RISPERIDONE 1 mg /Ml Roztwór Doustny

Treść ulotki

1. RISPERIDONE SANDOZ GMBH 1 mg/ml oral solution
   1. What is Risperidone Sandoz GmbH and what it is used for
   2. What you need to know before you take Risperidone Sandoz GmbH
   3. How to take Risperidone Sandoz GmbH
   4. Possible side effects
   5. How to store Risperidone Sandoz GmbH
   6. Contents of the pack and other information

RISPERIDONE SANDOZ GMBH 1 mg/ml oral solution

Generic medicine

Read this leaflet carefully before you start taking this medicine as 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 Risperidone Sandoz GmbH is and what it is used for
• 2. What you need to know before you take Risperidone Sandoz GmbH
• 3. How to take Risperidone Sandoz GmbH
• 4. Possible side effects
• 5. How to store Risperidone Sandoz GmbH
• 6. Contents of the pack and other information

1. What is Risperidone Sandoz GmbH and what it is used for

Risperidone Sandoz GmbH contains the active ingredient risperidone. It belongs to a group of medicines
called “antipsychotics”.
Risperidone Sandoz GmbH is used for the treatment of:

• Schizophrenia, a condition in which you may see, hear or feel things that are not there, believe things that are not true or feel suspicious in an unusual way or confused
• Mania, a condition in which you may feel very excited, euphoric, agitated, elated or hyperactive. Mania occurs during an illness called “bipolar disorder”
• Short-term treatment (up to 6 weeks) of persistent aggression in people with Alzheimer's dementia, who harm themselves or others. Non-pharmacological alternatives must have been adopted before treatment
• Short-term treatment (up to 6 weeks) of persistent aggression in children with intellectual disabilities (aged 5 years and over) and adolescents with conduct disorder.

Risperidone Sandoz GmbH can help to relieve the symptoms of the illness and to stop them from returning.

2. What you need to know before you take Risperidone Sandoz GmbH

Do not take Risperidone Sandoz GmbH if:

• You are allergic to risperidone or to any of the other ingredients of this medicine (listed in section 6).

If you are not sure whether the conditions mentioned above apply to you, talk to your doctor or pharmacist before using Risperidone Sandoz GmbH.

Warnings and precautions
Talk to your doctor or pharmacist before taking Risperidone Sandoz GmbH if:

• You have a heart problem. Examples include an irregular heartbeat, or if you tend to have low blood pressure or if you are taking medicines for blood pressure. Risperidone Sandoz GmbH may cause a drop in blood pressure. Your dose may need to be adjusted.
• You are aware of any factors that could expose you to the risk of stroke, such as high blood pressure, cardiovascular disorders or circulatory disorders of the brain
• You have experienced involuntary movements of the tongue, mouth and face
• You have had a condition whose symptoms included fever, muscle stiffness, sweating or reduced level of consciousness (also known as Neuroleptic Malignant Syndrome)
• You suffer from Parkinson’s disease or dementia
• You are aware of having had low levels of white blood cells in your blood in the past (which may or may not have been caused by other medicines)
• You are diabetic
• You suffer from epilepsy
• You are a man and have experienced a prolonged or painful erection
• You have difficulty controlling your body temperature or excessive overheating
• You have kidney problems
• You have liver problems
• You have an abnormally high level of the hormone prolactin in your blood or have a tumor that may depend on prolactin
• You or someone in your family has a history of blood clot formation (thrombosis), as antipsychotic medicines like risperidone have been associated with blood clot formation

If you are not sure whether any of the conditions mentioned above apply to you, talk to your doctor or pharmacist before using Risperidone Sandoz GmbH.
Since a dangerously low number of a certain type of white blood cells needed to fight infections in the blood has been observed very rarely in patients who have taken risperidone, your doctor may check the count of white blood cells in your blood.
Risperidone can cause an increase in your weight. Significant weight gain can negatively affect your health. Your doctor should check your body weight regularly.
Since the onset or worsening of diabetes mellitus has been observed in patients taking risperidone, your doctor should check for high blood glucose levels. Blood glucose levels should be monitored regularly in patients with pre-existing diabetes mellitus.
Risperidone often increases the levels of a hormone called "prolactin". This can cause undesirable effects such as menstrual disorders and fertility problems in women, breast enlargement in men (see section “Possible side effects”). If you experience such side effects, it is recommended to assess the level of prolactin in your blood.
During an eye operation for cataracts (clouding of the lens), the pupil (the black circle in the center of your eye) may not increase in size as needed. In addition, the iris (the colored part of the eye) may become floppy during surgery and this may cause damage to the eye. If you are planning to have an eye operation, be sure to inform your ophthalmologist that you are taking this medicine.

