Drugs List

Therapeutic Indications

Uses

Dyspepsia

Contraindications

Children under 8 years

Precautions and Warnings

Antacids should not be taken at the same time as other drugs
May affect the gastro-intestinal absorption of other drugs

Pregnancy and Lactation

Pregnancy

Co-simalcite is considered safe for use in pregnancy.

There is consensus that antacids as a class are safe to use during all phases of pregnancy and have been widely prescribed without evidence of adverse effects at normal therapeutic use (Schaefer et al, 2007 and Lee et al, 2000). Unrestricted and long term use of antacids during pregnancy should however be avoided (Schaefer et al, 2007). The data regarding the safety of the drugs used in the treatment of heartburn are limited and mainly been derived from observational studies and case reports.

Both simeticone and hydrotalcite have very limited systemic absorption following oral administration and Schaefer (2007) considers that the aluminium-magnesium complexes such as hydrotalcite lead to less aluminium absorption in comparison to other aluminium-containing antacids. It should be noted that this product is licensed for the treatment of pregnancy-associated heartburn. Nevertheless, there remain concerns about the use of antacids in early pregnancy. Given such doubts, a conservative approach to treatment throughout pregnancy is generally recommended.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Co-simalcite is considered safe for use in breastfeeding.

No reports describing the use of simeticone during human lactation have been located. The risk to the nursing infant from maternal use of simeticone is negligible because the drug is not absorbed (Briggs et al, 2011).

Because oral absorption of aluminium and magnesium is poor, most reviewers consider antacid use to be safe during breastfeeding (LactMed).

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Diarrhoea
Vomiting

Presentation

Oral formulations of simeticone and hydrotalcite.

Drugs List

Therapeutic Indications

Uses

Dyspepsia

Dosage

Adults

Elderly

Children

Contraindications

Children under 8 years

Precautions and Warnings

Antacids should not be taken at the same time as other drugs
May affect the gastro-intestinal absorption of other drugs

Pregnancy and Lactation

Pregnancy

Co-simalcite is considered safe for use in pregnancy.

There is consensus that antacids as a class are safe to use during all phases of pregnancy and have been widely prescribed without evidence of adverse effects at normal therapeutic use (Schaefer et al, 2007 and Lee et al, 2000). Unrestricted and long term use of antacids during pregnancy should however be avoided (Schaefer et al, 2007). The data regarding the safety of the drugs used in the treatment of heartburn are limited and mainly been derived from observational studies and case reports.

Both simeticone and hydrotalcite have very limited systemic absorption following oral administration and Schaefer (2007) considers that the aluminium-magnesium complexes such as hydrotalcite lead to less aluminium absorption in comparison to other aluminium-containing antacids. It should be noted that this product is licensed for the treatment of pregnancy-associated heartburn. Nevertheless, there remain concerns about the use of antacids in early pregnancy. Given such doubts, a conservative approach to treatment throughout pregnancy is generally recommended.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Co-simalcite is considered safe for use in breastfeeding.

No reports describing the use of simeticone during human lactation have been located. The risk to the nursing infant from maternal use of simeticone is negligible because the drug is not absorbed (Briggs et al, 2011).

Because oral absorption of aluminium and magnesium is poor, most reviewers consider antacid use to be safe during breastfeeding (LactMed).

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Diarrhoea
Vomiting

Overdosage

It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

The following number will direct the caller to the relevant local centre (0844) 892 0111

Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Further Information

Last Full Review Date: June 2015

Reference Sources

Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.

Joint Formulary Committee. British National Formulary(online) London: BMJ Group and Pharmaceutical Press Accessed on 03 June 2015.

Paediatric Formulary Committee. BNF for Children (online) London: BMJ Group, Pharmaceutical Press, and RCPCH Publications Accessed on 03 June 2015.

Summary of Product Characteristics: Altacite Plus. Peckforton Pharmaceuticals. Revised April 2004.

Therapeutics in Pregnancy and Lactation (2000) Lee, A., Inch, S. and Finnigan, D. Radcliffe Medical Press, Abingdon.

US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Antacids, Oral. Last revised: 07 September 2013
Last accessed: 03 June 2015