1 mg, 2 mg film-coated tablets
prucalopride
What Prucalopride Orifarm is and what it is used for
Prucalopride Orifarm contains the active substance prucalopride.
Prucalopride Orifarm belongs to a group of medicines that increase intestinal motility ( gastrointestinal prokinetics). It acts on the muscle wall of the intestine and helps to restore normal intestinal function. Prucalopride Orifarm is used to treat chronic constipation in adults where laxatives do not work well enough.
Should not be given to children and adolescents under 18 years of age.
Prucalopride contained in Prucalopride Orifarm may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you take Prucalopride Orifarm
Do not take Prucalopride Orifarm:
- if you are allergic to prucalopride or any of the other ingredients of this medicine (listed in section 6).
- if you have kidney failure that requires dialysis.
- if you suffer from perforation or obstruction of the intestinal wall, severe inflammation of the intestinal tract, such as Crohn’s disease, ulcerative colitis, or toxic megacolon/megarectum.
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before taking Prucalopride Orifarm.
Take special care with Prucalopride Orifarm and tell your doctor if you:
- suffers from serious kidney disease.
- suffers from serious liver disease.
- is under the ongoing supervision of a doctor for a serious medical problem such as lung or heart disease, problems with the nervous system or mental health problems, cancer, AIDS, or a hormonal disorder.
If you have very severe diarrhea, birth control pills may not work properly and the use of an additional method of contraception is recommended. See the instructions in the patient information for the contraceptive pill you are taking.
Other medicines and Prucalopride Orifarm
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Prucalopride Orifarm with food and drink
Prucalopride Orifarm can be taken with or without food and drink at any time of the day or night.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Prucalopride Orifarm should not be used during pregnancy.
- Tell your doctor if you are pregnant or planning to have a baby.
- Use a reliable method of contraception while taking Prucalopride Orifarm to prevent pregnancy.
- If you become pregnant during treatment with Prucalopride Orifarm, tell your doctor.
Prucalopride passes into breast milk as you breastfeed. You should not breastfeed during treatment with Prucalopride Orifarm. Talk to your doctor about this.
Consult a doctor before taking any medicine.
Driving and using machines
Prucalopride Orifarm is unlikely to affect your ability to drive and use machines. However, Prucalopride orifarm may cause dizziness and fatigue, especially during the first day of treatment and this may affect the ability to drive and use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Prucalopride Orifarm contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
How to take Prucalopride Orifarm
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Take Prucalopride Orifarm every day for as long as your doctor prescribes it.
Your doctor may want to assess your condition and benefit from continued treatment after the first four weeks and thereafter at regular intervals.
The usual dose of Prucalopride Orifarm for most patients is a 2 mg tablet once a day.
If you are over 65 years of age or have severe liver disease, the starting dose is 1 mg tablet once a day which your doctor may increase to 2 mg once a day, if needed.
Your doctor may also recommend a lower dose of a 1 mg tablet once a day if you have severe kidney disease.
The effect of the medicine will not be better if you take a higher dose than the recommended one.
Prucalopride Orifarm is for adults only and should not be taken by children and adolescents under 18 years of age.
If you take more Prucalopride Orifarm than you should
If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice.
You must adhere to a dose prescribed by your doctor. If you take more Prucalopride Orifarm than you should, you may have diarrhea, headaches, and/or nausea. If you get diarrhea, make sure you drink enough water.
If you forget to take Prucalopride Orifarm
Do not take a double dose to make up for a forgotten tablet. Take your next dose at the usual time.
If you stop taking Prucalopride Orifarm
If you stop taking Prucalopride Orifarm, your constipation symptoms may return.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. The side effects usually appear at the beginning of the treatment and usually disappear within a couple of days with continued treatment.
Very common (may affect more than 1 user in 10):
- headache.
- nausea, diarrhea, and abdominal pain.
Common (may affect up to 1 in 10 people):
- decreased appetite.
- dizziness.
- vomiting, indigestion ( dyspepsia ), flatulence, and abnormal bowel movements.
- fatigue.
Uncommon (may affect up to 1 in 100 people):
- tremors, migraines.
- dizziness ( vertigo ).
- palpitation. If you get a palpitation, tell your doctor.
- rectal bleeding increased the frequency of urination ( pollakiuria ).
- fever and malaise.
How to store Prucalopride Orifarm
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and carton after EXP.
The expiration date is the last day of the specified month.
Store in the original package. Moisture sensitive.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
- The active substance is prucalopride succinate equivalent to 1 mg or 2 mg prucalopride.
- The other ingredients are Tablet core: Lactose monohydrate; microcrystalline cellulose; colloidal anhydrous silica; magnesium stearate. Tablet coating: Hypromellose; macrogol; polysorbate 80; titanium dioxide (E171). The 2 mg tablet also contains red iron oxide (E172).
What the medicine looks like and the contents of the pack
1 mg: White to off-white, round, 6 mm film-coated tablet marked “C” on one side and “11” on the other side.
2 mg: Pink, round, 8 mm film-coated tablet marked “C” on one side and “12” on the other side.
Perforated unit dose blisters (showing weekdays): 7 x 1, 14 x 1, 28 x 1, 84 x 1 tablets.
Blister: 28, 30, 56, 60, 90, 98, 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Orifarm Generics A / S
Energizer 15
5260 Odense S
Denmark
Manufacturer
Chanelle Medical
Dublin Road
Loughrea, Co. Galway
Ireland
or
Orifarm Generics A / S
Energizer 15
5260 Odense S
Denmark
Local representative
Orifarm Generics AB
Box 56048
102 17 Stockholm
info@orifarm.com
This medicinal product is authorized under the European Economic Area under the names:
DK, SE, NO, FI: Prucalopride Orifarm