RIOPAN 800 mg Chewable Tablets

Зміст інструкції

1. RIOPAN 800 mg chewable tablets
   1. What is RIOPAN and what is it used for
   2. What you need to know before taking RIOPAN
   3. How to take RIOPAN
   4. Possible side effects
   5. How to store RIOPAN
   6. Contents of the pack and other information
2. RIOPAN 80 mg/ml oral suspension
   1. What is RIOPAN and what is it used for
   2. What you need to know before taking RIOPAN
   3. How to take RIOPAN
   4. Possible side effects
   5. How to store RIOPAN
   6. Contents of the pack and other information

RIOPAN 800 mg chewable tablets

magaldrate

Read this leaflet carefully before taking this medicine as 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is RIOPAN and what is it used for

RIOPAN contains magaldrate and belongs to a group of medicines called antacids which
are used to neutralize excess acids that form in the stomach.
RIOPAN is indicated in adults and adolescents over the age of 12 for the
treatment:

• of lesions of the stomach and intestine (duodenal and gastric ulcer),
• of inflammation of the esophagus, the tube that connects the mouth to the stomach, caused by the return of acid from the stomach to the mouth (reflux esophagitis),
• of inflammation of the stomach and intestine (gastritis and gastro-duodenitis) from various causes characterized by hyperacidity (increased acid in the stomach). See your doctor if you do not feel better or if you feel worse.

2. What you need to know before taking RIOPAN

Do not take RIOPAN

• If you are allergic to magaldrate or any of the other ingredients of this medicine (listed in section 6).
• If you suffer from a disease that interferes with the production of certain blood cells, red blood cells (porphyria).
• If you suffer from low levels of phosphates in the blood, substances useful for the body (hypophosphatemia).
• If you suffer from severe kidney disease (severe renal insufficiency).
• If the subject to be treated is less than 12 years old.
• If you are severely debilitated (cachexia). If you have a hereditary fructose intolerance Warnings and precautionsTalk to your doctor or pharmacist before taking RIOPAN:
• If your kidneys are not functioning properly (creatinine clearance <30 ml/min). During treatment with RIOPAN, your doctor will ask you to undergo regular blood tests to monitor your magnesium and aluminum levels.
• If you are undergoing dialysis, a blood filtration system, as you may develop a brain disease caused by high levels of aluminum in the blood. Moderately elevated levels of aluminum in the blood have been occasionally detected in people with normally functioning kidneys.
• If you are using aluminum-containing antacids for a long time, as this may cause reduced absorption of phosphates, substances useful for the body.
• If you suffer from diabetes, as a chewable tablet contains 0.07 bread units. If you suffer from high blood pressure, you can take RIOPAN as the chewable tablets have a low sodium content.

Other medicines and RIOPAN
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
In particular, tell your doctor and leave 1-2 hours between taking RIOPAN and taking
other medicines such as:

• antibiotics, medicines used to treat infections (ciprofloxacin, ofloxacin and norfloxacin),
• digoxin, a medicine used to treat heart disorders,
• isoniazid, a medicine used to treat tuberculosis, a lung infection,
• iron preparations,
• chlorpromazine, a medicine used to treat mental disorders,
• coumarin derivatives, medicines used to thin the blood,
• effervescent tablets containing citric or tartaric acid,
• benzodiazepines, medicines used to treat depression,
• indometacin, a medicine used to treat inflammation,
• cheno- and ursodeoxycholic acid, medicines used to treat gallstones (calculi) in the gallbladder, an organ that helps digestion.

RIOPAN with drinks
Do not take RIOPAN with acidic drinks (fruit juice, wine, etc.) as this increases
intestinal absorption of aluminum.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, or if you
are breastfeeding, ask your doctor or pharmacist for advice before taking
this medicine.
Pregnancy
RIOPAN is not recommended during pregnancy.
The doctor will prescribe RIOPAN only if absolutely necessary, prescribing a lower dose
to avoid the possible occurrence of toxic effects in the fetus due to an increase
in aluminum in the blood.
Breastfeeding
Aluminum compounds pass into breast milk. Given the low absorption, it is
believed there is no risk to the baby.
Fertility
No data are available.

Driving and operating machinery
No effects of RIOPAN on the ability to drive and operate machinery are known.
However, it is unlikely that the medicine will interfere with the ability to drive vehicles and
use machinery.

RIOPAN contains sorbitol
This medicine contains 774 mg of sorbitol per dose.
Sorbitol is a source of fructose. If your doctor has diagnosed you with hereditary fructose
intolerance, a rare genetic disease, you should not take this medicine. Patients
with hereditary fructose intolerance are unable to metabolize fructose, the accumulation of which can cause
serious side effects. Before taking this medicine, tell your doctor if you suffer from hereditary fructose intolerance or if you feel unwell, vomit or have
unpleasant reactions such as bloating and stomach cramps or diarrhea when you take sweet foods or
drinks.

