DOLSTIP 5 mg /2.5 Mg Extended-Release Tablet

Зміст інструкції

1. Dolstip 5 mg/2.5 mg prolonged-release tablets, 10 mg/5 mg prolonged-release tablets, 20 mg/10 mg prolonged-release tablets, 30 mg/15 mg prolonged-release tablets, 40 mg/20 mg prolonged-release tablets
   1. What Dolstip is and what it is used for
   2. What you need to know before taking Dolstip
   3. How to take Dolstip
   4. Possible side effects
   5. How to store Dolstip
   6. Content of the pack and other information

Dolstip 5 mg/2.5 mg prolonged-release tablets, 10 mg/5 mg prolonged-release tablets, 20 mg/10 mg prolonged-release tablets, 30 mg/15 mg prolonged-release tablets, 40 mg/20 mg prolonged-release tablets

oxycodone/naloxone
Equivalent medicinal product

Read this leaflet carefully before you start to take this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

• 1. What Dolstip is and what it is used for
• 2. What you need to know before you take Dolstip
• 3. How to take Dolstip
• 4. Possible side effects
• 5. How to store Dolstip
• 6. Contents of the pack and other information

1. What Dolstip is and what it is used for

Dolstip is an extended-release tablet, which means that the active ingredients contained within it are released over a long period of time. Their action lasts for 12 hours. These tablets are only for use in adults.

Pain relief
You have been prescribed Dolstip for the treatment of severe pain, which can only be adequately treated with opioid analgesics. Naloxone hydrochloride is added to counteract constipation.

How these tablets work for pain relief
Dolstip contains the active ingredients oxycodone hydrochloride and naloxone hydrochloride. Oxycodone hydrochloride is responsible for the pain-relieving effect of Dolstip and is a potent analgesic (pain reliever) belonging to the opioid group.
Naloxone hydrochloride, the second active ingredient of Dolstip, counteracts constipation. Intestinal dysfunction (constipation) is a typical undesirable effect of treatment with opioid pain relievers.

Restless legs syndrome
You have been prescribed Dolstip as a secondary treatment for severe to very severe restless legs syndrome, which cannot be adequately treated with dopaminergic medications. Patients with restless legs syndrome have unpleasant sensations in their limbs. These sensations begin as soon as the person sits or rests and can only be relieved by the irresistible urge to move their legs and sometimes also their arms and other parts of the body. These symptoms make it extremely difficult to stay still and sleep. Naloxone hydrochloride is added to counteract constipation.

How these tablets work for restless legs syndrome
These tablets help to relieve unpleasant sensations and therefore reduce the urge to move the legs.
Naloxone hydrochloride, the second active ingredient of Dolstip, counteracts constipation. Intestinal dysfunction (constipation) is a typical undesirable effect of treatment with opioids.

2. What you need to know before taking Dolstip

Do not take Dolstip

• if you are allergic to oxycodone hydrochloride, naloxone hydrochloride or any of the other ingredients of this medicine (listed in section 6);
• if you have breathing problems, such as breathing more slowly or weakly than expected (respiratory depression);
• if you suffer from a serious 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, following an increase in pressure within the blood vessels in the lung, etc. (for example as a consequence of COPD - see above);
• if you suffer from severe bronchial asthma;
• if you suffer from paralytic ileus (a type of intestinal obstruction) not caused by opioids;
• if you have moderate to severe hepatic dysfunction.

Warnings and precautions
Talk to your doctor or pharmacist before taking Dolstip:

• if you are elderly or debilitated (weak);

