GADRAL 800 mg Tabletka Do Żucia

Treść ulotki

1. GADRAL 800 mg chewable tablets
   1. What is GADRAL and what is it used for
   2. What you need to know before using GADRAL
   3. How to take GADRAL
   4. Possible side effects
   5. How to store GADRAL
   6. Contents of the pack and other information
2. GADRAL 800 mg/10 ml oral suspension
   1. What is GADRAL and what is it used for
   2. What you need to know before using GADRAL
   3. How to take GADRAL
   4. Possible side effects
   5. How to store GADRAL
   6. Contents of the pack and other information

GADRAL 800 mg chewable tablets

Magaldrate
Generic medicine

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

1. What is GADRAL and what is it used for

GADRAL contains magaldrate and belongs to a group of medicines called antacids which
are used to neutralize excess acids that form in the stomach.
GADRAL 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 gastroduodenitis)
• from various causes characterized by hyperacidity (increased acid present in the stomach). Consult your doctor if you do not feel better or if you feel worse.

2. What you need to know before using GADRAL

Do not use GADRAL

• 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).

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

• If your kidneys are not functioning properly (creatinine clearance <30 ml/min). During treatment with GADRAL, 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 taking aluminum-containing antacids for a long time, as this may lead to reduced absorption of phosphates, substances useful to the body.
• If you suffer from high blood pressure, you can take GADRAL as the chewable tablets have a low sodium content.

Other medicines and GADRAL
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
In particular, tell your doctor and leave 1-2 hours between taking GADRAL 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 (stones) in the gallbladder, an organ that helps digestion.

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

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
GADRAL is not recommended during pregnancy.
The doctor will prescribe GADRAL only if absolutely necessary, prescribing a lower dose
to avoid the possible onset 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
There are no known effects of GADRAL on the ability to drive vehicles and operate machinery. However,
it is unlikely that the medicine will interfere with the ability to drive vehicles and/or operate
machinery.

GADRAL 800 mg chewable tablets contains sodium
One GADRAL tablet contains less than 1 mmol (23mg) of sodium, i.e. essentially ‘sodium-free’.

GADRAL 800 mg chewable tablets contains sorbitol
One GADRAL tablet may contain up to 147 mg of sorbitol.
Sorbitol is a source of fructose. If your doctor has told you that you are intolerant to some sugars,
or if you have a diagnosis of hereditary fructose intolerance, a rare genetic disease in which
patients are unable to metabolize fructose, talk to your doctor before taking this
medicine.

3. How to take GADRAL

Take this medicine following exactly the instructions of your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Quantity
The recommended dose in adults and adolescents over the age of 12 is one tablet
four times a day, one hour after main meals and immediately before bedtime.
The doctor may adjust the dose based on your clinical condition.
Do not exceed the dose of 6400 mg per day (8 tablets).
How
The tablets should be chewed or sucked.
Duration of treatment
Treatment should be continued for at least 4 weeks even after the disappearance of the
symptoms.
If symptoms persist for more than 2 weeks during treatment, contact your doctor for a
clinical reassessment.

If you take more GADRAL 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 serious kidney disease, may
consist of:

• brain disease (encephalopathy),
• uncontrolled body movements (convulsions),
• dementia. In case of accidental ingestion/taking of an excessive dose of GADRAL, inform your doctor immediately or go to the nearest hospital.

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

If you stop taking GADRAL
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 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 increased magnesium in the blood (hypermagnesemia)

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

Reporting of side effects
If you get any side effects, even 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 GADRAL

This medicine does not require any special storage conditions.
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 pack 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 GADRAL contains
The active ingredient is anhydrous magaldrate 800.0 mg.
The other ingredients are: sorbitol, mannitol, corn starch, magnesium stearate, sodium
saccharinate, caramel flavour.

Description of the appearance of GADRAL and contents of the pack
Gadral 800 mg chewable tablets: pack of 40 tablets of 800 mg.

