Paliperidone Viatris Pharma

Package leaflet: Information for the user

Paliperidone Viatris Pharma 25 mg prolonged-release injectable suspension in pre-filled syringe

Paliperidone Viatris Pharma 50 mg prolonged-release injectable suspension in pre-filled syringe
Paliperidone Viatris Pharma 75 mg prolonged-release injectable suspension in pre-filled syringe
Paliperidone Viatris Pharma 100 mg prolonged-release injectable suspension in pre-filled syringe
Paliperidone Viatris Pharma 150 mg prolonged-release injectable suspension in pre-filled syringe
Paliperidone Viatris Pharma 100 mg + 150 mg prolonged-release injectable suspension in
pre-filled syringe
paliperidone
Generic medicine

Read this entire leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

1. What Paliperidone Viatris Pharma is and what it is used for
2. What you need to know before using Paliperidone Viatris Pharma
3. How to use Paliperidone Viatris Pharma
4. Possible side effects
5. How to store Paliperidone Viatris Pharma
6. Contents of the pack and other information

1. What Paliperidone Viatris Pharma is and what it is used for

Paliperidone Viatris Pharma contains the active substance paliperidone, which belongs to the class of antipsychotic medicines and is used as maintenance treatment for the symptoms of schizophrenia in adult patients stabilized on paliperidone or risperidone.
If you have previously shown a response to paliperidone or risperidone and have mild to moderate symptoms, your doctor may start treatment with Paliperidone Viatris Pharma without prior stabilization with paliperidone or risperidone.
Schizophrenia is a disorder characterized by “positive” and “negative” symptoms. Positive symptoms refer to an excess of symptoms that are normally not present. For example, a person with schizophrenia may hear voices or see things that do not actually exist (called hallucinations), believe things that are not true (called delusions), or be unusually suspicious of others. Negative symptoms refer to a lack of behaviours or feelings that are normally present. For example, a person with schizophrenia may tend to isolate themselves and may not respond emotionally, or may have difficulty speaking clearly and logically. People with this disorder may also feel depressed, anxious, guilty, or tense.
Paliperidone Viatris Pharma can help relieve the symptoms of your illness and help prevent them from returning.

2. What you need to know before using Paliperidone Viatris Pharma

Do not use Paliperidone Viatris Pharma

• if you are allergic to paliperidone or to any of the other excipients of this medicine (listed in section 6).
• if you are allergic to another antipsychotic medicine, including risperidone.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Paliperidone Viatris Pharma.
This medicine has not been studied in elderly patients with dementia. However, elderly patients with dementia treated with similar medicines may have an increased risk of stroke or death (see section 4, possible side effects).
All medicines have side effects, and some of the side effects of this medicine may worsen symptoms of other medical conditions. For this reason, it is important that you discuss with your doctor if you have any of the following conditions, which could potentially worsen during treatment with this medicine:

• if you have Parkinson’s disease
• if you have ever been diagnosed with a condition whose symptoms include high body temperature and muscle stiffness (also known as Neuroleptic Malignant Syndrome)
• if you have ever experienced abnormal movements of the tongue or face (Tardive Dyskinesia)
• if you know you have previously had low levels of white blood cells in your blood (whether or not caused by other medicines)
• if you have diabetes or are predisposed to diabetes
• if you have been diagnosed with breast cancer or a tumour of the pituitary gland in the brain
• if you have heart disease or are being treated for heart disease with medicines that tend to lower your blood pressure
• if you have low blood pressure when standing up or changing suddenly from lying down to sitting
• if you have epilepsy
• if you have kidney problems
• if you have liver problems
• if you have a prolonged and/or painful erection
• if you have difficulty regulating your internal body temperature or are exposed to excessive heat
• if you have abnormally high levels of the hormone prolactin in your blood or if you may have a prolactin-dependent tumour
• if you or someone in your family has a history of blood clots (thrombi), as antipsychotics have been associated with blood clot formation.

