Scopoderm 1.5 Mg Patch
PACKAGE LEAFLET: INFORMATION FOR THE USER
Scopoderm 1.5mg Patches
Hyoscine 1.5mg
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
This medicine is available without prescription. However you still need to use Scopoderm 1.5mg Patches carefully to get the best results from them.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist if you need more information or advice.
- You must contact a doctor if your symptoms worsen or do not improve.
- If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet:
1. What Scopoderm 1.5mg Patches are and what they are used for
2. Before you use Scopoderm 1.5mg Patches
3. How to use Scopoderm 1.5mg Patches
4. Possible side effects
5. How to store Scopoderm 1.5mg Patches
6. Further information
1. What Scopoderm 1.5mg Patches are and what they are used for
Scopoderm 1.5mg Patches contain the active substance hyoscine which belongs to the group of medicines called anti-emetics or anti-sickness medicines. They are used to prevent the symptoms of motion sickness such as nausea (feeling sick), vomiting (being sick) and vertigo (loss of balance), which can occur when travelling by boat, train or car. Travel sickness occurs when your body's internal balancing system becomes confused by receiving different messages - your eyes say one thing about the position of your body, but your balance mechanisms tell you differently. Anyone can suffer from travel sickness: children are more prone but often grow out of it as they get older.
2. Before you use Scopoderm 1.5mg Patches
Do not use Scopoderm 1.5mg Patches if you:
• have glaucoma or a history of glaucoma (pressure behind the eye)
• are allergic (hypersensitive) to hyoscine or any of the other ingredients in the patch (see Section 6).
Take special care with Scopoderm 1.5mg Patches if you:
• suffer from pyloric stenosis (a condition which affects your stomach)
• have problems urinating due to a bladder obstruction
• have a blockage of your intestines
• are an elderly patient or have any metabolic, liver or kidney disease
• suffer from epilepsy (increased number of fits have been reported)
• have had pain in the eyes, blurred vision, or see rainbow-coloured halos around light.
Care should be taken after removal of the patch as side effects may persist for up to 24 hours or longer under these circumstances, Scopoderm 1.5mg patches may be unsuitable for you.
Remove the patch before a medical scan as aluminium is present in one of the patch layers.
Scopoderm 1.5mg patches are not recommended for use in children under 10 years of age.
Taking other medicines with Scopoderm 1.5mg Patches
Please tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines, including those obtained without a prescription.
In particular, tell your doctor if you are taking any of the following medicines, because Scopoderm may interact with them:
• alcohol
• other drugs acting on the brain
• antiallergic medicines
• antidepressants
• antiparkinsons and antivirals
• antiarrhythmics
• other travel sickness medicines.
Using Scopoderm 1.5mg Patches with food and drink
Do not drink alcohol whilst using the patches or until the effects of the patches have worn off (this may last up to 24 hours or longer from the time you have removed it).
Pregnancy and breast-feeding
Do not use Scopoderm 1.5mg Patches during pregnancy and breast-feeding unless your doctor advises you to.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Scopoderm 1.5mg Patches may make you feel drowsy, confused or dizzy and may affect your vision. Do not drive, operate any machinery or perform any activity that requires concentration. Care should be taken after removal of the patch as these effects may persist for up to 24 hours or longer.
3. How to use Scopoderm 1.5mg Patches
Always use the patches exactly as described in this leaflet or as your doctor or pharmacist have told you.
Adults
One patch should be applied about 5-6 hours before leaving on your journey (or the evening before) to a clean, dry, hairless area of intact skin behind the ear.
1. Remove the patch from the sachet. Peel off the clear, hexagonal plastic backing, holding the patch by its edge so as not to touch the sticky side (Figure 1).
2. Press the silver coloured sticky side of the patch firmly on to a clean, dry, hairless area of skin behind the ear (Figure 2). Avoid areas of skin that are cut or irritated in any way.
3. Wash your hands thoroughly after applying the patch. Do not touch the patch once it is in place as you may get the active ingredient on your fingers. If you do touch the patch, wash your hands immediately. Do not get the active ingredient near your eyes. If you get hyoscine on your fingers then touch your eyes, your vision may be temporarily affected.
