HYDROTALCIT-

HYDROTALCIT-ratiopharm 500 mg chewable tablets

Important notes (mandatory information)

Hydrotalcit-ratiopharm 500 mg chewable tablets. Active ingredient: Hydrotalcite. Areas of application: for the symptomatic treatment of conditions in which stomach acid should be bound: for heartburn and acid-related stomach complaints and/or for stomach or duodenal ulcers.

For risks and side effects, read the package leaflet and ask your doctor or pharmacist!


PACKAGE LEAFLET: INFORMATION FOR THE USER

Hydrotalcit-ratiopharm 500 mg chewable tablets
Active ingredient: Hydrotalcite

Read the entire package leaflet carefully before you start taking this medicine, as 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, talk to 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 14 days, contact your doctor.

What this package leaflet contains

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

1. WHAT IS HYDROTALCIT-RATIOPHARM AND WHAT IS IT USED FOR?

Hydrotalcit-ratiopharm is a medicine for binding excess stomach acid (antacid).

Hydrotalcit-ratiopharm is used for the symptomatic treatment of conditions in which stomach acid should be bound:

• for heartburn and acid-related stomach complaints.
• for stomach or duodenal ulcers.

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING HYDROTALCIT-RATIOPHARM?

Hydrotalcit-ratiopharm must not be taken:

• if you are allergic to hydrotalcite or any of the other ingredients of this medicine listed in section 6.
• in severe renal impairment.
• in the case of a lowered phosphate concentration in the blood (hypophosphatemia).
• in the case of pathological muscle weakness or fatigability (myasthenia gravis).

Warnings and precautions

Please talk to your doctor or pharmacist before taking Hydrotalcit-ratiopharm. Prolonged and recurring stomach complaints can be a sign of a serious illness, such as a stomach or duodenal ulcer. Treatment with Hydrotalcit-ratiopharm should therefore not last longer than 14 days without a medical examination. If tarry stools, blood in the stools or vomiting of blood occur, a doctor should be consulted immediately. In the case of long-term use of Hydrotalcit-ratiopharm, regular checks of aluminium levels are necessary. 40 µg/l should not be exceeded. If a stomach or duodenal ulcer is suspected, an examination for Helicobacter pylori - and, if detected, - a recognised antibacterial combination therapy should be considered, as successful use of such a therapy usually also heals the ulcer disease. High doses and long-term use should be avoided in patients suffering from Alzheimer's disease or other forms of dementia, as well as in patients with phosphate depletion or on a low-phosphate diet. In the case of long-term intake of high doses and a low-phosphate diet, phosphate depletion with the risk of bone softening (osteomalacia) can occur.

Children

Hydrotalcit-ratiopharm should not be used to treat children under 12 years of age, as there is insufficient experience in this age group.

Patients with impaired renal function

In patients with impaired renal function and chronic intake of high doses, there is a possibility of poisoning such as an increase in the magnesium level and an increase in serum aluminium levels. Therefore, long-term intake of high doses should be avoided in patients with impaired renal function.

Taking Hydrotalcit-ratiopharm with other medicines

Tell your doctor or pharmacist if you are taking/using, have recently taken/used or intend to take/use any other medicines. This is particularly important in the case of certain antibiotics (e.g. tetracyclines and quinolone derivatives such as ciprofloxacin, ofloxacin and norfloxacin) and medicines that increase the strength of the heart (cardiac glycosides), as well as H2 receptor blockers (medicines for heartburn), coumarin derivatives (medicines for blood thinning), sodium fluoride (a medicine for caries prophylaxis and treatment of osteoporosis) or chenodeoxycholic acid (a medicine for treating gallstones). It is also important to note that the solubility of medicines that are excreted in the urine, such as salicylate or quinidine, may be affected. Therefore, other medicines should generally be taken 1 - 2 hours before or after taking Hydrotalcit-ratiopharm.

Taking Hydrotalcit-ratiopharm with food and drink

Hydrotalcit-ratiopharm must not be taken at the same time as acidic foods (e.g. wine, fruit juices), as simultaneous intake leads to an undesirable increase in aluminium absorption from the intestine. Effervescent tablets also contain fruit acids, which can increase aluminium absorption.

Pregnancy and breast-feeding

The benefit-risk ratio should be carefully weighed before taking Hydrotalcit during pregnancy. The medicine should only be used for a short period of time and in the lowest possible dosage during pregnancy to avoid aluminium exposure to the child. In general, aluminium compounds pass into breast milk. However, there are no studies on the passage of hydrotalcite into breast milk. A risk to the newborn is not to be assumed, as only very small amounts are absorbed.