If you have any of these conditions, speak to your doctor so they can assess whether you need a dose adjustment or closer monitoring for a certain period.
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 taking this medicine, your doctor may monitor your white blood cell count.
Even if you previously tolerated oral paliperidone or oral risperidone, allergic reactions may rarely occur after receiving injections of Paliperidone Viatris Pharma. Seek immediate medical attention if you develop rash, throat swelling, itching, or breathing difficulties, as these may be signs of a serious allergic reaction.
This medicine may cause weight gain. Significant weight gain may negatively affect your health. Your doctor should weigh you regularly.
Since diabetes mellitus has been observed or worsening of pre-existing diabetes mellitus has occurred in patients taking this medicine, your doctor should check for high blood sugar levels. In patients with pre-existing diabetes mellitus, blood glucose levels should be monitored regularly.
Because this medicine may reduce the vomiting reflex, it may mask the body’s normal response to ingesting toxic substances or other medical conditions.
During cataract surgery (eye surgery to remove clouding of the lens), the pupil (the black circle in the center of your eye) may not dilate as required. In addition, the iris (the coloured part of the eye) may become floppy during surgery, which could lead to eye damage. If you are planning eye surgery, make sure to inform your ophthalmologist that you are taking this medicine.

Children and adolescents
This medicine must not be used in children and adolescents under 18 years of age.

Other medicines and Paliperidone Viatris Pharma
Tell your doctor if you are taking, have recently taken, or might take any other medicines.
Taking this medicine with carbamazepine (an antiepileptic and mood stabilizer) may require a dose adjustment of this medicine.
Since this medicine acts mainly on the brain, interactions with other medicines acting on the brain—such as other psychiatric medicines, opioids, antihistamines, and sleep medications—may lead to an increased risk of side effects such as drowsiness or other brain-related effects.
Because this medicine may lower blood pressure, caution is advised when used together with other medicines that lower blood pressure.
This medicine may reduce the effectiveness of medicines used to treat Parkinson’s disease and restless legs syndrome (e.g., levodopa).
This medicine may cause an abnormality in the electrocardiogram (ECG), characterized by a longer time for an electrical impulse to travel through a specific part of the heart (known as “QT interval prolongation”). Other medicines that have this effect include certain medicines used to treat heart rhythm disorders or infections, and other antipsychotics.
If you are predisposed to seizures, this medicine may increase the likelihood of experiencing them. Other medicines with this effect include certain antidepressants, antibiotics, and other antipsychotics.
Paliperidone Viatris Pharma should be used with caution together with medicines that increase central nervous system activity (psychostimulants such as methylphenidate).

Paliperidone Viatris Pharma and alcohol
Alcohol should be avoided.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine. You must not use this medicine during pregnancy unless you have discussed it with your doctor. The following symptoms may occur in newborns of mothers who used paliperidone during the third trimester (last three months of pregnancy): tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If your baby shows any of these symptoms, you may need to contact your doctor.
This medicine may pass from mother to child through breast milk and may harm the baby. Therefore, do not breastfeed while using this medicine.

Driving and using machines
While being treated with this medicine, dizziness, extreme tiredness, and vision problems may occur (see section 4). This should be taken into account in situations requiring full alertness, such as driving a car or operating machinery.

Paliperidone Viatris Pharma contains sodium and polysorbate
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., essentially ‘sodium-free’.
This medicine contains 12 mg of polysorbate per mL, equivalent to 12 mg/mL. Polysorbates may cause allergic reactions. Inform your doctor if you have known allergies.

3. How to use Paliperidone Viatris Pharma

This medicine will be administered by a doctor or another healthcare professional. It will be injected into the muscle. Your doctor will determine when you will need your next injection. It is important not to miss your scheduled dose. If you think you will be unable to attend your appointment, contact your doctor immediately to arrange a new appointment as soon as possible.

You will receive a first injection (150 mg) and a second injection (100 mg) of this medicine in the upper arm, approximately one week apart. Afterwards, you will receive an injection (ranging from 25 mg to 150 mg) either in the upper arm or in the buttock once a month.