RIOPAN may contain traces of sodium.
RIOPAN may contain traces of sodium derived from the production process of the active
ingredient.

3. How to take RIOPAN

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

How much
The recommended dose in adults and adolescents over 12 years of age is one
tablet four times a day, one hour after main meals and immediately before
going to bed.
The doctor may modify the dose based on your clinical condition.
Do not exceed the maximum daily dose of 6400 mg (8 tablets).

How
The tablets should be chewed or allowed to dissolve in the mouth.

Duration of treatment
Treatment should be continued for at least 4 weeks even after the disappearance of
symptoms.
If symptoms persist for more than 2 weeks during treatment, contact your doctor for
clinical re-evaluation.

If you take more RIOPAN than you should
If you have taken too many tablets, contact your doctor or go to hospital immediately.
Symptoms of an overdose, especially if you suffer from a severe kidney disease,
may consist of:

• brain disease (encephalopathy),
• uncontrolled body movements (convulsions),
• dementia.

In case of accidental ingestion/intake of an excessive dose of RIOPAN, inform
your doctor immediately or go to the nearest hospital.

If you forget to take RIOPAN
Do not take a double dose to make up for the forgotten RIOPAN tablet.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
The possible side effects are listed below according to the following frequency:

very common (may affect more than 1 in 10 people)
soft stools

very rare (may affect up to 1 in 10,000 people)
diarrhoea, constipation and hypermagnesemia (increased magnesium in the blood)

not known (frequency cannot be estimated from available data)
hypersensitivity (allergic) reactions, nausea, vomiting, indigestion, abdominal pain,
neurotoxicity (toxicity to the nervous system), hypophosphatemia (decreased phosphate in the
blood)

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet,
tell your doctor or pharmacist. You can also report side effects directly
through the national reporting system at:
https://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 RIOPAN

Store at a temperature below 30°C.
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package after Scad.
The expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What RIOPAN contains

• The active ingredient is anhydrous magaldrate 800 mg
• The other ingredients are macrogol 4000, caramel flavour, calcium stearate, cream flavour, maltol, sorbitol(see section 2 “RIOPAN contains sorbitol”).

Description of the appearance of RIOPAN and contents of the pack
Chewable or orally disintegrating tablets.
Round and flat tablets, from white to light beige in colour, speckled, with “800”
embossed on one side.

Marketing authorisation holder and manufacturer

Marketing authorisation holder
Takeda Italia S.p.A., Viale Manzoni 30 - 00185 Roma

Manufacturer
Takeda GmbH
Lehnitzstrasse, 70-98
16515 Oranienburg
Germany

RIOPAN 80 mg/ml oral suspension

magaldrate

Read this leaflet carefully before you start taking this medicine as 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is RIOPAN and what is it used for

RIOPAN contains magaldrate and belongs to a group of medicines called antacids which
are used to neutralize excess acids that form in the stomach.
RIOPAN is indicated in adults and adolescents over the age of 12 for the
treatment:

• of lesions of the stomach and intestine (duodenal and gastric ulcer),
• of inflammation of the esophagus, the tube that connects the mouth to the stomach, caused by the return of acid from the stomach to the mouth (reflux esophagitis),
• of inflammation of the stomach and intestine (gastritis and gastro-duodenitis) from various causes characterized by hyperacidity (increased acid in the stomach). Consult a doctor if you do not feel better or if you feel worse.

2. What you need to know before taking RIOPAN

Do not take RIOPAN

• If you are allergic to magnesium hydroxide or any of the other ingredients of this medicine (listed in section 6).
• If you suffer from a disease that interferes with the production of certain blood cells, red blood cells (porphyria).
• If you suffer from low levels of phosphates in the blood, substances useful for the body (hypophosphataemia).
• If you suffer from severe kidney disease (severe renal insufficiency).
• If the subject to be treated is less than 12 years old.
• If you are severely debilitated (cachectic state).

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

• If your kidneys do not function well (creatinine clearance <30 ml/min). During treatment with RIOPAN, your doctor will ask you to undergo regular blood tests to monitor your magnesium and aluminium levels.
• If you are undergoing dialysis, a blood filtration system, as you may develop a brain disease caused by high levels of aluminium in the blood. Moderately elevated levels of aluminium in the blood have been occasionally detected in people with normally functioning kidneys.
• If you are taking aluminium-containing antacids for a long time, as this may cause reduced absorption of phosphates, substances useful to the body.

