Rilaten

Package leaflet: Information for the user

RILATEN 10 mg film-coated tablets, 20 mg/2 ml injectable solution

rociverine
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 other people, even if they have the same symptoms as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What RILATEN is and what it is used for
2. What you need to know before taking RILATEN
3. How to take RILATEN
4. Possible side effects
5. How to store RILATEN
6. Contents of the pack and other information

1. What RILATEN is and what it is used for

RILATEN contains the active substance rociverine, which belongs to a group of medicines used to treat disorders of gastrointestinal function.
RILATEN is used in adults to treat severe contractions of the muscles of the gastrointestinal, biliary, and urinary tracts associated with pain (spastic painful conditions).

2. What you should know before taking RILATEN

Do not take RILATEN

• if you are allergic to the active substance (rociverine) or to any of the other ingredients of this medicine (listed in section 6);
• if you have increased internal eye pressure (glaucoma);
• if you have enlargement of the prostate (prostatic hypertrophy);
• if you have narrowing of the pylorus and consequently obstruction from the stomach into the small intestine (pyloric stenosis), or other conditions causing narrowing of an opening or passage in the gastrointestinal or genitourinary tract (stenotic conditions);
• if you are unable to empty urine from the bladder (urinary retention).

Warnings and precautions
Talk to your doctor or pharmacist before taking RILATEN.
Use RILATEN with caution if:

• you have heart diseases (you are a cardiac patient);
• you suffer from diseases affecting the blood vessels supplying the heart (coronary diseases);
• you have high blood pressure (hypertension);
• you are elderly.

Children and adolescents
No data are available.
Other medicines and RILATEN
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Take RILATEN with caution, and under strict medical supervision, when used concomitantly with anti-inflammatory corticosteroid medicines or medicines used to treat depression (tricyclic antidepressants), as this combination may increase the risk of glaucoma or urinary retention in particularly susceptible patients.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
If you are pregnant, take RILATEN only if clearly needed.

Driving and using machines
RILATEN may cause visual disturbances; therefore, it may affect your ability to drive or operate machinery.

RILATEN 10 mg film-coated tablets contain sucrose
If your doctor has diagnosed you with an intolerance to certain sugars, consult him/her before taking this medicine.

RILATEN 10 mg film-coated tablets contain less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially 'sodium-free'.

RILATEN 20 mg/2 ml injectable solution contains esters of p-hydroxybenzoic acid
which may cause allergic reactions (including delayed reactions).

RILATEN 20 mg/2 ml injectable solution contains less than 1 mmol (23 mg) of sodium per vial, i.e. essentially 'sodium-free'.

3. How to take RILATEN

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
RILATEN 10 mg film-coated tablets
The recommended dose is 1 tablet taken 3 to 4 times daily.
In more severe cases, your doctor may consider increasing the dose up to 2 tablets, to be taken as a single
administration.
RILATEN 20 mg/2 ml injectable solution
The recommended dose is 1 vial per day, administered intravenously, intramuscularly, or by infusion,
which may be repeated, if deemed necessary by the doctor, after intervals of at least 2 hours.
If you take more RILATEN than you should
In case of overdose, contact your doctor or pharmacist immediately.
If you forget to take RILATEN
Do not take a double dose to make up for the missed dose.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody experiences them.

The following adverse reactions may occur with the use of RILATEN, particularly in especially sensitive individuals:

• dry mouth (xerostomia);
• dilation of the eye pupil (mydriasis);
• visual disturbances (accommodation disorders);
• increased heart rate (tachycardia);
• mild drowsiness;
• constipation (stipsis);
• hot flushes;
• chills.

In such cases, it is advisable to reduce the dosage or, as a last resort, discontinue treatment.

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist. You may also report adverse reactions directly through the national reporting system at the following website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. How to store RILATEN

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 and to the product in its original sealed packaging, correctly stored.
RILATEN 10 mg film-coated tablets
Do not store above 25°C.
Keep in the original packaging to protect the medicine from moisture.
RILATEN 20 mg/2 ml injectable solution
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What RILATEN contains
RILATEN 10 mg coated tablets
Each coated tablet contains:
Active substance: Rociverine 10 mg
Other components: Anhydrous citric acid, Hydrated colloidal silica, Dicalcium hydrogen phosphate dihydrate, Microcrystalline cellulose, Maize starch, Talc, Magnesium stearate, Spray-dried acacia, Cellulose acetate phthalate, Diethyl phthalate, Titanium dioxide, Polysorbate 80, Sucrose, Indigotine (E 132).

RILATEN 20 mg/2 ml injectable solution
Each 2 ml vial contains:
Active substance: Rociverine 20 mg
Other components: Monosodium citrate, p-Hydroxybenzoic acid esters, Sodium hydroxide, Sodium chloride, Water for injections.

Description of the appearance of RILATEN and contents of the pack
RILATEN 10 mg coated tablets
Biconvex coated tablets of uniform blue colour.
Carton containing 30 coated tablets.

RILATEN 20 mg/2 ml injectable solution
Clear, colourless injectable solution.
Carton containing 6 glass vials with 2 ml of solution.

Marketing Authorization Holder
Laboratori Guidotti S.p.A. - Via Livornese 897 – PISA – La Vettola.

Manufacturer
RILATEN 10 mg coated tablets
A. Menarini Manufacturing Logistics and Services S.r.l. - Via Campo di Pile - L'Aquila

RILATEN 20 mg/2 ml injectable solution
A. Menarini Manufacturing Logistics and Services S.r.l., Via Sette Santi, 3 - Florence
Biologici Italia Laboratories S.r.l., Via Filippo Serpero, 2 – Masate (MI)