4. Once your journey is over, take the patch off and dispose of it carefully.
5. When you take a patch off wash your hands and also the area of skin where the patch has been.
Each patch will last for up to 3 days. If you are travelling for more than three days, take the patch off after 3 days and apply a new one. You can swim, bathe or shower with little risk of the patch coming off, provided that you have applied the patch properly. However, it is best not to stay in the water too long. If the patch accidentally comes off, dispose of it carefully and put on a new patch.
Elderly
Scopoderm 1.5mg Patches may be used in the elderly (see dosage for adults) although they may be more prone to suffer from the side-effects of hyoscine (see Section 4: Possible Side Effects).
Children
Scopoderm 1.5mg patches can be used in children aged 10 years or over (see dosage for adults).
The use of these patches is not recommended in younger children. See your doctor or pharmacist for alternative medicines.
If you use more Scopoderm 1.5mg Patches than you should
If you accidentally use too many patches, you may feel restless, excited or confused. In cases of higher overdose, you may become disorientated, hallucinate or have fits. In severe cases of overdose, coma and breathing difficulties may occur. Remove the patch /patches immediately, and tell your doctor or go to your nearest casualty department immediately. Take any remaining patches with you.
If you forget to use Scopoderm 1.5mg Patches
If you forget to put a patch on, apply it as soon as you remember. Do not apply two patches at once to make up for the one that you forgot.
If you stop using Scopoderm TTS Patches
In rare cases - usually after several days of use - symptoms such as dizziness, nausea (feeling sick), vomiting (being sick), headache and disturbances of balance have been reported after discontinuation of the treatment. These symptoms are more likely to occur if you have been wearing a patch for several days. If you are affected in this way, avoid any activities requiring concentration, e.g. driving, or operating machinery, until your symptoms have worn off and consult a doctor.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Scopoderm 1.5mg Patches can cause side effects, although not everybody gets them.
STOP using Scopoderm TTS and seek medical help immediately if you or your child has any of the following which may be signs of an allergic reaction:
• difficulty in breathing or swallowing
• swelling of the face, lips, tongue or throat
• severe itching of the skin, with a red rash or raised bumps
Some side effects could be serious which are very rare (may affect 1 in every 10,000 people)
• Changes in vision with increased pressure in the eye (possible signs of glaucoma)
If you experience this, tell your doctor straight away.
Some side effects are very common (may affect more than 1 in 10 people)
• dryness of the mouth.
• drowsiness, dizziness
• Frequently blurring of (near) vision and enlargement of the pupils (sometimes in one eye only),
• loss of ability to focus on close or far objects (visual accommodation)
Some side effects are common (may affect between 1 and 10 in every 100 people)
• irritation of the eyelids
• skin irritation
Some side effects are rare (may affect between 1 and 10 in every 10,000 people)
• difficulty in passing water (urinating)
• impairment of memory or concentration, restlessness, disorientation, confusion, or hallucinations.
Some side effects are very rare (may affect less than 1 in every 10,000 people)
• skin rash
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 affects you can help provide more information on the safety of this medicine.
5. How to store Scopoderm 1.5mg Patches
Keep out of the reach and sight of children.
Do not store above 25°C.
Do not freeze the patches.
Do not remove from the protective pouch until you need it.
Do not use Scopoderm 1.5mg Patches after the ‘Use By' date which is stated on the carton and pouch. The ‘Use By' date refers to the last day of that month.
The transdermal patch should be folded in half (sticky side inwards) before being discarded. 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. Further information
What Scopoderm 1.5mg Patches contain
The active ingredient in each patch is hyoscine 1.5mg (the average amount of hyoscine absorbed from each patch in 72 hours is 1mg).
The other ingredients are light mineral oil, polyisobutylene and polypropylene .
What Scopoderm 1.5mg Patches look like and contents of the pack
Scopoderm TTS patches are flat, round patches approximately 1.8 cm in diameter. One side of the patch is tan; the other side is silver and is placed on an oversized clear hexagonal film. Each patch is individually packed into a foil pouch. Each cardboard carton contains two patches.
Marketing Authorisation Holder
Novartis Consumer Health UK Limited Park View, Riverside Way Watchmoor Park, Camberley Surrey, GU15 3YL
Manufacturer
Famar S.A.
48th KM National Road, Athens-Lamia Avlonas Attiki, GR-190 11, Greece
For any information about this medicinal product, please contact the Marketing Authorisation Holder.
This leaflet was last approved in November 2013.