Ariclaim - patient leaflet, side effects, dosage

What ARICLAIM is and what it is used for

ARICLAIM contains the active substance duloxetine. ARICLAIM increases the levels of serotonin and noradrenaline in the nervous system.

ARICLAIM is used in adults to treat a condition called diabetic neuropathic pain (often described as burning, stabbing, stinging, shooting or aching or like an electric shock. There may be loss of feeling in the affected area, or sensations such as touch, heat, cold or pressure may cause pain).

In people with diabetic neuropathic pain it can take some weeks before you feel better. Talk to your doctor if you do not feel better after 2 months.

2.   What you need to know before you take ARICLAIM

DO NOT take ARICLAIM if you:

• – are allergic to duloxetine or any of the other ingredients of this medicine (listed in section 6)

• – have liver disease

• – have severe kidney disease

• – are taking or have taken within the last 14 days, another medicine known as a monoamine oxidase inhibitor (MAOI) (see ‘Other medicines and ARICLAIM’)

• – are taking fluvoxamine which is usually used to treat depression, ciprofloxacin or enoxacin which are used to treat some infections

• – are taking other medicines containing duloxetine (see ‘Other medicines and ARICLAIM’)

Talk to your doctor if you have high blood pressure or heart disease. Your doctor will tell you if you should be taking ARICLAIM.

Warnings and precautions

The following are reasons why ARICLAIM may not be suitable for you. Talk to your doctor before you take ARICLAIM if you:

are taking medicines to treat depression (see ‘Other medicines and ARICLAIM’) are taking St. John’s Wort, a herbal treatment (Hypericum perforatum ) have kidney disease have had seizures (fits) have had mania

suffer from bipolar disorder

have eye problems, such as certain kinds of glaucoma (increased pressure in the eye)

have a history of bleeding disorders (tendency to develop bruises)

are at risk of low sodium levels (for example if you are taking diuretics, especially if you are elderly)

are currently being treated with another medicine which may cause liver damage

are taking other medicines containing duloxetine (see ‘Other medicines and ARICLAIM

ARICLAIM may cause a sensation of restlessness or an inability to sit or stand still. You s your doctor if this happens to you.

Thoughts of suicide and worsening of depression or anxiety disorder

Although ARICLAIM is not indicated for the treatment of depression, its activ ient (duloxetine) is used as an antidepressant medicine. If you are depressed and/or anxiety disorders you can sometimes have thoughts of harming or killing yourself. These may be increased when first starting antidepressants, since these medicines all take time to work, usually about two weeks but sometimes longer.

You may be more likely to think like this if you:

• – have previously had thoughts about killing or harming yourself

• – are a young adult. Information from clinical trials has shown an increased risk of suicidal behaviour in adults aged less than 25 years with psychiatric conditions who were treated with an antidepressant

If you have thoughts of harming or killing yourself at any time, contact your doctor or go to a hospital straight away.

You may find it helpful to tell a relative or close friend that you are depressed or have an anxiety disorder, and ask them to read this leaflet. You might ask them to tell you if they think your depression or anxiety is getting worse, or if they are worried about changes in your behaviour.

Children and adolescents under 18 years of age

ARICLAIM should normally not be used for children and adolescents under 18 years. Also, you should know that patients under 18 have an increased risk of side-effects such as suicide attempt, suicidal thoughts and hostility (predominantly aggression, oppositional behaviour and anger) when they take this class of medicines. Despite this, your doctor may prescribe ARICLAIM for patients under 18 because he/she decides that this is in their best interests. If your doctor has prescribed ARICLAIM for a patient under 18 and you want to discuss this, please go back to your doctor. You should inform your doctor if any of the symptoms listed above develop or worsen when patients under 18 are taking ARICLAIM. Also, the long-term safety effects concerning growth, maturation, and cognitive and behavioural development of ARICLAIM in this age group have not yet been demonstrated.

Other medicines and ARICLAIM

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines., including medicines obtained without a prescription.

The main ingredient of ARICLAIM, duloxetine, is used in other medicines for other conditions:

• depression, anxiety and urinary incontinence

Using more than one of these medicines at the same time should be avoided. Check with your doctor if you are already taking other medicines containing duloxetine.

Your doctor should decide whether you can take ARICLAIM with other medicines. Do not start or stop taking any medicines, including those bought without a prescription and herbal remedies, before checking with your doctor.

