GlaxoSmithKline

Film-coated tablet 0.25 mg 
(White pentagonal tablets, 7.5 x 7.5 mm, marked with “SB” on one side and “4890” on the other)

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

  • Save 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 give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet you will find information about: 
1. What Adartrel is and what it is used for 
2. What you need to know before you take Adartrel 
3. How to take Adartrel 
4. Possible side effects 
5. How to store Adartrel 
6. Contents of the packaging and other information 

1. What Adartrel is and what it is used for

The active substance in Adartrel is ropinirole, which belongs to a group of medicines called dopamine agonists. Dopamine agonists have a similar effect to dopamine, which is a naturally occurring substance in the brain.

Adartrel is used to treat the symptoms of moderate to severe Restless Legs Syndrome.

Restless Legs Syndrome (RLS) is also called Ekbom’s syndrome. People with Restless Legs Syndrome have an unrestrained need to move their legs and sometimes their arms and other parts of the body. They usually have unpleasant sensations in the legs and/or arms – sometimes described as “crawling” or “bubbling”, which can begin immediately after they sit down or lie down and relief is obtained only by movement. They therefore often have problems sitting still and especially sleeping.

Adartrel relieves the unpleasant sensations and therefore reduces the compulsive need for movement in the legs and/or arms.

What you need to know before taking Adartrel

Do not take Adartrel:

  • if you are allergic to ropinirole or any of the other ingredients of this medicine (listed in section 6).
  • if you have severe kidney disease
  • if you have severe liver disease
  • Tell your doctor if you think any of the above apply to you.

Warnings and cautions

Talk to your doctor or pharmacist before taking Adartrel:

  • if you are pregnant or think you may be pregnant
  • if you are breast-feeding
  • if you are under 18 years of age
  • if you have liver disease
  • if you have a serious heart condition
  • if you have severe mental health problems
  • if you have had any unusual cravings and/or behaviors (such as excessive gambling or excessively sexual behavior )
  • if you do not tolerate certain sugars (eg lactose monohydrate ).

Tell your doctor if you experience symptoms such as depression, apathy, anxiety, fatigue, sweating, or pain after stopping or reducing your treatment with Adartrel. If the problems persist for more than a few weeks, your doctor may need to adjust your treatment.

Tell your doctor if you or your family/caregiver notice that you develop a strong desire or desire to behave in ways that are unusual for you, or if you can not resist the impulse, drive, or temptation to perform certain activities. which may harm you or others. These behaviors are called disturbed impulse control and can include gambling addiction, compulsive eating, compulsive buying, an abnormally high sex drive, or an increase in sexual thoughts and feelings. Your doctor may need to adjust your dose or discontinue treatment.

  • Tell your doctor if any of the above apply to you. If you and your doctor decide that you can take Adartrel, your doctor will probably want you to have extra check-ups during treatment.

Other medicines and Adartrel

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription or over-the-counter medicines. Remember to tell your doctor or pharmacist if you start taking a new medicine while taking Adartrel.

Some medicines may affect the way Adartrel works or make you more likely to get side effects. Adartrel may also affect the effectiveness of other medicines.

These include:

  • fluvoxamine, an antidepressant
  • drugs for other mental problems, such as sulpiride
  • metoclopramide, which is used to treat nausea and heartburn
  • HRT (hormone replacement)
  • ciprofloxacin or enoxacin ( antibiotics )
  • any other drug that can block the action of dopamine in the brain.
  • Tell your doctor if you are taking or have recently taken any of the above medicines.

You will need to take additional blood tests if you are taking the following medicines with Adartrel:

  • vitamin K antagonists (used to reduce the formation of blood clots) such as e.g. warfarin (Warren).

Pregnancy and breastfeeding

Adartrel is not recommended for use if you are pregnant unless your doctor considers that the benefit to you outweighs the risk to your unborn baby. Adartrel is not recommended for breastfeeding as it may affect milk production.

  • Tell your doctor immediately if you are pregnant, think you may be pregnant, or are planning to have a baby. Your doctor will also advise you if you are breast-feeding or planning to do so. Your doctor may advise you to stop taking Adartrel.