• if you suffer from paralytic ileus (a type of intestinal obstruction) caused by opioids;
• if you have kidney problems;
• if you have mild liver problems;
• if you have severe lung problems (for example reduced respiratory capacity);
• if you suffer from recurrent breathing interruptions during the night that can cause extreme drowsiness during the day (sleep apnea syndrome);
• if you have myxedema (a thyroid disorder, with dry, cold and swollen skin [edema] in the areas of the face and limbs);
• if your thyroid gland does not produce enough hormones (thyroid insufficiency or hypothyroidism);
• if your adrenal glands do not produce enough hormones (adrenal insufficiency, or Addison's disease);
• if you have mental disorders accompanied by a (partial) loss of sense of reality (psychosis) due to alcohol or intoxication with other substances (substance-induced psychosis);
• if you suffer from gallstones;
• if your prostate gland is abnormally enlarged (prostatic 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 diseases;
• if you have had a head injury (due to the risk of increased intracranial pressure);
• if you suffer from epilepsy or are prone to seizures;
• if you are also taking MAO inhibitors (used to treat depression, Parkinson's disease or bacterial infections), such as medicines containing tranylcypromine, phenelzine, isocarboxazide, moclobemide and linezolid;
• if you feel sleepy or if you sometimes suddenly fall asleep.

Tell your doctor if any of the above cases had occurred in the past. Also, tell your doctor if you develop any of the above disorders while taking Dolstip.
The most serious effect of an opioid overdose is respiratory depression(slow and shallow breathing). This also causes a lowering of oxygen levels in the blood, resulting in possible fainting, etc.
Tell your doctor in case of cancer associated with peritoneal metastases or with the onset of intestinal occlusion in advanced stage digestive and pelvic cancer.
If you experience severe diarrhea at the beginning of treatment, this may be due to the effect of naloxone. It may be a sign that intestinal function is returning to normal. Diarrhea may occur within the first 3-5 days of treatment. If the diarrhea persists after 3-5 days, or if you are concerned, contact your doctor.
When switching to treatment with Dolstip, if you are using high doses of another opioid, withdrawal symptoms may initially occur, such as agitation, sweating attacks and muscle pain. If these symptoms occur, careful monitoring by the doctor may be necessary. Similar to other opioids, oxycodone can affect the normal production of hormones in the body such as cortisol or sex hormones, especially if you take high doses for long periods of time. If you develop symptoms that persist, such as feeling unwell or sick (including vomiting), loss of appetite, fatigue, weakness, dizziness, changes in your menstrual cycle, impotence, infertility or decreased sexual desire, see your doctor as they may monitor your hormone levels .
Surgical interventions
Tell your doctor that you are taking Dolstip if you are going to have surgery.

Long-term treatment
You may become tolerant to the medicine Dolstip if you use it for a long time. This means that a higher dose may be needed to obtain the desired pain relief. In addition, long-term use of Dolstip can lead to physical dependence. Withdrawal symptoms may occur if treatment is stopped too abruptly (agitation, sweating attacks, muscle pain). If you no longer need treatment, you must gradually reduce the daily dose, under the control of your doctor.

Psychological dependence
The active ingredient oxycodone hydrochloride, alone, has an abuse profile similar to other strong opioids (strong painkillers). There is a possibility of developing psychological dependence. Medicines containing oxycodone hydrochloride should be avoided in patients with alcohol, drug or medicine abuse - present or past.

Improper use of Dolstip
These tablets are not suitable for the treatment of withdrawal.

Dolstip 5 mg/2.5 mg
The tablet must be swallowed whole and must not be divided, broken, chewed or crushed.
Taking divided, broken, chewed or crushed tablets may result in the absorption of a potentially lethal dose of oxycodone hydrochloride (see below in section 3 “If you take more Dolstip than you should”).

Dolstip 10 mg/5 mg, 20 mg/10 mg, 30 mg/15 mg, 40 mg/20 mg
The tablet must not be broken, chewed or crushed. However, the tablets can be divided into two equal halves (see section 3 “How to take it”).
Taking broken, chewed or crushed tablets may result in the absorption of a potentially lethal dose of oxycodone hydrochloride (see below in section 3 “If you take more Dolstip than you should”).
You should never abuse Dolstip, especially if you are addicted to drugs. If you are addicted to substances such as heroin, morphine or methadone, withdrawal symptoms are similar if you abuse Dolstip as it contains the active ingredient naloxone. Pre-existing withdrawal symptoms may worsen.
You should not use these tablets improperly, dissolving them and injecting them (for example into a blood vessel). In particular, they contain talc, which can locally cause tissue destruction (necrosis) and changes in lung tissue (pulmonary granuloma). Such abuse can also have other serious consequences and can even be fatal.
You may observe tablet residue in your stools. Do not be alarmed, as the active ingredients (oxycodone hydrochloride and naloxone hydrochloride) have already been released into the stomach and intestine, and absorbed into your body.

