Package leaflet: Information for the user

TARIM 5 mg/2.5 mg, 10 mg/5 mg, 20 mg/10 mg, 30 mg/15 mg, 40 mg/20 mg PROLONGED-RELEASE TABLETS

oxycodone hydrochloride/naloxone hydrochloride

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

•    Keep this leaflet. You may need to read it again.

•    If you have any further questions, ask your doctor or pharmacist.

•    This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

•    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1.    What Tarim is and what it is used for

2.    What you need to know before you take Tarim

3.    How to take Tarim

4.    Possible side effects

5.    How to store Tarim

6.    Contents of the pack and other information

1. What Tarim is and what it is used for Pain relief

You have been prescribed Tarim for the treatment of severe pain, which can only be adequately managed with opioid analgesics. Tarim 5 mg/2.5 mg, 10 mg/5 mg, 20 mg/10 mg and 30 mg/15 mg Prolonged-release Tablets: Naloxone is added to counteract constipation.

How Tarim works in pain relief

Tarim contains oxycodone hydrochloride and naloxone hydrochloride as active substances. Oxycodone hydrochloride is responsible for the pain-killing effect of Tarim, and is a potent analgesic (“painkiller”) that belongs to a group of medicines called opioids.

Tarim 5 mg/2.5 mg, 10 mg/5 mg, 20 mg/10 mg and 30 mg/15 mg Prolonged-release Tablets: The second active substance of Tarim, naloxone hydrochloride, is intended to counteract constipation. Bowel dysfunction (e.g. constipation) is a typical side effect of treatment with opioid painkillers.

Tarim is a prolonged-release tablet, which means that its active substances are released over an extended period. Their action lasts for 12 hours.

Oxycodone hydrochloride and naloxone hydrochloride which are contained in Tarim may also be authorised to treat other conditions which are not mentioned in this leaflet. Ask your doctor or pharmacist if you have further questions.

2. What you need to know before you take Tarim

Do not take Tarim if:

•    you are allergic to oxycodone hydrochloride, naloxone hydrochloride or any of the other ingredients of this medicine (listed in section 6)

•    your breathing is not able to supply enough oxygen to the blood, and get rid of carbon dioxide produced in the body (respiratory depression)

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

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

•    you suffer from severe bronchial asthma

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

•    you have moderate to severe liver problems.

Warnings and precautions

Talk to your doctor or pharmacist before taking Tarim if

•    you are elderly or debilitated (weak)

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

•    you have kidney problems

•    you have mild liver problems

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

•    you suffer from a condition that is accompanied by common respiratory interruptions and makes you feel sleepy during the day (sleep apnoea)

•    you have myxoedema (a thyroid disorder, with dryness, coldness and swelling [‘puffiness’] of the skin, affecting the face and limbs)

•    your thyroid gland is not producing enough hormones (underactive thyroid, or hypothyroidism)

•    your adrenal glands are not producing enough hormones (adrenal insufficiency, or Addison’s disease)

•    you have a mental illness accompanied by a (partial) loss of reality (psychosis), due to alcohol or intoxication with other substances (substance-induced psychosis)

•    you suffer from gallstone problems

•    your prostate gland is abnormally enlarged (prostate hypertrophy)

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

•    your pancreas is inflamed (pancreatitis)

•    you have low blood pressure (hypotension)

•    you have high blood pressure (hypertension)

•    you have pre-existing cardiovascular disease

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

•    you suffer from epilepsy or are prone to seizures

•    you are also taking MAO inhibitors (used to treat depression or Parkinson’s disease), e.g. medicines containing tranylcypromine, phenelzine, isocarboxazid, moclobemide and linezolid

•    you feel sleepy or if you fall asleep sometimes.

Tell your doctor if any of the above has ever applied to you in the past. Also, please tell your

doctor if you develop any of the above disorders while you are taking Tarim.

The most serious result of opioid overdose is respiratory depression (slow and shallow breathing). This may also cause blood oxygen levels to fall, resulting in possible fainting, etc.

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

Children and adolescents

This medicine must not be given to children and adolescents under 18 years of age as the safety and benefits have not been shown yet.

How to use Tarim correctly:

Diarrhoea

If you experience severe diarrhoea at the start of treatment, this may be due to the effect of naloxone. It may be a sign that your bowel function is returning to normal. Such diarrhoea can occur within the first 3-5 days of treatment. If diarrhoea should persist after 3-5 days, or gives you cause for concern, please contact your doctor.