Elderly patients with dementia
Elderly patients with dementia have an increased risk of stroke. If your dementia is caused by stroke, you should not take risperidone.
During treatment with risperidone you should see your doctor frequently.
If you or the person assisting you notice a sudden change in your mental state or sudden weakness or numbness of the face, arms or legs, especially on one side, or incomprehensible speech, even for a short period of time, you should seek immediate medical attention. These could be signs of a stroke.

Children and Adolescents
Before starting treatment for behavioral disorder, other causes for aggressive behavior must be ruled out.
Before starting treatment, your body weight, or that of your child, must be measured and monitored carefully during treatment.
If fatigue occurs during treatment with risperidone, changing the time of administration of the medicine may improve attention difficulties.
A small and not definitive study has recorded an increase in height in children who have taken risperidone, but it is not known whether this is an effect of the medicine or is due to some other reason.

Other medicines and Risperidone Sandoz GmbH
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

It is particularly important to inform your doctor or pharmacist if you are taking any of the following:

• Medicines that act on your brain, to help you calm down (benzodiazepines), or some medicines for pain (opioids), medicines for allergies (some antihistamines), as risperidone may increase the sedative effects of all these medicines.
• Medicines that could change the electrical activity of your heart, such as medicines for malaria, medicines for heart rhythm problems, for allergies (antihistamines), some antidepressants or other medicines for mental problems
• Medicines that cause a slowing of the heartbeat
• Medicines that cause a decrease in potassium in the blood (such as some diuretics)
• Medicines to treat high blood pressure. Risperidone Sandoz GmbH can cause a drop in blood pressure
• Medicines for Parkinson’s disease (such as levodopa)
• Medicines to make you urinate (diuretics), used for heart problems or for swelling of parts of the body, due to fluid buildup (such as furosemide or chlorothiazide). Risperidone Sandoz GmbH taken alone or with furosemide, may increase the risk of stroke or death in elderly patients with dementia.
• Medicines that increase the activity of the central nervous system (stimulants, such as methylphenidate).

The following medicines may reduce the effect of risperidone

• Rifampicin (a medicine to treat some infections)
• Carbamazepine, phenytoin (medicines for epilepsy)
• Phenobarbital If you start or stop taking these medicines, you may need a different dose of risperidone

The following medicines may increase the effect of risperidone

• Quinidine (used for some heart conditions)
• Antidepressants such as paroxetine, fluoxetine, tricyclic antidepressants
• Medicines known as beta-blockers (used to treat high blood pressure)
• Phenothiazines (used to treat psychosis or as sedatives)
• Cimetidine, ranitidine (stomach acid blockers)
• Itraconazole and ketoconazole (medicines for the treatment of fungal infections)
• Some medicines used to treat HIV/AIDS, such as ritonavir
• Verapamil, a medicine used to treat high blood pressure and/or abnormal heart rhythm.
• Sertraline and fluvoxamine, medicines used to treat depression and other psychiatric disorders.

If you start or stop taking these medicines, you may need a different dose of risperidone
If you are not sure whether any of the conditions mentioned above apply to you, talk to your doctor or pharmacist before using Risperidone Sandoz GmbH.

Risperidone Sandoz GmbH with food, drinks and alcohol
During treatment with Risperidone Sandoz GmbH you should avoid drinking alcohol. Risperidone Sandoz GmbH oral solution should not be mixed with tea.

Pregnancy, breastfeeding and fertility

• If you are pregnant, suspect you are pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before using this medicine. Your doctor will decide whether you can use it.
• The following symptoms may occur in newborns of mothers who have used risperidone in the last trimester (last three months of pregnancy): tremor, muscle stiffness and/or weakness, drowsiness, agitation, difficulty breathing, feeding disorder (difficulty taking food). If your baby experiences any of these symptoms, you should contact your doctor/pediatrician immediately.
• Risperidone Sandoz GmbH may increase the levels of a hormone called "prolactin" which can affect fertility (see section 4 “Possible side effects”).

