SCHEDULING STATUS
S4
PROPRIETARY NAME, STRENGTH AND PHARMACEUTICAL FORM
MISOPROSTOL PFIZER® tablets
Read Before Taking MISOPROSTOL PFIZER
Read this information carefully before you start to take MISOPROSTOL PFIZER.
Keep this information because you may need to read it again.
If you have further questions, ask your doctor or pharmacist.
MISOPROSTOL PFIZER has been prescribed for you personally and should not be shared with other people. It may harm them, even if their symptoms are the same as yours.
1. What MISOPROSTOL PFIZER Contains
The active ingredient of MISOPROSTOL PFIZER is misoprostol.
The inactive ingredients include:
| Inactive ingredients |
|---|
| Microcrystalline cellulose |
| Sodium starch glycolate |
| Hydrogenated castor oil |
2. What MISOPROSTOL PFIZER Is Used For
MISOPROSTOL PFIZER is used together with non-steroidal anti-inflammatory drugs, also called NSAIDs.
It is used for the prevention of:
| NSAID-induced condition |
|---|
| Gastric ulcers |
| Duodenal ulcers |
| Haemorrhagic lesions |
| Erosions |
3. Before You Take MISOPROSTOL PFIZER
If you take medicines regularly, using MISOPROSTOL PFIZER together with other medicines may cause undesirable interactions.
Consult your doctor, pharmacist or other healthcare professional for advice.
Do Not Take MISOPROSTOL PFIZER
Do not take MISOPROSTOL PFIZER if any of the following apply:
| Do not take MISOPROSTOL PFIZER if | Details |
|---|---|
| You are pregnant | MISOPROSTOL PFIZER should not be used during pregnancy |
| You are breastfeeding | MISOPROSTOL PFIZER should not be used while breastfeeding |
| You are allergic to misoprostol | This includes allergy to the active ingredient |
| You are allergic to other prostaglandins | This may increase the risk of allergic reaction |
| You are allergic to any other ingredient in MISOPROSTOL PFIZER | See the ingredients section |
Take Special Care With MISOPROSTOL PFIZER
Some people need special care from their doctors when taking MISOPROSTOL PFIZER.
Talk to your doctor or pharmacist before taking MISOPROSTOL PFIZER if any of the following apply:
| Question to consider before taking MISOPROSTOL PFIZER |
|---|
| Have you ever had a reaction to misoprostol or any of its ingredients? |
| Are you pregnant, trying to become pregnant, or breast-feeding? |
| Do you suffer from diarrhoea? |
| Do you suffer from dehydration? |
| Do you suffer from inflammatory bowel disease? |
| Do you suffer from low blood pressure? |
MISOPROSTOL PFIZER may not be suitable if the answer to any of these questions is “yes”.
Taking Other Medicines With MISOPROSTOL PFIZER
MISOPROSTOL PFIZER may affect the action of other medicines, and other medicines may affect MISOPROSTOL PFIZER.
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines that were not prescribed and herbal medicines.
4. How to Use MISOPROSTOL PFIZER
Always take MISOPROSTOL PFIZER exactly as your doctor has instructed you.
Your doctor will decide the correct dose for you.
Check with your doctor or pharmacist if you are unsure.
MISOPROSTOL PFIZER is available as a tablet.
Take the tablet as prescribed by your doctor.
If You Take More MISOPROSTOL PFIZER Tablets Than You Should
If you accidentally take too many tablets, speak to your doctor straight away.
You may require medical attention.
If You Forget to Take MISOPROSTOL PFIZER Tablets
Do not take a double dose to make up for a forgotten dose.
5. Possible Side Effects
MISOPROSTOL PFIZER can have side effects.
If your general health worsens while taking MISOPROSTOL PFIZER, consult your doctor, pharmacist or other healthcare professional for advice.
Side Effects Table
| Side-effect category | Side effects / symptoms | Recommended action |
|---|---|---|
| Other side effects | Dizziness | Tell your doctor if this occurs |
| Other side effects | Headache | Tell your doctor if this occurs |
| Other side effects | Diarrhoea | Tell your doctor if this occurs |
| Other side effects | Abdominal pain | Tell your doctor if this occurs |
| Other side effects | Nausea | Tell your doctor if this occurs |
| Other side effects | Vomiting | Tell your doctor if this occurs |
| Other side effects | Vaginal bleeding | Tell your doctor if this occurs |
| Other side effects | Menstrual disorder | Tell your doctor if this occurs |
| Side effects not listed | Any other effects while on MISOPROSTOL PFIZER treatment | Tell your doctor |
6. Storing and Disposing of MISOPROSTOL PFIZER
Store MISOPROSTOL PFIZER tablets out of reach and sight of children.
This medicine is for you. Only a doctor can prescribe it for you.
Do not share it with anyone else. It may harm them, even if they have the same symptoms as you.
Do not use MISOPROSTOL PFIZER after the expiry date printed on the label.
Return all unused medicine to your pharmacist.
Do not dispose of unused medicine in drains or sewerage systems, including toilets.
7. Presentation of MISOPROSTOL PFIZER
MISOPROSTOL PFIZER tablets are supplied in blister packs of 60 or 120 tablets, packed in cartons.
8. Identification of MISOPROSTOL PFIZER
MISOPROSTOL PFIZER tablets are white, scored, uncoated, flat, hexagonal-shaped tablets, debossed on one side “Searle” over “1461”.
9. Registration Number
S/11.10/392
10. Name and Address of Registration Holder
Pfizer Laboratories (Pty) Ltd.
85 Bute Lane
Sandton 2196
South Africa
11. Date of Publication of This Patient Leaflet
25 November 2011
Medical Disclaimer
This article is intended as patient information based on the approved leaflet structure. It does not replace advice from a doctor, pharmacist or other healthcare professional. For regulated medical product use, follow the approved patient information leaflet and healthcare professional guidance.
