Securon Iv

Document: leaflet MAH BRAND_PL 43900-0026 change

• Yellowing of the skin or eyes, a fever or tenderness around the middle. These are signs that your liver may not be functioning as well as usual

Other side effects with verapamil include flushing of the face or neck, sweating, headaches, tiredness, seizures, dizziness, vertigo, nervousness, movement disorders, abnormal discomfort, nausea, abdominal pain or vomiting.

Other side effects may sometimes occur with long-term verapamil treatment. Tell your doctor if you develop swollen gums which spread over your teeth, or (in males) if your breasts swell. These effects are very rare and resolve on stopping treatment.

If you experience any other unusual symptoms after you have received Securon IV, tell your doctor, nurse or pharmacist.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard By reporting side effects you can help provide more information on the safety of this medicine.

5. How should Securon IV be stored?

Do not store above 30°C and protect from light. The doctor or nurse will check that the expiry date on the label has not passed before you are given the injection. It should NOT be used after the expiry date printed on the label.

6. Further information about Securon IV

What Securon IV contains:

Each ampoule of injection solution contains 2.5 mg per ml verapamil hydrochloride in water for injections and sodium chloride, with hydrochloric acid as pH adjuster.

What Securon IV looks like:

The product is available in 2 ml ampoules, each containing 5 mg of verapamil hydrochloride.

This leaflet was last revised in July 2016.

=1 Abbott

Marketing Authorisation and Manufacturer’s Details

Marketing Authorisation Holder: BGP Products Ltd., Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire, SL6 4XE, United Kingdom. Manufacturer:

FAMAR HEALTHCARE SERVICES MADRIDSAU. Avda.de Legan.62 28923 Alcorc6n-Madrid, Spain.

Patient Information Leaflet

Securon® IV 2.5 mg/ml aqueous solution for intravenous injection

Verapamil Hydrochloride

IMPORTANT INFORMATION

Read all of this leaflet carefully

before you receive Securon IV

• Keep this leaflet as you may need to read it again

• This leaflet provides a summary of the information currently available on Securon IV

• For further information or advice ask your doctor or pharmacist

• Tell your doctor or pharmacist if you experience any side effects

Leaflet contents:

1. What is Securon IV and what is it used for?

2. What should you know before receiving Securon IV?

3. How will you receive Securon IV?

4. Possible side effects

5. How should Securon IV be stored?

6. Further information about Securon IV

1. What is Securon IV and what is it used for?

Securon IV belongs to a group of medicines called calcium channel blockers; its active ingredient is verapamil hydrochloride. Securon IV is used to treat abnormal heart rhythms such as an irregular or rapid heart rate.

2. What should you know before receiving Securon IV?_

If the answer to any of the following questions is ‘YES’ please tell your doctor or pharmacist BEFORE receiving Securon IV:

• Are you are sensitive (allergic) to the active ingredient verapamil hydrochloride or any of the other ingredients in the medicine? (See section 6)

• Are you pregnant, planning to become pregnant or breastfeeding?

• Do you have kidney problems?

• Do you have very low blood pressure?

• Do you have an abnormally slow, fast or irregular heartbeat?

• Do you have or have you ever suffered from heart problems such as heart failure, or the heart condition called Wolff-Parkinson-White syndrome?

• Are you currently receiving intravenous beta-blockers, e.g. atenolol, propranolol?

Gastrointestinal disorders: gingival hyperplasia may occur very rarely when the drug is administered over prolonged periods, and is fully reversible when the drug is discontinued. On rare occasions, vomiting has also been reported.

Skin and subcutaneous tissue disorders: Steven-Johnson syndrome, erythema and hyperhidrosis.

Reproductive system and breast disorders: On very rare occasions, gynaecomastia has been observed in elderly male patients under long-term verapamil treatment; this was fully reversible in all cases when the drug was discontinued.

Investigations: A reversible impairment of liver function characterized by an increase of transaminase and/or alkaline phosphatase may occur on very rare occasions during verapamil treatment and is most probably a hypersensitivity reaction.

