Package leaflet: Information for the patient

RIGES 10 mg tablets

Domperidone
Equivalent medicine
Please read this leaflet carefully before taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as yours, because it could be harmful.
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What RIGES is and what it is used for
What you need to know before taking RIGES
How to take RIGES
Possible side effects
How to store RIGES
Contents of the pack and other information

1. What RIGES is and what it is used for

This medicinal product is indicated for the relief of symptoms of nausea and vomiting.

2. What you should know before taking RIGES

Do not take RIGES:

if you are allergic to domperidone or to any of the other ingredients of this medicine (listed in section 6).
if you have pituitary gland tumours associated with prolactin secretion (prolactinomas).
if you have moderate or severe liver disease.
if your ECG (electrocardiogram) shows a heart condition known as "QT interval prolongation".
if you have or have had a condition in which your heart is unable to pump blood properly (a condition known as heart failure).
if you are taking any medicines that prolong the QT interval.
if you have stomach or intestinal problems such as gastrointestinal bleeding, perforation, or mechanical obstruction.
if you have a condition causing low levels of potassium or magnesium, or high levels of potassium in the blood.

Warnings and precautions
Talk to your doctor or pharmacist before taking RIGES if:

you have liver problems (hepatic impairment or liver failure) (see "Do not take RIGES").
you have kidney problems (renal impairment or kidney failure). Consult your doctor for advice if long-term treatment is needed, as you may need to take a lower dose or take the medicine less frequently. Your doctor may also wish to monitor you regularly.
Domperidone may be associated with an increased risk of heart rhythm disorders and cardiac arrest. The risk may be higher in patients over 60 years of age or those taking doses exceeding 30 mg per day. The risk is further increased when domperidone is taken together with other medicines. Inform your doctor or pharmacist if you are taking medicines for infections (fungal or bacterial infections) and/or if you have heart problems or AIDS/HIV (see "Other medicines and RIGES").
Domperidone should be used at the lowest effective dose.
While taking RIGES, contact your doctor if you experience symptoms of heart rhythm disturbances such as palpitations, difficulty breathing, or loss of consciousness. In such cases, treatment with RIGES must be discontinued.

Children and adolescents
RIGES must not be administered to children and adolescents.

Other medicines and RIGES
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Do not take RIGES if you are taking the following medicines:

medicines for heart conditions or high blood pressure (disopyramide, hydroquinidine, quinidine, amiodarone, dofetilide, dronedarone, ibutilide, sotalol).
medicines for psychosis (haloperidol, pimozide, sertindole).
medicines for depression (citalopram, escitalopram).
medicines to treat infections (antibiotics such as erythromycin, levofloxacin, moxifloxacin, spiramycin, clarithromycin, telithromycin).
medicines for fungal infections (pentamidine or azole antifungals, particularly itraconazole, oral ketoconazole, fluconazole, posaconazole, or voriconazole).
medicines for malaria (halofantrine, lumefantrine).
medicines for stomach and intestinal disorders (cisapride, dolasetron, prucalopride).
medicines for allergies (mequitazine, mizolastine).
AIDS/HIV medicines such as ritonavir or saquinavir (these are protease inhibitors).
Hepatitis C medicines (e.g. telaprevir).
medicines for treating tumours (toremifene, vandetanib, vincamine).
other medicines such as bepridil, dofetilide, methadone.

It is not recommended to take RIGES together with the following medicines:

medicines that interfere with liver activity such as diltiazem, verapamil, and certain macrolides. Be cautious if you are taking medicines that may slow heart rate (bradycardia), cause decreased potassium levels in the blood, or prolong the QT interval, such as azithromycin and roxithromycin.

Inform your doctor or pharmacist if you are taking medicines for infections, heart conditions, AIDS/HIV, or Parkinson's disease.
RIGES and apomorphine
Before using RIGES and apomorphine together, your doctor will ensure that your body can tolerate taking both medicines simultaneously. Seek personalized advice from your doctor or a specialist. Refer to the apomorphine package leaflet.
It is important to ask your doctor or pharmacist whether RIGES is safe for you while taking other medicines, including over-the-counter medicines.

RIGES with food and drink
Take RIGES before meals. If taken after meals, absorption of the medicine is slightly delayed.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine. There are insufficient data to determine whether RIGES is harmful during pregnancy.
Small amounts of domperidone have been detected in breast milk. RIGES may cause unwanted effects on the heart of a breastfed newborn. RIGES should be used during breastfeeding only if strictly necessary. Consult your doctor before taking this medicine.