Other medicines and RIOPAN
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
In particular, tell your doctor and leave 1-2 hours between taking RIOPAN and taking
other medicines such as:

• antibiotics, medicines used to treat infections (ciprofloxacin, ofloxacin and norfloxacin),
• digoxin, a medicine used to treat heart disorders,
• isoniazid, a medicine used to treat tuberculosis, a lung infection,
• iron preparations,
• chlorpromazine, a medicine used to treat mental disorders,
• coumarin derivatives, medicines used to thin the blood,
• effervescent tablets containing citric or tartaric acid,
• benzodiazepines, medicines used to treat depression,
• indometacin, a medicine used to treat inflammation,
• chenodeoxycholic and ursodeoxycholic acid, medicines used to treat gallstones in the gallbladder, an organ that helps digestion.

RIOPAN with drinks
Do not take RIOPAN with acidic drinks (fruit juice, wine etc.) as this increases
intestinal absorption of aluminium.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, or if you
are breastfeeding, ask your doctor or pharmacist for advice before taking
this medicine.
Pregnancy
RIOPAN is not recommended during pregnancy.
The doctor will prescribe RIOPAN only if absolutely necessary, prescribing a lower dose
to avoid the possible onset of toxic effects in the fetus due to increased
aluminium in the blood.
Breastfeeding
Aluminium compounds pass into breast milk. Given the low absorption, it is
believed there is no risk to the baby.
Fertility
No data are available.

Driving and operating machinery
No effects of RIOPAN on the ability to drive and operate machinery are known.
However, it is unlikely that the medicine will interfere with the ability to drive vehicles and
use machinery.

Riopan contains sodium
RIOPAN contains less than 1 mmol (23mg) of sodium per dose, i.e. essentially ‘sodium-free’.

3. How to take RIOPAN

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

How much
The recommended dose in adults and adolescents over 12 years of age is 10 ml
(corresponding to two teaspoons) or the contents of one sachet, four times a day, one hour after main meals and immediately before bedtime.
The doctor may modify the dose according to your clinical condition.
Do not exceed the maximum daily dose of 6400 mg (corresponding to 8 sachets or
80 ml of product from the bottle, equivalent to sixteen teaspoons).

How
Shake the bottle vigorously or homogenize the contents of the sachet by manipulating
it before opening.

Duration of treatment
The treatment should be continued for at least 4 weeks even after the disappearance of the
symptoms have disappeared.
If symptoms persist for more than 2 weeks during treatment, contact your doctor for
clinical re-evaluation.

If you take more RIOPAN than you should
If you have taken too many sachets or too many teaspoons of this medicine, contact your doctor or
go to hospital immediately.
Symptoms of an overdose, especially if you suffer from a serious kidney disease,
may consist of:

• brain disease (encephalopathy),
• uncontrolled body movements (convulsions),
• dementia.

In case of accidental ingestion/intake of an excessive dose of RIOPAN, inform
your doctor immediately or go to the nearest hospital.

If you forget to take RIOPAN
Do not take a double dose to compensate for forgetting to take RIOPAN.

If you stop taking RIOPAN
If you have any doubts about 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 everyone will experience them.
The possible side effects are listed below according to the following frequency:

very common (may affect more than 1 in 10 people)
soft stools

very rare (may affect up to 1 in 10,000 people)
diarrhea, constipation and hypermagnesemia (increased magnesium in the blood)

not known (frequency cannot be estimated from available data)
hypersensitivity (allergic) reactions, nausea, vomiting, indigestion, abdominal pain,
neurotoxicity (toxicity to the nervous system), hypophosphatemia (decreased phosphate in the
blood)

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet,
please inform your doctor or pharmacist. You can also report side effects directly
through the national reporting system at:
https://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 RIOPAN

Do not refrigerate or freeze.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date that is stated on the pack after Scad.
The expiry date refers to the last day of that month.
Once opened, the product can be stored for a maximum of 6 months.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What RIOPAN contains
The active ingredient is anhydrous magaldrate 800 mg.
The other ingredients are gum arabic, hypromellose, caramel essence, cream essence, simeticone emulsion, sodium cyclamate, chlorhexidine digluconate 20%, silver sulfate, purified water.

Description of the appearance of RIOPAN and contents of the pack
Oral suspension, from white to cream in colour.
It is available in:

• pack of 40 sachets containing 10 ml of oral suspension;
• 250 ml bottle.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Takeda Italia S.p.A., Viale Manzoni 30 - 00185 Rome

Manufacturer
Takeda GmbH
Robert Bosch Strasse, 8
Singen – Germany