Switching to Tarim

If you have been using high doses of another opioid, withdrawal symptoms may occur when you initially switch to Tarim treatment, e.g. restlessness, bouts of sweating and muscle pain.

If you experience such symptoms, you may need to be specially monitored by your doctor. Tarim is not suitable for withdrawal treatment.

Surgery

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

Long-term treatment

If used over the long term, you may become tolerant to Tarim. This means you may need a higher dose to achieve the desired pain relief. Also, long-term use of Tarim may lead to physical dependence. Withdrawal symptoms may occur if treatment is stopped too suddenly (restlessness, bouts of sweating, muscle pain). If you no longer need treatment, you should reduce your daily dose gradually, in consultation with your doctor.

Psychological dependence

The active substance oxycodone hydrochloride alone has an abuse profile similar to other strong opioids (strong analgesics). There is potential for development of psychological dependence. Oxycodone hydrochloride containing products should be avoided in patients with a present or past abuse of alcohol, drugs or medicines.

Incorrect use of Tarim:

Tarim 5mg/2.5mg

The prolonged-release tablet must be swallowed whole and must not be divided, broken, chewed or crushed. Taking divided, broken, chewed or crushed tablets may lead to the absorption of a potentially lethal dose of oxycodone hydrochloride (see under ‘If you take more Tarim than you should’).

Tarim 10mg/5mg, 20mg/10mg, 30mg/15mg, 40mg/20mg

The prolonged-release tablet can be divided into equal doses but must not be chewed or crushed.

Taking chewed or crushed tablets may lead to the absorption of a potentially lethal dose of oxycodone hydrochloride (see under ‘If you take more Tarim than you should’).

Misuse

You should never misuse Tarim prolonged-release tablets by dissolving and injecting them (e.g. into a blood vessel). In particular, they contain talc, which can cause destruction of local tissue (necrosis) and changes in lung tissue (lung granuloma). Such abuse can also have other serious consequences and may even be fatal.

Doping

Athletes must be aware that this medicine may cause a positive reaction to ‘anti-doping’ tests. The use of Tarim as a doping agent may become a health hazard.

Other medicines and Tarim

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

The risk of side effects is increased if you take Tarim at the same time as medicines which affect brain function. In this case, the side effects of Tarim may be enhanced. For example, tiredness/drowsiness may occur, or respiratory depression (slow, shallow breathing) may get worse.

Examples of medicines which affect brain function include:

•    other potent painkillers (opioids)

•    sleep medication and tranquilisers (sedatives, hypnotics)

•    antidepressants

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

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

Tell your doctor if you are taking one of the following medicinal products:

•    medicines that decrease the blood’s clotting ability (coumarin derivatives), this clotting time may be increased or slowed down

•    antibiotics of the macrolide type (such as clarithromycin)

•    antifungal medicines of the azole type (e.g. ketoconazole)

•    ritonavir or other protease inhibitors (used to treat HIV)

•    rifampicin (used to treat tuberculosis)

•    carbamazepine (used to treat seizures, fits or convulsions and certain pain conditions)

•    phenytoin (used to treat seizures, fits or convulsions).

No interactions are expected between Tarim and paracetamol, acetylsalicylic acid or naltrexone.

Tarim with food, drink and alcohol

Drinking alcohol whilst taking Tarim 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 Tarim.

You should avoid drinking grapefruit juice while you are taking Tarim.

Pregnancy and breast-feeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Use of Tarim during pregnancy should be avoided unless your doctor thinks treatment is essential. If used over prolonged periods during pregnancy, oxycodone hydrochloride may lead to withdrawal symptoms in newborn infants. If oxycodone hydrochloride is given during childbirth, respiratory depression (slow and shallow breathing) may occur in the newborn infant.

Breast-feeding

Breast-feeding should be discontinued during treatment with Tarim. Oxycodone hydrochloride passes into breast milk. It is not known whether naloxone hydrochloride also passes into breast milk. Therefore, a risk for the suckling infant cannot be excluded in particular following intake of multiple doses of Tarim.

Driving and using machines

Tarim may affect your ability to drive or operate machines as it can make you sleepy or dizzy. This is most likely at the start of Tarim therapy, after a dose increase or after switching from a different medication. However, these side effects should disappear once you are on a stable dose.

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

Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.