If your doctor is switching you from long-acting injectable risperidone to this medicine, you will receive your first injection of this medicine (ranging from 25 mg to 150 mg) in the upper arm or in the buttock on the date already scheduled for your next injection. Afterwards, you will receive an injection (ranging from 25 mg to 150 mg) in the upper arm or in the buttock once a month.

Depending on your symptoms, your doctor may increase or decrease by one dose level the amount of medicine you receive at your scheduled monthly injection.

Patients with kidney problems
Your doctor may adjust the dose of this medicine based on your kidney function. If you have mild kidney problems, your doctor may prescribe a lower dose. If you have moderate to severe kidney problems, this medicine must not be used.

Elderly patients
Your doctor may reduce the dose of this medicine if kidney function is reduced.

If you take more Paliperidone Viatris Pharma than you should
This medicine will be administered under medical supervision; therefore, it is unlikely that you will receive an overdose.

In patients who have received an excessive dose of paliperidone, the following symptoms may occur: drowsiness or sedation, increased heart rate, low blood pressure, abnormal electrocardiogram (recording of the heart's electrical activity), or slow or abnormal movements of the face, body, arms, or legs.

If you stop treatment with Paliperidone Viatris Pharma
If you stop receiving your injections, you will lose the medicine's effects. You must not stop using this medicine unless instructed by your doctor, as your symptoms may return.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact your doctor immediately if:

• you suspect you have blood clots in the veins, particularly in the legs (symptoms include swelling, pain and redness in the legs), which may travel through the blood vessels to the lungs, causing chest pain and breathing difficulties. If you notice any of these symptoms, consult your doctor immediately.
• you have dementia and notice a sudden change in your mental state, sudden weakness or numbness of the face, arms or legs, especially on one side, or if your speech becomes slurred, even briefly. These may be signs of a stroke.
• you develop fever, muscle stiffness, sweating or reduced level of consciousness (a condition called "Neuroleptic Malignant Syndrome"). Immediate medical treatment may be required.
• you are male and experience a prolonged or painful erection. This condition is called priapism. Immediate medical treatment may be necessary.
• you experience involuntary rhythmic movements of the tongue, mouth or face. Paliperidone may need to be discontinued.
• you develop a severe allergic reaction with fever, swelling of the mouth, face, lips or tongue, shortness of breath, itching, skin rash and sometimes a drop in blood pressure (consistent with an 'anaphylactic reaction'). Although you may have previously tolerated oral risperidone or oral paliperidone, allergic reactions may rarely occur after receiving paliperidone injections.
• you are planning to undergo eye surgery, make sure to inform your ophthalmologist that you are taking this medicine. During cataract surgery (removal of clouded lens), the iris (the colored part of the eye) may become floppy during the procedure (known as "intraoperative floppy iris syndrome"), which may lead to eye damage.
• you know you have a dangerously low count of a certain type of white blood cells in your blood needed to fight infections.

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

• difficulty falling asleep or staying asleep.

Common: may affect up to 1 in 10 people

• symptoms of common cold, urinary tract infection, feeling as if you have the flu
• Paliperidone Viatris Pharma may increase levels of a hormone called "prolactin" detected in blood tests (which may or may not cause symptoms). When symptoms due to high prolactin levels occur, they may include (in men) breast enlargement, difficulty achieving or maintaining erections or other sexual dysfunction; (in women) breast tenderness, milk discharge from the breasts, loss of menstrual periods or other menstrual problems
• high blood sugar levels, weight gain, weight loss, decreased appetite
• agitation, depression, anxiety
• parkinsonism: this condition may include slow or abnormal movements, a feeling of stiffness or muscle tension (making movements jerky), and sometimes a sensation of movement starting and stopping. Other signs of parkinsonism include slow shuffling gait, resting tremor, increased saliva and/or drooling, and loss of facial expression
• restlessness, drowsiness or reduced alertness
• dystonia: this is a condition involving slow or prolonged involuntary muscle contractions. While it may affect any part of the body (resulting in abnormal posture), dystonia often involves facial muscles, including abnormal eye, mouth, tongue or jaw movements.
• dizziness
• dyskinesia: this is a condition involving involuntary muscle movements and may include repetitive, jerky or twisting movements, or spasms.
• tremor
• headache
• rapid heart rate
• high blood pressure
• cough, nasal congestion
• abdominal pain, vomiting, nausea, constipation, diarrhea, indigestion, toothache
• increased liver transaminases in blood
• bone or muscle pain, back pain, joint pain
• loss of menstrual periods
• fever, weakness, fatigue (tiredness)
• injection site reaction, including itching, pain or swelling.

