Adartrel 2.0 mg film-coated Tablets

• 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. It may harm them, even if their signs of illness are the same as yours.
• If you get any of the side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

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 pack and other information

• if you are allergic to ropinirole or any of the other ingredients of this medicine (listed in section 6)
• if you have serious kidney disease
• if you have serious liver disease.

• Tell your doctor if you think any of these may apply to you.

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 old
• if you have liver disease
• if you have a serious heart complaint
• if you have a serious mental health problem
• if you have experienced any unusual urges and/or behaviours (such as excessive gambling or excessive sexual behaviour)
• if you have an intolerance to some sugars (such as lactose monohydrate).

Tell your doctor if you experience symptoms such as depression, apathy, anxiety, fatigue, sweating or pain after stopping or reducing your Adartrel treatment (called dopamine agonist withdrawal syndrome or DAWS). If the problems persist more than a few weeks, your doctor may need to adjust your dose.

Tell your doctor if you or your family/carer notices that you are developing urges or cravings to behave in ways that are unusual for you and you cannot resist the impulse, drive or temptation to carry out certain activities that could harm yourself or others. These are called impulse control disorders and can include behaviours such as addictive gambling, excessive eating or spending, an abnormally high sex drive or an increase in sexual thoughts or feelings. Your doctor may need to adjust or stop your dose.

Tell your doctor if you or your family/carer notices that you are developing episodes of overactivity, elation or irritability (symptoms of mania). These may occur with or without the symptoms of impulse control disorders (see above). Your doctor may need to adjust or stop your dose.

• Talk to your doctor if any of these may apply to you. If you and your doctor decide that you can take Adartrel, your doctor will probably ask you to have extra check-ups while you are taking it.

Please tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines, including any herbal medicines or other medicines you obtained without a prescription. Remember to tell your doctor or pharmacist if you begin taking a new medicine while you are taking Adartrel.

Some medicines can affect the way Adartrel works or make it more likely that you will have side effects. Adartrel can also affect how some other medicines work.

These include:

• the anti-depressant fluvoxamine
• medication for other mental health problems, for example sulpiride
• metoclopramide, which is used to treat nausea and heartburn
• HRT (hormone replacement therapy)
• the antibiotics ciprofloxacin or enoxacin
• any other drug which blocks the action of dopamine in the brain.

• Tell your doctor if you are taking, or have recently taken, any of these.

You will require additional blood tests if you are taking these medicines with Adartrel:

• Vitamin K antagonists (used to reduce blood clotting) such as Warfarin (coumadin).

Adartrel is not recommended if you are pregnant, unless your doctor advises that the benefit to you of taking it is greater than the risk to your unborn baby. Adartrel is not recommended if you are breast-feeding, as it can affect your milk production.

• Talk to your doctor immediately if you are pregnant, if you think you might be pregnant, or if you are planning to become pregnant. 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.

Tell your doctor if you or your family notices that you are developing any unusual behaviours (such as an unusual urge to gamble or increased sexual urges and/or behaviours) while you are taking Adartrel. Your doctor may need to adjust or stop your dose.

• Driving and using machines
  Adartrel can make you feel drowsy. In very rare cases, Adartrel can make people feel extremely sleepy, and it sometimes makes people fall asleep very suddenly without warning.
  Adartrel can cause hallucinations (seeing, hearing or feeling things that are not there). If affected, do not drive or use machines.
  If you could be affected: do not drive, do not operate machines and do not put yourself in any situation where feeling sleepy or falling asleep could put you (or other people) at risk of serious injury or death. Do not take part in these activities until you are no longer affected.

• Talk to your doctor if this causes problems for you.

• Smoking and Adartrel
  Tell your doctor if you start smoking, or give up smoking, while you are taking Adartrel. Your doctor may need to adjust your dose.

If you take Adartrel with food, you may be less likely to feel sick (nauseous) or be sick (vomit). So it may be best to take it with food if you can.

