SCOPODERM 1.5 MG PATCH - patient leaflet, side effects, dosage

Scopoderm 1.5mg Patch

(hyoscine)

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

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.

The name of your medicine may be known by any of the above names but will be referred to as Scopoderm 1.5mg Patch throughout this leaflet.

What is in this leaflet

• 1. What Scopoderm 1.5mg Patch are and what they are used for

• 2. What you need to know before you use Scopoderm 1.5mg Patch

• 3. How to use Scopoderm 1.5mg Patch

• 4. Possible side effects

• 5. How to store Scopoderm 1.5mg Patch

• 6. Contents of the pack and other information

1. what scopoderm 1.5mg patch is and what it is used for

Scopoderm 1.5mg Patch 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. what you need to know before you use scopoderm 1.5mg patch

Do not use Scopoderm 1.5mg 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 1.5mg Patch 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. (Scopoderm 1.5mg 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 1.5mg 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.

Children

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

Other medicines and Scopoderm 1.5mg 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 may interact with them:

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

Scopoderm 1.5mg Patch with food, drink and alcohol

Do not drink alcohol whilst using the patch or until the effects of the patch 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 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 Patch 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 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 1.5mg 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 forget to use Scopoderm 1.5mg 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 1.5mg 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 1.5mg Patch can cause side effects, although not everybody gets them.

STOP using Scopoderm 1.5mg 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

Not known (frequency cannot be estimated from the available data)

• Reactions at the application site such as 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: 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 1.5mg patch

• Keep this medicine out of the sight and reach 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 Patch 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.

6. contents of the pack and other information

What Scopoderm 1.5mg Patch 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 ingredient is polyisobutylene.

The patch material contains: pigmented PE/AL/PET/HE, light mineral oil, polyester siliconised and polypropylene film.

What Scopoderm 1.5mg Patch look like and contents of the pack

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.

Manufacturer

GlaxoSmithKline Consumer Healthcare GmbH & Co. KG, 80258 Munich, Germany.

Procured from within the EU.

Product Licence Holder and Repackaged by:

Cross Healthcare Ltd,

Unit 2a, Bandeath Industrial Estate,

Throsk,

Stirlking.

FK7 7NP.

PL: 20 504/0092 Scopoderm® 1.5 mg Patch

P

Scopoderm® is a registered trademark of GlaxoSmithKline Consumer Healthcare (UK) Trading Limited, Brentford, TW8 9GS, UK.

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Call 01786–817717 (Regulatory Department)
to obtain the leaflet in a format suitable for you.

This leaflet was last revised on the 03rd July 2019.

LFSCO0092CR-03/07/2019-R01