Aripiprazole Sandoz - patient leaflet, side effects, dosage

■ 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 Aripiprazole Sandoz tablets are and what they are used for

• 2. What you need to know before you take Aripiprazole Sandoz tablets

• 3. How to take Aripiprazole Sandoz tablets

• 4. Possible side effects

• 5. How to store Aripiprazole Sandoz tablets

• 6. Contents of the pack and other information

1. What Aripiprazole Sandoz is and what it is used for

Aripiprazole Sandoz contains the active substance aripiprazole and belong to a group of medicines called antipsychotics. It is used to treat adults and adolescents aged 15 years and older who suffer from a disease characterised by symptoms such as hearing, seeing or sensing things which are not there, suspiciousness, mistaken beliefs, incoherent speech and behaviour and emotional flatness. People with this condition may also feel depressed, guilty, anxious or tense.

Aripiprazole Sandoz is used to treat adults and adolescents aged 13 years and older who suffer from a condition with symptoms such as feeling „high“, having excessive amounts of energy, needing much less sleep than usual, talking very quickly with racing ideas and sometimes severe irritability. In adults it also prevents this condition from returning in patients who have responded to the treatment with Aripiprazole Sandoz.

2. What you need to know before you take Aripiprazole Sandoz

Do not take Aripiprazole Sandoz

• if you are allergic to aripiprazole or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor before taking Aripiprazole Sandoz.

Suicidal thoughts and behaviours have been reported during aripiprazole treatment. Tell your doctor immediately if you are having any thoughts or feelings about hurting yourself.

Before treatment with Aripiprazole Sandoz, tell your doctor if you suffer from

• high blood sugar (characterised by symptoms such as excessive thirst, passing of large amounts of urine, increase in appetite and feeling weak) or family history of diabetes
• fits (seizures) since your doctor may want to monitor you more closely
• involuntary, irregular muscle movements, especially in the face
• cardiovascular diseases (diseases of the heart and circulation), family history of cardiovascular disease, stroke or „mini“ stroke, abnormal blood pressure
• blood clots, or family history of blood clots, as antipsychotics have been associated with formation of blood clots
• past experience with excessive gambling

If you notice you are gaining weight, develop unusual movements, experience somnolence that interferes with normal daily activities, any difficulty in swallowing or allergic symptoms, please tell your doctor.

If you are an elderly patient suffering from dementia (loss of memory and other mental abilities), you or your carer/relative should tell your doctor if you have ever had a stroke or „mini“ stroke.

Tell your doctor immediately if you are having any thoughts or feelings about hurting yourself. Suicidal thoughts and behaviours have been reported during aripiprazole treatment.

Tell your doctor immediately if you suffer from muscle stiffness or inflexibility with high fever, sweating, altered mental status, or very rapid or irregular heartbeat.

Tell your doctor if you or your family/carer notices that you are developing urges or cravings to behave in ways that are unusual for you and you cannot resist the impulse, drive or temptation to carry out certain activities that could harm yourself or others. These are called impulse control disorders and can include behaviours such as addictive gambling, excessive eating or spending, an abnormally high sex drive or preoccupation with an increase in sexual thoughts or feelings.

Your doctor may need to adjust or stop your dose.

Aripiprazole may cause sleepiness, fall in blood pressure when standing up, dizziness and changes in your ability to move and balance, which may lead to falls. Caution should be taken, particularly if you are an elderly patient or have some debility.

Children and adolescents

Do not use this medicine in children and adolescents under 13 years of age. It is not known if it is safe and effective in these patients.

Other medicines and Aripiprazole Sandoz

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

Blood pressure-lowering medicines: Aripiprazole Sandoz may increase the effect of medicines used to lower the blood pressure. Be sure to tell your doctor if you take a medicine to keep your blood pressure under control.

