Adalat LA 30
- Name:
Adalat LA 30
- Company:
Bayer Limited
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may be renewed (B)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 10/11/20

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Bayer Limited

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Updated on 10 November 2020 PIL
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - use in children and adolescents
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
- Change to section 6 - manufacturer
Free text change information supplied by the pharmaceutical company
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
-If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4
2 What you need to know before you take Adalat LA
If you are allergic to nifedipine, to any other similar medicines (known as dihydropyridines) or any of the other ingredients of this medicine (listed in section 6).
Warning and precautions
Talk to your doctor or pharmacist before taking Adalat LA:
Children and adolescents
Adalat LA is not recommended for use in children and adolescents below 18 years of age, because there is only limited data on the safety and efficacy in this population.
Tell your doctor if you are taking, have recently taken or might take any other medicines.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you might be pregnant or are planning a family, ask your doctor for advice before taking Adalat LA.
Drugs like Adalat LA have been shown to impair sperm function. If you are a man who has been unable to father a child by in vitro fertilisation, this should be taken into consideration.
Adalat contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’
3 How to take Adalat LA
Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.
• Swallow the tablets whole. Do not bite, chew or break them – if you do they will not work properly. If you have difficulty swallowing tablets, consult your doctor as he or she may wish to change your medicine.
4 Possible side effects
If you experience any of the following serious side effects, stop taking this medication and seek urgent medical attention immediately:
[‘Uncommon’ 1 in 100]; [‘Rare’ 1 in 1000]; [‘Uncommon’ 1 in 100]; [frequency ‘Not Known’] - added
Not known: frequency cannot be estimated from the available data
Reporting of side effects
Deletion of email address and physical address
Do not use this medicine after the expiry date which is stated on the carton and on each blister strip of tablets. The expiry date refers to the last day of that month.
Do not throw away anymedicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
Updated on 10 November 2020 SPC
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 2. Qualitative and Quantitative Composition
"Excipients with known effect", "Please see section 4.4 for further information" added.
4.2 Posology and method of administration
Method of Administration
As a rule Adalat LA tablets are swallowed whole with a little liquid, irrespective of meal times. Grapefruit juice is to be avoided (See Section 4.5).
The coated tablet should not be broken or chewed, as the coating is intended to ensure a prolonged release (see Section 5.2)
4.4 Special warnings and precautions for use
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium- free’.
4.8 Undesirable effects
Email Address and Physical Address Deleted.
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: selective calcium channel blockers with mainly vascular effect, dihydropyridine derivatives.
10. Date of Revision of the Text
November 2020
Updated on 31 March 2020 SPC
Reasons for updating
- Change to section 6.3 - Shelf life
- Change to section 6.5 - Nature and contents of container
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 18 April 2017 PIL
Reasons for updating
- New PIL for new product
Updated on 18 April 2017 PIL
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 12 August 2016 PIL
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 11 July 2016 PIL
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 8 July 2016 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 8 July 2016 SPC
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Acute pulmonary oedema has been observed when calcium channel blockers, among others nifedipine, have been used as a tocolytic agent during pregnancy (see section 4.8), especially in cases of multiple pregnancy (twins or more), with the intravenous route and/or concomitant use of beta-2 agonists. -was added.
In Section 4.8 Undesirable effects
Pulmonary oedema* -was added as a side effect. under the frequency 'Not Known', with the following condition* :
*cases have been reported when used as tocolytic during pregnancy (see section 4.6) -was added
10. Date of Revision of the Text
June 2016 -was added
Updated on 9 January 2015 PIL
Reasons for updating
- Change to date of revision
- Addition of information on reporting a side effect.
Updated on 9 January 2015 SPC
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 11 March 2014 SPC
Reasons for updating
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 4.9 - Overdose
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
4.2 Posology and method of administration
Additional information on special populations
Elderly (>65)Geriatric patients
4.3 Contraindications
The safety of Adalat LA during pregnancy or in nursing mothers has not been established (see sections 4.4, 4.6 and 5.3).
Adalat LA must not be administered during pregnancy or to nursing mothers.
Adalat LA must not be used in cases of cardiogenic shock, clinically significant aortic stenosis, unstable angina pectoris, or during or within one month of a myocardial infarction.
4.4 Special warnings and precautions for use
Care must be exercised in patients with very low blood pressure (severe hypotension with systolic pressure less than 90 mm HG), in cases of manifest heart failure and in the case of severe aortic stenosis.
Nifedipine should not be used during pregnancy unless the clinical condition of the woman requires treatment with nifedipine. Nifedipine should be reserved for women with severe hypertension who are unresponsive to standard therapy (see section 4.6).
