Verapamil 2.5 mg/ml Solution for injection – patient leaflet, side effects, dosage

1. What is Verapamil Injection and what is it used for

Verapamil Injection contains the active substance verapamil hydrochloride. Verapamil Injection belongs to a group of medicines called calcium channel blockers.

Verapamil Injection is used to treat abnormal heart rhythms such as an irregular or rapid heart rate in adults, and children aged 0 to 15 years.

2. What you need to know before you use Verapamil Injection

Do not take Verapamil Injection:

• If you are allergic to verapamil hydrochloride or any of the other ingredients of this medicine (listed in section 6).
• If you have had a heart attack with shock.
• If you had a heart attack, particularly if a slow heartbeat, low blood pressure or a type of heart failure called ‘left ventricular failure’.
• If you have an abnormally slow, fast or irregular heartbeat.
• If you have second- or third-degree atrioventricular block or sino-atrial block. This is a disorder where parts of your heart may beat at the wrong time causing it not to pump blood around the body very well (unless a permanent pacemaker is in place).
• If you have a problem where your heart beats very slowly (bradycardia), unless you have been fitted with a pacemaker.
• If you have suffered from heart problems such as heart failure, or the heart condition called Wolff-Parkinson-White syndrome.
• If you are currently being treated with ivabradine (for heart conditions).
• If you have very low blood pressure.
• If you are currently receiving intravenous beta-blockers, e.g. atenolol, propranolol.

Warnings and precautions

Talk to your doctor or nurse before using Verapamil Injection.

The following information is intended for healthcare

professionals only: Verapamil 2.5 mg/ml Solution for injection.

verapamil hydrochloride 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 Verapamil 2.5 mg/ml Solution for 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. 1. Trade Name of the Medicinal Product

Verapamil 2.5 mg/ml Solution for injection.

1. 2. Qualitative and Quantitative Composition

Verapamil Hydrochloride 2.5 mg/ml For the full list of excipients, see section 6.1.

1. 3. Pharmaceutical Form

Solution for injection.

1. 4. Clinical Particulars

4.1. Therapeutic Indications

Verapamil Injection 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: Verapamil Injection 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. 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); sino-atrial 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.

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.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/ yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

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 and acute respiratory distress syndrome. 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.

1. 7. Marketing Authorisation Holder

Viatris Products Limited,

Station Close,

Potters Bar,

EN6 1TL,

United Kingdom.

1. 8. Marketing Authorisation Number

PL 46302/0026

LEGAL CATEGORY: POM

This technical leaflet was last revised in October 2025.

Sodium:

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’. Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Driving and using machines

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

This medicine can affect the way the body gets rid of alcohol. This means that you may not have to drink as much for the blood alcohol levels to be above the legal limit to drive. It will also take you longer to sober up.

This is particularly important if you

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

3. How to use Verapamil Injection

Verapamil Injection 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.

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

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. Use in children and adolescents

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.

If you use more Verapamil Injection than you should

If you think you have been given too much of his medicine, talk to your doctor or nurse straight away. If you stop using Verapamil Injection

Your doctor or nurse will let you know when to stop having this medicine. You may need to stop having it gradually.

If you have any further questions on the use of this medicine, ask your doctor or nurse.

4. Possible side effects

Like all medicines, Verapamil Injection can cause side effects. Verapamil Injection 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 side effects tell your doctor IMMEDIATELY:

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

3

Verapamil hydrochloride 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. 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

Frequency Undesirable

Effects

Nervous

system

disorders

common - dizziness

• headache Cardiac

disorders/

vascular

disorders

common - bradycardia

• hypotension

uncommon - tachycardia

Gastrointestinal

disorders

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, 2nd and 3rd 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.

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

3

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 hydrochloride injection should be given as a slow intravenous injection over at least a two-minute period of time under continuous ECG and blood pressure monitoring. A small fraction of patients treated with verapamil hydrochloride respond with life-threatening adverse responses including (rapid ventricular rate (in atrial flutter/fibrillation in the presence of an accessory bypass tract), marked hypotension or extreme bradycardia/asystole).

