Section 2–        Changes relating to QRD update

Section 4.2 –    Changes relating to QRD update

Section 4.3 –    Changes relating to QRD update

Section 4.4 –    Changes relating to QRD update

Section 4.6 –    Changes relating to QRD update

Section 4.7 –    Changes relating to QRD update

Section 4.8 –    Changes relating to QRD update including ADR reporting and addition of side effect ‘lupus-like syndrome’

Section 5.1 –    Changes relating to QRD update

Section 6.1 –    Changes relating to inclusion of sub-headings

Section 6.6 –    Changes relating to QRD update

Section 9 –       Changes relating to QRD update

Section 10 –     Update to Date of Revision

-                      Section 4.1: Indication wording revised

-                      Section 4.2: Update on use in patients with renal, hepatic impairment and adolescents (<18 years). Wording updated to improve readability. 

-              Section 4.3: Contra-indications added: Severe renal impairment added. Minor update to wording known hypersensitivity to atenolol and chlortalidone.

-              Section 4.4: Update to warning and precautions including: patients with phaeochromocytoma, use with anaesthetic agents and ophthalmic beta-blockers, patients with bronchospastic disease, patients with diabetes and additional plasma electrolyte monitoring. Minor editorial changes.

-              Section 4.5: Update to include caution with anaesthetic agents and concomitant use of prostaglandin synthetase-inhibiting drugs, dihydropyridines and baclofen. Minor editorial changes.

-              Section 4.6: Changed the subject heading to Fertility, Pregnancy and Lactation.

-              Section 4.8: Reporting of suspect adverse reaction wording added.

-              Section 10: Amendment to revision date

Section 4.5

New additional text 3^rd paragraph:

Concomitant use of baclofen may increase the antihypertensive effect making dose adjustments necessary.

 

Section 4.8

Additional undesirable effect in section of Gastrointestinal disorders:

Not known: Constipation.

 

Section 10

Date of revision of text: 7 September 2010

Section 4.6

Deletion of text under heading Pregnancy:

Atenolol/chlortalidone is suspected to cause birth defects when administered during pregnancy. Tenoret 50 mg/12.5 mg Film-coated Tablets is contraindicated in pregnancy (see section 4.3)

Deletion of text under heading Lactation:

Atenolol is excreted in breast milk to such an extend that effects on the suckling child are likely if therapeutic doses of Tenoret 50 mg/12.5 mg Film-coated Tablets are administered to breast feeding women.

Section 4.7

Deletion of last sentence:

The medicinal product has no or negligible influence on these abilities.

Section 9

Change of renewal date to:

9th September 2007

Section 10

Change of date to:

19th August 2009

Section 4.5

Following text deleted:

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

And replaced by following new text:

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

 

 

Section 4.8

Undesirable effects now listed by body system with frequencies.

New text added:

The following undesirable effects, listed by body system, have been reported with the following frequencies: Very common (¡Ý10%), common (1-9.9%), uncommon (0.1-0.9%), rare (0.01-0-09%), very rare (<0.01%):

 

Undesirable effects now listed as shown below:

 

Blood and lymphatic system disorders:

Rare:             Purpura, thrombocytopenia, leucopenia (related to chlortalidone).

Psychiatric disorders:

Uncommon: Sleep disturbances of the type noted with other beta blockers.

Rare:    Mood changes, nightmares, confusion, psychoses and hallucinations.

Nervous system disorders:

Rare:             Dizziness, headache, paraesthesia.

Eye disorders:

Rare:    Dry eyes, visual disturbances.

Cardiac disorders:

Common:             Bradycardia

Rare:    Heart failure deterioration, precipitation of heart block.

Vascular disorders:

Common:             Cold extremities.

Rare:             Postural hypotension which may be associated with syncope, intermittent claudication may be increased if already present, in susceptible patients Raynaud¡¯s phenomenon.

Respiratory, thoracic and mediastinal disorders:

Rare:             Bronchospasm may occur in patients with bronchial asthma or a history of asthmatic complaints.

Gastrointestinal disorders:

Common:             Gastrointestinal disturbances (including nausea related to chlortalidone).

Rare:    Dry mouth.

Hepatobiliary disorders:

Rare:    Hepatic toxicity including intrahepatic cholestasis, pancreatitis (related to chlortalidone).

Skin and subcutaneous tissue disorders:

Rare:             Alopecia, psoriasiform skin reaction, exacerbation of psoriasis, skin rashes.

Reproductive system and breast disorders:

Rare:             Impotence.

General disorders and administration site conditions:

Common:             Fatigue.

Investigations:

Common:             Related to chlortalidone: Hyperuricaemia, hyponatraemia, hypokalaemia, impaired glucose tolerance.

Uncommon: Elevations of transaminase levels.

Very rare:             An increase in ANA (Antinuclear Antibodies) has been observed, however the clinical relevance of this is not clear.

 

 

Section 10

Date changed to 27^th November 2007

Section 1

• The name is now expressed as Tenoret 50 mg/12.5 mg Film‑coated Tablets.

Section 3

·        ‘White, biconvex, film-coated tablet imprinted with the name Tenoret 50 on one face.’ has been added.

Section 5.1

·        ‘Beta-blocking agents, selective and other diuretics. C07C B03.’ has been added.

·        Atenolol and Chlortalidone Pharmacodynamic properties are now listed separately.

 

Section 6.4

·        ‘Store in the original package’ and ‘Keep the blister in the outer carton’ have been added.

Section 6.6

·        ‘Use as directed by the prescriber’ has been replaced by ‘No special requirements’.

 

Section 9

• The date of Renewal has been updated.