You should also tell your doctor if you are taking any of the following:

Monoamine oxidase inhibitors (MAOIs): You should not take ARICLAIM if you are taking, or have recently taken (within the last 14 days) an antidepressant medicine called a monoamine oxidase inhibitor (MAOI). Examples of MAOIs include moclobemide (an antidepressant) and linezolid (an antibiotic). Taking a MAOI together with many prescription medicines, including ARICLAIM, can cause serious or even life-threatening side effects. You must wait at least 14 days after you have stopped taking an MAOI before you can take ARICLAIM. Also, you need to wait at least 5 days after you stop taking ARICLAIM before you take a MAOI.

Medicines that cause sleepiness: These include medicines prescribed by your doctor in benzodiazepines, strong painkillers, antipsychotics, phenobarbital and antihistamines.

Medicines that increase the level of serotonin: Triptans, tramadol, tryptophan, SSRIs (such as paroxetine and fluoxetine), SNRIs (such as venlafaxine), tricyclic antidepressants (such as clomipramine, amitriptyline), pethidine, St John’s Wort and MAOIs (such as moclobemide and linezolid). These medicines increase the risk of side effects; if you get any unusual symptom taking any of these medicines together with ARICLAIM, you should see your doctor.

Oral anticoagulants or antiplatelet agents : Medicines wh clotting. These medicines might increase the risk of bleedi

ARICLAIM with food, drink and alcohol

ARICLAIM may be taken with or without food. Care should be taken if you drink alcohol while you are being treated with ARICLAIM.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, your doctor or pharmacist for advice before taking this medicine.

Tell your doctor if you become pregnant, or you are trying to become pregnant, while you are taking ARICLAIM. You should use ARICLAIM only after discussing the potential benefits and any potential risks to your unborn child with your doctor.

Make sure your midwife and/or doctor knows you are on ARICLAIM. When taken during pregnancy, similar drugs (SSRIs) may increase the risk of a serious condition in babies, called persistent pulmonary hypertension of the newborn (PPHN), making the baby breathe faster and appear bluish. These symptoms usually begin during the first 24 hours after the baby is born. If this happens to your baby you should contact your midwife and/or doctor immediately.

If you take ARICLAIM near the end of your pregnancy, your baby might have some symptoms when it is born. These usually begin at birth or within a few days of your baby being born. These symptoms may include floppy muscles, trembling, jitteriness, not feeding properly, trouble with breathing and fits. If your baby has any of these symptoms when it is born, or you are concerned about your baby’s health, contact your doctor or midwife who will be able to advise you.

• Tell your doctor if you are breast-feeding. The use of ARICLAIM while breastfeeding is not

recommended. You should ask your doctor or pharmacist for advice.

Driving and using machines

ARICLAIM may make you feel sleepy or dizzy. Do not drive or use any tools or machines until you know how ARICLAIM affects you.

ARICLAIM contains sucrose

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

3. How to take ARICLAIM

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

ARICLAIM is for oral use. You should swallow your capsule whole with a drink of water.

The usual dose of ARICLAIM is 60 mg once a day, but your doctor will prescribe the dose right for you.

To help you remember to take ARICLAIM, you may find it easier to take it at the same times every day.

Talk with your doctor about how long you should keep taking ARICLAIM. Do not stop taking ARICLAIM, or change your dose, without talking to your doctor. Treating your disorder properly is

important to help you get better. If it is not treated, your condition more serious and difficult to treat.

If you take more ARICLAIM than you should

Call your doctor or pharmacist immediately if you take more than the amount of ARICLAIM prescribed by your doctor. Symptoms of overdose include sleepiness, coma, serotonin syndrome (a rare reaction which may cause feelings of great happiness, drowsiness, clumsiness, restlessness, feeling of being drunk, fever, sweating or rigid muscles), fits, vomiting and fast heart rate.

If you forget to take ARICLAIM

If you miss a dose, take it as soon as you remember. However, if it is time for your next dose, skip the missed dose and take only a single dose as usual. Do not take a double dose to make up for a forgotten dose. Do not take more than the daily amount of ARICLAIM that has been prescribed for you in one day.

