Patient leaflet - Voltarol suppositories 50 mg
1. What Voltarol Suppositories are and what they are used for
Diclofenac sodium, the active ingredient in Voltarol Suppositories, is one of a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs reduce pain and inflammation.
Voltarol Suppositories relieve pain, reduce
swelling and ease inflammation in conditions affecting the joints, muscles and tendons including:
Rheumatoid arthritis, osteoarthritis, acute
gout, ankylosing spondylitis
Backache, sprains and strains, soft
tissue sports injuries, frozen shoulder, dislocations and fractures
- Tendonitis, tenosynovitis, bursitis.
They are also used to treat pain and
inflammation associated with dental and minor surgery.
In children aged 1 to 12 Voltarol
Suppositories 12.5 and 25 mg are used to treat juvenile chronic arthritis.
In children aged over 6 they can also be
used alone, or in combination with other painkillers, for the short term treatment of any pain experienced after an operation.
2. What you need to know before you use Voltarol Suppositories Some people MUST NOT use Voltarol Suppositories. Talk to your doctor if:
you think you may be allergic to diclofenac
sodium, aspirin, ibuprofen or any other
NSAID, or to any of the other ingredients of Voltarol Suppositories. (These are listed at the end of the leaflet.) Signs of a hypersensitivity reaction include swelling of the face and mouth (angioedema), breathing problems, chest pain, runny nose, skin rash or any other allergic type reaction
you have now, or have ever had, a stomach
(gastric) or duodenal (peptic) ulcer, or bleeding in the digestive tract (this can include blood in vomit, bleeding when emptying bowels, fresh blood in faeces or black, tarry faeces)
you have had stomach or bowel problems
after you have taken other NSAIDs
- you have heart, kidney or liver failure
if you have established heart disease and/
or cerebrovascular disease e.g. if you have had a heart attack, stroke, mini-stroke (TIA) or blockages to blood vessels to the heart or brain or an operation to clear or bypass blockages
if you have or have had problems with your
blood circulation (peripheral arterial disease)
- you are more than six months pregnant
you suffer from ineffectual straining to empty
the bowels, diarrhoea or rectal bleeding You should also ask yourself these questions before using Voltarol Suppositories:
Do you suffer from any stomach or bowel
disorders including ulcerative colitis or Crohn’s disease?
Do you have kidney or liver problems, or are
you elderly?
- Do you have a condition called porphyria?
Do you suffer from any blood or bleeding
disorder? If you do, your doctor may ask you
to go for regular check-ups while you are using these suppositories.
- Have you ever had asthma?
- Are you breast-feeding?
Do you have angina, blood clots, high blood
pressure, abnormally high levels of fat in your blood (raised cholesterol or raised triglycerides)?
Do you have heart problems, or have you
had a stroke, or do you think you might be at risk of these conditions (for example, if you have high blood pressure, diabetes or high cholesterol or are a smoker)?
- Do you have diabetes?
- Do you smoke?
Do you have Lupus (SLE) or any similar
condition?
If the answer to any of these questions is YES, discuss your treatment with your doctor or pharmacist because Voltarol Suppositories might not be the right medicine for you.
Are you taking other medicines?
Some medicines can interfere with your treatment. Tell your doctor or pharmacist if you are taking any of the following:
- Medicines to treat diabetes
Anticoagulants (blood thinning tablets like
warfarin)
- Diuretics (water tablets)
Lithium (used to treat some mental
problems)
Methotrexate (for some inflammatory
diseases and some cancers)
Ciclosporin and tacrolimus (used to treat
some inflammatory diseases and after transplants)
Trimethoprim (a medicine used to prevent or
treat urinary tract infections)
- Quinolone antibiotics (for infections)
Any other NSAID or COX-2 (cyclo-
oxgenase-2) inhibitor, for example aspirin or ibuprofen
Mifepristone (a medicine used to terminate
pregnancy)
Cardiac glycosides (for example digoxin),
used to treat heart problems
Medicines known as SSRIs used to treat
depression
- Oral steroids (an anti-inflammatory drug)
Medicines used to treat heart conditions
or high blood pressure, for example beta-blockers or ACE inhibitors.
Voriconazole (a medicine used to treat fungal
infections).