Some people taking Adartrel find that their RLS symptoms get worse - for example, symptoms may start earlier than usual or be more intense, or affect other previously unaffected limbs, such as the arms or return in the early 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 an intolerance to lactose monohydrate or any other sugars, ask your doctor for advice before you take Adartrel.

Adartrel tablets contain less than 1 mmol sodium (23 mg) per tablet, that is to say essentially “sodium-free”.

It may take a while to find out what is the best dose of Adartrel for you.

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

If a 2 mg daily dose does not improve your RLS symptoms enough, your doctor may gradually increase your dose some more, up to a maximum of 4 mg daily. After you have been taking Adartrel for three months, your doctor may adjust your dose or advise you to stop taking it.

If you feel that the effects of Adartrel are too strong or too weak, talk to your doctor or your pharmacist. Do not take more tablets than your doctor has recommended.

Carry on taking Adartrel as your doctor advises, even if you do not feel better. Adartrel may take a few weeks to work for you.

Take your Adartrel tablet(s) once a day.

Swallow the tablet(s) with a glass of water.

You can take Adartrel with or without food. If you take it with food, you may be less likely to feel sick (nauseous).

Adartrel is usually taken just before bedtime, but you can take it up to 3 hours before you go to bed.

Contact a doctor or pharmacist immediately. If possible, show them the Adartrel pack.

Someone who has taken an overdose of Adartrel may have any of these symptoms: feeling sick (nausea), being sick (vomiting), dizziness (a spinning sensation), feeling drowsy, mental or physical tiredness, fainting, hallucinations.

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

If you have missed your dose for more than a few days, ask your doctor for advice on how to start taking it again.

Do not stop taking Adartrel without advice.

Take Adartrel for as long as your doctor recommends. Do not stop unless your doctor advises you to.

If you suddenly stop taking Adartrel, your Restless leg syndrome symptoms may quickly get much worse.

A sudden stop could cause you to develop a medical condition called neuroleptic malignant syndrome which may represent a major health risk. The symptoms include: akinesia (loss of muscle movement), rigid muscles, fever, unstable blood pressure, tachycardia (increased heart rate), confusion, depressed level of consciousness (e.g. coma).

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

• inability to resist that impulse, drive or temptation to perform an action that could be harmful to you or others, which may include:
  • strong impulse to gamble excessively despite serious personal or family consequences
  • altered or increased sexual interest and behaviour of significant concern to you or to others, for example, an increased sexual drive
  • uncontrollable excessive shopping or spending
  • binge eating (eating large amounts of food in a short time period) or compulsive eating (eating more food than is needed to satisfy your hunger).
• episodes of overactivity, elation or irritability

• Tell your doctor if you experience any of these behaviours; they will discuss ways of managing or reducing the symptoms.

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 via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects, you can help provide more information on the safety of this medicine.

The active substance is ropinirole (as hydrochloride).

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

The other ingredients are:

• tablet core: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, magnesium stearate
• film coat:
  0.25 mg tablet: hypromellose, macrogol 400, titanium dioxide (E171), polysorbate 80 (E433)
  0.5 mg tablet: hypromellose, macrogol 400, titanium dioxide (E171), iron oxide yellow (E172), iron oxide red (E172), indigo carmine aluminium lake (E132)
  2 mg tablet: hypromellose, macrogol 400, titanium dioxide (E171), iron oxide yellow (E172), iron oxide red (E172)

Adartrel 0.25 mg is provided as white, pentagonal-shaped film-coated tablets, marked ‘SB’ on one side and ‘4890’ on the other. Each pack contains 12 tablets.

Adartrel 0.5 mg is provided as yellow, pentagonal-shaped film-coated tablets marked ‘SB’ on one side and ‘4891’ on the other. Each pack contains 28 tablets.

Adartrel 2 mg is provided as pink, pentagonal-shaped film-coated tablets marked ‘SB’ on one side and ‘4893’ on the other. Each pack contains 28 tablets.