ROPINIROLE TARBIS 5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Ropinirol Tarbis 5 mg film-coated tablets EFG

Ropinirol

Read all of this leaflet carefully before you start taking this medicine.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others, as it may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Contents of the pack:

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

1. What Ropinirol Tarbis 5 mg is and what it is used for

Ropinirol belongs to a group of medicines called dopamine agonists. Dopamine agonists work in a similar way to a natural substance called dopamine that is found in the brain.

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 not sufficient, in order to improve control of your symptoms.

2. Before taking Ropinirol Tarbis 5 mg

Do not take Ropinirol Tarbis:

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

Be cautious with Ropinirol Tarbis:

• If you have severe mental disorders.
• If you have 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 sleepiness or suddenly fall asleep without feeling tired, do not drive or use machinery, and contact your doctor.

Using other medicines

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription. Some medicines may cause problems if taken with this one.

Be careful with the following medicines

• Hormone replacement therapy (also called HRT) such as estrogens.
• Ciprofloxacin or enoxacin (antibiotics).
• Fluvoxamine (a medicine used to treat depression).
• Theophylline (a medicine used to treat asthma).
• Antipsychotics and other drugs 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 medicine.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine.

Ropinirol should not be taken during pregnancy. Tell 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 medicine.

Ropinirol should not be used during breast-feeding, as it may affect milk production. Tell your doctor immediately if you are breast-feeding or plan to breast-feed. Your doctor will advise you to stop taking this medicine.

Driving and using machines

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

If you experience these effects, you should not drive or operate machinery until these episodes have resolved.

Important information about some of the ingredients of Ropinirol Tarbis:

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medicine.

3. How to take Ropinirol Tarbis 5 mg

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

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

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

Then the dose may be increased in increments of 0.25 mg of ropinirol per week, following this 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, following this 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 occurrence of nausea (feeling dizzy), which is a possible side effect of this medicine. Do not chew or break the tablets.

You should continue taking your medicine even if you do not feel better, as it may take several weeks for the medicine 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 pack of tablets.

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

If you forget to take Ropinirol Tarbis

If you miss 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, ask 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 gradually stop taking the medicine, as sudden interruption may worsen your symptoms.

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

4. Possible side effects

Like all medicines, Ropinirol Tarbis can cause side effects, although not everybody gets them.

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

• Somnolence.
• Fainting (syncope).
• Abnormal involuntary movements (dyskinesia).
• Feeling dizzy (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).
• Excessive 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 rare(affect less than 1 in 10,000 people):

• Increased liver enzymes.

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

5. Storage of Ropinirol Tarbis 5 mg

Keep out of the reach and sight of children.

Do not use Ropinirol Tarbisafter the expiry date stated on the pack after EXP. The expiry date is the last day of the month indicated.

Do not store above 25°C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. FURTHER INFORMATION

Composition of Ropinirol Tarbis

The active substance is ropinirol.

Ropinirol Tarbis 5 mg: Each film-coated tablet contains 5 mg of ropinirol (as hydrochloride).

The other ingredients are:

Core of the tablet: lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, magnesium stearate.

Coating of the tablet:

Hypromellose, titanium dioxide (E-171), macrogol 400, aluminum lake carmine indigo (E-132).

Appearance of Ropinirol Tarbis and pack contents

Film-coated tablet

Ropinirol Tarbis 5 mg: Film-coated tablets, round, blue.

PEAD bottle of 84 tablets.

Marketing authorisation 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 leaflet was approved in October 2020