Scopoderm 1.5mg Patch

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• 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.
• You must talk to a doctor if you do not feel better or if you feel worse.

1. What Scopoderm 1.5mg Patches are and what they are used for
2. What you need to know 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. Contents of the pack and other information

• 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).

Talk to you doctor or pharmacist before using Scopoderm 1.5mg Patches 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 1.5mg Patches 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 1.5mg patches 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 patch you should carefully wash your hands and application site

Scopoderm 1.5mg patches are not recommended for use in children under 10 years of age.

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 may interact with them:

• alcohol
• other drugs acting on the brain
• antiallergic medicines
• antidepressants
• antiparkinsons and antivirals
• antiarrhythmics
• other travel sickness medicines.

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).

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.

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 or engage in any other activities in which such symptoms could be dangerous (see possible side-effects). Care should be taken after removal of the patch as these effects may persist for up to 24 hours or longer.

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.

If you are elderly, you may be more prone to suffer from the side-effects of hyoscine (see Section 4: Possible Side Effects).

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 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 a rise in body temperature after using the Scopoderm Patch you should take immediate action to lower body temperature in addition to seeking medical help and removing the 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.

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.

• 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
• Reactions at the application site such as rash, itching, redness and burning.

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.

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.

Scopoderm 1.5mg 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.