3. How to take Tarim

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Unless otherwise prescribed by your doctor, the usual dose is:

To treat pain Adults

The usual starting dose is 10 mg oxycodone hydrochloride/5 mg naloxone hydrochloride as prolonged-release tablet(s) every 12 hours.

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

The maximum daily dose is 160 mg oxycodone hydrochloride and 80 mg naloxone hydrochloride. If you need a higher dose, your doctor may give you additional oxycodone hydrochloride without naloxone hydrochloride. However, the maximum daily dose of oxycodone hydrochloride should not exceed 400 mg.

The beneficial effect of naloxone hydrochloride on bowel activity may be affected if additional oxycodone hydrochloride is given without additional naloxone hydrochloride.

If you are switched from Tarim to another strong opioid pain medication you have to anticipate, that your bowel function will probably worsen.

If you experience pain between two doses of Tarim, you may need to take an additional rapidacting painkiller. Tarim is not suitable for this. In this case, please talk to your doctor.

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

To treat pain Elderly patients

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

Liver or kidney problems

If you have kidney or mild liver problems, your doctor may prescribe a lower dose. If you have moderate or severe liver problems, Tarim must not be used (see also section 2 “Do not take Tarim” and “Warnings and precautions”).

Use in children and adolescents below 18 years of age

Tarim has not yet been studied in children and adolescents under 18 years of age. Its safety and effectiveness have not been proven in children and adolescents. For this reason, Tarim use in children and adolescents under 18 years of age is not recommended.

Method of administration Tarim 5mg/2.5mg

These tablets are for oral use. You should take Tarim with sufficient liquid ('A glass of water). The tablet must be swallowed whole and not divided, broken, chewed or crushed. The tablet may be taken with or without food.

Tarim 10mg/5mg, 20mg/10mg, 30mg/15mg, 40mg/20mg

These tablets are for oral use. You should take Tarim with sufficient liquid ('A glass of water). The tablet can be divided into equal doses but must not be chewed or crushed. The tablet may be taken with or without food.

Take Tarim every 12 hours, according to a fixed time schedule (e.g. at 8 o’clock in the morning and 8 o’clock in the evening).

Duration of use

In general, you should not take Tarim for any longer than you need to. If you are on long-term treatment with Tarim, your doctor should regularly check whether you still need Tarim.

If you take more Tarim than you should

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

An overdose may result in:

•    narrowed pupils

•    slow and shallow breathing (respiratory depression)

•    a narcotic-like state (drowsiness to the point of unconsciousness)

•    low muscle tone (hypotonia)

•    reduced pulse rate

•    a drop in blood pressure.

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

You should avoid situations which require a high level of alertness, e.g. driving.

If you forget to take Tarim

If you forget to take Tarim or if you take a dose lower than the one prescribed, you may not feel any effect.

If you should forget to take your dose, please follow the instructions below:

•    if your next usual dose is due in 8 hours’ time or more: take the forgotten dose immediately and continue with your normal dosing schedule

•    if your next usual dose is due within less than 8 hours’ time: take the forgotten dose.

Then, wait another 8 hours before taking your next dose. Try to get back on track with your original dosing schedule (e.g. 8 o’clock in the morning and 8 o’clock in the evening)

•    do not take more than one dose within any 8-hour period.

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

If you stop taking Tarim

Do not stop your treatment with Tarim without consulting your doctor.

If you do not require any further treatment, you must reduce the daily dose gradually after talking to your doctor. In this way, you will avoid withdrawal symptoms, such as restlessness, bouts of sweating and muscle pain.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

If you are affected by any of the following important side effects, consult your nearest doctor immediately:

Slow and shallow breathing (respiratory depression) is the most serious side effect of an opioid overdose. It mostly occurs in elderly and debilitated (weak) patients. Opioids can also cause a severe drop in blood pressure in susceptible patients.

The following side effects were observed in patients being treated for pain

Common: may affect up to 1 in 10 people

•    decreased appetite up to loss of appetite

•    difficulty in sleeping, tiredness or debility

•    a feeling of dizziness or 'spinning', headache, drowsiness

•    vertigo

•    hot flushes

•    abdominal pain, constipation, diarrhoea, dry mouth, indigestion, being sick, feeling sick, wind

•    itchy skin, skin reactions, sweating

•    general weakness.

