Requip (Ropinirole) 21 Tablets

REQUIP XL extended release tablet.

Active substance

Excipients

Hypromellose 2208, hydrogenated castor oil, carboxymethyl cellulose sodium, povidone, maltodextrin, magnesium stearate, lactose monohydrate, colloidal silicon dioxide, mannitol (E421), yellow iron oxide (E172), glyceryl behenate, hypromellose 2910, titanium dioxide (E171) , polyethylene glycol / macrogol 400, yellow iron oxide (E172), black iron oxide (E172), red iron oxide (E172)

• When using this medicine, tell your doctor that you are taking this medicine when you go to a doctor or hospital.

• Follow the instructions in this manual. Do not use high or low doses other than the recommended dose for the drug.

In these Instructions For Use:

1. What is REQUIP XL and what is it used for?

2. Things to consider before using REQUIP XL

3. How to use REQUIP XL?

4. What are the possible side effects?

5. Storage of

What is REQUIP XL and what is it used for?

REQUIP XL is in the form of a red colored capsule in the form of film coated tablets. Tablets have GS on one side and 5CC on the other. REQUIP XL is available in blister packs and contains 28 tablets per box.

REQUIP XL is a member of a group of drugs called dopamine agonists and contains ropinirole as an active ingredient.

REQUIP XL is used in the treatment of Parkinson's disease. Parkinson's disease is a brain disease that affects the ability to act characterized by symptoms such as tremor, inelastic body posture, heavy movements, foot swing and unbalanced gait.

REQUIP XL can be used alone or in combination with other drugs (levodopa) in the treatment of Parkinson's disease.

How to use REQUIP XL?

Instructions for proper use and dose / frequency of administration

Your doctor may increase or decrease the dose of your medication according to your response to your treatment so that you can achieve maximum benefit.

The recommended starting dose is 2 mg taken once a day for one week.

Your doctor will then gradually increase the dose of your medicine. The dose24

can be increased up tomg daily.

Inform your physician if you have drowsiness to affect your daily activity. It may be necessary to reduce the dose of your medicine.

If you are going to take REQUIP XL while using L-dopa, your doctor will reduce the dose of L-dopa gradually.

Application route and method

REQUIP XL should be taken at the same time every day, in the form of a single daily dose. The tablets should be swallowed as a whole, not chewed, broken or broken. REQUIP XL can be taken with or without meals.

Different age groups

Use in children Use in the

elderly Use in the

elderly As your

kidney function decreases with age,doctor will

youradjust the dose of your medication according to your condition.

Specific UseUse in

ConditionsRenal Disorder: In patients with severe renal impairment, the use of REQUIP XL is not recommended.

Use in patients with severe hepatic impairment: REQUIP XL is not recommended for patients with severe hepatic impairment.

If you have an impression that the effect of REQUIP XL is too strong or too weak, talk to your doctor or pharmacist.

use more REQUIP XL thanREQUIP XL

If youyou should use, talk to a doctor or pharmacist if you have used more than you should use from.

If you have forgotten to use REQUIP XL If you forgot to takeREQUIP XL for

aa day or more, ask your doctor to start the REQUIP XL again. Because the dose should be adjusted to start treatment again.

Do not take double doses to compensate for forgotten doses.

Effects after treatment with REQUIP XL

Take your medicine as long as your doctor recommends. Do not cut unless recommended by your doctor. REQUIP should be discontinued within a week by gradually decreasing the number of daily doses. If you cut the REQUIP XL suddenly, the symptoms of your disease may deteriorate rapidly.

4. What are the possible side effects?

Like all medicines, REQUIP XL may have side effects in people who are sensitive to the substances contained in its content.

Stop using REQUIP if any of the following and immediately report to your doctor or contact your nearest hospital emergency department:

No serious side effects were reported for REQUIP XL.

If you notice any of the following, tell your doctor immediately or contact the nearest emergency department of the hospital:

REQUIP XL is used alone:

• Fainting

• Dizziness, especially when you stand up when you are sitting or lying down

• Low blood pressure

REQUIP XL with another drug when used together:

• Dizziness, especially when standing up when sitting or lying down

• Low blood pressure

Side effects after marketing:

• Low blood pressure

• Dizziness seen when standing up, especially when sitting or lying down These are serious side effects. Emergency medical intervention may be required.

Tell your doctor if you notice any of the following

:REQUIP XL is used alone:

•• Sleep

• Nausea

• Swelling of the hands and ankles or feet (including legs)

• Seeing, hearing, or feeling things that do not actually exist (Hallucinations)

• Head dizziness

• abdominal pain

• vomiting

• Indigestion

• Constipation

Requip XL, when used together with another medicine:

• uncontrollable muscular twitching, convulsions or contractions

• Hand ankles or swelling of the feet

• seeing things that are not there Indeed, hearing or feeling

• mind blur

• Drowsiness

• Dizziness

• Nausea

•Constipation

side effects observed afterMarketing:

• others that share will not change, illogical thoughts

• Paranoia and severe psychotic reactions sizes, including confusion and (hallucinations outside

• Impulse control symptoms

• SnitchIncreased libido including sexual desire

•• Gambling

• Severe drowsiness

• Sudden fall asleep

These are mild side effects of REQUIP XL.

2. Before using the

REQUIP XL DO NOT use the REQUIP XL in the following cases

:

• Do not use this medicine if you are allergic to any of the other components of Ropinirole or REQUIP XL (see the list of excipients).

USE REQUIP XL CAUTION

:If you have

•any cardiovascular diseaseIf you

•have any existing or ongoing psychological problems in the past Also:

• Patients using REQUIP XL may experience obsessive behaviors such as gambling or excessive sexual desire.

Please consult your doctor if these warnings are valid for you, even at any time in the past.

REQUIP XL can be used with food and drink

4.6. Pregnancy and lactation

General advice:

Pregnancy category: C.

Women with childbearing potential / Contraception:

There is not enough data on the use of ropinirole in pregnant women.

Animal studies are insufficient in terms of effects on pregnancy, embryonal / fetal development, birth or postnatal development (see section 5.3 Preclinical safety data). The potential risk for humans is unknown.

Pregnancy: It

is not recommended to use REQUIP XL during pregnancy unless the potential benefit to the mother outweighs the potential risk to the fetus (see section 5.3 Preclinical safety data).

Lactation period:

REQUIP XL should not be used in nursing mothers since it may inhibit lactation.

Reproductive ability / Fertility:

4.7. Effects onon the effects of

ability to drive and use machines No data is availableropinirole on vehicle and machine use.

Patients should be cautioned about the use of vehicles and machines due to somnolence and dizziness (including vertigo) when using REQUIP XL.

8.4. Adverse effects

, as well as vehicle or machine

Adverse effects, are listed in the table below. The overall safety profile of ropinirole includes adverse reactions from clinical trial data and post-marketing experience.

Adverse effects are listed according to organ systems and their frequency. Frequencies are very common (> 1/10), widespread (> 1/100 and <1/10), non-prevalent (> 1 / 1.000 and <1/100), infrequent (> 1 / 10.000 and <1 / 1,000) , very rare (<1 / 10,000) and unknown (unpredictable).

Clinical Trial Data

Adverse Drug Reactions Reported in Parkinson's Patients

Unless indicated otherwise, the following data were observed with both immediate release and extended release formulations.

Use in monotherapy studies

Psychiatric disorders

Common: Hallucinations

Nervous system disorders

Very common: Somnolans, syncope1

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