Driving and using machines
Some patients have reported dizziness or drowsiness after taking RIGES.
Do not drive or operate machinery while taking RIGES until you know how this medicine affects you.

RIGES contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.

RIGES contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., essentially 'sodium-free'.

3. How to take RIGES

Take this medicine exactly as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
Always follow these instructions unless your doctor has given you different instructions.
It is recommended to take RIGES before meals. If taken after meals, absorption of the medicine may be considerably delayed.

Duration of treatment:
Symptoms usually resolve within 3–4 days of taking this medicine. Do not take RIGES for more than 7 days without consulting your doctor.

The recommended dose is one tablet taken up to three times daily, preferably before meals.
Take the tablets with some water or another liquid. Do not chew them. Do not take more than three tablets per day.

If you take more RIGES than you should
The following symptoms may occur after taking an excessive dose of this medicine:

agitation;
disturbances in consciousness;
seizures;
disorientation;
drowsiness;
movement difficulties (extrapyramidal symptoms).

If you have taken an excessive amount of RIGES, contact your doctor, pharmacist, or the nearest poison control center immediately. In case of overdose, symptomatic treatment should be administered. Electrocardiogram monitoring may be performed due to the possibility of a heart problem known as "QT interval prolongation".

If you forget to take RIGES
Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the next one at the regular time. Do not take a double dose to make up for the forgotten dose.

If you stop taking RIGES
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Following the instructions in this leaflet reduces the risk of side effects.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Uncommon (may affect up to 1 in 100 people)
Involuntary movements of the face, arms or legs, excessive tremor, excessive muscle rigidity or muscle spasms.
Not known (frequency cannot be estimated from the available data)
Seizures.
A type of reaction that may occur immediately after administration, characterised by skin rash, itching, shortness of breath and/or facial swelling.
A severe hypersensitivity reaction that may occur immediately after administration, characterised by urticaria, itching, hot flushes, fainting and, among other possible symptoms, breathing difficulties.
Cardiovascular system disorders have been reported: heart rhythm disorders (fast or irregular heartbeat); if you experience any of these disorders, you should stop treatment immediately.
Domperidone may be associated with an increased risk of heart rhythm disorders and cardiac arrest. This risk may be higher in patients aged over 60 years or in those taking doses exceeding 30 mg per day. Domperidone should be used at the lowest effective dose.
Stop treatment with domperidone and contact your doctor immediately if you experience any of the side effects described above.
Other side effects reported with RIGES are listed below.
Common (may affect up to 1 in 10 people)
Dry mouth.
Uncommon (may affect up to 1 in 100 people)
Anxiety.
Agitation.
Nervousness.
Loss or reduction in libido.
Headache.
Somnolence.
Diarrhoea.
Skin rash.
Itching.
Urticaria.
Breast tenderness or soreness.
Milk secretion from the breast.
General feeling of weakness.
Dizziness.
Rare (may affect up to 1 in 1,000 people)
Gastrointestinal disorders, including transient intestinal cramps.
Not known (frequency cannot be estimated from the available data)
Upward movement of the eyes.
Disruption of the menstrual cycle in women.
Breast enlargement in men.
Inability to urinate.
Changes in the results of certain laboratory tests.
Restless legs syndrome (a sensation of discomfort with an irresistible urge to move the legs, and sometimes arms or other body parts).
Some patients who have used RIGES for conditions and at doses requiring medical supervision have experienced the following side effects: restlessness; breast swelling or enlargement, abnormal breast secretions, irregular menstrual cycle in women, difficulties with breastfeeding, depression, hypersensitivity.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please consult your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store RIGES

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp.". The expiry date refers to the last day of that month. Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.
Do not store above 25°C.

6. Package contents and other information

What RIGES contains
The active substance is: domperidone 10 mg.
The other components are: lactose, maize starch, povidone, sodium lauryl sulfate, microcrystalline cellulose, hydrated colloidal silica, sodium carmellose, hydrogenated vegetable oil, magnesium stearate.
Description of the appearance of RIGES and contents of the pack
RIGES 10 mg tablets – 30 tablets
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
S.F. GROUP SRL, Via Tiburtina, 1143 - 00156 - Rome - Italy
Manufacturer
LACHIFARMA S.r.l., S.S. 16 - Industrial Zone – 73010 – ZOLLINO (LE) - Italy