While taking Adartrel

Tell your doctor if you or your family have noticed that you develop any unusual behaviors (such as unusual gambling or increased sexual desire and/or behavior ) while taking Adartrel. Your doctor may need to change your dose or stop treatment.

  • Driving and using machines

Adartrel may make you feel drowsy. In very rare cases, Adartrel may make people feel extremely sleepy and cause people to fall asleep very suddenly without warning.

Adartrel can cause hallucinations (see, hear, or feel things that are not there). Do not drive or use machines if you are affected.

If you experience these symptoms: do not drive, use machines, and Do not enter into any situation where sleepiness or risk falling asleep could put you (or others) in serious injury or death. Do not participate in any of these activities until the discomfort has resolved.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

  • Tell your doctor if this becomes a problem for you.
  • Smoking and Adartrel

Tell your doctor about:

You start smoking or stop smoking while taking Adartrel. Your doctor may need to change your dose.

  • Taking Adartrel with food and drink

If you take Adartrel with food, you are less likely to get nauseous or start vomiting. If you can, it is, therefore, best to take the medicine with food.

  • If your problems get worse

Some people taking Adartrel experience that their RLS symptoms get worse, e.g. the symptoms may start earlier than usual, be more intense or affect parts of the body that were previously unaffected such as the arms or return early in the morning.

  • Tell your doctor as soon as possible if you get any of these symptoms.

Adartrel tablets contain a small amount of sugar called lactose monohydrate.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

How to take Adartrel

Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

Do not give Adartrel to children. Adartrel is not normally prescribed for children under 18 years of age.

How much Adartrel do you need to take?

It may take a while to decide which dose of Adartrel is best for you.

The usual starting dose is 0.25 mg once daily. After two days, your doctor will probably increase your dose to 0.5 mg daily for the rest of the week. Thereafter, your doctor may gradually increase your dose over the next three weeks, to a dose of 2 mg per day.

If 2 mg per day does not improve your RLS symptoms enough, your doctor may want to gradually increase your dose slightly up to the maximum dose of 4 mg per day. After taking Adartrel for three months, your doctor may want to change your dose or advise you to stop treatment.

If you have the impression that the effect of Adartrel is too strong or too weak, talk to your doctor or pharmacist. Do not take more tablets than your doctor has recommended.

Continue to take Adartrel as your doctor advises, even if you do not feel better. It may take a few weeks for Adartrel to start working.

Take your dose of Adartrel

Take your Adartrel tablet once a day.

Swallow the tablets with a glass of water.

You can take Adartrel with or without food. If you take the tablet with food, you are less likely to get nauseous.

Adartrel is usually taken just before bedtime in the evening. You can take it up to 3 hours before you go to bed.

A person taking an overdose of Adartrel may experience any of these symptoms: nausea, vomiting, dizziness (a rotating sensation), drowsiness, mental or physical fatigue, fainting, hallucinations

If you forget to take Adartrel

Do not take extra tablets or a double dose to make up for a forgotten dose. Just take your next dose at the usual time.

If you have missed your dose for several days, consult your doctor for advice on how to start treatment again.

If you stop taking Adartrel

Do not stop taking Adartrel without your doctor’s advice.

Take Adartrel for as long as your doctor prescribes it. Do not stop unless your doctor tells you to.

If you suddenly stop taking Adartrel, your symptoms of Restless Legs Syndrome can quickly get much worse.

A sudden stop can cause you to develop a medical condition called malignant neuroleptic syndrome which can pose a major health risk. Symptoms include: akinesia (loss of muscle mobility), stiff muscles, fever, unstable blood pressure, tachycardia (increased heart rate), confusion, decreased level of consciousness (eg coma ).

If you need to stop taking Adartrel, your doctor will gradually reduce your dose.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The side effects of this medicine are most likely to occur when you start taking it or when your dose has just been increased. They are usually mild and become less troublesome after taking a dose for a while.

If you get any side effects, talk to your doctor or pharmacist. It also includes side effects not listed in this leaflet.

Very common side effects are

Occurs in more than 1 in 10 people taking Adartrel:

  • nausea
  • vomiting.

