Riopan

Patient Information Leaflet

RIOPAN 800 mg Chewable Tablets

magaldrate
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 you, 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 RIOPAN is and what it is 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

1. What RIOPAN is and what it is used for

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

• lesions of the stomach and intestine (duodenal and gastric ulcers),
• inflammation of the esophagus, the tube connecting the mouth to the stomach, caused by the backflow of acid from the stomach to the mouth (reflux esophagitis),
• inflammation of the stomach and intestine (gastritis and gastro-duodenitis) due to various causes characterized by hyperacidity (increased acid in the stomach).
  Consult 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 to any of the other ingredients of this medicine (listed in section 6).
• If you suffer from a disease that affects the production of certain blood cells, red blood cells (porphyria).
• If you suffer from low phosphate levels in the blood, substances useful for the body (hypophosphatemia).
• If you have severe kidney disease (severe renal insufficiency).
• If the person to be treated is under 12 years of age.
• If you are severely weakened (cachexia state). If you have hereditary fructose intolerance.

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

• If your kidneys do not function 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 aluminium levels.
• If you are undergoing dialysis, a blood filtration system, as you may develop a brain disorder caused by high levels of aluminium in the blood. Moderately elevated blood aluminium levels have occasionally been detected in individuals with normally functioning kidneys.
• If you have been using aluminium-containing antacids for a long time, as you may experience reduced absorption of phosphates, substances beneficial to the body.
• If you have diabetes, because one chewable tablet contains 0.07 bread units. If you have high blood pressure, you may take RIOPAN, as the chewable tablets have a low sodium content.

Other medicines and RIOPAN
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor and leave an interval of 1–2 hours between taking RIOPAN and 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,
• indomethacin, a medicine used to treat inflammation,
• chenodeoxycholic and ursodeoxycholic acid, medicines used to treat gallstones (small stones) in the gallbladder, an organ that aids 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, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
RIOPAN is not recommended during pregnancy.
Your doctor will prescribe RIOPAN only if strictly necessary and will prescribe a lower dose to avoid potential toxic effects on the fetus due to increased aluminium levels in the blood.
Breastfeeding
Aluminium compounds pass into breast milk. Given the low absorption, it is considered unlikely that there is risk to the infant.
Fertility
No data are available.
Driving and using machines
No effects of RIOPAN on the ability to drive vehicles or use machinery are known.
However, it is unlikely that this medicine affects the ability to drive vehicles or 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 disorder, you must not take this medicine. Patients with hereditary fructose intolerance are unable to metabolize fructose, and its accumulation may cause serious adverse effects. Before taking this medicine, inform your doctor if you have hereditary fructose intolerance or if you feel unwell, vomit, or experience unpleasant reactions such as bloating, stomach cramps, or diarrhoea after consuming sweet foods or drinks.
RIOPAN may contain traces of sodium.
RIOPAN may contain traces of sodium originating from the manufacturing process of the active ingredient.

3. How to take RIOPAN

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Dosage
The recommended dose for adults and adolescents over 12 years of age is one tablet four times daily, one hour after each main meal and immediately before bedtime.
Your doctor may adjust the dose according to your clinical condition.
Do not exceed the maximum daily dose of 6400 mg (8 tablets).

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

Duration of treatment
Treatment should continue for at least 4 weeks, even after symptoms have disappeared.
If symptoms persist for more than 2 weeks during treatment, contact your doctor for clinical reassessment.

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 overdose, particularly if you suffer from severe kidney disease, may include:

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

In case of accidental ingestion/overdose 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 missed tablet.

If you stop taking RIOPAN
If you have any questions 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 everybody gets 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 hypermagnesaemia (increased magnesium in the blood)
not known (frequency cannot be estimated from the available data)
hypersensitivity reactions (allergic reactions), nausea, vomiting, indigestion, abdominal pain,
neurotoxicity (toxicity to the nervous system), hypophosphataemia (decrease in phosphate in the blood)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at the following address:
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 below 30°C.
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 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 you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What RIOPAN contains

• The active substance 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 pack contents
Chewable or orodispersible tablets.
White to light beige, flat, round tablets, scored, with "800" engraved on one side.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Takeda Italia S.p.A., Viale Manzoni 30 - 00185 Rome, Italy
Manufacturer
Takeda GmbH
Lehnitzstrasse, 70-98
16515 Oranienburg
Germany

