Zomestine 80 Mg Prolonged-Release Tablets
a :ord
PACKAGE LEAFLET: Information for the user
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
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
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.
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.
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
- 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 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
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.
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.
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 1X 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 (1X 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 (1X 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.
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.
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)
- 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
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
- 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.aov.uk/vellowcard. 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), macrogol 3350, talc (5mg, 20 mg). Titanium dioxide (E 171), macrogol 3350, talc, red iron oxide (10mg, 40 mg). Macrogol 3350, talc, red iron oxide (80 mg).
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, 60, 98, 100, 120 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
Accord Healthcare Limited, Sage house, 319 Pinner road,
North Harrow, Middlesex HA1 4HF, United Kingdom
Manufacturer
Accord Healthcare Limited, Sage house, 319 Pinner road,
North Harrow, Middlesex HA1 4HF, United Kingdom
Develco Pharma GmbH
Grienmatt 42, 79650 Schopfheim, Germany
This leaflet was last revised in 09/2015.
E
E
o
o
CM