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Propulsid the most important consumer information:

Brand name : PREPULSID™ - Prepulsid (Propulsid, Cisapride)
Common questions about PREPULSID Tablets and Suspension.

It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist.If you have any concerns about using PREPULSID, ask your doctor or pharmacist.

Your doctor and pharmacist have more information. Keep this leaflet with your PREPULSID. You may need to read it again.
What PREPULSID is used for

PREPULSID is used to treat : CIPLACTIN (Cyproheptadine, Periactin) Severe reflux oesophagitis - The burning indigestion pain caused when the acidic stomach contents flow the wrong way back up the gullet. Your doctor can only prescribe PREPULSID for this condition after other treatments, including medicines called "proton pump inhibitors", have failed to bring relief.
CIPLACTIN (Cyproheptadine, Periactin) Gastroparesis - The discomfort caused by a slow working stomach. For example, the inability to finish a meal, a feeling of being "too full" or bloated after a meal, a loss of appetite, feeling sick and maybe vomiting, or belching without relief.
CIPLACTIN (Cyproheptadine, Periactin) Severe gastro-oesophageal reflux in children - The discomfort caused to babies and children when they continually bring up their stomach contents after feeding.A specialist physician or surgeon will have confirmed that you, or your child, have one of these conditions .PREPULSID works by strengthening the muscle contractions of the digestive system. Food then moves through the stomach more easily.

PREPULSID has been approved for the uses listed above. However, your doctor may prescribe this medicine for another use. If you would like more information ask your doctor.
Before you use PREPULSID
When you must not use it

Do not use PREPULSID if you know you are allergic to any of the ingredients. (See the last section of this leaflet for a list of ingredients). Signs of allergy include a skin rash, itching, shortness of breath and/or a swollen face.

Do not use PREPULSID:

CIPLACTIN (Cyproheptadine, Periactin) if you know you have a rare heart disorder known as a QT-prolongation. Sometimes this runs in the family;
CIPLACTIN (Cyproheptadine, Periactin) if you know you have a very slow heart beat.
CIPLACTIN (Cyproheptadine, Periactin) in babies born 6 weeks or more prematurely, for the first three months after delivery.

Your doctor will not prescribe PREPULSID if an increase in muscle contractions of the digestive system could harm you. For example, if you have had bleeding, a blockage or puncture in your stomach or bowel.

Do not use PREPULSID with any of the following when either taken by mouth or given by injection:

CIPLACTIN (Cyproheptadine, Periactin) certain medicines called azoles, used to treat fungal infections. Examples of azoles are ketoconazole, itraconazole, miconazole and fluconazole;
CIPLACTIN (Cyproheptadine, Periactin) certain antibiotics called macrolides, such as erythromycin, clarithromycin and troleandomycin;
CIPLACTIN (Cyproheptadine, Periactin) certain antidepressants, such as nefazodone, amitriptylline and maprotiline.
CIPLACTIN (Cyproheptadine, Periactin) certain medicines used to treat mental illness, such as chlorpromazine, pimozide and sertindole;
CIPLACTIN (Cyproheptadine, Periactin) certain medicines that act on the heart, such as quinidine, disopyramide, procainamide, amiodarone, sotalol and bepridil;
CIPLACTIN (Cyproheptadine, Periactin) certain antihistamines, such as astemizole and terfenadine;
CIPLACTIN (Cyproheptadine, Periactin) certain medicines used to treat AIDS such as ritonavir and indinavir.
CIPLACTIN (Cyproheptadine, Periactin) the antimalarial halofantrine;
CIPLACTIN (Cyproheptadine, Periactin) the antibacterial sparfloxacin.

It is important to ensure that your doctor knows about your personal and family medical history. If you have not told your doctor or pharmacist about any of the above, tell them before you start taking or are given PREPULSID.Your doctor will advise you whether or not to take PREPULSID or if you need to adjust the dose, or adapt your treatment. Other medicines and alcoholMedicines that you should not take by mouth or receive by injection whilst you are using PREPULSID are listed above under the heading " When you must not use it ".

Tell your doctor if you are taking any medicines that slow down blood clotting (anticoagulants) because PREPULSID may increase their effect.

PREPULSID can speed up and increase the sedative effects of alcohol and sleeping tablets. Be careful and tell your doctor if you are taking any of these products with PREPULSID.

Tell your doctor if you are taking any medicines to slow down the stomach or bowel as they may reduce or cancel the effect of PREPULSID.

There are also some other drugs that may cause problems if used together with PREPULSID. So, make a point of telling your doctor or pharmacist if you are taking any other medicines , including medicines you can buy without a prescription from a pharmacy, supermarket or health food shop.. They will tell you which drugs should not be taken or what other measures (e.g. a change of dose) are necessary. Also, while you are taking PREPULSID, do not start taking a new medicine without first informing your doctor or pharmacist.
Using PREPULSID
How to use it

PREPULSID is best taken 15 minutes before meals and if necessary, before going to bed. Swallow the tablets with some water or drink other than grapefruit juice.