Package leaflet: information for the patient

RIOPAN 80 mg/ml oral suspension

magaldrate
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 their symptoms are the same as yours, as it may 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:

1. What RIOPAN is and what it is 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

1. What RIOPAN is and what it is used for

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

• of lesions of the stomach and intestine (duodenal and gastric ulcers),
• of inflammation of the esophagus, the tube connecting the mouth to the stomach, caused by the backflow of acid from the stomach into the mouth (reflux esophagitis),
• of inflammation of the stomach and intestine (gastritis and gastro-duodenitis) due to various causes characterized by hyperacidity (increased acid in the stomach).
  Consult 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 to 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 have low levels of phosphates in the blood, substances useful to the body (hypophosphatemia).
• If you suffer from severe kidney disease (severe renal insufficiency).
• If the person to be treated is under 12 years of age.
• If the person is severely weakened (cachectic state).

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

• If your kidneys do not function properly (creatinine clearance <30 ml/min). During treatment with RIOPAN, your doctor will ask you to have 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 disorder caused by high levels of aluminium in the blood. Moderately elevated levels of aluminium in the blood have occasionally been detected in people with normally functioning kidneys.
• If you have been using aluminium-containing antacids for a long time, as you may experience 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, inform your doctor and leave an interval of 1–2 hours between taking RIOPAN and other medicines such as:

• antibiotics 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,
• indomethacin, a medicine used to treat inflammation,
• chenodeoxycholic and ursodeoxycholic acid, medicines used to treat gallstones in the gallbladder, an organ that aids digestion.

RIOPAN and beverages
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, think you may be pregnant or are planning to become pregnant, or if you are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
RIOPAN is not recommended during pregnancy.
Your doctor will prescribe RIOPAN only if clearly needed, and will prescribe a lower dose to avoid potential toxic effects on the fetus due to increased aluminium levels in the blood.
Breastfeeding
Aluminium compounds pass into breast milk. Given the low absorption, it is considered unlikely to pose risks to the infant.
Fertility
No data are available.
Driving and using machines
No effects of RIOPAN on the ability to drive vehicles and operate machinery are known.
However, it is unlikely that the medicine affects the ability to drive vehicles or operate machinery.
RIOPAN contains sodium
RIOPAN contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially 'sodium-free'.

3. How to take RIOPAN

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.

Dosage
The recommended dose for adults and adolescents over 12 years of age is 10 ml
(equivalent to two teaspoonfuls) or the contents of one sachet, four times daily, one hour after main meals and immediately before going to bed.

Your doctor may adjust the dose according to your clinical condition.
Do not exceed the maximum daily dose of 6400 mg (equivalent to 8 sachets or 80 ml of product from the bottle, corresponding to sixteen teaspoonfuls).

How to take
Shake the bottle vigorously or mix the contents of the sachet thoroughly by kneading it before opening.

Duration of treatment
Treatment should be continued for at least 4 weeks, even after symptoms have disappeared.
If symptoms persist for more than 2 weeks during treatment, contact your doctor for a clinical reassessment.

If you take more RIOPAN than you should
If you have taken too many sachets or too many spoonfuls of this medicine, contact your doctor or go to hospital immediately.

Symptoms of overdose, especially if you suffer from severe kidney disease, may include:

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

In case of accidental ingestion or overdose 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 dose of RIOPAN.

If you stop taking RIOPAN
If you have any questions about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The possible side effects are listed below, classified 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 hypermagnesaemia (increased magnesium in the blood)
not known (frequency cannot be estimated from the available data)
hypersensitivity reactions (allergic reactions), nausea, vomiting, indigestion, abdominal pain,
neurotoxicity (toxicity to the nervous system), hypophosphataemia (decreased phosphate in the blood)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at the following website:
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 stated on the packaging after "Exp".
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 via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What RIOPAN contains
The active substance is magaldrate anhydrous 800 mg.
The other components are acacia gum, hypromellose, caramel flavor, cream flavor, simethicone emulsion, sodium cyclamate, chlorhexidine digluconate 20%, silver sulfate, purified water.
Description of the appearance of RIOPAN and contents of the pack
Oral suspension, white to cream in colour.
It is available in:

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

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Takeda Italia S.p.A., Viale Manzoni 30 - 00185 Roma, Italy
Manufacturer
Takeda GmbH
Robert Bosch Strasse, 8
Singen – Germany