingly higher doses to obtain the same level
of pain relief (tolerance).
- chills
Rare (may affect up to 1 in 1,000 people)
- lymph node disease (lymphadenopathy)
- seizures, in particular in patients suffering from epilepsy or with a
tendency to seizures
- gum bleeding, tarry stool
- manifestation of herpes simplex (disorder of the skin and
mucosa)
- blood in urine (haematuria)
- changes in body weight (loss or rise)
- cellulitis
- intestinal hypomotility (ileus)
- sensitivity to light (increased photosensitivity)
- lowering of blood pressure, rarely accompanied by symptoms
such as pounding or racing heartbeat
- hives (urticaria)
Not known (frequency cannot be estimated from the available data)
increased sensitivity to pain (hyperalgesia)
tooth decay
- A blockage in the flow of bile from the liver (cholestasis). This can
cause itchy skin, yellow skin, very dark urine and very pale stools.
Tolerance and dependence may develop.
Counteractive measures
If you observe any of the above listed side effects your doctor
usually will take appropriate measures. The side effect
constipation may be prevented by fiber enriched diet and
increased drinking. If you are suffering from sickness or vomiting
your doctor will prescribe you an appropriate medicine.
If you get any of the side effects talk to your doctor or pharmacist
or nurse. This includes any side effects not listed in this leaflet.
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 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 Zomestine
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 blister/bottle and the carton after “EXP”. The expiry date refers
to the last day of that month.
Do not use this medicine if you notice deterioration of the tablets
(broken or crushed) has occurred.
This medicinal product does not require any special storage
conditions.
Do not throw away any medicines via wastewater or household

waste. Ask your pharmacist how to throw away you no longer use.
These measures will help to protect the environment.

6. Contents of the pack and other information
What Zomestine contains
The active substance is oxycodone hydrochloride.
Each prolonged-release tablet contains 5 mg / 10 mg / 20 mg / 40
mg / 80 mg oxycodone hydrochloride equivalent to 4.5 mg /
9.0 mg / 17.9 mg / 36 mg / 72 mg oxycodone.
The other ingredients are:
Tablet core: Sugar spheres (contains sucrose, maize starch,
starch hydrolysates and colour additives sucrose, maize starch),
hypromellose, talc, ethylcellulose, hyprolose, propylene glycol,
carmellose sodium, microcrystalline cellulose, magnesium
stearate [plant-based], colloidal anhydrous silica.
Tablet coating: Titanium dioxide (E 171), hypromellose, macrogol
6000, talc. 10 mg, 40 mg and 80 mg strengths contains Red iron
oxide additionally.
What Zomestine looks like and contents of the pack
Zomestine 5 mg prolonged-release tablets are white to off-white,
round, biconvex film-coated tablets.
Zomestine 10 mg prolonged-release tablets are pink, oblong,
biconvex film-coated tablets with break scores on both sides. The
tablet can be divided into equal halves.
Zomestine 20 mg prolonged-release tablets are white to off-white,
oblong, biconvex film-coated tablets with break scores on both
sides. The tablet can be divided into equal halves.
Zomestine 40 mg prolonged-release tablets are pale pink, oblong,
biconvex film-coated tablets with break scores on both sides. The
tablet can be divided into equal halves.
Zomestine 80 mg prolonged-release tablets are red, oblong,
biconvex film-coated tablets with break scores on both sides. The
tablet can be divided into equal halves.
Pack sizes:
10, 14, 20, 28, 30, 50, 56, 98, 100 prolonged-release tablets in
PVC/PE/PVDC-aluminium blister.
10, 20, 30, 50, 100 prolonged-release tablets in HDPE bottles.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Accord Healthcare Limited,
Sage house, 319 Pinner road, Harrow, HA1 4HF, United Kingdom
This leaflet was last revised in 04/2014.

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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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