When a pharmaceutical company changes an SPC or PIL, 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.
New additional text 4th paragraph:
Concomitant use of baclofen may increase the antihypertensive effect making dose adjustments necessary.
Additional undesirable effect in section of Gastrointestinal disorders:
Not known: Constipation.
Section 10
Date of revision of text: 7 September 2010
Addition of text:
Each film-coated tablet contains atenolol 100mg and Chlortalidone 25 mg
Addition of last sentence:
The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.
Addition of text to first bullet point:
- Known hypersensitivity to either component or any of the excipients
Deletion of text under heading Pregnancy:
Atenolol/chlortalidone is suspected to cause birth defects when administered during pregnancy. Tenoretic 100 mg/25 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 Tenoretic 100 mg/25 mg Film-coated Tablets are administered to breast feeding women.
Deletion of last sentence:
The medicinal product has no or negligible influence on these abilities.
Change to shelf life:
4 years
Change of renewal date to:
9th September 2007
Change of date to: 19th August 2009
New text added 3rd paragraph:
Although contraindicated in severe peripheral arterial circulatory disturbances (see section 4.3 - Contraindications), Tenoretic 100 mg/25 mg Film-coated Tablets may also aggravate less severe peripheral arterial circulatory disturbances.
New text added 5th paragraph:
Tenoretic 100 mg/25 mg Film-coated Tablets may cause a more severe reaction to a variety of allergens, when given to patients with a history of anaphylactic reaction to such allergens. Such patients may be unresponsive to the usual doses of adrenaline (epinephrine) used to treat the allergic reactions.
Following text deleted:
Care should be taken in prescribing a beta-blocking drug with Class 1 antidysrhythmic 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.
Tenoretic 100 mg/25 mg Film-coated Tablets may aggravate peripheral arterial circulatory disorders.
Patients with a history of anaphylactic reaction to a variety of allergens may be unresponsive to the usual doses of adrenaline (epinephrine) used to treat the allergic reactions.
Section 4.6
Sentence did read:
Like all other drugs, Tenoretic 100 mg/25 mg Film-coated Tablets should not be given in pregnancy or during lactation unless its use is essential.
Sentence now reads:
Tenoretic 100 mg/25 mg Film-coated Tablets should not be given in pregnancy or during lactation
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 4.9
Excessive bradycardia can be countered with atropine 1-2 mg intravenously. If necessary, this may be followed by a bolus dose of glucagon 10 mg intravenously. If required, this may be repeated or followed by an intravenous infusion of glucagon 1-10 mg/hour depending on response. If no response to glucagon occurs, or if glucagon is unavailable, a beta-blocking stimulant such as dobutamine 2.5 to 10 micrograms/kg/minute by intravenous infusion 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.
There is a possibility of hypotension occurring following the use of beta-blocking agonists, but this will be reduced by the use of the more selective agent dobutamine.
Excessive diuresis may be countered by maintaining normal fluid and electrolyte balance.
The symptoms of overdosage may include bradycardia, hypotension, acute cardiac insufficiency and bronchospasm.
General treatment should include: close supervision, treatment in an intensive care ward, the use of gastric lavage, activated charcoal and 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.
Excessive bradycardia can be countered with atropine 1‑2 mg intravenously and/or a cardiac pacemaker. If necessary, this may be followed by a bolus dose of glucagon 10 mg intravenously. If required, this may be repeated or followed by an intravenous infusion of glucagon 1‑10 mg/hour depending on response. If no response to glucagon occurs or if glucagon is unavailable, a beta‑adrenoceptor stimulant such as dobutamine 2.5 to 10 micrograms/kg/minute by intravenous infusion may be given. Dobutamine, because of its positive inotropic effects could 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 patient.
Bronchospasm can usually be reversed by bronchodilators.
Excessive diuresis should be countered by maintaining normal fluid and electrolyte balance
Sections 1, 4.1, 4.2, 4.4, 4.5, 4.6, 4.7, 4.8, 5.1, 5.2- Name change to Tenoretic 100mg/25mg Film-coated Tablets
Section 4.5. Addition of word “epinephrine”
Section 4.5. Addition of word “norepinephrine”
Section 10. Change to the date of the revision of the text.