SCHEDULING STATUS
S1
Product Name
SCOPEX TABLETS, 10 mg, film-coated tablets
Active Ingredient
Hyoscine Butylbromide
Sugar Information
SCOPEX TABLETS contains sugar: Lactose 32 mg.
Read Before Taking SCOPEX TABLETS
SCOPEX TABLETS is available without a doctor’s prescription for the treatment of a mild illness.
Nevertheless, SCOPEX TABLETS should still be used carefully to get the best results.
Keep this information because it may be needed again.
Do not share SCOPEX TABLETS with any other person.
Ask your health care provider or pharmacist if more information or advice is needed.
A doctor should be consulted if symptoms worsen or do not improve after 10 days.
What Is in This Article
- What SCOPEX TABLETS is and what it is used for
- What you need to know before you take SCOPEX TABLETS
- How to take SCOPEX TABLETS
- Possible side effects
- How to store SCOPEX TABLETS
- Contents of the pack and other information
1. What SCOPEX TABLETS Is and What It Is Used For
SCOPEX TABLETS contains hyoscine butylbromide.
It is used in the treatment of conditions associated with gastrointestinal spasm.
2. What You Need to Know Before You Take SCOPEX TABLETS
Do Not Take SCOPEX TABLETS
Do not take SCOPEX TABLETS if any of the following apply:
| Do not take SCOPEX TABLETS if | Details |
|---|---|
| You are hypersensitive or allergic to hyoscine butylbromide | This includes allergy to the active ingredient |
| You are allergic to any other ingredient of SCOPEX TABLETS | See the contents section |
| You have enlarged prostate | SCOPEX TABLETS should not be used |
| You have paralysis of intestinal muscles | SCOPEX TABLETS should not be used |
| You have narrowing of the opening from the stomach to the first part of the small intestine | SCOPEX TABLETS should not be used |
| You have eye problems | SCOPEX TABLETS should not be used |
| You have a fever | SCOPEX TABLETS should not be used |
| You have myasthenia gravis | This is a muscle weakness problem |
| You have a very fast heart rate | SCOPEX TABLETS should not be used |
| You have other heart problems | SCOPEX TABLETS should not be used |
| You have low or high blood pressure | SCOPEX TABLETS should not be used |
| You develop a life-threatening allergic reaction | This is called anaphylaxis |
Warnings and Precautions
Special Care Should Be Taken With SCOPEX TABLETS
Do not take SCOPEX TABLETS if you have:
| Condition |
|---|
| Diarrhoea |
| Fever |
| A very fast heart rate |
| Enlarged bowel |
In patients with ulcerative colitis, the use of SCOPEX TABLETS may lead to ileus or megacolon.
Its effects on the lower oesophageal sphincter may worsen reflux.
Other Medicines and SCOPEX TABLETS
Always tell your health care provider if you are taking any other medicine. This includes complementary or traditional medicine.
SCOPEX TABLETS should not be taken together with:
| Medicine or medicine group | Use or concern |
|---|---|
| Amantadine | Medicine for Parkinson’s disease and flu |
| Antihistamines | Medicines for allergies and travel sickness |
| Butyrophenones | Interaction risk |
| Phenothiazines | Interaction risk |
| Tricyclic antidepressants | Medicines for depression |
The absorption of other medicines may also be affected because SCOPEX TABLETS can reduce gastric motility.
SCOPEX TABLETS may make you sleepy. This can be worsened by alcohol or other depressants.
SCOPEX TABLETS With Food and Drink and Alcohol
SCOPEX TABLETS may make you sleepy.
This sleepiness can be worsened by taking alcohol or other depressants.
Pregnancy, Breastfeeding and Fertility
Safety in pregnancy, fertility and lactation has not been established.
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor, pharmacist or other health care provider for advice before taking SCOPEX TABLETS.
Driving and Using Machines
SCOPEX TABLETS may make you feel drowsy or sleepy.
Do not drive because SCOPEX TABLETS could interfere with your ability to drive safely.
Do not operate any tools or machines.
Do not climb dangerous heights.
It is not always possible to predict to what extent SCOPEX TABLETS may interfere with daily activities. Patients should make sure they do not engage in these activities until they know how SCOPEX TABLETS affects them.
SCOPEX TABLETS Contains Lactose
SCOPEX TABLETS contains lactose.
