GELUSIL LAC

GELUSIL LAC chewable tablets

Important notes (mandatory information)

Gelusil Lac, 500 mg, chewable tablets. Active ingredient: Aluminium-Magnesium-Silicate (1:2:3). Areas of application: for various types of acid discomfort such as heartburn or acid reflux and for supportive therapy for Ulcus ventriculi or Ulcus duodeni.

For risks and side effects, read the package leaflet and consult your doctor or pharmacist.


PACKAGE LEAFLET: INFORMATION FOR THE USER

Gelusil Lac, 500 mg, chewable tablets
Active ingredient: Aluminium-Magnesium-Silicate (1:2:3)

Read the entire package leaflet carefully before you start taking this medicine, because it contains important information. Always take this medicine exactly as described in this package leaflet or exactly as directed by your doctor or pharmacist.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you notice any side effects, contact your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. See section 4.
• If you do not feel better or even worse after 2 weeks at the latest, contact your doctor.

What this package leaflet contains

1. WHAT IS GELUSIL LAC AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING GELUSIL LAC?
3. HOW TO TAKE GELUSIL LAC?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE GELUSIL LAC?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS GELUSIL LAG AND WHAT IS IT USED FOR?

Gelusil Lac is a gastric acid binder (antacid). Gelusil Lac is used for various types of acid discomfort such as heartburn or acid reflux and for supportive therapy for Ulcus ventriculi or Ulcus duodeni.

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING GELUSIL LAC?

Gelusil Lac must not be taken if you:

• are allergic to aluminium-magnesium-silicate or any of the other ingredients of this medicine listed in section 6.
• have a low phosphate level in your blood (hypophosphatemia).
• have a blockage of the narrow passages in your large intestine (stenosis).

Gelusil Lac must not be given to infants.

Warnings and precautions

Special care must be taken when taking Gelusil Lac:

• if you have impaired kidney function (creatinine clearance less than 30 ml/min), you may only take Gelusil Lac if the aluminium concentration in your urine and/or the magnesium and aluminium serum levels are checked regularly.
• in patients with chronic renal insufficiency, the aluminium concentrations in the serum should also be determined even with short-term use of Gelusil Lac. In addition, regular medical examinations (approximately every six months) are advisable for these patients in order to detect any accumulation of aluminium in the nervous system, bones, liver and other tissues as early as possible.
• in patients with liver dysfunction, especially in patients with concomitant renal dysfunction, examinations to rule out the accumulation of aluminium in the organs should also be carried out.

Antacids should not be taken in high doses over a long period of time. The aluminium serum levels should be checked regularly with long-term use. This applies in particular to patients with impaired renal function. In patients with Ulcus ventriculi or Ulcus duodeni, an examination for H. pylori - and in the case of detection - a recognised eradication therapy should be considered, since successful eradication usually also heals the ulcer disease. Please talk to your doctor or pharmacist before taking Gelusil Lac.

Children

Do not give Gelusil Lac to children under 12 years of age, as there is not yet sufficient experience for a general recommendation for this age group.

Taking Gelusil Lac with other medicines

Please note that this information may also apply to medicines that you have recently taken. The absorption and thus also the effectiveness of other medicines is reduced by Gelusil Lac. This is particularly important for certain antibiotics (e.g. tetracyclines and quinolone derivatives such as ciprofloxacin, ofloxacin and norfloxacin) and also for sodium fluoride, iron, cardiac glycosides, chenodeoxycholic acid, H2-receptor inhibitors and coumarin derivatives. Therefore, other medicines should be taken 1 to 2 hours before or after taking Gelusil Lac. Inform your doctor or pharmacist if you are taking/using, have recently taken/used or intend to take/use any other medicines.

Taking Gelusil Lac with food and drink

You should not take Gelusil Lac at the same time as acidic drinks (e.g. fruit juice, wine) or food, as this leads to an undesirable increase in aluminium absorption from the intestine. Effervescent tablets also contain fruit acids, which can increase the absorption of aluminium from the intestine.

Pregnancy and

breastfeeding

Pregnancy

The benefit-risk ratio should be carefully weighed before taking aluminium-containing antacids during pregnancy. You should only use the medicine for a short period of time during pregnancy to avoid exposing the child to aluminium.

Breastfeeding

Aluminium compounds pass into breast milk. A risk to the newborn is not to be assumed, as only very small amounts are absorbed.

If you are pregnant or breastfeeding, or if you suspect you may be pregnant or intend to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.

Driving and operating machinery

No special precautions are required.

Gelusil Lac contains lactose and sucrose

Please only take Gelusil Lac after consulting your doctor if you know that you suffer from an intolerance to certain sugars.