Uncommon: may affect up to 1 in 100 people

• lung infection, chest infection (bronchitis), respiratory tract infection, sinusitis, bladder infection, ear infection, fungal nail infection, tonsillitis, skin infection
• decreased white blood cell count, decreased count of a certain type of white blood cells that protect the body from infections, anaemia
• allergic reaction
• diabetes or worsening of diabetes, increased insulin in blood (a hormone that controls blood sugar levels)
• increased appetite
• loss of appetite leading to malnutrition and low body weight
• increased triglycerides (a fat) in blood, increased cholesterol in blood
• sleep disorders, elevated mood (mania), reduced sexual drive, nervousness, nightmares
• tardive dyskinesia (spasms or jerky movements that cannot be controlled affecting the face, tongue or other body parts). Contact your doctor immediately if you experience involuntary rhythmic movements of the tongue, mouth or face. Discontinuation of this medicine may be necessary.
• fainting, urgent need to move a body part, dizziness upon standing, attention disturbances, speech problems, loss or altered sense of taste, reduced skin sensitivity to pain and touch, a sensation of tingling, prickling or numbness of the skin
• blurred vision, eye infection or "conjunctivitis", dry eyes
• sensation of spinning (vertigo), ringing in the ears, ear pain
• interruption of conduction between upper and lower parts of the heart, abnormal electrical conduction of the heart, QT interval prolongation, rapid heartbeat upon standing, slow heartbeat, abnormal heart electrical tracing (electrocardiogram or ECG), sensation of rapid heartbeat or pounding in the chest (palpitations)
• low blood pressure, drop in blood pressure upon standing (as a result, some people taking this medicine may feel faint, lightheaded or may faint when standing up or sitting down suddenly)
• shortness of breath, sore throat, nosebleed
• abdominal discomfort, stomach or intestinal infection, difficulty swallowing, dry mouth
• excessive passing of gas or air
• increased GGT in blood (a liver enzyme called gamma-glutamyltransferase), increased liver enzymes in blood
• skin rash (or hives), itching, rash, hair loss, eczema, dry skin, red skin, acne, subcutaneous abscess
• increased CPK (creatine phosphokinase) in blood, an enzyme sometimes released in case of muscle damage, muscle spasms, joint stiffness, muscle weakness
• urinary incontinence (lack of control), frequent urination, painful urination
• erectile dysfunction, ejaculation disorders, absence of menstruation or other menstrual problems (females), breast development in males, sexual dysfunction, breast pain, milk discharge from the breasts
• swelling of the face, mouth, eyes or lips, body swelling, swelling of arms or legs
• increased body temperature
• change in walking pattern
• chest pain, chest discomfort, feeling of uneasiness
• skin hardening
• fall.

