Magaldrate Teva

Package leaflet: Information for the patient

Magaldrate Teva 800 mg oral suspension in sachets

Magaldrate
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 their symptoms are the same as yours, as 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 Magaldrate Teva is and what it is used for
2. What you need to know before using Magaldrate Teva
3. How to take Magaldrate Teva
4. Possible side effects
5. How to store Magaldrate Teva
6. Contents of the pack and other information

1. What Magaldrate Teva is and what it is used for

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

• stomach and intestinal lesions (duodenal and gastric ulcers),
• inflammation of the esophagus, the tube connecting the mouth to the stomach, caused by stomach acid flowing back into 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 using Magaldrate Teva

Do not use Magaldrate Teva

• 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 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 person to be treated is under 12 years of age.
• If you are severely weakened (cachectic state).

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

• If your kidneys do not function properly (creatinine clearance <30 ml/min). During treatment with Magaldrate Teva, 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 levels of aluminium in the blood have occasionally been detected even in people with normally functioning kidneys.
• If you have been using aluminium-containing antacid medicines for a long time, as you may experience reduced absorption of phosphates, substances beneficial to the body.

Other medicines and Magaldrate Teva
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 Magaldrate Teva 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-containing 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,
• cheno- and ursodeoxycholic acid, medicines used to treat gallstones (small stones) in the gallbladder, an organ that aids digestion.

Magaldrate Teva with beverages
Do not take Magaldrate Teva with acidic drinks (fruit juice, wine, etc.), as this increases intestinal absorption of aluminium.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Magaldrate Teva is not recommended during pregnancy.
Your doctor will prescribe Magaldrate Teva 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, no risk to the infant is expected.
Fertility
No data are available.
Driving and using machines
No effects of Magaldrate Teva on the ability to drive vehicles or use machinery are known.
However, it is unlikely that the medicine affects the ability to drive vehicles and/or use machinery.
Magaldrate Teva contains sodium
Magaldrate Teva contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially 'sodium-free'.

3. How to take Magaldrato Teva

Take this medicine exactly as directed by your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
How much
The recommended dose for adults and adolescents over 12 years of age is 10 ml, corresponding to 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 (8 sachets or 80 ml).
How to take
Mix the contents of the sachet thoroughly by manipulating the sachet before opening.
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 Magaldrato Teva than you should
If you have taken too many sachets of this medicine, contact your doctor or go to hospital immediately.
Symptoms of an overdose, especially if you suffer from severe kidney disease, may include:

• brain disease (encephalopathy),
• uncontrolled body movements (convulsions),
• dementia.
  In case of accidental ingestion/overdose of Magaldrato Teva, inform your doctor immediately or go to the nearest hospital.

If you forget to take Magaldrato Teva
Do not take a double dose to make up for the missed dose of Magaldrato Teva.
If you stop taking Magaldrato Teva
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
The possible side effects listed below are 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), 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: 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 Magaldrato Teva

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.
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 Magaldrato Teva contains
The active substance is anhydrous magaldrate; each sachet contains 800 mg.
The other components are: dried acacia (E414), hypromellose (E464), simethicone emulsion, sodium
cyclamate (E952), chlorhexidine digluconate 20%, silver sulfate, blueberry flavour (flavour components,
propylene glycol (E1520), water), peppermint flavour (flavour components), fruit fantasy flavour
(flavour components, propylene glycol (E1520), water), purified water.
Description of the appearance of Magaldrato Teva and contents of the pack
White to greyish-pink suspension.
Pack containing 40 single-dose sachets in polyester-aluminium-polyethylene, each containing 10 ml of oral suspension.
Marketing Authorisation Holder and Manufacturer
Teva Italia S.r.l.
Piazzale Luigi Cadorna, 4
20123 Milan
Manufacturer
Special Product’s Line S.p.A.
Via Fratta Rotonda Vado Largo, 1
03012 Anagni (FR)
Italy