Uncommon: may affect up to 1 in 100 people

•    hypersensitivity/ allergic reactions

•    restlessness, abnormal thoughts, anxiety, confusion, depression, nervousness

•    epileptic seizures (especially in persons with epileptic disorder or predisposition to seizures), difficulty concentrating, impaired speech, fainting, shaking

•    vision impairment

•    chest tightness especially if you already have coronary heart disease, palpitations

•    drop in blood pressure, rise in blood pressure

•    difficulty breathing,    runny    nose, cough

•    abdominal bloating

•    increase in hepatic enzymes, biliary    colic

•    muscle cramps, muscle twitches, muscle pain

•    increased urge to urinate

•    withdrawal symptoms such as agitation, chest pain, chills, generally feeling unwell, pain, swelling of hands, ankles or feet, weight loss

•    injuries from accidents.

Rare: may affect up to 1 in 1,000 people

•    increase in pulse rate

•    yawning

•    dental changes

•    weight gain.

Not known: frequency cannot be estimated from the available data

•    euphoric mood, hallucinations, nightmares

•    pins and needles, severe drowsiness

•    shallow breathing

•    belching

•    difficulties in passing urine

•    erectile dysfunction.

The active substance oxycodone hydrochloride, if not combined with naloxone hydrochloride, is known to have the following differing side effects

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

Common: may affect up to 1 in 10 people

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

•    hiccups

•    difficulties in passing urine.

Uncommon: may affect up to 1 in 100 people

•    dehydration

•    agitation, perception disturbances (e.g. hallucination, derealisation), reduced sexual drive, drug dependence

•    impaired concentration, migraines, taste anomalies, increased muscle tension, involuntary muscle contractions, reduced sensitivity to pain or touch, abnormal coordination

•    difficulties in hearing

•    flushing of the skin

•    vocal changes (dysphonia)

•    difficulties in swallowing, ileus, mouth ulcers, sore gums

•    dry skin

•    swelling due to water retention, thirst, drug tolerance.

Rare: may affect up to 1 in 1,000 people

•    herpes simplex

•    increased appetite

•    black (tarry) stools, gingival bleeding

itching rash (urticaria).

Not known: frequency cannot be estimated from the available data

•    acute generalised allergic reactions (anaphylactic reactions)

•    problems with bile flow

•    absence of menstrual periods.

The following side effects have been seen in patients being treated for another indication

Very common: may affect 1 in 10 people or more

•    headache

•    drowsiness

•    constipation

•    feel sick

•    sweating

•    tiredness or exhaustion.

Common: may affect up to 1 in 10 people

•    decreased appetite to loss of appetite

•    difficulty in sleeping

•    depression

•    a feeling of dizziness or ‘spinning’

•    difficulty in concentrating

•    shaking

•    tingling in hands or feet

•    vision impairment

•    vertigo

•    hot flushes

•    drop in blood pressure

•    rise in blood pressure

•    abdominal pain

•    dry mouth

•    vomiting (being sick)

•    increased hepatic enzymes (alanine aminotransferase increased, gamma glutamyltransferase increased)

•    itchy skin

•    skin reactions/rash

•    chest pain

•    chills

•    pain

•    thirst.

Uncommon: may affect up to 1 in 100 people

•    reduced sexual drive

•    episodes of suddenly falling asleep

•    altered taste

•    difficulty in breathing

•    wind

•    erectile dysfunction

•    withdrawal symptoms such as agitation

•    swelling of hands, ankles or feet

•    injuries from accidents.

Not known: frequency cannot be estimated from available data

•    hypersensitivity/ allergic reactions

•    abnormal thoughts

•    anxiety

•    confusion

•    nervousness

•    restlessness

•    euphoric mood

•    hallucinations

•    nightmares

•    epileptic seizures (especially in persons with epileptic disorder or predisposition to seizures)

•    severe drowsiness

•    impaired speech

•    fainting

•    chest tightness especially if you already have coronary heart disease

•    palpitations

•    increase in pulse rate

•    shallow breathing

•    cough

•    runny nose

•    yawning

•    abdominal bloating

•    diarrhoea

•    indigestion

•    belching

•    dental changes

•    biliary colic

•    muscle cramps

•    muscle twitches

•    muscle pain

•    difficulties in passing urine

•    increased urge to urinate

•    generally feeling unwell

•    weight loss

•    weight increase.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: 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 Tarim

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton, label and blister after “EXP”. The expiry date refers to the last day of that month.