Taking Aripiprazole Sandoz with some medicines may mean the doctor will need to change your dose of Aripiprazole Sandoz or the other medicines. It is especially important to mention the following to your doctor:

• medicines to correct heart rhythm (such as quinidine, amiodarone, flecainide)
• antidepressants or herbal remedy used to treat depression and anxiety (such as fluoxetine, paroxetine, venlafaxine, St. John's Wort)
• antifungal medicines (such as ketoconazole, itraconazole)
• certain medicines to treat HIV infection (such as efavirenz, nevirapine, an protease inhibitors e.g. indinavir, ritonavir)
• anticonvulsants used to treat epilepsy (such as carbamazepine, phenytoin, phenobarbital)
• certain antibiotics used to treat tuberculosis (rifabutin, rifampicin)

These medicines may increase the risk of side effects or reduce the effect of Aripiprazole Sandoz; if you get any unusual symptom taking any of these medicines together with Aripiprazole Sandoz you should see your doctor.

Medicines that increase the level of serotonin are typically used in conditions including obsessive-compulsive disorder (OCD) andas well as migraine and pain:

• triptans, tramadol and tryptophan used for conditions including depression, generalised anxiety disorder, obsessive compulsive disorder (OCD) and social phobia as well as migraine and pain
• SSRI s (such as paroxetine and fluoxetine) used for depression, OCD, panic and anxiety
• other anti-depressants (such as venlafaxine and tryptophan) used in major depression
• tricyclic’s (such as clomipramine and amitriptyline) used for depressive illness
• St John’s Wort (Hypericum perforatum) used as a herbal remedy for mild depression
• pain killers (such as tramadol and pethidine) used for pain relief
• triptans (such as sumatriptan and zolmitripitan) used for treating migraine

These medicines may increase the risk of side effects; if you get any unusual symptom taking any of these medicines together with Aripiprazole Sandoz, you should see your doctor.

Aripiprazole Sandoz with food, drink and alcohol

This medicine can be taken regardless of meals.

Alcohol should be avoided.

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 for advice before taking this medicine.

The following symptoms may occur in newborn babies, of mothers that have used Aripiprazole Sandoz in the last trimester (last three months of their pregnancy): shaking, muscle stiffness and/or weakness, sleepiness, agitation, breathing problems, and difficulty in feeding. If your baby develops any of these symptoms you may need to contact your doctor.

If you are taking Aripiprazole Sandoz, your doctor will discuss with you whether you should breast-feed considering the benefit to you of your therapy and the benefit to your baby of breast-feeding. You should not do both. Talk to your doctor about the best way to feed your baby if you are taking this medicine.

Driving and using machines

Dizziness and vision problems may occur during treatment with this medicine (see section 4).

This should be considered in cases where full alertness is required, e.g. when driving a car or handling machines.

Aripiprazole Sandoz contains lactose

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 Aripiprazole Sandoz

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

The recommended dose for adults is 15 mg once a day. However your doctor may prescribe a lower or higher dose to a maximum of 30 mg once a day.

Use in children and adolescents

To allow the start of the treatment at a low dose you can use an alternative formulation (oral solution – liquid) more suitable than Aripiprazole Sandoz tablets. The dose may be gradually increased to the recommended dose for adolescents of 10 mg once a day. However your doctor may prescribe a lower or higher dose to a maximum of 30 mg once a day.

If you have the impression that the effect of Aripiprazole Sandozis too strong or too weak, talk to your doctor or pharmacist.

Try to take Aripiprazole Sandoz at the same time each day. It does not matter whether you take it with or without food. Always take the tablet with water and swallow it whole.

Even if you feel better, do not alter or discontinue the daily dose of Aripiprazole Sandoz without first consulting your doctor.

If you take more Aripiprazole Sandoz than you should

If you realise you have taken more Aripiprazole Sandoz than your doctor has recommended (or if someone else has taken some of your Aripiprazole Sandoz), contact your doctor right away. If you cannot reach your doctor, go to the nearest hospital and take the pack with you.

Patients who have taken too much aripiprazole have experienced the following symptoms:

• rapid heartbeat, agitation/aggres­siveness, problems with speech.
• unusual movements (especially of the face or tongue) and reduced level of consciousness.

Other symptoms may include:

• acute confusion, seizures (epilepsy), coma, a combination of fever, faster breathing, sweating,
• muscle stiffness, and drowsiness or sleepiness, slower breathing, choking, high or low blood pressure, abnormal rhythms of the heart.

Contact your doctor or hospital immediately if you experience any of the above.

If you forget to take Aripiprazole Sandoz

If you miss a dose, take the missed dose as soon as you remember but do not take two doses in one day.

