What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Below is a text only representation of the Patient Information Leaflet. The original can be viewed in PDF format using the link above.

The text only version may be available from RNIB in large print, Braille or audio CD. For further information call RNIB Medicine Leaflet Line on 0800 198 5000. The product code(s) for this leaflet is: PL 15142 / 0028.

Nabilone 1mg Capsules

PATIENT INFORMATION LEAFLET

Nabilone 1 mg Capsules

(nabilone)

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. It may harm them, even if their symptoms are the same as yours.
  • If you experience any side effect and this becomes serious, tell your doctor or pharmacist.

In this leaflet:

1. What Nabilone is and what it is used for
2. Before you take Nabilone Capsules
3. How to take Nabilone Capsules
4. Possible side effects
5. How to store Nabilone Capsules
6. Further information

1. WHAT NABILONE IS AND WHAT IT IS USED FOR

Nabilone is a medicine that helps to reduce nausea and vomiting caused by many anticancer medicines.

Nabilone is often used when other medicines have not helped your nausea or vomiting.

Nabilone is a man-made chemical known as a cannabinoid. It is not made from the Cannabis plant but it is similar to some marijuana extracts and can cause similar effects.

2. BEFORE YOU TAKE NABILONE CAPSULES

Do not take Nabilone

  • If you are allergic (hypersensitive) to any of the other ingredients of Nabilone Capsules (these are listed in section 6, “Further Information”).
  • If your nausea / vomiting is not due to anticancer treatment.
  • If you are under 18 years. Nabilone is not meant for children.

Take special care with Nabilone

It is best if you take Nabilone Capsules in hospital, as you may experience side effects.

Tell your doctor before you start treatment if you have any of the following problems or if you develop any of these during treatment:

  • Any liver problems.
  • High blood pressure or any other heart problem.
  • Any mental illness, for example depression or schizophrenia.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

In particular, tell your doctor if you are taking any sleeping pills, pain killers or tranquillisers.

Taking Nabilone with alcohol

Do not drink alcohol while you are taking Nabilone.

Pregnancy and breast-feeding

Tell your doctor before you start treatment

  • If you are pregnant, if you think that you are pregnant, or if you intend to become pregnant.
  • If you are breast-feeding or planning to breast-feed.

Your doctor will then decide if you can take this medicine.

Driving and using machines

Nabilone Capsules may cause side effects such as sleepiness, confusion, hallucinations, a feeling of dizziness or spinning, poor muscle co-ordination, problems with your sight and problems with concentration. These side effects may occur up to 3 days after taking Nabilone. This may affect your ability to operate machinery. Do not operate machinery if you experience any of these side effects.

The medicine can affect your ability to drive as it may make you sleepy or dizzy.

Do not drive while taking this medicine until you know how it affects you.

It is an offence to drive if this medicine affects your ability to drive.

However, you would not be committing an offence if: -

The medicine has been prescribed to treat a medical or dental problem and

  • You have taken it according to the instructions given by the prescriber or in the information provided with the medicine and
  • It was not affecting your ability to drive safely

Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.

3. HOW TO TAKE NABILONE CAPSULES

Always take Nabilone exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure how to take it. Your doctor will usually start you on the lowest possible dose.

It is best if you take Nabilone Capsules in hospital, especially the first time that you take Nabilone. This is because you may experience side effects.

The hospital doctor or nurse may give you your first dose the night before you start chemotherapy and the second dose one to three hours before it begins.

Swallow the capsules with water.

Dose

  • The usual dose is 1 or 2 capsules twice a day.
  • You should never take more than 2 capsules three times a day. You can take Nabilone while you are having chemotherapy treatment and for up to 2 days after your last dose of chemotherapy.

The dosing recommendations for elderly patients are the same as for other adults.

If you take more Nabilone than you should

If you ever take too many capsules, tell your doctor or get someone to take you to the nearest hospital casualty department immediately together with your medicine to show to the doctor.

If you forget to take Nabilone

If you miss a dose, wait until it is time for the next dose, and then continue as before.

Do not take a double dose to make up for a forgotten dose.

4. POSSIBLE SIDE EFFECTS

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

Side effects that you may experience are:

  • Feeling sleepy, relaxed, or “high”. A few patients have had hallucinations, felt confused, depressed, anxious or had other changes in their mood or mental state.
  • A feeling of dizziness or spinning, especially when you stand up.
  • Poor muscle co-ordination.
  • Dry mouth, problems with your sight or concentration, difficulty sleeping, or headaches.
  • Shaking, a faster heart beat than normal, low blood pressure, losing your appetite and stomach pains.

Any changes in your mood, such as feeling depressed, relaxed or “high”, may last for 2 or 3 days after you stop taking Nabilone. You may find that you get used to these feelings.

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 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.

5. HOW TO STORE NABILONE CAPSULES

  • Keep Nabilone Capsules out of the reach and sight of children.
  • Do not use Nabilone after the expiry date which is stated on the bottle and carton after “EXP”. The expiry date refers to the last day of that month.
  • Keep the container tightly closed.
  • Store your capsules at room temperature (15-25°C) in a dry place.
  • If your doctor tells you to stop taking the capsules, please take them back to the pharmacist. Medicines should not be disposed of via wastewater or household waste.
  • Only keep the capsules if your doctor tells you to.

6. FURTHER INFORMATION

What Nabilone contains

Active substance: Nabilone. Each capsule contains 1 mg of nabilone.

Other ingredients: Povidone, starch, gelatin and the colourants E132, E172 and E171.

What Nabilone looks like and contents of the pack

  • Nabilone capsules are blue and white and have CL 3101 printed on them.
  • Each bottle or blister pack of Nabilone contains 20 capsules.

Marketing Authorisation Holder

Meda Pharmaceuticals Ltd.
Skyway House
Parsonage Road
Takeley
Bishop's Stortford
CM22 6PU
UK

Manufacturer

Dales Pharmaceuticals Limited
Snaygill Industrial Estate
Keighley Road
Skipton
North Yorkshire
BD23 2RW
UK

For any information about this medicine, please contact the Marketing Authorisation Holder.

This leaflet was last revised in May 2014.

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