Patient leaflet - Scopoderm 1.5 mg patch
1. What Scopoderm 1.5 mg Patch is and what it is used for
Scopoderm 1.5 mg Patch contains 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. What you need to know before you use Scopoderm 1.5 mg Patch
Do not use Scopoderm 1.5 mg Patch 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).
Warnings and precautions
Talk to you doctor or pharmacist before using Scopoderm 1.5 mg Patch if you:
- suffer from pyloric stenosis (a condition which affects your stomach)
- have problems urinating – for example due to a bladder obstruction or diseases of the prostate
- 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. (Scopoderm 1.5 mg Patch should only be used after an eye examination by a doctor). 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 1.5 mg Patch may be unsuitable for you.
- Remove the patch before a medical scan as aluminium is present in one of the patch layers.
- Do not cut the patch.
- Dispose of used patches carefully.
- Do not apply more than one patch at a time.
- After handling the Scopoderm 1.5 mg Patch you should carefully wash your hands and application site
Children
Scopoderm 1.5 mg Patch is not recommended for use in children under 10 years of age.
Other medicines and Scopoderm 1.5 mg Patch
Tell your doctor or pharmacist if you are taking, have recently taken or might take 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 1.5 mg Patch may interact with them:
- alcohol
- other drugs acting on the brain
- antiallergic medicines
- antidepressants
- antiparkinsons and antivirals
- antiarrhythmics
- other travel sickness medicines.
Scopoderm 1.5 mg Patch with food, drink and alcohol
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
If you are pregnant or breastfeeding, you should talk to your doctor. Do not use 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 1.5 mg Patch may make you feel drowsy, confused or dizzy and may affect your vision or give rise to any other adverse reactions which may adversely affect your reaction. 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 1.5 mg Patch
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Do not exceed the recommended dose.
Adults and the elderly
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 fresh patch behind the other ear. 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.
Use in the elderly
If you are elderly, you may be more prone to suffer from the side-effects of hyoscine (see Section 4: Possible Side Effects).
Use in children
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 1.5 mg Patch 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 experience rise in body temperature after using the Scopoderm Patch you should take immediate action to lower body temperature (cold baths are recommended).
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If you forget to use Scopoderm 1.5 mg Patch
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 1.5 mg Patch
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 1.5 mg Patch can cause side effects, although not everybody gets them.
STOP using Scopoderm 1.5 mg Patch 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 1,000 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
There are some side effects with not known frequency (frequency cannot be estimated from the available data)
- Agitation, co-ordination abnormalities, headache
- Increase in body temperature due to decreased sweating.
- Reactions at the application site such as rash, itching, redness and burning.
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 or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Scopoderm 1.5 mg Patch
- Keep out of the sight and reach of children.
- Do not store above 25°C.
- Do not remove from the protective pouch until you need it.
- Do not use Scopoderm 1.5 mg Patch after the ‘EXP’ date which is stated on the carton and pouch. The ‘EXP’ date refers to the last day of that month.
If your medicine shows visible signs of deterioration, show it to a pharmacist who will advise you what to do.
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. Contents of the pack and other information
What Scopoderm 1.5 mg Patch contains
Each transdermal patch contains a total of 1.5 mg scopolamine (hyoscine).
Average absorption rate: 1 mg scopolamine (hyoscine) in 72 hours.
Ingredients include light mineral oil, polyisobutylene, pigmented MDPE/AI/PET/HS film, polypropylene film and silicone/polyester film.
What Scopoderm 1.5 mg Patch looks like and contents of the pack
Scopoderm 1.5 mg Patch is a flat, round patch 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 sealed aluminium foil/paper pouch. Each cardboard carton contains two patches.
Manufactured by Famar S.A., 48-49th km National Road Athens-Lamia, 19011 Avlonas, Attiki, Greece.
Procured from within the EU by Product Licence holder: Star Pharmaceuticals Ltd, 5 Sandridge Close, Harrow, Middlesex,
HA1 1XD. Repackaged by Servipharm Ltd.
Leaflet revision and issue date (Ref.) 27.01.25[2]
Scopoderm is a trademark of Novartis AG.
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