1 mg and 2 mg film-coated tablets
prucalopride
What Recolor is and what it is used for
Resolor contains the active substance prucalopride.
Resolor 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. Resolor 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.
What you need to know before taking Resolor
Do not take Resolor:
- 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 before taking Resolor.
Take special care with Resolor and tell your doctor
- if you suffer from serious kidney disease.
- if you suffer from serious liver disease.
- if you are under the ongoing supervision of a doctor for a serious medical problem such as lung or heart disease, nervous system problems 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 Resolor
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Bookcases with food and drink
Recolors can be taken with or without food and drink at any time of the day.
Pregnancy and breastfeeding
Recolors 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 Resolor to prevent pregnancy.
- If you become pregnant during treatment with Resolor, tell your doctor.
Prucalopride passes into breast milk as you breastfeed. You should not breastfeed during treatment with Resolor. Talk to your doctor about this.
Consult a doctor before taking any medicine.
Driving and using machines
Resolor is unlikely to affect your ability to drive and use machines. However, resolvers can cause dizziness and fatigue, especially during the first day of treatment and this can affect the ability to drive and use machines.
Resolor 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 Resolor
Always take this medicine as described in this leaflet or as your doctor advised. Ask your doctor or pharmacist if you are unsure. Take Resolor 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 Resolor for most patients is one 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.
Resolor is only intended for adults and should not be taken by children and young people under 18 years of age.
If you take more Resolor than you should
You must adhere to a dose prescribed by your doctor. If you take more Resolor 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 Resolor
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 Resolor
If you stop taking Resolor, your constipation symptoms may return.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
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.
The following very common side effects have been reported (may affect more than 1 in 10 people): headache, nausea, diarrhea, and abdominal pain.
The following common side effects have been reported (may affect up to 1 in 10 people): decreased appetite, dizziness, vomiting, indigestion ( dyspepsia ), flatulence, abnormal bowel movements, and fatigue.
The following uncommon side effects have also been observed (may affect up to 1 in 100 people): tremors, palpitations, rectal bleeding, increased frequency of urination ( pollakiuria ), fever, and malaise. If you get a palpitation, tell your doctor.
If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information.
How to store Resolor
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. day. The expiration date is the last day of the specified month.
Store in the original blister pack. 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.
One Resolor 1 mg film-coated tablet contains 1 mg prucalopride (as succinate).
One Resolor 2 mg film-coated tablet contains 2 mg prucalopride (as succinate).
Other ingredients are:
Lactose monohydrate (see section 2), microcrystalline cellulose, colloidal silica, magnesium stearate, hypromellose, triacetin, titanium dioxide (E171), and macrogol. The 2 mg tablet also contains red iron oxide (E172), yellow iron oxide (E172), and indigo carmine (E132).
What the medicine looks like and the contents of the pack
Resolor 1 mg film-coated tablets are white or off-white, round tablets marked “PRU 1” on one side.
Resolor 2 mg film-coated tablets are light red, round tablets marked “PRU 2” on one side.
Resolor is available in perforated single-dose blisters of aluminum/aluminum which show the days of the week and which contain 7 tablets. Each pack contains 7 x 1, 14 x 1, 28 x 1 or 84 x 1 film-coated tablets.
Not all pack sizes may be marketed in your country.
Marketing Authorisation Holder
Takeda Pharmaceuticals International AG Ireland Branch
Block 3 Miesian Plaza
50 – 58 Baggot Street Lower
Dublin 2
Ireland
Tel: +800 66838470
Email: medinfoEMEA@takeda.com
Manufacturer
Sanico NV
Veedijk 59
B-2300 Turnhout
Belgium
Janssen Cilag SPA
Via C. Janssen
I-04100 Borgo San Michele (Latina)
Italy