For athletes:the use of the drug without therapeutic necessity constitutes doping and may still result in a positive doping test.

Children and adolescents
Dolstip has not yet been studied in children and adolescents under 18 years of age. Its safety and efficacy have not been demonstrated in children and adolescents. For this reason, the use of Dolstip in children and adolescents under 18 years of age is not recommended

Other medicines and Dolstip
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
The concomitant use of Dolstip and sedative medicines such as benzodiazepines or related medicines (medicines that affect brain function - see below) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma and could be life-threatening. For this reason, concomitant use should only be considered when other treatment options are not possible.
However, if your doctor prescribes Dolstip together with sedative medicines, the dose and duration of concomitant treatment must be limited by your doctor. Tell your doctor all the sedative medicines you are taking and carefully follow your doctor's recommendations regarding dosage. It may be helpful to inform friends or family members to be aware of the signs and symptoms above. See your doctor when these symptoms occur.
The medicines that affect brain function are for example:

• other strong painkillers (opioids),
• sleeping pills and tranquilizers (sedative medicines including benzodiazepines, hypnotics, anxiolytics),
• medicines to treat depression,
• medicines used to treat allergies, motion sickness or nausea (antihistamines or antiemetics),
• medicines for the treatment of mental or psychiatric illnesses (phenothiazines, neuroleptics, antipsychotics)

If you take Dolstip in conjunction with other medicines, the effects of Dolstip or the other medicines may be altered. Tell your doctor if you are taking:

• medicines that decrease the ability of blood to clot (coumarin derivatives), the coagulation time may be accelerated or slowed down,
• macrolide antibiotics (e.g. clarithromycin, erythromycin or telithromycin),
• azole antifungals (e.g. ketoconazole, voriconazole, itraconazole or posaconazole),
• some medicines used to treat HIV infections (protease inhibitors such as ritonavir, indinavir, nelfinavir or saquinavir)
• cimetidine (used to treat stomach ulcers, indigestion or heartburn)
• rifampicin (used to treat tuberculosis),
• carbamazepine (used to treat seizures, attacks or convulsions and in some conditions of pain),
• phenytoin (used to treat seizures, attacks or convulsions).
• St John's wort (a herbal remedy for the treatment of depression also known as Hypericum perforatum),
• quinidine (a medicine used to treat irregular heartbeat).

The risk of side effects increases with the intake of antidepressants (such as citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, venlafaxine). These medicines can interact with oxycodone and you may experience symptoms such as involuntary and rhythmic muscle contractions, including the muscles that control eye movements, agitation, excessive sweating, tremor, exaggerated reflexes, increased muscle tension and a body temperature above 38°C. See your doctor if you experience these symptoms.

Dolstip with food, drinks and alcohol
Drinking alcohol while taking Dolstip may increase the feeling of drowsiness or the risk of serious side effects such as shallow breathing with the risk of respiratory arrest and loss of consciousness. It is recommended not to drink alcohol while taking Dolstip.
You should avoid drinking grapefruit juice when taking Dolstip.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
The use of Dolstip should be avoided as much as possible during pregnancy. If oxycodone hydrochloride is used for prolonged periods during pregnancy, it can lead to withdrawal symptoms in the newborn. If oxycodone hydrochloride is administered during childbirth, the newborn may have breathing problems (respiratory depression).

Breastfeeding
Breastfeeding should be discontinued during treatment with Dolstip. Oxycodone passes into breast milk. It is not known whether naloxone hydrochloride also passes into breast milk. Therefore, a risk to the infant cannot be excluded, particularly after taking multiple doses of Dolstip.