4.9. Overdose

The symptoms of overdosage include hypotension, shock, loss of consciousness, first and second degree AV block (frequently as Wenckebach’s phenomenon with or without escape rhythms), total AV block with total AV dissociation, escape rhythm, asystole, bradycardia up to high degree AV block and, sinus arrest, hyperglycaemia, stupor and metabolic acidosis. Fatalities have occurred as a result of overdose.

Treatment of overdosage depends on the type and severity of symptoms. The specific antidote is calcium, e.g. 10-20 ml of 10% calcium gluconate solution i.v. (2.25-4.5 mmol) if necessary by repeated injection or continuous infusion (e.g. 5 mmol/hour). The usual emergency measures for acute cardiovascular collapse should be applied and followed by intensive care. Verapamil hydrochloride cannot be removed by haemodialysis. Similarly, in the case of second or third degree AV block, atropine, orciprenaline, isoprenaline and if required, pacemaker therapy should be considered. If there are signs of myocardial insufficiency, dopamine, dobutamine, cardiac glycosides or calcium gluconate (10-20 ml of a 10% solution) can be administered.

In the case of hypotension, after appropriately positioning the patient, dopamine, dobutamine or noradrenaline may be given.

6.4.Special Precautions for Storage

Do not store above 30°C. Protect from light.

7. Marketing Authorisation Holder

BGP Products Ltd.

Abbott House, Vanwall Business Park, Vanwall Road,

Maidenhead, Berkshire, SL6 4XE , UK.

8. Marketing Authorisation Number PL 43900/0026

LEGAL CATEGORY: POM

This technical leaflet was last revised in

February 2016. _

=1 Abbott

■

The following information is intended for healthcare professionals only:

Securon® IV 2.5 mg/ml aqueous solution for intravenous injection

Verapamil Hydrochloride BP

The following information is intended for healthcare professionals only:

This is an extract from the Summary of Product Characteristics (SmPC) to assist in the administration of Securon IV 2.5 mg/ml aqueous solution for intravenous injection.

The prescriber should be familiar with the full SmPC in order to determine the appropriateness of the use of the product in a particular patient. The full SmPC can be found on the electronic Medicines Compendium (eMC) website: http://www.medicines.org.uk/emc/. The Patient Information Leaflet provided (see other half of this leaflet) should be given to the patient.

1. Trade Name of the Medicinal Product

Securon IV

2. Qualitative and Quantitative Composition

Verapamil Hydrochloride BP 2.5 mg/ml

3. Pharmaceutical Form

Aqueous solution for intravenous injection.

4. Clinical Particulars

4.1. Therapeutic Indications

Securon IV is indicated for the treatment of paroxysmal supraventricular tachycardia and the reduction of ventricular rate in atrial flutter/fibrillation.

4.2. Posology and Method of Administration

For slow intravenous injection.

Adults: 5-10 mg by slow intravenous injection over a period of 2 minutes.

The patient should be observed continuously, preferably under ECG and blood pressure control. If necessary, e.g. in paroxysmal tachycardia, a further 5 mg may be given after 5 to 10 minutes.

Children: Securon IV must always be administered under ECG monitoring in young patients.

0- 1 year: 0.1-0.2 mg/kg bodyweight (usual single dose range: 0.75-2 mg).

1- 15 years: 0.1-0.3 mg/kg bodyweight (usual single dose range: 2-5 mg).

The dose may be repeated after 30 minutes if necessary. Many cases are controlled by doses at the lower end of the range. The injection should be stopped at the onset of the desired effect.

Elderly: The dosage should be administered over 3 minutes to minimise the risk of adverse effects.

Dosage in impaired liver and renal function: Significant hepatic and renal impairment should not increase the effects of a single intravenous dose but may prolong its duration of action.

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• Do you have a condition where the nerve to muscle transmission is affected e.g. myasthenia gravis, Lambert-Eaton syndrome, advanced Duchenne muscular dystrophy?

• Are you being treated with ivabradine (for heart condition)?