Phenytoin (a medicine used to treat
seizures)
Colestipol/cholestyramine (used to lower
cholesterol)
Always tell your doctor or pharmacist about all the medicines you are taking. This means medicines you have bought yourself as well as medicines on prescription from your doctor.
Pregnancy, breast-feeding and fertility
Do not use Voltarol Suppositories if you
are in the last 3 months of pregnancy as it could harm your unborn child or cause problems at delivery. It can cause kidney and heart problems in your unborn baby. It may affect your and your baby’s tendency to bleed and cause labour to be later or longer than expected. You should not use Voltarol Suppositories during the first 6 months
of pregnancy unless absolutely necessary and advised by your doctor. If you need treatment during this period or while you are trying to get pregnant, the lowest dose for the shortest time possible should be used. If used for more than a few days from 20 weeks of pregnancy onward, Voltarol Suppositories can cause kidney problems in your unborn baby that may lead to low levels of amniotic fluid that surrounds the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the heart of the baby. If you need treatment for longer than a few days, your doctor may recommend additional monitoring.
Are you trying for a baby? Using Voltarol
Suppositories may make it more difficult to conceive. You should talk to your doctor if you are planning to become pregnant, or if you have problems getting pregnant.
Will there be any problems with driving or using machinery?
Very occasionally people have reported that Voltarol Suppositories have made them feel dizzy, tired or sleepy. Problems with eyesight have also been reported. If you are affected in this way, you should not drive or operate machinery.
Other special warnings
You should take the lowest dose of Voltarol
for the shortest possible time, particularly if you are underweight or elderly.
There is a small increased risk of heart
attack or stroke when you are taking any medicine like Voltarol. The risk is higher if you are taking high doses for a long time.
Always follow the doctor’s instructions on how much to take and how long to take it for.
If at any time while taking Voltarol you
experience any signs or symptoms of problems with your heart or blood vessels such as chest pain, shortness of breath, weakness, or slurring of speech, contact your doctor immediately.
Whilst you are taking these medicines your
doctor may want to give you a check-up from time to time.
If you have a history of stomach problems
when you are taking NSAIDs, particularly if you are elderly, you must tell your doctor straight away if you notice any unusual symptoms.
If you have ever developed a severe skin
rash or skin peeling, blistering and/or mouth sores after taking Voltarol Suppositories or other pain medications.
Because it is an anti-inflammatory medicine,
Voltarol may reduce the symptoms of infection, for example, headache and high temperature. If you feel unwell and need to see a doctor, remember to tell him or her that you are taking Voltarol.
VOLTAROL Suppositories 50 mg and
100 mg are not suitable for children.
- VOLTAROL Suppositories 12.5 mg are not used for adults.
Tell your doctor if you recently had or you are going to have a surgery of the stomach or intestinal tract before using Voltarol Suppositories, as Voltarol Suppositories can sometimes worsen wound healing in your gut after surgery.
Information about sodium content
This medicine contains less than 1mmol sodium (23mg) per suppository, that is to say essentially ‘sodium free’.
3. How to use Voltarol Suppositories
The doctor will tell you how to use Voltarol Suppositories. Always follow his/her instructions carefully. The dose will be on the pharmacist’s label. Check the label carefully. If you are not sure, ask your doctor or pharmacist. Keep using the suppositories for as long as you have been told, unless you have any problems. In that case, check with your doctor.
Suppositories are designed for insertion into the back passage (rectum). Never take them by mouth.
The doctor may also prescribe another drug to protect the stomach to be taken at the same time, particularly if you have had stomach problems before, or if you are elderly, or taking certain other drugs as well.
Adults
Voltarol Suppositories are normally inserted one, two or three times a day up to a maximum total daily dose of 150mg. The number of suppositories you need will depend on the strength which the doctor has given you.
Elderly
Your doctor may advise you to take a dose that is lower than the usual adult dose if you are elderly. Your doctor may also want to check closely that the Voltarol Suppositories are not affecting your stomach, particularly during the first 4 weeks that you are using the suppositories. 300150168 GB (60)
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Technical approval by Packaging Site not using OneArt: electronic or handwritten signature. (If handwritten, it must be legible, include the approver’s full name and date of approval) Children
For the treatment of chronic juvenile arthritis in
children aged 1 to 12:
Doses vary with age, but are usually between
1 and 3 mg/kg body weight every day divided into
2 or 3 doses.