Nifedipine is not recommended for use during breastfeeding because nifedipine has been reported to be excreted in human milk and the effects of oral absorption of small amounts of nifedipine are not known (see section 4.6).
There are no safety and efficacy data from well-controlled studies in pregnant women (See Section 4.6).
Animal studies have shown a variety of embryotoxic, placentotoxic and fetotoxic effects (see Section 5.3) when administered during and after the period of organogenesis.
Whilst nifedipine is contra-indicated in pregnancy, particular care must be exercised when administering nifedipine in combination with i.v. magnesium sulphate to pregnant women.
Careful monitoring of blood pressure must be exercised, also when administered nifedipine with i.v. magnesium sulfate, owing to the possibility of an excessive fall in blood pressure which could harm both mother and fetus.
In single cases obstructive symptoms have been described without known history of gastrointestinal disorders.
Nifedipine is metabolised via the cytochrome P450 3A4 system. Drugs that are known to either inhibit or to induce this enzyme system may therefore alter the first pass or the clearance of nifedipine (See Section 4.5)
Drugs, which are inhibitors of the cytochrome P450 3 A4 system, and which may therefore lead to increased plasma concentrations of nifedipine include, for example:
-macrolide antibiotics (e.g., erythromycin)
-anti-HIV protease inhibitors (e.g., ritonavir)
-azole antimycotics (e.g., ketoconazole)
-the antidepressants, nefazodone and fluoxetine
-quinupristin/dalfopristin
-valproic acid
-cimetidine
Upon co-administration with these drugs, the blood pressure should be monitored and, if necessary, a reduction of the nifedipine dose should be considered.
For use in special populations see section 4.2.
4.5 Interaction with other medicinal products and other forms of interactions
Macrolide antibiotics (e.g., erythromycin):
No interaction studies have been carried out between nifedipine and macrolide antibiotics. Certain macrolide antibiotics are known to inhibit the cytochrome P450 3A4 mediated metabolism of other drugs. Therefore the potential for an increase of nifedipine plasma concentrations upon co-administration of both drugs cannot be excluded (see Section 4.4).
Anti-HIV protease inhibitors (e.g., ritonavir):
A clinical study investigating the potential of a drug interaction between nifedipine and certain anti-HIV protease inhibitors has not yet been performed. Drugs of this class are known to inhibit the cytochrome P450 3A4 system. In addition, dDrugs of this class have been shown to inhibit in vitro the cytochrome P450 3A4 mediated metabolism of nifedipine. When administered together with nifedipine, a substantial increase in plasma concentrations of nifedipine due to a decreased first pass metabolism and a decreased elimination cannot be excluded (see Section 4.4).
Azole anti-mycotics (e.g., ketoconazole):
A formal interaction study investigating the potential of a drug interaction between nifedipine and certain azole anti-mycotics has not yet been performed. Drugs of this class are known to inhibit the cytochrome P450 3A4 system. When administered orally together with nifedipine, a substantial increase in systemic bioavailability of nifedipine due to a decreased first pass metabolism cannot be excluded (see Section 4.4).
Fluoxetine:
A clinical study investigating the potential of a drug interaction between nifedipine and fluoxetine has not yet been performed. Fluoxetine has been shown to inhibit in vitro the cytochrome P450 3A4 mediated metabolism of nifedipine. Therefore an increase of nifedipine plasma concentrations upon co-administration of both drugs cannot be excluded (see Section 4.4).
Nefazodone:
A clinical study investigating the potential of a drug interaction between nifedipine and nefazodone has not yet been performed. Nefazodone is known to inhibit the cytochrome P450 3 A4 mediated metabolism of other drugs. Therefore an increase in nifedipine plasma concentrations upon co-administration of both drugs cannot be excluded (see Section 4.4).
Quinupristin/dalfopristin
Simultaneous administration of quinupristin / dalfopristin and nifedipine, may lead to increased plasma concentrations of nifedipine (see Section 4.4).
Valproic acid:
No formal studies have been performed to investigate the potential interaction between nifedipine and valproic acid. As valproic acid has been shown to increase the plasma concentrations of the structurally similar calcium channel blocker, nimodipine, due to enzyme inhibition, an increase in nifedipine plasma concentrations and hence an increase in efficacy cannot be excluded (see Section 4.4).
Effects of nifedipine on other drugs
Blood pressure lowering drugs
4.6 Fertility, pregnancy and lactation
Pregnancy
Adalat LA is contra-indicated during pregnancy.