Your doctor will monitor you closely if:

• You have any other heart problems in addition to the one you are being treated for

• You need any other medication to treat your abnormal heart rhythm

• You need to be given an anaesthetic

You MUST tell your doctor if you are taking any medicines with or without a prescription or have recently taken any of the following medicines:

• Beta-blockers used to treat high blood pressure and heart conditions (these include atenolol, propranolol and metoprolol)

• Alpha blockers used to treat high blood pressure and heart conditions (these include prazosin and terazosin)

• Medicines Known as ‘statins’ such as atorvastatin, lovastatin, simvastatin used to lower cholesterol levels

• Any other medicine for high blood pressure or an abnormal heart beat (arrhythmia) such as quinidine, flecainide, disopyramide, digoxin and digitoxin

• Dabigatran (medicine to prevent the formation of blood clots)

• Medicines containing ivabradine for the treatment of certain heart diseases

• Medicines used to treat depression (including the herbal product St John’s Wort}, anxiety or psychosis. These may include imipramine, buspirone and lithium

• Medicines known as immunosuppressants such as ciclosporin, sirolimus, everolimus and tacrolimus. These are used to prevent organ transplant rejection

• Glibenclamide, used to treat certain types of diabetes

• Aspirin, a non-steroidal antiinflammatory painkiller (NSAID) used to relieve pain and reduce fever

• Almotriptan, used to treat migraine

• Midazolam, used as a sedative or anaesthetic

• Theophylline, used to treat asthma

• Cimetidine, used to treat indigestion or stomach ulcers

• Rifampicin, used to treat tuberculosis and other types of infection

• Carbamazepine, phenytoin or phenobarbital (phenobarbitone). These medicines are used as anticonvulsants

• Ritonavir, used to treat HIV

• Erythromycin, clarithromycin and telithromycin, used to treat types of infection

• Colchicines or sulfinpyrazone, used to treat gout

Driving and using machinery

Verapamil may affect your ability to drive or operate machinery, you MUST check with your doctor before you do so.

This is particularly important if you have had prolonged intravenous therapy or if you have switched to oral (tablet) treatment.

Pregnancy and breast feeding

Please discuss with your doctor if you are pregnant, planning to become pregnant or are breast feeding.

Other important information

Do NOT drink grapefruit juice whilst taking Securon IV as it can effect the absorption of this medicine. This does not occur with other fruit juices such as orange, apple or tomato juice.

3. How will you receive Securon IV?

Securon IV is given to you by injection into a vein (Intravenously). This will be carried out by a doctor.

The dose will vary according to your condition this will be decided by the doctor. The medical team in the hospital may monitor your blood pressure and ECG (The electrical activity of the heart) throughout your treatment. The usual doses are as follows

Adults:

5-10 mg by slow intravenous injection over a period of 2 minutes.

In elderly patients, the injection may be given at a slower rate.

If necessary, an extra 5 mg may be injected after 5 to 10 minutes.

Children:

0- 1 Year: 0.1 to 0.2 mg per kg bodyweight

1- 15 years: 0.1 to 0.3 mg per kg bodyweight

The injection may be repeated after 30 minutes, if necessary.

4. Possible side effects

As with all medicines, Securon IV can cause side effects. Securon IV affects the rhythm of the heart, but may also slow down the heart rate and cause a drop in blood pressure in some patients.

The medical team will therefore monitor you closely during your treatment.

If you experience any of the following rare side effects tell your doctor IMMEDIATELY:

• Changes in heart rhythm, chest pains for the first time or chest pains becoming frequent

• Swollen ankles

• Unexpected wheezing, difficulty breathing, swelling of the mouth, lips or tongue, itching or a severe skin rash

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For use with beta-blocker therapy, see ‘Contra-indications’ and ‘Special Warnings and Precautions for Use’.

4.3.Contra-indications

Hypersensitivity to the active substance or to any of the excipients.