Heart Block/ 1st Degree AV block/ Bradycardia/Asystole

Verapamil hydrochloride affects the AV and SA nodes and prolongs AV conduction time. Use with caution as development of second-or third-degree AV block (contraindication) or unifascicular, bifascicular

or trifascicular bundle branch block requires discontinuation in subsequent doses of verapamil hydrochloride and institution of appropriate therapy, if needed. Verapamil hydrochloride affects the AV and SA nodes and rarely may produce second- or third-degree AV block, bradycardia, and, in extreme cases, asystole. This is more likely to occur in patients with a sick sinus syndrome (SA nodal disease), which is more common in older patients. Asystole in patients other than those with sick sinus syndrome is usually

of short duration (few seconds or less), with spontaneous return to AV nodal or normal sinus rhythm. If this does not occur promptly, appropriate treatment should be initiated immediately. See Undesirable Effects Section.

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).

Sodium:

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’. 4.6. Fertility, Pregnancy and lactation

There are no adequate and well-controlled study data in pregnant women. Although animal studies have not shown any teratogenic effects (see section 5.3), 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.

2

11507830-02

• If you are pregnant, planning to

  become pregnant or breast-feeding.

• If you have liver or kidney problems.

  If you are currently receiving lipid lowering agents (e.g., simvastatin, atorvastatin or lovastatin).

• If you have a condition where the

  nerve to muscle transmission is affected e.g. myasthenia gravis, Lambert-Eaton syndrome, advanced Duchenne muscular dystrophy. Take special care with Verapamil Injection

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 Your doctor may perform ECGs and blood pressure monitoring prior to and during treatment to monitor your individual dose.

Other medicines and Verapamil Injection

Tell your doctor if you are taking, have recently taken or might take any other medicines.

• Beta-blockers such as atenolol,

  propranolol and metoprolol (used to treat high blood pressure and heart conditions)

• Alpha blockers such as prazosin and

  terazosin (used to treat high blood pressure and heart conditions)

• Medicines known as ‘statins’ such as

  atorvastatin, lovastatin, simvastatin (used to lower cholesterol levels)

• Quinidine, flecainide, disopyramide,

  digoxin and digitoxin (used to treat high blood pressure or an abnormal heart beat (arrhythmia))

• Dabigatran (medicine to prevent the

  formation of blood clots) and direct oral anticoagulants (DOACs)

• Ivabradine (used to treat certain

  heart diseases)

  • Medicines used to treat depression,

    anxiety or psychosis. These include the herbal product St John’s Wort or imipramine, buspirone and lithium

  • Medicines known as

    immunosuppressants such as cyclosporine, sirolimus, everolimus and tacrolimus (used to prevent organ transplant rejection)

  • Glyburide (Glibenclamide), medicine

    used to treat certain types of diabetes

  • Aspirin (a non-steroidal anti-

    inflammatory 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), medicines used as anti-convulsants

  • Ritonavir (used to treat HIV)

  • Erythromycin, clarithromycin and

    telithromycin (used to treat types of infection)

  • Colchicine or sulfinpyrazone (used to

    treat gout)

  • Metformin. Verapamil may decrease

    the glucose-lowering effect of metformin.

Verapamil Injection with drink and alcohol

• Do NOT drink grapefruit juice whilst

  taking Verapamil Injection as it can affect the absorption of this medicine. This does not occur with other fruit juices such as orange, apple or tomato juice.

• Before having Verapamil Injection,

  inform your doctor or nurse if you have recently had alcohol. This is because alcohol can affect how the medicine works.

₂ 11507830-02

• Unexpected wheezing, difficulty

  breathing, swelling of the mouth, lips or tongue, itching or a severe skin rash

• 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 Verapamil Injection, tell your doctor or nurse .

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 or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Verapamil Injection

Keep this medicine out of the sight and reach of children.

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. Contents of the pack and other information

What Verapamil Injection contains:

• The active substance is verapamil

  hydrochloride. Each ampoule of injection solution contains 2.5 mg per ml verapamil hydrochloride.

• The other ingredients are water for

  injections, sodium chloride, and hydrochloric acid as pH adjuster. What Verapamil Injection looks like and contents of the pack

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

Marketing Authorisation Holder:

Viatris Products Limited,

Station Close,

Potters Bar,

EN6 1TL,

United Kingdom.

Manufacturer:

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

Spain.

This leaflet was last revised in October 2025.

1

1

4

4

11507830-02

3915627 11507830-02

Date: Time:

30-AUG-2025 15:20