Driving and operating machinery
During treatment with Risperidone Sandoz GmbH, dizziness, fatigue and vision problems may occur. Do not drive, or use tools or machinery, until you have spoken to your doctor.

Risperidone Sandoz GmbH contains benzoic acid
This medicine contains 2.0 mg of benzoic acid in each ml of solution. Benzoic acid can increase jaundice (yellowing of the skin and eyes) in newborns (up to 4 weeks).

3. How to take Risperidone Sandoz GmbH

Take this medicine exactly as your doctor has told you. If you have any doubts, ask your doctor or pharmacist.

The recommended dose is as follows:
For the treatment of schizophrenia
Adults

• The initial dose is generally 2 ml of oral solution (2 mg of risperidone) per day, which may be increased to 4 ml of oral solution (4 mg of risperidone) daily from the second day
• The dose may then be increased by your doctor depending on how you respond to treatment
• Most people feel better with daily doses between 4 and 6 ml of oral solution (4 to 6 mg of risperidone)
• The total daily dose can be divided into one or two administrations. Your doctor will tell you what is best for you

Elderly people

• The initial dose will generally be 0.5 ml of oral solution (0.5 mg of risperidone) twice a day
• The dose may then be gradually increased by your doctor to 1-2 ml of oral solution (1-2 mg of risperidone) twice a day
• Your doctor will tell you what is best for you.

For the treatment of mania
Adults

• The initial dose will generally be 2 ml of oral solution (2 mg of risperidone) once a day
• The dose may then be gradually adjusted by your doctor, depending on your response to treatment
• Most people will feel better with doses between 1 and 6 ml of oral solution (1-6 mg of risperidone) once a day
• Elderly peopleThe initial dose will generally be 0.5 ml of oral solution (0.5 mg of risperidone) twice a day
• The dose may then be gradually adjusted by your doctor to 1 - 2 ml of oral solution (1 - 2 mg of risperidone) twice a day, depending on your response to treatment

For the treatment of persistent aggression in people with Alzheimer's dementia
Adults (including elderly patients)

• The initial dose will generally be 0.25 ml of oral solution (0.25 mg of risperidone) twice a day
• The dose may then be gradually adjusted by your doctor, depending on your response to treatment
• Most people will feel better with 0.5 ml of oral solution (0.5 mg of risperidone) twice a day. Some patients may need 1 ml of oral solution (1 mg of risperidone) twice a day
• The duration of treatment in patients with Alzheimer's dementia should not exceed 6 weeks

Patients with kidney or liver problems
Regardless of the condition being treated, all initial doses and subsequent doses of risperidone
must be halved. Dose increases should occur more slowly in these patients.
Risperidone must be used with caution in this group of patients.

Children and adolescents
Children and adolescents under 18 years of age should not be treated with Risperidone Sandoz
GmbH for schizophrenia or mania.
For the treatment of conduct disorderthe dose will depend on your child's weight:
For children weighing less than 50 kg:

• The initial dose will generally be 0.25 ml of oral solution (0.25 mg of risperidone) once a day
• The dose may be increased on alternate days with increments of 0.25 ml of oral solution (0.25 mg of risperidone) per day
• The maintenance dose is generally between 0.25 ml and 0.75 ml of oral solution (between 0.25 and 0.75 mg of risperidone) once a day

For children weighing 50 kg or more:

• The initial dose will generally be 0.5 ml of oral solution (0.5 mg of risperidone) once a day
• The dose may be increased on alternate days with increments of 0.5 ml of oral solution (0.5 mg of risperidone) per day
• The maintenance dose is generally between 0.5 ml and 1.5 ml (between 0.5 mg and 1.5 mg of risperidone) once a day. The duration of treatment in patients with conduct disorder should not exceed 6 weeks.

Children under 5 years of age should not be treated with Risperidone Sandoz GmbH for conduct disorder.