Cardiogenic shock; acute myocardial infarction complicated by bradycardia, marked hypotension or left ventricular failure; second or third degree AV block (except in patients with a functioning artificial ventricular pacemaker); sinoatrial block; sick sinus syndrome (except in patients with a functioning artificial ventricular pacemaker); uncompensated heart failure; bradycardia of less than 50 beats/minute; hypotension of less than 90 mmHg systolic; simultaneous administration of intravenous beta-blockers.

Patients with atrial flutter/fibrillation in the presence of an accessory pathway (e.g. WPW syndrome) may develop increased conduction across the anomalous pathway and ventricular tachycardia may be precipitated.

Combination with ivabradine (see section Interactions with other medicinal products and other forms of interaction).

4.4.Special Warnings and Precautions for Use

Verapamil may affect impulse conduction. For this reason, Securon IV should be used with caution in patients with bradycardia or first degree AV block. Verapamil may affect left ventricular contractility; this effect is

small and normally not important but cardiac failure may be precipitated or aggravated. In patients with poor ventricular function, therefore, Securon IV should only be given after cardiac failure has been controlled with appropriate therapy, e.g. digitalis.

Although the pharmacokinetics of verapamil in patients with renal impairment are not affected, caution should be exercised and careful patient monitoring is recommended. Verapamil is not removed during dialysis.

Caution should be exercised in treatment with HMG CoA reductase inhibitors (e.g., simvastatin, atorvastatin or lovastatin) for patients taking verapamil. These patients should be started at the lowest possible dose of verapamil and titrated upwards. If verapamil treatment is to be added to patients already taking an HMG CoA reductase inhibitor (e.g., simvastatin, atorvastatin or lovastatin), refer to advice in the respective statin product information.

Use with caution in the presence of diseases in which neuromuscular transmission is affected (myasthenia gravis, Lambert-Eaton syndrome, advanced Duchenne muscular dystrophy)

4.6.Pregnancy and Lactation

Although animal studies have not shown any teratogenic effects, verapamil should not be given during the first trimester of pregnancy unless, in the clinician’s judgement, it is essential for the welfare of the patient. Verapamil crosses the placental barrier and can be detected in umbilical vein blood at delivery.

Also, verapamil is excreted in human breast milk. Limited human data from oral administration has shown that the infant relative dose of verapamil is low (0.1-1% of the mother’s oral dose) and that verapamil use may be compatible with breastfeeding. However, there are currently no reports of verapamil injection or infusion use during breastfeeding. Due to the potential for serious adverse reactions in nursing infants, verapamil should only be used during lactation if it is essential for the welfare of the mother.

4.8.Undesirable Effects

Adverse events observed in clinical trials are depicted in the following table. Within each system organ class, the adverse drug reactions are ranked under headings of frequency, using the following convention: common (>1/100, <1/10), uncommon (>1/1,000, <1/100), rare (>1/10,000, <1/1,000), very rare (<1/10,000), including isolated reports.

System Organ Class

Nervous system disorder

Undesirable

Effects

Cardiac disorders/ vascular disorders

common - dizziness

- headache

common - bradycardia

- hypotension uncommon - tachycardia

System Organ Class

Gastrointestinal disorders

Frequency Undesirable Effec

uncommon - nausea

- abdominal pain

Cases of seizures during verapamil hydrochloride injection have been reported.

In rare cases of hypersensitivity, bronchospasm accompanied by pruritis and urticaria has been reported.

Other Reactions from Postmarketing Surveillance or Phase IV Clinical Trials

Other adverse events reported with verapamil are listed below by system organ class:

Psychiatric disorders: on rare occasions, nervousness has been reported.

Nervous system disorders: somnolence and extrapyramidal syndrome.

Ear and labyrinth disorders: vertigo.

Cardiac disorders/vascular disorders: decreased myocardial contractility has been reported. On rare occasions, 2^ndand 3^rd block may occur and in extreme cases, this may lead to asystole. The asystole is usually of short duration and cardiac action returns spontaneously after a few seconds, usually in the form of sinus rhythm. If necessary, the procedures for the treatment of overdosage should be followed as described below. On rare occasions, flushing has been reported.

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