If you stop taking ARICLAIM

DO NOT stop taking your capsules without the advice of your doctor even if you feel better. If your doctor thinks that you no longer need ARICLAIM he or she will ask you to reduce your dose over at least 2 weeks before stopping treatment altogether.

Some patients who stop taking ARICLAIM suddenly have had symptoms such as:

• dizziness, tingling feelings like pins and needles or electric shock-like feelings (particularly in the head), sleep disturbances (vivid dreams, nightmares, inability to sleep), fatigue, sleepiness, feeling restless or agitated, feeling anxious, feeling sick (nausea) or being sick (vomiting), shaking (tremor), headaches, muscle pain, feeling irritable, diarrhoea, excessive sweating or vertigo.

These symptoms are usually not serious and disappear within a few days, but if you have symptoms that are troublesome you should ask your doctor for advice.

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. These effects are normally mild to moderate and often disappear after a few weeks.

Very common side effects (may affect more than 1 in 10 people)

• headache, feeling sleepy
• feeling sick (nausea), dry mouth

Common side effects (may affect up to 1 in 10 people)

• lack of appetite
• trouble sleeping, feeling agitated, less sex drive, anxiety, difficulty or failure to experience

orgasm, unusual dreams

• dizziness, feeling sluggish, tremor, numbness, including numbness, pricking or tingling of the skin
• blurred eyesight
• tinnitus (hearing sound in the ear when there is no external sound)
• feeling the heart pumping in the chest,
• increased blood pressure, flushing
• increased yawning
• constipation, diarrhoea, stomach pain, being sick (vomiting), heartburn or indigestion, breaking wind
• increased sweating, (itchy) rash
• muscle pain, muscle spasm
• painful urination, frequent urination
• problems getting an erection, changes in ejaculation
• falls (mostly in elderly people), fatigue
• weight loss

Uncommon side effects (may affect up to 1 in 100 people)

• throat inflammation that causes a hoarse voice
• suicidal thoughts, difficulty sleeping, grinding or clenching the teeth, feeling disorientated, lack of motivation
• sudden involuntary jerks or twitches of the muscles, sensation of restlessness or an inability to sit or stand still, feeling nervous, difficulty concentrating, changes in sense of taste, difficulty controlling movement e.g. lack of coordination or involuntary movements of the muscles, restless legs syndrome, poor sleep quality
• large pupils (the dark centre of the eye), problems with eyesight
• feeling of dizziness or “spinning” (vertigo), ear pain
• fast and/or irregular heart beat
• fainting, dizziness, lightheadedness or fainting on standing up, cold fingers and/or toes
• throat tightness, nose bleeds
• vomiting blood, or black tarry stools (faeces), gastroenteritis, burping, difficulty swallowing
• inflammation of the liver that may cause abdominal pain and yellowing of the skin or whites of

the eyes

• night sweats, hives, cold sweats, sensitivity to sunlight, increased tendency to bruise
• muscle tightness, muscle twitching
• difficulty or inability to pass urine, difficulty to start urinating, needing to pass urine during the night, needing to pass more urine than normal, having a decreased urine flow
• abnormal vaginal bleeding, abnormal periods, including heavy, painful, irregular or prolonged periods, unusually light or missed periods, pain in the testicles or scrotum
• chest pain, feeling cold, thirst, shivering, feeling hot, abnormal gait
• weight gain

Ariclaim may cause effects that you may not be aware of, such as increases in liver enzymes or blood levels of potassium, creatine phosphokinase, sugar, or cholesterol

Rare side effects (may affect up to 1 in 1000 people)

• serious allergic reaction which causes difficulty in breathing or dizziness with swollen tongue or lips, allergic reactions
• decreased thyroid gland activity which can cause tiredness or weight gain
• dehydration, low levels of sodium in the blood (mostly in elderly people; the symptoms may include feeling dizzy, weak, confused, sleepy or very tired, or feeling or being sick, more serious symptoms are fainting, fits or falls), syndrome of inappropriate secretion of anti-diuretic hormone (SIADH)
• suicidal behaviour, mania (over activity, racing thoughts and decreased need for sleep), hallucinations, aggression and anger
• “Serotonin syndrome” (a rare reaction which may cause feelings of great happiness, drowsiness, clumsiness, restlessness, feeling of being drunk, fever, sweating or rigid muscles), fits
• increased pressure in the eye (glaucoma)
• inflammation of the mouth, passing bright red blood in your stools, bad breath, inflammation of the large intestine (leading to diarrhoea)
• liver failure, yellowing of the skin or whites of the eyes (jaundice)
• Stevens-Johnson syndrome (serious illness with blistering of the skin, mouth, eyes and

genitals), serious allergic reaction which causes swelling of the face or throat (angioedema)

