ZOLVERA 40MG/5ML ORAL SOLUTION

Active substance: VERAPAMIL HYDROCHLORIDE

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Patient Information Leaflet

If you get any of the following side effects, see your doctor as soon as possible:
n swelling of your ankles
n swelling of your blood vessels which may show as pain in the fingers and toes and numbness
n stomach pain / discomfort
n muscle or joint pain
n shaking
n unusual body movements, particularly of your face, neck, eyes and jaw.
Tell your doctor if you get any of these side effects:
n breast development in older men or difficulty in getting an erection
n constipation
n flushing of your face
n ringing in the ears
n headaches, feeling dizzy or tired
n feeling sick (nausea) or being sick (vomiting)
n swollen and overgrown gums
n muscle weakness.
This medicine may also cause side effects in your liver and breasts that will only be detected through tests
performed by your doctor.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your
doctor or pharmacist.

Zolvera® 40mg/5ml Oral Solution
Verapamil Hydrochloride

Read all of this leaflet carefully before you start taking this medicine.
n Keep this leaflet. You may need to read it again.
n If you have any further questions, ask your doctor or pharmacist.
n This medicine has been prescribed for you. Do not pass

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5. How to store Zolvera
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Keep out of the reach and sight of children.
Do not store above 25°C.
Any unused medicine should be disposed of 3 months after you have opened it.
Do not use after the expiry date which is stated on the label and carton (Exp: month, year).
The expiry date refers to the last day of that month.
Do not use Zolvera if you notice a change in the appearance or smell of the medicine. Talk to your
pharmacist.
n Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how
to dispose of medicines no longer required. These measures will help to protect the environment.

6. Further information
What Zolvera contains
n The active ingredient is verapamil hydrochloride. Each 5ml of solution contains 40mg of verapamil
hydrochloride.
n The other ingredients are propylene glycol (E1520), benzoic acid (E210), liquid maltitol (E965), dill water
concentrate, liquorice flavour, citric acid monohydrate (E330), sodium citrate (E331) and purified water.
What Zolvera looks like and contents of the pack
A clear to slightly cloudy colourless liquid.
It comes in a brown glass bottle holding 150ml of solution.
Marketing Authorisation Holder and Manufacturer
Rosemont Pharmaceuticals Ltd, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE, UK.

it on to others. It may harm them, even if their symptoms
are the same as yours.
n If any of the side effects gets serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor or
pharmacist.

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In this leaflet:
1. What Zolvera is and what it is used for
2. Before you take Zolvera
3. How to take Zolvera
4. Possible side effects
5. How to store Zolvera
6. Further information

1. What Zolvera is and what it is used for
The name of your medicine is Zolvera. It contains verapamil hydrochloride. This belongs to a group of
medicines called calcium channel blockers. The heart muscle and the muscle in your blood vessel walls
need calcium to contract and tighten.
Zolvera stops calcium from getting into these muscles. This:
n relaxes your heart and blood vessels
n makes your heart pump out less blood every time it beats
n slows down your heart rate (pulse).
Zolvera can be used to:
n treat high blood pressure (hypertension)
n treat chest pain (angina)
n treat heart rhythm problems such as heart flutter (supraventricular tachycardia).

2. Before you take Zolvera
Do not take Zolvera and tell your doctor if:

n you are allergic (hypersensitive) to verapamil or any other ingredients in this liquid (listed in



Section 6). The signs of an allergic reaction include a rash, itching or shortness of breath



parts of your heart may beat at the wrong time causing it not to pump blood around the body very well



Lown-Ganong-Levine syndrome



This leaflet was last revised in 12/2013.



fitted with a pacemaker

n you have second- or third-degree atrioventricular block or sino-atrial block. This is a disorder where
n you have a heart beat disorder, such as sick sinus syndrome, Wolff-Parkinson-White syndrome or
n you have a problem where your heart beats very slowly (severe bradycardia), unless you have been
n you have an inherited blood disorder known as porphyria
n you have low blood pressure (hypotension)
n you have been given intravenous dantrolene.

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Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist
before taking this medicine.

You will not be given Zolvera if:

n you have a sudden and rapid fall in blood pressure (cardiogenic shock)
n you have heart failure that is not being treated
n you have a sudden heart attack, particularly if a slow heart beat, low blood pressure or a type of heart failure

called ‘left ventricular failure’.
You will not be given this medicine if any of the above apply to you. If you are not sure, talk to your doctor or
pharmacist before taking this medicine.



Continued overleaf

Take special care with Zolvera
Before you take Zolvera, tell your doctor if:
n you have liver or kidney problems
n you have an abnormally slow heart beat (bradycardia)
n you have first degree atrioventricular 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
n you have a nerve to muscle transmission disease, such as myasthenia gravis, Lambert-Eaton syndrome
or advanced Duchenne muscular dystrophy
n you are pregnant or breast feeding. See ‘Pregnancy and Breast-feeding’ section below.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist
before taking Zolvera.

