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

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.

Updates to the following SmPC section:

Section 7- MA Holder

Section 8- Marketing Authorisation number

Section 10- Date of revision of the text

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

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

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 4.5

Change of text in 6^th 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

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 C_max 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:

29^th September 2003

Section 10

Text change:

Previous dates removed new date added 31^st march 2006