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Risperdal 4 Mg 20 Tablets ingredient Risperidon

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Risperdal 4 Mg 20 Tablets ingredient Risperidon

RISPERDAL with food and drink:

You can use RISPERDAL before or after meals.

Do not use RISPERDAL with alcohol.

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Pregnancy

Consult your doctor or pharmacist before using the medicine.

If you are pregnant or plan to become pregnant,for advice before taking this medicine

consult your doctor or pharmacist. If youRISPERDAL in the last three months of your pregnancy, you

usedmay experience tremors in your newborns, which may vary in severity following,muscles

tensiontension in the, drowsiness, restlessness, respiratory distress or malnutrition

. If your baby experiences any of these symptoms, contact your doctor

. RISPERDAL may elevate your il prolactin ene hormone level andthis

affectfertility (fertility). (See 4. Possible side effects)

If you notice that you are pregnant during your treatment,doctor or pharmacist immediately

consult your.

Breastfeeding

Consult your doctor or pharmacist before using the medicine.

Do notRISPERDALdoctor decides that it is absolutely necessary during breastfeeding

useas long as your.

Use ofand machinesmay

toolsRISPERDAL treatmentcause dizziness, fatigue and vision problems

. Do not use tools and machines before talking to your doctor about this.

Important information about some of the excipients in the content of

RISPERDAL contains sodium hydroxide as the RISPERDAL pH adjuster. Nodue to sodium are

negative effectsexpected.

Use with other drugsuse

If youany of the following medicines, be sure to telldoctor

your:

- Calming drugs (benzodiazepines) acting on your brain;for pain

some medications taken(opiates); allergy medications (some antihistamines). Risperidonetheir

may increasesedative effects.

- drugs that affect the electrical activity in your heart; eg. malarial drugs,the heart rhythm

which regulatemedications, allergy medications (antihistamines),some medications for depression  mental

other drugs used forandillness

- heart slowing down the shot medications

- reducing potassium in the blood medications (certain diuretics)

- Parkinson's medication you are taking medication for the disease or epilepsy treatment (such as levodopa

- High blood pressure therapy drugs. RISPERDAL may decrease blood pressure.

-of swelling due to problems in the heart or fluid accumulation in one part of your body

Diuretic drugs (eg furosemide or chlorothiazide) used for the treatment.alone

Risperdal  or taken together with furosemide in elderly patients with dementia

may increase the risk of stroke or death.

The following drugs may reduce the effect of risperidone

- Rifampicin (a drug used in the treatment of certain infections)

- Carbamazepine, phenytoin (epilepsy drugs)

- Phenobarbital (epilepsy and sleeping medication)

If you have started or stopped using such drugs, you maya different dose of risperidone

need.

The following drugs may increase the effect of risperidone

- Quinidine (a drug used in the treatment of certain types of heart diseases)

- Depression drugs such as paroxetine, fluoxetine, tricyclic antidepressants

- Drugs known as beta-blockers (used in the treatment of heart diseases and blood pressure)

- Phenothiazines (in the treatment of used drugs

- cimetidine, ranitidine (drugs used to prevent acid in the stomach)

CT Page 6 of 18

If you have started or stopped using such drugs, you maya different dose of risperidone

need.

are currently using any prescription or non-prescription medication or if you have recently

Please inform your doctor or pharmacist if youused it.

3. How is RISPERDAL used?

Instructions for proper use and dose / frequency of administration:

Your doctorhow long your treatment will take with RISPERDAL and what dose

will tell youyou should take. Alwaysyour doctor's advice exactly

follow. Do not interrupt your treatment by yourself.

If you are not sure how to take RISPERDAL, ask your doctor

or pharmacist.

The daily dose of RISPERDALfrom 0.50 milligrams to 6 milligrams, depending on your disease

varies. Follow your doctor's instructions.

Application route and method:

It is used by mixing with a drink other than tea and alcohol.

You can use RISPERDAL before or after meals.

Different age groups:

Use in children:

• In schizophrenia:

There is not enough experience in children under 18 years of age.

• In bipolar mania:

There is not enough experience in children under 18 years of age.

• In disruptive behavior disorders:

patients below 50 kg:

0.25 mg once daily is recommended as initial dose.

This dose may be increased by a dose of 0.25 mg, maximum daily, if necessary.

In general, the maintenance dose is between 0.25 mg and 0.75 mg.

Patients with a weight of 50 kg or more:

Fig. 1. Bottle with child safety cap,

open as follows:

plastic screwwhile turning counterclockwise

Push down and remove thecap.

Figure 2. Insert the pipette from the top of the bottle.lower

While holding thering, move the upper ring to

the milliliter or milligram line you need.