For the treatment of post-operative pain in children
aged 6 and over:
Doses vary with age, but are usually between
1 and 2 mg/kg body weight per day divided into
2 or 3 doses for no more than 4 days.
Your child’s doctor will work out the dose that is
suitable for your child and will tell you how many
Voltarol Suppositories to use and how often.
Follow his/her instructions carefully. If you are not
sure about the dose, check with your doctor or
pharmacist.
How to insert the suppositories
Empty your bowels before inserting
a suppository.
- Wash your hands.
Take out the strip of suppositories and tear off
one along the perforation.
Then take the suppository out of the plastic
wrapping by pulling back the loose end.
Lie on one side with your knees pulled up
towards your chest.
Gently push the suppository pointed end
first into your back passage (rectum) with your finger. Push the suppository in as far as possible as shown in the diagram.
Lower your legs and, if possible, stay still for
a few minutes.
If you feel as if you need to push the suppository
out, try to resist this by lying still with your buttocks pressed together. It is important to keep the suppository in the rectum to allow it to melt and the medicine to be absorbed. Pushing the suppository high into the rectum with your finger will help to reduce this feeling.
- Wash your hands.
The procedure is the same for a child. Once they have emptied their bowels, get them to lie down on their front or side. Gently push the suppository into the child’s back passage until it disappears. Try and stop the child moving around for a few minutes to reduce the risk of the suppository coming out. What if you forget to take a dose?
If you forget to use a suppository, do not worry. Use one as soon as you remember. If it is nearly time for your next dose though, just take the next dose and forget about the one you missed. Do not double up the next dose to make up for the one you missed. Do not insert 2 suppositories at the same time. The total dose should not be
more than 150 mg each day if you are an adult. Children should not take more than the dose that is prescribed by their doctor.
What if you use too many suppositories?
You should not take more than 150 mg in one day if you are an adult. Children should not take more than the dose that is prescribed by their doctor. If you accidentally use too many suppositories or use them too often, tell your doctor or go to your nearest casualty department straight away.
4. Possible side effects
Voltarol Suppositories are suitable for most people, but, like all medicines, they can sometimes cause side effects. Side effects may be minimised by using the lowest effective dose for the shortest duration necessary.
Some side effects can be serious
Stop using the suppositories and tell your doctor straight away if you notice:
Sudden and crushing chest pain (signs of
myocardial infarction or heart attack)
Breathlessness, difficulty breathing when lying
down, swelling of the feet or legs (signs of heart failure)
Sudden weakness or numbness in the face,
arm or leg especially on one side of the body; sudden loss or disturbance of vision; sudden difficulty in speaking or ability to understand speech; sudden migraine-like headaches which happen for the first time, with or without disturbed vision. These symptoms can be an early sign of a stroke
Stomach pain, indigestion, heartburn, wind,
nausea (feeling sick) or vomiting (being sick)
Any sign of bleeding in the stomach or intestine,
for example, when emptying your bowels, blood in vomit or black, tarry faeces
Allergic reactions which can include skin rash,
itching, bruising, painful red areas, peeling or blistering
A serious allergic skin reaction which may
include large widespread red and/or dark patches, swelling of the skin, blisters, and itching (signs of Generalised bullous fixed drug eruption)
- Wheezing or shortness of breath (bronchospasm)
- Swollen face, lips, hands or fingers
- Yellowing of your skin or the whites of your eyes
- Persistent sore throat or high temperature
An unexpected change in the amount of urine
produced and/or its appearance.
Mild cramping and tenderness of the abdomen,
starting shortly after the start of the treatment with Voltarol Suppositories and followed by rectal bleeding or bloody diarrhoea usually within 24 hours of the onset of abdominal pain.
Chest pain, which can be a sign of a potentially
serious allergic reaction called Kounis syndrome. If you notice that you are bruising more easily than usual or have frequent sore throats or infections, tell your doctor.
Voltarol Suppositories may also occasionally cause itching or burning in your back passage or make any haemorrhoids (piles) worse.
The side effects listed below have also been reported.