Note for diabetics

1 chewable tablet corresponds to 0.035 BE.

3. HOW TO TAKE GELUSIL LAC?

Always take this medicine exactly as described in this package leaflet or exactly as agreed with your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure. The recommended dose is up to 3 Gelusil Lac chewable tablets several times a day as needed. The daily dose should not exceed 9 Gelusil Lac chewable tablets corresponding to 4500 mg aluminium-magnesium-silicate.

How and when should you take Gelusil Lac?
Gelusil Lac chewable tablets are intended for oral use (for chewing or sucking). Other medicines should generally be taken 1 to 2 hours before or after taking Gelusil Lac (see "What should you consider before taking Gelusil Lac?/Taking Gelusil Lac with other medicines"). Furthermore, you should take Gelusil Lac 1 to 2 hours after meals and before going to bed.

How long should you take Gelusil Lac?
The duration of treatment depends on the type, severity and course of the disease. If the symptoms have not subsided during treatment, the doctor should clarify possible causes after 2 weeks at the latest. Do not take Gelusil Lac for more than 14 days without medical or dental advice.

Please talk to your doctor or pharmacist if you have the impression that the effect of Gelusil Lac is too strong or too weak.

If you have taken more Gelusil Lac than you should

Poisoning by Gelusil Lac is unlikely due to the low absorption of aluminium and magnesium. Overdosage may cause changes in bowel movements such as loose stools or constipation.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following frequency information is used to evaluate side effects:
Very common:	more than 1 in 10 treated persons
Common:	1 to 10 in 100 treated persons
Uncommon:	1 to 10 in 1,000 treated persons
Rare:	1 to 10 in 10,000 treated persons
Very rare:	less than 1 in 10,000 treated persons
Not known:	frequency cannot be estimated from the available data.

Possible side effects

Immune system

Very rare: Allergies to milk protein in Gelusil Lac.

Nervous system

Not known: In case of insufficient kidney function (renal insufficiency) and long-term intake of high doses, aluminium can accumulate, especially in the nervous tissue.

Gastrointestinal tract

Not known: High doses can cause gastrointestinal symptoms such as soft stools, but also constipation, flatulence and a feeling of fullness. In isolated cases, intestinal obstruction has been observed during long-term therapy with aluminium hydroxide.

Metabolism

Very rare: Lactose intolerance to lactose in Gelusil Lac.

Musculoskeletal system

Not known. In case of insufficient kidney function (renal insufficiency) and long-term intake of high doses, aluminium can accumulate, especially in the bone tissue, and phosphate depletion can occur.

Kidney and urinary tract

Not known: Silicate stones in the kidney or bladder in isolated cases during long-term therapy.

Laboratory tests

Not known: In severely impaired renal function, taking magnesium- and aluminium-containing medicines such as Gelusil Lac can cause an increased magnesium content in the blood (hypermagnesemia) and an increase in serum aluminium levels.

Reporting of side effects

If you notice any side effects, contact your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. of Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help provide more information about the safety of this medicine.

5. HOW TO STORE GELUSIL LAC?

Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the blister and carton after "Use by". The expiry date refers to the last day of the month indicated. Do not store above 25°C. Store the blisters in the outer carton in order to protect the contents from moisture.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Gelusil Lac contains

The active ingredient is: Aluminium-Magnesium-Silicate (1:2:3). 1 chewable tablet contains 500 mg Aluminium-Magnesium-Silicate (1:2:3) (corresponding to a neutralisation capacity of 7-9 mval HCl). The other ingredients are: Vanilla-cream flavouring; vanilla flavouring; skimmed milk powder (contains lactose monohydrate), magnesium stearate (Ph. Eur.), sucrose.

What Gelusil Lac looks like and contents of the pack

Packs of 20, 50 or 100 yellowish-white, round chewable tablets. Not all pack sizes may be marketed.

Pharmaceutical entrepreneur

Cheplapharm Arzneimittel GmbH
Bahnhofstraße 1a
17498 Mesekenhagen
Tel.: 03834 / 8539-0
Fax.: 03834 / 8539-119

Manufacturer

Farmea
10 rue Bouche Thomas
ZAC Sud d'Orgemont
49000 Angers/France

allphamed Pharbil Arzneimittel GmbH
Hildebrandstraße 12
37081-Göttingen

This package leaflet was last revised in November 2014.

Source: Information from the package leaflet
Status: 04/2018
Active ingredient: Aluminium-Magnesium-Silicate (1:2:3). Areas of application: for various types of acid discomfort such as heartburn or acid reflux and for supportive therapy for Ulcus ventriculi or Ulcus duodeni.