How to administer
Risperidone Sandoz GmbH is for oral use.
Take the medicine with a glass of water.
Risperidone Sandoz GmbH can be taken with or without food
Opening the bottle and handling the dropper
Each bottle is equipped with a dropper. The bottle is equipped with a child-resistant cap.

• 1. Open the cap by pressing it firmly downwards and turning it counterclockwise.
• 2. Insert the dropper into the bottle. In order to measure the dose, hold the dropper firmly by the lower ring with one hand and with the other hand pull up the upper ring of the dropper until the exact amount of medicine to be taken is visible from the dropper (e.g. ml or mg)
• 3. Holding the lower ring firmly, carefully remove the entire dropper from the bottle. Empty the contents of the dropper into a glass containing a drink (neither alcoholic nor black/green tea), sliding the upper ring downwards. Drink immediately until the glass is empty.
• 4. Close the bottle and rinse the empty dropper with water.

If you use more Risperidone Sandoz GmbH than you should

• Consult your doctor immediately. Bring the medicine packaging with you
• In case of overdose you may feel sleepy or tired or have strange movements of your body, difficulty standing and walking, dizziness caused by low blood pressure, or irregular heartbeat or seizures

If you forget to take Risperidone Sandoz GmbH

• If you forget to take a dose, take it as soon as you remember. However, if it is almost time for the next dose, skip the forgotten dose and continue as usual. If you forget two or more doses, contact your doctor.
• Do not take a double dose (two doses at the same time) to make up for a forgotten dose.

If you stop taking Risperidone Sandoz GmbH
Do not stop taking this medicine unless your doctor tells you to do so. Your symptoms
may return. If your doctor decides to stop this medicine, your dose may
be gradually reduced over a few days.
If you have any further questions about 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 everyone will experience them.

Immediately inform your doctor if you experience any of the following serious side effects:
Uncommon: may affect up to 1 in 100 people

• Tardive dyskinesia (spasms or jerking movements that you cannot control in the face, tongue or other parts of the body). Contact your doctor immediately if you experience involuntary rhythmic movements of the tongue, mouth and face. It may be necessary to discontinue risperidone.
• A sudden change in your mental state or sudden weakness or numbness of the face, arms or legs, especially on one side, or slurred speech, even for a short period of time. These may be signs of a stroke or "mini" stroke caused by a sudden loss of blood to the brain. If you are at special risk, if you have dementia. Rare: may affect up to 1 in 1,000
• Neuroleptic malignant syndrome (confusion, decreased or loss of consciousness, high fever and severe muscle rigidity). Immediate medical treatment may be necessary.
• Priapism (a prolonged and painful erection that may require surgical treatment) Very rare: may affect up to 1 in 10,000
• Life-threatening complications of uncontrolled diabetes
• Severe allergic reaction with swelling that can involve the throat and lead to difficulty breathing Not known: the frequency cannot be estimated based on available data
• Blood clots in the veins, particularly in the legs (symptoms include swelling, pain and redness of the legs), which can move along the blood vessels to the lungs, causing chest pain and difficulty breathing. If you notice any of these symptoms, consult your doctor immediately.

The following side effects may occur
Very common may affect more than 1 in 10 people

• Difficulty falling asleep or staying asleep.
• Parkinsonism: this condition may include: slow or impaired body movements, a feeling of stiffness or tension in the muscles (making movements jerky) and sometimes also a feeling of movement that stops and then restarts. Other signs of parkinsonism include a slow walk dragging the feet, a tremor at rest, increased saliva and/or loss of saliva and a loss of facial expression.
• Feeling sleepy or reduced alertness.
• Headache.