Driving and using machines
Dolstip can affect your ability to drive or use machines. This is more likely to happen at the beginning of therapy with Dolstip, after an increase in dose or after switching from a different medicine. However, these side effects should disappear once you have stabilized the dose of Dolstip.
Dolstip has been associated with drowsiness and episodes of sudden-onset sleep. If you experience this side effect, you should not drive or use machines. See your doctor if you experience these side effects.
Ask your doctor if you can drive or use machines.

Dolstip contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per prolonged-release tablet, i.e. it is essentially “sodium-free”.

3. How to take Dolstip

Take this medicine following exactly the instructions of your doctor. If you have
any doubts, consult your doctor or pharmacist.
Dolstip tablets are extended-release, which means that the active ingredient will be
released over an extended period. Its action lasts 12 hours.
Unless otherwise prescribed by your doctor, the recommended dose is:

Treatment of pain
Adults
The recommended starting dose is 10 mg of oxycodone hydrochloride/5 mg of naloxone hydrochloride
as extended-release tablets every 12 hours.
The doctor will decide how much Dolstip you should take each day and how to divide the dose
total daily between morning and evening. The doctor will also decide on any dose adjustment
eventually necessary during treatment. The dose will be adjusted according to the
level of pain and individual sensitivity. You should be given the lowest dose necessary
for pain relief. If you have already been treated with opioids, treatment with Dolstip may
be started at a higher dosage.
The maximum daily dose is 160 mg of oxycodone hydrochloride and 80 mg of naloxone
hydrochloride. If you need a higher dose, your doctor may give you additional doses of
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 reduced if higher doses of oxycodone hydrochloride are
administered without further doses of naloxone hydrochloride.
If you switch from Dolstip to another strong opioid medicine for pain treatment, your
bowel function will likely worsen.
If you feel pain between two doses of Dolstip, you may need a fast-acting pain reliever. Dolstip is not suitable for this. In this case, consult your doctor.
If you feel that the effect of Dolstip is too strong or too weak, talk to your
doctor or pharmacist.

Treatment of restless legs syndrome
Adults
The recommended starting dose is 5 mg of oxycodone hydrochloride/2.5 mg of naloxone
hydrochloride as extended-release tablets every 12 hours.
The doctor will decide how much Dolstip you should take each day and how to divide the dose
total daily between morning and evening. The doctor will also decide on any dose adjustment
eventually necessary during treatment. The dose will be adjusted according to the
individual sensitivity. You should be given the lowest dose necessary to relieve the symptoms
of restless legs syndrome.
If you feel that the effect of these tablets is too strong or too weak, talk to your
doctor or pharmacist.
The maximum daily dose is 60 mg of oxycodone hydrochloride and 30 mg of naloxone
hydrochloride.

Treatment of pain or restless legs syndrome
For doses not achievable/practicable with this dosage, other dosages of
this medicine are available.

Elderly patients
In general, a dose adjustment is not necessary in elderly patients with normal
kidney and/or liver function.

Liver or kidney problems
If you have impaired kidney function or mild liver impairment, your doctor will prescribe Dolstip with particular caution. If you suffer from a
moderate or severe impairment of liver function, Dolstip should not be used
(see also paragraph 2 “Do not take Dolstip” and “Warnings and precautions”).

How to administer
Oral use.

• Take Dolstip with a glass of water.
• Dolstip 5 mg/2.5 mg:The tablet must be swallowed whole and must not be divided, broken, chewed or crushed.
• Dolstip 10 mg/5 mg, 20 mg/10 mg, 30 mg/15 mg, 40 mg/20 mg:

The tablet can be divided into equal doses. The tablet should not be broken,
chewed or crushed.

• You can take the extended-release tablets with or without food.

Take Dolstip every 12 hours, according to a fixed schedule (for example at 8 am
and at 8 pm).
Blister with peelable opening

How to remove the tablets from the “child-resistant” blister
The tablets are packaged in a single-dose perforated blister “child-resistant”.

Do not pushthe tablets throughthe blister coating.
Remove the tablets as follows:

• 1. Bend the blister back and forth along the perforation line.

• 2. Separate a cavity from the blister using the perforation lines.