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

• eye infection
• skin inflammation caused by mites, scalp or skin flaking and itching
• increased eosinophils (a type of white blood cells) in blood
• decreased platelets (blood cells that help stop bleeding)
• head tremor
• inappropriate secretion of a hormone controlling urine volume
• sugar in urine
• complications leading to life-threatening uncontrolled diabetes
• low blood sugar
• excessive water intake
• absence of movement or response while awake (catatonia)
• confusion
• sleepwalking
• lack of emotion
• inability to achieve orgasm
• neuroleptic malignant syndrome (confusion, reduced or lost consciousness, high fever and severe muscle rigidity), vascular problems in the brain including sudden loss of blood supply to the brain (stroke or "mini" stroke), unresponsiveness to stimuli, loss of consciousness, reduced level of consciousness, seizures (fits), balance disturbances
• abnormal coordination
• glaucoma (increased pressure within the eyeball)
• eye movement problems, eye rolling, light sensitivity of the eyes, increased tearing, eye redness
• atrial fibrillation (abnormal heart rhythm), irregular heartbeat
• blood clots in the lungs which may cause chest pain and breathing difficulties. If you notice any of these symptoms, contact your doctor immediately
• blood clots in the veins, particularly in the legs (symptoms include swelling, pain and redness in the legs). If you notice any of these symptoms, consult your doctor immediately.
• hot flushes
• breathing problems during sleep (sleep apnoea), lung congestion, respiratory congestion
• lung crackles, wheezing
• pancreatitis (inflammation of the pancreas), tongue swelling, faecal incontinence, very hard stools
• intestinal blockage
• chapped lips
• drug-related skin rash, skin thickening, dandruff
• muscle fibre breakdown and muscle pain (rhabdomyolysis)
• joint swelling
• inability to urinate
• breast discomfort, enlargement of mammary glands, breast enlargement
• vaginal discharge
• priapism (a prolonged penile erection that may require surgical treatment)
• very low body temperature, chills, feeling of thirst
• drug withdrawal symptoms
• pus accumulation due to infection at injection site, deep skin infection, cyst at injection site, bruising at injection site.

Not known: cannot be estimated from available data

• dangerous decrease in a certain type of white blood cells in the blood that helps protect the body from infections
• severe allergic reaction characterized by fever, swelling of the mouth, face, lips or tongue, shortness of breath, itching, skin rash and sometimes drop in blood pressure
• dangerous and excessive water intake
• sleep-related eating disorder
• coma due to uncontrolled diabetes
• reduced oxygen supply to parts of the body (due to reduced blood flow)
• rapid and shallow breathing, pneumonia caused by aspiration of food, voice disturbance
• lack of intestinal muscle movement causing blockage
• yellowing of the skin and eyes (jaundice)
• severe or life-threatening skin rash with blisters and skin peeling that may start inside and around the mouth, nose, eyes and genitals and spread to other body areas (Stevens-Johnson syndrome or toxic epidermal necrolysis)
• severe allergic reaction with swelling that may affect the throat causing breathing difficulties
• skin discoloration
• abnormal posture
• babies born to mothers who took Paliperidone Viatris Pharma during pregnancy may have experienced adverse drug reactions and/or withdrawal symptoms such as irritability, slow or prolonged muscle contractions, tremor, drowsiness, breathing or feeding difficulties
• reduced body temperature
• death of skin cells at injection site and ulceration at injection site.

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

5. How to store Paliperidone Viatris Pharma

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pre-filled syringe and
on the outer carton. The expiry date refers to the last day of that month.
Do not freeze.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Paliperidone Viatris Pharma contains
The active substance is paliperidone.
Each 25 mg pre-filled syringe contains paliperidone palmitate equivalent to 25 mg of
paliperidone.
Each 50 mg pre-filled syringe contains paliperidone palmitate equivalent to 50 mg of
paliperidone.
Each 75 mg pre-filled syringe contains paliperidone palmitate equivalent to 75 mg of
paliperidone.
Each 100 mg pre-filled syringe contains paliperidone palmitate equivalent to 100 mg of
paliperidone.
Each 150 mg pre-filled syringe contains paliperidone palmitate equivalent to 150 mg of
paliperidone.
Initiation treatment pack
Each 100 mg pre-filled syringe contains paliperidone palmitate equivalent to 100 mg of
paliperidone.
Each 150 mg pre-filled syringe contains paliperidone palmitate equivalent to 150 mg of
paliperidone.

The other components are:
Polysorbate 20
Macrogol
Monohydrate citric acid
Disodium phosphate
Monohydrate sodium dihydrogen phosphate
Sodium hydroxide (for pH adjustment)
Water for injections

Description of the appearance of Paliperidone Viatris Pharma and contents of the pack
Paliperidone Viatris Pharma is a white to off-white suspension for injection in a pre-filled syringe (injection suspension).
Each single pack contains:
1 pre-filled syringe (clear, type I glass) with plunger stopper, anti-retraction device, and closure cap, together with a 22 G, 1½ inch safety needle and a 23 G, 1 inch safety needle.

