ROPINIROLE TARBIS 0.50 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Ropinirol Tarbis 0.5 mg film-coated tablets EFG

Ropinirol

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you consider that any of the side effects you are experiencing is serious or if you notice any side effect not mentioned in this package leaflet, inform your doctor or pharmacist.

Contents of the package leaflet:

1. What is Ropinirol Tarbis 0.5 mg and what is it used for
2. Before taking Ropinirol Tarbis 0.5 mg
3. How to take Ropinirol Tarbis 0.5 mg
4. Possible side effects
5. Storage of Ropinirol Tarbis 0.5 mg
6. Additional information

1. What is Ropinirol Tarbis 0.5 mg and what is it used for

Ropinirol belongs to a group of medications called dopamine agonists. Dopamine agonists work in the same way as a natural substance found in the brain called dopamine.

Ropinirol Tarbis is used to treat Parkinson's disease in the following conditions:

• Initial treatment as monotherapy to delay the introduction of levodopa.
• In combination with levodopa, when the effect of levodopa is no longer sufficient, in order to improve control of your symptoms.

2. BEFORE TAKING Ropinirol Tarbis 0.5 mg

Do not take Ropinirol Tarbis:

• If you are allergic (hypersensitive) to ropinirol or any of the other components.
• If you have a severe liver or kidney disease.
• If you are pregnant, plan to become pregnant, or think you may be pregnant.
• If you are breastfeeding.

Be careful with Ropinirol Tarbis:

• If you have a severe mental disorder.
• If you have a severe heart or vascular disease. You should check your blood pressure regularly, especially at the start of treatment.

Tell your doctor if you notice symptoms such as depression, apathy, anxiety, fatigue, sweating, or pain when stopping or reducing treatment with ropinirol (called dopamine agonist withdrawal syndrome or DAWS). If the symptoms persist after a few weeks, your doctor may need to adjust your treatment.

During treatment with ropinirol, be careful when driving or using machinery. If you experience excessive drowsiness or suddenly fall asleep without feeling tired, do not drive or use machinery, and contact your doctor.

Use of other medications

Tell your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription. Some medications can cause problems if taken with this one.

Be careful with the following medications

• Hormone replacement therapy (also called HRT) such as estrogens.
• Ciprofloxacin or enoxacin (antibiotics).
• Fluvoxamine (medication to treat depression).
• Theophylline (medication used to treat asthma).
• Antipsychotics and other medications that block dopamine in the brain (such as sulpiride or metoclopramide).

Taking Ropinirol Tarbis with food and drinks

Taking Ropinirol Tarbis tablets with food may reduce the likelihood of you feeling dizzy.

Do not drink alcohol while taking this medication.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

Ropinirol should not be taken during pregnancy. Inform your doctor immediately if you are pregnant, think you may be pregnant, or plan to become pregnant. Your doctor will advise you to stop taking this medication.

Ropinirol should not be used during breastfeeding, as it may affect milk production. Inform your doctor immediately if you are breastfeeding or plan to do so.

Your doctor will advise you to stop treatment with this medication.

Driving and using machines

Ropinirol may cause excessive sleepiness (drowsiness) and sudden sleep episodes.

If you experience these effects, you should avoid driving or performing activities where drowsiness or falling asleep may put you at risk of serious harm or death (e.g., using machinery) until these episodes have resolved.

Important information about some of the components of Ropinirol Tarbis:

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

3. HOW TO TAKE Ropinirol Tarbis 0.5 mg

Follow the administration instructions for Ropinirol Tarbis exactly as indicated by your doctor. Consult your doctor or pharmacist if you have any questions.

Your doctor will decide the dose you need to take each day, and you should follow the instructions given by your doctor.

In case this dose is not feasible, other doses of this product are available.

When you take ropinirol for the first time, the dose you take will be gradually increased.

The initial dose is usually 0.25 mg of ropinirol three times a day for the first week.

Subsequently, the dose may be increased in increments of 0.25 mg of ropinirol per week, following the scheme:

• Week 1: 0.25 mg three times a day.
• Week 2: 0.5 mg three times a day.
• Week 3: 0.75 mg three times a day.
• Week 4: 1 mg three times a day.

After this month of treatment, your doctor may gradually increase or decrease the amount of ropinirol you are taking to achieve the best effect.