• 3. To open the cavity, slowly peel off the coating starting from the marked corner.

Remove the tablet.
Push-through blister

How to remove the tablets from the “child-resistant” blister
The tablets are packaged in a single-dose perforated blister “child-resistant”.
To remove the tablet, push the tablet through the reinforced coating of the
blister.

Duration of use
In general, you should not take Dolstip for longer than necessary. If you are
being treated with Dolstip for a long time, your doctor should regularly check if
you still need treatment with Dolstip.

If you take more Dolstip than you should
If you have taken more than the prescribed dose of Dolstip, tell your doctor immediately.
An overdose can cause:

• constricted pupils,
• slow and shallow breathing (respiratory depression),
• drowsiness (up to loss of consciousness),
• low muscle tone (hypotonia),
• reduced pulse rate and
• low blood pressure.

In severe cases, loss of consciousness (coma), fluid accumulation in the
lungs and circulatory collapse may occur, which in some cases can be fatal.
You should avoid situations that require a high level of alertness, such as driving.

If you forget to take Dolstip
If you forget to take Dolstip or if you take a dose lower than prescribed,
you may not feel any analgesic effect.
If you forget to take the dose, follow these instructions:

• if you are to take your next usual dose in 8 hours or more: take the forgotten tablet immediately, then continue with your usual schedule.
• if you are to take your next usual dose in less than 8 hours: take the forgotten tablet. Then wait at least 8 hours before taking the next tablet. Try to return to the original schedule (e.g. 8 am and 8 pm). Do not take more than one dose within an 8-hour period.

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

If you stop taking Dolstip
Do not stop treatment with Dolstip without consulting your doctor.
If you no longer need further treatment, you should gradually reduce the daily dosage
after talking to your doctor. This will avoid withdrawal symptoms
such as agitation, sweating attacks and muscle pain.
If you have any questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Important side effects to watch out for, and what to do if they occur:
If you experience any of the following important side effects, consult your nearest doctor immediately.
Slow and shallow breathing (respiratory depression) is the main danger of opioid overdose. It occurs especially in elderly and debilitated (weak) patients. Opioids can also cause a severe drop in blood pressure in predisposed patients.

The following side effects have been observed in patients treated for pain:
Common(may affect up to 1 in 10 people)

• decreased appetite up to loss of appetite
• difficulty sleeping, fatigue or weakness
• feeling of dizziness or “lightheadedness”, headache, drowsiness
• hot flashes
• abdominal pain, constipation, diarrhea, dry mouth, indigestion, feeling unwell, general malaise, flatulence
• itching, skin reactions, increased sweating
• feeling of unusual weakness

Not common(may affect up to 1 in 100 people)

• hypersensitivity/allergic reactions
• agitation, abnormal thoughts, anxiety, confusion, depression, nervousness
• decreased sexual drive
• seizures (especially in people with epilepsy or a predisposition to convulsions), difficulty concentrating, taste disturbances, speech disorders, fainting, tremors, loss of energy
• vision impairment
• chest tightness especially if you already suffer from coronary heart disease, palpitations
• decreased blood pressure, increased blood pressure
• difficulty breathing, runny nose, cough
• abdominal bloating
• increased liver enzymes, biliary colic
• muscle cramps, muscle spasms, muscle pain
• increased urge to urinate
• withdrawal symptoms such as agitation
• chest pain
• tremors, feeling generally unwell, pain, thirst
• swelling of the hands, ankles or feet
• weight loss
• injury due to accidents

Rare(may affect up to 1 in 1,000 people)

• increased heart rate
• drug addiction
• yawning
• dental changes
• weight gain

Frequency not known(frequency cannot be estimated on the basis of available data)

• euphoria, hallucinations, nightmares, aggression
• tingling (pins and needles), severe drowsiness
• shallow breathing
• belching
• difficulty urinating
• erectile dysfunction

It is known that the active ingredient oxycodone hydrochloride, when not in combination with
naloxone hydrochloride, has the following side effects:
Oxycodone can cause respiratory problems (respiratory depression), reduction in pupil size, bronchial muscle cramps and smooth muscle cramps, and depression of the cough reflex.