Hydrotalcit-ratiopharm contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per chewable tablet, i.e. it is virtually "sodium-free".

Hydrotalcit-ratiopharm contains sorbitol

Sorbitol is a source of fructose. Talk to your doctor before you (or your child) take (or receive) this medicine if your doctor has told you (or your child) that you (or your child) have an intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI) - a rare, inherited condition in which a person cannot break down fructose.

Note for diabetics

1 chewable tablet of Hydrotalcit-ratiopharm contains carbohydrates, corresponding to 0.04 BE.

3. HOW TO TAKE HYDROTALCIT-RATIOPHARM?

Always take this medicine exactly as described in this package leaflet or exactly as directed by your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure.

The recommended dose is

Please follow the instructions for use, otherwise Hydrotalcit-ratiopharm will not work properly!

Adolescents over 12 years of age and adults

Take 1 - 2 chewable tablets of Hydrotalcit-ratiopharm several times a day as needed. The daily dose should not exceed 12 chewable tablets of Hydrotalcit-ratiopharm, corresponding to 6,000 mg of hydrotalcite.

Use in children

Hydrotalcit-ratiopharm should not be used to treat children under 12 years of age, as there is insufficient experience in this age group.

Method of administration

Hydrotalcit-ratiopharm is taken several times a day between meals and before bedtime. The chewable tablets are easy to chew and are then swallowed with a little liquid (see "Taking Hydrotalcit-ratiopharm with food and drink"). Other medicines should generally be taken 1 - 2 hours before or after taking Hydrotalcit-ratiopharm (see "Taking Hydrotalcit-ratiopharm with other medicines").

Duration of use

The duration of treatment depends on the type and severity as well as the course of the disease. If the symptoms persist for more than 2 weeks during treatment, a doctor should be consulted.

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

If you have taken more Hydrotalcit-ratiopharm than you should

Poisoning by Hydrotalcit-ratiopharm is unlikely due to the low absorption of aluminium and magnesium. In case of overdose, changes in bowel movements such as stool softening and increased stool frequency may occur. Therapeutic measures are generally not necessary here.

If you forget to take Hydrotalcit-ratiopharm

Do not take a double dose to make up for a forgotten dose.

If you stop taking Hydrotalcit-ratiopharm

In any case, talk to your doctor before you - e.g. due to the occurrence of side effects - interrupt or prematurely terminate treatment with Hydrotalcit-ratiopharm on your own.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, this medicine can cause side effects, although not everybody gets them. At high doses, gastrointestinal complaints such as soft stools, increased stool frequency, diarrhoea and vomiting may occur. Taking Hydrotalcit-ratiopharm can also lead to a decreased phosphate level and an increased magnesium content in the blood. Allergic reactions are possible. In long-term treatment of patients with impaired renal function, aluminium poisoning can occur, which can lead to bone softening (osteomalacia) and pathological changes in the brain (encephalopathy).

Countermeasures

Talk to your doctor if you get diarrhoea while taking Hydrotalcit-ratiopharm. Reducing the dose will usually improve the symptoms.

Reporting of side effects

If you notice any side effects, talk to 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 HYDROTALCIT-RATIOPHARM?

Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the carton and blister packs. The expiry date refers to the last day of the month indicated. This medicine does not require any special storage conditions.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Hydrotalcit-ratiopharm contains

The active ingredient is hydrotalcite. Each chewable tablet contains 500 mg hydrotalcite corresponding to a neutralisation capacity of at least 13 mval HCl. The other ingredients are: mannitol (Ph.Eur.), sorbitol (Ph.Eur.), saccharin sodium, maize starch, highly dispersed silicon dioxide, magnesium stearate (Ph.Eur.), blackcurrant flavour.

What Hydrotalcit-ratiopharm looks like and contents of the pack

White, round chewable tablet with a break notch on one side. Hydrotalcit-ratiopharm is available in packs of 20, 50 and 100 chewable tablets.

Pharmaceutical entrepreneur

ratiopharm GmbH
Graf-Arco-Straße 3
89079 Ulm

Manufacturer

Merckle GmbH
Ludwig-Merckle-Straße 3
89143 Blaubeuren

This package leaflet was last revised in September 2018.

Source: Information from the package leaflet
Status: 07/2020
Active ingredient: Hydrotalcite. Areas of application: for the symptomatic treatment of conditions in which stomach acid should be bound: for heartburn and acid-related stomach complaints and/or for stomach or duodenal ulcers.