Marketing authorisation holder and manufacturer
Marketing authorisation holder
NEOPHARMED GENTILI S.p.A.
Via San Giuseppe Cottolengo, 15
20143 Milano
Manufacturer
Therabel Industries S.A.S.,
La Seyne sur Mer (France)
Doppel Farmaceutici S.r.l.
Quinto de’ Stampi
Rozzano - MI

GADRAL 800 mg/10 ml oral suspension

Magaldrate
Generic medicine

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

1. What is GADRAL and what is it used for

GADRAL contains magaldrate and belongs to a group of medicines called antacids which
are used to neutralize excess acids that form in the stomach.
GADRAL 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 gastroduodenitis),
• from various causes characterized by hyperacidity (increased acid in the stomach). If you do not feel better or if you feel worse, consult your doctor.

2. What you need to know before using GADRAL

Do not use GADRAL

• 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 (cachectic state).

Warnings and precautions
Consult your doctor or pharmacist before taking GADRAL:

• If your kidneys do not function properly (creatinine clearance <30 ml/min). During treatment with GADRAL, 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 taking aluminum-containing antacids for a long time, as this may cause reduced absorption of phosphates, substances useful for the body.

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

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

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant, are planning a pregnancy, or are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before taking this
medicine.
Pregnancy
GADRAL is not recommended during pregnancy.
Your doctor will prescribe GADRAL only if absolutely necessary, prescribing a lower dose
to avoid the possible onset 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 GADRAL on the ability to drive vehicles and operate machinery are known.
However, it is unlikely that the medicine will interfere with the ability to drive vehicles and/or
operate machinery.

GADRAL 800 mg/10 ml oral suspension contains sodium benzoate
10 ml of oral suspension contains 50 mg of sodium benzoate.

GADRAL 800 mg/10 ml oral suspension contains ethanol
10 ml of oral suspension contains 480 mg of alcohol (ethanol) equivalent to less than 12 ml
of beer or 5 ml of wine.
The small amount of alcohol in this medicine will not produce significant effects.

GADRAL 800 mg/10 ml oral suspension contains sodium
10 ml of oral suspension contains less than 1 mmol (23mg) of sodium, i.e. essentially
‘sodium-free’.

GADRAL 800 mg/10 ml oral suspension contains sorbitol
10 ml of oral suspension contains 840 mg of sorbitol.
Sorbitol is a source of fructose. If your doctor has told you that you are intolerant to some
sugars, or if you have a diagnosis of hereditary fructose intolerance, a rare genetic
disease in which patients cannot transform fructose, talk to your doctor before taking
this medicine.

GADRAL 800 mg/10 ml oral suspension contains propylene glycol (contained in the
passion fruit flavour)
10 ml of oral suspension contains 11.15 mg of propylene glycol

3. How to take GADRAL

Take this medicine following exactly the instructions of your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Quantity
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 adjust the dose according to your clinical condition.
Do not exceed the maximum daily dose of 6400 mg (8 sachets or 80 ml).
How
Shake the bottle vigorously or homogenize the contents of the sachet by manipulating it before
opening.
Duration of treatment
Treatment should be continued for at least 4 weeks even after the disappearance of
symptoms have disappeared.
If symptoms persist for more than 2 weeks during treatment, contact your doctor for a
clinical reassessment.

If you take more GADRAL than you should
If you have taken too many sachets or 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 GADRAL, inform your doctor immediately or go to the nearest hospital.

If you forget to take GADRAL
Do not take a double dose to make up for a missed dose.

If you stop taking GADRAL
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 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 increased magnesium in the blood (hypermagnesemia)

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

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not
listed in this leaflet. 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 GADRAL

This medicine does not require any special storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date that is reported 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 GADRAL contains
The active ingredient is anhydrous magaldrate 800 mg.
The other ingredients are: sorbitol 70%, hydroxyethylcellulose, citric acid, sodium cyclamate,
sodium saccharinate, simethicone, sodium benzoate, potassium sorbate, ethanol (96%), cream flavour,
passion fruit flavour, purified water.

Description of the appearance of GADRAL and contents of the pack
GADRAL 800 mg/10 ml oral suspension, available in:

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

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
NEOPHARMED GENTILI S.p.A.
Via San Giuseppe Cottolengo, 15
20143 Milan
Manufacturer
ZETA FARMACEUTICI S.p.A.
Via Galvani, 10
36066 Sandrigo (VI)