• contraction of the jaw muscle
• abnormal urine odour

menopausal symptoms, abnormal production of breast milk in men or women

Very rare side effects (may affect up to 1 in 10,000 people)

• inflammation of the blood vessels in the skin (cutaneous vasculitis)

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 national reporting system listed in By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store ARICLAIM

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.

Store in the original package to protect from moisture. 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 to protect the environment.

6. Contents of the pack and other information

What ARICLAIM contains

The active substance is duloxetine.

Each capsule contains 30 or 60 mg of duloxetine (as hydrochloride).

The other ingredients are:

Capsule content : hypromellose, hypromellose acetate succinate, sucrose, sugar spheres, talc, titanium dioxide (E171), triethyl citrate (See end of section 2 for further information on sucrose).

Capsule shell: gelatin, sodium lauryl sulfate, titanium dioxide (E171), indigo carmine (E132), yellow iron oxide (E172) (60 mg only) and edible green ink (30 mg) or edible white ink (60 mg).

Edible green ink: synthetic black iron oxide (E172), synthetic yellow iron oxide (E172), propylene glycol, shellac.

Edible white ink : titanium dioxide (E171), propylene glycol, shellac, povidone.

What ARICLAIM looks like and contents of the pack

ARICLAIM is a hard gastro-resistant capsule. Each capsule of ARICLAIM contains pellets of duloxetine hydrochloride with a covering to protect them from stomach acid.

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ARICLAIM is available in 2 strengths: 30 mg and 60 mg.

The 30 mg capsules are blue and white and are printed with ‘30 mg’ and the code ‘9543’.

The 60 mg capsules are blue and green and are printed with ‘60 mg’ and the code ‘9542’.

ARICLAIM 30 mg is available in packs of 7, 28 and 98 capsules.

ARICLAIM 60 mg is available in packs of 28 and 98 capsules.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands.

Manufacturer: Lilly S.A., Avda. De la Industria, 30, 28108 Alcobendas, Madrid, Spain.

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Lietuva

Eli Lilly Holdings Limited atstovybé

Tel. +370 (5) 2649600

Luxembourg/Lu­xemburg

Eli Lilly Benelux S.A./N.V.

Tél/Tel: + 32-(0)2 548 84 84

ELI LILLY CR, s.r.o.

Tel: + 420 23 4 6 64 m

Magyarorszag Lilly Hungaria Kft.

Tel: + 36 1 328 5100

Danmark

Eli Lilly Danmark A/S

Tf +45 45 26 60 00

Malta

Charles de Giorgio Ltd.

Tel: + 356 25600 500

Deutschland

Lilly Deutschland GmbH

Tel. + 49-(0) 6172 273 2222

Nederland

Eli Lilly Nederland B.V.

Tel: + 31-(0) 30 60 25 800

Eesti

Eli Lilly Holdings Limited Eesti filiaal

Tel: + 372 6 817 280

EMáóa

OAPMAZEPB-AIAAY A.E.B.E.

Tql: +30 210 629 4600

España

Dista S.A..

I Tel: + 34 91 623 17 32

Polska

Eli Lilly Polska Sp. z o.o.

Tel: +48 (0)-22 440 33 00

France

Lilly France SAS

Tél: +33-(0) 1 55 49 34 34

Hrvatska

Eli Lilly Hrvatska d.o.o.

Tel: +385 1 2350 999

Ireland

Eli Lilly and Company (Ireland) Limited

Tel: + 353-(0) 1 661 4377

Portugal

Lilly Portugal Produtos Farmacéuticos, Lda

Tel: + 351–21–4126600

Romania

Eli Lilly Romania S.R.L. 4

Tel: + 40 21 4023000

Slovenija

Eli Lilly farmacevtska družba, d.o.o.

Tel: +386 (0)1 580 00 10

island

Icepharma hf.

Sími + 354 540 8000

Slovenská repub’ika

Eli Lilly Slovakia, s.r.o.

Tel: + 421 220 663 111

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