Patient leaflet - SETOFILM 4 MG ORODISPERSIBLE FILMS
Package Leaflet: Information for the user
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
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– Keep this leaflet. You may need to read it again.
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– If you have any further questions, ask your doctor, nurse or pharmacist.
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– 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.
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– If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
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1. What Setofilm is and what it is used for
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2. What you need to know before you use Setofilm
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3. How to use Setofilm
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4. Possible side effects
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5. How to store Setofilm
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6. Contents of the pack and other information
The name of your medicine is Setofilm 4mg Orodispersible Films but will be referred to as Setofilm throughout the remainder of this leaflet.
Your medicine is also available in an 8mg orodispersible film.
1. what setofilm is and what it is used for
- rifampicin (for treating serious bacterial infections, like TB)
- antibiotics such as erythromycin
- antifungal agents such as ketoconazole
- tramadol (for managing pain)
- anti-arrhythmics (used to treat irregular or fast heart beat) beta-blockers (used to treat certain heart or eye problems, anxiety or prevent migraines)
- medicines that can affect the heart (such as haloperidol or methadone)
- cancer medicines (especially anthracyclines and trastuzumab)
- SSRIs (selective serotonin reuptake inhibitors) used to treat depression and/or anxiety including fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram
- SNRIs (serotonin noradrenaline reuptake inhibitors) used to treat depression and/or anxiety including venlafaxine, duloxetine.
If you are not sure if any of the above applies to you, talk to your doctor, nurse or pharmacist before having Setofilm.
Setofilm with food and drink
You may take Setofilm with food and drink.
Pregnancy and breast-feeding
Pregnancy:
Only use Setofilm during the first trimester of pregnancy after discussion with your doctor of the potential benefits and risks to you and your unborn baby of the different treatment options. This is because Setofilm can slightly increase the risk of a baby being born with cleft lip and/or cleft palate (openings or splits in the upper lip and/or the roof of the mouth). If you are already pregnant, think you might be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking Setofilm. If you are a woman of childbearing potential you may be advised to use effective contraception.
Breast-feeding:
You should not breast-feed whilst using Setofilm as it can pass into your breast milk.
Driving and using machines
Setofilm has little or no effect on your ability to drive or use machines.
3. how to use setofilm
Always use Setofilm exactly as your doctor or pharmacist has told you. Check with your doctor, or pharmacist if you are not sure. Setofilm is for oral use only. It may be recommended for patients who may have problems with taking or swallowing tablets; for example children or elderly.
- Remove Setofilm orodispersible film from each individual sachet taking care not to damage the film as follows: Open the sachet only at the tear tag and tear this off slowly. Do not cut the sachet.
- Before use check the film for damage as you should only use undamaged films.
- Ensure the mouth is empty (and your fingers are dry) before placing Setofilm orodispersible film on to the tongue.
- The film should disintegrate on your tongue without water in a few seconds (in saliva which can be subsequently swallowed).
Treatment and prevention of sickness (nausea and vomiting) in patients receiving chemotherapy or radiotherapy
Elderly:
Setofilm is well tolerated by elderly patients. They may take the same dosage as adults (see below).
Adults:
8mg 1–2 hours before chemotherapy or radiotherapy, followed by 8mg every 12 hours for up to 5 days. Your doctor may recommend that your first dose is given by injection.
Children (aged 6 months and over) and adolescents (<18 years):
Your doctor will recommend what dose of ondansetron should be given. The individualised dose will depend on the weight or body surface area of the child.
Prevention and treatment of post-operative sickness (nausea and vomiting).
Elderly:
Ondansetron is well tolerated by elderly patients. They may take the same dosage as adults; see below.
Adults:
Take 16mg of Setofilm 1 hour before your operation or 8mg administered one hour before your operation, followed by two further doses of 8mg 8 hours apart as directed by your doctor.
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Children aged over 4 years and adolescents:
In children weighing 40kg and above, take 4mg of Setofilm 1 hour before your operation, followed by one further dose of 4mg after 12 hours.
Liver dysfunction:
Do not take more than 8mg of ondansetron daily if your liver does not work properly (moderate to severe liver problems).