Common may affect up to 1 in 10 people

• Pneumonia, chest infection (bronchitis), cold symptoms, sinusitis.
• Urinary tract infection.
• Ear infection, feeling like you have the flu.
• Increased levels of a hormone called “prolactin” found in a blood test (which may or may not cause symptoms). Symptoms due to a high level of prolactin do not commonly occur and may include: (in men) breast enlargement, difficulty having or maintaining erections, decreased sexual desire or other sexual dysfunction; (in women) breast discomfort, milk leakage from the breasts, missed periods or other problems with the cycle or fertility problems.
• Weight gain, increased appetite, decreased appetite.
• Sleep disorders, irritability, depression, anxiety, agitation.
• Dystonia: this is a condition involving a slow or prolonged involuntary muscle contraction. While it can involve any part of the body (resulting in an abnormal posture), dystonia often involves the muscles of the face, including abnormal movements of the eyes, mouth, tongue or jaw.
• Dizziness.
• Dyskinesia: this is a condition involving involuntary muscle movements and may include repetitive, jerky or contorted movements or spasms.
• Tremor (shaking).
• Blurred vision, eye infection or conjunctivitis.
• Rapid heart rate, high blood pressure, shortness of breath.
• Sore throat, cough, nosebleed, stuffy nose.
• Abdominal pain, abdominal discomfort, vomiting, nausea, constipation, diarrhea, indigestion, dry mouth, toothache.
• Skin rash, skin redness.
• Muscle spasms, bone or muscle pain, back pain, joint pain.
• Urinary incontinence (loss of control).
• Swelling of the body, arms or legs, fever, chest pain, weakness, fatigue (tiredness), pain.
• Falls.

Uncommon may affect up to 1 in 100 people

• Respiratory tract infection, bladder infection, eye infection, tonsillitis, fungal nail infection, skin infection, infection of a single area of skin or part of the body, viral infection, skin inflammation caused by mites.
• Decreased in the blood of a type of white blood cell that helps protect the body from infections.
• Reduced number of white blood cells, reduced platelets (blood cells that help stop bleeding), anemia, reduced number of red blood cells, increased eosinophils (particular white blood cells) in the blood.
• Allergic reaction.
• Diabetes or worsening of diabetes, high blood sugar, excessive water intake, weight loss, loss of appetite resulting in malnutrition and low body weight.
• Increased cholesterol in the blood.
• Euphoria (mania), confusion, decreased sexual drive, nervousness, nightmares.
• Tardive dyskinesia (spasms or jerking movements that you cannot control in the face, tongue or other parts of the body). Contact your doctor immediately if you experience involuntary rhythmic movements of the tongue, mouth and face. It may be necessary to discontinue Risperidone Sandoz GmbH.
• Sudden loss of blood flow to the brain (stroke or “mini” stroke).
• Unresponsiveness, loss of consciousness, reduced level of consciousness.
• Convulsions (seizures), fainting.
• An urgent need to move a part of the body, balance disorders, abnormal coordination, dizziness when getting up, attention problems, speech problems, loss or abnormal sense of taste, reduced skin sensitivity to pain and touch, a sensation of tingling, prickling or numbness of the skin.
• Hypersensitivity of the eyes to light, dry eyes, increased tearing, redness of the eyes.
• Feeling of spinning (vertigo), ringing in the ears, ear pain.
• Atrial fibrillation (an abnormal heart rhythm), a disruption of the conduction of the heart between the upper and lower parts of the heart, abnormal electrical conduction of the heart, prolongation of the QT interval of the heart, slow heart rate, abnormal heart tracing (electrocardiogram or ECG), a feeling of a racing heart or palpitations in the chest.
• Low blood pressure, low blood pressure when getting up (consequently, some patients taking risperidone may feel faint, dizzy or may faint when getting up or sitting down suddenly), hot flashes.
• Pneumonia caused by inhalation of food, congestion of the lungs, congestion of the airways, crackling sounds in the lungs, wheezing, voice disorder, airway disorder.
• Stomach or intestinal infection, fecal incontinence, very hard stools, difficulty swallowing, excessive passing of gas or air.
• Hives, itching, hair loss, thickening of the skin, eczema, dry skin, discoloration of the skin, acne, scaling and itching of the scalp or skin, skin disorder, skin injury.
• An increase in the levels of CPK (creatine phosphokinase) in the blood, an enzyme that is sometimes released when there is muscle damage.
• Abnormal posture, stiff joints, swollen joints, muscle weakness, neck pain.
• Frequent urination, inability to urinate, pain during urination.
• Erectile dysfunction, ejaculation disorders.
• Loss of menstrual cycle, missed menstrual period or problems with the cycle (females).
• Development of breast in men, milk leakage from the breasts, sexual dysfunction, breast pain, breast discomfort, vaginal discharge.
• Swelling of the face, mouth, eyes or lips.
• Chills, increased body temperature.
• Change in the way you walk.
• Feeling thirsty, feeling unwell, chest pain, feeling down, discomfort.
• Increased liver transaminases in the blood, increased GGT in the blood (a liver enzyme called gamma-glutamyl transferase), increased liver enzymes in the blood.
• Procedural pain.