Common(may affect up to 1 in 10 people)

• mood changes and personality changes (e.g. depression, feeling of extreme happiness), decreased activity, increased activity
• hiccups
• difficulty urinating

Not common(may affect up to 1 in 100 people)

• dehydration
• agitation, perceptual disturbances (e.g. hallucinations, derealization),
• impaired ability to concentrate, migraine, increased muscle tension, involuntary muscle contractions, reduced sensitivity to pain or touch, abnormal coordination
• hearing difficulties
• dilation of blood vessels
• changes in voice (dysphonia)
• difficulty swallowing
• a condition in which the intestine stops functioning properly (ileus)
• mouth ulcers, inflamed gums
• dry skin
• a reduction in the concentration of sex hormones, which can alter sperm production in men or the menstrual cycle in women swelling due to fluid retention, tolerance to the medicine Rare(may affect up to 1 in 1,000)
• infections such as cold sores or herpes (which can cause blisters around the mouth or genital area)
• increased appetite
• black (tarry) stools, bleeding gums
• itchy rash (urticaria)

Frequency not known(frequency cannot be estimated on the basis of available data)

• acute generalized allergic reactions (anaphylactic reactions)
• increased sensitivity to pain
• dental caries
• problems in the flow of bile
• absence of menstruation
• withdrawal symptoms in newborns

• muscle cramps, muscle tics, muscle pain
• need to urinate, difficulty urinating
• general feeling of discomfort
• feeling of unusual weakness
• weight gain, weight loss

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet,
tell your doctor or pharmacist. You can also report side effects
directly through the national reporting system at:
www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa .
By reporting side effects you can help provide more information on the
safety of this medicine.

5. How to store Dolstip

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 package, bottle
or blister after Exp. The expiry date refers to the last day of that month.
Blister:
Do not store at a temperature above 25°C.
Bottle:
Do not store at a temperature above 30°C.
Shelf life after first opening: 3 months.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Content of the pack and other information

What Dolstip contains
The active ingredients are oxycodone hydrochloride and naloxone hydrochloride.

Dolstip 5 mg/2.5 mg:
Each prolonged-release tablet contains 5 mg of oxycodone hydrochloride (equivalent to
4.5 mg of oxycodone) and 2.5 mg of naloxone hydrochloride (as 2.74 mg of naloxone hydrochloride
dihydrate, equivalent to 2.25 mg of naloxone).
The other ingredients are:
Tablet core
Vinyl acetate
Povidone
Sodium lauryl sulfate
Anhydrous colloidal silica
Microcrystalline cellulose
Magnesium stearate
Tablet coating
Polyvinyl alcohol
Titanium dioxide (E171)
Macrogol 3350
Talc

Dolstip 10 mg/5 mg:
Each prolonged-release tablet contains 10 mg of oxycodone hydrochloride (equal to 9 mg of
oxycodone) and 5 mg of naloxone hydrochloride (as 5.45 mg of naloxone hydrochloride dihydrate,
equivalent to 4.5 mg of naloxone).
The other ingredients are:
Tablet core
Vinyl acetate
Povidone
Sodium lauryl sulfate
Anhydrous colloidal silica
Microcrystalline cellulose
Magnesium stearate
Tablet coating
Polyvinyl alcohol
Titanium dioxide (E171)
Macrogol 3350
Talc

Dolstip 20 mg/10 mg:
Each prolonged-release tablet contains 20 mg of oxycodone hydrochloride (equivalent to
18 mg of oxycodone) and 10 mg of naloxone hydrochloride (as 10.9 mg of naloxone hydrochloride
dihydrate, equivalent to 9 mg of naloxone).
The other ingredients are:
Tablet core
Vinyl acetate
Povidone
Sodium lauryl sulfate
Anhydrous colloidal silica
Microcrystalline cellulose
Magnesium stearate
Tablet coating
Polyvinyl alcohol
Titanium dioxide (E171)
Macrogol 3350
Talc