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

Important information about what is in Zolvera
This medicine contains liquid maltitol. If your doctor has told you that you cannot tolerate some sugars, see your
doctor before taking this medicine.

3. How to take Zolvera
Take this medicine as your doctor or pharmacist has told you. Look on the label and ask the doctor or pharmacist
if you are not sure.

Taking this medicine

n this medicine contains 40mg of verapamil hydrochloride in

Having tests and operations while you are taking Zolvera

n your doctor will monitor your blood pressure regularly
n if you are having an anaesthetic, tell your doctor or dentist

that you are taking this medicine.

each 5ml.

n take this medicine by mouth.



Adults

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes
medicines you buy without a prescription, including herbal medicines. This is because Zolvera can affect the way
some other medicines work. Also, some medicines can affect the way Zolvera works.
You must not be given intravenous dantrolene (a medicine to relax muscles) at the same time as verapamil. If
you go to hospital, tell them you are taking verapamil (Zolvera).
In particular, tell your doctor if you are taking any of the following:
n digoxin or digitoxin, used for heart failure
n medicines used to lower blood pressure and treat abnormal heart rhythms, including quinidine,
flecainide, alpha-blockers (e.g. prazosin and terazosin) and beta-blockers (e.g. propranolol). If you are
going to be given a beta-blocker by injection, tell the doctor that you are taking Zolvera
n simvastatin, atorvastatin or lovastatin, used to lower cholesterol levels
n diuretics (water tablets)
n medicines used to treat depression, anxiety or psychosis. These may include imipramine, buspirone,
lithium or the herbal product St John’s Wort
n medicines used to treat epilepsy such as carbamazepine, phenytoin or phenobarbital glibenclamide, used to
treat certain types of diabetes
n midazolam, used to make you sleepy
n theophylline, used for asthma
n doxorubicin, used to treat cancer
n almotriptan, used to treat migraine
n aspirin, used to relieve pain and reduce fever
n cimetidine, used to treat stomach ulcers
n rifampicin, used to treat TB (tuberculosis)
n medicines used to treat infections such as ketoconazole, erythromycin, clarithromycin and telithromycin
n ritonavir, used to treat HIV
n medicines that are given after organ transplants to stop the body rejecting the organ such as
ciclosporin, everolimus, sirolimus and tacrolimus
n colchicine or sulfinpyrazone, used in the treatment of gout.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Zolvera.
n do not drink grapefruit juice whilst you are taking Zolvera. This is because grapefruit juice may

The usual dose for children is:
n up to 2 years of age: 20mg two or three times a day.
n 2 years of age and above: 40mg to 120mg three times a day.
n children under 3 months should not be given this medicine.

Older people

The dose will be the same as that for adults. If you have a kidney or liver problem, your doctor may lower your
dose.

If you take more Zolvera than you should

If you take more Zolvera than you should, talk to a doctor or go to a hospital straight away. Take the medicine
pack with you so the doctor knows what you have taken.

If you forget to take Zolvera

n if you forget a dose, take it as soon as you remember it. However, if it is nearly time for the next

dose, skip the missed dose.

n do not take a double dose (two doses at the same time) to make up for a forgotten dose.

If you stop taking Zolvera

Do not stop taking this medicine without talking to your doctor first. If you stop taking this medicine it may make
your condition worse.

4. Possible side effects

change the blood levels of your medicine.



Children

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

Taking Zolvera with food and drink


The usual dose is:
For high blood pressure
n take 120mg twice a day.
n your doctor may increase this to a maximum of 160mg twice a day.
For angina
n take 120mg three times a day.
n your doctor may lower this dose.
Heart Rhythm Disorders
n take 40mg to 120mg three times a day.

machines below).

n you should monitor the amount of alcohol you drink whilst taking Zolvera (see driving and using

Pregnancy and breast-feeding

Talk to your doctor before taking this medicine if you are pregnant, planning to become pregnant or are breastfeeding.
n you must only take this medicine in the first 3 months of pregnancy (1st trimester) if your doctor
thinks it is essential.
n you must only take this medicine when you are breast-feeding if your doctor thinks it is necessary.

Driving and using machines

When starting a new medicine, you may find that your ability to drive a car or use machinery can be impaired.
You should take care when driving, using machines or working under hazardous conditions until you know how
you react to this medicine.



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Like all medicines, Zolvera can cause side effects although not everybody gets them.
If you have any of the following, stop taking Zolvera and see a doctor straight away. You may need urgent
medical attention:
n If you have an allergic reaction to Zolvera.
The signs of an allergic reaction may include:
- any kind of skin rash, flaking skin, boils or sore lips and mouth
- sudden wheezing, fluttering or tightness of your chest or collapse
- swelling of your face, lips, tongue or throat or difficulty breathing or swallowing
- bruise like, red / purple patches on the skin and hair loss
n heart problems such as slow or fast heart beats, unusual heart beats, heart attack and heart failure. This is
more likely if you are taking high doses or you already have damage to your heart.

Continued overleaf

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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