Figure 3.the whole pipette from theholding the lower ring

Removebottle.top ringdragging it down into

byalcoholic, except for tea

Empty thea non-beverage.bottle

Close theand rinse the pipette with water.

0.50 mg is recommended once daily as a starting dose.

This dose may be increased with doses of 0.50 mg, with a maximum daily exposure.

In general, the maintenance dose is between 0.50 mg and 1.5 mg.

There is not enough experience in children under 5 years of age.

• In autism:

The recommended daily dose of autism for children and adolescents isper day for patients under

0.25 mg20 kg and 0.50 mg per day for patients over 20 kg.

Use in elderly:

Schizophrenia The

initial dose is usually 0.50 mg twice a day.

The dose you use by your doctor may be incrementally1 mg to 2 mg twice a day

increased from.

Mania The initial dose is usually 0.50 mg twice a day.

Depending on how you respond to treatment, the dose you use by your doctor may beday

incrementally increased from 1 mg to 2 mg twice a.

Your doctor will tell you how many tablets you should take.

Special Use Cases:

Renal insufficiency:

All starting and maintenance doses of risperidone should beregardless of the disease to be treated

halved,. Dose increase should be slow in these patients. Risperidonethese patient

should be used with caution ingroups.

Liver failure:

All starting and maintenance doses of risperidone should beregardless of the disease to be treated

halved,. Dose increase should be slow in these patients. Risperidonethese patient

should be used with caution ingroups.

If you have an impression that the effect of RISPERDAL is too strong or too weak

, talk to your doctor or pharmacist.

If you have used more RISPERDAL than you should use:

If you have used more than you should use from RISPERDAL,a doctor or pharmacist

talk to.

The patient may have the following symptoms when using RISPERDAL: headache

, fatigue, abnormal body movements, standing and walking problems,

dizziness caused by low blood pressure and abnormalities in your heart rate or

seizures.

Ifforget to use RISPERDAL:

youIf you forget to take a dose, take that dose as soon as you remember. But ifnext

yourdose is due, skip the missed dose and continue as usual.two

Contact your doctor if you have forgottenor more doses.

Do not double-dose to compensate for forgotten doses.

Effects that may occur when RISPERDAL is discontinued:discontinue

If youyour treatment without consulting your doctor, the symptoms of your disease may reappear

. When you are discontinuing RISPERDAL treatment,doctor gives you a separate recommendation

reduce the dose until your.

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

4. What are the possible side effects?

As with all medications, RISPERDALhave sidein people who are sensitive to the substances contained in its content

mayeffects.

If you have any of the following, stop using RISPERDAL and IMMEDIATELY

tell your doctor or contact your nearest hospital emergency department:

- Especially if you have swelling, pain and redness in your legs. This mayin the vessel

be indicative of a clot formation. This clot can travel up to the lung in the vein

and cause chest pain and difficulty in breathing. If you have dementia and for a short period of time,

you may notice a sudden change in your mental state, aface, arms and legs,

sudden weakness in youror a loss of numbness or speech.

These may be signs of a stroke.

- If you experience fever, muscles hardening, sweating or loss of consciousness. TheseNeurolepticBunlar

may be signs of a disease called ınMalignant Syndrome.

- If you are a man and you have a long-lasting or painful erection. This situation isBu

called ”priapism.

- Your tongue, your mouth or your face is rhythmic movements outside your request. This

may require cutting of risperidone.

- Fever, swelling in the mouth, swelling of the face, tongue and lips, shortness of breath, itching, rashes in the skin

, allergic reactions sometimes characterized by low blood pressure.

These are all very serious side effects. If you have one of these, you

have a serious allergy to RISPERDAL.urgent medical attention or hospitalization

You may need.

All of these very serious side effects are very rare.

If you notice any of the following, tell your doctor: The

following side effects may occur:

Very common: It can be seen in at least 1 of 10 patients.

Common: Less than one in 10 patients, but more than one in 100 patients.

Uncommon: Less than one in 100 patients, but more than one in 1,000 patients.

Rare: Less than one in 1,000 patients, but more than one in 10,000 patients

.

Very rare: less than one in 10,000 patients.

Unknown: Unpredictable from available data

Very common (affects more than 1 in 10 users)

- Common cold symptoms

- Difficulties in falling asleep or sleep

- Parkinsonism: Symptoms of slowing ormovement

disruption of, muscular stiffness or tension (smooth movement will make you lose),

sometimes suddenly freeze and then re-start of a movement, slow and feet

lot by walking, tremors at rest, watery increased salivation or mouth, so that

the ordinary expression of the loss

- a sleepy feel, reduced response

- Headache

Common (affects 1 to 10 in 100 users)

- Lung infection (pneumonia), chest infections (bronchitis),

sinusitis (sinusitis), urinary tract inflammation, ear pain, feeling like going through the flu

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