Dolstip 30 mg/15 mg:
Each prolonged-release tablet contains 30 mg of oxycodone hydrochloride (equivalent to
27 mg of oxycodone) and 15 mg of naloxone hydrochloride (as 16.35 mg of naloxone hydrochloride
dihydrate, equivalent to 13.5 mg of naloxone).
The other ingredients are:
Tablet core
Vinyl acetate
Povidone
Sodium lauryl sulfate
Anhydrous colloidal silica
Microcrystalline cellulose
Magnesium stearate
Tablet coating
Polyvinyl alcohol
Titanium dioxide (E171)
Macrogol 3350
Talc

Dolstip 40 mg/20 mg:
Each prolonged-release tablet contains 40 mg of oxycodone hydrochloride (equivalent to
36 mg of oxycodone) and 20 mg of naloxone hydrochloride (as 21.8 mg of naloxone hydrochloride
dihydrate, equivalent to 18 mg of naloxone).
The other ingredients are:
Tablet core
Vinyl acetate
Povidone
Sodium lauryl sulfate
Anhydrous colloidal silica
Microcrystalline cellulose
Magnesium stearate
Tablet coating
Polyvinyl alcohol
Titanium dioxide (E171)
Macrogol 3350
Talc

Description of the appearance of Dolstip and contents of the pack

Dolstip 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.

Dolstip 10 mg/5 mg
Pink, oblong, biconvex prolonged-release tablet, with a fracture line 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.

Dolstip 20 mg/10 mg
White, oblong, biconvex prolonged-release tablet, with a fracture line 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.

Dolstip 30 mg/15 mg
Yellow, oblong, biconvex prolonged-release tablet, with a fracture line 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.

Dolstip 40 mg/20 mg
Pink, oblong, biconvex prolonged-release tablet, with a fracture line 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.
Dolstip is available in perforated single-dose “child-resistant” blisters with lifting

openingor push-inpacks of 10x1 (hospital pack), 14x1, 20x1, 28x1, 30x1,
50x1, 56x1, 60x1 and 100x1 prolonged-release tablets or “child-resistant” blisters of
28, 56 and 84 prolonged-release tablets or bottles with a child-resistant screw cap
containing 50 and 100 prolonged-release tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sandoz S.p.A.
L.go U. Boccioni, 1
21040 Origgio (VA)
Italy

Manufacturer
Develco Pharma GmbH
Grienmatt 27, Baden-Wuerttemberg 79650 Schopfheim, Germany
Salutas Pharma GmbH
Barleben, Otto-von-Guericke-Allee 1, Sachsen-Anhalt, 39179 Barleben, Germany