Blister: Do not store above 25°C.

Bottles: Do not store above 30°C.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information What Tarim contains:

The active substances are oxycodone hydrochloride and naloxone hydrochloride.

Each 5 mg/2.5 mg prolonged-release tablet contains 5 mg of oxycodone hydrochloride (equivalent to 4.5 mg oxycodone) and 2.5 mg of naloxone hydrochloride (as 2.74 mg naloxone hydrochloride dihydrate equivalent to 2.25 mg naloxone).

Each 10 mg/5 mg prolonged-release tablet contains 10 mg of oxycodone hydrochloride (equivalent to 9.0 mg oxycodone) and 5 mg of naloxone hydrochloride (as 5.45 mg naloxone hydrochloride dihydrate equivalent to 4.5 mg naloxone).

Each 20 mg/10 mg prolonged-release tablet contains 20 mg of oxycodone hydrochloride (equivalent to 18.0 mg oxycodone) and 10mg of naloxone hydrochloride (as 10.9 mg naloxone hydrochloride dihydrate equivalent to 9 mg naloxone).

Each 30 mg/15 mg prolonged-release tablet contains 30 mg of oxycodone hydrochloride (equivalent to 27.0 mg oxycodone) and 15 mg of naloxone hydrochloride (as 16.35 mg naloxone hydrochloride dihydrate equivalent to 13.5 mg naloxone).

Each 40 mg/20 mg prolonged-release tablet contains 40 mg of oxycodone hydrochloride (equivalent to 36.0 mg oxycodone) and 20 mg of naloxone hydrochloride (as 21.8 mg naloxone hydrochloride dihydrate equivalent to 18 mg naloxone).

The other ingredients are:

Tablet core:

Polyvinyl acetate, povidone, sodium laurilsulfate, silica, colloidal anhydrous, cellulose, microcrystalline and magnesium stearate.

Tablet coating:

Tarim 5 mg/2.5 mg:

Polyvinyl alcohol, titanium dioxide (E171), macrogol and talc.

Tarim 10 mg/5 mg:

Polyvinyl alcohol, titanium dioxide (E171), macrogol, talc and iron oxide red (E172).

Tarim 20 mg/10 mg:

Polyvinyl alcohol, titanium dioxide (E171), macrogol and talc.

Tarim 30 mg/15 mg:

Polyvinyl alcohol, titanium dioxide (E171), macrogol, talc and iron oxide yellow (E172). Tarim 40 mg/20 mg:

Polyvinyl alcohol, titanium dioxide (E171) , macrogol, talc and iron oxide red (E172).

What Tarim looks like and contents of the pack:

Tarim 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.

Tarim 10 mg/5 mg:

Pink, oblong, biconvex prolonged-release tablet with break scores on both sides, with a length of 10.2 mm, a width of 4.7 mm and a height of 3.0 - 4.0 mm.

The tablet can be divided into equal doses.

Tarim 20 mg/10 mg:

White, oblong, biconvex prolonged-release tablet with break scores on both sides, with a length of 11.2 mm, a width of 5.2 mm and a height of 3.3 - 4.3 mm.

The tablet can be divided into equal doses.

Tarim 30 mg/15 mg:

Yellow, oblong, biconvex prolonged-release tablet with break scores on both sides, with a length of 12.2 mm, a width of 5.7 mm and a height of 3.3 - 4.3 mm.

The tablet can be divided into equal doses.

Tarim 40 mg/20 mg:

Pink, oblong, biconvex prolonged-release tablet with break scores on both sides, with a length of 14.2 mm, a width of 6.7 mm and a height of 3.6 - 4.6 mm The tablet can be divided into equal doses.

Tarim is available in:

Child-resistant blisters of 10, 14, 20, 28, 30, 50, 56, 60, 98 and 100 prolonged-release tablets; child-resistant perforated unit-dose blisters of 56x1 prolonged-release tablets or bottles with a child-resistant closure containing 50, 100, 200 or 250 prolonged-release tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer TEVA UK Limited, Eastbourne, BN22 9AG, UK

OR*

Marketing Authorisation Holder

TEVA UK Limited, Eastbourne, BN22 9AG, UK

Manufacturer

Develco Pharma GmbH, Grienmatt 42, Schopfheim 79650, Germany This leaflet was last revised in 12/2015 PL 00289/1974-8

*Only the actual site of batch release will appear on the printed version of the leaflet.