NIF-TEN 50mg/20mg Capsules

  • Name:

    NIF-TEN 50mg/20mg Capsules

  • Company:
    info
  • Active Ingredients:

    Atenolol, Nifedipine

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 25/09/20

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Summary of Product Characteristics last updated on medicines.ie: 25/9/2020

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AstraZeneca Pharmaceuticals (Ireland) DAC

AstraZeneca Pharmaceuticals (Ireland) DAC

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1 - 0 of 54 items.Total: Infinity pages

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 25 September 2020

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

Inserted Text; Deleted Text

4.4 Special warning and precautions for use

[..]

Lactose intolerance

Patients with rare hereditary problems of galactose intolerance, the Lapp total lactase deficiency or glucose-galactose malabsorption should not take this medicine. 

Sodium content

This medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially ‘sodium-free’.

 [..]

4.8 Undesirable effects

[..]

Reporting of suspected adverse reactions

[..]

HPRA Pharmacovigilance

Earlsfort Terrace

IRL - Dublin 2

Tel: +353 1 6764971

Fax: +353 1 6762517

Website: www.hpra.ie

e-mail:  medsafety@hpra.ie

[..]

10. Date of revision of the text

22nd September 2020

Updated on 25 September 2020 PIL

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 4 - how to report a side effect
  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

Inserted Text; Deleted Text

2. What you need to know before you take NIF-TEN

[..]

NIF-TEN contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially ‘sodium-free’.

[..]

4. Possible side effects

[..]

Reporting of side effects

[..]

HPRA Pharmacovigilance

Earlsfort Terrace

IRL - Dublin 2

Tel: +353 1 6764971

Fax: +353 1 6762517

Website: www.hpra.ie

e-mail:  medsafety@hpra.ie

[..]

6. Contents of the pack and other information

What NIF-TEN contains

[..]

  • The other ingredients are gelatin, red iron oxide (E172), lactose monohydrate, macrogol, heavy magnesium carbonate, magnesium stearate, maize starch, hypromellose, microcrystalline cellulose, polysorbate 80, sodium laurilsulfate and titanium dioxide (E171) and printing ink (ink 1 - titanium dioxide (E171), shellac or ink 2 – titanium dioxide (E171), shellac povidone). See section 2 ‘NIF-TEN contains lactose’ and ‘NIF-TEN contains sodium’ for more information.

[..]

This leaflet was last revised in October 2018 June 2020.

Updated on 14 January 2019 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - marketing authorisation number
  • Change to section 6 - date of revision

Updated on 11 January 2019

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

Updates to the following SmPC section:

Section 7- MA Holder

Section 8- Marketing Authorisation number

Section 10- Date of revision of the text

Updated on 13 January 2016

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 13 January 2016 SPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • 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

Section 4.2-     Editorial changes relating to latest QRD template

Section 4.8-     Addition of lupus-like syndrome to musculoskeletal and connective tissue disorders

Section 10 -     Update to Date of Revision

Updated on 12 January 2016 PIL

Reasons for updating

  • New PIL for new product

Updated on 12 January 2016 PIL

Reasons for updating

  • Change to side-effects
  • Change to date of revision
  • Change to improve clarity and readability

Updated on 14 July 2015 SPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.1 - Therapeutic indications
  • 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 - how to report a side effect
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.1 - List of excipients
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 9 - Date of renewal of authorisation
  • 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

Editorial changes to reflect Latest QRD for the following sections:
Section 2

 

Section4.1

Section4.2

Section4.3

Section4.4

Section4.5

Section4.6

Section4.7

Section4.8

Section4.9

Section5.1

Section6.1

Section6.4

Section6.6

Section9

Section10

Updated on 8 July 2015 PIL

Reasons for updating

  • Change to date of revision
  • Change to improve clarity and readability
  • Addition of information on reporting a side effect.
  • Improved electronic presentation

Updated on 2 April 2013 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 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 4.2 Reference to the lactose excipient included.
- Section 4.4 Lactose warning included.
- Section 10 Updated date of revision of text

Updated on 5 December 2012 PIL

Reasons for updating

  • Change to date of revision
  • Correction of spelling/typing errors

Updated on 16 October 2012 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 4.9 - Overdose
  • 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

Section 4.3

 

List of contraindications amended to include acute coronary syndromes and severe hepatic insufficiency.

 

Section 4.4

 

Updated to Special warnings and special precautions for use re atenolol, phaeochromocytoma  and anaesthetic agents,

 

Addition of information regarding doping tests and galactose intolerance, lactase deficiency or glucose-galactose malabsorption.

 

Update to information re obstructive airways disease.

 

Paragraph re vitro fertilisation deleted.

 

Section 4.5


Major amendments and updates to this section.

 

Section 4.6


Paragraph re in-vitro fertilisation added.

 

Section 4.8

 

Information re undesirable effects converted to table.

 

Section 4.9

 

Information re overdose updated.

 

Section 6.1

 

Information re printing ink updated.

 

Section 10

 

Date of revision updated to 8th October 2012.