This medicinal product is authorised in the Member States of the European Economic Area with the
following names:
Germany Oxycodon comp - HEXAL 5 mg/2,5 mg Retardtabletten
Oxycodon comp - HEXAL 10 mg/5 mg Retardtabletten
Oxycodon comp - HEXAL 20 mg/10 mg Retardtabletten
Oxycodon comp - HEXAL 30 mg/15 mg Retardtabletten
Oxycodon comp - HEXAL 40 mg/20 mg Retardtabletten
Belgium Oxycodone/ Naloxone Sandoz 5 mg/2.5 mg tabletten met verlengde
afgifte
Oxycodone/ Naloxone Sandoz 10 mg/5 mg tabletten met verlengde
afgifte
Oxycodone/ Naloxone Sandoz 20 mg/10 mg tabletten met verlengde
afgifte
Oxycodone/ Naloxone Sandoz 30 mg/15 mg tabletten met verlengde
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Oxycodone/ Naloxone Sandoz 40 mg/20 mg tabletten met verlengde
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Bulgaria Oxycodone Naloxone Sandoz 5 mg/2.5 mg prolonged-release tablets
Oxycodone Naloxone Sandoz 10 mg/5 mg prolonged-release tablets
Oxycodone Naloxone Sandoz 20 mg/10 mg prolonged-release tablets
Oxycodone Naloxone Sandoz 40 mg/20 mg prolonged-release tablets
Greece Oxycodone+Naloxone/Sandoz
Czech Republic Oxycodon/Naloxon Sandoz 5 mg/2,5 mg
Oxycodon/Naloxon Sandoz 10 mg/5 mg
Oxycodon/Naloxon Sandoz 20 mg/10 mg
Oxycodon/Naloxon Sandoz 40 mg/20 mg
Spain Oxicodona/Naloxona Sandoz 5 mg/2,5 mg comprimidos de liberación
prolongada EFG
Oxicodona/Naloxona Sandoz 10 mg/5 mg comprimidos de liberación
prolongada EFG
Oxicodona/Naloxona Sandoz 20 mg/10 mg comprimidos de liberación
prolongada EFG
Oxicodona/Naloxona Sandoz 40 mg/20 mg comprimidos de liberación
prolongada EFG
Finland Tanonalla 5 mg/2,5 mg depottabletti
Tanonalla 10 mg/5 mg depottabletti
Tanonalla 20 mg/10 mg depottabletti
Tanonalla 30 mg/15 mg depottabletti
Tanonalla 40 mg/20 mg depottabletti
Ireland Dancex SR Plus 5 mg/2.5 mg Prolonged-release tablets
Dancex SR Plus 10 mg/5 mg Prolonged-release tablets
Dancex SR Plus 20 mg/10 mg Prolonged-release tablets
Dancex SR Plus 40 mg/20 mg Prolonged-release tablets
Italy Dolstip
Luxembourg Oxycodone/ Naloxone Sandoz 5 mg/2.5 mg comprimés à libération
prolongée
Oxycodone/ Naloxone Sandoz 10 mg/5 mg comprimés à libération
prolongée
Oxycodone/ Naloxone Sandoz 20 mg/10 mg comprimés à libération
prolongée
Oxycodone/ Naloxone Sandoz 30 mg/15 mg comprimés à libération
prolongée
Oxycodone/ Naloxone Sandoz 40 mg/20 mg comprimés à libération
prolongée
Poland Xanconalon
Romania Oxicodonă/Naloxonă Sandoz 5 mg/2,5 mg comprimate cu eliberare
prelungită
Oxicodonă/Naloxonă Sandoz 10 mg/5 mg comprimate cu eliberare
prelungită
Oxicodonă/Naloxonă Sandoz 20 mg/10 mg comprimate cu eliberare
prelungită
Oxicodonă/Naloxonă Sandoz 30 mg/15 mg comprimate cu eliberare
prelungită
Oxicodonă/Naloxonă Sandoz 40 mg/20 mg comprimate cu eliberare
prelungită
Sweden Oxycodone/Naloxone Sandoz 5 mg/2,5 mg depottabletter
Oxycodone/Naloxone Sandoz 10 mg/5 mg depottabletter
Oxycodone/Naloxone Sandoz 20 mg/10 mg depottabletter
Oxycodone/Naloxone Sandoz 30 mg/15 mg depottabletter
Oxycodone/Naloxone Sandoz 40 mg/20 mg depottabletter
Slovenia Codilek Combo 5 mg/2,5 mg tablete s podaljšanim sproščanjem
Codilek Combo 10 mg/5 mg tablete s podaljšanim sproščanjem
Codilek Combo 20 mg/10 mg tablete s podaljšanim sproščanjem
Codilek Combo 30 mg/15 mg tablete s podaljšanim sproščanjem
Codilek Combo 40 mg/20 mg tablete s podaljšanim sproščanjem
Slovakia Oxycodone/Naloxone Sandoz 5 mg/2,5 mg
Oxycodone/Naloxone Sandoz 10 mg/5 mg
Oxycodone/Naloxone Sandoz 20 mg/10 mg
Oxycodone/Naloxone Sandoz 40 mg/20 mg
Hungary Oxycodone/Naloxone Sandoz 5 mg/2,5 mg retard tabletta
Oxycodone/Naloxone Sandoz 10 mg/5 mg retard tabletta
Oxycodone/Naloxone Sandoz 20 mg/10 mg retard tabletta
Oxycodone/Naloxone Sandoz 40 mg/20 mg retard tabletta