Common side effects are

Occurs in less than 1 in 10 people taking Adartrel:

  • nervousness
  • fainting
  • drowsiness
  • fatigue (mental or mental)
  • dizziness (a rotating sensation)
  • abdominal pain
  • worsening of RLS (symptoms may start earlier than usual or be more intense or affect parts of the body that have previously been unaffected such as the arms or return early in the morning)
  • swollen legs, feet, or hands.

Uncommon side effects are

Occurs in less than 1 in 100 people taking Adartrel:

  • confusion
  • hallucinations (“seeing” things that do not exist)
  • dizziness or fainting, especially when you stand up suddenly (this is caused by a drop in blood pressure).

Very rare side effect s

A very small number of people who have taken Adartrel (up to 1 in 10,000) have:

  • had altered liver function, which has been shown in blood tests
  • felt very sleepy during the day (extreme sleepiness)
  • fell asleep very suddenly without first feeling sleepy (sudden sleep attacks).

Some patients may experience the following side effects (no known frequency: cannot be calculated from the available data )

  • allergic reactions such as red, itchy swelling of the skin ( hives ). Swelling of the face, lips, mouth, tongue, or throat may cause difficulty in swallowing or breathing as well as rash or intense itching (see section 2)
  • other psychotic reactions in addition to hallucinations such as pronounced confusion ( delirium ), irrational ideas (delusions), and morbid suspicion ( paranoia)
  • aggression
  • excessive use of Adartrel (request for high doses of dopaminergic drugs that are higher than needed to control motor symptoms, known as dopamine dysregulation syndrome)
  • Depression, lethargy, anxiety, fatigue, sweating, or pain may occur after you stop taking or reduce your treatment with Adartrel (known as withdrawal syndrome after treatment with dopamine agonist or DAWS).

You may experience the following side effects:

  • Inability to resist an impulse to perform an action that can be harmful such as:
    • a strong impulse to excessive gambling despite serious consequences for you personally or for your family
    • altered or increased sexual interest or behavior that makes you or others noticeably concerned, e.g. an increased sexual drive
    • uncontrollable and excessive need to buy things and spend money
    • binge eating (eating large amounts of food in a short time) or compulsive eating (eating more food than normal and more than is needed to satiate your hunger).

Tell your doctor if you experience any of these behaviors. You will discuss ways to manage or reduce the symptoms.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. How to store Adartrel

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. respectively exp. The expiration date is the last day of the specified month.

Store below 25 ° C.

Store in the original package.

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

6. Contents of the packaging and other information

Content declaration

The active substance in Adartrel is ropinirole (as hydrochloride).

Each tablet contains 0.25, 0.5 or 2 mg ropinirole (as hydrochloride).

Other ingredients are:

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

film coating:

0.25 mg tablet: hypromellose, macrogol 400, titanium dioxide (dye E171), polysorbate 80 (E433)

0.5 mg tablet: hypromellose, macrogol 400, titanium dioxide (dye E171), yellow iron oxide (E172), red iron oxide (E172), indigo carmine aluminum lacquer (E132)

2 mg tablet: hypromellose, macrogol 400, titanium dioxide (dye E171), yellow iron oxide (E172), red iron oxide (E172)

What the medicine looks like and the contents of the pack

Adartrel 0.25 mg is supplied as white pentagonal film-coated tablets marked “SB” on one side and “4890” on the other. Each pack contains 2 or 12 tablets.

Adartrel 0.5 mg is supplied as yellow pentagonal film-coated tablets marked “SB” on one side and “4891” on the other. Each pack contains 28 or 84 tablets.

Adartrel 2 mg is supplied as pink pentagonal film-coated tablets marked “SB” on one side and “4893” on the other. Each pack contains 28 or 84 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder:

GlaxoSmithKline AB, Box 516, 169 29 Solna 
Tel: 08-638 93 00 
E-mail: info.produkt@gsk.com

Manufacturer:

Glaxo Wellcome SA, Avenida de Extremadura 3, 09400 Aranda de Duero, Burgos, Spain

This medicinal product is authorized under the European Economic Area under the names:

France, Germany, Iceland, the Netherlands, Norway, Poland, Portugal, Slovakia, Spain, Sweden, and the United Kingdom: Adartrel

Muhammad Nadeem

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