Rare may affect up to 1 in 1,000

• Infection.
• Inappropriate secretion of the hormone that controls urine volume.
• Sleepwalking
• Sleep-related eating disorder
• Sugar in the urine.
• Low blood sugar, high levels of triglycerides (a fat).
• Inability to move or react when awake (catatonia)
• Lack of emotion, inability to reach orgasm.
• Problems with blood vessels in the brain.
• Coma due to diabetes not kept under control.
• Head shaking.
• Glaucoma (increased pressure inside the eyeball), eye movement problems, eye rotation, crusts on the eyelid margin.
• Problems with the eyes during cataract surgery. During cataract surgery, a condition called iris flag syndrome (IFIS) may occur if you take or have taken risperidone. If you are to undergo cataract surgery, be sure to inform your doctor if you take or have taken this medicine.
• Dangerously low number of a certain type of white blood cells in the blood needed to fight infections.
• Severe allergic reaction characterized by fever, swelling of the mouth, face, lips or tongue, shortness of breath, itching, rash and sometimes low blood pressure.
• Dangerously excessive intake of water.
• Irregular heartbeat.
• Blood clots in the legs, blood clots in the lungs.
• Breathing problems during sleep (sleep apnea), fast and shallow breathing.
• Inflammation of the pancreas.
• Blockage of the colon.
• Swelling of the tongue, chapped lips, drug rash.
• Dandruff.
• Rupture of muscle fibers and muscle pain (rhabdomyolysis).
• A delay in the menstrual cycle, enlargement of the mammary glands, breast enlargement, discharge from the breasts.
• Increased levels of insulin (a hormone that controls blood sugar levels).
• Hardening of the skin.
• Very low body temperature, cold arms and legs.
• Drug withdrawal syndrome.
• Yellowing of skin and eyes (jaundice).

Very rare may affect up to 1 in 10,000

• Lack of intestinal muscle movement causing blockage.

The following side effects have been observed with the use of another medicine called paliperidone
which is very similar to risperidone, so these effects can also be expected with Risperidone Sandoz
GmbH: fast heartbeat when getting up.

Additional side effects in children and adolescents
In general, the type of side effects in children is expected to be similar to that observed in
adults.
The following side effects have been reported more frequently in children and adolescents (from
5 to 17 years) compared to adults: feeling sleepy or less alert, fatigue, headache, increased
appetite, vomiting, common cold symptoms, nasal congestion, abdominal pain, dizziness,
cough, fever, tremor (shaking), diarrhea and urinary incontinence (loss of control).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the
national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-
avverse
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Risperidone Sandoz GmbH

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the package and on the label of the bottle
after “Exp.”. The expiry date refers to the last day of the month.
Do not freeze.
Do not use Risperidone Sandoz GmbH after 6 months from the first opening of the bottle.
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. Contents of the pack and other information

What Risperidone Sandoz GmbH contains
The active ingredient is risperidone
Each ml of oral solution contains 1 mg of risperidone.
The other ingredients are benzoic acid (E 210), purified water

Description of the appearance of Risperidone Sandoz GmbH and contents of the pack
Risperidone Sandoz GmbH 1 mg/ml oral solution is a clear, colorless solution.
It is available in brown glass bottles with white child-resistant plastic closures,
containing 30 ml, 60 ml, 100 ml or 120 ml of oral solution. A dropper
with a pipette holder is attached to the bottle.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:
SANDOZ GMBH – Biochemiestrasse 10 – 6250 Kundl (Austria)
Representative for Italy: Sandoz Spa – Largo U. Boccioni, 1 – 21040 Origgio (VA)

Manufacturer responsible for batch release:

• Salutas Pharma GmbH - Otto von Guericke Allee 1 - 39179 Barleben - Germany
• LEK Pharmaceuticals d.d. - Veroskova 57 - 1526 Ljubljana - Slovenia

This leaflet was last revised in