Patients with rare hereditary conditions of lactose/fructose or galactose intolerance should not take SCOPEX TABLETS.
SCOPEX TABLETS contains lactose, which may have an effect on the control of blood sugar in patients with diabetes mellitus.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. How to Take SCOPEX TABLETS
Always take SCOPEX TABLETS exactly as described in the patient leaflet or as your doctor or pharmacist has told you.
Check with your doctor or pharmacist if you are not sure.
The Usual Dose Is
| Patient group | Dose |
|---|---|
| Adults | Two tablets, equal to 20 mg, four times daily |
If You Take More SCOPEX TABLETS Than You Should
In the event of overdosage, consult your doctor or pharmacist.
If neither is available, contact the nearest hospital or poison centre.
If You Forget to Take SCOPEX TABLETS
Do not take a double dose to make up for forgotten doses.
If You Stop Taking SCOPEX TABLETS
Not applicable.
4. Possible Side Effects
SCOPEX TABLETS can have side effects.
Not all side effects reported for SCOPEX TABLETS are included here.
If general health worsens or if any untoward effects occur while taking SCOPEX TABLETS, consult a doctor, pharmacist or other healthcare professional for advice.
Side Effects Table
| Frequency | Side effects |
|---|---|
| Less frequent | Dryness of the mouth with difficulty in swallowing or talking |
| Less frequent | Occasional vomiting |
| Less frequent | Thirst |
| Less frequent | Redness and dryness of the skin |
| Less frequent | Reduced heart rate followed by increased heart rate |
| Less frequent | Irregular or fast heartbeat |
| Less frequent | Being unable to pass urine |
| Frequency not known | Dilation of the black centre of the eye |
| Frequency not known | Loss of the eye’s ability to change the point of focus from a distant object to a near object |
| Frequency not known | Sensitivity to light |
| Frequency not known | Confusion |
| Frequency not known | Dizziness |
| Frequency not known | Staggering |
| Frequency not known | Low blood pressure |
| Frequency not known | Inability in a man to get an erection |
| Frequency not known | Reduced bronchial secretions, meaning reduced fluids produced in the bronchial tubes |
| Side effects not listed | Any side effect not mentioned should be reported to a doctor or pharmacist |
Reporting of Side Effects
If side effects occur, talk to your doctor, pharmacist or nurse.
Side effects may also be reported to SAHPRA through the Med Safety App and eReporting platform.
Reporting side effects helps provide more information on the safety of SCOPEX TABLETS.
Side effects may also be reported to Adcock Ingram Limited.
5. How to Store SCOPEX TABLETS
Store all medicines out of reach of children.
Store in an airtight container at or below 25 °C.
Protect from light.
Do not use after the expiry date stated on the label.
6. Contents of the Pack and Other Information
What SCOPEX TABLETS Contains
SCOPEX TABLETS contains the active ingredient hyoscine butylbromide.
Each film-coated tablet contains 10 mg hyoscine butylbromide.
The other ingredients are:
| Other ingredients |
|---|
| Paraben blend |
| Lactose |
| Magnesium stearate |
| Maize starch |
| Opadry II White 85F18422 |
| Opaglos NA – 7150 |
| Purified talc |
What SCOPEX TABLETS Looks Like and Contents of the Pack
SCOPEX TABLETS are white, round, biconvex, coated tablets, and are odourless.
SCOPEX TABLETS are supplied in:
| Pack type | Contents |
|---|---|
| White polypropylene securitainers with white LDPE closures | 10 tablets |
| Blisters using PVC film and printed aluminium foil | 10 tablets |
Holder of Certificate of Registration
Adcock Ingram Limited
1 New Road
Erand Gardens
Midrand
1685
Customer care: 0860 ADCOCK / 232625
This Leaflet Was Revised In
20 January 2025
Registration Number
| Country | Registration number |
|---|---|
| South Africa | C674, Act 101/1965 |
| Namibia | NS1 14/11.2/0140 |
| Botswana | S2 B9323925 |
Medical Disclaimer
This article is intended as patient information based on the approved patient leaflet structure. It does not replace advice from a doctor, pharmacist, nurse or other healthcare provider. For regulated medical product use, follow the approved patient information leaflet and healthcare professional guidance.