Common side effects (These may affect between 1 and 10 in every 100 patients):
Stomach pain, heartburn , nausea, vomiting,
diarrhoea, indigestion, wind, loss of appetite
- Headache, dizziness, vertigo
- Skin rash or spots
- Raised levels of liver enzymes in the blood
- Irritation where the suppository is inserted
Uncommon side effects (these may affect between 1 and 10 in every 1000 patients):
Fast or irregular heart beat (palpitations), chest
pain, heart disorders, including heart attack or breathlessness, difficulty breathing when lying down, or swelling of the feet or legs (signs of heart failure), especially if you have been taking a higher dose (150 mg per day) for a long period of time.
Rare side effects (These may affect between 1 in every 1000 to 1 in every 10,000 patients):
Stomach ulcers or bleeding (there have been
very rare reported cases resulting in death, particularly in the elderly)
Gastritis (inflammation, irritation or swelling of
the stomach lining)
- Vomiting blood
Diarrhoea with blood in it or bleeding from the
back passage
- Black, tarry faeces or stools
- Drowsiness, tiredness
- Skin rash and itching
Fluid retention, symptoms of which include
swollen ankles
Liver function disorders, including hepatitis and
jaundice
Asthma (symptoms may include wheezing,
breathlessness, coughing and a tightness across the chest).
Very rare side effects (These may affect less than 1 in every 10,000 patients):
Effects on the nervous system:
Inflammation of the lining of the brain (meningitis), tingling or numbness in the fingers, tremor, visual disturbances such as blurred or double vision, taste changes, hearing loss or impairment, tinnitus (ringing in the ears), sleeplessness, nightmares, mood changes, depression, anxiety, irritability, mental disorders, disorientation and loss of memory, fits, headaches together with a dislike of bright lights, fever and a stiff neck.
Effects on the stomach and digestive system: Constipation, inflammation of the tongue, mouth ulcers, inflammation of the inside of the mouth or lips, lower gut disorders (including inflammation of the colon, or worsening of ulcerative colitis or Crohn’s disease), inflammation of the pancreas.
Effects on the chest or blood:
Hypertension (high blood pressure), hypotension (low blood pressure, symptoms of which may include faintness, giddiness or light headedness), inflammation of blood vessels (vasculitis), inflammation of the lung (pneumonitis), blood disorders (including anaemia).
Effects on the liver or kidneys:
Kidney or severe liver disorders including liver failure, presence of blood or protein in the urine. Effects on skin or hair:
Facial swelling, serious skin rashes including Stevens-Johnson syndrome, Lyell’s syndrome and other skin rashes which may be made worse by exposure to sunlight.
Hair loss.
Effects on the reproductive system:
Impotence.
Other side effects that have also been reported with unknown frequency include:
Throat disorders, confusion, hallucinations,
malaise (general feeling of discomfort), inflammation of the nerves in the eye, disturbances of sensation
An allergic skin reaction, that may include
round or oval patches of redness and swelling of the skin, blistering, and itching (Fixed drug eruption). Darkening of the skin in affected areas, which may persist after healing, may also occur. Fixed drug eruption usually reoccurs at the same site(s) if the medication is taken again.
Do not be alarmed by this list - most people use Voltarol Suppositories without any problems. Reporting of side effects
If you get any side effects, talk your doctor or pharmacist. 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 Voltarol Suppositories
Do not store above 30°C.
Keep this medicine out of the sight and reach of children.
Do not use the suppositories after the expiry date which is printed on the outside of the pack. If your doctor tells you to stop using them, please take any unused suppositories back to your
pharmacist to be destroyed. Do not throw them away with your normal household water or waste. This will help to protect the environment.
6. Contents of the pack and other information What Voltarol Suppositories contain
Each suppository contains either 12.5,
25, 50 or 100 mg of the active ingredient, diclofenac sodium.
- The other excipient is hard wax, a fatty suppository base.
What Voltarol Suppositories look like and the contents of the pack
The suppositories are white to yellowish, torpedo-shaped, with smooth or slightly rough surfaces. They come in foil packs of 10.
Marketing Authorisation Holder and Manufacturer
Novartis Pharmaceuticals UK Limited, 2nd Floor, The WestWorks Building, White City Place,
195 Wood Lane,
London,
W12 7FQ
United Kingdom.
This leaflet was last revised in September 2025.
If you would like any more information, or would like the leaflet in a different format, please contact Medical Information at Novartis Pharmaceuticals UK Ltd, telephone number
VOLTAROL is a registered trade mark
Copyright Novartis Pharmaceuticals UK Limited
300150168 GB