The dose may be increased at intervals of 0.5 mg of ropinirol per week up to 9 mg per day, according to the scheme:

• Week 1: 1.5 mg three times a day.
• Week 2: 2.0 mg three times a day.
• Week 3: 2.5 mg three times a day.
• Week 4: 3 mg three times a day.

Normally, the most effective doseis between 3 and 9 mg per day. In some cases, your doctor may need to increase your daily dose up to a maximum doseof 24 mg per day (8 mg three times a day).

Swallow the tablets whole with a glass of water. Taking the tablets with food may reduce the appearance of nausea (feeling of dizziness), which is a possible side effect of this medication. Do not chew or break the tablets.

You should continue taking your medication even if you do not feel better, as it may take several weeks for the medication to take effect. If you think the effect of ropinirol is too strong or too weak, tell your doctor or pharmacist.

Do not take more tablets than your doctor has recommended.

To end therapy, it is necessary to gradually withdraw ropinirol, reducing the daily doses over a week.

If you take more Ropinirol Tarbis than you should

If you or a child take too many tablets, consult your doctor immediately or go directly to a hospital and show them the tablet packaging.

The most likely signs of overdose are: feeling dizzy, fainting, feeling sleepy, fatigue, stomach pain, fainting, or nervousness.

If you forget to take Ropinirol Tarbis

If you forget to take a dose of Ropinirol Tarbis, simply continue with the next dose, but do not take a double dose to make up for the missed dose.

If you have any doubts, consult your doctor or pharmacist.

If you stop taking Ropinirol Tarbis

Do not stop taking Ropinirol Tarbis without consulting your doctor or pharmacist.

This is because you should finish the medication gradually, as sudden interruption may worsen your symptoms.

If you have any other questions about the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, Ropinirol Tarbis can cause side effects, although not everyone will experience them.

The following side effects are very common(affect at least 1 in 10 people):

• Drowsiness.
• Fainting (syncope).
• Abnormal involuntary movements (dyskinesia).
• Feeling of dizziness (nausea).

The following side effects are common(affect more than 1 in 100 people and less than 1 in 10 people):

• Hallucinations (seeing or hearing things that do not exist) and confusion.
• Fainting (including vertigo).
• Abdominal pain, vomiting, heartburn.
• Swelling of the legs due to water retention (edema).

The following side effects are uncommon(affect more than 1 in 1,000 people and less than 1 in 100 people):

• Psychotic reactions, illusions, paranoia.
• Pathological gambling.
• Increased sexual desire (libido).
• Extreme daytime sleepiness, sudden sleep episodes without feeling tired beforehand.
• Decreased blood pressure (hypotension) that can make you feel dizzy or have vertigo, mainly when standing up from a sitting or lying position. This side effect can be serious in some cases.

The following side effects are very rare(affect less than 1 in 10,000 people):

• Increased liver enzymes.

If you consider that any of the side effects you are experiencing is serious or if you notice any side effect not mentioned in this package leaflet, inform your doctor or pharmacist.

5. Storage of Ropinirol Tarbis 0.5 mg

Keep out of the reach and sight of children.

Do not use Ropinirol Tarbisafter the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not store above 25°C.

Medications should not be disposed of through wastewater or household waste. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. ADDITIONAL INFORMATION

Composition of Ropinirol Tarbis

The active ingredient is ropinirol.

Ropinirol Tarbis 0.5 mg: Each film-coated tablet contains 0.5 mg of ropinirol (as hydrochloride).

The other components are:

Tablet core: lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, magnesium stearate.

Tablet coating:

Hypromellose, titanium dioxide (E-171), macrogol 400, yellow iron oxide (E-172), red iron oxide (E-172), aluminum lake FD&C blue no. 2 (E-132).

Appearance of Ropinirol Tarbis and packaging contents

Film-coated tablet

Ropinirol Tarbis 0.5 mg: Yellow, round, film-coated tablets.

Aluminum/Aluminum blister pack, containing 21 tablets.

Marketing authorization holder

Tarbis Farma, S.L.

Gran Vía Carlos III, 94

08028 Barcelona (Spain)

Manufacturer

• Uriach & Cía, S.A.

Av. Camí Reial 51-57

08184 Palau-solità i Plegamans (Barcelona-Spain)

This package leaflet was approved in October 2020