Patient leaflet - PRUCALOPRIDE STADA 1 MG FILM-COATED TABLETS
Prucalopride 1 mg and 2mg film-coated tablets
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
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– Keep this leaflet. You may need to read it again.
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– If you have any further questions, ask your
doctor or pharmacist.
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– This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
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– If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
Prucalopride 1 mg film-coated tablets: The name of the medicinal product is Prucalopride 1 mg film-coated tablets but will be referred to as Prucalopride throughout the leaflet.
Prucalopride 2 mg film-coated tablets: The name of the medicinal product is Prucalopride 2 mg film-coated tablets but will be referred to as Prucalopride throughout the leaflet.
What is in this leaflet
1. What Prucalopride is and what it is used for 2. What you need to know before you take Prucalopride
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3. How to take Prucalopride
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4. Possible side effects
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5. How to store Prucalopride
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6. Contents of the pack and other information
1. what prucalopride is and what it is used for
This medicine contains the active substance prucalopride.
Prucalopride belongs to a group of gut motility enhancing medicines (gastrointestinal prokinetics). It acts on the muscle wall of the gut, helping to restore the normal functioning of the bowel. It is used for the treatment of chronic constipation in adults in whom laxatives do not work well enough.
Not for use in children and adolescents younger than 18 years.
2. what you need to know before you take prucalopride do not take prucalopride:
- if you are allergic to prucalopride or any of the other ingredients of this medicine (listed in section 6)
- if you are on renal dialysis
- if you suffer from perforation or obstruction of the gut wall, severe inflammation of the intestinal tract, such as Crohn’s disease, ulcerative colitis or toxic megacolon/ megarectum
Warnings and precautions
Talk to your doctor before taking this medicine.
Take special care with this medicine and tell your doctor if you:
- suffer from severe kidney disease
- suffer from severe liver disease
- are currently under supervision by a doctor for a serious medical problem such as lung or heart disease, nervous system or mental health problems, cancer, AIDS or a hormonal disorder
If you have very bad diarrhoea, the contraceptive pill may not work properly and the use of an extra method of contraception is recommended.
See the instructions in the patient leaflet of the contraceptive pill you are taking.
Other medicines and Prucalopride Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Prucalopride with food and drink Prucalopride can be taken with or without food and drinks, at any time of the day.
Pregnancy and breast-feeding Prucalopride is not recommended for use during pregnancy.
- Tell your doctor if you are pregnant or planning to become pregnant.
- Use a reliable method of contraception while you are taking prucalopride, to prevent pregnancy.
- If you do become pregnant during treatment
with prucalopride, tell your doctor.
When breast-feeding, prucalopride can pass into breast milk. Breast-feeding is not recommended during treatment with this medicine. Talk to your doctor about this.
Ask your doctor for advice before taking any medicine.
Driving and using machines
Prucalopride is unlikely to affect your ability to drive or use machines. However, sometimes Prucalopride may cause dizziness and tiredness, especially on the first day of treatment, and this may have an effect on driving and use of machines.
Prucalopride 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.
3. how to take prucalopride
Always take this medicine exactly as described in this leaflet or as your doctor has told you.
Check with your doctor or pharmacist if you are not sure.
Dosage
Taking a higher dose than recommended will not make the product work better.
Adults
The recommended dose for most patients is one 2 mg tablet once a day.
Elderly or patients with liver or kidney disease If you are older than 65 years or have severe liver disease, the starting dose is one 1 mg tablet once a
92911281910 day, which your doctor may increase to 2 mg once a day if needed.
Your doctor may also recommend a lower dose of one 1 mg tablet daily if you have severe kidney disease.
Children and adolescents
Prucalopride is only for adults and should not be taken by children and adolescents up to 18 years.
Method of administration
Prucalopride is for oral use.
Duration of use
Take this medicine every day for as long as your doctor prescribes it.
The doctor may want to reassess your condition and the benefit of continued treatment after the first 4 weeks and thereafter at regular intervals.
If you take more Prucalopride than you should
It is important to keep to the dose as prescribed by your doctor. If you have taken more Prucalopride than you should, it is possible that you will get diarrhoea, headache and/or nausea. In case of diarrhoea, make sure that you drink enough water.
If you forget to take Prucalopride Donottakeadoubledosetomakeupfora forgotten tablet. Just take your next dose at the usual time.
If you stop taking Prucalopride
If you stop taking Prucalopride, your constipation symptoms may come back again.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. The side effects mostly occur at the start of treatment and usually disappear within a few days with continued treatment.
The following side effects have been reported very commonly (may affect more than 1 in 10 people):
- headache
- feeling sick
- diarrhoea
- abdominal pain
The following side effects have been reported commonly (may affect up to 1 in 10 people):
- decreased appetite
- dizziness
- vomiting
- disturbed digestion (dyspepsia)
- windiness
- abnormal bowel sounds
- tiredness
The following uncommon side effects have also been seen (may affect up to 1 in 100 people):
- tremors
- migraine
- pounding heart
- feeling of dizziness and spinning (vertigo)
- rectal bleeding
- increase in frequency of passing urine (pollakiuria)
- fever and feeling unwell
5. how to store prucalopride 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 expiry date refers to the last day of that month.
This medicinal product does not require any special temperature storage conditions. Store in the original package in order to protect from moisture.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. contents of the pack and other information
What Prucalopride contains
The active substance is prucalopride.
Prucalopride 1 mg film-coated tablets: One film-coated tablet of Prucalopride 1 mg contains 1 mg of pruclopride (as succinate).
Prucalopride 2 mg film-coated tablets: One film-coated tablet of Prucalopride 2 mg contains 2 mg of pruclopride (as succinate).
The other ingredients are:
Lactose monohydrate (see section 2), cellulose microcrystalline, silica colloidal anhydrous, magnesium stearate, hypromellose, polysorbate 80, macrogol 400 and titanium dioxide (E171). The 2 mg tablet also contains iron oxide red (E172).
What Prucalopride looks like and contents of the pack
Prucalopride 1 mg film-coated tablets: Prucalopride 1 mg film-coated tablets are white to off white, circular, film-coated tablets with “C” debossed on one side and “11” on the other side. Prucalopride 2 mg film-coated tablets: Prucalopride 2 mg film-coated tablets are pink, circular, film-coated tablets with “C” debossed on one side and “12” on the other side.
Each pack contains 28 film-coated tablets in blisters of 7 or 28 × 1 film-coated tablets in unit dose blisters of 7. Unit dose blisters have perforations to allow each individual unit to be separated for single unit administration.
Marketing Authorisation Holder
STADA, Linthwaite, Huddersfield, HD7 5QH, UK
Manufacturer
Chanelle Medical Limited, Dublin Road, H62 FH90 Loughrea, Ireland
This leaflet was last revised in 11/2019.
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