If you stop taking Aripiprazole Sandoz

Do not stop your treatment just because you feel better. It is important that you carry on taking your Aripiprazole Sandoz for as long as your doctor has told you to.

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.

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

• diabetes mellitus,
• difficulty sleeping,
• feeling anxious,
• feeling restless and unable to keep still, difficulty sitting still,
• uncontrollable twitching, jerking or writhing movements, restless legs,
• trembling,
• headache,
• tiredness,
• sleepiness,
• light-headedness,
• shaking and blurred vision,
• decreased number of or difficulty making bowel movements,
• indigestion,
• feeling sick,
• more saliva in mouth than normal,
• vomiting,
• feeling tired.

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

• increased blood levels of the hormone prolactin,
• too much sugar in the blood,
• depression,
• altered or increased sexual interest,
• uncontrollable movements of mouth, tongue and limbs (tardive dyskinesia),
• muscle disorder causing twisting movements (dystonia),
• double vision,
• eye sensitivity to light,
• fast heartbeat,
• a fall in blood pressure on standing up which causes dizziness, light-headedness or fainting,
• hiccups.

The following side effects have been reported since the marketing of oral aripiprazole but the frequency for them to occur is not known:

• low levels of white blood cells,
• low levels of blood platelets,
• allergic reaction (e.g. swelling in the mouth, tongue, face and throat, itching, hives),
• onset or worsening of diabetes, ketoacidosis (ketones in the blood and urine) or coma,
• high blood sugar,
• not enough sodium in the blood,
• loss of appetite (anorexia),
• weight loss,
• weight gain,
• thoughts of suicide, suicide attempt and suicide,
• feeling aggressive,
• agitation,
• nervousness,
• combination of fever, muscle stiffness, faster breathing, sweating, reduced consciousness and sudden changes in blood pressure and heart rate, fainting (neuroleptic malignant syndrome),
• seizure,
• serotonin syndrome (a reaction which may cause feelings of great happiness, drowsiness, clumsiness, restlessness, feeling of being drunk, fever, sweating or rigid muscles),
• speech disorder,
• fixation of the eyeballs in one position,
• sudden unexplained death,
• life-threatening irregular heartbeat,
• heart attack,
• slower heartbeat,
• blood clots in the veins especially in the legs (symptoms include swelling, pain and redness in the leg), which may travel through blood vessels to the lungs causing chest pain and difficulty in breathing (if you notice any of these symptoms, seek medical advice immediately),
• high blood pressure,
• fainting,
• accidental inhalation of food with risk of pneumonia (lung infection),
• spasm of the muscles around the voice box,
• inflammation of the pancreas,
• difficulty swallowing,
• diarrhoea,
• abdominal discomfort,
• stomach discomfort,
• liver failure,
• inflammation of the liver,
• yellowing of the skin and white part of eyes,
• reports of abnormal liver tests values,
• skin rash,
• skin sensitivity to light,
• baldness,
• excessive sweating,
• abnormal muscle breakdown which can lead to kidney problems,
• muscle pain,
• stiffness,
• involuntary loss of urine (incontinence),
• difficulty in passing urine,
• withdrawal symptoms in newborn babies in case of exposure during pregnancy,
• prolonged and/or painful erection,
• difficulty controlling core body temperature or overheating,
• chest pain,
• swelling of hands, ankles or feet,
• in blood tests: increased or fluctuating blood sugar, increased glycosylated haemoglobin.
• inability to resist the impulse, drive or temptation to perform an action that could be harmful to you or

others, which may include:

• – strong impulse to gamble excessively despite serious personal or family consequences

• – altered or increased sexual interest and behaviour of significant concern to you or to others, for example, an increased sexual drive

• – uncontrollable excessive shopping

• – binge eating (eating large amounts of food in a short time period) or compulsive eating (eating more food than normal and more than is needed to satisfy your hunger)

• – a tendency to wander away.

Tell your doctor if you experience any of these behaviours; he/she will discuss ways of managing or reducing the symptoms.

In elderly patients with dementia, more fatal cases have been reported while taking aripiprazole. In addition, cases of stroke or „mini“ stroke have been reported.