The following are the most often used doses, but your doctor may adjust them to suit your needs. Do not take more than the dose prescribed by your doctor.

The usual dose is 2.5 mL to 5.0 mL (equal to 2.5 mg to 5.0 mg) of suspension, given three to four times daily, 15 minutes before meals and at bedtime.
Important Note:

The dose for children should not be more than 5 mL (equal to 5 mg) of suspension of PREPULSID at a time.

5mL of suspension is equal to a full measuring cap provided with the 200 mL bottle or a full pipette provided with the 100 mL bottle.


How to use the liquid suspension
Before each use, shake the bottle well. The bottle comes with a child-proof cap and should be opened by pushing the plastic screw cap down and turning it anti-clockwise.

Directions for using the pipette provided with the 100 mL bottle of liquid suspension:

1. Pull the white plastic cover off the pipette with a firm tug so that the blue markings can be seen;
2. Insert the pipette into the bottle;
3. While holding the grey bottom ring, pull the white top ring up to the blue line which corresponds to the child's weight in kilograms. For example, pull the white plunger up to the 5 kg mark for a child weighing 5 kg;
4. Hold the grey bottom ring and take the pipette out of the bottle;
5. Empty the liquid from the pipette into some drink other than grapefruit juice by pressing the white top ring down. Give the drink to the child;
6. Rinse and dry the pipette after use and store it in its case. Close the bottle.Directions for using the measuring cap provided with the 200 mL bottle of liquid suspension:

A measuring cap is supplied with graduation marks at 2.5 mL (equal to 2.5 mg) and 5 mL (equal to 5 mg).Fill the measuring cap up to the required amount;Give the dose to the child. Alternatively, the measured amount of liquid suspension can be poured into a drink other than grapefruit juice and given to the child;Rinse and dry the measuring cap after use. Close the bottle.
If you forget to take a dose

CIPLACTIN (Cyproheptadine, Periactin) Take it as soon as you remember, and then continue taking it as you would normally.
CIPLACTIN (Cyproheptadine, Periactin) If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.
CIPLACTIN (Cyproheptadine, Periactin) Do not take a double dose to make up for the one you missed. If you have trouble remembering when to take your medicine, ask your pharmacist for some hints.


Overdose

Telephone your doctor, or the Poisons Information Centre, or go to the Accident & Emergency Department at your nearest hospital immediately if you think you or anybody else has taken too much PREPULSID.

If you have taken too much you may get stomach cramps and diarrhoea or irregular heart beat. Very young children can become listless and weak.Your doctor may give charcoal to stop any PREPULSID remaining in the stomach from entering the bloodstream. You or your child will also need to be watched closely.The doctor may want to do an ECG test for a rare condition known as QT-prolongation, and may check for a slow heart beat and take a blood sample to measure changes in substances called electrolytes (especially for a low potassium or magnesium level).


CIPLACTIN (Cyproheptadine, Periactin) you have to pass urine more often.

These side effects are rare. Tell your doctor about them because medical attention might be necessary.STOP taking PREPULSID and tell your doctor immediately if any of the following happen:

CIPLACTIN (Cyproheptadine, Periactin) you have an allergic reaction to PREPULSID (allergy can be recognised, for instance, by skin rash, itching, shortness of breath and/or a swollen face);
CIPLACTIN (Cyproheptadine, Periactin) dark brown urine, pale stools or yellowing of the skin;
CIPLACTIN (Cyproheptadine, Periactin) you feel faint, become dizzy or have irregular heartbeats.
These side effects are rare. You should tell your doctor about them because you may need urgent medical attention.

Do not hesitate to report any other side effects to your doctor or pharmacist.
After using PREPULSID
Storage

CIPLACTIN (Cyproheptadine, Periactin) Keep PREPULSID tablets in the blister pack until it is time to take them.
CIPLACTIN (Cyproheptadine, Periactin) Keep your PREPULSID tablets below 30ºC and store them in a dry place.
CIPLACTIN (Cyproheptadine, Periactin) Keep your PREPULSID suspension stored below 25ºC.
CIPLACTIN (Cyproheptadine, Periactin) Check the suspension bottle is properly sealed. Keep it where young children cannot reach it. A locked cupboard at least one-and-a-half metres (1.5m) above the ground is a good place to store medicines.
CIPLACTIN (Cyproheptadine, Periactin) Do not store PREPULSID, or any medicine in the bathroom or near a sink. Heat and dampness can destroy some medicines.
CIPLACTIN (Cyproheptadine, Periactin) Do not use PREPULSID Tablets and Suspension beyond the date (month and year) printed on the pack after the letters 'EXP', even if it has been stored properly. Medicines cannot be stored indefinitely.

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