Each multiple-pack initiation treatment pack contains:

• 1 pack of Paliperidone Viatris Pharma 150 mg, 1 pre-filled syringe and 2 needles (administered on treatment day 1)
• 1 pack of Paliperidone Viatris Pharma 100 mg, 1 pre-filled syringe and 2 needles (administered on
  treatment day 8)

Not all pack sizes may be marketed.

Marketing Authorization Holder
Mylan S.p.A.
Via Vittor Pisani 20
20124 Milan
Italy

Manufacturer
Universal Farma, S.L
Polígono Industrial Miralcampo
C/ El Tejido 2
19200 Azuqueca de Henares – Guadalajara, Spain
Pharmascience International Limited
1st Floor Iacovides Tower
81-83 Griva Digeni Avenue
1090 Nicosia
Cyprus

The following information is intended exclusively for physicians or healthcare professionals and
must be read by physicians or healthcare professionals together with the complete prescribing information
(Summary of Product Characteristics):
The injectable suspension is for single use only. Perform a visual inspection to ensure absence of particulate matter prior to administration. Do not use if the syringe is not visually free from particulate matter.
The pack contains one pre-filled syringe and two safety needles (one 1½ inch, 22 G [38.1 mm x 0.72 mm] and one 1 inch, 23 G [25.4 mm x 0.64 mm]) for intramuscular injection.
The initiation treatment pack contains two pre-filled syringes (150 mg + 100 mg) and a total of 4 needles.

1. Shake the syringe vigorously for at least 10 seconds to ensure a homogeneous suspension.

2. Select the appropriate needle.

The first initiation dose of Paliperidone Viatris Pharma (150 mg) must be administered on Day 1 into the DELTOID muscle using the needle for DELTOID injection. The second initiation dose of Paliperidone Viatris Pharma (100 mg) must also be administered into the DELTOID muscle one week later (Day 8) using the needle for DELTOID injection.
If the patient is switching from long-acting risperidone injection to Paliperidone Viatris Pharma, the first injection of Paliperidone Viatris Pharma (which may range from 25 mg to 150 mg) may be administered either into the DELTOID or GLUTEAL muscle at the time of the next scheduled injection, using the needle appropriate for the injection site.
Subsequently, monthly maintenance injections may be administered either into the DELTOID or GLUTEAL muscle using the appropriate needle for the injection site.
For DELTOID injection: if the patient weighs < 90 kg, use the 1 inch, 23 G (25.4 mm x 0.64 mm) needle (the needle with the blue hub); if the patient weighs ≥ 90 kg, use the 1½ inch, 22 G (38.1 mm x 0.72 mm) needle (the needle with the grey hub).
For GLUTEAL injection, use the 1½ inch, 22 G (38.1 mm x 0.72 mm) needle (the needle with the grey hub).

3. Holding the syringe in an upright position, remove the rubber closure cap with a twisting motion.

4. Open the safety needle blister. Grasp the base of the needle, not the safety cap. Attach the safety needle to the Luer connection of the syringe by pushing and turning with a simple clockwise rotation.

5. Remove the safety cap by pulling it away from the needle at the angle shown.

6. Remove the needle protective cap with a straight pull. Do not rotate the cap, as the needle may loosen from the syringe.

7. Hold the syringe with the attached needle in an upright position to remove air. Expel air from the syringe by gently pushing the plunger forward.

8. Inject the entire contents slowly and deeply into the selected deltoid or gluteal muscle by intramuscular route. Do not administer by intravenous or subcutaneous route.
9. After completing the injection, use the fingers of one hand (9a) or a flat surface (9b) to activate the needle safety system. The system is fully activated when a "click" sound is heard. Dispose of the syringe with the needle appropriately.

9a

9b

Any unused medicine and waste material derived from this medicine must be disposed of in accordance with local regulations.