Additional side effects in children and adolescents

Adolescents aged 13 years and older experienced side effects that were similar in frequency and type to those in adults except that sleepiness, uncontrollable twitching or jerking movements, restlessness, and tiredness were very common (greater than 1 in 10 patients) and upper abdominal pain, dry mouth, increased heart rate, weight gain, increased appetite, muscle twitching, uncontrolled movements of the limbs, and feeling dizzy, especially when getting up from a lying or sitting position, were common (greater than 1 in 100 patients).

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 Aripiprazole Sandoz tablets

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 carton after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Use within 3 months after first opening of the bottle.

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 Aripiprazole Sandoz tablets contain

The active substance is aripiprazole. Each tablet contains 5 mg of aripiprazole.

The other ingredients are lactose monohydrate, maize starch, microcrystalline cellulose, hydroxypropyl cellulose, magnesium stearate, indigo carmine (E132) aluminium lake.

The active substance is aripiprazole. Each tablet contains 10 mg of aripiprazole.

The other ingredients are lactose monohydrate, maize starch, microcrystalline cellulose, hydroxypropyl cellulose, magnesium stearate, red iron oxide (E172).

The active substance is aripiprazole. Each tablet contains 15 mg of aripiprazole.

The other ingredients are lactose monohydrate, maize starch, microcrystalline cellulose, hydroxypropyl cellulose, magnesium stearate, yellow iron oxide.

Aripiprazole Sandoz 20 mg tablets

• ■ The active substance is aripiprazole. Each tablet contains 20 mg of aripiprazole.

• ■ The other ingredients are lactose monohydrate, maize starch, microcrystalline cellulose,

hydroxypropyl cellulose, magnesium stearate.

Aripiprazole Sandoz 30 mg tablets

• ■ The active substance is aripiprazole. Each tablet contains 30 mg of aripiprazole.

• ■ The other ingredients are lactose monohydrate, maize starch, microcrystalline cellulose,

What Aripiprazole Sandoz tablets look like and contents of the pack'

Aripiprazole Sandoz 5 mg tablets

Aripiprazole Sandoz 5 mg tablets are blue coloured, mottled, round shaped tablets, with an approximate diameter of 6.0 mm, debossed with “SZ” on one side and “444” on the other side.

Aripiprazole Sandoz 10 mg tablets

Aripiprazole Sandoz 10 mg tablets are pink coloured, mottled, round shaped tablets, with an approximate diameter of 6.0 mm, debossed with “SZ” on one side and “446” on the other side.

Aripiprazole Sandoz 15 mg tablets

Aripiprazole Sandoz 15 mg tablets are yellow coloured, mottled, round shaped tablets, with an approximate diameter of 7.0 mm, debossed with “SZ” on one side and “447” on the other side.

Aripiprazole Sandoz 20 mg tablets

Aripiprazole Sandoz 20 mg tablets are white coloured, round shaped tablets, with an approximate diameter of 7.8 mm, debossed with “SZ” on one side and “448” on the other side.

Aripiprazole Sandoz 30 mg tablets

Aripiprazole Sandoz 30 mg tablets are pink coloured, mottled, round shaped tablets, with an approximate diameter of 9.0 mm, debossed with “SZ” on one side and “449” on the other side.

The 5 mg, 10 mg, 15 mg and 30 mg tablets are supplied in the following presentations: AluminiumAluminium blisters packed in cartons containing 10, 14, 16, 28, 30, 35, 56 or 70 tablets.

AluminiumAluminium unit dose blisters packed in cartons containing 14 × 1, 28 × 1, 49 × 1, 56 × 1 or 98 × 1 tablet.

HDPE bottle containing a silica gel desiccant and a polyester coil packed in cartons containing 100 tablets.

The 20 mg tablets are supplied in Aluminium//Alu­minium blisters packed in cartons containing 14, 28, 49, 56 or 98 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Sandoz GmbH

Biochemiestrasse 10 6250 Kundl

Austria

Manufacturer

Lek Pharmaceuticals d.d.

Verovskova 57 1526 Ljubljana Slovenia

S.C. Sandoz, S.R.L.