Nifedipine should not be used during pregnancy unless the clinical condition of the woman requires treatment with nifedipine. Nifedipine should be reserved for women with severe hypertension who are unresponsive to standard therapy (see section 4.4).
The safety of Adalat LA for use in human pregnancy has not been established. Evaluation of experimental animal studies has shown reproductive toxicity consisting of embryotoxicity and teratogenic effects at maternally toxic doses.
There are no adequate and well controlled studies in pregnant women.
The available information is inadequate to rule out adverse drug effects on the unborn and newborn child.
In animal studies nifedipine has been shown to produce embryotoxicity, fetotoxicity and teratogenicity (see section 5.3).
From the clinical evidence available a specific prenatal risk has not been identified. Although an increase in perinatal asphyxia, caesarean delivery as well as prematurity and intrauterine growth retardation has been reported. It is unclear whether these reports are due to the underlying hypertension, its treatment or to a specific drug effect.
Breast-feedingLactation
Adalat Retard 20mg is contra-indicated in breastfeeding. Nifedipine passes into the breast milk. As there is no experience of possible effects on infants, breastfeeding should first be stopped if nifedipine treatment becomes necessary during the breastfeeding period.
Nifedipine is excreted in the breast milk. The nifedipine concentration in the milk is almost comparable with mother serum concentration. For immediate release formulations, it is proposed to delay breastfeeding or milk expression for 3 to 4 hours after drug administration to decrease the nifedipine exposure to the infant (see section 4.4).
In- vitro fertilisation
Fertility
4.8 Undesirable effects
System Organ Class (MedDRA) |
Common |
Uncommon |
Rare |
Not known |
Oedema (incl. peripheral oedema)
Vasodilation
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the online reporting option (preferred method) accessible from the IMB homepage (www.imb.ie). A downloadable report form is also accessible from the IMB website, which may be completed manually and submitted to the IMB via ‘freepost’ (see details below). Alternatively, the traditional post-paid ‘yellow card’ option may also be used.
Ireland
IMB Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.imb.ie
e-mail: imbpharmacovigilance@imb.ie
10. Date of Revision of the Text
February 2014
June 2012To be inserted upon approval
Updated on 10 March 2014 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change of contraindications
- Change to information about pregnancy or lactation
- Change to date of revision
- Addition of information on reporting a side effect.
Updated on 5 July 2012 SPC
Reasons for updating
- Change to paediatric information
- Change to section 4.2 - Posology and method of administration
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 5.1 has had paediatric information added.
The date of revision has been updated.
Updated on 4 July 2012 PIL
Reasons for updating
- Change to further information section
Updated on 20 June 2012 PIL
Reasons for updating
- Change to date of revision
- Change to dosage and administration
Updated on 12 January 2012 SPC
Reasons for updating
- Change to section 6.1 - List of excipients
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 12 September 2011 SPC
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 24 May 2011 PIL
Reasons for updating
- Change due to user-testing of patient information
Updated on 5 October 2009 PIL
Reasons for updating
- Change of manufacturer
- Change to date of revision
Updated on 22 June 2009 SPC
Reasons for updating
- Change to section 6.1 - List of excipients
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
- In section 6.1 ( List of Excipients ), Structure updated to include; Osmotic Blend, Orgainc Coating and Light Protective Coating; Macrogol 4000 was removed and replaced with Macrogol 3350, Iron oxide red ( E172) was removed and replaced with Ferric Oxide, red (E172).
- In section 10 (Date of Revision of Text) , November 2008 was removed and replaced with May 2009.
Updated on 22 December 2008 SPC
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 10 December 2008 PIL
Reasons for updating
- Change to information about pregnancy or lactation
- Change to date of revision
Updated on 4 December 2008 SPC
Reasons for updating
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 26 August 2008 SPC
Reasons for updating
- New SPC for medicines.ie
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 6 June 2008 PIL
Reasons for updating
- Change to marketing authorisation holder
- Change to date of revision
Updated on 31 August 2006 PIL
Reasons for updating
- Change to instructions about overdose
- Change to date of revision
Updated on 18 February 2005 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to date of revision
Updated on 31 January 2005 PIL
Reasons for updating
- Change of manufacturer
- Change to warnings or special precautions for use
- Change to side-effects
- Change to drug interactions
- Change to date of revision
Updated on 3 November 2004 PIL
Reasons for updating
- Change of active ingredient
- Change of manufacturer
- Change to warnings or special precautions for use
- Change to side-effects
- Change to drug interactions
- Change to date of revision
Updated on 28 July 2004 PIL
Reasons for updating
- New PIL for new product