If you take more Setofilm than you should
Contact your doctor, or go to the hospital immediately if you or your child have taken more Setofilm than recommended in this package leaflet or than prescribed by your doctor. Take the medicine pack with you.
If you forget to take Setofilm
If you forget to take Setofilm and feel sick or vomit
- Take a dose of Setofilm as soon as possible
- Take your next dose of Setofilm at the usual time
- Do not take a double dose to make up for a forgotten dose
If you miss a dose but do not feel sick or vomit
- Take the next dose
- Do not take a double dose to make up for the forgotten dose
If you stop taking Setofilm
If you feel unwell and stop taking Setofilm tell your doctor or nurse as soon as possible.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
4. possible side effects
Like all medicines, Setofilm can cause side effects, although not everybody gets them.
Allergic reactions:
If you have an allergic reaction, stop taking Setofilm and immediately contact your doctor or go to the nearest hospital. The signs of an allergic reaction may include:
- Sudden wheezing and chest pain or chest tightness
- Severe itching of the skin
- Skin rash – red spots or lumps under your skin (hives) anywhere on your body
- Swelling of the eyelids, throat, face, lips, tongue or mouth
- Difficulty in breathing or swallowing
- Collapse
Other side effects include:
Very common side effects (affects more than 1 in 10 people)
- Headache
- Sensation of warmth or flushing
- Constipation; tell your doctor, if you have crampy abdominal pain or difficulty in passing stools. They will need to monitor you carefully to see how the treatment is affecting you.
Uncommon side effects (affects less than 1 in 100 people)
- Hiccups
- Low blood pressure, which may make you feel faint or dizzy
- Palpitations (conscious awareness of heart beat) or irregular or slow heart beat
- Chest pain
- Fits (convulsions)
- Unusual unintentional eye or body movements or shaking
- Changes to liver function test results (changes are more common if you take ondansetron with a medicine called Cisplatin).
- Allergic reactions, sometimes severe, including anaphylaxis
- Feeling dizzy or lightheaded [when ondansetron is given intravenously (i.e. through a tube in your vein)]
- Blurred vision or temporary loss of eyesight, (predominantly when ondansetron is given intravenously) which normally comes back within 20 minutes
- Disturbance in heart rhythm and ECG changes, including a special form of heart rhythm disorder called Torsade de Pointes, (sometimes causing sudden loss of consciousness)
Very rare (affects less than 1 in 10,000 people)
- Temporary visual disturbances e.g. blurred vision (predominantly when ondansetron is given intravenously)
- A widespread rash with blisters and skin peeling on much of the body surface (toxic epidermal necrolysis)
5. how to store setofilm
Keep out of the sight and reach of children.
Keep the sachet tightly closed to protect from moisture.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date is the last day of the month indicated.
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.
If your medicine shows any signs of discolouration or deterioration consult your pharmacist for advice.
6. contents of the pack and other information
The active substance is ondansetron. Each film contains 4mg of ondansetron.
The other ingredients are: polyvinyl alcohol, macrogol 1000, acesulfame potassium (E950), glycerol (E422), titanium dioxide (E171), rice starch, levomenthol and polysorbate 80 (E433).
What Setofilm looks like and contents of the pack
Setofilm 4mg are white, rectangular (3cm2 in size) orodispersible films.
Setofilm 4mg orodispersible films are supplied in sachets.
Available in boxes containing 10 sachets.
Manufactured by: LTS Lohmann Therapie-Systeme AG, Lohmannstrasse 2, D-56626 Andernarch, Germany.
Procured from within the EU. Product Licence Holder: Quadrant Pharmaceuticals Ltd, Lynstock House, Lynstock Way, Lostock, Bolton, BL6 4SA. Repackaged by Maxearn Ltd, Unit 29, Oakhill Trading Estate, Devonshire Road, Worsley, Manchester, M28 3PT
PL 20774/2463 Setofilm 4mg Orodispersible Films
Date of preparation 6th October 2021
POM
Setofilm is a registered trademark of Norgine Ltd.
Blind or partially sighted?
Is this leaflet hard to see or read? Contact Quadrant Pharmaceuticals Ltd, Tel: 01204 471269
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