Updated on 15 October 2012 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to side-effects
  • Change to drug interactions
  • Change to information about pregnancy or lactation
  • Change to further information section
  • Change to date of revision

Updated on 17 August 2009 SPC

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • 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

Section 4.5
New third paragraph:
"Class I anti-arrhythmic drugs (eg, disopyramide) and amiodarone may have a potentiating effect on atrial-conduction time and induce negative inotropic effect."

Section 6.1
Reformatted list of excipients
"

Granule

Maize starch

Heavy magnesium carbonate

Sodium laurilsulfate

Gelatin

Magnesium stearate

 

Tablet core

Microcrystalline cellulose

Maize starch

Lactose monohydrate

Polysorbate 80

Magnesium stearate

 

Tablet coating

Hypromellose

Macrogol 4000

Titanium dioxide (E171)

Iron oxide red (E172)

 

Capsule shell

Iron oxide red (E172)

Titanium dioxide (E171)

Gelatin

 

Printing ink

Shellac

Soya lecithin

Titanium dioxide (E171)

2-ethoxyethanol

                Dimethylpolysiloxane"

Section 10
31st July 2009

Updated on 11 August 2009 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to storage instructions

Updated on 19 September 2008 SPC

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • 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 4.5

Change of text in 6th paragraph

Original text: Caution must be exercised when prescribing a beta-blocker with Class 1 antiarrhythmic agents such as disopyramide.

Changed to:

Class I anti-arrhythmic drugs (eg, disopyramide) and amiodarone may have a potentiating effect on atrial-conduction time and induce negative inotropic effect.

 

Section 10
Date of revision of text: 29 August 2008

Updated on 19 September 2008 PIL

Reasons for updating

  • Change to drug interactions

Updated on 17 April 2007 PIL

Reasons for updating

  • Improved electronic presentation
  • Change to drug interactions
  • Change from the BAN of the active substance to the rINN

Updated on 16 April 2007 SPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • 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 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.1 - List of excipients
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 9 - Date of renewal of authorisation
  • 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

Text change:

Each capsule contains 50 mg atenolol and 20 mg nifedipine added and Atenolol 50mg , Nifedipine 20mg removed

Additional text added:

For excipients, see section 6.

 

Section 3

Additional text added:

Capsules, hard added

 

Section 4.2

Additional text added, last paragraph:

Renal Impairment

NIF-TEN should not be used in patients with marked renal impairment (see section 4.3).

 

Section 4.3

Additional text added(bold), first line in list:

Known hypersensitivity to either active component or any of the excipients.

 

Section 4.4

Additional text added (bold), second bullet point:

consequently the use of NIF-TEN may

 

Additional text added, ninth bullet point:

(epinephrine)

 

Section 4.5

Additional text added seventh paragraph:

(epinephrine)

 

Additional text added thirteenth paragraph:

Due to enzyme induction, rifampicin has been shown to decrease the nifedipine AUC and Cmax by 95% (288 ng.L/ml to 8 ng.L/ml and 154 ng/ml to 7.5 ng/ml respectively.  This may result in reduced efficacy, therefore co-administration of nifedipine with rifampicin is contraindicated (see section 4.3).

 

 

Section 4.8 

Additional text added(CNS):

dizziness, headache

Additional text added (Others)

fatigue

 

Section 4.9

Additional text added beginning of section:

Symptoms

The symptoms of overdosage may include bradycardia, hypotension, acute cardiac insufficiency and bronchospasm.

Treatment

General treatment should include: close supervision, treatment in an intensive care ward, the use of gastric lavage, activated charcoal as a laxative to prevent absorption of any drug still present in the gastrointestinal tract, the use of plasma or plasma substitutes to treat hypotension and shock. The possible use of haemodialysis or haemoperfusion may be considered.

 

Additional text added end of section:

or isoprenaline 10 to 25 micrograms given as an infusion at a rate not exceeding 5 micrograms/minute may be given, although larger doses may be required. Dobutamine, because of its positive inotropic effect could also be used to treat hypotension and acute cardiac insufficiency.  It is likely that these doses would be inadequate to reverse the cardiac effects of beta-blockade if a large overdose has been taken.  The dose of dobutamine should therefore be increased, if necessary, to achieve the required response according to the clinical condition of the patients.  In severe cases of hypotension, cardiac pacing with appropriate cardiac respiratory support may be necessary.  Bronchospasm can usually be reversed by bronchodilators.

 

 

Section 5.1

Additional text added beginning of section:

Beta-blocking agents and other antihypertensives

C07 FB

 

Section 6.1

Additional text added(bold):

Sodium laurilsulfate added and sodium Lauryl Sulphate removed

Lactose monohydrate

Hypromellose added and Methylhydroxypropylcellulose removed

 

Section 6.2

Text change:

None known changed to Not applicable

 

Section 6.4

Additional text added:

Store in the original package.  Keep the container in the outer carton.

 

Section 6.5

Foil/PVC removed and Additional text added:

PVC/PVDC/AL

 

Section 6.6

Text change:

None changed to No special requirements

 

Section 9

Additional text added:

29th September 2003

 

 

Section 10

Text change:

Previous dates removed new date added 31st march 2006

Updated on 10 August 2004 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 15 August 2003 SPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Product subject to medical prescription which may be renewed (B)