Str. Livezeni nr. 7A Târgu Mure§ 540472 Romania

Lek S.A.

ul. Domaniewska 50 C 02–672 Warszawa

Poland

For any information about this medicine, please Authorisation Holder:

België/Belgiqu­e/Belgien

Sandoz nv/sa

Medialaan 40

B-1800 Vilvoorde

Tél/Tel.: +32 2 722 97 97

Efc^rapufl

Regulatory Affairs Department Representative Office Sandoz d.d. 55 Nikola Vaptzarov blvd.

Building 4, floor 4 1407 Sofia, Bulgaria Ten.: + 359 2 970 47 47

Česká republika Sandoz s.r.o. Na Pankráci 1724/129 CZ-140 00 Praha 4 – Nusle

Magyarország Sandoz Hungária Kft. Tel.: +36 1 430 2890

Tel: +420 225 775 111

Danmark Sandoz A/S Edvard Thomsens Vej 14 DK-2300 K0benhavn S Danmark Tlf: + 45 6395 1000	Malta Medical Logistics Ltd. ADC Building, Triq L-Esportaturi Mriehel, BKR 3000 Malta Tel: +356 2277 8000
Deutschland Hexal AG Industriestrasse 25 D-83607 Holzkirchen Tel: +49 8024 908 0 E-mail:	Nederland Sandoz B.V. Veluwezoom 22 NL-1327 AH Almere Tel: +31 36 5241600
Eesti Sandoz d.d. Eesti filiaal Pärnu mnt105 EE-11312 Tallinn Tel.: +372 665 2400	Norge Sandoz A/S Edvard Thomsens Vej 14 DK-2300 K0benhavn S Danmark Tlf: + 45 6395 1000
EXXáSa Novartis (Hellas) S.A.C.I. E0viki] 05óg No 1 (12o km) MsTapóp^oon GR-144 51 A0qva. Tql: +30210 2811712	Österreich Sandoz GmbH Biochemiestr. 10 A-6250 Kundl Tel: +43 5338 2000
España Sandoz Farmacéutica, S.A. Centro empresarial Parque Norte Edificio Roble C/Serrano Galvache, N°56 28033 Madrid Spain	Polska Sandoz Polska Sp. z o.o. ul. Domaniewska 50C 02–672 Warszawa Tel.: + 48 22 209 70 00

Tel: +34 900 456 856

France Sandoz SAS 49 avenue Georges Pompidou F-92593 Levallois-Perret Cedex Tél: + 33 1 4964 4800	Portugal Sandoz Farmacéutica Lda. Avenida Professor Doutor Cavaco Silva, n° 10E Taguspark 2740–255 Porto Salvo Tel: +351 21 924 19 11
Hrvatska Sandoz d.o.o.	Romania S.C. Sandoz Pharma Services S.R.L.

Maksimirska 120 10000 Zagreb Tel: + 385 1 2353111 e-mail:	Calea Floreasca nr. 169A, Cladirea A, etaj 1, sector 1, Bucuresti
Ireland Rowex Ltd., Bantry, Co. Cork, Ireland.	Slovenija Lek farmacevtska družba d.d. Tel: +386 1 580 21 11

Tel: + 353 27 50077

e-mail:

Ísland Sandoz A/S Edvard Thomsens Vej 14 DK-2300 K0benhavn S Danmörk Tlf: + 45 6395 1000	Slovenská republika Sandoz d.d. organizačná zložka Žižkova 22B SK-811 02 Bratislava Tel: + 421 2 48 200 600
Italia Sandoz S.p.A Largo Umberto Boccioni 1 I – 21040 Origgio/VA Tel: + 39 02 96541	Suomi/Finland Sandoz A/S Edvard Thomsens Vej 14 DK-2300 Kööpenhamina S Tanska Tlf: + 45 6395 1000
Kvnpog Panayiotis Hadjigeorgiou 31 Yildiz Street, 3042 CY-000 00 Town: Limassol Tql: 00357 25372425	Sverige Sandoz A/S Edvard Thomsens Vej 14 DK-2300 Köpenhamn S Danmark Tlf: + 45 6395 1000
Latvija Sandoz d..d Pärstävnieciba Latvijä K.Valdemära iela 33–30 Riga, LV1010 Tel: + 371 67892006	United Kingdom Sandoz Limited Frimley Business Park Camberley, GU16 7SR, UK Tel: + 44 1276 698020

This leaflet was last revised in {MM/YYYY }.

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:

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